guillaume duthoit hôpital pitié-salpêtrière, paris ... · hta 65% diabète 18% coronaropathie...
TRANSCRIPT
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Formateur pour Saint Jude Medicaltrade
Ablations par radiofreacutequence - Velocityreg
Orateur pour la Journeacutee de Broca 011014
Boston Scientific - Watchmannreg
Epideacutemiologie
gt 6106 Europeacuteens
x 2 dans 50 ans
gt750 000 franccedilais fibrillent
Sous-estimation (FA silencieuse)
Preacutevalence
1-2 population geacuteneacuterale
lt05 de 40-50 ans
10 des gt 80 ans 18 des ge 85 ans
Un individu sur 4 preacutesentera un eacutepisode de FA apregraves 40 anshellip
Furberg CD Am J Cardiol 1994
Feinberg Arch Intern Med 1995
Et cela va continuerhellip
x1000 x1000
Autres Dysthyroiumldies Obeacutesiteacute BPCO SAS IRC Congeacutenitaux
Valves 30 des
FA
HTA 65
Diabegravete 18
Coronaropathie
FA Insuffisance Cardiaque
30 des FA
FA chez 13 IC
Cause 1 AVC sur 5
AVC 10
Nieuwlaat EHJ 2006263018
AJ Camm et al Eur Heart J 2010
Guidelines for the management of atrial fibrillation
AJ Camm et al Eur Heart J 2010
Rocircle de reacuteservoir en rythme sinusal
Seacutecreacutetion Peptide Natriureacutetique Atrial
Reacutegulation de la voleacutemiepreacutecharge
Pas de retentissement de lrsquoexclusion drsquoapregraves eacutetudes chirurgicales apregraves conservation auricule Dt (auparavant reacutetention hydro-sodeacutee)
Rocircle meacutecanique mineur de lrsquoOG
dans le maintien du deacutebit cardiaque en RS
Lorsque la synchronisation OD-VD est respecteacutee et que la diastole VG eacutegalement
Williams J Thorac Cardiovasc Surg 198080373-80 JL Cox J Thorac Cardiovasc Surg 20131461018-27
Williams J Thorac Cardiovasc Surg 198080373-80 JL Cox J Thorac Cardiovasc Surg 20131461018-27
LA isolation procedure
Triade de Virchow Leacutesion endotheacuteliumendocarde (+inflammation
fibrose)
Stase sanguine (basses vitesses auriculaires)
Alteacuteration de lrsquoheacutemostase fonction plaquettaire fibrinolyse Contraste spontaneacute
Thrombus
Parce que Peu utile voire dangereux gt 75 ans surtout en FA
Risque annuel AVC gt 4
Les techniques chirurgicales Laissent souvent un deacutefect 34 dans LAOOStudy
Healey Am Heart J 2005150288ndash293
Impliquent une chirurgie cardiaque concomitante en particulier pour le sujet gt75 ans
Reacuteduisent les AVC postopeacuteratoires lt1 peacuteriopeacuteratoire
Cox JL J Thorac Cardiovasc Surg 1999118833-40 Contre 32 (Pontages) 28 (Valve) 67 (Pontage+valve)
Salazar Ann Thorac Surg 2001721195-201
Risque thrombo-embolique et heacutemorragique plus eacuteleveacutes
Comorbiditeacutes plus freacutequentes Plus sensibles aux effets pro-arythmiques des
AAR
Pour controcircle du rythme
Alteacuteration des fonctions reacutenale et heacutepatique
Risque thrombo-embolique et heacutemorragique plus eacuteleveacutes
Plus vieux que ds les eacutetudes randomiseacuteeshellip (dont lrsquoablation de FA)
Plus de dysfonction sinusale (MRA) Plus drsquoIC diastolique donc plus de sensibibiliteacute agrave
la perte de systole atriale Plus de co-morbiditeacutes Attention au mode drsquoeacutelimination
Des anti-arythmiques effet pro-arythmique Des anticoagulants (dabigatran et IR ++) Adapter les doses eacuteviter les associations ou sous surveillance
stricte ECG (Dysf sinusale PR QT)
Santangeli JCE 201223(7)687-93
Wind Sock Chicken Wing Broccoli
Maximum LAA
Ostium (mm)
Device Size (mm) (uncompressed
diameter)
17-19 21
20-22 24
23-25 27
26-28 30
29-31 33
bull Choix sur base du diamegravetre maxi aG
bull gt17mm ou lt31mm
bull Longueur aG ge diamegravetre de lrsquoostium
Double Curve
Single Curve
Transseptal Access System
bull Double Single Anterior Curves
bull 14F OD (47 mm) 12F ID
bull 75 cm working length
Preformed curve shapes guide position in LAA
WATCHMANreg LAA Closure System Components
Mi
VG
aG
Accegraves vasculaire Epanchement peacutericardique Embolie gazeuse Deacuteplacement de prothegravese
PLAATO
Sievert Circulation 20021051887ndash1889
CI aux AVK n=64
98 fermeture (flux lt3mm)
AVCAIT agrave 5 ans = 38an contre 66an attendus selon CHADSsup2
Randomized study of WATCHMAN LAA Device vs Long-term Warfarin Therapy CHADSsup2 ge 1
21 allocation ratio device to control N=707 (intervention 463 control 244) Intention to treat non inferiority trial
59 Enrolling Centers (US amp Europe) Follow-up Requirements
TEE follow-up at 45 days 6 months and 1 year Clinical follow-up biannually up to 5 years Regular INR monitoring while taking warfarin
Enrollment continues in Continued Access Registry
D Holmes Lancet 2009 374 534ndash42
PROTECT AF D Holmes Lancet 2009 374 534ndash42 PREVAIL D Holmes J Am Coll Cardiol 2014641ndash12
88 de succegraves drsquoimplantation (ITT) 45j 86 arrecirct de warfarine 6 mois 92 arrecirct warfarine
Suivi moyen = 18 mois Primary EP AVC Deacutecegraves CV embolie systeacutemique
Safety EP Saignement majeur eacutepanchement peacutericardique migration de prothegravese
3 vs 49pt-y 102 vs 68 at 2 y
D Holmes Lancet 2009 374 534ndash42
Age moyen 72 ans
2621 ptanneacutee critegravere de supeacuterioriteacute RR 060 pour DC cardioV AVC embolie
systeacutemique
Diminution mortaliteacute toutes causes hazard ratio = 066 95 CI 045ndash098 P=0038
Beacuteneacutefice supeacuterieur Score HAS-BLED eacuteleveacute
gt75 ans
Diabegravete
Preacutevention IIaire AVC Reddy VY Long term results of PROTECT AF Heart Rhythm Society Scientific Sessions May 8ndash112013 Denver CO Reddy VY Circulation 2011123417ndash424
39 patients opeacutereacutes dans un centre deacutebutant lrsquoactiviteacute drsquoocclusion
Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212 Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212
Expeacuterience opeacuterateurs Formation
07
08
09
10
0 365 730 1095
Intent-to-Treat
Hemorrhagic Stroke
ITT cohort Superiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 53 12
463 275 95 23
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort (no) pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 1 4167 02 4 2247 18 013 0998 0986 pt-yr (00 09) (05 39) (000 080)
900 1 5936 02 6 3194 19 009 gt0999 0998 pt-yr (00 06) (07 37) (000 045)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Formateur pour Saint Jude Medicaltrade
Ablations par radiofreacutequence - Velocityreg
Orateur pour la Journeacutee de Broca 011014
Boston Scientific - Watchmannreg
Epideacutemiologie
gt 6106 Europeacuteens
x 2 dans 50 ans
gt750 000 franccedilais fibrillent
Sous-estimation (FA silencieuse)
Preacutevalence
1-2 population geacuteneacuterale
lt05 de 40-50 ans
10 des gt 80 ans 18 des ge 85 ans
Un individu sur 4 preacutesentera un eacutepisode de FA apregraves 40 anshellip
Furberg CD Am J Cardiol 1994
Feinberg Arch Intern Med 1995
Et cela va continuerhellip
x1000 x1000
Autres Dysthyroiumldies Obeacutesiteacute BPCO SAS IRC Congeacutenitaux
Valves 30 des
FA
HTA 65
Diabegravete 18
Coronaropathie
FA Insuffisance Cardiaque
30 des FA
FA chez 13 IC
Cause 1 AVC sur 5
AVC 10
Nieuwlaat EHJ 2006263018
AJ Camm et al Eur Heart J 2010
Guidelines for the management of atrial fibrillation
AJ Camm et al Eur Heart J 2010
Rocircle de reacuteservoir en rythme sinusal
Seacutecreacutetion Peptide Natriureacutetique Atrial
Reacutegulation de la voleacutemiepreacutecharge
Pas de retentissement de lrsquoexclusion drsquoapregraves eacutetudes chirurgicales apregraves conservation auricule Dt (auparavant reacutetention hydro-sodeacutee)
Rocircle meacutecanique mineur de lrsquoOG
dans le maintien du deacutebit cardiaque en RS
Lorsque la synchronisation OD-VD est respecteacutee et que la diastole VG eacutegalement
Williams J Thorac Cardiovasc Surg 198080373-80 JL Cox J Thorac Cardiovasc Surg 20131461018-27
Williams J Thorac Cardiovasc Surg 198080373-80 JL Cox J Thorac Cardiovasc Surg 20131461018-27
LA isolation procedure
Triade de Virchow Leacutesion endotheacuteliumendocarde (+inflammation
fibrose)
Stase sanguine (basses vitesses auriculaires)
Alteacuteration de lrsquoheacutemostase fonction plaquettaire fibrinolyse Contraste spontaneacute
Thrombus
Parce que Peu utile voire dangereux gt 75 ans surtout en FA
Risque annuel AVC gt 4
Les techniques chirurgicales Laissent souvent un deacutefect 34 dans LAOOStudy
Healey Am Heart J 2005150288ndash293
Impliquent une chirurgie cardiaque concomitante en particulier pour le sujet gt75 ans
Reacuteduisent les AVC postopeacuteratoires lt1 peacuteriopeacuteratoire
Cox JL J Thorac Cardiovasc Surg 1999118833-40 Contre 32 (Pontages) 28 (Valve) 67 (Pontage+valve)
Salazar Ann Thorac Surg 2001721195-201
Risque thrombo-embolique et heacutemorragique plus eacuteleveacutes
Comorbiditeacutes plus freacutequentes Plus sensibles aux effets pro-arythmiques des
AAR
Pour controcircle du rythme
Alteacuteration des fonctions reacutenale et heacutepatique
Risque thrombo-embolique et heacutemorragique plus eacuteleveacutes
Plus vieux que ds les eacutetudes randomiseacuteeshellip (dont lrsquoablation de FA)
Plus de dysfonction sinusale (MRA) Plus drsquoIC diastolique donc plus de sensibibiliteacute agrave
la perte de systole atriale Plus de co-morbiditeacutes Attention au mode drsquoeacutelimination
Des anti-arythmiques effet pro-arythmique Des anticoagulants (dabigatran et IR ++) Adapter les doses eacuteviter les associations ou sous surveillance
stricte ECG (Dysf sinusale PR QT)
Santangeli JCE 201223(7)687-93
Wind Sock Chicken Wing Broccoli
Maximum LAA
Ostium (mm)
Device Size (mm) (uncompressed
diameter)
17-19 21
20-22 24
23-25 27
26-28 30
29-31 33
bull Choix sur base du diamegravetre maxi aG
bull gt17mm ou lt31mm
bull Longueur aG ge diamegravetre de lrsquoostium
Double Curve
Single Curve
Transseptal Access System
bull Double Single Anterior Curves
bull 14F OD (47 mm) 12F ID
bull 75 cm working length
Preformed curve shapes guide position in LAA
WATCHMANreg LAA Closure System Components
Mi
VG
aG
Accegraves vasculaire Epanchement peacutericardique Embolie gazeuse Deacuteplacement de prothegravese
PLAATO
Sievert Circulation 20021051887ndash1889
CI aux AVK n=64
98 fermeture (flux lt3mm)
AVCAIT agrave 5 ans = 38an contre 66an attendus selon CHADSsup2
Randomized study of WATCHMAN LAA Device vs Long-term Warfarin Therapy CHADSsup2 ge 1
21 allocation ratio device to control N=707 (intervention 463 control 244) Intention to treat non inferiority trial
59 Enrolling Centers (US amp Europe) Follow-up Requirements
TEE follow-up at 45 days 6 months and 1 year Clinical follow-up biannually up to 5 years Regular INR monitoring while taking warfarin
Enrollment continues in Continued Access Registry
D Holmes Lancet 2009 374 534ndash42
PROTECT AF D Holmes Lancet 2009 374 534ndash42 PREVAIL D Holmes J Am Coll Cardiol 2014641ndash12
88 de succegraves drsquoimplantation (ITT) 45j 86 arrecirct de warfarine 6 mois 92 arrecirct warfarine
Suivi moyen = 18 mois Primary EP AVC Deacutecegraves CV embolie systeacutemique
Safety EP Saignement majeur eacutepanchement peacutericardique migration de prothegravese
3 vs 49pt-y 102 vs 68 at 2 y
D Holmes Lancet 2009 374 534ndash42
Age moyen 72 ans
2621 ptanneacutee critegravere de supeacuterioriteacute RR 060 pour DC cardioV AVC embolie
systeacutemique
Diminution mortaliteacute toutes causes hazard ratio = 066 95 CI 045ndash098 P=0038
Beacuteneacutefice supeacuterieur Score HAS-BLED eacuteleveacute
gt75 ans
Diabegravete
Preacutevention IIaire AVC Reddy VY Long term results of PROTECT AF Heart Rhythm Society Scientific Sessions May 8ndash112013 Denver CO Reddy VY Circulation 2011123417ndash424
39 patients opeacutereacutes dans un centre deacutebutant lrsquoactiviteacute drsquoocclusion
Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212 Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212
Expeacuterience opeacuterateurs Formation
07
08
09
10
0 365 730 1095
Intent-to-Treat
Hemorrhagic Stroke
ITT cohort Superiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 53 12
463 275 95 23
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort (no) pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 1 4167 02 4 2247 18 013 0998 0986 pt-yr (00 09) (05 39) (000 080)
