低频耳迷走神经刺激在阵发性心房颤动肺静脉隔离术中安全性及有效性随机对照研究  

Randomized Controlled Study on the Safety and Efficacy of Low-Frequency Transcutaneous Auricular Vagus Nerve Stimulation During Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation

作　　者：彭飞 龚辉 连晓雨 PENG Fei;GONG Hui;LIAN Xiao-yu(Department of Cardiology,Jinshan Hospital Affiliated to Fudan University,Shanghai 201508)

机构地区：[1]复旦大学附属金山医院心内科,上海201508

出　　处：《中国医疗器械信息》2024年第5期113-115,136,共4页China Medical Device Information

基　　金：上海市卫生健康委员会青年课题(项目编号:20214Y0367);金山区卫健系统第五周期“优秀青年人才”(项目编号:JSYQ202306/课题编号:JSKJ-KTYQ-2023-06);复旦大学附属金山医院青年课题(项目编号:JYQN-LC-202204)。

摘　　要：目的:自主神经失平衡在阵发性心房颤动起重要作用,该研究探索经皮耳迷走神经刺激(ta-VNS)在肺静脉隔离(PVI)术中有效性。方法:按照纳入标准及排除标准,连续入组阵发性心房颤动射频消融患者,共入组120例心房颤动患者,平均年龄(64.3±8.6)岁。随机分2组,观察组(PVI+ta-VNS)和对照组(PVI+假ta-VNS)各60例。使用华佗刺激仪于耳迷走神经区域进行刺激,刺激时间为整个消融过程。主要终点:单次消融后,空白期至随访结束,无心房颤动复发患者的比例。每3个月进行门诊/电话随访,第12月中期分析。结果:中位随访时间16.5个月,12个月无心房颤动发生率在观察组和对照组分别81.6%和70%(P<0.05)。结论:在阵发性心房颤动的PVI+ta-VNS较PVI+假ta-VNS更有效和更安全。Objective:Autonomic imbalance plays a significant role in paroxysmal atrial fibrillation(PAF).This study investigates the efficacy of transcutaneous auricular vagus nerve stimulation(ta-VNS)during pulmonary vein isolation(PVI)procedures.Methods:Following inclusion and exclusion criteria,120 patients with paroxysmal atrial fibrillation undergoing radiofrequency ablation were consecutively enrolled,with an average age of(64.3±8.6)years.They were randomly divided into two groups:the observation group(PVI+ta-VNS)and the control group(PVI+sham ta-VNS),with 60 patients in each.Stimulation of the auricular vagus nerve region was conducted using a Hua Tuo stimulator throughout the ablation process.The primary endpoint was the proportion of patients without atrial fibrillation recurrence after a single ablation procedure,up to the end of the follow-up period.Follow-up was conducted every 3 months through outpatient visits or phone calls,with an interim analysis at 12 months.Results:The median follow-up time was 16.5 months,with a 12-month atrial fibrillation-free rate of 81.6%in the observation group and 70%in the control group(P<0.05).Conclusion:PVI+ta-VNS is more effective and safer than PVI+sham ta-VNS in patients with paroxysmal atrial fibrillation.

关 键 词：阵发性心房颤动 肺静脉隔离 经皮耳迷走神经刺激 

分 类 号：TH782[机械工程—仪器科学与技术]