经导管Amplatzer封堵器和外科手术治疗动脉导管未闭对照试验的Meta分析

目的评估经导管Amplatzer封堵器治疗动脉导管未闭(PDA)的疗效,为临床应用提供指导。方法采用Meta分析方法,对国内外有关经导管Amplatzer封堵器和外科手术治疗PDA的对比临床研究进行综合定量分析,采用RevMan4.2.2软件进行数据处理,计算各组技术失败率、并发症及严重并发症发生率、残余分流率等的相对危险度(RR)及其95%可信区间(CI)。结果符合纳入标准共5篇文献,总样本量349例。经导管Amplatzer封堵器组技术失败率高于外科手术组[5组对照试验(CT),349例,3.0%vs0,RR=4.29,95%CI(0.77,23.95)],但无显著性差异(P=0.10);并发症发生率低于外科手术[5组CT,343例,3.1%vs38.0%,RR=0.11,95%CI(0.05,0.23)](P<0.00001);严重并发症发生率显著低于手术组[5组CT,343例,0.5%vs6.0%,RR=0.23,95%CI(0.06,0.90)](P=0.03);Amplatzer封堵器组治疗后即时残余分流率高于手术组[4组CT,304例,16.3%vs0,RR=16.06,95%CI(3.0,86.12)](P=0.001);出院时残余分流率虽高于手术组,但无显著性差异(2.5%vs0,P=0.33)。结论经导管Amplatzer封堵器治疗PDA尽管成功率低于外科手术,但其创伤小、并发症发生率低、疗效与手术相仿,随着封堵器及其输送系统的不断改进和完善,在适应证范围内经导管Amplatzer封堵器治疗可作为PDA外科手术治疗的替代方法。

Meta-Analysis on Controlled Trials of Transcatheter Amplatzer Device Closure and Cardiac Surgery on Patent Ductus Arteriosus

ObjectiveTo evaluate the effectiveness of transcatheter Amplatzer device closure on patent ductus arteriosus(PDA),and to give some evidences for the clinical application.MethodsAll studies in the world regard to the controlled trials(CT) about transcatheter Amplatzer device closure and cardiac surgery on PDA were searched and made synthetic evaluation by means of Meta-analysis.RevMan 4.2.2 software was used for statistical analysis.Cases relative risk(RR)and its 95% confidence interval(CI)of procedure failure,the incidence of complication and residual shunt were calculated.ResultsTotally 5 studies including 349 cases were analyzed.Operation failure of Amplatzer device occlusion was higher than cardiac surgery [5 CT,349 cases,3.0% vs 0,RR=4.29,95%CI(0.77,23.95)](P=0.10).Incidence of complication of Amplatzer device occlusion was lower than cardiac surgery[5 CT,343 cases,3.1% vs 38.0%,RR=0.11,95%CI(0.05,0.23)](P<0.000 01) and incidence of serious complication was also lower than cardiac surgery[5 CT,343 cases,0.5% vs 6.0%,RR=0.23,95%CI(0.06,0.90)](P=0.03).Postoperative redidual shunt of Amplatzer device occlusion was higher than cardiac surgery[4 CT,304 cases,16.3%vs 0,RR=16.06,95%CI(3.0,86.12)](P=0.001) and discharge redidual shunt was higher than cardiac surgery but there was no significant difference(2.5% vs 0,P=0.33).ConclusionsExcept operation failure rate is higher than cardiac surgery,Amplatzer device closure shows similar effect as surgery but with minimal trauma and low incidence of complication.For indications with the development of closure divece and delivery mechanism transcatheter Amplatzer device closure of PDA is an alternative to cardiac surgery.