An Evolving Strategy in Stroke Prevention in patients with nonvalvular(AF)
Left Atrial Appendage Closure: An Evolving Strategy in Stroke Prevention in patients with nonvalvular(AF).
Abbott’s Amulet LAAO Device Shows Long-Term Safety and Effectiveness
📅 AHA Highlighted: March 17, 2025
📄 Source: Journal of the American College of Cardiology
📑 Study: Lakkireddy D, et al. J Am Coll Cardiol. 2025.
Left atrial appendage (LAA) closure has emerged as a crucial intervention for stroke prevention in patients with nonvalvular atrial fibrillation (AF) who are at high thromboembolic risk and have contraindications to long-term oral anticoagulation (OAC). The procedure involves implanting a device to occlude the LAA, the primary site of thrombus formation in AF.
According to current guidelines, LAA closure is recommended as a Class IIb indication for patients with AF at high stroke risk (CHA₂DS₂-VASc ≥2 in men, ≥3 in women) who cannot tolerate OAC due to bleeding risks. It is also considered for selected patients under Class IIa when an alternative stroke prevention strategy is needed.
With growing clinical evidence and advancements in device technology, LAA closure continues to gain recognition as a viable stroke prevention strategy, providing an alternative to lifelong anticoagulation while maintaining safety and efficacy over the long term.( https://www.ahajournals.org).
Key Findings:
• Long-Term Safety & Efficacy:
• The Amplatzer Amulet Left Atrial Appendage Occluder (LAAO) from Abbott demonstrated safety and effectiveness five years post-treatment in patients with nonvalvular atrial fibrillation (AFib).
• The study compared Amulet vs. Watchman 2.5 in 1,800+ high-risk patients from the Amulet IDE trial (2016–2019).
• Stroke Prevention & Bleeding Risk:
• Both devices had similar rates of ischemic stroke/systemic embolism, major bleeding, and all-cause mortality after five years.
• However, Watchman patients had more fatal/disabling strokes (39 vs. 22 in Amulet patients), potentially due to higher risks of device-related thrombus (DRT) and peridevice leaks (PDL).
• Oral Anticoagulation (OAC) Use:
• Immediate post-discharge: 78.9% of Amulet patients were free of OAC vs. only 4.2% of Watchman patients.
• At five years: OAC discontinuation rates were similar (94% Amulet vs. 90.9% Watchman).
• Regulatory Approval:
• Amulet received FDA approval in 2021, while Watchman was approved in 2015.
Clinical Implications:
• LAAO is a durable stroke prevention strategy for nonvalvular AFib patients.
• Future research should optimize post-implant antithrombotic regimens to further improve outcomes.
• Newer Watchman versions may have reduced stroke and complication rates, narrowing performance differences.
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