900 1 5936 02 6 3194 19 009 gt0999 0998 pt-yr (00 06) (07 37) (000 045)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Epideacutemiologie
gt 6106 Europeacuteens
x 2 dans 50 ans
gt750 000 franccedilais fibrillent
Sous-estimation (FA silencieuse)
Preacutevalence
1-2 population geacuteneacuterale
lt05 de 40-50 ans
10 des gt 80 ans 18 des ge 85 ans
Un individu sur 4 preacutesentera un eacutepisode de FA apregraves 40 anshellip
Furberg CD Am J Cardiol 1994
Feinberg Arch Intern Med 1995
Et cela va continuerhellip
x1000 x1000
Autres Dysthyroiumldies Obeacutesiteacute BPCO SAS IRC Congeacutenitaux
Valves 30 des
FA
HTA 65
Diabegravete 18
Coronaropathie
FA Insuffisance Cardiaque
30 des FA
FA chez 13 IC
Cause 1 AVC sur 5
AVC 10
Nieuwlaat EHJ 2006263018
AJ Camm et al Eur Heart J 2010
Guidelines for the management of atrial fibrillation
AJ Camm et al Eur Heart J 2010
Rocircle de reacuteservoir en rythme sinusal
Seacutecreacutetion Peptide Natriureacutetique Atrial
Reacutegulation de la voleacutemiepreacutecharge
Pas de retentissement de lrsquoexclusion drsquoapregraves eacutetudes chirurgicales apregraves conservation auricule Dt (auparavant reacutetention hydro-sodeacutee)
Rocircle meacutecanique mineur de lrsquoOG
dans le maintien du deacutebit cardiaque en RS
Lorsque la synchronisation OD-VD est respecteacutee et que la diastole VG eacutegalement
Williams J Thorac Cardiovasc Surg 198080373-80 JL Cox J Thorac Cardiovasc Surg 20131461018-27
Williams J Thorac Cardiovasc Surg 198080373-80 JL Cox J Thorac Cardiovasc Surg 20131461018-27
LA isolation procedure
Triade de Virchow Leacutesion endotheacuteliumendocarde (+inflammation
fibrose)
Stase sanguine (basses vitesses auriculaires)
Alteacuteration de lrsquoheacutemostase fonction plaquettaire fibrinolyse Contraste spontaneacute
Thrombus
Parce que Peu utile voire dangereux gt 75 ans surtout en FA
Risque annuel AVC gt 4
Les techniques chirurgicales Laissent souvent un deacutefect 34 dans LAOOStudy
Healey Am Heart J 2005150288ndash293
Impliquent une chirurgie cardiaque concomitante en particulier pour le sujet gt75 ans
Reacuteduisent les AVC postopeacuteratoires lt1 peacuteriopeacuteratoire
Cox JL J Thorac Cardiovasc Surg 1999118833-40 Contre 32 (Pontages) 28 (Valve) 67 (Pontage+valve)
Salazar Ann Thorac Surg 2001721195-201
Risque thrombo-embolique et heacutemorragique plus eacuteleveacutes
Comorbiditeacutes plus freacutequentes Plus sensibles aux effets pro-arythmiques des
AAR
Pour controcircle du rythme
Alteacuteration des fonctions reacutenale et heacutepatique
Risque thrombo-embolique et heacutemorragique plus eacuteleveacutes
Plus vieux que ds les eacutetudes randomiseacuteeshellip (dont lrsquoablation de FA)
Plus de dysfonction sinusale (MRA) Plus drsquoIC diastolique donc plus de sensibibiliteacute agrave
la perte de systole atriale Plus de co-morbiditeacutes Attention au mode drsquoeacutelimination
Des anti-arythmiques effet pro-arythmique Des anticoagulants (dabigatran et IR ++) Adapter les doses eacuteviter les associations ou sous surveillance
stricte ECG (Dysf sinusale PR QT)
Santangeli JCE 201223(7)687-93
Wind Sock Chicken Wing Broccoli
Maximum LAA
Ostium (mm)
Device Size (mm) (uncompressed
diameter)
17-19 21
20-22 24
23-25 27
26-28 30
29-31 33
bull Choix sur base du diamegravetre maxi aG
bull gt17mm ou lt31mm
bull Longueur aG ge diamegravetre de lrsquoostium
Double Curve
Single Curve
Transseptal Access System
bull Double Single Anterior Curves
bull 14F OD (47 mm) 12F ID
bull 75 cm working length
Preformed curve shapes guide position in LAA
WATCHMANreg LAA Closure System Components
Mi
VG
aG
Accegraves vasculaire Epanchement peacutericardique Embolie gazeuse Deacuteplacement de prothegravese
PLAATO
Sievert Circulation 20021051887ndash1889
CI aux AVK n=64
98 fermeture (flux lt3mm)
AVCAIT agrave 5 ans = 38an contre 66an attendus selon CHADSsup2
Randomized study of WATCHMAN LAA Device vs Long-term Warfarin Therapy CHADSsup2 ge 1
21 allocation ratio device to control N=707 (intervention 463 control 244) Intention to treat non inferiority trial
59 Enrolling Centers (US amp Europe) Follow-up Requirements
TEE follow-up at 45 days 6 months and 1 year Clinical follow-up biannually up to 5 years Regular INR monitoring while taking warfarin
Enrollment continues in Continued Access Registry
D Holmes Lancet 2009 374 534ndash42
PROTECT AF D Holmes Lancet 2009 374 534ndash42 PREVAIL D Holmes J Am Coll Cardiol 2014641ndash12
88 de succegraves drsquoimplantation (ITT) 45j 86 arrecirct de warfarine 6 mois 92 arrecirct warfarine
Suivi moyen = 18 mois Primary EP AVC Deacutecegraves CV embolie systeacutemique
Safety EP Saignement majeur eacutepanchement peacutericardique migration de prothegravese
3 vs 49pt-y 102 vs 68 at 2 y
D Holmes Lancet 2009 374 534ndash42
Age moyen 72 ans
2621 ptanneacutee critegravere de supeacuterioriteacute RR 060 pour DC cardioV AVC embolie
systeacutemique
Diminution mortaliteacute toutes causes hazard ratio = 066 95 CI 045ndash098 P=0038
Beacuteneacutefice supeacuterieur Score HAS-BLED eacuteleveacute
gt75 ans
Diabegravete
Preacutevention IIaire AVC Reddy VY Long term results of PROTECT AF Heart Rhythm Society Scientific Sessions May 8ndash112013 Denver CO Reddy VY Circulation 2011123417ndash424
39 patients opeacutereacutes dans un centre deacutebutant lrsquoactiviteacute drsquoocclusion
Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212 Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212
Expeacuterience opeacuterateurs Formation
07
08
09
10
0 365 730 1095
Intent-to-Treat
Hemorrhagic Stroke
ITT cohort Superiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 53 12
463 275 95 23
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort (no) pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 1 4167 02 4 2247 18 013 0998 0986 pt-yr (00 09) (05 39) (000 080)
900 1 5936 02 6 3194 19 009 gt0999 0998 pt-yr (00 06) (07 37) (000 045)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Feinberg Arch Intern Med 1995
Et cela va continuerhellip
x1000 x1000
Autres Dysthyroiumldies Obeacutesiteacute BPCO SAS IRC Congeacutenitaux
Valves 30 des
FA
HTA 65
Diabegravete 18
Coronaropathie
FA Insuffisance Cardiaque
30 des FA
FA chez 13 IC
Cause 1 AVC sur 5
AVC 10
Nieuwlaat EHJ 2006263018
AJ Camm et al Eur Heart J 2010
Guidelines for the management of atrial fibrillation
AJ Camm et al Eur Heart J 2010
Rocircle de reacuteservoir en rythme sinusal
Seacutecreacutetion Peptide Natriureacutetique Atrial
Reacutegulation de la voleacutemiepreacutecharge
Pas de retentissement de lrsquoexclusion drsquoapregraves eacutetudes chirurgicales apregraves conservation auricule Dt (auparavant reacutetention hydro-sodeacutee)
Rocircle meacutecanique mineur de lrsquoOG
dans le maintien du deacutebit cardiaque en RS
Lorsque la synchronisation OD-VD est respecteacutee et que la diastole VG eacutegalement
Williams J Thorac Cardiovasc Surg 198080373-80 JL Cox J Thorac Cardiovasc Surg 20131461018-27
Williams J Thorac Cardiovasc Surg 198080373-80 JL Cox J Thorac Cardiovasc Surg 20131461018-27
LA isolation procedure
Triade de Virchow Leacutesion endotheacuteliumendocarde (+inflammation
fibrose)
Stase sanguine (basses vitesses auriculaires)
Alteacuteration de lrsquoheacutemostase fonction plaquettaire fibrinolyse Contraste spontaneacute
Thrombus
Parce que Peu utile voire dangereux gt 75 ans surtout en FA
Risque annuel AVC gt 4
Les techniques chirurgicales Laissent souvent un deacutefect 34 dans LAOOStudy
Healey Am Heart J 2005150288ndash293
Impliquent une chirurgie cardiaque concomitante en particulier pour le sujet gt75 ans
Reacuteduisent les AVC postopeacuteratoires lt1 peacuteriopeacuteratoire
Cox JL J Thorac Cardiovasc Surg 1999118833-40 Contre 32 (Pontages) 28 (Valve) 67 (Pontage+valve)
Salazar Ann Thorac Surg 2001721195-201
Risque thrombo-embolique et heacutemorragique plus eacuteleveacutes
Comorbiditeacutes plus freacutequentes Plus sensibles aux effets pro-arythmiques des
AAR
Pour controcircle du rythme
Alteacuteration des fonctions reacutenale et heacutepatique
Risque thrombo-embolique et heacutemorragique plus eacuteleveacutes
Plus vieux que ds les eacutetudes randomiseacuteeshellip (dont lrsquoablation de FA)
Plus de dysfonction sinusale (MRA) Plus drsquoIC diastolique donc plus de sensibibiliteacute agrave
la perte de systole atriale Plus de co-morbiditeacutes Attention au mode drsquoeacutelimination
Des anti-arythmiques effet pro-arythmique Des anticoagulants (dabigatran et IR ++) Adapter les doses eacuteviter les associations ou sous surveillance
stricte ECG (Dysf sinusale PR QT)
Santangeli JCE 201223(7)687-93
Wind Sock Chicken Wing Broccoli
Maximum LAA
Ostium (mm)
Device Size (mm) (uncompressed
diameter)
17-19 21
20-22 24
23-25 27
26-28 30
29-31 33
bull Choix sur base du diamegravetre maxi aG
bull gt17mm ou lt31mm
bull Longueur aG ge diamegravetre de lrsquoostium
Double Curve
Single Curve
Transseptal Access System
bull Double Single Anterior Curves
bull 14F OD (47 mm) 12F ID
bull 75 cm working length
Preformed curve shapes guide position in LAA
WATCHMANreg LAA Closure System Components
Mi
VG
aG
Accegraves vasculaire Epanchement peacutericardique Embolie gazeuse Deacuteplacement de prothegravese
PLAATO
Sievert Circulation 20021051887ndash1889
CI aux AVK n=64
98 fermeture (flux lt3mm)
AVCAIT agrave 5 ans = 38an contre 66an attendus selon CHADSsup2
Randomized study of WATCHMAN LAA Device vs Long-term Warfarin Therapy CHADSsup2 ge 1
21 allocation ratio device to control N=707 (intervention 463 control 244) Intention to treat non inferiority trial
59 Enrolling Centers (US amp Europe) Follow-up Requirements
TEE follow-up at 45 days 6 months and 1 year Clinical follow-up biannually up to 5 years Regular INR monitoring while taking warfarin
Enrollment continues in Continued Access Registry
D Holmes Lancet 2009 374 534ndash42
PROTECT AF D Holmes Lancet 2009 374 534ndash42 PREVAIL D Holmes J Am Coll Cardiol 2014641ndash12
88 de succegraves drsquoimplantation (ITT) 45j 86 arrecirct de warfarine 6 mois 92 arrecirct warfarine
Suivi moyen = 18 mois Primary EP AVC Deacutecegraves CV embolie systeacutemique
Safety EP Saignement majeur eacutepanchement peacutericardique migration de prothegravese
3 vs 49pt-y 102 vs 68 at 2 y
D Holmes Lancet 2009 374 534ndash42
Age moyen 72 ans
2621 ptanneacutee critegravere de supeacuterioriteacute RR 060 pour DC cardioV AVC embolie
systeacutemique
Diminution mortaliteacute toutes causes hazard ratio = 066 95 CI 045ndash098 P=0038
Beacuteneacutefice supeacuterieur Score HAS-BLED eacuteleveacute
gt75 ans
Diabegravete
Preacutevention IIaire AVC Reddy VY Long term results of PROTECT AF Heart Rhythm Society Scientific Sessions May 8ndash112013 Denver CO Reddy VY Circulation 2011123417ndash424
39 patients opeacutereacutes dans un centre deacutebutant lrsquoactiviteacute drsquoocclusion
Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212 Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212
Expeacuterience opeacuterateurs Formation
07
08
09
10
0 365 730 1095
Intent-to-Treat
Hemorrhagic Stroke
ITT cohort Superiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 53 12
463 275 95 23
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort (no) pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 1 4167 02 4 2247 18 013 0998 0986 pt-yr (00 09) (05 39) (000 080)
900 1 5936 02 6 3194 19 009 gt0999 0998 pt-yr (00 06) (07 37) (000 045)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Autres Dysthyroiumldies Obeacutesiteacute BPCO SAS IRC Congeacutenitaux
Valves 30 des
FA
HTA 65
Diabegravete 18
Coronaropathie
FA Insuffisance Cardiaque
30 des FA
FA chez 13 IC
Cause 1 AVC sur 5
AVC 10
Nieuwlaat EHJ 2006263018
AJ Camm et al Eur Heart J 2010
Guidelines for the management of atrial fibrillation
AJ Camm et al Eur Heart J 2010
Rocircle de reacuteservoir en rythme sinusal
Seacutecreacutetion Peptide Natriureacutetique Atrial
Reacutegulation de la voleacutemiepreacutecharge
