Safety profiles of percutaneous left atrial appendage closure devices: An analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database from 2009 to 2016

Abstract

Background: Percutaneous left atrial appendage closure (LAAC) is a viable option for AF patients who are unable to tolerate long-term oral anticoagulation (OAC). Objective:We sought to assess the safety of two commonly used percutaneous devices for LAA closure in the United States by analysis of surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database. Methods

Exploring the dark side of left atrial appendage closure devices

“…During the study period, the LARIAT ® was implanted in 4,889 patients while the WATCHMAN™ in 5,849 patients. Interestingly, the complication rate observed with WATCHMAN™ appeared higher than what has been reported in recent registries, with higher point estimates for pericardial tamponade (0.5% higher), pericardial effusion (+0.15%), periprocedural stroke (+0.082%), device embolization (+0.28%), and death (+0.21%) . In addition, the composite endpoint of stroke/TIA, pericardiocentesis, cardiac surgery, and death appeared higher with WATCHMAN™ compared with LARIAT ® (1.93% vs. 1.15%, P = 0.001 for comparison).…”

“…Data gaps of this magnitude are unacceptable by any standard, especially when some of the gaps were related to death. Finally, the problem of under‐reporting is highlighted by the absence of reports for postprocedural LAA leaks and intracardiac thrombi, as correctly highlighted by Jazayeri et al . It is even more unlikely that there were no LARIAT ® ‐related complications reported to the MAUDE database during the 2016 portion of the study.…”

“…In this issue of the Journal , Jazayeri et al. present an analysis of complications of the WATCHMAN™ and LARIAT ® reported to the FDA Manufacturer and User Facility Device Experience (MAUDE) database between years 2006 and 2016 . During the study period, the LARIAT ® was implanted in 4,889 patients while the WATCHMAN™ in 5,849 patients.…”

“…In conclusion, Jazayeri et al . have taught us several valuable lessons: first, FDA approval does not ensure safety.…”

The Authors’ reply

“…These patients have been shown to be at extremely high risk of both thromboembolic events and recurrent bleeding, and often have no viable alternative other than LAAO 2. We believe that provided patients are appropriately counselled about the procedural risks of LAAO,3 they will likely stand to benefit from this important technology. The low rate of recurrent thromboembolic events seen in this patient cohort on follow-up in our study, as well as the mild and completely reversible nature of such events, offers optimism in this regard.…”