新型柔性贴片式心电仪的临床应用

Preliminary research on clinical application of a new flexible patch ECG

目的探讨可穿戴式柔性贴片式心电仪在心律失常方面的诊断价值,临床应用过程中的报警情况,患者满意度和安全性。方法1443例受试者同时佩戴24 h的柔性贴片式心电仪和常规动态心电仪(对照),检验两者对心律失常诊断的有效性及一致性,统计远程心电的报警情况及仪器佩戴过程中相关不良事件的发生情况。结果柔性贴片式心电仪检出心律失常987例,常规动态心电仪检出心律失常992例,心律失常诊断总符合率为98.7%。柔性贴片式心电仪测量平均心率(75.4±11.4)次/min,常规动态心电仪(71.5±12.1)次/min,2种仪器检测心率的组内相关系数(ICC)为0.892(95%CI:0.537~0.956),可重复性好。柔性贴片式心电仪正确报警例次率为100%。佩戴柔性贴片式心电仪期间皮肤瘙痒(0.28%vs.1.32%),皮肤过敏、红肿(0.14%vs.0.69%)和电极片脱落(0 vs.0.28%)的发生率低于常规动态心电仪(P<0.05)。结论柔性贴片式心电仪不良反应少、舒适度高,具有良好的安全性和临床适用性。

Objective To explore the diagnostic value of a wearable flexible patch ECG instrument in arrhythmia,the alarm situation during clinical application,patient satisfaction and safety.Methods A total of 1443 subjects wore flexible patch ECG and conventional dynamic ECG(control)for 24 h to test the validity and consistency of arrhythmia diagnosis,and counted the alarm of remote ECG and the occurrence of related adverse events during the wearing of the instrument.Results There were 987 cases of arrhythmia detected by flexible patch ECG and 992 cases by conventional dynamic ECG.The total coincidence rate of arrhythmia diagnosis was 98.7%.The mean heart rate was measured by flexible patch ECG(75.4±11.4)times/min,conventional dynamic heart rate(71.5±12.1)times/min,the intra-group correlation coefficient(ICC)of 2 instruments was 0.892(95%CI:0.537-0.956),with good repeatability.The correct alarm rate of flexible patch ECG was 100%.The incidences of skin pruritus(0.28%vs.1.32%),skin allergy,redness and swelling(0.14%vs.0.69%)and electrode strip shedding(0 vs.0.28%)during wearing the flexible patch electrocardiogram were lower than those of the conventional holter electrocardiogram(P<0.05).Conclusion The flexible patch ECG has few adverse reactions,high comfort,good safety and clinical applicability.