Researchers have compared the safety and effectiveness of Abbott’s Amplatzer Amulet left atrial appendage (LAA) occluder with Boston Scientific’s first-generation Watchman LAA occluder, publishing their findings in Circulation.
The analysis, first presented at ESC Congress 2021, included data from more than 1,800 adult patients presenting with paroxysmal, persistent or permanent nonvalvular atrial fibrillation (AFib). All patients were randomized to either receive the Amulet device or the Watchman device. Sixty percent of patients were men, and the average age was 75 years old.
Overall, implantation success occurred in 98.4% of Amulet patients and 96.4% of Watchman patients. While 75.7% of Amulet patients were discharged on dual antiplatelet therapy consisting of aspirin and clopidogrel, another 20% were discharged on anticoagulation plus aspirin. Eighty-two percent of Watchman patients were discharged on warfarin plus aspirin.
In addition, the Amulet device had a higher LAA closure rate (98.9% vs. 96.8%).
The study’s primary safety endpoint was a composite of procedure-related complications that included all-cause mortality and major bleeding events after 12 months. The two devices achieved similar results (14.5% for the Amulet, 14.7% for the Watchman).
The primary effectiveness endpoint, meanwhile, was a composite of ischemic stroke and systemic embolism after 18 months. The two devices had identical rates—2.8%—for this endpoint.
“The Amulet LAA occluder was superior with respect to LAA closure and noninferior with respect to safety and effectiveness for stroke prevention in patients with nonvalvular AFib compared to the Watchman device,” lead author Dhanunjaya Lakkireddy, MD, a specialist with the Kansas City Heart Rhythm Institute and Research Foundation, said in a statement. The dual seal design of the Amulet LAA occluder helps 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. In addition, immediate closure of the LAA with the Amulet disc allows some patients to be treated without the need for anticoagulation therapy after the procedure.”
Abbott did design and fun this analysis. Multiple study authors, including Lakkireddy, reported having a prior relationship with Abbott and/or Boston Scientific.
Read the full study here.
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Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.