冷冻球囊消融与磁导航指导的射频消融治疗阵发性心房颤动的临床对照研究  

Cryoballoon ablation versus remote magnetic navigation ablation in patients with paroxysmal atrial fibrillation：a prospective controlled study

作　　者：金奇[1] 张凝[1] 罗庆志[1] 韩岩新 王义龙[1] 凌天佑[1] 陈康[1] 潘文麒[1] 谢玉才[1] 吴立群[1] 

机构地区：[1]上海交通大学医学院附属瑞金医院心脏内科,200025

出　　处：《中华心律失常学杂志》2016年第4期336-341,347,共7页Chinese Journal of Cardiac Arrhythmias

基　　金：国家自然科学基金（81270260,81470450,81470451）,上海市科委项目（14411961100）

摘　　要：目的：冷冻球囊消融（CBA）和磁导航指导（RMN）的射频消融是治疗心房颤动（房颤）的两大新技术。本项研究旨在评估和比较两种消融新技术的有效性、安全性以及手术相关结果。方法入选2015年2月至2016年1月期间,在上海交通大学医学院附属瑞金医院心脏内科接受消融治疗的阵发性房颤患者60例,1∶1配对,分别行 CBA（CBA 组,30例）和 RMN 消融（RMN 组,30例）。主要研究终点为完成双侧肺静脉电隔离（PVI）成功率。次要研究终点为手术相关参数,包括手术相关并发症、手术时间、消融时间以及 X 线曝光时间等。术后至少随访3个月,观察两组患者消融空白期内房颤复发率和并发症。结果 CBA 组所有患者首次消融术均获得急性 PVI,RMN 组急性 PVI 成功率为97％,两组差异无统计学意义（P＝1.0）。 RMN 组,术中及术后3个月内无心脏压塞、左心房食管瘘等严重手术相关并发症,腹股沟血肿1例。 CBA 组,发生1例膈神经损伤,无其他严重并发症,两组并发症发生率差异无统计学意义。与 RMN 组相比,CBA 组手术时间明显缩短[（142±36） min 对（108±30） min, P〈0.01]；但是,X 线曝光时间显著增加[（6.5±2.8） min 对（16.4±4.8） min,P〈0.001]。术后3个月随访结果显示,两组患者消融空白期内房颤复发率差异无统计学意义（RMN 对 CBA：16.7％对23.0％, P＝0.75）。结论应用 CBA 和 RMN 房颤 PVI 均是安全和有效的。 RMN 指导的房颤消融有助于降低X 线曝光时间,CBA 房颤手术时间更短。Objective Cryoballoon-based ablation （ CBA） and remote magnetic navigation-guided （RMN）ablation are two novel means to treat paroxysmal atrial fibrillation（PAF）,however,no controlled data have been reported in China.This prospective,controlled study was to assess the safety and efficacy of these two techniques and compare the procedure-related outcome. Methods A total of 60 patients with PAF were enrolled and divided into two groups（CBA group,n= 30;RMN group,n = 30）.The primary endpoint was acute success of complete pulmonary vein isolation（PVI）.The secondary endpoints were procedural parameters inclu-ding complications,procedure time,ablation time,and fluoroscopy time.Freedom from atrial fibrillation（AF）re-currence was evaluated at 3 months follow-up. Results Complete PVI were achieved during the first ablation procedure in CBA group.Acute success rate of PVI was 97% of patients in RMN group.No major complication including cardiac temponade and atrial-esophageal fistulae occurred in RMN group.Phrenic nerve palsy occurred in one patient of CBA group.The complication rate was not different.Compared to RMN group,procedure time of CBA group was significantly reduced [ （142±36） min vs.（108±30） min,P〈0. 01] ;However,fluoroscopy＆amp;nbsp;time was increased by 10 min[（6. 5±2. 8） min vs. （16. 4±4. 8） min,P〈0. 001]. AF recurrence was similar between these two groups（RMN vs. CBA：16. 7% vs. 23. 0%,P = 0. 75） within 3 months（blanking period）. Conclusion Both CBA and RMN are safe and effective to complete PVI in patients with PAF.Our data indica-ted that RMN-guided PAf ablation can markedly reduce the fluoroscopy time,and CBA can shorten the proce-dure time.

关 键 词：心房颤动 肺静脉电隔离 冷冻球囊消融 磁导航 

分 类 号：R541.75[医药卫生—心血管疾病]