Department of Cardiology, Beijing Anzhen Hospital affiliated Capital Medical University, No. 2 Anzhen Road, Chaoyang District, Beijing, 100026, China.
National Clinical Research Center for Cardiovascular Diseases, Beijing, China.
BMC Cardiovasc Disord. 2024 Feb 14;24(1):108. doi: 10.1186/s12872-023-03651-8.
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.
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.
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.
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.
在非瓣膜性心房颤动(NVAF)患者中,左心耳封堵术(LAAC)预防脑血管意外和血栓栓塞的临床特征和长期安全性、有效性数据仍十分有限。
回顾性收集 2014 年 6 月 1 日至 2021 年 12 月 31 日在北京安贞医院行 LAAC 的连续 NVAF 患者的数据。主要有效性终点是卒中/短暂性脑缺血发作、全身性栓塞和心血管原因死亡的复合终点。主要安全性终点是 LAAC 慕尼黑共识定义的严重出血。
共纳入 222 例患者,平均年龄 66.90±9.62 岁,多数为男性(77.03%)。许多患者为非阵发性 AF(71.19%),AF 持续时间中位数为 4.00 年。CHA2DS2-VASc 评分平均为 3.78±1.49,HAS-BLED 评分平均为 1.68±0.86。血栓栓塞事件(76.58%)是 LAAC 的最常见适应证。器械、技术和程序成功率分别为 98.65%、98.65%和 93.69%。抗凝治疗的继续率分别为术后 3、6 和 12 个月时的 56.36%、31.25%和 22.60%。平均 2.81 年的随访期间,主要有效性终点的发生率为每 100 患者年 4.27 例,主要归因于卒中/TIA(3.12 例/100 PYs)。5 例患者在随访期间发生大出血。术后影像学检查显示轻微并发症,仅 1 例存在大量器械周围漏。2.33%的患者发生器械相关血栓,抗凝后得到解决。
该研究表明,LAAC 是中国 AF 患者的一种安全有效的替代治疗选择,成功率高,并发症少,长期不良结局事件少。