[Safety and efficacy of Laager left atrial appendage occlusion system in patients with nonvalvular atrial fibrillation: a prospective, multicenter clinical study].
MY, D., CY, J., H, C., ML, C., ZP, N., J, P., JB, L., XY, Q., RM, W., & YL, X. (2026). [Safety and efficacy of Laager left atrial appendage occlusion system in patients with nonvalvular atrial fibrillation: a prospective, multicenter clinical study].. Zhonghua xin xue guan bing za zhi. https://doi.org/10.3760/cma.j.cn112148-20260306-00144
MY D, CY J, H C, ML C, ZP N, J P, et al. [Safety and efficacy of Laager left atrial appendage occlusion system in patients with nonvalvular atrial fibrillation: a prospective, multicenter clinical study].. Zhonghua xin xue guan bing za zhi. 2026; doi: 10.3760/cma.j.cn112148-20260306-00144
MY D, CY J, H C, et al. [Safety and efficacy of Laager left atrial appendage occlusion system in patients with nonvalvular atrial fibrillation: a prospective, multicenter clinical study].[J]. Zhonghua xin xue guan bing za zhi. 2026. DOI: 10.3760/cma.j.cn112148-20260306-00144.
@article{my2026,
author = {Ding MY and Jiang CY and Cai H and Chen ML and Ning ZP and Peng J and Li JB and Qi XY and Wang RM and Xia YL},
title = {[Safety and efficacy of Laager left atrial appendage occlusion system in patients with nonvalvular atrial fibrillation: a prospective, multicenter clinical study].},
journal = {Zhonghua xin xue guan bing za zhi},
year = {2026},
doi = {10.3760/cma.j.cn112148-20260306-00144},
note = {PMID: 42595523},
}
TY - JOUR AU - Ding MY AU - Jiang CY AU - Cai H AU - Chen ML AU - Ning ZP AU - Peng J AU - Li JB AU - Qi XY AU - Wang RM AU - Xia YL TI - [Safety and efficacy of Laager left atrial appendage occlusion system in patients with nonvalvular atrial fibrillation: a prospective, multicenter clinical study]. T2 - Zhonghua xin xue guan bing za zhi PY - 2026 DO - 10.3760/cma.j.cn112148-20260306-00144 AN - PMID:42595523 ER -
Objective: To investigate the safety and efficacy of the Laager left atrial appendage occlusion system in stroke prevention in patients with atrial fibrillation. Methods: This was a prospective, multicenter, non-randomized, single-arm cohort study with prespecified performance goal. Patients with nonvalvular atrial fibrillation were enrolled at 12 centers nationwide from November 2017 to April 2019. All enrolled patients had CHA2DS2-VASc scores of ≥2 for males and ≥3 for females, and were not suitable for long-term warfarin anticoagulation therapy. All patients underwent left atrial appendage occlusion with the Laager occlusion system and were followed up. The primary efficacy endpoint was the rate of successful left atrial appendage occlusion, defined as a residual shunt ≤3 mm on transesophageal echocardiography at 12 months postoperatively. The primary safety endpoint was the incidence of ischemic stroke. Results: A total of 212 patients with nonvalvular atrial fibrillation were enrolled, with an age of (65.9±8.5) years, including 86 females (40.6%). Immediate procedural success was achieved in 210 patients (99.1%), and residual shunt >3 mm was observed in 2 patients post-procedure. At 12 months postoperatively, 187 patients completed transesophageal echocardiography (including 2 patients with residual shunt >3 mm post-procedure), and the success rate of left atrial appendage occlusion was 96.8% (181/187). The incidence of ischemic stroke was 0.5% (1/212). Conclusion: The Laager left atrial appendage occlusion system demonstrates favorable safety and efficacy for stroke prevention in patients with nonvalvular atrial fibrillation. 目的： 探讨Laager左心耳封堵系统在心房颤动（房颤）患者卒中预防中的安全性及有效性。 方法： 本研究为前瞻性、多中心、非随机、单臂目标值法的队列研究，2017年11月至2019年4月在全国12家中心连续纳入非瓣膜性房颤患者。所有入选患者CHA2DS2-VASc评分男性≥2分，女性≥3分，且不适合长期应用华法林抗凝治疗。所有患者接受Laager封堵系统左心耳封堵治疗并进行随访，主要有效性终点为左心耳封堵成功，定义为在术后12个月经食管超声心动图提示残余分流≤3 mm，主要安全终点为缺血性卒中。 结果： 共纳入212例非瓣膜性房颤患者，年龄（65.9±8.5）岁，女性86例（40.6%），210例（99.1%）患者实现术后即刻器械成功，2例患者术后即刻封堵器残余分流>3 mm。术后12个月187例患者完成经食管超声心动图检查（包含2例术后即刻封堵器残余分流>3 mm的患者），左心耳封堵成功率为96.8%（181/187），缺血性卒中发生率为0.5%（1/212）。 结论： Laager左心耳封堵器系统在非瓣膜性房颤患者的卒中预防方面具有良好的安全性和有效性。.