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First Experience With Amulet in the United States
Quick Takes
- The Amulet occluder demonstrated favorable rates of periprocedural complications in the real-world setting.
- There was a low incidence of peridevice leak, although the follow-up at 45 days with TEE was limited.
- Operators with more experience had higher implant success and fewer pericardial effusions, suggesting a learning curve effect for this device.
Study Questions:
What are the early postapproval outcomes of the Amulet occluder in the United States?
Methods:
The EMERGE Left Atrial Appendage study investigators used data from the National Cardiovascular Data Registry Left Atrial Appendage Occlusion (LAAO) Registry. The study included patients with a commercial Amulet occluder implant attempt between Food and Drug Administration approval (August 14, 2021) and December 31, 2022. The safety composite endpoint included all-cause death, ischemic stroke, systemic embolism, or device/procedure-related events requiring open cardiac surgery or endovascular intervention between device implantation and 7 days or hospital discharge (whichever is later). Major adverse events through 45 days were also reported and stratified by operator experience (early [<10 cases], moderate [10-29 cases], and high [30+ cases]). Odds ratios and 95% confidence intervals were calculated for the safety composite and clinical outcomes in pairwise comparisons between categories of operator experience.
Results:
A total of 5,499 patients underwent attempted Amulet occluder implantation. Implant success was 95.8%, and complete closure was 97.2% post-LAAO and 87.1% at 45 days. A safety composite endpoint event occurred in 0.76% of patients. Any major adverse event occurred in 2.9% and 5.7% of patients in-hospital and through 45 days, respectively, driven by major bleeding and pericardial effusion (PE) requiring intervention. PE requiring surgery or percutaneous intervention decreased significantly with increasing experience both in-hospital (early vs. high operator experience, 1.8% vs. 1.1%; p = 0.006) and at 45 days (2.3% vs. 1.5%; p = 0.012).
Conclusions:
The investigators report favorable safety and effectiveness of the Amulet occluder in the real-world setting.
Perspective:
This LAAO registry study reports that the Amulet occluder demonstrated favorable rates of periprocedural complications in the real-world setting with low incidence of peridevice leak, although the follow-up at 45 days with transesophageal echocardiography (TEE) was limited. Of note, operators with more experience had higher implant success and fewer pericardial effusions, suggesting a learning curve effect for this device. Additional studies with longer-term follow-up are needed to further determine the long-term safety and effectiveness of the Amulet occluder in the US commercial setting.
Clinical Topics: Arrhythmias and Clinical EP, Invasive Cardiovascular Angiography and Intervention
Keywords: Atrial Appendage, Coronary Occlusion, LAAO Registry
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