国产脉冲消融系统治疗阵发性心房颤动的可行性和安全性  

Feasibility and safety of a new domestic pulsed field ablation system in treatment of paroxysmal atrial fibrillation

作　　者：储慧民[1] 张劲林[2] 王祖禄 何斌[1] 王彬浩 邓成刚[2] 丰明俊[1] 杜先锋[1] 郭再雄[2] 刘晶[1] 郁一波[1] 程光辉[2] 傅国华[1] 唐闽 张澍[4] Chu Huimin;Zhang Jinlin;Wang Zulu;He Bin;Wang Binhao;Deng Chenggang;Feng Mingjun;Du Xianfeng;Guo Zaixiong;Liu Jing;Yu Yibo;Cheng Guanghui;Fu Guohua;Tang Min;Zhang Shu(Arrhythmia Center,Ningbo First Hospital,Ningbo 315010,China;Department of Cardiology,Wuhan Asia Heart Hospital,Wuhan 435000,China;Department of Cardiology,General Hospital of Northern Theater Command,Shenyang 110016,China;Center of Arrhythmia,Fuwai Hospital,State Key Laboratory of Cardiovascular Disease,National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences,Peking Union Medical College,Beijing 100037,China)

机构地区：[1]宁波市第一医院心律失常中心,宁波315010 [2]武汉亚洲心脏病医院心内科,武汉435000 [3]北部战区总医院心内科,沈阳110016 [4]中国医学科学院,北京协和医学院,国家心血管病中心,心血管疾病国家重点实验室,阜外医院心律失常中心,北京100037

出　　处：《中华心律失常学杂志》2022年第1期91-95,共5页Chinese Journal of Cardiac Arrhythmias

摘　　要：目的观察国产脉冲消融系统治疗阵发性心房颤动(房颤)的可行性及安全性。方法入选2021年3月至7月于宁波市第一医院心律失常中心(9例)和武汉亚洲心脏病医院心内科(8例)住院接受脉冲消融治疗的阵发性房颤患者,观察安全性、治疗效果、围术期并发症和随访结果。本研究为单组患者可行性及安全性观察,使用合适的统计学方法描述研究结果,无组间比较统计学结果。结果共入选17例患者,其中男9例,女8例。年龄(60.6±6.8)岁,年龄范围49~76岁。入选患者均在X线透视引导下完成脉冲消融治疗,手术时间、消融导管停留时间及X线曝光时间分别为(118.1±26.3)min、(47.7±17.2)min及(21.4±5.0)min。累计脉冲消融时间为(124.6±5.8)s,其中左上、左下、右上及右下肺静脉消融时间分别为(32.5±3.0)s、(30.4±1.5)s、(32.8±3.7)s及(28.9±3.2)s。术中消融即刻成功率为100%(17/17)。术后3个月均完成门诊随访,1例(1/17,5.9%)动态心电图检查记录到房颤发作超过30 s,手术成功率为94.1%(16/17)。围术期及随访过程中均未出现死亡、脑卒中或短暂性脑缺血发作(TIA)、膈神经损伤、肺静脉狭窄、食管损伤以及出血等事件。结论国产脉冲消融系统治疗阵发性房颤是安全、可行的。Objective To investigate the feasibility and safety of a new domestic pulsed field ablation system(CardioPulse™)in treating paroxysmal atrial fibrillation.Methods Patients with paroxysmal atrial fibrillation undergone pulsed field ablation in Arrhythmia Center,Ningbo First Hospital(n=9)and Department of Cardiology,Department of Cardiology,Wuhan Asia Heart Hospital(n=8)from March to July 2021 was included.The safety,therapeutic effect,perioperative complications and follow-up results were observed.Results A total of 17 patients were enrolled,including 9 males and 8 females.The age range was(60.6±6.8)years,ranging from 49 to 76 years.The procedures were guided by fluoroscopy.The time of procedure,ablation catheter staying,and X-ray exposure were(118.1±26.3)min,(47.7±17.2)min,and(21.4±5.0)min,respectively.The total ablation time was(124.6±5.8)s.The ablation time for left superior,left inferior,right superior,and right inferior pulmonary vein were(32.5±3.0)s,(30.4±1.5)s,(32.8±3.7)s,(28.9±3.2)s,respectively.Acute pulmonary vein isolation rate was 100%(17/17).All the patients completed the outpatient follow-up 3 months after the procedure.Holter monitors(24 h)showed that 1 patient(1/17,5.9%)experienced atrial fibrillation(>30 s),resulting in a success rate of 94.1%(16/17).No death,stroke or transient ischemic attack,phrenic nerve injury,pulmonary vein stenosis,esophageal injury,and bleeding events occurred perioperative and during follow-up.Conclusion The new domestic pulsed field ablation system(CardioPulse™)for treating paroxysmal atrial fibrillation was safe and feasible.

关 键 词：心房颤动 脉冲消融 肺静脉隔离 可行性 安全性 

分 类 号：R541.75[医药卫生—心血管疾病]