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Updated: May 14, 2026
The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
1-Year Real-World Outcomes With the Amulet Occluder From the EMERGE LAA Postapproval Study
Dhanunjaya Lakkireddy1, Atman P Shah2, Himanshu Agarwal3
1Kansas City Heart Rhythm Institute and Research Foundation, Overland Park, Kansas, USA.
Insights
The Amulet occluder effectively reduces stroke risk in nonvalvular atrial fibrillation patients. One-year real-world data show high success, safety, and low thromboembolic event rates.
Area of Science:
- Cardiology
- Medical Devices
- Clinical Research
Background:
- The Amulet occluder is designed to prevent thrombus embolization from the left atrial appendage (LAA) in patients with nonvalvular atrial fibrillation.
- This device aims to reduce the risk of stroke in this patient population.
Purpose of the Study:
- To evaluate the 1-year outcomes of the Amulet occluder within the EMERGE LAA postapproval study.
- Assessing the safety and effectiveness of the Amulet occluder in a real-world clinical setting.
Main Methods:
- Analysis of 12,180 patients who underwent attempted Amulet occluder implantation between August 2021 and December 2023.
- Inclusion in the National Cardiovascular Data Registry LAAO Registry.
- Evaluation of a composite safety endpoint including all-cause death, stroke, embolism, and device/procedure-related events within 7 days or hospital discharge. Major adverse events and peridevice leak were assessed through 1 year.
Main Results:
- Successful implantation was achieved in 96.0% of patients, with clinically relevant closure (≤3 mm leak) in 97.2% at 45 days.
- The composite safety endpoint occurred in 0.9% of patients.
- At 1 year, Kaplan-Meier rates were: 1.6% for all stroke, 6.3% for major bleeding, 2.9% for cardiovascular death, and 7.9% for all-cause death.
Conclusions:
- The EMERGE LAA study demonstrates the Amulet occluder's success, safety, and effectiveness in real-world practice.
- Short-term safety events were acceptable and decreased with operator experience.
- One-year outcomes indicate a low incidence of thromboembolic events, supporting the device's role in LAA closure.
Background:
The Amulet occluder is indicated to reduce the risk for thrombus embolization from the left atrial appendage in patients with nonvalvular atrial fibrillation.
Objectives:
The aim of this analysis was to evaluate outcomes through 1 year with the Amulet occluder in the EMERGE LAA postapproval study.
Methods:
Patients with commercial Amulet occluder implantation attempts between August 14, 2021, and December 15, 2023, and entered into the National Cardiovascular Data Registry LAAO (Left Atrial Appendage Occlusion) Registry were included. The safety endpoint composite included all-cause death, ischemic stroke, systemic embolism, and device- or procedure-related events requiring open cardiac surgery or endovascular intervention between device implantation and 7 days or hospital discharge (whichever was later). Major adverse events were also reported through 1 year and stratified by operator experience and prior LAAO attempt.
Results:
A total of 12,180 patients underwent attempted Amulet occluder implantation (median follow-up 1 year (Q1-Q3: 1-1 year). Implantation success was 96.0% (11,693 of 12,180) (88.9% [353 of 397] in patients with prior failed LAAO attempts) with clinically relevant closure (peridevice leak ≤3 mm) achieved in 97.2% of patients (4,293 of 4,418) at 45 days postprocedure. A safety endpoint composite event occurred in 0.9% of patients (112 of 12,180). Any major adverse event through 45 days decreased with increased operator experience (<10 cases, 8.4% [166 of 1,969]; 10-29 cases, 6.5% [274 of 4,224]; ≥30 cases, 5.8% [348 of 5,987]; P < 0.001). At 1 year, Kaplan-Meier event rates of 1.6% for all stroke (n = 143), 6.3% for major bleeding (n = 610), 2.9% for cardiovascular-related death or death of unknown cause (n = 257), and 7.9% for all-cause death (n = 693) were observed.
Conclusions:
One-year outcomes from EMERGE LAA for the first 12,180 patients demonstrated the success, safety, and effectiveness of the Amulet occluder in the real-world setting. Short-term rates of safety events were acceptable and decreased with operator experience, and 1-year outcomes demonstrate a low incidence of thromboembolic events.
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