Samir Maher Shamieh, Barakat Wael Alsaqqa, Armstrong Nicholas Kpachi, Mohamed Kamal Said, Krishnanjali Kishore, Jui Kanetkar, Iqra Tariq, Muskan Shrestha, Nima Rasti, Deng Siang Lee, Roya Lalzai, Ashesh Das, Malik Sohail Riaz, Muneeb Khawar
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.
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.