The Amulet left atrial appendage (LAA) occluder (Abbott) shows that procedural success rates improved and periprocedural complications dropped as operators learned how to use the device, according to new results from the EMERGE LAA study. Atman P. Shah, MD, of the University of Chicago, presented these findings Monday during a Late-Breaking Clinical Trials session at Cardiovascular Research Technologies (CRT) 2024 in Washington, D.C. The study analyzed 8,626 patients who were attempted to undergo LAA occlusion with the Amulet device between August 2021 and June 2023 and entered into the National Cardiovascular Data Registry’s Left Atrial Appendage Occlusion Registry. The safety composite endpoint is all-cause mortality, ischemic stroke, systemic embolism or device-/procedure-related events requiring cardiac surgery or major endovascular intervention between device implantation and 7 days or hospital discharge, whichever is later. The major adverse event (MAE) composite includes all-cause mortality, all stroke, systemic embolization, transient ischemic attack, device embolization, major vascular complications, myocardial infarction or cardiac arrest, all reported in-hospital. The investigators grouped patients by the experience levels of their operators into early (n=1,794), moderate (n=3,194) and high (n=3,638) experience. At baseline, the patients’ mean age was 77 years, about 40% were female and nearly all (94%) were white. Implant success and procedure efficiency increased with operator experience. Implant success was 93.9% in the early experience group, rising to 95.7% in the moderate experience group to 97.3% among highly experienced operators (p<0.001). Peridevice leak decreased as well: >3 mm leak dropped from 0.6% in the early experience group to 0.4% in the highly experienced group (p=0.026), and >5 mm leak dropped from 0.2% in the early group to 0.0% in the highly experienced group (p=0.028). Procedure time also decreased as experience increased, with a mean time of 100.3 minutes in the early experience group, 90.0 minutes in the moderate group and 79.2 minutes in the highly experienced group. Compared to early experienced operators, highly experienced operators had fewer periprocedural pericardial effusions requiring surgery or intervention (1.2% vs. 1.8%; OR; 0.34; 0.88; p=0.01), major bleeding events (0.8% vs. 1.3%; OR: 0.66 [0.37, 1.16]; p=0.15), device embolizations (0.1% vs. 0.2%; OR: 0.93 [0.17, 5.00]; p=0.21), and all-cause deaths (0.1% vs. 0.4%; OR: 0.35 [0.11, 1.12]; p=0.08),. “The dual-seal Amplatzer Amulet LAA occluder provided a high degree of acute implant success, clinically relevant closure, and a favorable periprocedural safety profile with improved outcomes as more experience was gained with the device,” Shah concluded. Photo Credit: Michael Kress Photo Caption: Atman P. Shah, MD, presents results from the EMERGE LAA study Monday at CRT 2024 in Washington, D.C.