新型脉冲电场消融在阵发性心房颤动中的效果
New pulsed field ablation system in a Chinese population with paroxysmal atrial fibrillation
杨刚 1居维竹 2亓树莹 3智昱 3王海雄 4周贤惠 5蒋晨阳 6钟敬泉 7杨平珍 8周纬 9刘启明 10李述峰 11贾秀月 12陈明龙2
作者信息
- 1. 南京医学大学第一附属医院(江苏省人民医院)心血管内科,南京 210029;江苏省人民医院重庆医院心内科,重庆 401420
- 2. 南京医学大学第一附属医院(江苏省人民医院)心血管内科,南京 210029
- 3. 博鳌超级医院心内科,琼海 571435
- 4. 山西省心血管病医院心内科,太原 030001
- 5. 新疆医科大学第一附属医院心脏中心起搏电生理科,乌鲁木齐 830011
- 6. 浙江大学医学院附属邵逸夫医院,杭州 310016
- 7. 山东大学齐鲁医院心血管内科,济南 250012
- 8. 南方医科大学珠江医院心血管内科,广州 510280
- 9. 贵州医科大学附属医院心血管内科,贵阳 550025
- 10. 中南大学湘雅二医院心血管内科,长沙 410008
- 11. 哈尔滨医科大学附属第二医院心血管内科,哈尔滨 150086
- 12. 波科国际医疗贸易(上海)有限公司医学部,上海 200023
- 折叠
摘要
目的 观察法拉普尔赛(FARAPULSE)脉冲电场消融(PFA)系统在中国阵发性心房颤动(房颤)患者中使用的安全性和有效性.方法 本研究为前瞻性、单臂观察性研究.分析2023年2月至7月在博鳌超级医院首次接受消融治疗阵发性房颤患者30例,术中使用PFA系统(FARAPULSE)完成肺静脉电隔离(PVI).研究共涉及来自11家中心的15例患者.主要有效性终点为即刻手术成功率,即仅使用PFA完成PVI的患者比例.主要安全性终点为术后7 d内的器械或操作相关的主要严重不良事件心脏压塞、重度肺静脉狭窄、心房食管瘘及膈神经麻痹等发生率.结果 共纳入30例阵发性房颤患者,其中男17例(56.7％,17/30),年龄(57.6±12.5)岁.冠心病病史占30％(9/30),抗心律失常用药史占70％(21/30).总手术时间(77.8±22.9)min,左心房操作时间(37.9±12.8)min.患者即刻手术成功率100％.术后7 d主要严重不良事件发生率为0.结论 PFA用于PVI手术的安全性和有效性良好.
Abstract
Objective To observe the safety and effectiveness of FARAPULSE pulsed field ablation system(PFA)for treatment of paroxysmal atrial fibrillation(PAF)in a Chinese population.Methods This was a prospective sing-arm observational study.Thirty patients with PAF who were planning to receive ablation for the first time was enrolled from February to July 2023 in Boao Super Hospital.All enrolled patients would accept pulmonary vein isolation(PVI)with FARAPULSE PFA system.These procedures were done by 15 operators from 11 centers in this study.The primary effectiveness endpoint was the acute procedural success rate,defined as the proportion of subjects who achieved PVI using FARAPULSE PFA system only.The primary safety endpoint was the occurrence of the predefined serious procedure-related and/or device-related adverse events(pericardial tamponade,severe pulmonary vein stenosis,atrial esophageal fistula,or phrenic nerve paralysis etc.)at 7 days after the procedure respectively.Results Thirty patients with PAF were enrolled,56.7％(17/30)male,average age(57.6±12.5)years.Patients with the history of coronary heart disease accounted for 30％(9/30),and 70％(21/30)of the patients had used antiarrhythmic drugs before the procedure.The total procedural time was(77.8±22.9)min and the left atrial dwell time was(37.9±12.8)min.The acute procedural success rate was 100％.The incidence of the major serious adverse events within 7 days was 0.Conclusion The safety and efficacy of PFA for PVI remain favorable.
关键词
心房颤动/脉冲电场消融/肺静脉电隔离/电压标测/超高密度标测Key words
Atrial fibrillation/Pulsed field ablation/Pulmonary vein isolation/Voltage mapping/Ultra-high density mapping引用本文复制引用
出版年
2024
NETL
NSTL
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