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

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I;<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,CI95%CI:0.55–0.99,P=0.04,I;=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,I;=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。

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 I;<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,I;=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,I;=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.