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《天津医科大学学报》[ISSN:1006-8147/CN:12-1259/R]

卷:

29卷

期数:

2023年06期

页码:

636-640

栏目:

临床医学

出版日期:

2023-11-20

文章信息/Info

Title:

The short-term and long-term safety clinical trial of pulse field ablation to treat atrial fibrillation

文章编号:

1006-8147(2023) 04-0636-05

作者:

张茂芃¹; 2; 陈炳伟³; 卢成志³; 薛志孝¹

（1.天津医科大学生物医学工程与技术学院医学仪器教研室，天津300070；2.天津医科大学眼科医院设备科，天津300384；3.天津市第一中心医院心内科，天津300192）

Author(s):

ZHANG Mao-peng¹; 2; CHEN Bing-wei³; LU Cheng-zhi³; XUE Zhi-xiao¹

（1.Departmentof Medical Instruments, School of Biomedical Engineering and Technology, Tianjin Medical University, Tianjin 300070, China; 2.Equipmentdepartment, Eye Hospital, Tianjin Medical University, Tianjin 300384, China; 3.Department of Cardiology, Tianjin First Central Hospital, Tianjin 300192, China）

关键词:

脉冲场消融; 心房颤动; 肺静脉隔离

Keywords:

pulse field ablation; atrial fibrillation; vein isolation

分类号:

R541.7

DOI:

-

文献标志码:

A

摘要:

目的：评估脉冲场消融治疗用于心房颤动患者进行导管消融的短期及长期（6个月）安全性。方法：本研究是一项前瞻性、单臂的临床研究，纳入18～75岁临床明确诊断为症状性心房颤动的10例患者，使用脉冲消融治疗系统（天津市鹰泰利安康医疗科技有限责任公司）对患者进行脉冲消融治疗，评估受试者在手术即刻至术后6个月并发症的发生情况，检测患者生命体征、不良事件、严重不良事件的发生率以及手术后器械相关或手术相关不良事件的发生率。结果：本研究10例心房颤动患者中3例为持续性心房颤动，7例为阵发性心房颤动。平均总手术时间为（220.1±47.2）min；平均透视时间为（35.1±10.6）min；脉冲场消融导管在体内的平均停留时间为（69.1±8.3）min。无1例发生与消融导管相关的并发症。十二导联心电图未见房性或室性心动过速，亦未见明显复极异常。所有患者术后均无明显的胸椎或上肢肌肉不适或神经运动或感觉症状。所有患者在术后2 d内生命体征平稳，均未出现器械相关或手术相关重大不良事件及并发症，并且在术后6个月随访期间也未发生严重不良事件及相关并发症。结论：在脉冲场消融治疗后为期6个月的观察结果表明脉冲场消融治疗房颤具有短期及长期安全性，且脉冲场消融治疗可以实现组织选择性。

Abstract:

Objective： To evaluate the short-term and long-term safety of pulsed field ablation for catheter ablation in patients with atrial fibrillation（AF）. Methods：This was a prospective, one-arm clinical study. Ten patients aged 18-75 years who were clinically diagnosed with symptomatic atrial fibrillation were enrolled in a pulsed ablation system（Tianjin Ying Tai Li An Kang Medical Technology Co., LTD.） to assess the incidence of complications from immediate surgery to 6 months after surgery. Vital signs， the incidence of adverse and serious adverse events were measured, as well as the incidence of instrument-related or surgery-related adverse events after surgery. Results：Among the 10 patients with AF in this study, 3 cases were persistent AF and 7 cases were paroxysmal AF. The mean total operation time was （220.1±47.2）min. The average perspective time was （35.1±10.6）min. The average residence time of pulsed field ablation catheter in vivo was （69.1±8.3）min. None of the complications related to catheter ablation occurred. ECG showed no atrial or ventricular tachycardia, and no significant repolarization abnormalities. None of the patients had significant thoracic or upper extremity muscle discomfort or neuromotor or sensory symptoms. All patients had stable vital signs 2 days after surgery，no instrument-related or surgery-related major adverse events or complications, and no serious adverse events or related complications during the 6-month follow-up. Conclusion：PFA（pulse field ablation）has short-term and long-term safety for AF during the observation for 6 months after pulse field ablation therapy,and PFA can achieve tissue selectivity.

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备注/Memo

备注/Memo:

作者简介 张茂芃（1990-），男，硕士在读，研究方向：生物医学工程；通信作者：卢成志，E-mail：5020200072@nankai.edu.cn；薛志孝，E-mail：xuezhixiao@126.com。

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更新日期/Last Update: 2023-12-01