Why the study?
The Amplatzer Amulet and Watchman devices are the two most frequently used devices for percutaneous LAA closure globally, but their comparative safety and clinical outcomes needed evaluation.
Does the Amplatzer Amulet device improve safety and clinical outcomes compared to the Watchman device in patients undergoing percutaneous left atrial appendage closure?
Does the Amplatzer Amulet device improve safety and clinical outcomes compared to the Watchman device in patients undergoing percutaneous left atrial appendage closure?
In patients undergoing percutaneous LAA closure, the Amplatzer Amulet device is associated with higher procedure-related complications but lower peri-device leak compared to the Watchman device, with no significant differences in stroke or mortality.
Amplatzer Amulet raises procedural complication risk versus Watchman; extends comparative evidence on device trade-offs without stroke or mortality differences.
BACKGROUND: The Amplatzer Amulet (AA) and Watchman devices (WD) are the 2 most frequently used devices for percutaneous LAA closure globally. OBJECTIVE: To evaluate the safety and clinical outcomes associated with these 2 devices in patients undergoing percutaneous LAA closure. METHOD: We systematically searched all electronic databases from inception until February 21, 2023. The primary endpoint was procedure related complications. Secondary endpoints were device related thrombus, stroke, cardiovascular mortality, peri device leak, systemic embolism, and all-cause mortality. RESULTS: A total of 3 randomized clinical trials with 2150 patients were included in this meta-analysis. The mean age was 75 and 76 years in the Amplatzer group and in the Watchman group, respectively. The odds of procedure-related complications (OR, 1.80 [95% CI: 1.21-2.67], P < .001) were significantly higher among patients with AA compared to the WD. However, the odds of all-cause mortality (OR, 0.75 (95% CI: 0.49-1.16), P = .20), stroke (OR, 0.79 [95% CI: 0.47-1.34], P = .39), systemic/pulmonary embolism (OR, 1.34 [95% CI: 0.30-6.04], P = .70), and major bleeding (OR, 1.10 [95% CI: 0.83-1.48], P = .50) were comparable between the two devices. The odds of device related thrombus (OR, 0.72 [95% CI: 0.46-1.14], P = .17) was comparable between both the group of patients, however the incidence of peri device leak was significantly lower in AA group (OR, 0.41 [95% CI: 0.26-0.66], P < .001) compared with WD group of patients. CONCLUSION: The AA was not superior to the Watchman device in terms of safety and efficacy. However, the Amulet occluder was associated with a higher incidence of procedure-related complications, and lower peri device leak.
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Jaiswal et al. (2023) studied this question.
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