JACC. Cardiovascular interventions · 2025
Clinical Effectiveness of Transcatheter Left Atrial Appendage Occlusion With Watchman FLX Compared With First-Generation Watchman.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Price Matthew J, Tan Zhen, Zimmerman Sarah, Curtis Jeptha P, Freeman James V
Аннотация
BACKGROUND: Procedural complications, device-related thrombus, and peridevice leak may limit the benefit of transcatheter left atrial appendage occlusion (LAAO). Although next-generation devices incorporate design modifications meant to address these phenomena, the longer term impact of these modifications on outcomes has not been described.
OBJECTIVES: The aim of this study was to compare 1-year safety and clinical effectiveness of the Watchman FLX with the predicate Watchman 2.5 device.
METHODS: The National Cardiovascular Data Registry LAAO Registry was used to identify: 1) patients who received the Watchman FLX; and 2) an identical number of patients receiving the Watchman 2.5 at the same sites directly preceding the first Watchman FLX case at each site. The primary endpoint was ischemic stroke. A secondary analysis was performed using 2:1 propensity score matching.
RESULTS: The study cohort consisted of 27,141 patients receiving each device. Among patients undergoing transesophageal echocardiography at 45 days, the rate of device-related thrombus was not different for Watchman FLX compared with Watchman 2.5 (0.4% vs 0.5%; P = 0.27) while the rate of any peridevice leak was significantly lower (14.7% vs 23.5%; P < 0.001). At 1 year, Watchman FLX was associated with a significantly lower risk for major adverse events (adjusted HR: 0.84; 95% CI: 0.80-0.88; P < 0.0001), ischemic stroke (adjusted HR: 0.82; 95% CI: 0.68-0.98; P = 0.02), and ischemic stroke or systemic embolism (adjusted HR: 0.74; 95% CI: 0.62-0.87; P = 0.0003). The findings of the propensity score matching analysis were similar.
CONCLUSIONS: Transcatheter LAAO with the Watchman FLX is associated with significantly lower risks for major adverse events and ischemic stroke at 1 year compared with the predicate Watchman device. These findings suggest that enhanced procedural safety and completeness of anatomical closure translate into better longer term safety and clinical effectiveness after transcatheter LAAO.
OBJECTIVES: The aim of this study was to compare 1-year safety and clinical effectiveness of the Watchman FLX with the predicate Watchman 2.5 device.
METHODS: The National Cardiovascular Data Registry LAAO Registry was used to identify: 1) patients who received the Watchman FLX; and 2) an identical number of patients receiving the Watchman 2.5 at the same sites directly preceding the first Watchman FLX case at each site. The primary endpoint was ischemic stroke. A secondary analysis was performed using 2:1 propensity score matching.
RESULTS: The study cohort consisted of 27,141 patients receiving each device. Among patients undergoing transesophageal echocardiography at 45 days, the rate of device-related thrombus was not different for Watchman FLX compared with Watchman 2.5 (0.4% vs 0.5%; P = 0.27) while the rate of any peridevice leak was significantly lower (14.7% vs 23.5%; P < 0.001). At 1 year, Watchman FLX was associated with a significantly lower risk for major adverse events (adjusted HR: 0.84; 95% CI: 0.80-0.88; P < 0.0001), ischemic stroke (adjusted HR: 0.82; 95% CI: 0.68-0.98; P = 0.02), and ischemic stroke or systemic embolism (adjusted HR: 0.74; 95% CI: 0.62-0.87; P = 0.0003). The findings of the propensity score matching analysis were similar.
CONCLUSIONS: Transcatheter LAAO with the Watchman FLX is associated with significantly lower risks for major adverse events and ischemic stroke at 1 year compared with the predicate Watchman device. These findings suggest that enhanced procedural safety and completeness of anatomical closure translate into better longer term safety and clinical effectiveness after transcatheter LAAO.