Key result
LACbes occluder shows comparable efficacy to WATCHMAN for major events after appendage closure.
Why the study?
Different LAAC devices have been introduced with varying mechanisms, and comparative clinical outcomes between the WATCHMAN and the new LACbes® device remain to be evaluated.
Does the LACbes device improve safety and efficacy outcomes compared to the WATCHMAN device in patients with atrial fibrillation undergoing left atrial appendage closure?
Cohort (n=368)
No
Does the LACbes device improve safety and efficacy outcomes compared to the WATCHMAN device in patients with atrial fibrillation undergoing left atrial appendage closure?
The LACbes occluder demonstrates comparable overall safety and efficacy to the WATCHMAN device for stroke prevention in atrial fibrillation, with potentially lower rates of all-cause stroke and bleeding.
LACbes may offer comparable stroke prevention to WATCHMAN in AF; hypothesis-generating and requires RCTs before practice change.
BACKGROUND: Different left atrial appendage closure (LAAC) devices have been introduced into the clinical setting. A new dual-seal mechanism LACbes® occluder with isogenous barbs for LAAC has been designed to facilitate easier delivery and improve safety. The purpose of this study is to compare the clinical outcomes of the WATCHMAN with those of the LACbes® device for LAAC. METHODS: Consecutive patients with atrial fibrillation (AF) who had undergone LAAC performed using a WATCHMAN or LACbes® device from June 2016 to February 2022 were included. The primary efficacy endpoint included ischemic stroke, cardiovascular/unexplained death and device-related thrombus, while the primary safety endpoint included major peri-procedural complications and major bleeding events during clinical follow-ups. 1:1 propensity score matching (PSM) was performed. RESULTS: -VASc score was 3.1 ± 1.5 (LACbes®) vs. 3.1 ± 1.4 (WATCHMAN), and the HAS-BLED score was 2.7 ± 1.1 vs. 2.7 ± 1.0. At a mean follow-up of 2.5 ± 1.5 vs. 2.4 ± 0.9 years, the defined three endpoints were comparable between the two groups. The occurrence of all-cause stroke was lower in 5/452 (1.8%) with LACbes® vs. 16/433 (3.7%) with WATCHMAN occluders (HR, 0.40, 95% confidence interval (CI), 0.18-0.89, P = 0.023), and the incidence of any bleeding was higher in the WATCHMAN group (41/433, 9.5% vs. 8/452, 1.8%; HR, 0.19, 95% CI, 0.11-0.33). CONCLUSION: The LACbes® occluder exhibited comparable safety and efficacy of stroke prevention for AF when compared with the WATCHMAN device.
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Zhang et al. (2025) conducted a cohort in Nonvalvular atrial fibrillation (n=368). LACbes device vs. WATCHMAN device was evaluated on Composite of ischemic stroke, cardiovascular/unexplained death, and device-related thrombus (HR 0.55, 95% CI 0.29-1.07, p=0.072). The LACbes occluder demonstrated comparable efficacy to the WATCHMAN device in preventing the primary composite endpoint of ischemic stroke, cardiovascular/unexplained death, and device-related thrombus (HR 0.55).
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