Pas de retentissement de lrsquoexclusion drsquoapregraves eacutetudes chirurgicales apregraves conservation auricule Dt (auparavant reacutetention hydro-sodeacutee)
Rocircle meacutecanique mineur de lrsquoOG
dans le maintien du deacutebit cardiaque en RS
Lorsque la synchronisation OD-VD est respecteacutee et que la diastole VG eacutegalement
Williams J Thorac Cardiovasc Surg 198080373-80 JL Cox J Thorac Cardiovasc Surg 20131461018-27
Williams J Thorac Cardiovasc Surg 198080373-80 JL Cox J Thorac Cardiovasc Surg 20131461018-27
LA isolation procedure
Triade de Virchow Leacutesion endotheacuteliumendocarde (+inflammation
fibrose)
Stase sanguine (basses vitesses auriculaires)
Alteacuteration de lrsquoheacutemostase fonction plaquettaire fibrinolyse Contraste spontaneacute
Thrombus
Parce que Peu utile voire dangereux gt 75 ans surtout en FA
Risque annuel AVC gt 4
Les techniques chirurgicales Laissent souvent un deacutefect 34 dans LAOOStudy
Healey Am Heart J 2005150288ndash293
Impliquent une chirurgie cardiaque concomitante en particulier pour le sujet gt75 ans
Reacuteduisent les AVC postopeacuteratoires lt1 peacuteriopeacuteratoire
Cox JL J Thorac Cardiovasc Surg 1999118833-40 Contre 32 (Pontages) 28 (Valve) 67 (Pontage+valve)
Salazar Ann Thorac Surg 2001721195-201
Risque thrombo-embolique et heacutemorragique plus eacuteleveacutes
Comorbiditeacutes plus freacutequentes Plus sensibles aux effets pro-arythmiques des
AAR
Pour controcircle du rythme
Alteacuteration des fonctions reacutenale et heacutepatique
Risque thrombo-embolique et heacutemorragique plus eacuteleveacutes
Plus vieux que ds les eacutetudes randomiseacuteeshellip (dont lrsquoablation de FA)
Plus de dysfonction sinusale (MRA) Plus drsquoIC diastolique donc plus de sensibibiliteacute agrave
la perte de systole atriale Plus de co-morbiditeacutes Attention au mode drsquoeacutelimination
Des anti-arythmiques effet pro-arythmique Des anticoagulants (dabigatran et IR ++) Adapter les doses eacuteviter les associations ou sous surveillance
stricte ECG (Dysf sinusale PR QT)
Santangeli JCE 201223(7)687-93
Wind Sock Chicken Wing Broccoli
Maximum LAA
Ostium (mm)
Device Size (mm) (uncompressed
diameter)
17-19 21
20-22 24
23-25 27
26-28 30
29-31 33
bull Choix sur base du diamegravetre maxi aG
bull gt17mm ou lt31mm
bull Longueur aG ge diamegravetre de lrsquoostium
Double Curve
Single Curve
Transseptal Access System
bull Double Single Anterior Curves
bull 14F OD (47 mm) 12F ID
bull 75 cm working length
Preformed curve shapes guide position in LAA
WATCHMANreg LAA Closure System Components
Mi
VG
aG
Accegraves vasculaire Epanchement peacutericardique Embolie gazeuse Deacuteplacement de prothegravese
PLAATO
Sievert Circulation 20021051887ndash1889
CI aux AVK n=64
98 fermeture (flux lt3mm)
AVCAIT agrave 5 ans = 38an contre 66an attendus selon CHADSsup2
Randomized study of WATCHMAN LAA Device vs Long-term Warfarin Therapy CHADSsup2 ge 1
21 allocation ratio device to control N=707 (intervention 463 control 244) Intention to treat non inferiority trial
59 Enrolling Centers (US amp Europe) Follow-up Requirements
TEE follow-up at 45 days 6 months and 1 year Clinical follow-up biannually up to 5 years Regular INR monitoring while taking warfarin
Enrollment continues in Continued Access Registry
D Holmes Lancet 2009 374 534ndash42
PROTECT AF D Holmes Lancet 2009 374 534ndash42 PREVAIL D Holmes J Am Coll Cardiol 2014641ndash12
88 de succegraves drsquoimplantation (ITT) 45j 86 arrecirct de warfarine 6 mois 92 arrecirct warfarine
Suivi moyen = 18 mois Primary EP AVC Deacutecegraves CV embolie systeacutemique
Safety EP Saignement majeur eacutepanchement peacutericardique migration de prothegravese
3 vs 49pt-y 102 vs 68 at 2 y
D Holmes Lancet 2009 374 534ndash42
Age moyen 72 ans
2621 ptanneacutee critegravere de supeacuterioriteacute RR 060 pour DC cardioV AVC embolie
systeacutemique
Diminution mortaliteacute toutes causes hazard ratio = 066 95 CI 045ndash098 P=0038
Beacuteneacutefice supeacuterieur Score HAS-BLED eacuteleveacute
gt75 ans
Diabegravete
Preacutevention IIaire AVC Reddy VY Long term results of PROTECT AF Heart Rhythm Society Scientific Sessions May 8ndash112013 Denver CO Reddy VY Circulation 2011123417ndash424
39 patients opeacutereacutes dans un centre deacutebutant lrsquoactiviteacute drsquoocclusion
Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212 Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212
Expeacuterience opeacuterateurs Formation
07
08
09
10
0 365 730 1095
Intent-to-Treat
Hemorrhagic Stroke
ITT cohort Superiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 53 12
463 275 95 23
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort (no) pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 1 4167 02 4 2247 18 013 0998 0986 pt-yr (00 09) (05 39) (000 080)
900 1 5936 02 6 3194 19 009 gt0999 0998 pt-yr (00 06) (07 37) (000 045)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Guidelines for the management of atrial fibrillation
AJ Camm et al Eur Heart J 2010
Rocircle de reacuteservoir en rythme sinusal
Seacutecreacutetion Peptide Natriureacutetique Atrial
Reacutegulation de la voleacutemiepreacutecharge
Pas de retentissement de lrsquoexclusion drsquoapregraves eacutetudes chirurgicales apregraves conservation auricule Dt (auparavant reacutetention hydro-sodeacutee)
Rocircle meacutecanique mineur de lrsquoOG
dans le maintien du deacutebit cardiaque en RS
Lorsque la synchronisation OD-VD est respecteacutee et que la diastole VG eacutegalement
Williams J Thorac Cardiovasc Surg 198080373-80 JL Cox J Thorac Cardiovasc Surg 20131461018-27
Williams J Thorac Cardiovasc Surg 198080373-80 JL Cox J Thorac Cardiovasc Surg 20131461018-27
LA isolation procedure
Triade de Virchow Leacutesion endotheacuteliumendocarde (+inflammation
fibrose)
Stase sanguine (basses vitesses auriculaires)
Alteacuteration de lrsquoheacutemostase fonction plaquettaire fibrinolyse Contraste spontaneacute
Thrombus
Parce que Peu utile voire dangereux gt 75 ans surtout en FA
Risque annuel AVC gt 4
Les techniques chirurgicales Laissent souvent un deacutefect 34 dans LAOOStudy
Healey Am Heart J 2005150288ndash293
Impliquent une chirurgie cardiaque concomitante en particulier pour le sujet gt75 ans
Reacuteduisent les AVC postopeacuteratoires lt1 peacuteriopeacuteratoire
Cox JL J Thorac Cardiovasc Surg 1999118833-40 Contre 32 (Pontages) 28 (Valve) 67 (Pontage+valve)
Salazar Ann Thorac Surg 2001721195-201
Risque thrombo-embolique et heacutemorragique plus eacuteleveacutes
Comorbiditeacutes plus freacutequentes Plus sensibles aux effets pro-arythmiques des
AAR
Pour controcircle du rythme
Alteacuteration des fonctions reacutenale et heacutepatique
Risque thrombo-embolique et heacutemorragique plus eacuteleveacutes
Plus vieux que ds les eacutetudes randomiseacuteeshellip (dont lrsquoablation de FA)
Plus de dysfonction sinusale (MRA) Plus drsquoIC diastolique donc plus de sensibibiliteacute agrave
la perte de systole atriale Plus de co-morbiditeacutes Attention au mode drsquoeacutelimination
Des anti-arythmiques effet pro-arythmique Des anticoagulants (dabigatran et IR ++) Adapter les doses eacuteviter les associations ou sous surveillance
stricte ECG (Dysf sinusale PR QT)
Santangeli JCE 201223(7)687-93
Wind Sock Chicken Wing Broccoli
Maximum LAA
Ostium (mm)
Device Size (mm) (uncompressed
diameter)
17-19 21
20-22 24
23-25 27
26-28 30
29-31 33
bull Choix sur base du diamegravetre maxi aG
bull gt17mm ou lt31mm
bull Longueur aG ge diamegravetre de lrsquoostium
Double Curve
Single Curve
Transseptal Access System
bull Double Single Anterior Curves
bull 14F OD (47 mm) 12F ID
bull 75 cm working length
Preformed curve shapes guide position in LAA
WATCHMANreg LAA Closure System Components
Mi
VG
aG
Accegraves vasculaire Epanchement peacutericardique Embolie gazeuse Deacuteplacement de prothegravese
PLAATO
Sievert Circulation 20021051887ndash1889
CI aux AVK n=64
98 fermeture (flux lt3mm)
AVCAIT agrave 5 ans = 38an contre 66an attendus selon CHADSsup2
Randomized study of WATCHMAN LAA Device vs Long-term Warfarin Therapy CHADSsup2 ge 1
21 allocation ratio device to control N=707 (intervention 463 control 244) Intention to treat non inferiority trial
59 Enrolling Centers (US amp Europe) Follow-up Requirements
TEE follow-up at 45 days 6 months and 1 year Clinical follow-up biannually up to 5 years Regular INR monitoring while taking warfarin
Enrollment continues in Continued Access Registry
D Holmes Lancet 2009 374 534ndash42
PROTECT AF D Holmes Lancet 2009 374 534ndash42 PREVAIL D Holmes J Am Coll Cardiol 2014641ndash12
88 de succegraves drsquoimplantation (ITT) 45j 86 arrecirct de warfarine 6 mois 92 arrecirct warfarine
Suivi moyen = 18 mois Primary EP AVC Deacutecegraves CV embolie systeacutemique
Safety EP Saignement majeur eacutepanchement peacutericardique migration de prothegravese
3 vs 49pt-y 102 vs 68 at 2 y
D Holmes Lancet 2009 374 534ndash42
Age moyen 72 ans
2621 ptanneacutee critegravere de supeacuterioriteacute RR 060 pour DC cardioV AVC embolie
systeacutemique
Diminution mortaliteacute toutes causes hazard ratio = 066 95 CI 045ndash098 P=0038
Beacuteneacutefice supeacuterieur Score HAS-BLED eacuteleveacute
gt75 ans
Diabegravete
Preacutevention IIaire AVC Reddy VY Long term results of PROTECT AF Heart Rhythm Society Scientific Sessions May 8ndash112013 Denver CO Reddy VY Circulation 2011123417ndash424
39 patients opeacutereacutes dans un centre deacutebutant lrsquoactiviteacute drsquoocclusion
Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212 Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212
Expeacuterience opeacuterateurs Formation
07
08
09
10
0 365 730 1095
Intent-to-Treat
Hemorrhagic Stroke
ITT cohort Superiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 53 12
463 275 95 23
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort (no) pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 1 4167 02 4 2247 18 013 0998 0986 pt-yr (00 09) (05 39) (000 080)
900 1 5936 02 6 3194 19 009 gt0999 0998 pt-yr (00 06) (07 37) (000 045)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Rocircle de reacuteservoir en rythme sinusal
Seacutecreacutetion Peptide Natriureacutetique Atrial
Reacutegulation de la voleacutemiepreacutecharge
Pas de retentissement de lrsquoexclusion drsquoapregraves eacutetudes chirurgicales apregraves conservation auricule Dt (auparavant reacutetention hydro-sodeacutee)
Rocircle meacutecanique mineur de lrsquoOG
dans le maintien du deacutebit cardiaque en RS
Lorsque la synchronisation OD-VD est respecteacutee et que la diastole VG eacutegalement
Williams J Thorac Cardiovasc Surg 198080373-80 JL Cox J Thorac Cardiovasc Surg 20131461018-27
Williams J Thorac Cardiovasc Surg 198080373-80 JL Cox J Thorac Cardiovasc Surg 20131461018-27
LA isolation procedure
Triade de Virchow Leacutesion endotheacuteliumendocarde (+inflammation
fibrose)
Stase sanguine (basses vitesses auriculaires)
Alteacuteration de lrsquoheacutemostase fonction plaquettaire fibrinolyse Contraste spontaneacute
Thrombus
Parce que Peu utile voire dangereux gt 75 ans surtout en FA
Risque annuel AVC gt 4
Les techniques chirurgicales Laissent souvent un deacutefect 34 dans LAOOStudy
Healey Am Heart J 2005150288ndash293
Impliquent une chirurgie cardiaque concomitante en particulier pour le sujet gt75 ans
Reacuteduisent les AVC postopeacuteratoires lt1 peacuteriopeacuteratoire
Cox JL J Thorac Cardiovasc Surg 1999118833-40 Contre 32 (Pontages) 28 (Valve) 67 (Pontage+valve)
Salazar Ann Thorac Surg 2001721195-201
Risque thrombo-embolique et heacutemorragique plus eacuteleveacutes
Comorbiditeacutes plus freacutequentes Plus sensibles aux effets pro-arythmiques des
AAR
Pour controcircle du rythme
Alteacuteration des fonctions reacutenale et heacutepatique
Risque thrombo-embolique et heacutemorragique plus eacuteleveacutes
Plus vieux que ds les eacutetudes randomiseacuteeshellip (dont lrsquoablation de FA)
Plus de dysfonction sinusale (MRA) Plus drsquoIC diastolique donc plus de sensibibiliteacute agrave
