Abbott's Amplatzer Amulet left atrial appendage (LAA) occluder system has demonstrated significant long-term benefits in preventing stroke in patients with atrial fibrillation (AFib), according to new five-year data presented at the American Heart Association’s Scientific Sessions 2024 and published in the Journal of the American College of Cardiology. The data highlight Amulet's superiority in LAA closure and reduced reliance on blood-thinning medication compared to Boston Scientific’s Watchman device.
Superior Outcomes with Amplatzer Amulet
The Amulet IDE trial, the largest randomized LAA occlusion study to date, evaluated over 1,800 patients and compared Amplatzer Amulet head-to-head with Watchman. The results indicated that a significantly higher percentage of Amulet patients were not using blood-thinner medication at five years compared to Watchman patients (94% vs. 90.9%).
Furthermore, the study revealed a notably lower number of fatal or disabling strokes with Amulet (22 vs. 39). Data also demonstrated superior closure of the LAA with Amulet compared to Watchman (89.2% vs. 83.3%). These findings underscore the long-term efficacy and safety of the Amplatzer Amulet device in reducing stroke risk for AFib patients.
Clinical Significance and Expert Commentary
Dr. Dhanunjaya Lakkireddy, principal investigator for the Amulet IDE trial, emphasized the importance of these findings: "Because blood thinners may cause excessive bleeding and side effects like nausea or dizziness, we as physicians want to avoid these medications for our patients following an LAA closure procedure. With the five-year findings from Abbott’s Amulet IDE study, doctors can even more confidently offer AFib patients the minimally invasive Amulet device that not only closes the LAA and reduces their risk of stroke, but can also keep them off blood-thinning medication long-term."
Addressing the Challenges of AFib and Stroke Prevention
AFib disrupts the heart’s ability to effectively pump blood, potentially leading to blood clots in the LAA. If these clots enter the bloodstream, they can travel to the brain and cause a stroke. Abbott's Amplatzer Amulet helps seal off the LAA entirely, reducing the risk of stroke caused by AFib. For many patients, long-term blood-thinning medication is not a viable option due to side effects such as bleeding. The Amulet device offers a dual-seal design to effectively treat nearly all LAA structures and achieve permanent closure, providing a crucial alternative for these patients.
Abbott's Perspective
Sandra Lesenfants, SVP of Abbott’s Structural Heart business, highlighted the impact of the Amplatzer Amulet: "For years, doctors and their patients only had one minimally invasive option to close the LAA. The Amplatzer Amulet redefined LAA closure by offering dual-seal technology that completely and immediately seals the LAA without requiring blood-thinning medication following the procedure. These data reinforce that the Amulet device is safe and effective, and also, importantly, that it’s helping people enjoy their lives and worry less about the risk of having a stroke."
The Amplatzer Amulet is approved in more than 80 countries, including the U.S., Canada, Australia, and Europe.
