冷冻球囊消融治疗阵发性心房颤动的中长期临床结果

Cryoballoon ablation for paroxysmal atrial fibrillation：long-term clinical outcome

目的评估应用冷冻球囊消融（cryoballoon ablation,CBA）治疗阵发性心房颤动（房颤）的安全性及远期临床有效性。方法连续入选2013年12月至2015年3月在上海交通大学医学院附属瑞金医院接受 CBA 治疗的阵发性房颤患者共118例,主要研究终点为空白期（术后90 d）后发生的房颤事件；同时观察分析肺静脉隔离（PVI）成功率,手术时间、X 线曝光时间及并发症等临床参数。术后随访患者至少1年以上,观察 CBA 远期临床疗效。结果共110例患者[男77例,平均年龄（60.1±10.7）岁]最终完成终点事件的随访。平均随访（15.9±5.7）个月,27例患者（男20例）空白期后记录到〉30 s 的房颤事件达到研究终点,Kaplan-Meier 生存曲线估测的1年期无房颤复发率为77.3％。 PVI 成功率为98.3％,平均手术时间为（110.3±12.2） min,平均 X 线曝光时间为（18.6±5.5） min。所有患者围术期未发生心脏压塞、左心房食管瘘及症状性肺静脉狭窄等严重并发症。2.54％（3例）的患者发生一过性膈神经损伤,3例患者膈神经功能于随访5个月时恢复正常。结论 CBA 治疗阵发性房颤具有良好的安全性及远期有效性。

Objective This study was to assess the safety and effectiveness of cryoballoon ablation for paroxysmal atrial fibrillation（AF）during a long period of follow-up. Methods One hundred and eighteen con-secutive AF patients were enrolled from December 2013 to March 2015 in Shanghai Ruijin Hospital for cryobal-loon ablation.The primary study endpoint was the first documented AF event following a 90-day blanking period after the procedure.Pulmonary vein isolation（PVI）success rate,procedure time,X-ray exposure time and com-plications were analyzed as well.Patients who had been followed up more than 12 months were accepted in 1 year effectiveness analysis. Results A total of 110 patients were finally enrolled in long-term effectiveness a-nalysis[77 in male,mean age（60. 1±10. 7）years].The mean follow-up period was（15. 9±5. 7）months.The pri-mary clinical endpoint occurred in 27 patients with documentation of AF event more than 30 s.One-year Kaplan-Meier sinus rate estimates at 77. 3%.Successful PVI occurred in 98. 3% of patients,mean procedure time was （110. 3±12. 2）minutes,mean X-ray exposure time was（18. 6±5. 5）minutes.There were no any severe compli-cations in this study population.Temporary phrenic nerve palsy（PNP） happened in 2. 54%（n = 3） of patients and all PNP patients had a full recovery of their phrenic nerve function within 5 months after the procedure. Conclusion This study demonstrated that cryoballoon ablation is a safe method for treatment of paroxysmal at-rial fibrillation and it has good 1-year clinical effectiveness.