Key result
WATCHMAN shows no difference in ischemic stroke risk compared to Amulet for LAA closure.
Why the study?
WATCHMAN and Amplatzer Amulet devices are alternatives to oral anticoagulation for left atrial appendage closure in NVAF patients, but their relative safety and efficacy needed direct comparison.
Does the WATCHMAN device compared to the Amplatzer Amulet device improve safety and efficacy outcomes in patients with non-valvular atrial fibrillation undergoing left atrial appendage closure?
Meta-Analysis
Does the WATCHMAN device compared to the Amplatzer Amulet device improve safety and efficacy outcomes in patients with non-valvular atrial fibrillation undergoing left atrial appendage closure?
Relative Risk: 1.1 (95% CI 0.83–1.46)
p-value: p=0.51
WATCHMAN and Amplatzer Amulet devices offer comparable efficacy and safety for left atrial appendage closure in non-valvular atrial fibrillation, though WATCHMAN is associated with a higher risk of device thrombosis and a lower risk of pericardial effusion.
Comparable stroke rates support individualized LAAC device selection by thrombosis vs effusion risk; extends comparative evidence.
Background: WATCHMAN and Amplatzer Amulet devices are an effective alternative to oral anticoagulation for left atrial appendage closure (LAAC) in non-valvular atrial fibrillation (NVAF) patients. This study aims to compare their safety and efficacy. Methods: This systematic review and meta-analysis followed PRISMA guidelines. PubMed, Embase, and ScienceDirect, were searched from inception to May 2025 for comparative studies in NVAF patients. Pooled risk ratios (RRs) with 95% confidence intervals (CIs) were calculated using random-effects models. Heterogeneity was assessed via I 2 statistic; statistical significance was at P < 0.05. Results: Sixteen studies were included. No significant differences were found in ischemic stroke (RR 1.10, 95% CI 0.83–1.46; P = 0.51; I 2 = 0%), all-cause mortality (RR 0.92, 95% CI 0.75–1.14; P = 0.45; I 2 = 0%), major bleeding (RR 1.11, 95% CI 0.90–1.38; P = 0.33; I 2 = 0%), minor bleeding (RR 1.11, 95% CI 0.76–1.61; P = 0.59; I 2 = 22%), cardiac mortality (RR 0.86, 95% CI 0.39–1.93; P = 0.72; I 2 = 51%), major procedure-related complications (RR 0.93, 95% CI 0.44–1.96; P = 0.55; I 2 = 62%), cardiac tamponade (RR 0.57, 95% CI 0.25–1.29; P = 0.18; I 2 = 30%), device embolization (RR 0.74, 95% CI 0.30–1.86; P = 0.53; I 2 = 0%), vascular complications (RR 0.74, 95% CI 0.34–1.52; P = 0.38; I 2 = 0%), or peridevice leak (RR 0.88, 95% CI 0.56–1.36; P = 0.55; I 2 = 77%). WATCHMAN showed higher device thrombosis (RR 1.73, 95% CI 1.20–2.49; P = 0.003; I 2 = 0%) but lower pericardial effusion (RR 0.47, 95% CI 0.29–0.76; P = 0.002; I 2 = 0%). Conclusions: WATCHMAN and Amulet demonstrate no significant difference in efficacy and safety for most LAAC outcomes, including stroke and major bleeding. However, WATCHMAN is associated with a significantly lower risk of pericardial effusion but a higher risk of device thrombosis.
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Shamieh et al. (2026) conducted a meta-analysis in Non-valvular atrial fibrillation (NVAF). WATCHMAN device vs. Amplatzer Amulet device was evaluated on Ischemic stroke (RR 1.10, 95% CI 0.83-1.46, p=0.51). WATCHMAN and Amulet devices demonstrated no significant difference in ischemic stroke (RR 1.10, 95% CI 0.83-1.46, P=0.51), though WATCHMAN had higher device thrombosis but lower pericardial effusion.
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