Why is this study important?

The 8-center SWISS-APERO trial was the first trial to compare LAAO with the Amulet and Watchman FLX devices.

Should I change my practice because of these findings?

Amulet and Watchman FLX had similar technical and clinical outcomes. More procedure-related complications were observed with Amulet.  

What question was this study supposed to answer?

The study's primary endpoint was residual LAAO patency by CT angiography at 45 days or intraprocedural crossover due to inadequate closure.  

What did the study show?

221 patients were randomized to undergo LAAO with the Amulet device (n=111) or the Watchman device (n=110; 25 received Watchman 2.5, 85 received Watchman FLX). The primary endpoint occurred at similar frequency in the two groups (risk ratio [RR] 0.97, 95% confidence interval [CI] 0.80-1.16). Amulet was associated with more procedure-related complications than Watchman (9.0% vs. 2.7%, p=0.047), driven principally by major bleeding (7.2% vs.1.8%, p=0.054). Device-related thrombus by CT was similar between the groups (Amulet 1 [0.9%], Watchman 3 [3.0%]).  At 45 days, both device groups had similar clinical outcomes.   

How good was the approach/methodology?

Well-designed and run study. Sample size was small, and duration of follow-up was short. Larger studies with long-term outcomes will be important to compare these two LAAO devices.  
 

All editors: Andrew M. Goldsweig, MD, MSC, RPVI, FSCAI