Left atrial appendage occlusion

Transcription

1 Kardiologie Left atrial appendage occlusion Mischa Kühne Kardiolunch,

2 Overall stroke rate 5% per year CHA 2 DS 2 VASC score Most AF patients need protection from stroke ESC guidelines AF, 2010/2012

3 Oral anticoagulation for stroke prevention Warfarin NOAC versus Warfarin W vs Placebo W vs W low dose W vs Aspirin W vs Aspirin + Clop W vs Ximelagatran Stroke and SE Relative risk (95% CI) Death CV death Stroke and SE Ischemic stroke Major bleeding ICH Myocardial infarction N= relatives Risiko (95% CI) -10% % % Favors Warfarin Favors other Rx Favors NOAC Favors Warfarin 1. Lip G, Edwards SJ. Thromb Res Dentali F. Circluation 2012.

4 probability of persistence (%) Real world? Overuse and underuse! Non-persistence Kaplan Meier curve for persistence on therapy 100 ahr=0.63 ( ), p< % 78% 74% 67% rivaroxaban warfarin 64% 50 53% Basel time to non-persistence (days) Altmann D et al., Swiss Med Wkly 2010 Nelson WW, et al. Curr Med Res Opin 2014

5 Reasons for stopping/not using OAC

6 The LAA: the lethal attachment? ACUTE study: - Thrombus in 14% of patients with AF and without OAC - 88% of thrombi in the LAA Atrial Diastole Atrial Systole Sinus Rhythm patient AF patient, in sinus rhythm - LAA paralysis - Poor LAA filling Klein, et al. N Engl J Med, 2001 Holmes D, et al. Circulation 2009

7 Surgical elimination Recommended during Mitral valve surgery AF surgery Paucity of data Incomplete occlusions 55% with suture 28% stapler clip (AtriClip ) Occlusion of the LAA

8 Interventional LAA closure

9 The evidence PROTECT AF: Randomized Prospective Trial of Percutaneous LAA Closure vs Warfarin for Stroke Prevention in AF Prospective, randomized study of WATCHMAN LAA Device vs. Long-term Warfarin Therapy 2:1 allocation ratio device to control Device Group (463) Control Group (244) 59 Enrolling Centers (U.S. & Europe) TTR: 70% Holmes DR at al., Lancet 2009

10 Warfarin Discontinuation 87% of implanted subjects were able to cease warfarin at 45 days and the rate further increased at later time points Visit Watchman n/total (%) 45 day 349/401 (87.0) 6 month 347/375 (92.5) 12 month 261/280 (93.2) 24 month 95/101 (94.1) Reasons for remaining on warfarin therapy after 45-days: Observation of flow in the LAA (n = 30) Physician Order (n = 13) Other (n = 9)

11 PROTECT AF: Study design Primary Efficacy Endpoint All stroke Systemic embolization Cardiovascular and unexplained death Primary Safety Endpoint Device embolization requiring retrieval Pericardial effusion requiring intervention Cranial bleeds and gastrointestinal bleeds Any bleed that required 2uPRBC Key Inclusion Criteria Age 18 years or older Documented non-valvular AF Eligible for long-term warfarin therapy Calculated CHADS2 score > 1

12 Event-free probability PROTECT AF: Randomized Prospective Trial of Percutaneous LAA Closure vs Warfarin for Stroke Prevention in AF Primary Efficacy Endpoint All stroke Systemic embolization Cardiovascular and unexplained death Primary Safety Endpoint Device embolization Tamponade Cranial and GI bleeds Any bleed that required 2uPRBC WATCHMAN N= centers TTR: 70% Non-inferiority criteria met Control '095 Days Holmes DR at al., Lancet 2009

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14 Safety was an issue! Peri-procedural risk must be weighed against risk of long-term anticoagulation! Reddy V et al., Circulation 2011 Reddy V et al., Circulation 2013

15 Safety?

16 Safety?

17 Will LAA closure PREVAIL? PREVAIL trial Prospective Randomized Evaluation of the Watchman LAA Closure Device in Patients with AF vs Long-term Warfarin Therapy 1. First coprimary endpoint - (composite of stroke, SE and CV/unexplained death) Criteria met? 2. Second coprimary endpoint - (stroke or SE >7days post randomization) BUT safety performance goals were met (2.2% early safety events) Holmes DR at al., JACC 2014

18 PREVAIL Update June 2014 Late strokes occurring in the device group (n=13) Versus n=1 in the control (NB: 2:1 randomization) 1. First coprimary endpoint - (composite of stroke, SE and CV/unexplained death) Criteria met? 2. Second coprimary endpoint - (stroke or SE >7days post randomization) Holmes DR at al., JACC 2014

19 Back to PROTECT-AF: Results after 4 years Stroke Syst. Embolism CV Death Major bleeding Procedural complications Reddy V et al., JAMA 2014

20 Mortality benefit compared to Warfarin! Reddy V et al., JAMA 2014

21 In the news!

22 Approval letter from the FDA

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24 3 endovascular devices currently available PLAATO WATCHMAN Boston Scientific vorher WaveCrest Biosense Webster Amplatzer Amulet St. Jude Medical nachher

25 Performing LAA occlusion Sizing is the challenging part of LAA closure

26 Performing LAA occlusion

27 Endo-epi device-based ligature (Lariat)

28 Antithrombotic protocols post LAA closure Depends on the indication Loading Aspirin + Clopidogrel Aspirin + Clopidogrel for 1 month, then Aspirin for 6 months > STOP Lifelong Aspirin recommended by many Watchman: Warfarin continued for 45 days after LAA closure Follow-up using TEE Lewalter T, et al. Europace 2014

29 Guidelines and EHRA survey 2015 Clinical practice in Europe (33 centers): Main indication (94%): AF, CHA 2 DS 2 VASC 2 AND Pison, L, et al. Europace 2015 contraindication to OAC Camm AJ et al, Eur Heart J 2012

30 EHRA/EAPCI expert consensus statement Meier B, et al, Europace 2014

31 Patient selection De Backer, Open Heart 2014

32 Summary OAC underused in AF LAA closure in patients with a contraindication to OAC LAA closure as a primary alternative? Only 2 RCT -> More studies needed! (NOAC!!!) Selected patients with a high bleeding risk

33 Fragen? Ich bin ganz Ohr