la perte de systole atriale Plus de co-morbiditeacutes Attention au mode drsquoeacutelimination
Des anti-arythmiques effet pro-arythmique Des anticoagulants (dabigatran et IR ++) Adapter les doses eacuteviter les associations ou sous surveillance
stricte ECG (Dysf sinusale PR QT)
Santangeli JCE 201223(7)687-93
Wind Sock Chicken Wing Broccoli
Maximum LAA
Ostium (mm)
Device Size (mm) (uncompressed
diameter)
17-19 21
20-22 24
23-25 27
26-28 30
29-31 33
bull Choix sur base du diamegravetre maxi aG
bull gt17mm ou lt31mm
bull Longueur aG ge diamegravetre de lrsquoostium
Double Curve
Single Curve
Transseptal Access System
bull Double Single Anterior Curves
bull 14F OD (47 mm) 12F ID
bull 75 cm working length
Preformed curve shapes guide position in LAA
WATCHMANreg LAA Closure System Components
Mi
VG
aG
Accegraves vasculaire Epanchement peacutericardique Embolie gazeuse Deacuteplacement de prothegravese
PLAATO
Sievert Circulation 20021051887ndash1889
CI aux AVK n=64
98 fermeture (flux lt3mm)
AVCAIT agrave 5 ans = 38an contre 66an attendus selon CHADSsup2
Randomized study of WATCHMAN LAA Device vs Long-term Warfarin Therapy CHADSsup2 ge 1
21 allocation ratio device to control N=707 (intervention 463 control 244) Intention to treat non inferiority trial
59 Enrolling Centers (US amp Europe) Follow-up Requirements
TEE follow-up at 45 days 6 months and 1 year Clinical follow-up biannually up to 5 years Regular INR monitoring while taking warfarin
Enrollment continues in Continued Access Registry
D Holmes Lancet 2009 374 534ndash42
PROTECT AF D Holmes Lancet 2009 374 534ndash42 PREVAIL D Holmes J Am Coll Cardiol 2014641ndash12
88 de succegraves drsquoimplantation (ITT) 45j 86 arrecirct de warfarine 6 mois 92 arrecirct warfarine
Suivi moyen = 18 mois Primary EP AVC Deacutecegraves CV embolie systeacutemique
Safety EP Saignement majeur eacutepanchement peacutericardique migration de prothegravese
3 vs 49pt-y 102 vs 68 at 2 y
D Holmes Lancet 2009 374 534ndash42
Age moyen 72 ans
2621 ptanneacutee critegravere de supeacuterioriteacute RR 060 pour DC cardioV AVC embolie
systeacutemique
Diminution mortaliteacute toutes causes hazard ratio = 066 95 CI 045ndash098 P=0038
Beacuteneacutefice supeacuterieur Score HAS-BLED eacuteleveacute
gt75 ans
Diabegravete
Preacutevention IIaire AVC Reddy VY Long term results of PROTECT AF Heart Rhythm Society Scientific Sessions May 8ndash112013 Denver CO Reddy VY Circulation 2011123417ndash424
39 patients opeacutereacutes dans un centre deacutebutant lrsquoactiviteacute drsquoocclusion
Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212 Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212
Expeacuterience opeacuterateurs Formation
07
08
09
10
0 365 730 1095
Intent-to-Treat
Hemorrhagic Stroke
ITT cohort Superiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 53 12
463 275 95 23
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort (no) pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 1 4167 02 4 2247 18 013 0998 0986 pt-yr (00 09) (05 39) (000 080)
900 1 5936 02 6 3194 19 009 gt0999 0998 pt-yr (00 06) (07 37) (000 045)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Williams J Thorac Cardiovasc Surg 198080373-80 JL Cox J Thorac Cardiovasc Surg 20131461018-27
LA isolation procedure
Triade de Virchow Leacutesion endotheacuteliumendocarde (+inflammation
fibrose)
Stase sanguine (basses vitesses auriculaires)
Alteacuteration de lrsquoheacutemostase fonction plaquettaire fibrinolyse Contraste spontaneacute
Thrombus
Parce que Peu utile voire dangereux gt 75 ans surtout en FA
Risque annuel AVC gt 4
Les techniques chirurgicales Laissent souvent un deacutefect 34 dans LAOOStudy
Healey Am Heart J 2005150288ndash293
Impliquent une chirurgie cardiaque concomitante en particulier pour le sujet gt75 ans
Reacuteduisent les AVC postopeacuteratoires lt1 peacuteriopeacuteratoire
Cox JL J Thorac Cardiovasc Surg 1999118833-40 Contre 32 (Pontages) 28 (Valve) 67 (Pontage+valve)
Salazar Ann Thorac Surg 2001721195-201
Risque thrombo-embolique et heacutemorragique plus eacuteleveacutes
Comorbiditeacutes plus freacutequentes Plus sensibles aux effets pro-arythmiques des
AAR
Pour controcircle du rythme
Alteacuteration des fonctions reacutenale et heacutepatique
Risque thrombo-embolique et heacutemorragique plus eacuteleveacutes
Plus vieux que ds les eacutetudes randomiseacuteeshellip (dont lrsquoablation de FA)
Plus de dysfonction sinusale (MRA) Plus drsquoIC diastolique donc plus de sensibibiliteacute agrave
la perte de systole atriale Plus de co-morbiditeacutes Attention au mode drsquoeacutelimination
Des anti-arythmiques effet pro-arythmique Des anticoagulants (dabigatran et IR ++) Adapter les doses eacuteviter les associations ou sous surveillance
stricte ECG (Dysf sinusale PR QT)
Santangeli JCE 201223(7)687-93
Wind Sock Chicken Wing Broccoli
Maximum LAA
Ostium (mm)
Device Size (mm) (uncompressed
diameter)
17-19 21
20-22 24
23-25 27
26-28 30
29-31 33
bull Choix sur base du diamegravetre maxi aG
bull gt17mm ou lt31mm
bull Longueur aG ge diamegravetre de lrsquoostium
Double Curve
Single Curve
Transseptal Access System
bull Double Single Anterior Curves
bull 14F OD (47 mm) 12F ID
bull 75 cm working length
Preformed curve shapes guide position in LAA
WATCHMANreg LAA Closure System Components
Mi
VG
aG
Accegraves vasculaire Epanchement peacutericardique Embolie gazeuse Deacuteplacement de prothegravese
PLAATO
Sievert Circulation 20021051887ndash1889
CI aux AVK n=64
98 fermeture (flux lt3mm)
AVCAIT agrave 5 ans = 38an contre 66an attendus selon CHADSsup2
Randomized study of WATCHMAN LAA Device vs Long-term Warfarin Therapy CHADSsup2 ge 1
21 allocation ratio device to control N=707 (intervention 463 control 244) Intention to treat non inferiority trial
59 Enrolling Centers (US amp Europe) Follow-up Requirements
TEE follow-up at 45 days 6 months and 1 year Clinical follow-up biannually up to 5 years Regular INR monitoring while taking warfarin
Enrollment continues in Continued Access Registry
D Holmes Lancet 2009 374 534ndash42
PROTECT AF D Holmes Lancet 2009 374 534ndash42 PREVAIL D Holmes J Am Coll Cardiol 2014641ndash12
88 de succegraves drsquoimplantation (ITT) 45j 86 arrecirct de warfarine 6 mois 92 arrecirct warfarine
Suivi moyen = 18 mois Primary EP AVC Deacutecegraves CV embolie systeacutemique
Safety EP Saignement majeur eacutepanchement peacutericardique migration de prothegravese
3 vs 49pt-y 102 vs 68 at 2 y
D Holmes Lancet 2009 374 534ndash42
Age moyen 72 ans
2621 ptanneacutee critegravere de supeacuterioriteacute RR 060 pour DC cardioV AVC embolie
systeacutemique
Diminution mortaliteacute toutes causes hazard ratio = 066 95 CI 045ndash098 P=0038
Beacuteneacutefice supeacuterieur Score HAS-BLED eacuteleveacute
gt75 ans
Diabegravete
Preacutevention IIaire AVC Reddy VY Long term results of PROTECT AF Heart Rhythm Society Scientific Sessions May 8ndash112013 Denver CO Reddy VY Circulation 2011123417ndash424
39 patients opeacutereacutes dans un centre deacutebutant lrsquoactiviteacute drsquoocclusion
Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212 Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212
Expeacuterience opeacuterateurs Formation
07
08
09
10
0 365 730 1095
Intent-to-Treat
Hemorrhagic Stroke
ITT cohort Superiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 53 12
463 275 95 23
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort (no) pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 1 4167 02 4 2247 18 013 0998 0986 pt-yr (00 09) (05 39) (000 080)
900 1 5936 02 6 3194 19 009 gt0999 0998 pt-yr (00 06) (07 37) (000 045)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Triade de Virchow Leacutesion endotheacuteliumendocarde (+inflammation
fibrose)
Stase sanguine (basses vitesses auriculaires)
Alteacuteration de lrsquoheacutemostase fonction plaquettaire fibrinolyse Contraste spontaneacute
Thrombus
Parce que Peu utile voire dangereux gt 75 ans surtout en FA
Risque annuel AVC gt 4
Les techniques chirurgicales Laissent souvent un deacutefect 34 dans LAOOStudy
Healey Am Heart J 2005150288ndash293
Impliquent une chirurgie cardiaque concomitante en particulier pour le sujet gt75 ans
Reacuteduisent les AVC postopeacuteratoires lt1 peacuteriopeacuteratoire
Cox JL J Thorac Cardiovasc Surg 1999118833-40 Contre 32 (Pontages) 28 (Valve) 67 (Pontage+valve)
Salazar Ann Thorac Surg 2001721195-201
Risque thrombo-embolique et heacutemorragique plus eacuteleveacutes
Comorbiditeacutes plus freacutequentes Plus sensibles aux effets pro-arythmiques des
AAR
Pour controcircle du rythme
Alteacuteration des fonctions reacutenale et heacutepatique
Risque thrombo-embolique et heacutemorragique plus eacuteleveacutes
Plus vieux que ds les eacutetudes randomiseacuteeshellip (dont lrsquoablation de FA)
Plus de dysfonction sinusale (MRA) Plus drsquoIC diastolique donc plus de sensibibiliteacute agrave
la perte de systole atriale Plus de co-morbiditeacutes Attention au mode drsquoeacutelimination
Des anti-arythmiques effet pro-arythmique Des anticoagulants (dabigatran et IR ++) Adapter les doses eacuteviter les associations ou sous surveillance
stricte ECG (Dysf sinusale PR QT)
Santangeli JCE 201223(7)687-93
Wind Sock Chicken Wing Broccoli
Maximum LAA
Ostium (mm)
Device Size (mm) (uncompressed
diameter)
17-19 21
20-22 24
23-25 27
26-28 30
29-31 33
bull Choix sur base du diamegravetre maxi aG
bull gt17mm ou lt31mm
bull Longueur aG ge diamegravetre de lrsquoostium
Double Curve
Single Curve
Transseptal Access System
bull Double Single Anterior Curves
bull 14F OD (47 mm) 12F ID
bull 75 cm working length
Preformed curve shapes guide position in LAA
WATCHMANreg LAA Closure System Components
Mi
VG
aG
Accegraves vasculaire Epanchement peacutericardique Embolie gazeuse Deacuteplacement de prothegravese
PLAATO
Sievert Circulation 20021051887ndash1889
CI aux AVK n=64
98 fermeture (flux lt3mm)
AVCAIT agrave 5 ans = 38an contre 66an attendus selon CHADSsup2
Randomized study of WATCHMAN LAA Device vs Long-term Warfarin Therapy CHADSsup2 ge 1
21 allocation ratio device to control N=707 (intervention 463 control 244) Intention to treat non inferiority trial
59 Enrolling Centers (US amp Europe) Follow-up Requirements
TEE follow-up at 45 days 6 months and 1 year Clinical follow-up biannually up to 5 years Regular INR monitoring while taking warfarin
Enrollment continues in Continued Access Registry
D Holmes Lancet 2009 374 534ndash42
PROTECT AF D Holmes Lancet 2009 374 534ndash42 PREVAIL D Holmes J Am Coll Cardiol 2014641ndash12
88 de succegraves drsquoimplantation (ITT) 45j 86 arrecirct de warfarine 6 mois 92 arrecirct warfarine
Suivi moyen = 18 mois Primary EP AVC Deacutecegraves CV embolie systeacutemique
Safety EP Saignement majeur eacutepanchement peacutericardique migration de prothegravese
3 vs 49pt-y 102 vs 68 at 2 y
D Holmes Lancet 2009 374 534ndash42
Age moyen 72 ans
2621 ptanneacutee critegravere de supeacuterioriteacute RR 060 pour DC cardioV AVC embolie
systeacutemique
Diminution mortaliteacute toutes causes hazard ratio = 066 95 CI 045ndash098 P=0038
Beacuteneacutefice supeacuterieur Score HAS-BLED eacuteleveacute
gt75 ans
Diabegravete
Preacutevention IIaire AVC Reddy VY Long term results of PROTECT AF Heart Rhythm Society Scientific Sessions May 8ndash112013 Denver CO Reddy VY Circulation 2011123417ndash424
39 patients opeacutereacutes dans un centre deacutebutant lrsquoactiviteacute drsquoocclusion
Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212 Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212
Expeacuterience opeacuterateurs Formation
07
08
09
10
0 365 730 1095
Intent-to-Treat
Hemorrhagic Stroke
ITT cohort Superiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 53 12
463 275 95 23
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort (no) pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 1 4167 02 4 2247 18 013 0998 0986 pt-yr (00 09) (05 39) (000 080)
