第二代冷冻球囊消融治疗心房颤动的有效性与安全性的Meta分析

Efficacy and safety of second-generation of cryoballoon radiofrequency ablation in treatment of atrial fibrillation: a Meta-analysis

目的系统评价第二代冷冻球囊消融(G2)治疗心房颤动的有效性和安全性。方法在中国学术期刊全文数据库(CNKI,1997~2015.4)、万方数据库(1989~2015.4)、EMBASE(1974~2015.4)、PUBMED(1966~2015.4)、MEDLINE(1966~2015.4)及The Cochrane Library(1989~2015.4)检索有关第二代冷冻球囊与射频消融治疗心房颤动的病例对照研究,观察组即G2组应用第二代冷冻球囊消融,对照组即射频消融(RF)组应用冷盐水灌注导管射频消融。G2组相对于RF组在肺静脉隔离成功率、术后12个月房颤未复发率比值比(OR)为有效性及两组手术X线曝光时间(min)、手术时间(min)2个方面的加权均数差(WMD)、手术主要并发症发生率的比值比(OR)为安全性指标进行Meta分析。结果共纳入5项临床对照试验,包括2049例患者,其中G2组1117例,RF组932例。分析结果显示,在心房颤动消融治疗中,G2组相对于RF组在肺静脉隔离成功率更高(OR=2.54,95%CI:1.31~4.89,P=0.005,I^2=0%),G2组术后12个月房颤未复发率与RF组无显著差异(OR=0.71,95%CI:0.44~1.16,P=0.17,I^2=67%),G2组手术主要并发症发生率与RF组无显著差异(OR=2.73,95%CI:1.00~7.46,P=0.05,I^2=72%),G2组手术X线曝光时间与RF组无显著差异(WMD=0.72,95%CI:-4.50~5.95,P=0.79,I^2=96%),G2组手术时间与RF组无显著差异(WMD=-20.37,95%CI:-48.92~8.18,P=0.16,I^2=97%)。结论第二代冷冻球囊和冷盐水灌注导管射频消融治疗心房颤动有效性与安全性相似。

Objective To review systematically the efficacy and safety of second-generation of cryoballoonradiofrequency ablation (G2) in treatment of atrial fibrillation (AF). Methods The databases of CNKI (1997~2015.4),WanFang Database (1989~2015.4), EMbase (1974~2015.4), PubMed (1966~2015.4), MedLine (1966~2015.4)and Cochrane Library (1989~2015.4) were retrieved for collecting case control studies on treatment of AF with G2.The observation group was treated with G2 and control group was treated with cold saline water perfusion catheterradiofrequency ablation (RF). The odds ratio (OR) of success rate of pulmonary vein isolation and AF non-recurrentrate 12 m after ablation between 2 groups were taken as effective indicators, weighted mean difference (WMD) of X-rayexposure time (min) and ablation procedure duration (min), and OR of major complication incidence were taken assafety indexes for Meta-analysis. Results There were totally 5 clinical control studies included involved 2049 patients(1117 in G2 group and 932 in RF group). The results of Meta-analysis showed that the success rate of pulmonary veinisolation was higher in G2 group than that in RF group (OR=2.54,95%CI:1.31～4.89,P=0.005,I2=0%). TheAF non-recurrent rate 12 m after ablation had no significant difference between both groups (OR=0.71,95%CI:0.44～1.16,P=0.17,I2=67%). The incidence of major complications had no significant difference between bothgroups (OR=2.73,95%CI:1.00～7.46,P=0.05,I2=72%). X-ray exposure time had no significant differencebetween both groups (WMD=0.72,95%CI:-4.50～5.95,P=0.79,I2=96%), and ablation procedure durationhad no significant difference between both groups (WMD=-20.37,95%CI:-48.92～8.18,P=0.16,I2=97%).Conclusion The efficacy and safety of second-generation of cryoballoon radiofrequency ablation are similar to those ofsaline water perfusion catheter radiofrequency ablation.