Core Concepts
No significant difference between Amulet and Watchman FLX for left atrial appendage closure outcomes.
Abstract
The SWISS-APERO trial compared the Amulet and Watchman FLX devices for left atrial appendage closure (LAAC) outcomes. Both devices showed similar results in residual LAA patency, device-related thrombus rates, and clinical outcomes at 13 months. The trial included patients with high bleeding risk and suitable LAA anatomy for either device. Key highlights include:
- Similar rates of residual LAA patency and subtypes at 13 months.
- Comparable device-related thrombus rates at 13 months.
- No significant differences in clinical outcomes between the two devices.
- High-risk patient population with prior bleeding events.
- Challenges in interpreting CT imaging for leaks and thrombus.
- Need for consensus on leak definitions and further prospective studies.
- Association between leaks and clinical events not clearly established.
- Importance of minimizing leaks to reduce thromboembolic events.
Stats
Rates of residual LAA patency for Amulet was 53.6% vs 48.8% for Watchman FLX.
Device-related thrombus rates were 1.2% vs 1.3% for Amulet and Watchman FLX, respectively.
Major bleeding (BARC 3-5) occurred in 16.5% of Amulet patients and 9.3% of Watchman patients.
Quotes
"One thing that was interesting at that time was that the leak rates as identified by CT were about 70% in both groups, plus minus." - Roberto Galea
"Leaks approximately double the rate of ischemic stroke." - Vivek Reddy
"With a CT, we see too much, and we are seeing some difficulties, difficulties to interpret what we see." - Roberto Galea