900 1 5936 02 6 3194 19 009 gt0999 0998 pt-yr (00 06) (07 37) (000 045)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Parce que Peu utile voire dangereux gt 75 ans surtout en FA
Risque annuel AVC gt 4
Les techniques chirurgicales Laissent souvent un deacutefect 34 dans LAOOStudy
Healey Am Heart J 2005150288ndash293
Impliquent une chirurgie cardiaque concomitante en particulier pour le sujet gt75 ans
Reacuteduisent les AVC postopeacuteratoires lt1 peacuteriopeacuteratoire
Cox JL J Thorac Cardiovasc Surg 1999118833-40 Contre 32 (Pontages) 28 (Valve) 67 (Pontage+valve)
Salazar Ann Thorac Surg 2001721195-201
Risque thrombo-embolique et heacutemorragique plus eacuteleveacutes
Comorbiditeacutes plus freacutequentes Plus sensibles aux effets pro-arythmiques des
AAR
Pour controcircle du rythme
Alteacuteration des fonctions reacutenale et heacutepatique
Risque thrombo-embolique et heacutemorragique plus eacuteleveacutes
Plus vieux que ds les eacutetudes randomiseacuteeshellip (dont lrsquoablation de FA)
Plus de dysfonction sinusale (MRA) Plus drsquoIC diastolique donc plus de sensibibiliteacute agrave
la perte de systole atriale Plus de co-morbiditeacutes Attention au mode drsquoeacutelimination
Des anti-arythmiques effet pro-arythmique Des anticoagulants (dabigatran et IR ++) Adapter les doses eacuteviter les associations ou sous surveillance
stricte ECG (Dysf sinusale PR QT)
Santangeli JCE 201223(7)687-93
Wind Sock Chicken Wing Broccoli
Maximum LAA
Ostium (mm)
Device Size (mm) (uncompressed
diameter)
17-19 21
20-22 24
23-25 27
26-28 30
29-31 33
bull Choix sur base du diamegravetre maxi aG
bull gt17mm ou lt31mm
bull Longueur aG ge diamegravetre de lrsquoostium
Double Curve
Single Curve
Transseptal Access System
bull Double Single Anterior Curves
bull 14F OD (47 mm) 12F ID
bull 75 cm working length
Preformed curve shapes guide position in LAA
WATCHMANreg LAA Closure System Components
Mi
VG
aG
Accegraves vasculaire Epanchement peacutericardique Embolie gazeuse Deacuteplacement de prothegravese
PLAATO
Sievert Circulation 20021051887ndash1889
CI aux AVK n=64
98 fermeture (flux lt3mm)
AVCAIT agrave 5 ans = 38an contre 66an attendus selon CHADSsup2
Randomized study of WATCHMAN LAA Device vs Long-term Warfarin Therapy CHADSsup2 ge 1
21 allocation ratio device to control N=707 (intervention 463 control 244) Intention to treat non inferiority trial
59 Enrolling Centers (US amp Europe) Follow-up Requirements
TEE follow-up at 45 days 6 months and 1 year Clinical follow-up biannually up to 5 years Regular INR monitoring while taking warfarin
Enrollment continues in Continued Access Registry
D Holmes Lancet 2009 374 534ndash42
PROTECT AF D Holmes Lancet 2009 374 534ndash42 PREVAIL D Holmes J Am Coll Cardiol 2014641ndash12
88 de succegraves drsquoimplantation (ITT) 45j 86 arrecirct de warfarine 6 mois 92 arrecirct warfarine
Suivi moyen = 18 mois Primary EP AVC Deacutecegraves CV embolie systeacutemique
Safety EP Saignement majeur eacutepanchement peacutericardique migration de prothegravese
3 vs 49pt-y 102 vs 68 at 2 y
D Holmes Lancet 2009 374 534ndash42
Age moyen 72 ans
2621 ptanneacutee critegravere de supeacuterioriteacute RR 060 pour DC cardioV AVC embolie
systeacutemique
Diminution mortaliteacute toutes causes hazard ratio = 066 95 CI 045ndash098 P=0038
Beacuteneacutefice supeacuterieur Score HAS-BLED eacuteleveacute
gt75 ans
Diabegravete
Preacutevention IIaire AVC Reddy VY Long term results of PROTECT AF Heart Rhythm Society Scientific Sessions May 8ndash112013 Denver CO Reddy VY Circulation 2011123417ndash424
39 patients opeacutereacutes dans un centre deacutebutant lrsquoactiviteacute drsquoocclusion
Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212 Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212
Expeacuterience opeacuterateurs Formation
07
08
09
10
0 365 730 1095
Intent-to-Treat
Hemorrhagic Stroke
ITT cohort Superiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 53 12
463 275 95 23
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort (no) pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 1 4167 02 4 2247 18 013 0998 0986 pt-yr (00 09) (05 39) (000 080)
900 1 5936 02 6 3194 19 009 gt0999 0998 pt-yr (00 06) (07 37) (000 045)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Risque thrombo-embolique et heacutemorragique plus eacuteleveacutes
Comorbiditeacutes plus freacutequentes Plus sensibles aux effets pro-arythmiques des
AAR
Pour controcircle du rythme
Alteacuteration des fonctions reacutenale et heacutepatique
Risque thrombo-embolique et heacutemorragique plus eacuteleveacutes
Plus vieux que ds les eacutetudes randomiseacuteeshellip (dont lrsquoablation de FA)
Plus de dysfonction sinusale (MRA) Plus drsquoIC diastolique donc plus de sensibibiliteacute agrave
la perte de systole atriale Plus de co-morbiditeacutes Attention au mode drsquoeacutelimination
Des anti-arythmiques effet pro-arythmique Des anticoagulants (dabigatran et IR ++) Adapter les doses eacuteviter les associations ou sous surveillance
stricte ECG (Dysf sinusale PR QT)
Santangeli JCE 201223(7)687-93
Wind Sock Chicken Wing Broccoli
Maximum LAA
Ostium (mm)
Device Size (mm) (uncompressed
diameter)
17-19 21
20-22 24
23-25 27
26-28 30
29-31 33
bull Choix sur base du diamegravetre maxi aG
bull gt17mm ou lt31mm
bull Longueur aG ge diamegravetre de lrsquoostium
Double Curve
Single Curve
Transseptal Access System
bull Double Single Anterior Curves
bull 14F OD (47 mm) 12F ID
bull 75 cm working length
Preformed curve shapes guide position in LAA
WATCHMANreg LAA Closure System Components
Mi
VG
aG
Accegraves vasculaire Epanchement peacutericardique Embolie gazeuse Deacuteplacement de prothegravese
PLAATO
Sievert Circulation 20021051887ndash1889
CI aux AVK n=64
98 fermeture (flux lt3mm)
AVCAIT agrave 5 ans = 38an contre 66an attendus selon CHADSsup2
Randomized study of WATCHMAN LAA Device vs Long-term Warfarin Therapy CHADSsup2 ge 1
21 allocation ratio device to control N=707 (intervention 463 control 244) Intention to treat non inferiority trial
59 Enrolling Centers (US amp Europe) Follow-up Requirements
TEE follow-up at 45 days 6 months and 1 year Clinical follow-up biannually up to 5 years Regular INR monitoring while taking warfarin
Enrollment continues in Continued Access Registry
D Holmes Lancet 2009 374 534ndash42
PROTECT AF D Holmes Lancet 2009 374 534ndash42 PREVAIL D Holmes J Am Coll Cardiol 2014641ndash12
88 de succegraves drsquoimplantation (ITT) 45j 86 arrecirct de warfarine 6 mois 92 arrecirct warfarine
Suivi moyen = 18 mois Primary EP AVC Deacutecegraves CV embolie systeacutemique
Safety EP Saignement majeur eacutepanchement peacutericardique migration de prothegravese
3 vs 49pt-y 102 vs 68 at 2 y
D Holmes Lancet 2009 374 534ndash42
Age moyen 72 ans
2621 ptanneacutee critegravere de supeacuterioriteacute RR 060 pour DC cardioV AVC embolie
systeacutemique
Diminution mortaliteacute toutes causes hazard ratio = 066 95 CI 045ndash098 P=0038
Beacuteneacutefice supeacuterieur Score HAS-BLED eacuteleveacute
gt75 ans
Diabegravete
Preacutevention IIaire AVC Reddy VY Long term results of PROTECT AF Heart Rhythm Society Scientific Sessions May 8ndash112013 Denver CO Reddy VY Circulation 2011123417ndash424
39 patients opeacutereacutes dans un centre deacutebutant lrsquoactiviteacute drsquoocclusion
Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212 Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212
Expeacuterience opeacuterateurs Formation
07
08
09
10
0 365 730 1095
Intent-to-Treat
Hemorrhagic Stroke
ITT cohort Superiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 53 12
463 275 95 23
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort (no) pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 1 4167 02 4 2247 18 013 0998 0986 pt-yr (00 09) (05 39) (000 080)
900 1 5936 02 6 3194 19 009 gt0999 0998 pt-yr (00 06) (07 37) (000 045)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Risque thrombo-embolique et heacutemorragique plus eacuteleveacutes
Plus vieux que ds les eacutetudes randomiseacuteeshellip (dont lrsquoablation de FA)
Plus de dysfonction sinusale (MRA) Plus drsquoIC diastolique donc plus de sensibibiliteacute agrave
la perte de systole atriale Plus de co-morbiditeacutes Attention au mode drsquoeacutelimination
Des anti-arythmiques effet pro-arythmique Des anticoagulants (dabigatran et IR ++) Adapter les doses eacuteviter les associations ou sous surveillance
stricte ECG (Dysf sinusale PR QT)
Santangeli JCE 201223(7)687-93
Wind Sock Chicken Wing Broccoli
Maximum LAA
Ostium (mm)
Device Size (mm) (uncompressed
diameter)
17-19 21
20-22 24
23-25 27
26-28 30
29-31 33
bull Choix sur base du diamegravetre maxi aG
bull gt17mm ou lt31mm
bull Longueur aG ge diamegravetre de lrsquoostium
Double Curve
Single Curve
Transseptal Access System
bull Double Single Anterior Curves
bull 14F OD (47 mm) 12F ID
bull 75 cm working length
Preformed curve shapes guide position in LAA
WATCHMANreg LAA Closure System Components
Mi
VG
aG
Accegraves vasculaire Epanchement peacutericardique Embolie gazeuse Deacuteplacement de prothegravese
PLAATO
Sievert Circulation 20021051887ndash1889
CI aux AVK n=64
98 fermeture (flux lt3mm)
AVCAIT agrave 5 ans = 38an contre 66an attendus selon CHADSsup2
Randomized study of WATCHMAN LAA Device vs Long-term Warfarin Therapy CHADSsup2 ge 1
21 allocation ratio device to control N=707 (intervention 463 control 244) Intention to treat non inferiority trial
59 Enrolling Centers (US amp Europe) Follow-up Requirements
TEE follow-up at 45 days 6 months and 1 year Clinical follow-up biannually up to 5 years Regular INR monitoring while taking warfarin
Enrollment continues in Continued Access Registry
D Holmes Lancet 2009 374 534ndash42
PROTECT AF D Holmes Lancet 2009 374 534ndash42 PREVAIL D Holmes J Am Coll Cardiol 2014641ndash12
88 de succegraves drsquoimplantation (ITT) 45j 86 arrecirct de warfarine 6 mois 92 arrecirct warfarine
Suivi moyen = 18 mois Primary EP AVC Deacutecegraves CV embolie systeacutemique
Safety EP Saignement majeur eacutepanchement peacutericardique migration de prothegravese
3 vs 49pt-y 102 vs 68 at 2 y
D Holmes Lancet 2009 374 534ndash42
Age moyen 72 ans
2621 ptanneacutee critegravere de supeacuterioriteacute RR 060 pour DC cardioV AVC embolie
systeacutemique
Diminution mortaliteacute toutes causes hazard ratio = 066 95 CI 045ndash098 P=0038
Beacuteneacutefice supeacuterieur Score HAS-BLED eacuteleveacute
gt75 ans
Diabegravete
Preacutevention IIaire AVC Reddy VY Long term results of PROTECT AF Heart Rhythm Society Scientific Sessions May 8ndash112013 Denver CO Reddy VY Circulation 2011123417ndash424
39 patients opeacutereacutes dans un centre deacutebutant lrsquoactiviteacute drsquoocclusion
Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212 Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212
Expeacuterience opeacuterateurs Formation
07
08
09
10
0 365 730 1095
Intent-to-Treat
Hemorrhagic Stroke
ITT cohort Superiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 53 12
463 275 95 23
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort (no) pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 1 4167 02 4 2247 18 013 0998 0986 pt-yr (00 09) (05 39) (000 080)
900 1 5936 02 6 3194 19 009 gt0999 0998 pt-yr (00 06) (07 37) (000 045)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Santangeli JCE 201223(7)687-93
Wind Sock Chicken Wing Broccoli
Maximum LAA
Ostium (mm)
Device Size (mm) (uncompressed
diameter)
17-19 21
20-22 24
23-25 27
26-28 30
29-31 33
bull Choix sur base du diamegravetre maxi aG
bull gt17mm ou lt31mm
bull Longueur aG ge diamegravetre de lrsquoostium
Double Curve
Single Curve
Transseptal Access System
bull Double Single Anterior Curves
bull 14F OD (47 mm) 12F ID
bull 75 cm working length
Preformed curve shapes guide position in LAA
WATCHMANreg LAA Closure System Components
Mi
VG
aG
Accegraves vasculaire Epanchement peacutericardique Embolie gazeuse Deacuteplacement de prothegravese
PLAATO
Sievert Circulation 20021051887ndash1889
CI aux AVK n=64
