Comparison of Amulet and Watchman for Left Atrial Appendage Closure

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

Key Insights Distilled From

Amulet and Watchman Equal for Left Atrial Appendage Closure

by Daniel M Kel... at www.medscape.com 12-08-2023

https://www.medscape.com/viewarticle/amulet-and-watchman-equal-left-atrial-appendage-closure-2023a1000urp

Deeper Inquiries

What implications do the findings of this trial have for the selection of LAAC devices in clinical practice?

The findings of the SWISS-APERO trial comparing the Amulet and Watchman FLX devices for left atrial appendage closure (LAAC) have significant implications for the selection of LAAC devices in clinical practice. The trial demonstrated that outcomes at 13 months did not differ between the two devices in terms of residual LAA patency, device-related thrombus (DRT), and clinical outcomes. This suggests that both the Amulet and Watchman FLX devices are equally effective in reducing thrombus formation and stroke risk in patients with non-valvular atrial fibrillation. Therefore, clinicians can choose either device based on factors such as patient preference, device availability, and procedural expertise.

Is the sensitivity of CT imaging for leaks in LAAC devices a limitation in clinical decision-making?

The sensitivity of CT imaging for leaks in LAAC devices can be considered a limitation in clinical decision-making. While CT imaging is more sensitive in detecting leaks compared to transesophageal echocardiography (TEE), it may lead to the identification of leaks that do not have significant clinical implications. This can create challenges in interpreting the clinical relevance of these leaks and determining the appropriate course of action. Standardizing the definition of leaks and thrombus across imaging modalities could help address this limitation and improve the accuracy of clinical decision-making in LAAC procedures.

How can the definition of leaks and thrombus be standardized to improve clinical outcomes in LAAC procedures?

Standardizing the definition of leaks and thrombus in left atrial appendage closure (LAAC) procedures is crucial for improving clinical outcomes. One approach to standardization could involve developing a consensus document that clearly defines different types of leaks and thrombus based on imaging findings from both CT and TEE. This document would provide guidelines for interpreting imaging results consistently across different centers and practitioners. Additionally, conducting prospective studies with adequately powered sample sizes to assess the clinical impact of leaks and thrombus could help establish clear associations between imaging findings and patient outcomes. By standardizing definitions and conducting robust research, clinicians can make more informed decisions during LAAC procedures, ultimately leading to improved clinical outcomes for patients.