Clinical Electrophysiology -> Atrial Fibrillation & Atrial Flutter: -> Left Atrial Appendage Closure D-PO02 - Poster Session II (ID 47) Poster

D-PO02-210 - Adverse Events After Watchman Left Atrial Appendage Closure: 5-year Post-approval Report From The Manufacturer And User Facility Device Experience (MAUDE) Database (ID 1062)


Background: There is limited “real-world” post-approval safety data regarding Watchman left atrial appendage closure (LAAC) for stroke prevention in non-valvular atrial fibrillation (AF).
Objective: To perform an analytical review of the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database to identify adverse events (AE) reported by real-world clinical practitioners using the Watchman LAAC device in the 5-year post-approval era.
Methods: Database was independently searched by three independent investigators between 4/1/2015- 9/30/2019. AE and clinical outcomes were identified as discrete events and reported cumulatively as absolute numbers or %.
Results: A total of 2,789 AE were reported with an estimated rate of 3.9% ( ̴ 70,000 devices were sold in the United States since Watchman’s approval). Reporting of AE increased from 2015-2019 (Figure). Mortality reported in 6.6% (N=185). The most commonly reported AE was pericardial effusion 30.9% (N=863) of which 77% (N=665) required intervention/surgery. Device-related thrombus (DRT) was reported in 12.8% (N=359), majority of which occurred within 1-year (52.3%) of implant. Cerebrovascular accident (CVA) was reported in 8.1% (N = 226) of which 28.7% occurred within 1 year. Device embolization (DE) was reported in 5.8% (N = 163), 64% were retrieved of which 40% required surgery.
Conclusion: Watchman related-adverse events are low but continue to be reported in the MAUDE database. It is anticipated that further refinement in technology with the Watchman FLX and improving operator experience will minimize these complications.