Amulet Left Atrial Appendage Occluder Shows Promise in 3-Year Outcomes Study
The investigational Amulet Left Atrial Appendage (LAA) Occluder, developed by Abbott, has demonstrated favourable outcomes in a study comparing it to Boston Scientific's Watchman 2.5 device through three years as published in JACC: Cardiovascular Interventions by Dhanunjaya Lakkireddy and colleagues. This study is part of the largest randomised trial evaluating the safety and effectiveness of the Amulet device.
The study aimed to assess the device's impact on key clinical outcomes at the three-year mark. These outcomes included:
The composite of ischemic stroke or systemic embolism (SE).
The composite of all strokes, SE, or cardiovascular (CV) death.
Incidence of major bleeding.
All-cause death and CV death.
● The trial involved 1,878 patients across 108 sites who were randomised into two groups. Some key findings from the study include:
● Reduced Anticoagulation Usage: A significantly higher percentage of patients using the Amulet device (96.2%) were free from oral anticoagulation at three years compared to those using the Watchman device (92.5%).
● Comparable Clinical Outcomes: The study found similar clinical outcomes between the two devices, with no significant differences in the rates of ischemic stroke or SE (5.0% vs. 4.6%), the composite of all strokes, SE, or CV death (11.1% vs. 12.7%), major bleeding (16.1% vs. 14.7%), all-cause death (14.6% vs. 17.9%), and CV death (6.6% vs. 8.5%) for the Amulet and Watchman devices, respectively.
● Device-Related Factors: Device-related factors such as device-related thrombus or peridevice leak ≥3 mm were more frequently observed in Watchman patients compared to Amulet patients.
The Amulet LAA Occluder demonstrated continued safety and effectiveness over three years. Importantly, it showed a higher percentage of patients free from oral anticoagulation compared to the Watchman device, which could have significant implications for patient management. The study results suggest that the Amulet device is a promising option for high-risk patients. However, it's essential to note that these findings should be considered within the context of ongoing research and clinical practice, and individual patient care decisions should involve consultation with healthcare professionals. This study contributes valuable insights into the evolving landscape of LAA occlusion devices and their potential benefits for patients at risk of stroke or embolism.
Reference:
Lakkireddy, D., Thaler, D., Ellis, C. R., Swarup, V., Gambhir, A., Hermiller, J., Nielsen-Kudsk, J. E., Worthley, S., Nair, D., Schmidt, B., Horton, R., Gupta, N., Anderson, J. A., Gage, R., Alkhouli, M., & Windecker, S. (2023). 3-year outcomes from the Amplatzer amulet left atrial appendage occluder randomized controlled trial (amulet IDE). JACC. Cardiovascular Interventions, 16(15), 1902–1913. https://doi.org/10.1016/j.jcin.2023.06.022
