Gao Chao, Su Fangju, Liu Jianzheng, Zhang Tingting, Ning Zhongping, Yang Bing, Chu Huimin, He Ben, Zhang Junfeng, Zhou Ling, Li Yuechun, Zhang Yushun, Hu Hao, Xu Yawei, Zeng Jie, Guo Jun, Su Xi, Ruan Zhong-Bao, Liu Haitao, Wang Ping, Garg Scot, Soliman Osama, Holmes David R, Serruys Patrick W, Tao Ling
Department of Cardiology, Xijing Hospital, Xi'an, China.
Department of Cardiology, The 940th Hospital of Joint Logistic Support Force of PLA, Lanzhou, China.
JACC Asia. 2024 Oct 1;4(10):777-790. doi: 10.1016/j.jacasi.2024.07.013. eCollection 2024 Oct.
The clinical performance of left atrial appendage occlusion (LAAO) as a procedure and the long-term impact of its varied implantation configurations and anticoagulation regimens remain unclear.
This study sought to provide data in routine practice from a prospective multicenter registry.
A total of 3,096 consecutive patients from 39 Chinese centers undergoing LAAO were enrolled between April 1, 2019, and October 31, 2020.
The baseline CHADS-VASc and HAS-BLED scores were 4.0 ± 1.8 and 2.4 ± 1.2, respectively; mean age was 69 ± 9 years. One-year follow-up was completed in 3,013 (97.8%) patients. The ischemic endpoint of death, stroke, and systemic embolism occurred in 133 (4.51%) patients, and life-threatening, disabling, or major bleeding occurred in 71 (2.36%) patients. After inverse probability of treatment weighting, no significant association was found between anesthesia type (moderate sedation vs general anesthesia) or image guidance (transesophageal/intracardiac echocardiography vs fluoroscopy) and ischemic or bleeding events. In 1,295 (42.0%) cases, LAAO combined with catheter ablation was associated with a significantly lower rate of death, stroke, or systemic embolism than LAAO only (3.5% vs 5.2%, inverse probability of treatment weighting HR: 0.68; 95% CI: 0.47-0.99). The most common post-LAAO antithrombotic regimen was warfarin/direct oral anticoagulant monotherapy for 45 days, followed by single-/dual-antiplatelet therapy (38.1%).
In Chinese centers, patients undergoing LAAO had low rates of ischemic and bleeding events at 1 year. Combining LAAO with catheter ablation was associated with a lower rate of ischemic events than LAAO only. (Registry to Evaluate Chinese Real-World Clinical Outcomes in Patients With Atrial Fibrillation Using the Watchman Left Atrial Appendage Closure Technology [RECORD]; NCT03917563).
作为一种手术,左心耳封堵术(LAAO)的临床表现以及其不同植入构型和抗凝方案的长期影响仍不明确。
本研究旨在从前瞻性多中心注册研究中提供常规实践中的数据。
2019年4月1日至2020年10月31日期间,共纳入了来自中国39个中心的3096例连续接受LAAO的患者。
基线CHADS-VASc和HAS-BLED评分分别为4.0±1.8和2.4±1.2;平均年龄为69±9岁。3013例(97.8%)患者完成了1年随访。133例(4.51%)患者发生了死亡、卒中及全身性栓塞的缺血性终点事件,71例(2.36%)患者发生了危及生命、致残或大出血事件。在进行治疗权重逆概率分析后,未发现麻醉类型(中度镇静与全身麻醉)或影像引导方式(经食管/心内超声心动图与荧光透视)与缺血或出血事件之间存在显著关联。在1295例(42.0%)病例中,LAAO联合导管消融术与仅行LAAO相比,死亡、卒中或全身性栓塞发生率显著更低(3.5%对5.2%,治疗权重逆概率分析HR:0.68;95%CI:0.47 - 0.99)。LAAO术后最常见的抗栓方案是华法林/直接口服抗凝药单药治疗45天,其次是单/双联抗血小板治疗(38.1%)。
在中国各中心,接受LAAO的患者1年时缺血和出血事件发生率较低。LAAO联合导管消融术与仅行LAAO相比,缺血事件发生率更低。(使用Watchman左心耳封堵技术评估中国心房颤动患者真实世界临床结局的注册研究[RECORD];NCT03917563)