压力感知导管行环肺静脉隔离治疗阵发性心房颤动的有效性和安全性:一项多中心临床登记研究  

Real-world effectiveness and safety of a contact force-sensing catheter for atrial fibrillation ablation in China

作　　者：黄从新[1] 蔡衡[2] 姚焰[3] 钟敬泉[4] 苏晞[5] 高连君[6] 陈明龙[7] 王祖禄 程晓曙[9] 韩冰 杨新春[11] 郑良荣 Huang Congxin;Cai Heng;Yao Yan;Zhong Jingquan;Su Xi;Gao Lianjun;Chen Minglong;Wang Zulu;Cheng Xiaoshu;Han Bing;Yang Xinchun;Zheng Liangrong(Department of Cardiology,Renmin Hospital of Wuhan University,Cardiovascular Research Institute,Wuhan University,Hubei Key Laboratory of Cardiology,Wuhan 430060,China;Department of Cardiology,Tianjin Medical University General Hospital,Tianjin 300070,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;Department of Cardiology,Qilu Hospital of Shandong University,Ji′nan 250000,China;Department of Cardiology,Wuhan Asia Heart Hospital,Wuhan 430022,China;Department of Cardiology,The First Affiliated Hospital of Dalian Medical University,Dalian 116044,China;Department of Cardiology,The First Affiliated Hospital of Nanjing Medical University,Nanjing 210029,China;Department of Cardiology,General Hospital of Northern Theater Command,Shenyang 110016,China;Department of Cardiology,The Second Affiliated Hospital of Nanchang University,Nanchang 330006,China;Department of Cardiology,Xuzhou Central Hospital,Xuzhou 221009,China;Department of Cardiology,Affiliated Beijing Chaoyang Hospital,Capital Medical University,Beijing 100020,China;Department of Cardiology,The First Affiliated Hospital of Zhejiang University,Hangzhou 310000,China)

机构地区：[1]武汉大学人民医院心内科武汉大学心血管病研究所心血管病湖北重点实验室,430060 [2]天津医科大学总医院心内科,300070 [3]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,100037 [4]山东大学齐鲁医院心内科,济南250000 [5]武汉亚洲心脏病医院心内科,430022 [6]大连医科大学附属第一医院心内科,116044 [7]南京医科大学附属第一医院心内科,210029 [8]北部战区总医院心内科,沈阳110016 [9]南昌大学第二附属医院心内科,330006 [10]徐州中心医院心内科,221009 [11]首都医科大学附属北京朝阳医院心内科,100020 [12]浙江大学附属第一医院心内科,杭州310000

出　　处：《中华心律失常学杂志》2021年第2期107-111,共5页Chinese Journal of Cardiac Arrhythmias

摘　　要：目的在亚洲人群中使用接触压力感知导管进行阵发性心房颤动(PAF)消融的数据有限。SMART CHINA是使用压力感知技术评估中国药物难治性PAF患者消融结果的登记研究。方法该登记研究(2015年6月23日至2017年9月29日)在12家医疗中心招募了患者。消融后3、6、9和12个月对患者进行随访。主要的有效性终点为首次消融后12个月内未记录到有症状的心房颤动(房颤)/房性心动过速(房速)/心房扑动(房扑)发作。次要结局包括即刻成功率、平均压力、手术参数和不良事件(AE)。结果共200例患者使用本研究导管进行了消融手术(安全性分析人群)[年龄(61.2±9.3)岁,男62.5%]。在193例合格患者(意向性分析人群)中,166例有主要有效性终点数据(符合方案人群)。96.0%(192/200)的患者接受了单次消融手术。压力为(12.9±3.8)g。中位手术时间和射频消融时间分别为135.0 min和22.4 min。99.5%(199/200)的患者达到了即刻成功。80.7%的患者在12个月时未记录到有症状的房颤/房速/房扑发作。出现了6例与手术或器械相关的严重AE(心包积液2例,心脏压塞1例,动静脉瘘2例,咯血1例)。结论该多中心观察性登记研究显示,采用压力感知技术进行PAF消融可在中国患者中获得12个月的高成功率和良好的安全性。Objective Data for paroxysmal atrial fibrillation(PAF)ablation using contact force(CF)-sensing catheters in Asian populations are limited.SMART CHINA is the first real-world registry to evaluate drug-refractory PAF ablation outcomes in Chinese patients using CF-sensing technologies.Methods The registry(from June 23,2015 to September 29,2017)enrolled patients at 12 high-volume centers across China.Patients were followed up at 3,6,9,and 12-months post-ablation.The primary endpoint was freedom from documented symptomatic atrial fibrillation(AF)/atrial tachycardia(AT)/atrial flutter(AFL)at 12-months.Secondary endpoints included acute success(confirmation of entrance block for all targeted pulmonary veins),average CF,procedural data and adverse events(AE).Results All 200 enrolled patients[mean age(61.2±9.3)years;62.5%men]underwent the ablation procedure with the study catheter(safety population).Of the 193 eligible patients(intent-to-treat population),166 had available primary effectiveness data(per-protocol population).Most[96.0%(192/200)]patients underwent a single ablation procedure.Mean CF was(12.9±3.8)g.Median procedure and radiofrequency ablation times were 135.0 min and 22.4 min,respectively.Acute success was achieved in 99.5%(199/200)patients.Freedom from documented symptomatic AF/AT/AFL at 12-months was achieved in 80.7%of patients.Six procedure-or device-related serious AE[pericardial effusion(n=2),cardiac tamponade(n=1),arteriovenous fistula(n=2),hemoptysis(n=1)]were reported.Conclusion This multicenter observational registry shows that PAF ablation with CF-technologies resulted in high 12-month success rate and good safety profile in Chinese patients.

关 键 词：心房颤动 导管消融术 肺静脉 登记研究 

分 类 号：R541.75[医药卫生—心血管疾病]