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

D-PO02-211 - Post-Approval Safety Outcomes Of Percutaneous Left Atrial Appendage Closure With Watchman Device: An Analysis Of The FDA MAUDE Database From 2015 To 2019 (ID 256)

 P.A. Ledesma: Nothing relevant to disclose.


Background: Recent studies suggest that occlusion of the left atrial appendage (LAA) is a viable strategy for stroke risk reduction in patients with non-valvular AF who qualify for OAC therapy but are not good candidates for long-term anticoagulation.
Objective: Real-world assessment of the safety profile associated with the Watchman procedure post-FDA approval remains limited. In this study, we queried the FDA Manufacturer and User Facility Device Experience (MAUDE) database to identify adverse events and analyze the safety profile of the Watchman device after FDA approval in the United States.
Methods: A review of complications associated with the Watchman device was performed using the FDA MAUDE database from March 2015 (FDA approval date) through February 2019.
Results: Over the four-year study period, 2,257 valid reports were identified in the MAUDE database, accounting for 3,652 unique adverse events. An estimated 50,000 Watchman implants were performed in the U.S. during the study period, resulting in an estimated adverse event rate of 7.3% and a fatality rate of 0.36%. From the total pool of 3,652 adverse events, a total of 159 unique types of adverse events were identified (Figure 1). The most frequent complication was pericardial effusion (1.41%), and the most frequent interventions reported were pericardiocentesis (1.0%) and cardiac surgery (0.4%).
Conclusion: LAA closure is an important alternative for stroke prevention in high-risk patients in whom oral anticoagulant therapy is contraindicated. The closure procedure may be associated with serious adverse events.