Author + information
- Received June 18, 2019
- Revision received August 29, 2019
- Accepted September 16, 2019
- Published online December 2, 2019.
- David R. Holmes Jr., MDa,∗ (, )@MayoClinicCV,
- Vivek Y. Reddy, MDb,
- Nicole T. Gordon, BSEEc,
- David Delurgio, MDd,
- Shephal K. Doshi, MDe,
- Amish J. Desai, MDf,
- James E. Stone Jr., MDg and
- Saibal Kar, MDh
- aMayo Clinic, Rochester, Minnesota
- bIcahn School of Medicine at Mount Sinai, New York, New York
- cBoston Scientific, St. Paul, Minnesota
- dEmory University, Atlanta, Georgia
- ePacific Heart Institute, Santa Monica, California
- fLegacy Health Cardiology, Portland, Oregon
- gNorth Mississippi Medical Center, Tupelo, Missouri
- hCenter of Advanced Cardiac and Vascular Interventions, Los Angeles, California
- ↵∗Address for correspondence:
Dr. David R. Holmes, Jr., Mayo Clinic, 200 First Street SW, Rochester, Minnesota 55905.
Background Long-term data on the safety and efficacy of left atrial appendage closure (LAAC) for stroke prevention in patients with nonvalvular atrial fibrillation remain limited.
Objectives The purpose of this study was to evaluate 4.5- to 5-year data in 2 U.S. Food and Drug Association LAAC mandated registries (CAP [Continued Access to PROTECT-AF] and CAP2 [Continued Access to PREVAIL]) for safety and efficacy.
Methods Two registries of patients implanted with LAAC devices provide the largest source of follow-up data. Both accompanied their respective randomized clinical trials, PROTECT-AF (Watchman Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation) and PREVAIL (Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device In Patients with Atrial Fibrillation versus Long Term Warfarin Therapy), which used the same endpoints (primary efficacy of composite of stroke, systemic embolism, cardiovascular/unexplained death, and safety).
Results CAP included 566 patients with an average follow-up of 50.1 months (2,293 patient-years), and CAP2 included 578 patients with an average follow-up of 50.3 months (2,227 patient-years). CAP2 patients were significantly older and had higher CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke/transient ischemic attack, vascular disease, age 65 to 74 years, sex category) scores (4.51 vs. 3.88; p < 0.001). Procedural success was similar in both (94%). The primary composite endpoint occurred at a rate of 3.05 per 100 patient-years in CAP and 4.80 per 100 patient-years in CAP2; events contributing to this endpoint were most commonly cardiovascular/unexplained death (1.69 per 100 patient-years for CAP and 2.92 per 100 patient-years for CAP2). Hemorrhagic stroke was significantly less than ischemic stroke (0.17 per 100 patient-years in CAP and 0.09 per 100 patient-years in CAP2), and total stroke rates were significantly less than predicted by CHA2DS2-VASc score (78% reduction with CAP, 69% reduction with CAP2).
Conclusions These registries, which contain the longest and largest follow-up data of patients with the Watchman device, support LAAC as a safe and effective therapy for long-term anticoagulation in patients with nonvalvular atrial fibrillation, and document the lowest rate of hemorrhagic stroke identified in this population.
Dr. Holmes is a member of the advisory board (unreimbursed) for Boston Scientific. Dr. Reddy has received research grant support from and served as a consultant to Boston Scientific, Abbott, and Biosense Webster (significant); and has served as a consultant for and has equity in Surecor (significant). Ms. Gordon is a salaried employee of Boston Scientific. Dr. Delurgio has received speaking fees and research support from and served as a consultant to Abbott Medical and Boston Scientific. Dr. Doshi has received research grant support from, served as a consultant for, and served as National Principal Investigator for CAP2 for Boston Scientific (significant). Dr. Desai has served as an Advisory Board Member and Proctor for Boston Scientific. Dr. Stone has performed consulting work in the form of physician training and proctoring cases for Boston Scientific. Dr. Kar has received research grant support from, served on the Advisory Board for, served as National Principal Investigator for CAP and CAP2, and served as proctor for left atrial appendage closure for Boston Scientific (significant); has received research grant support from and served as a member of the Advisory Board for structural heart disease for Abbott Vascular (significant); and has received personal fees from Valcore, W.L. Gore, and Medtronic. Lucas V. Boersma, MD, PhD, served as Guest Associate Editor for this paper.
- Received June 18, 2019.
- Revision received August 29, 2019.
- Accepted September 16, 2019.
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