经胸微创封堵手术与传统外科修补手术治疗房间隔缺损的系统评价及Meta分析

Efficacy of transthoracic device closure versus traditional surgical repair on atrial septal defects: A systematic review and meta-analysis

目的系统评价经胸微创封堵手术和传统外科修补手术治疗房间隔缺损(ASD)的效果及安全性。方法制定原始的文献纳入标准、排除标准及检索策略,计算机检索PubMed、EMbase、The Cochrane Library、VIP、CNKI、CBM及万方数据库等,纳入临床对照试验,检索时间均为从建库至2018年7月,采用RevMan5.3软件和Stata12.0软件进行Meta分析。结果纳入文献30篇,其中3篇随机对照试验(RCT),27篇队列研究(CCT),共计3 321例患者。Meta分析结果显示:在手术成功率的比较中,经胸封堵组低于传统外科修补组,差异有统计学意义[CCT,OR=0.34,95%CI(0.16,0.69),P=0.003]。而两组间手术死亡率的差异无统计学意义[CCT,OR=0.43,95%CI(0.12,1.52),P=0.19]。经胸封堵组术后并发症发生率低于传统外科修补组,差异有统计学意义[RCT,OR=0.30,95%CI(0.12,0.77),P=0.01;CCT,OR=0.27,95%CI(0.17,0.42),P<0.000 01]。两组间的术后1个月残余分流发生率[CCT,OR=4.52,95%CI(0.45,45.82),P=0.20]及术后1年残余分流发生率[CCT,OR=1.03,95%CI(0.29,3.68),P=0.97]的比较中,差异均无统计学意义。经胸封堵组的手术时间[RCT,MD=–55.90,95%CI(–58.69,–53.11),P<0.000 01;CCT,MD=–71.68,95%CI(–79.70,–63.66),P<0.000 01]、呼吸机辅助通气时间[CCT,MD=–228.68,95%CI(–247.60,–209.77),P<0.000 01]、住院时间[CCT,MD=–3.31,95%CI(–4.16,–2.46),P<0.000 01]及住ICU时间[CCT,MD=–10.15,95%CI(–14.38,–5.91),P<0.000 01]均低于传统手术修补组,差异有统计学意义。但是在住院费用方面,经胸封堵组高于传统手术修补组,差异有统计学意义[CCT,MD=1 221.42,95%CI(1 124.70,1 318.14),P<0.000 01]。结论对比传统外科修补手术,经胸微创封堵手术缩短了患者的住院时间、手术时间、 ICU停留时间及呼吸机辅助通气时间,降低了术后并发症的发生,对于符合适应证的房间隔缺损患者,是疗效确切,安全可行的方法。

Objective To compare the effects of transthoracic device closure and traditional surgical repair on atrial septal defect systemically. Methods A systematic literature search was conducted using the PubMed, EMbase, The Cochrane Library, VIP, CNKI, CBM, Wanfang Database up to July 31, 2018 to identify trials according to the inclusion and exclusion criteria. Quality was assessed and data of included articles were extracted. The meta-analysis was conducted by RevMan 5.3 and Stata 12.0 software. Results Thirty studies were identified, including 3 randomized controlled trials(RCTs) and 27 cohort studies involving 3 321 patients. For success rate, the transthoracic closure group was lower than that in the surgical repair group(CCT, OR=0.34, 95%CI 0.16 to 0.69, P=0.003). There was no statistical difference in mortality between the two groups(CCT, OR=0.43, 95%CI 0.12 to 1.52, P=0.19). Postoperative complication occurred less frequently in the transthoracic closure group than that in the surgical repair group(RCT, OR=0.30, 95%CI 0.12 to 0.77,P=0.01;CCT, OR=0.27, 95%CI 0.17 to 0.42, P<0.000 01). The risk of postoperative arrhythmia in the transthoracic closure group was lower than that in the surgical repair group(CCT, OR=0.56, 95%CI 0.34 to 0.90, P=0.02). There was no statistical difference in the incidence of postoperative residual shunt in postoperative one month(CCT, OR=4.52, 95%CI0.45 to 45.82, P=0.20) and in postoperative one year(CCT, OR=1.03, 95%CI 0.29 to 3.68, P=0.97) between the two groups.Although the duration of operation(RCT MD=–55.90, 95%CI –58.69 to –53.11, P<0.000 01;CCT MD=–71.68, 95%CI–79.70 to –63.66, P<0.000 01), hospital stay(CCT, MD=–3.31, 95%CI –4.16,–2.46, P<0.000 01) and ICU stay(CCT,MD=–10.15, 95%CI –14.38 to –5.91, P<0.000 01), mechanical ventilation(CCT, MD=–228.68, 95%CI –247.60 to–209.77, P<0.000 01) in the transthoracic closure group were lower than those in the traditional surgical repair group, the transthoracic closure costed more than traditional surgical repair during being in the hospital(CCT, MD=1 221.42, 95%CI1 124.70 to 1 318.14, P<0.000 01). Conclusion Compared with traditional surgical repair, the transthoracic closure reduces the hospital stay, shortens the length of ICU stay and the duration of ventilator assisted ventilation, while has less postoperative complications. It is safe and reliable for patients with ASD within the scope of indication.