背景:关于LAAC在中国非瓣膜性房颤(NVAF)患者中预防脑血管意外和血栓栓塞的安全性和有效性的临床特征和长期数据仍然有限。
方法:北京安贞医院连续行LAAC的NVAF患者数据,首都医科大学,从2014年6月1日至2021年12月31日,进行收集和回顾性分析。主要有效性终点是卒中/短暂性脑缺血发作的复合终点,全身性栓塞,和心血管原因导致的死亡。主要安全终点是LAAC慕尼黑共识定义的严重出血。
结果:在222名患者中,平均年龄为66.90±9.62岁,大多数是男性(77.03%)。许多患者是非阵发性房颤(71.19%),房颤的中位持续时间为4.00年。CHA2DS2-VASc平均得分为3.78±1.49,HAS-BLED平均得分为1.68±0.86。血栓栓塞事件(76.58%)是LAAC最常见的指征。该装置,技术,手术成功率为98.65%,98.65%,和93.69%,分别。抗凝延续率为56.36%,31.25%,和22.60%在3-,术后6个月和12个月,分别。在平均2.81年的随访中,主要疗效终点的发生率为4.27/100患者-年,主要归因于卒中/TIA(每100个PYs3.12)。5例患者在随访期间出现大出血。术后成像显示并发症极少,只有一个重大的设备周围泄漏。2.33%的患者发生装置相关血栓,用抗凝解决。
结论:研究表明,LAAC是中国房颤患者的一种安全有效的替代选择,成功率很高,并发症少,长期不良结局事件少.
BACKGROUND: Clinical characteristics and long-term data on the safety and efficacy of LAAC in preventing cerebrovascular accident and thromboembolism among Chinese patients with non-valvular AF (NVAF) remain limited.
METHODS: Data of consecutive NVAF patients who underwent LAAC at Beijing Anzhen Hospital, Capital Medical University, from June 1, 2014, to December 31, 2021, were collected and analyzed retrospectively. The primary effectiveness endpoint was the composite endpoint of stroke/transient ischemic attack, systemic embolism, and death from cardiovascular causes. The primary safety endpoint is the severe bleeding defined by the LAAC Munich consensus.
RESULTS: Of the 222 patients enrolled, the mean age was 66.90 ± 9.62 years, with a majority being male (77.03%). Many patients are non-paroxysmal AF (71.19%) with a median duration of AF of 4.00 years. The mean CHA2DS2-VASc score was 3.78 ± 1.49, and the mean HAS-BLED score was 1.68 ± 0.86. Thromboembolic events (76.58%) were the most common indication for LAAC. The device, technical, and procedural success rates were 98.65%, 98.65%, and 93.69%, respectively. The anticoagulation continuation rate was 56.36%, 31.25%, and 22.60% at 3-, 6- and 12 months post-procedure, respectively. Throughout a mean 2.81 years of follow-up, the incidence of the primary efficacy endpoint was 4.27 per 100 patient-years, predominantly attributable to stroke/TIA (3.12 per 100 PYs). Five patients experienced major bleeding during the follow-up period. Post-procedure imaging revealed minimal complications, with only one substantial peri-device leak. Device-related thrombus occurred in 2.33% of patients, resolving with anticoagulation.
CONCLUSIONS: The study demonstrates that LAAC is a safe and effective alternative option for Chinese patients with AF, with a high success rate, few complications as well as fewer long-term adverse outcome events.