射频消融治疗房室结或房室折返性心动过速的多中心随机临床试验

目的 通过与国外进口温控射频消融导管的比较,评价国产温控射频消融导管在房室结折返性心动过速(AVNRT)和房室折返性心动过速(AVRT)的临床疗效和安全性.方法 自2008年6月至11月共入选AVNRT或AVRT患者1342例.采用多中心随机平行对照开放试验设计,应用解放军第四军医大学设计的最小化随机统计方法进行动态随机分为二组,国产导管组应用国产温控射频消融导管,进口导管组应用强生或圣犹达等公司的进口温控射频消融导管.采用常规方法在X线透视下进行心内电生理检查和射频消融.结果 国产导管组672例,即时消融成功率97.9%,进口导管组670例,即时消融成功率99.1%,两组成功率均达到96.0%以上,差异无统计学意义.国产导管组与进口导管组的手术时间(68±36)min与(67±34)min]、曝光时间(14±14)min与(10±11)min]、放电次数(4.5±4.5)次与(4.6±3.9)次]、放电时间(260±218)s与(257±207)8]、导管性能总体评分(4.4±0.5)分与(4.5±0.4)分],两组间差异均无统计学意义.发生并发症3例,均为心包积液(国产导管组1例,进口导管组2例),经心包穿刺引流后转为正常出院,差异无统计学意义.随访3个月,复发30例,分别为国产导管组14例、进口导管组16例(2.1%与2.4%),差异无统计学意义.结论 国产温控射频消融导管可安全有效治疗AVNRT或AVRT.

Multi-center clinical trial on efficacy of nationul-made radiofrequency ablation catheter for the treatment of atrioventricular nodal reentrant tachycardia and atrioventricular reentrant tachycardia

Objective The aim of this trial is to compare the efficacy and safety between national-made and imported ablation catheters for the treatment of atrioventricular nodal reentrant tachycardia (AVNRT) and atrioventricular reentrant tachycardia (AVRT). Method A total of 1342 patients with AVNRV or AVRT were randomly treated with national-mode ablation catheter (Group 1, n = 672) or imported ablation catheter (Group 2, n=670). Results The immediate ablation success rate was similar in Group 1 and Group 2 (97.9% vs. 99.1%, P > 0.05). There were also no significant differences in the procedure time (68±36) min vs. (67±34 ) min], the fluoroscopic time (14±14) min vs. (10±11) min], the number of energy delivery (4.5±4.5) beats vs. (4.6±3.9) beats], the ablation time (260±218) s vs. (257±207) s] and the score of ablation catheter performance evaluation(4.4±0.5) vs. (4.5±0.4)] between the two groups (all P > 0.05). Three patients developed pericardial effusion (1 in Croup 1 and 2 in Group 2, P>0.05). Incidence of recurrence of tachycardia during the 3 months follow up was similar between the 2 groups (14 in Group1 vs. 16 in Group 2, P > 0.05). Conclusion National-made and imported radiofrequency ablation catheters have similar efficacy and safety for treatment of AVNRT and AVRT.