左心耳封堵治疗非瓣膜性房颤的安全性和有效性

目的 目前左心耳封堵术对于非瓣膜性房颤高卒中风险的美国和欧洲患者作为替代华法林预防卒中治疗是合理的选择,但在中国还缺乏大型的临床数据支持,本文旨在初步探讨左心耳封堵术后短期的安全性和有效性。 方法 根据纳入及排除标准,选择2018年11月—2019年9月中国科学技术大学附属第一医院心律失常亚专科行Watchman左心耳封堵治疗的非瓣膜性心房颤动(nonvalvular atrial fibrillation,NVAF)患者。在全麻或经心腔内超声心动图指导下行左心耳封堵术。随访观察术后7 d和6个月的器械或手术相关事件、缺血性脑卒中、系统性栓塞及心血管死亡组成的复合终点发生率及45 d和6个月的左心耳封堵程度。 结果 共入选70例患者,术后7 d内所有患者均无器械或手术相关严重事件、卒中、全身性栓塞及全因死亡发生,6个月随访中1例发生缺血性脑卒中1.4%(1/70),45 d经食道心脏超声(transesophageal echocardiography,TEE)提示48.5%(34/70)左心耳完全封堵,6个月TEE有55.7%(39/70)完全封堵,在45 d和6个月的随访中所有封堵器均达到有效封堵标准。 结论 左心耳封堵术治疗高卒中风险的非瓣膜性房颤是安全、有效的。该研究结果为中国长期需要口服抗凝药物的NVAF患者的治疗提供了新的思路。 

Efficacy and safety of left atrial appendage occlusion in the therapy for non-valvular atrial fibrillation

Objective To observe the short-term curative effect and safety of therapy of left atrial appendage closure(LAAC). Methods The patients with non-valvular atrial fibrillation(NVAF) were chosen according to inclusion and exclusion criteria from Department of Cardiology in the First Affiliated Hospital of USTC from November 2018 to September 2019. The therapy for NVAF of LAAC was performed under general anesthesia and mediated by intracardiac echocardiography. The composite end point rate of device or operation related events, ischemic stroke, systemic embolism and cardiovascular death were observed 7 days and 6 months after operation. The degree of left atrial appendage occlusion at 45 days and 6 months were observed. Results Total 70 patients were selected, there was no serious adverse events such as stroke, systemic embolism and overall death observed in the early 7 days after surgery. One ischemic stroke(1.4%, 1/70) occurred during the 6-month follow-up, 48.5%(34/70) completely sealed within 45 days, 55.7%(39/70) completely sealed within 6 months by transesophageal echocardiogram. The effective LAAC rate was 100%(70/70) at both 45 days and 6 months follow-up. Conclusion The therapy for NVAF of LAAC is safe and effective. The results of this study provide new ideas for the treatment of NVAF patients in China who need oral anticoagulants for a long time.