Watchman封堵器与ACP/Amulet封堵器应用于非瓣膜性房颤患者行左心耳封堵术的有效性与安全性Meta分析

孙冰; 张晓东; 赵勇; 刘鹏云; 杨静霄; 武欣蕾; 周海佳; 康晓辉; 杜瑞; 陈蕊蕊

doi:10.12125/j.chj.202103073

Watchman封堵器与ACP/Amulet封堵器应用于非瓣膜性房颤患者行左心耳封堵术的有效性与安全性Meta分析

Clinical efficacy and safety of Watchman occluders vs. ACP/Amulet occluders in patients with non-valvular atrial fibrillation: a patient-pooled meta-analysis of clinical trials

摘要

摘要:
目的比较Watchman封堵器与ACP/Amulet封堵器对非瓣膜性房颤患者行左心耳封堵术的有效性与安全性。
方法纳入标准为不适宜口服抗凝药物治疗、不能长期耐受抗凝治疗、具有高卒中或高出血风险的非瓣膜性房颤患者。文献检索由2名研究者独立筛选文献，提交资料并交叉核对，如遇分歧则讨论解决，或交由第三名研究者协助判断。统计学分析采用RevMan5.4进行软件统计Meta分析，因结局指标为二分类变量，故采用比值比（OR）为效应指标，各指标均给出点估值和95%CI。当P>0.05且I²<0.5时采用固定效应模型进行Meta分析。主要观察终点为住院期间以及术后随访的总计全因死亡、心源性死亡及脑卒中的发生率。次要观察终点为围手术期及住院期间的并发症发生率（包括心包积液、心脏压塞和封堵器脱落）。术后随访期间安全性观察包括复查经食管超声心动图（transesophageal echocardiography，TEE）封堵器相关血栓栓塞（device related thrombus，DRT）、残余漏≥5 mm及出血事件的发生率。
结果共纳入8篇文献，共计1821人。其中Watchman组896人，ACP/Amulet组925人。主要观察终点：Watchman封堵器组全因死亡率为10.7 %，低于ACP/Amulet组13.8 %( OR:0.74, CI 95% CI: 0.55–0.99, P=0.04, I²=0% )，两组总计心源性死亡率、卒中发生率无差异。次要观察终点：包括心包积液、心脏压塞和封堵器脱落发生率无差异。术后随访的安全性观察：残余漏发生率（≥5 mm）Watchman组1.8 %高于ACP/Amulet组0.8 %( OR: 2.64, CI 95% CI: 1.09–6.41, P=0.03, I²=0% )，出血事件及封堵器相关血栓发生率无差异。
结论应用Watchman封堵器对非瓣膜性房颤患者行左心耳封堵术对比ACP/Amulet封堵器有较低的全因死亡率。两组心源性死亡率、卒中发生率、围手术及住院期间并发症发生率相当，且均具有较高的安全性。

Abstract:
AIM To compare the clinical efficacy of Watchman occluders vs. ACP/Amulet occluders in patients with non-valvular atrial fibrillation (nVAF). METHODS Included in this analysis were nVAF patients who were not suitable for oral anticoagulant therapy, or did not tolerate a log-time anticoagulant therapy, or had high risk of stroke, or were bleeding. Two researchers independently screened the literature, submitted the data and cross-checked them. In case of differences, the third researcher would assist to make the judgment. RevMan5.4 was used for Meta analysis. As the outcome indicator was a binary variable, odds ratio (OR) was used as the effect indicator and point valuation/95%CI was given for each indicator. With P > 0.05 and I² < 0.5, the fixed effect model was used for Meta analysis. The primary endpoint was the incidence of all-cause death, cardiovascular death and stroke. Secondary endpoints were perioperative and in-hospital complications (including pericardial effusion, cardiac tamponade and loss of occlude dislodgement). The safety endpoints were device-related thrombus (DRT), residual complications ≥5 mm and bleeding events within follow-up.
RESULTS A total of 8 articles and 1821 patients were included in this study. Eight hundred and ninety-six patients were in the Watchman group and 925 patients were in the ACP/Amulet group. The all-cause death in the Watchman group was 10.7%, lower than that in the ACP/Amulet group (OR:0.74, CI 95% CI: 0.55 -- 0.99, P =0.04, I²=0%). There was no difference in the incidence of cardiovascular death and total stroke, pericardial effusion, cardiac tamponade and occluder dislodgement. The incidence of residual leakage (≥5 mm) in the Watchman group was 1.8% higher than that in the ACP/Amulet group (OR: 2.64, CI 95% CI: 1.09 -- 6.41, P =0.03, I²=0%). No differences were observed in the incidence of bleeding and device-related thrombosis.
CONCLUSION The all-cause death in Watchman group is lower than that in ACP/Amulet group. The incidence of perioperative and in-hospital complications is similar and both of the two devices are safe.

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