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

Area of Science:

• Cardiology
• Medical Devices
• Interventional Cardiology

Background:

• Atrial fibrillation-related stroke is a significant cause of death and disability.
• The comparative effectiveness and safety of different left atrial appendage closure (LAAC) devices, and their comparison to anticoagulation, require further clarification.

Purpose of the Study:

• To conduct a systematic review and network meta-analysis (NMA) comparing the Watchman and Amplatzer Amulet LAAC devices.
• To compare LAAC devices against each other and against warfarin or direct oral anticoagulants (DOACs).
• To evaluate primary effectiveness outcomes (stroke, all-cause death) and safety outcomes (thromboembolism, device embolization, pericardial effusion).

Main Methods:

• Systematic review and network meta-analysis (NMA) of randomized controlled trials (RCTs).
• Included 6 RCTs with 3666 participants comparing Watchman and Amulet LAAC devices, warfarin, or DOACs.
• Primary comparisons focused on LAAC devices, with secondary comparisons to anticoagulation.

Main Results:

• No significant difference in stroke risk between Amulet and Watchman (RR=1.48, 95% CI: 0.64-3.46).
• No significant difference in all-cause death risk between Amulet and Watchman (RR=1.00, 95% CI: 0.59-1.70).
• Higher risk of pericardial effusion with Amulet compared to Watchman (RR=2.12, 95% CI: 1.45-3.09).

Conclusions:

• The Amplatzer Amulet and Watchman LAAC devices demonstrate comparable risks for stroke, mortality, thromboembolism, and device embolization.
• The risk of pericardial effusion is significantly higher with the Amulet device than with the Watchman device.
• Both LAAC devices showed an increased risk of pericardial effusion compared to warfarin.