Comparing Effectiveness and Safety of Left Atrial Appendage Closure Devices: A Network Meta-Analysis of Randomized Controlled Trials.

INTRODUCTION

Atrial fibrillation-related stroke is a leading cause of morbidity and mortality. The comparative effectiveness and safety of left atrial appendage closure (LAAC) devices, compared with one another and with anticoagulation, is unclear.

METHODS

We conducted a systematic review and network meta-analysis (NMA) of all clinical trials comparing the Watchman and Amplatzer Amulet LAAC devices with each other or with warfarin or direct oral anticoagulants (DOACs). The primary comparison was between LAAC devices with secondary comparisons to anticoagulation. The primary effectiveness outcomes were any stroke and all-cause death. Safety outcomes included any thromboembolism, device embolization, and pericardial effusion.

RESULTS

There were 476 articles identified from the search and 6 eligible RCTs were included (n = 3666). There was no difference in the risk of stroke with Amulet versus Watchman (RR = 1.48, 95% CI: 0.64-3.46, I2 = 41.3%), nor in the risk of death (RR = 1.00, 95% CI: 0.59-1.70, I2 = 45.0%). Risk of thromboembolism was not significantly different with Amulet versus Watchman (RR = 0.73, 95% CI: 0.18-2.97, I2 = 0%), nor was risk of device embolization (RR = 2.29, 95% CI: 0.71, 7.43, I2 = 0%). Both devices exhibited increased risk of pericardial effusion compared with warfarin, with Amulet at highest relative risk (RR = 27.08, 95% CI: 3.53-207.98, I2 = 0%) followed by Watchman (RR = 12.79, 95% CI: 1.73-94.85, I2 = 0%). Amulet also carried higher relative risk of pericardial effusion than Watchman (RR = 2.12, 95% CI: 1.45-3.09).

CONCLUSION

In this NMA, the Amulet and Watchman LAAC devices were associated with similar risks for stroke, mortality, thromboembolism, and device embolization. Pericardial effusion risk was higher with Amulet than Watchman.