贴式可穿戴动态心电记录分析系统对心律失常检测的有效性和安全性研究  

Efficacy and safety of recording and analysis system of patch wearable ambulatory electrocardiograph monitoring in detecting arrhythmia

作　　者：吴嘉慧[1] 张筑欣 王建旗[2] 金泽宁 戴雯莉[1] 管宇 田俊萍[3] 蒋超[1] 黎旭[1] 贾长琪[1] 胡荣[1] 杜昕[1] 董建增[1] 马长生[1] Wu Jiahui;Zhang Zhuxin;Wang Jianqi;Jin Zening;Dai Wenli;Guan Yu;Tian Junping;Jiang Chao;Li Xu;Jia Changqi;Hu Rong;Du Xin;Dong Jianzeng;Ma Changsheng(Department of Cardiology,National Clinical Research Center for Cardiovascular Diseases,Beijing Anzhen Hospital,Capital Medical University,Beijing 100029,China;不详)

机构地区：[1]首都医科大学附属北京安贞医院心内科国家心血管疾病临床医学研究中心,北京100029 [2]首都医科大学附属北京同仁医院心内科,北京100730 [3]首都医科大学附属北京天坛医院心内科,北京100070

出　　处：《中国循证心血管医学杂志》2021年第6期755-757,761,共4页Chinese Journal of Evidence-Based Cardiovascular Medicine

摘　　要：目的评估贴式可穿戴动态心电记录分析系统检测心律失常的有效性和安全性。方法研究纳入2018年10月至2019年12月于首都医科大学附属北京安贞医院、北京天坛医院、北京同仁医院就诊的可疑心律失常患者115例。使用传统的24 h动态心电记录分析仪(对照组)和贴式可穿戴动态心电记录分析系统(试验组)同时记录动态心电图。主要终点是在监测期间内检测到的心律失常,定义为室上性心动过速(连续≥3跳)、室性心动过速(连续≥4跳)、心房颤动/心房扑动(持续≥1 min)、心脏停搏(≥3 s)、室上性早搏(累计≥10000跳)、室性早搏(累计≥10000跳)。以对照组检测结果为金标准,计算试验组的敏感性作为主要有效性评价指标。安全性评价指标为试验期间发生的不良事件。结果试验组检测心律失常的敏感性在全分析集为99.09%(95%CI:95.03%~99.84%),在符合方案集为99.07%(95%CI:94.94%~99.84%),95%CI下限均高于标准值85%。试验组患者的佩戴舒适度及应用偏好均优于对照组(P<0.0001),两组记录心电图波形一致率为92.7%。在试验期间,两组均未出现不良事件。结论贴式可穿戴动态心电记录分析系统可以安全有效地检测心律失常,可作为传统动态心电记录分析仪的替代方案。Objective To review the efficacy and safety of recording and analysis system of patch wearable ambulatory electrocardiograph monitoring(Holter)in detecting arrhythmia.Methods The patients with suspected arrhythmia(n=115)were chosen from Beijing Anzhen Hospital affiliated to Capital Medical University,Beijing Tiantan Hospital and Beijing Tongren Hospital from Oct.2018 to Dec.2019.The traditional 24-h Holter(control group)and recording and analysis system of patch wearable Holter(experimental group)were used to record ambulatory electrocardiograph(ECG)simultaneously.The primary endpoint is arrhythmia detected during the monitoring period,defined as supraventricular tachycardia(≥3 consecutive beats),ventricular tachycardia(≥4 consecutive beats),atrial fibrillation/atrial flutter(≥1 min),cardiac arrest(≥3 seconds),supraventricular premature contractions(cumulative≥10000 beats)and premature ventricular contractions(cumulative≥10000 beats).The test results in control group were regarded as a gold standard,and the sensitivity in experimental group was calculated as a main efficacy index.The safety index is the adverse events that occurred during trial period.Results The sensitivity of detecting arrhythmia was 99.09%(95%CI:95.03%~99.84%)in the full analysis set,and 99.07%(95%CI:94.94%~99.84%)in the per protocol set.The lower limits of 95%confidence intervals were all higher than standard value by 85%.The wearing comfort level and preference were better in experimental group than those in control group(P<0.0001).The coincidence rate of ECG waveform records was 92.7%between 2 groups.There were no adverse events in 2 groups during the trial period.Conclusion Recording and analysis system of patch wearable Holter can detect safely and effectively arrhythmia,which can be used as an alternative plan of traditional Holter.

关 键 词：贴式可穿戴动态心电记录分析系统 心律失常 有效性 安全性 

分 类 号：R540.41[医药卫生—心血管疾病]