一代与二代冷冻球囊电隔离肺静脉即刻有效性及安全性分析

Effectiveness and safety of the first and second generation cryoballoon of electrical isolation of pulmonary vein

目的 比较应用一代冷冻球囊（CB1st）及二代冷冻球囊（CB2nd）消融（cryoballoon ablation,CBA）电隔离肺静脉的即刻有效性及安全性.方法 连续入选2016年5月16日至2016年10月28日在阜外医院接受CBA治疗的心房颤动（房颤）患者,CB1st及CB2nd各100例,观察分析2组患者肺静脉隔离（PVI）隔离时间（TTI）及温度、手术时间、X线曝光时间及术中、术后并发症等临床指标.结果 两组患者基线资料相匹配.CB2nd组CBA失败需要射频（RF）补点1％,较CB1st组RF补点（13％）明显低（P〈0.01）.CB2nd组TTI较CB1st组短[（46.1±24.7） s对（52.6±34.1） s,P=0.01].CB1st CBA次数为（9.1±1.7）较CB2nd组（6.2±1.6）多（P〈0.01）.手术平均时间CB1st组为（72.2±18.2） min较CB2nd组为（53.7±9.7） min长（P=0.02）.X线曝光时间CB1st组平均时间（16.3±6.2） min较CB2nd组平均时间为（11.4±7.4） min长（P〈0.01）.X线曝光量CB1st组（296.9±203.0） mGy较CB2nd组（199.1±150.6） mGy多（P〈0.01）.CB2nd组患者术后出现痰中带血丝21例（21％）较CB1st组患者术后出现痰中带血丝5例（5％）多（P=0.01）,CB2nd组患者术后一过性呃逆16例（16％）较CB1st组患者术后一过性呃逆4例（4％）多（P〈0.01）.结论 CB2nd 28 mm冷冻球囊可适用于绝大多数的肺静脉.CB2nd较CB1st治疗房颤消融更为有效,PVI成功率高,明显缩短手术时间和X线曝光时间,但邻近器官组织损伤较高.

Objective This study was to assess the immediate efficacy and safety of cryoballoon ablation（CBA）on the pulmonary vein potential isolation by using the first generation cryoballoon（CB1st）and the second generation balloon（CB2nd）.Methods One hundred patients in CB1st group and 100 patients in CB2nd group with atrial fibrillation were enrolled from May 2016 to October 2016 in Beijing Fuwai Hospital for cryoballoon ablation.The pulmonary vein isolation（PVI）,isolation time（TTI）,temperature,operation time,X-ray exposure time and complications were analyzed.Results The baseline data of two groups were similar.The rate of radiofrequency after CBA in the CB2nd group was significantly lower than that in the CB1st group（（46.1±24.7） s对（52.6±34.1） s,P〈0.01）.The TTI（46.1±24.7）sec in the CB2nd group was shorter than that sec in the CB1st Group（P=0.01）.The number of CBA in the CB1st group（9.1±1.7）was more than that in CB2nd group（6.2±1.6,P〈0.01）.The average time of operation in the CB1st group was（72.2±18.2）minutes longer than that in the CB2nd group（53.7±9.7）minutes（P=0.02）.The average time of X-ray exposure in CB1st group（16.3±6.2）minutes was longer than that in CB2nd group（11.4±7.4,P〈0.01）.X-ray exposure in CB1st group was（296.9±203.0）mGy higher than that in CB2nd group（199.1±150.6 mGy,P〈0.01）.Hemoptysisand hiccup after CBA in the CB2nd group were more than that in the CB1st group.Conclusion The 28mm advance cryoballoon can be used in most of the pulmonary veins for PVI.In the CB2nd group cryoballoon ablation was more efficient for AF and the procedures was shorter than that in the CB1st group.This higher performance was associated with a higher incidence of the damage of adjacent organs.