Zhang Song, Xiong Sihuai, Zhang Sha, Chen Keyu, Wang Hua, Li Ke, Xu Xudong, Zhao Xianxian, Zhu Ni, Huang Xinmiao, Qin Yongwen, Guo Zhifu, Bai Yuan
Department of Cardiology, Changhai Hospital, Naval Medical University, No. 168 Changhai Road, Yangpu District, Shanghai, 200433, China.
BMC Cardiovasc Disord. 2025 Jan 11;25(1):18. doi: 10.1186/s12872-024-04383-z.
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.
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.
After PSM, 184 patients were included in each group. The mean CHADS-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).
The LACbes® occluder exhibited comparable safety and efficacy of stroke prevention for AF when compared with the WATCHMAN device.
不同的左心耳封堵(LAAC)装置已应用于临床。一种新型的具有同源倒刺的双密封机制LACbes®封堵器被设计用于LAAC,以便于更轻松地输送并提高安全性。本研究的目的是比较WATCHMAN和LACbes®装置用于LAAC的临床结果。
纳入2016年6月至2022年2月期间连续接受使用WATCHMAN或LACbes®装置进行LAAC的房颤(AF)患者。主要疗效终点包括缺血性卒中、心血管/不明原因死亡和与装置相关的血栓,而主要安全终点包括临床随访期间的主要围手术期并发症和大出血事件。进行1:1倾向评分匹配(PSM)。
PSM后,每组纳入184例患者。平均CHADS-VASc评分在LACbes®组为3.1±1.5,在WATCHMAN组为3.1±1.4;HAS-BLED评分在LACbes®组为2.7±1.1,在WATCHMAN组为2.7±1.0。平均随访时间分别为2.5±1.5年和2.4±0.9年,两组的三个既定终点具有可比性。LACbes®组全因卒中发生率为5/452(1.8%),低于WATCHMAN封堵器组的16/433(3.7%)(HR,0.40,95%置信区间(CI),0.18 - 0.89,P = 0.023),且WATCHMAN组任何出血的发生率更高(41/433,9.5% vs. 8/452,1.8%;HR,0.19,95% CI,0.11 - 0.33)。
与WATCHMAN装置相比,LACbes®封堵器在预防房颤患者卒中方面表现出相当的安全性和有效性。