The Amplatzer Amulet occluder (Abbott) device proves both safe and effective in the real-world setting, and operators who have more experience also have higher rate of implant success, the EMERGE Left Atrial Appendage study demonstrates. These data were reported by Mohamad Alkhouli, MD, of the Mayo Clinic, Rochester, Minnesota, and colleagues, in a manuscript published Friday online in JACC: Cardiovascular Interventions, simultaneously with a presentation of these data at the AF Symposium in Boston. Patients with atrial fibrillation (AF) sometimes experience a thrombus formation at the left atrial appendage (LAA), which increases the risk of stroke and systemic embolization. LAA occlusion (LAAO) devices have been developed for treating patients with AF who are high-risk for stroke and cannot go on anticoagulants long term. The Amulet device was recently approved by the U.S. Food and Drug Administration (FDA) for this procedure. The investigators in the EMERGE Left Atrial Appendage study sought to gather real-world data on the use of the Amulet device using the National Cardiovascular Data Registry (NCDR) LAAO Registry. Postapproval outcomes were gathered from patients in this registry between August 14, 2021—the date of the Amulet FDA approval—and December 31, 2022. The primary safety endpoint of this study included all-cause death, ischemic stroke, systemic embolism or device/procedure-related events that required open cardiac surgery or endovascular intervention either between initial implantation of the device and 7 days or at hospital discharge—whichever was later. Operators also reported and stratified all major adverse events (MAEs) through 45 days post-procedure. All MAEs were categorized as early (<10 cases), moderate (10-29 cases) or high (30 or more cases). A total of 5,499 (mean age=76.9 years, 40.3% female; 94.0% white) patients received the Amulet device, and 3,593 patients were evaluated at 45-day follow-up. Implantation success was reported in 95.8% of cases, and complete closure was reported in 97.2% of cases post-LAAO and 87.1% at 45 days post-procedure. The primary safety endpoint was experienced by 0.76% of patients. In-hospital, 2.9% of patients experienced a MAE, and through 45 days, 5.7% of patients experienced a MAE. Most of these events included major bleeding and pericardial effusion (PE) that required intervention. A significant decrease was observed in PE requiring surgery or percutaneous intervention with increasing operator experience in-hospital (early versus high operator experience 1.8% versus 1.1%, p=0.006) and at 45 days (2.3% versus 1.5%, p=0.012). Some limitations of this study included the relatively short follow-up period, and the lack of imaging techniques used to assess the patient outcomes of the Amulet device. Underreporting of adverse events was also a possibility and may have varied between centers. Overall, the EMERGE LAA registry provided the first round of real-world data needed for understanding the safety and efficacy of the Amulet device. This study suggests the Amulet device has favorable success in patients undergoing LAAO, and operators with more experience had higher implant success. Source: Alkhouli M, Freeman JV, Ellis CR, et al. First Experience With Amulet in the United States: Early Insights From EMERGE LAA Postapproval Study. JACC: Cardiovasc Interv. 2024 Feb 2 (Article in Press). Image Credit: Abbott Cardiovascular