Amulet LAAO Device Demonstrates Long-Term Safety and Effectiveness
Abbott’s Amplatzer Amulet Left Atrial Appendage Occluder (LAAO) has been shown to provide long-term safety and effectiveness, with new data confirming its durability five years after treatment. The findings, published in the Journal of the American College of Cardiology, provide valuable insights for healthcare professionals treating patients with nonvalvular atrial fibrillation (AFib) at high risk of stroke.
The study analyzed data from over 1,800 patients who underwent LAAO procedures between 2016 and 2019 as part of the Amulet IDE trial. Participants were randomized to receive either the Amulet or the Boston Scientific Watchman 2.5, a single-closure device. After five years, both devices demonstrated comparable rates of ischemic stroke, systemic embolism, major bleeding, and both all-cause and cardiovascular death, confirming their safety and efficacy in reducing stroke risk in these patients.
Researchers also noted that 94% of patients who received the Amulet were free from oral anticoagulation (OAC) therapy by the study’s end, compared to 90.9% of Watchman patients. In contrast, 78.9% of Amulet patients were OAC-free immediately post-discharge, a significantly higher rate than the 4.2% of Watchman patients.
Another key difference was the occurrence of fatal or disabling strokes. The Watchman cohort experienced more of these events (39) compared to the Amulet group (22), likely due to the Watchman’s higher risk of device-related thrombus (DRT) and peridevice leaks (PDL), according to the study.
The results reaffirm the safety of the Amulet device, which received FDA approval in 2021. While the Watchman was approved earlier in 2015, the study’s authors suggest that newer generations of the Watchman could potentially narrow the gap in stroke outcomes.
A separate editorial in the Journal of the American College of Cardiology highlighted that these findings are reassuring for both devices, with the next challenge being the optimal postimplantation antithrombotic regimen for improving outcomes further. The editorial also noted that subsequent versions of the Watchman device, designed to reduce complications, may change the device comparison in future studies.
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