98 fermeture (flux lt3mm)
AVCAIT agrave 5 ans = 38an contre 66an attendus selon CHADSsup2
Randomized study of WATCHMAN LAA Device vs Long-term Warfarin Therapy CHADSsup2 ge 1
21 allocation ratio device to control N=707 (intervention 463 control 244) Intention to treat non inferiority trial
59 Enrolling Centers (US amp Europe) Follow-up Requirements
TEE follow-up at 45 days 6 months and 1 year Clinical follow-up biannually up to 5 years Regular INR monitoring while taking warfarin
Enrollment continues in Continued Access Registry
D Holmes Lancet 2009 374 534ndash42
PROTECT AF D Holmes Lancet 2009 374 534ndash42 PREVAIL D Holmes J Am Coll Cardiol 2014641ndash12
88 de succegraves drsquoimplantation (ITT) 45j 86 arrecirct de warfarine 6 mois 92 arrecirct warfarine
Suivi moyen = 18 mois Primary EP AVC Deacutecegraves CV embolie systeacutemique
Safety EP Saignement majeur eacutepanchement peacutericardique migration de prothegravese
3 vs 49pt-y 102 vs 68 at 2 y
D Holmes Lancet 2009 374 534ndash42
Age moyen 72 ans
2621 ptanneacutee critegravere de supeacuterioriteacute RR 060 pour DC cardioV AVC embolie
systeacutemique
Diminution mortaliteacute toutes causes hazard ratio = 066 95 CI 045ndash098 P=0038
Beacuteneacutefice supeacuterieur Score HAS-BLED eacuteleveacute
gt75 ans
Diabegravete
Preacutevention IIaire AVC Reddy VY Long term results of PROTECT AF Heart Rhythm Society Scientific Sessions May 8ndash112013 Denver CO Reddy VY Circulation 2011123417ndash424
39 patients opeacutereacutes dans un centre deacutebutant lrsquoactiviteacute drsquoocclusion
Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212 Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212
Expeacuterience opeacuterateurs Formation
07
08
09
10
0 365 730 1095
Intent-to-Treat
Hemorrhagic Stroke
ITT cohort Superiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 53 12
463 275 95 23
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort (no) pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 1 4167 02 4 2247 18 013 0998 0986 pt-yr (00 09) (05 39) (000 080)
900 1 5936 02 6 3194 19 009 gt0999 0998 pt-yr (00 06) (07 37) (000 045)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Wind Sock Chicken Wing Broccoli
Maximum LAA
Ostium (mm)
Device Size (mm) (uncompressed
diameter)
17-19 21
20-22 24
23-25 27
26-28 30
29-31 33
bull Choix sur base du diamegravetre maxi aG
bull gt17mm ou lt31mm
bull Longueur aG ge diamegravetre de lrsquoostium
Double Curve
Single Curve
Transseptal Access System
bull Double Single Anterior Curves
bull 14F OD (47 mm) 12F ID
bull 75 cm working length
Preformed curve shapes guide position in LAA
WATCHMANreg LAA Closure System Components
Mi
VG
aG
Accegraves vasculaire Epanchement peacutericardique Embolie gazeuse Deacuteplacement de prothegravese
PLAATO
Sievert Circulation 20021051887ndash1889
CI aux AVK n=64
98 fermeture (flux lt3mm)
AVCAIT agrave 5 ans = 38an contre 66an attendus selon CHADSsup2
Randomized study of WATCHMAN LAA Device vs Long-term Warfarin Therapy CHADSsup2 ge 1
21 allocation ratio device to control N=707 (intervention 463 control 244) Intention to treat non inferiority trial
59 Enrolling Centers (US amp Europe) Follow-up Requirements
TEE follow-up at 45 days 6 months and 1 year Clinical follow-up biannually up to 5 years Regular INR monitoring while taking warfarin
Enrollment continues in Continued Access Registry
D Holmes Lancet 2009 374 534ndash42
PROTECT AF D Holmes Lancet 2009 374 534ndash42 PREVAIL D Holmes J Am Coll Cardiol 2014641ndash12
88 de succegraves drsquoimplantation (ITT) 45j 86 arrecirct de warfarine 6 mois 92 arrecirct warfarine
Suivi moyen = 18 mois Primary EP AVC Deacutecegraves CV embolie systeacutemique
Safety EP Saignement majeur eacutepanchement peacutericardique migration de prothegravese
3 vs 49pt-y 102 vs 68 at 2 y
D Holmes Lancet 2009 374 534ndash42
Age moyen 72 ans
2621 ptanneacutee critegravere de supeacuterioriteacute RR 060 pour DC cardioV AVC embolie
systeacutemique
Diminution mortaliteacute toutes causes hazard ratio = 066 95 CI 045ndash098 P=0038
Beacuteneacutefice supeacuterieur Score HAS-BLED eacuteleveacute
gt75 ans
Diabegravete
Preacutevention IIaire AVC Reddy VY Long term results of PROTECT AF Heart Rhythm Society Scientific Sessions May 8ndash112013 Denver CO Reddy VY Circulation 2011123417ndash424
39 patients opeacutereacutes dans un centre deacutebutant lrsquoactiviteacute drsquoocclusion
Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212 Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212
Expeacuterience opeacuterateurs Formation
07
08
09
10
0 365 730 1095
Intent-to-Treat
Hemorrhagic Stroke
ITT cohort Superiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 53 12
463 275 95 23
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort (no) pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 1 4167 02 4 2247 18 013 0998 0986 pt-yr (00 09) (05 39) (000 080)
900 1 5936 02 6 3194 19 009 gt0999 0998 pt-yr (00 06) (07 37) (000 045)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Maximum LAA
Ostium (mm)
Device Size (mm) (uncompressed
diameter)
17-19 21
20-22 24
23-25 27
26-28 30
29-31 33
bull Choix sur base du diamegravetre maxi aG
bull gt17mm ou lt31mm
bull Longueur aG ge diamegravetre de lrsquoostium
Double Curve
Single Curve
Transseptal Access System
bull Double Single Anterior Curves
bull 14F OD (47 mm) 12F ID
bull 75 cm working length
Preformed curve shapes guide position in LAA
WATCHMANreg LAA Closure System Components
Mi
VG
aG
Accegraves vasculaire Epanchement peacutericardique Embolie gazeuse Deacuteplacement de prothegravese
PLAATO
Sievert Circulation 20021051887ndash1889
CI aux AVK n=64
98 fermeture (flux lt3mm)
AVCAIT agrave 5 ans = 38an contre 66an attendus selon CHADSsup2
Randomized study of WATCHMAN LAA Device vs Long-term Warfarin Therapy CHADSsup2 ge 1
21 allocation ratio device to control N=707 (intervention 463 control 244) Intention to treat non inferiority trial
59 Enrolling Centers (US amp Europe) Follow-up Requirements
TEE follow-up at 45 days 6 months and 1 year Clinical follow-up biannually up to 5 years Regular INR monitoring while taking warfarin
Enrollment continues in Continued Access Registry
D Holmes Lancet 2009 374 534ndash42
PROTECT AF D Holmes Lancet 2009 374 534ndash42 PREVAIL D Holmes J Am Coll Cardiol 2014641ndash12
88 de succegraves drsquoimplantation (ITT) 45j 86 arrecirct de warfarine 6 mois 92 arrecirct warfarine
Suivi moyen = 18 mois Primary EP AVC Deacutecegraves CV embolie systeacutemique
Safety EP Saignement majeur eacutepanchement peacutericardique migration de prothegravese
3 vs 49pt-y 102 vs 68 at 2 y
D Holmes Lancet 2009 374 534ndash42
Age moyen 72 ans
2621 ptanneacutee critegravere de supeacuterioriteacute RR 060 pour DC cardioV AVC embolie
systeacutemique
Diminution mortaliteacute toutes causes hazard ratio = 066 95 CI 045ndash098 P=0038
Beacuteneacutefice supeacuterieur Score HAS-BLED eacuteleveacute
gt75 ans
Diabegravete
Preacutevention IIaire AVC Reddy VY Long term results of PROTECT AF Heart Rhythm Society Scientific Sessions May 8ndash112013 Denver CO Reddy VY Circulation 2011123417ndash424
39 patients opeacutereacutes dans un centre deacutebutant lrsquoactiviteacute drsquoocclusion
Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212 Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212
Expeacuterience opeacuterateurs Formation
07
08
09
10
0 365 730 1095
Intent-to-Treat
Hemorrhagic Stroke
ITT cohort Superiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 53 12
463 275 95 23
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort (no) pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 1 4167 02 4 2247 18 013 0998 0986 pt-yr (00 09) (05 39) (000 080)
900 1 5936 02 6 3194 19 009 gt0999 0998 pt-yr (00 06) (07 37) (000 045)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Double Curve
Single Curve
Transseptal Access System
bull Double Single Anterior Curves
bull 14F OD (47 mm) 12F ID
bull 75 cm working length
Preformed curve shapes guide position in LAA
WATCHMANreg LAA Closure System Components
Mi
VG
aG
Accegraves vasculaire Epanchement peacutericardique Embolie gazeuse Deacuteplacement de prothegravese
PLAATO
Sievert Circulation 20021051887ndash1889
CI aux AVK n=64
98 fermeture (flux lt3mm)
AVCAIT agrave 5 ans = 38an contre 66an attendus selon CHADSsup2
Randomized study of WATCHMAN LAA Device vs Long-term Warfarin Therapy CHADSsup2 ge 1
21 allocation ratio device to control N=707 (intervention 463 control 244) Intention to treat non inferiority trial
59 Enrolling Centers (US amp Europe) Follow-up Requirements
TEE follow-up at 45 days 6 months and 1 year Clinical follow-up biannually up to 5 years Regular INR monitoring while taking warfarin
Enrollment continues in Continued Access Registry
D Holmes Lancet 2009 374 534ndash42
PROTECT AF D Holmes Lancet 2009 374 534ndash42 PREVAIL D Holmes J Am Coll Cardiol 2014641ndash12
88 de succegraves drsquoimplantation (ITT) 45j 86 arrecirct de warfarine 6 mois 92 arrecirct warfarine
Suivi moyen = 18 mois Primary EP AVC Deacutecegraves CV embolie systeacutemique
Safety EP Saignement majeur eacutepanchement peacutericardique migration de prothegravese
3 vs 49pt-y 102 vs 68 at 2 y
D Holmes Lancet 2009 374 534ndash42
Age moyen 72 ans
2621 ptanneacutee critegravere de supeacuterioriteacute RR 060 pour DC cardioV AVC embolie
systeacutemique
Diminution mortaliteacute toutes causes hazard ratio = 066 95 CI 045ndash098 P=0038
Beacuteneacutefice supeacuterieur Score HAS-BLED eacuteleveacute
gt75 ans
Diabegravete
Preacutevention IIaire AVC Reddy VY Long term results of PROTECT AF Heart Rhythm Society Scientific Sessions May 8ndash112013 Denver CO Reddy VY Circulation 2011123417ndash424
39 patients opeacutereacutes dans un centre deacutebutant lrsquoactiviteacute drsquoocclusion
Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212 Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212
Expeacuterience opeacuterateurs Formation
07
08
09
10
0 365 730 1095
Intent-to-Treat
Hemorrhagic Stroke
ITT cohort Superiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 53 12
463 275 95 23
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort (no) pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 1 4167 02 4 2247 18 013 0998 0986 pt-yr (00 09) (05 39) (000 080)
900 1 5936 02 6 3194 19 009 gt0999 0998 pt-yr (00 06) (07 37) (000 045)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Mi
VG
aG
Accegraves vasculaire Epanchement peacutericardique Embolie gazeuse Deacuteplacement de prothegravese
PLAATO
Sievert Circulation 20021051887ndash1889
CI aux AVK n=64
98 fermeture (flux lt3mm)
AVCAIT agrave 5 ans = 38an contre 66an attendus selon CHADSsup2
Randomized study of WATCHMAN LAA Device vs Long-term Warfarin Therapy CHADSsup2 ge 1
21 allocation ratio device to control N=707 (intervention 463 control 244) Intention to treat non inferiority trial
59 Enrolling Centers (US amp Europe) Follow-up Requirements
TEE follow-up at 45 days 6 months and 1 year Clinical follow-up biannually up to 5 years Regular INR monitoring while taking warfarin
Enrollment continues in Continued Access Registry
D Holmes Lancet 2009 374 534ndash42
PROTECT AF D Holmes Lancet 2009 374 534ndash42 PREVAIL D Holmes J Am Coll Cardiol 2014641ndash12
88 de succegraves drsquoimplantation (ITT) 45j 86 arrecirct de warfarine 6 mois 92 arrecirct warfarine
Suivi moyen = 18 mois Primary EP AVC Deacutecegraves CV embolie systeacutemique
Safety EP Saignement majeur eacutepanchement peacutericardique migration de prothegravese
3 vs 49pt-y 102 vs 68 at 2 y
D Holmes Lancet 2009 374 534ndash42
Age moyen 72 ans
2621 ptanneacutee critegravere de supeacuterioriteacute RR 060 pour DC cardioV AVC embolie
systeacutemique
Diminution mortaliteacute toutes causes hazard ratio = 066 95 CI 045ndash098 P=0038
Beacuteneacutefice supeacuterieur Score HAS-BLED eacuteleveacute
gt75 ans
Diabegravete
Preacutevention IIaire AVC Reddy VY Long term results of PROTECT AF Heart Rhythm Society Scientific Sessions May 8ndash112013 Denver CO Reddy VY Circulation 2011123417ndash424
