Clinical efficacy and safety comparison of Watchman device versus ACP/Amulet device for percutaneous left atrial appendage closure in patients with nonvalvular atrial fibrillation: A study‐level meta‐analysis of clinical trials

• Published in: Clinical cardiology (Mahwah, N.J.) Vol. 46; no. 2; pp. 117 - 125
• Main Authors: Bing, Sun, Chen, Rui Rui
• Format: Journal Article
• Language: English
• Published: United States John Wiley & Sons, Inc 01.02.2023; John Wiley and Sons Inc
• Subjects: Amulet; Anticoagulants; Anticoagulants (Medicine); Anticoagulants - therapeutic use; Atrial Appendage - diagnostic imaging; Atrial Appendage - surgery; Atrial fibrillation; Atrial Fibrillation - complications; Atrial Fibrillation - diagnosis; Atrial Fibrillation - surgery; Bias; Cardiac arrhythmia; Cardiac Catheterization - adverse effects; Case reports; Clinical trials; Comparative analysis; Complications and side effects; Embolism - prevention & control; Embolisms; FDA approval; Hemorrhage - epidemiology; Hemorrhage - etiology; Humans; left atrial appendage closure; Medical research; Medicine, Experimental; Meta-analysis; nonvalvular atrial fibrillation; Review; Sensitivity analysis; Stroke; Stroke (Disease); Stroke - etiology; Stroke - prevention & control; Thrombosis; Treatment Outcome; Watchman; United States > US; atrial fibrillation; Amulet; Watchman; left atrial appendage closure; nonvalvular atrial fibrillation
• ISSN: 0160-9289; 1932-8737
• DOI: 10.1002/clc.23956

Left atrial appendage occlusion is not inferior to oral anticoagulants in the prevention of stroke in several randomized controlled trials. However, the clinical efficacy and safety comparison of the Watchman and amplatzer cardiac plug (ACP)/Amulet devices for percutaneous left atrial appendage closure (LAAC) in patients with non‐valvular atrial fibrillation was controversial. A database search was conducted using PubMed, EMBASE, Cochrane Library, and Clinicaltrials.gov for trials that compared Watchman device vs ACP/Amulet device. The effective outcomes were stroke and systemic embolism. Safety outcomes were all‐cause death, cardiovascular death, and major bleeding. Device‐related complications included device‐related thrombus (DRT), peri‐device leaks (PDL > 5 mm). A total of 19 articles involving 6224 patients were included in the present study. The Watchman and ACP/Amulet groups comprised 3267 and 2957 patients, respectively. No statistically significant differences were detected in the stroke (odd ratio [OR]:1.24, 95% confidence interval [CI]: 0.92−1.67, p = .17, I2 = 0), systemic embolism (OR:1.10, 95% CI: 0.51−2.35, p = .81, I2 = 0%), all‐cause death (OR:0.97, 95% CI: 0.80−1.18, p = .77, I2 = 1%), cardiogenic death (OR:0.99, 95% CI: 0.77−1.29, p = .96, I2 = 0%), major bleeding (OR:1.18, 95% CI: 0.98−1.43, p = .08, I2 = 25%). DRT (OR:1.48, 95% CI: 1.06−2.06, p = .02, I2 = 0%) and PDL > 5 mm (OR:2.57, 95% CI: 1.63−4.04, p < .0001, I2 = 0%) were significantly lower in ACP/Amulet group compared to Watchman group. The effective and safety outcomes were comparable between two groups. ACP/Amulet group had significantly lower rates of DRT and PDL > 5 mm than Watchman group.