Author + information
- Mohammad-Ali Jazayeri,
- Venkat Lakshmi Kishan Vuddanda,
- Valay Parikh,
- Madhav Lavu,
- M. Rizwan Afzal,
- Mohit Turagam,
- Sudharani Bommana,
- Donita Atkins,
- Luigi Di Biase,
- Andrea Natale,
- Saibal Kar,
- Vijay Swarup,
- Madhu Reddy and
- Dhanunjaya Lakkireddy
Background: Percutaneous left atrial appendage closure (LAAC) is effective for stroke prevention in atrial fibrillation (AF) patients unable to tolerate long-term oral anticoagulation. We analyzed the safety of two commonly used LAAC methods using surveillance data from the FDA MAUDE database.
Methods: Of 622 retrievals for LARIAT® & WATCHMAN™ devices between May 1, 2006 and May 1, 2016, 356 unique reports were analyzed and safety events extracted. The number of cases performed over the period was estimated from published literature and personal communication with manufacturers. Proportions of combined stroke/TIA, pericardiocentesis and death were compared with chi-squared test.
Results: LAAC was performed with LARIAT in approximately 4,000 cases. WATCHMAN was used in 2,027 patients prior to FDA approval and an estimated 1,808 post market cases. Temporal trends were notable in both groups for a surge in complications after introduction into routine clinical practice (Figure). The composite outcome occurred more frequently with WATCHMAN (2.50 vs. 0.83%; p < 0.0001) as compared to LARIAT. The same phenomenon was observed when comparing the WATCHMAN pre- and post-approval experiences (Figure).
Conclusions: MAUDE passive surveillance data show an increase in complications for both LARIAT and WATCHMAN during the early adoption phase. The composite outcome occurred more frequently with WATCHMAN, both compared to LARIAT and when comparing pre- and post-market WATCHMAN experiences.
Moderated Poster Contributions
Arrhythmias and Clinical EP Moderated Poster Theater, Poster Hall, Hall C
Friday, March 17, 2017, 10:00 a.m.-10:10 a.m.
Session Title: Atrial Fibrillation, Anticoagulation and Novel Device Therapies
Abstract Category: 5. Arrhythmias and Clinical EP: Devices
Presentation Number: 1134M-03
- 2017 American College of Cardiology Foundation