39 patients opeacutereacutes dans un centre deacutebutant lrsquoactiviteacute drsquoocclusion
Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212 Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212
Expeacuterience opeacuterateurs Formation
07
08
09
10
0 365 730 1095
Intent-to-Treat
Hemorrhagic Stroke
ITT cohort Superiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 53 12
463 275 95 23
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort (no) pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 1 4167 02 4 2247 18 013 0998 0986 pt-yr (00 09) (05 39) (000 080)
900 1 5936 02 6 3194 19 009 gt0999 0998 pt-yr (00 06) (07 37) (000 045)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Accegraves vasculaire Epanchement peacutericardique Embolie gazeuse Deacuteplacement de prothegravese
PLAATO
Sievert Circulation 20021051887ndash1889
CI aux AVK n=64
98 fermeture (flux lt3mm)
AVCAIT agrave 5 ans = 38an contre 66an attendus selon CHADSsup2
Randomized study of WATCHMAN LAA Device vs Long-term Warfarin Therapy CHADSsup2 ge 1
21 allocation ratio device to control N=707 (intervention 463 control 244) Intention to treat non inferiority trial
59 Enrolling Centers (US amp Europe) Follow-up Requirements
TEE follow-up at 45 days 6 months and 1 year Clinical follow-up biannually up to 5 years Regular INR monitoring while taking warfarin
Enrollment continues in Continued Access Registry
D Holmes Lancet 2009 374 534ndash42
PROTECT AF D Holmes Lancet 2009 374 534ndash42 PREVAIL D Holmes J Am Coll Cardiol 2014641ndash12
88 de succegraves drsquoimplantation (ITT) 45j 86 arrecirct de warfarine 6 mois 92 arrecirct warfarine
Suivi moyen = 18 mois Primary EP AVC Deacutecegraves CV embolie systeacutemique
Safety EP Saignement majeur eacutepanchement peacutericardique migration de prothegravese
3 vs 49pt-y 102 vs 68 at 2 y
D Holmes Lancet 2009 374 534ndash42
Age moyen 72 ans
2621 ptanneacutee critegravere de supeacuterioriteacute RR 060 pour DC cardioV AVC embolie
systeacutemique
Diminution mortaliteacute toutes causes hazard ratio = 066 95 CI 045ndash098 P=0038
Beacuteneacutefice supeacuterieur Score HAS-BLED eacuteleveacute
gt75 ans
Diabegravete
Preacutevention IIaire AVC Reddy VY Long term results of PROTECT AF Heart Rhythm Society Scientific Sessions May 8ndash112013 Denver CO Reddy VY Circulation 2011123417ndash424
39 patients opeacutereacutes dans un centre deacutebutant lrsquoactiviteacute drsquoocclusion
Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212 Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212
Expeacuterience opeacuterateurs Formation
07
08
09
10
0 365 730 1095
Intent-to-Treat
Hemorrhagic Stroke
ITT cohort Superiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 53 12
463 275 95 23
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort (no) pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 1 4167 02 4 2247 18 013 0998 0986 pt-yr (00 09) (05 39) (000 080)
900 1 5936 02 6 3194 19 009 gt0999 0998 pt-yr (00 06) (07 37) (000 045)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
PLAATO
Sievert Circulation 20021051887ndash1889
CI aux AVK n=64
98 fermeture (flux lt3mm)
AVCAIT agrave 5 ans = 38an contre 66an attendus selon CHADSsup2
Randomized study of WATCHMAN LAA Device vs Long-term Warfarin Therapy CHADSsup2 ge 1
21 allocation ratio device to control N=707 (intervention 463 control 244) Intention to treat non inferiority trial
59 Enrolling Centers (US amp Europe) Follow-up Requirements
TEE follow-up at 45 days 6 months and 1 year Clinical follow-up biannually up to 5 years Regular INR monitoring while taking warfarin
Enrollment continues in Continued Access Registry
D Holmes Lancet 2009 374 534ndash42
PROTECT AF D Holmes Lancet 2009 374 534ndash42 PREVAIL D Holmes J Am Coll Cardiol 2014641ndash12
88 de succegraves drsquoimplantation (ITT) 45j 86 arrecirct de warfarine 6 mois 92 arrecirct warfarine
Suivi moyen = 18 mois Primary EP AVC Deacutecegraves CV embolie systeacutemique
Safety EP Saignement majeur eacutepanchement peacutericardique migration de prothegravese
3 vs 49pt-y 102 vs 68 at 2 y
D Holmes Lancet 2009 374 534ndash42
Age moyen 72 ans
2621 ptanneacutee critegravere de supeacuterioriteacute RR 060 pour DC cardioV AVC embolie
systeacutemique
Diminution mortaliteacute toutes causes hazard ratio = 066 95 CI 045ndash098 P=0038
Beacuteneacutefice supeacuterieur Score HAS-BLED eacuteleveacute
gt75 ans
Diabegravete
Preacutevention IIaire AVC Reddy VY Long term results of PROTECT AF Heart Rhythm Society Scientific Sessions May 8ndash112013 Denver CO Reddy VY Circulation 2011123417ndash424
39 patients opeacutereacutes dans un centre deacutebutant lrsquoactiviteacute drsquoocclusion
Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212 Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212
Expeacuterience opeacuterateurs Formation
07
08
09
10
0 365 730 1095
Intent-to-Treat
Hemorrhagic Stroke
ITT cohort Superiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 53 12
463 275 95 23
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort (no) pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 1 4167 02 4 2247 18 013 0998 0986 pt-yr (00 09) (05 39) (000 080)
900 1 5936 02 6 3194 19 009 gt0999 0998 pt-yr (00 06) (07 37) (000 045)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Randomized study of WATCHMAN LAA Device vs Long-term Warfarin Therapy CHADSsup2 ge 1
21 allocation ratio device to control N=707 (intervention 463 control 244) Intention to treat non inferiority trial
59 Enrolling Centers (US amp Europe) Follow-up Requirements
TEE follow-up at 45 days 6 months and 1 year Clinical follow-up biannually up to 5 years Regular INR monitoring while taking warfarin
Enrollment continues in Continued Access Registry
D Holmes Lancet 2009 374 534ndash42
PROTECT AF D Holmes Lancet 2009 374 534ndash42 PREVAIL D Holmes J Am Coll Cardiol 2014641ndash12
88 de succegraves drsquoimplantation (ITT) 45j 86 arrecirct de warfarine 6 mois 92 arrecirct warfarine
Suivi moyen = 18 mois Primary EP AVC Deacutecegraves CV embolie systeacutemique
Safety EP Saignement majeur eacutepanchement peacutericardique migration de prothegravese
3 vs 49pt-y 102 vs 68 at 2 y
D Holmes Lancet 2009 374 534ndash42
Age moyen 72 ans
2621 ptanneacutee critegravere de supeacuterioriteacute RR 060 pour DC cardioV AVC embolie
systeacutemique
Diminution mortaliteacute toutes causes hazard ratio = 066 95 CI 045ndash098 P=0038
Beacuteneacutefice supeacuterieur Score HAS-BLED eacuteleveacute
gt75 ans
Diabegravete
Preacutevention IIaire AVC Reddy VY Long term results of PROTECT AF Heart Rhythm Society Scientific Sessions May 8ndash112013 Denver CO Reddy VY Circulation 2011123417ndash424
39 patients opeacutereacutes dans un centre deacutebutant lrsquoactiviteacute drsquoocclusion
Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212 Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212
Expeacuterience opeacuterateurs Formation
07
08
09
10
0 365 730 1095
Intent-to-Treat
Hemorrhagic Stroke
ITT cohort Superiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 53 12
463 275 95 23
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort (no) pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 1 4167 02 4 2247 18 013 0998 0986 pt-yr (00 09) (05 39) (000 080)
900 1 5936 02 6 3194 19 009 gt0999 0998 pt-yr (00 06) (07 37) (000 045)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
PROTECT AF D Holmes Lancet 2009 374 534ndash42 PREVAIL D Holmes J Am Coll Cardiol 2014641ndash12
88 de succegraves drsquoimplantation (ITT) 45j 86 arrecirct de warfarine 6 mois 92 arrecirct warfarine
Suivi moyen = 18 mois Primary EP AVC Deacutecegraves CV embolie systeacutemique
Safety EP Saignement majeur eacutepanchement peacutericardique migration de prothegravese
3 vs 49pt-y 102 vs 68 at 2 y
D Holmes Lancet 2009 374 534ndash42
Age moyen 72 ans
2621 ptanneacutee critegravere de supeacuterioriteacute RR 060 pour DC cardioV AVC embolie
systeacutemique
Diminution mortaliteacute toutes causes hazard ratio = 066 95 CI 045ndash098 P=0038
Beacuteneacutefice supeacuterieur Score HAS-BLED eacuteleveacute
gt75 ans
Diabegravete
Preacutevention IIaire AVC Reddy VY Long term results of PROTECT AF Heart Rhythm Society Scientific Sessions May 8ndash112013 Denver CO Reddy VY Circulation 2011123417ndash424
39 patients opeacutereacutes dans un centre deacutebutant lrsquoactiviteacute drsquoocclusion
Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212 Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212
Expeacuterience opeacuterateurs Formation
07
08
09
10
0 365 730 1095
Intent-to-Treat
Hemorrhagic Stroke
ITT cohort Superiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 53 12
463 275 95 23
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort (no) pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 1 4167 02 4 2247 18 013 0998 0986 pt-yr (00 09) (05 39) (000 080)
900 1 5936 02 6 3194 19 009 gt0999 0998 pt-yr (00 06) (07 37) (000 045)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
88 de succegraves drsquoimplantation (ITT) 45j 86 arrecirct de warfarine 6 mois 92 arrecirct warfarine
Suivi moyen = 18 mois Primary EP AVC Deacutecegraves CV embolie systeacutemique
Safety EP Saignement majeur eacutepanchement peacutericardique migration de prothegravese
3 vs 49pt-y 102 vs 68 at 2 y
D Holmes Lancet 2009 374 534ndash42
Age moyen 72 ans
2621 ptanneacutee critegravere de supeacuterioriteacute RR 060 pour DC cardioV AVC embolie
systeacutemique
Diminution mortaliteacute toutes causes hazard ratio = 066 95 CI 045ndash098 P=0038
Beacuteneacutefice supeacuterieur Score HAS-BLED eacuteleveacute
gt75 ans
Diabegravete
Preacutevention IIaire AVC Reddy VY Long term results of PROTECT AF Heart Rhythm Society Scientific Sessions May 8ndash112013 Denver CO Reddy VY Circulation 2011123417ndash424
39 patients opeacutereacutes dans un centre deacutebutant lrsquoactiviteacute drsquoocclusion
Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212 Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212
Expeacuterience opeacuterateurs Formation
07
08
09
10
0 365 730 1095
Intent-to-Treat
Hemorrhagic Stroke
ITT cohort Superiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 53 12
463 275 95 23
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort (no) pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 1 4167 02 4 2247 18 013 0998 0986 pt-yr (00 09) (05 39) (000 080)
900 1 5936 02 6 3194 19 009 gt0999 0998 pt-yr (00 06) (07 37) (000 045)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Suivi moyen = 18 mois Primary EP AVC Deacutecegraves CV embolie systeacutemique
Safety EP Saignement majeur eacutepanchement peacutericardique migration de prothegravese
3 vs 49pt-y 102 vs 68 at 2 y
D Holmes Lancet 2009 374 534ndash42
Age moyen 72 ans
2621 ptanneacutee critegravere de supeacuterioriteacute RR 060 pour DC cardioV AVC embolie
systeacutemique
Diminution mortaliteacute toutes causes hazard ratio = 066 95 CI 045ndash098 P=0038
Beacuteneacutefice supeacuterieur Score HAS-BLED eacuteleveacute
gt75 ans
Diabegravete
Preacutevention IIaire AVC Reddy VY Long term results of PROTECT AF Heart Rhythm Society Scientific Sessions May 8ndash112013 Denver CO Reddy VY Circulation 2011123417ndash424
39 patients opeacutereacutes dans un centre deacutebutant lrsquoactiviteacute drsquoocclusion
Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212 Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212
Expeacuterience opeacuterateurs Formation
07
08
09
10
0 365 730 1095
Intent-to-Treat
Hemorrhagic Stroke
ITT cohort Superiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 53 12
463 275 95 23
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort (no) pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 1 4167 02 4 2247 18 013 0998 0986 pt-yr (00 09) (05 39) (000 080)
900 1 5936 02 6 3194 19 009 gt0999 0998 pt-yr (00 06) (07 37) (000 045)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
