Annals of medicine and surgery (2012) · 2026
WATCHMAN and Amplatzer Amulet for left atrial appendage occlusion: a systematic review and meta-analysis.
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Shamieh Samir Maher, Alsaqqa Barakat Wael, Kpachi Armstrong Nicholas, Kamal Said Mohamed, Kishore Krishnanjali, Kanetkar Jui, Tariq Iqra, Shrestha Muskan, Rasti Nima, Lee Deng Siang, Lalzai Roya, Das Ashesh, Riaz Malik Sohail, Khawar Muneeb
Аннотация
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.
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.