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

D-PO02-218 - Time-To-Event Analysis Of Complications Associated With Watchman Implantation For LAA Closure: Analysis Of The FDA Maude Database 2015 To 2019 (ID 261)

 P.A. Ledesma: Nothing relevant to disclose.


Background: In March 2015, the FDA approved the Watchman device for left atrial appendage closure to reduce the risk of stroke in selected patients with AF in whom OAC is contraindicated.
Objective: To analyze the time course of adverse events associated with Watchman implantation procedures using the FDA MAUDE database.
Methods: A search of the MAUDE database for medical device reports (MDRs) pertaining to the WATCHMAN device returned 3,652 events reported in 2,257 MDRs between March 2015 (FDA approval date) and March 2019. The time course of the reported adverse events was analyzed.
Results: A majority of the adverse events (n=2,148; 58.8%) occurred intraoperatively and an additional 528 (14.5%) events occurred on the same day of the procedure. Among patients with stroke and TIA, 8 cases occurred intraoperatively, 19 additional cases occurred on the same day of the procedure, 32 cases occurred between postoperative day 2 and 30, 21 cases occurred within 12 months after the procedure, and 26 cases were reported after 1-year of Watchman implantation. The timing of stroke and TIA was not specified in 71 cases. Among 178 deaths, 27 occurred intraoperatively, 15 additional deaths occurred on the day of the procedure, 62 occurred between postoperative day 2 and 30, and 22 deaths occurred within 12 months after the procedure. Another 12 deaths occurred more than one year after the procedure, and the time of death was not specified in 40 cases (Table 1).
Conclusion: A majority of the adverse events (73.3%) related to Watchman implantation occur intraoperatively or during the day of implant. However, a low rate of serious complications may occur during and after the first year following device implantation.