Left Atrial Appendage Closure Devices. Atrial Fibrillation 10/11/2017

Transcription

1 Left Atrial Appendage Closure Devices Emile Daoud, MD Chief, Cardiac Electrophysiology Wexner Medical Center, The Ohio State University Atrial Fibrillation 1

2 Adjusted Annual Stroke Risk Using CHA 2 DS 2 -VASc Score n = 7329 Annual Stroke Risk ± ASA Esp Age OAC CHA 2 DS 2 -VASc Score Camm AJ et al. Eur Heart J. 2010;31: Stroke Related to AF Percent of Total Strokes Attributable to AF % 15 Age 2

3 Stroke in Atrial Fibrillation: Stockholm Cohort of AF Stroke risk persists and is equal in the asymptomatic AF, low AF burden or high AF burden patient Stroke risk unchanged despite a Unadjusted survival free from ischemic stroke strategy of rhythm control! Multivariably adjusted survival free from ischemic stroke Friberg L et al. Eur Heart J. 2010;31: Perception is Not Reality Use of AAD s and Maintenance of SR Does Not Reduce Stroke Risk. Anticoagulation is Forever!!! 3

4 Left Atrial Appendage Anatomy & Stroke LAA Thrombus 4

5 Use of OACs in AF Peaks at ~50% Use Declines with Increasing Risk Warfarin Bleeding risk Daily regimen High non-adherence rates Regular INR monitoring Food and drug interaction issues Complicates surgical procedures Novel Oral Anticoagulants Bleeding risk Daily regimen High non-adherence rates Complicates surgical procedures Lack of reversal agents High cost Red Line = OAC (DOAC + Warfarin) Hsu, J et al. JAMA Cardiol. ~30% of DOAC Patients Stop Drug at 2 Years Source: Martinez C, et al. Therapy Persistence in Newly Diagnosed Non-Valvular Atrial Fibrillation Treated with Warfarin or NOAC. A Cohort Study. Thromb Haemost Dec 22;115(1):31-9. doi: /TH

6 Left Atrial Appendage Occluders In US, WATCHMAN and Lariat Components for Lariat Percutaneous LAA Ligation Procedure 12 K Bartus et. Al. J Am Coll Cardiol

7 Percutaneous Pericardial Access Anterior Approach Krzysztof Bartus, Frederick T. Han, Jacek Bednarek, Jacek Myc, Boguslaw Kapelak, Jerzy Sadowski, Jacek Lela... Fluoroscopic Guidance to Assist in the Closure of the LAA 14 K Bartus et. Al. J Am Coll Cardiol 2012 i 7

8 TEE Guidance Of Lariat Closure Lariat LAA Ligation Results (N=89) Successful ligation, 96% Complications related to access, 3.3% No stroke 30 Day Closure 95% 1 Year Closure 100% No post procedure anticoagulation K Bartus et. Al. J Am Coll Cardiol

9 Lariat Clinical trials for FDA labeling Advantages Excellent closure results No post procedure anticoagulation required Disadvanatges Technically challenging Not for patients with prior heart surgery 17 WATCHMAN Procedure Percutaneous / Transseptal access via Femoral vein General Anesthesia TEE Anticoagulated 1-2 hour procedure Inpatient x 1 night Discharged on adequate OAC + ASA 9

10 WATCHMAN LAA Closure Device 160 Micron Membrane Anchors Percutaneous access Sizes: 21, 24, 27, 30, 33 mm Nitinol frame 10 Active fixation anchors 160 micron membrane cap 95% implant success rate Warfarin Cessation 92% after 45 days >99% after 12 months Holmes, DR et al. JACC 2014; Vol. 64, No. 1 TEE Views of WATCHAMN Device At or Just Distal to LAA Ostium 10

11 WATCHMAN: Left Atrial Appendage Occlusion Mechanical Anticoagulation Device Endothelialization Canine 30 Day Canine 45 Day Human Pathology - 9 Months Post- Implant (Non-device related death) 11

12 Procedural Outcomes Improve with Each Clinical Trial PROTECT-AF: Noninferiority Trial vs Warfarin Primary Efficacy Endpoint No difference in stroke Reduction in hemorrhagic stroke with Watchman resulted in reduction in CV Death 12

13 Pooled Analysis of WATCHMAN Trials Favors WATCHMAN Favors Warfarin Documented in medical record WATCHMAN Therapy National Coverage Determination Effective Feb. 8, 2016 CMS will cover percutaneous LAAC implants when: CHADS 2 score 2 or a CHA 2 DS 2 -VASc score 3 Suitable for short-term warfarin, but not long-term OAC Documentation of a formal shared decision interaction between patient and an independent non-interventional physician using OAC evidence-based decision tool LAA Registry: Patients must be enrolled in a prospective national registry Operator requirements: IC or EP or CV surgeon must perform at least 25 transseptal punctures in 2 years and 12 must be for LAAC Facility Requirements: The procedure must be in a hospital with structural heart disease and/or electrophysiology program 13

14 Initial US Post Approval WATCHMAN Experience Data collated by representative at procedure; No post discharge data Implant success: 95.6% Complications: 2.6% Procedure Mortality: 0.8% EWOLUTION Post Market Study WATCHMAN O-US Large Percent on Dual Antiplatelet Prospective, multicenter registry at 47 centers 1025 patients, Mean age 73 Higher CHA2DS2-VASc 4.5 ± 1.6 vs RCT Prior TIA/Ischemic CVA in 31% Hemorrhagic stroke in 15% Major bleeding in 73%, deemed unsuitable for OAC Would not have been enrolled in any US trial Procedure success in 98.5% 14

15 EWOLUTION Post Market Study WATCHMAN O-US: 1 Year Follow Up All cause mortality, 9.8% Major bleeding, 2.6% Predominantly non- procedure/device related Ischemic stroke rate was 1.1% Device-related thrombus, 3.7% No difference between patients treated with antiplatelet therapy (8.3%) vs warfarin (8%) Lessons from US & O-US Post Market Studies Procedural success is high Procedural complications are low Successful occlusion of LAA 15

16 Future Investigations Do we need to exclude patients who are truly intolerant to anticoagulants? Currently enrolling at OSU After implant, do pts require OAC If yes, which OAC studied on warfarin Warfarin higher rate of bleeding vs DOACs DOAC use in devices? Akin to mechanical valves Is DAPT adequate? Is WATCHMAN better than DOACs? Last Word Multiple RCTs with extended follow up confirm LAA occlusion with WATCHMAN reduces bleeding complications associated with chronic anticoagulation and provides mechanical thromboprophylaxis at least equivalent to warfarin Be ready many next generation devices are coming to clinical trials for LAA occlusion 16

17 Thank You 17