Key result
Amplatzer Amulet shows no difference in safety or efficacy versus Watchman 2.5 for LAAO.
Why the study?
LAAO is an alternative to OAC to reduce stroke risk in NVAF, but complications remain a concern, prompting an assessment of the safety and efficacy of the Amplatzer Amulet and Watchman.
Does the Amplatzer Amulet device improve safety and efficacy outcomes compared to the Watchman 2.5 device in patients with nonvalvular atrial fibrillation undergoing left atrial appendage occlusion?
Meta-Analysis (n=2,926)
Does the Amplatzer Amulet device improve safety and efficacy outcomes compared to the Watchman 2.5 device in patients with nonvalvular atrial fibrillation undergoing left atrial appendage occlusion?
The Amplatzer Amulet and Watchman 2.5 devices for left atrial appendage occlusion demonstrate comparable safety and efficacy profiles with low complication rates in patients with nonvalvular atrial fibrillation.
Clinicians may select either device based on anatomy or availability; confirms comparable safety and efficacy in nonvalvular AF.
BACKGROUND: Left atrial appendage occlusion (LAAO) is an alternative to oral anticoagulation (OAC) to decrease the risk of stroke in patients with nonvalvular atrial fibrillation (NVAF); however, certain complications remain a concern. Amplatzer Amulet and Watchman are the two most popular used devices for preventing stroke in patients with NVAF. We assessed the safety and efficacy of LAAO using the Amplatzer Amulet and Watchman. METHODS: A meta-analysis was conducted to compare the safety and efficacy outcomes associated with the use of the Amplatzer Amulet and Watchman 2.5. The Newcastle-Ottawa Scale has been utilized to assess the quality of study. RESULTS: The meta-analysis includes seven studies involving 2926 patients (1418 patients with an amulet and 1508 with a Watchman 2.5). Generally, adverse event rates for both systems were minimal. No significant differences between the two devices were found in safety (pericardial effusion, device embolization, and cardiac tamponade) or efficacy outcomes (death, TIA, stroke, major/minor bleeding, device leak, and thromboembolic events). CONCLUSIONS: The data suggest LAAO is a safe procedure, regardless of which device was used. LAAO devices generally have low complication rates. Outcomes were comparable between the two groups with no significant differences in their safety or efficacy.
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Zhu et al. (2022) conducted a meta-analysis in nonvalvular atrial fibrillation (NVAF) (n=2,926). Amplatzer Amulet vs. Watchman 2.5 was evaluated on Safety (pericardial effusion, device embolization, and cardiac tamponade) and efficacy outcomes (death, TIA, stroke, major/minor bleeding, device leak, and thromboembolic events). Left atrial appendage occlusion using Amplatzer Amulet (n=1418) or Watchman 2.5 (n=1508) showed no significant differences in safety or efficacy outcomes.
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