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Related Experiment Video

Updated: Sep 13, 2025

Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
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A Real-World Comparison of Left Atrial Appendage Occlusion Using Two Commercially Available Devices.

Stefan Preisendörfer1, Aakash Sheth1, Mehak Dhande1

  • 1Heart & Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.

The American Journal of Cardiology
|July 27, 2025
PubMed
Summary

The Amulet and Watchman FLX devices show similar procedural and clinical outcomes for left atrial appendage occlusion. This real-world study found comparable safety and efficacy, with longer procedure times for the Amulet device possibly due to a learning curve.

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Area of Science:

  • Cardiology
  • Medical Devices
  • Interventional Cardiology

Background:

  • Amplatzer and Watchman are leading left atrial appendage occlusion (LAAO) systems.
  • Real-world comparative data on newer generation systems, Amulet and Watchman FLX, are limited.
  • Understanding comparative outcomes is crucial for clinical decision-making in LAAO.

Purpose of the Study:

  • To compare procedural and clinical outcomes between the Amulet and Watchman FLX LAAO devices.
  • To evaluate safety and efficacy in a real-world setting.
  • To identify differences in peri-device leak (PDL) and device-related thrombosis (DRT).

Main Methods:

  • Retrospective analysis of early Amulet (n=131) adoption vs. Watchman FLX (n=194) cases.
  • Data collected from September 2021 to June 2023 at a large health system.
  • Comparison of procedural success, in-hospital complications, PDL, DRT, and 6-month clinical outcomes.

Main Results:

  • Similar procedural success rates (97.7% vs. 96.4%, p=0.5) and comparable in-hospital complications.
  • No significant difference in PDL at 45 days (24.6% vs. 23.4%, p=0.81) or DRT rates (3.3% vs. 3.3%, p=0.99).
  • Similar 6-month all-cause mortality, cardioembolic, and major bleeding events between the two devices.

Conclusions:

  • The Amulet device demonstrates comparable procedural and clinical outcomes to the Watchman FLX in real-world use.
  • Slightly longer procedural times for Amulet may be attributed to the learning curve associated with its deployment technique.
  • Both devices offer a safe and effective option for left atrial appendage occlusion.