AMULET IDE: Amulet LAA Occluder Superior to Watchman Device in Non-Valvular AFib Patients

The Amulet Left Atrial Appendage (LAA) Occluder was superior to the Watchman device in LAA closure and noninferior in terms of safety and effectiveness for stroke prevention in patients with non-valvular atrial fibrillation (AFib), based on findings from the AMULET IDE trial presented at ESC Congress 2021.

The multicenter trial – the first to directly compare the Amulet LAA Occluder with the Watchman device – randomized 1,878 adult patients (median age 75 years) with paroxysmal, persistent, or permanent non-valvular AFib and at high risk of stroke or systemic embolism to receive either the Amulet LAA Occluder or the Watchman device.

All patients were required to complete clinical follow-up during the following times: at discharge; at 45 days; at months three, six, nine, 12 and 18; and at years two, three, four and five. Researchers noted that follow-up beyond 18 months is currently ongoing. Most Watchman patients (82%) were discharged on warfarin plus aspirin, while in contrast, 75.7% of Amulet patients were discharged on dual antiplatelet therapy and 20% were on anticoagulation plus aspirin.

The primary safety endpoint was a composite of procedure-related complications, all-cause death, or major bleeding through 12 months. The primary effectiveness endpoint was a composite of ischemic stroke or systemic embolism through 18 months. The primary mechanism of action endpoint was device-based LAA closure as assessed by an independent core laboratory on transesophageal echocardiography at the 45-day visit.

Overall results found device-based LAA closure rates were higher in the Amulet LAA Occluder group (98.9%) compared with the Watchman device (96.8%) (difference=2.03; 95% confidence interval [CI] 0.41–3.66; p<0.001 for noninferiority; p=0.003 for superiority). Additionally, the Amulet LAA Occluder was noninferior to the Watchman device for the primary safety endpoint (14.5% vs. 14.7%) and the primary effectiveness endpoint (2.8% vs. 2.8%).

Principal investigator Dhanunjaya R. Lakkireddy, MD, FACC, also noted that the dual seal design of the Amulet LAA Occluder helped to overcome the limitations of a single-seal device, including but not limited to short LAA length, proximal lobes near the ostium, and very large ostia. Additionally, she added, that "immediate closure of the LAA with the Amulet disc allows some patients to be treated without the need for anticoagulation therapy after the procedure."

Clinical Topics: Arrhythmias and Clinical EP, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: ESC Congress, ESC21, Atrial Appendage, Atrial Fibrillation, Stroke, ACC International


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