D Holmes Lancet 2009 374 534ndash42
Age moyen 72 ans
2621 ptanneacutee critegravere de supeacuterioriteacute RR 060 pour DC cardioV AVC embolie
systeacutemique
Diminution mortaliteacute toutes causes hazard ratio = 066 95 CI 045ndash098 P=0038
Beacuteneacutefice supeacuterieur Score HAS-BLED eacuteleveacute
gt75 ans
Diabegravete
Preacutevention IIaire AVC Reddy VY Long term results of PROTECT AF Heart Rhythm Society Scientific Sessions May 8ndash112013 Denver CO Reddy VY Circulation 2011123417ndash424
39 patients opeacutereacutes dans un centre deacutebutant lrsquoactiviteacute drsquoocclusion
Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212 Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212
Expeacuterience opeacuterateurs Formation
07
08
09
10
0 365 730 1095
Intent-to-Treat
Hemorrhagic Stroke
ITT cohort Superiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 53 12
463 275 95 23
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort (no) pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 1 4167 02 4 2247 18 013 0998 0986 pt-yr (00 09) (05 39) (000 080)
900 1 5936 02 6 3194 19 009 gt0999 0998 pt-yr (00 06) (07 37) (000 045)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
2621 ptanneacutee critegravere de supeacuterioriteacute RR 060 pour DC cardioV AVC embolie
systeacutemique
Diminution mortaliteacute toutes causes hazard ratio = 066 95 CI 045ndash098 P=0038
Beacuteneacutefice supeacuterieur Score HAS-BLED eacuteleveacute
gt75 ans
Diabegravete
Preacutevention IIaire AVC Reddy VY Long term results of PROTECT AF Heart Rhythm Society Scientific Sessions May 8ndash112013 Denver CO Reddy VY Circulation 2011123417ndash424
39 patients opeacutereacutes dans un centre deacutebutant lrsquoactiviteacute drsquoocclusion
Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212 Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212
Expeacuterience opeacuterateurs Formation
07
08
09
10
0 365 730 1095
Intent-to-Treat
Hemorrhagic Stroke
ITT cohort Superiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 53 12
463 275 95 23
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort (no) pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 1 4167 02 4 2247 18 013 0998 0986 pt-yr (00 09) (05 39) (000 080)
900 1 5936 02 6 3194 19 009 gt0999 0998 pt-yr (00 06) (07 37) (000 045)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
39 patients opeacutereacutes dans un centre deacutebutant lrsquoactiviteacute drsquoocclusion
Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212 Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212
Expeacuterience opeacuterateurs Formation
07
08
09
10
0 365 730 1095
Intent-to-Treat
Hemorrhagic Stroke
ITT cohort Superiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 53 12
463 275 95 23
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort (no) pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 1 4167 02 4 2247 18 013 0998 0986 pt-yr (00 09) (05 39) (000 080)
900 1 5936 02 6 3194 19 009 gt0999 0998 pt-yr (00 06) (07 37) (000 045)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212 Holmes DR J Am Coll Cardiol 2014641ndash12 Price Circulation 2014130202-212
Expeacuterience opeacuterateurs Formation
07
08
09
10
0 365 730 1095
Intent-to-Treat
Hemorrhagic Stroke
ITT cohort Superiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 53 12
463 275 95 23
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort (no) pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 1 4167 02 4 2247 18 013 0998 0986 pt-yr (00 09) (05 39) (000 080)
900 1 5936 02 6 3194 19 009 gt0999 0998 pt-yr (00 06) (07 37) (000 045)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
07
08
09
10
0 365 730 1095
Intent-to-Treat
Hemorrhagic Stroke
ITT cohort Superiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 53 12
463 275 95 23
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort (no) pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 1 4167 02 4 2247 18 013 0998 0986 pt-yr (00 09) (05 39) (000 080)
900 1 5936 02 6 3194 19 009 gt0999 0998 pt-yr (00 06) (07 37) (000 045)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
07
08
09
10
0 365 730 1095
Intent-to-Treat All Stroke
ITT cohort Non-inferiority
criteria met
Eve
nt-
fre
e p
rob
ab
ility
Days 244 147 52 12
463 270 92 22
WATCHMAN
Control
900 patient-year analysis
Events Total Rate Events Total Rate RR Non- Superiority Cohort eve pt-yr (95 CI) (no) pt-yr (95 CI) (95 CI) inferiority
600 14 4093 34 8 2236 36 096 0927 0488 pt-yr (19 55) (15 63) (043 257)
900 15 5829 26 11 3181 35 074 0998 0731 pt-yr (15 41) (17 57) (036 176)
Device Control Posterior probabilities
Randomization allocation (2 device1 control)
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
95
n=407
Age moyen 74 ans
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
apixaban
rivaroxaban
dabigatran
Watchman
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Marquage CE Pas FDA
Etudes observationnelles
Reacuteduites
Aspirine + clopidogrel
Seacutecuriteacute similaire
Manque de donneacutees randomiseacutees
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
ASA-Plavix (ASAP) registry Watchmanreg prospective multicenter n=150 Received clopidogrel for 6 months and ASA indefinitely
without OAC (Hx of bleeding 93)
FU of 144plusmn86 months CHADSsup2 28 ndash CHAsup2DSsup2-VaSc 44
23y stroke (1 hemorragic stroke 06)
Ischaemic stroke rate was only 17year compared with 22y in the PROTECT AF device group and expected 73y (CHADSsup2)
By arbitrary practice it is usual to load ASA or clopidogrel naiumlve patients accordingly
Reddy V The ASA-Plavix (ASAP) Registry J Am Coll Cardiol 2013612551ndash2556
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Lrsquoavis du neurologuegastro-enteacuterologue prime
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Etude Multicentrique n=41 75 plusmn 10 ans CHADSsup2=30 plusmn 13 Succegraves exclusion 93 ETOScanner agrave 3 mois passage 24 Evegravenements
1 AIT (2) 8 (20) peacutericardiocentegraveses pour eacutep Peacutericardique 4 perforations of the LAA (9) 2 chirurgies
Patients devant ecirctre exclus
Diamegravetre aG gt40 mm Lobe derriegravere APulm Orientation posteacuterieure
Miller Heart Rhythm20140-1ndash7 In Press
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
The budget impact of left atrial appendage closure compared with adjusted-dose warfarin and dabigatran etexilate for stroke prevention in atrial fibrillation
METHODS AND RESULTS A budget impact model was constructed from a German payer
perspective across a 10-year time horizon Data from the PROTECT AF and RE-LY clinical studies
Clinical events included stroke major extracranial bleeding systemic embolism procedure-related complications and death
Costs for stroke included acute direct costs as well as long-term disability costs
The findings from this model suggest that LAAC provides long-term clinical and economic benefit while also reducing overall mortality
At 8 years LAAC was less expensive than dabigatran (euro15 061 vs euro16 184) and at 10 years it was only 10 more expensive than warfarin (euro16 736 vs euro15 168)
Amorosi Europace 2014 Aug16(8)1131-6
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Le coucirct drsquoune fermeture de lrsquoauricule G est limiteacute agrave la premiegravere anneacutee alors que celui drsquoun traitement ACO srsquoeacutelegraveve drsquoanneacutee en anneacutee
Indications actuelles limiteacutees agrave la FA compliqueacutee ou agrave risque (CHAsup2DSsup2-VaSc ge 2) avec contre-indication aux ACO (heacutemorragies+++) Consensus drsquoexpert
Proceacutedure invasive mais efficace y compris ge 75 ans Agrave proposer selon acircge physiologique Risques lieacutes agrave lrsquoAG une anticoagulation per-opeacuteratoire notamment Population agrave risque HAS-BLED eacuteleveacute et risque de chutes
Permet de sortir drsquoune impasse theacuterapeutique Etudes randomiseacutees disponibles non infeacuterioriteacute en
alternative aux AVK (PROTECT-AF PREVAIL) Pas de comparaison disponible vs NACO
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
FA Indications potentielles (prophylactiques) Score HAS-BLED ge 3 et CHAsup2DSsup2-VaSc gt3 (HAS)
Indication agrave une triple anticoagulation (cardiopathie ischeacutemique) prolongeacutee
Cancers Maladies inflammatoires du tube digestif IRC terminale (lt15mLmin) ThromboP
En compleacutement drsquoune ACO si AVC malgreacute INR theacuterapeutique
En compleacutement drsquoune ablation de FA par catheacuteter
+ =
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Meier Europace 2014 EHRAEAPCI Consensus Aug 29 pii euu174
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Guillaume DUTHOIT Hocircpital Pitieacute-Salpecirctriegravere PARIS Premiegravere Journeacutee Scientifique de Broca
01102014
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Protect AF
41 en ETO agrave 6 semaines
32 agrave un an
Pas de correacutelation avec eacutevegravenements mais faible occurrence
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
224 pts 17 subclinical high rate episodes ge5min within 6 months of PM implant FU 66 years
Gonzalez Heart Rhythm 2014 in press
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Gonzalez Heart Rhythm 2014 in press
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
thrombus sur la prothegravese
42 PROTECT AF
Indique une ACO +++
En cas de jet ge 5mm
14 agrave 6 semaines
8 agrave 6 mois
Maintien (N)ACO discussion fermeture percutaneacutee par coiumll si CI
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
uell
e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
bra
ux (
) FA paroxystique
FA permanenteNS
NS
NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Quelle FA faut-il anticoaguler
Incidence des accidents ischeacutemiques ceacutereacutebraux en fonction des co-facteurs
de risque chez les patients preacutesentant une FA chronique ou paroxystique
Analyse des patients inclus dans SPAF I II et III
ESC Guidelines EHJ 2010312369-2429 Recommandation IIa niveau A
0
2
4
6
8
10
Risque faible Risque modeacutereacute Risque eacuteleveacuteIncid
en
ce a
nn
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e d
es a
ccid
en
ts
isch
eacutem
iqu
es c
eacutereacute
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ux (
) FA paroxystique
FA permanenteNS
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NS
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke
Acta Cardiol 2013 Dec68(6)551-8 Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac
plug the Belgian Registry Kefer J1 Vermeersch P2 Budts W3 Depotter T4 Aminian A5 Benit E6 Stammen F7 Author information Abstract AIMS The aim of the present study was to evaluate the procedural feasibility the safety and the 1-year outcome
following left atrial appendage (LAA)closure using the Amplatzer cardiac plug (ACP) in Belgium METHODS AND RESULTS Data were prospectively collected among 90 consecutive patients undergoing LAA closure with an ACP in 7
Belgian centres between June 2009 and September 2012 The patients (56 males 74 +- 8 years) were at high risk for stroke (CHA2DS2-VASc = 44 +- 18) and bleeding (HAS-BLED = 33 +- 13)Technical success was obtained in all but one patient and procedural success was 95 Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case Minor complications were 3 insignificant pericardial effusions 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm At 1-y follow-up there were 4 deaths 2 minor strokes 1 tamponade and 1 myocardial infarction Overall survival was 94 and freedom from MAE was 88 In our population the expected annual stroke risk according to the CHA2DS2-VASc score was 508 while the observed stroke rate was 214year
CONCLUSIONS The Belgian registry shows that LAA closure using the ACP device is feasible and safe At 1-y follow-up the
observed stroke rate was 214year less than predicted by the CHA2DS2-VASc score Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke