Procedural and short-term follow-up outcomes of Amplatzer Amulet occluder versus Watchman FLX device: A meta-analysis.

Domenico G Della Rocca,Rodney P Horton,Amin Al-Ahmad,Carlo Lavalle,Michele Magnocavallo,Carola Gianni,Andrea Natale,Luigi Di Biase,Veronica N Natale,Sanghamitra Mohanty

doi:10.1016/j.hrthm.2022.02.007

Abstract

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Procedural and short-term follow-up outcomes of Amplatzer Amulet occluder versus Watchman FLX device: A meta-analysis.

Highlights

From the *Texas Cardiac Arrhythmia Institute, St. David’s Medical Center, Austin, Texas, †Department of Cardiovascular/Respiratory Diseases, Nephrology, Anesthesiology, and Geriatric Sciences, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy, ‡Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, xDepartment of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, {Department of Cardiology, MetroHealth Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio, and kInterventional Electrophysiology, Scripps Clinic, La Jolla, California
Two percutaneous devices currently are available in the United States for stroke prophylaxis: the WatchmanTM device (Boston Scientific Corporation, Marlborough, MA) and the AmplatzerTM AmuletTM Left atrial appendage (LAA) occluder (Abbott, Minneapolis, MN)
The primary safety endpoint was significantly higher in the Amulet group (4.7%; 95% CI 2.9–6.7) than the FLX group (0.6%; 95% CI 0–2.3) (P,.01) (Figure 1A)

Summary

Introduction

From the *Texas Cardiac Arrhythmia Institute, St. David’s Medical Center, Austin, Texas, †Department of Cardiovascular/Respiratory Diseases, Nephrology, Anesthesiology, and Geriatric Sciences, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy, ‡Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, xDepartment of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, {Department of Cardiology, MetroHealth Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio, and kInterventional Electrophysiology, Scripps Clinic, La Jolla, California. Left atrial appendage (LAA) occlusion (LAAO) provides effective protection against thromboembolic events in high-risk, atrial fibrillation patients. The latter recently received US Food and Drug Administration approval as a result of the findings of the Amulet IDE randomized trial,[1] which showed superiority for LAAO (lower rates of leaks .5 mm) based on a comparison between the second-generation AmplatzerTM plug, namely, the AmuletTM occluder, and the old-generation WatchmanTM 2.5.

Results

Conclusion