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Updated: Jul 23, 2026
The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Direct Comparative Safety and Anatomical Performance of Amulet Versus Watchman Devices for Left Atrial Appendage
Glen Silva Rojas1, Kevin J Silva-Rojas2, Ariana N Zea Olvera1
1Medicine, Catholic University of Santiago of Guayaquil, Guayaquil, ECU.
Insights
Left atrial appendage (LAA) occlusion devices like Amulet and Watchman offer safe alternatives to anticoagulation for atrial fibrillation (AF) patients. Amulet showed fewer leaks, suggesting a potential anatomical advantage in LAA closure.
Area of Science:
- Cardiology
- Medical Devices
- Interventional Cardiology
Background:
- Atrial fibrillation (AF) increases cardioembolic risk, especially ischemic stroke.
- Left atrial appendage (LAA) occlusion devices provide an alternative to anticoagulation for high-risk patients.
Purpose of the Study:
- To systematically review and compare the safety and anatomical performance of Amplatzer Amulet and Watchman LAA occlusion devices.
- To evaluate outcomes from head-to-head randomized controlled trials (RCTs) including Amulet IDE and SWISS-APERO.
Main Methods:
- Systematic review of two head-to-head RCTs.
- Analysis of clinical and procedural outcomes, including stroke incidence, major bleeding, and mortality.
- Comparison of anatomical outcomes, focusing on peri-device leaks.
Main Results:
- Both Amulet and Watchman devices demonstrated similar safety profiles regarding stroke, major bleeding, and mortality.
- The Amplatzer Amulet device exhibited lower rates of peri-device leaks compared to the Watchman device.
- Comparable efficacy in reducing thromboembolic risk was observed for both LAA occlusion devices.
Conclusions:
- Both Amulet and Watchman are effective for LAA closure in AF patients, offering comparable safety.
- The Amulet's dual-seal design may offer a structural advantage with reduced peri-device leaks.
- Optimizing outcomes requires consideration of procedural strategy, operator experience, and device-specific anatomy.
Abstract:
Atrial fibrillation (AF) is associated with increased risk of cardioembolic events, particularly ischemic stroke, and left atrial appendage (LAA) occlusion devices have emerged as alternatives to long-term anticoagulation in high-risk patients. This systematic review evaluates the comparative safety and anatomical performance of the Amplatzer Amulet (Abbott, Chicago, IL, US) and Watchman (Boston Scientific, Marlborough, MA, US) devices based on two head-to-head randomized controlled trials (RCTs), Amulet IDE (investigational device exemption) and SWISS-APERO, which provided complete follow-up data on clinical and procedural outcomes. Stroke incidence, major bleeding, and cardiovascular or all-cause mortality were similar between devices, reflecting comparable safety profiles. However, anatomical outcomes differed, with the dual-seal design of Amulet achieving lower rates of peri-device leaks, suggesting a potential structural advantage. Complementary studies addressing procedural techniques, arrhythmia recurrence, and post hoc mechanistic analyses were discussed to contextualize these findings, though they were excluded from primary quantitative synthesis due to heterogeneity in endpoints and follow-up. Methodological limitations, including small sample sizes, variable outcome definitions, and reliance on the Jadad scale for risk-of-bias assessment, constrain the generalizability of results. Despite these limitations, this review provides an updated synthesis of contemporary evidence on LAA closure, highlighting that both devices are effective in reducing thromboembolic risk while emphasizing the importance of procedural strategy, operator experience, and device-specific anatomical considerations in optimizing outcomes.
