上海交通大学学报（医学版）

上海交通大学学报(医学版) ›› 2021, Vol. 41 ›› Issue (7): 926-930.doi: 10.3969/j.issn.1674-8115.2021.07.013

• 论著 · 临床研究 • 上一篇    

穿戴式动态心电图记录仪在心房颤动筛查中的应用

傅文霞1(), 陈力秀1, 乐佳玮1, 李若谷1,2()   

  1. 1.上海市胸科医院／上海交通大学附属胸科医院心功能室，上海 200030
    2.上海市胸科医院／上海交通大学附属胸科医院心内科，上海 200030
  • 出版日期:2021-07-28 发布日期:2021-08-03
  • 通讯作者: 李若谷 E-mail:18553402856@163.com;liruogu1234@163.com
  • 作者简介:傅文霞（1989—），女，住院医师，硕士；电子信箱：18553402856@163.com。

Application of wearable dynamic electrocardiogram recorder to screening of atrial fibrillation

Wen-xia FU1(), Li-xiu CHEN1, Jia-wei LE1, Ruo-gu LI1,2()   

  1. 1.Cardiac Function Room, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, China
    2.Department of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, China
  • Online:2021-07-28 Published:2021-08-03
  • Contact: Ruo-gu LI E-mail:18553402856@163.com;liruogu1234@163.com

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摘要：

目的·比较穿戴式动态心电图（electrocardiogram，ECG）记录仪和12导联ECG的性能，验证穿戴式动态ECG记录仪对于检测心房颤动（atrial fibrillation，AF）的有效性及安全性。方法·纳入114例受试者，分别采取仰卧位、站立位和运动后站立位，使用穿戴式动态ECG记录仪和12导联ECG进行图像采集。将12导联ECG结果作为金标准，评估穿戴式动态ECG检测AF的一致性、灵敏度、特异度、阳性预测值、阴性预测值，并评价仪器使用过程中的安全性。结果·根据12导联ECG诊断结果分为2组，其中非AF组61例，AF组53例。AF组受试者年龄显著大于非AF组（P=0.000），CHA2DS2-VASc评分高于非AF组（P=0.001），合并冠状动脉粥样硬化性心脏病的比例高于非AF组（P=0.014）。服用口服抗凝药、抗血小板药、钙通道阻滞剂、利尿剂、地高辛、β-受体阻滞剂的比例在2组之间比较，差异均有统计学意义（均P<0.05）。受试者取仰卧位，佩戴穿戴式动态ECG记录仪60 s，ECG检测由AI算法自动判定AF 47例、非AF 65例、无法判断2例。与金标准心电图比较（无法判断为假阳假阴性），穿戴式动态ECG记录仪诊断AF的一致性为94.74%（95%CI 88.76%~97.80%），灵敏度为88.68%（95%CI 77.06%~95.07%），特异度为100%（95%CI 92.91%~100%），阳性预测值为100%（95%CI 90.98%~100%），阴性预测值为91.04%（95%CI 81.48%~96.16%）。受试者取站立位，佩戴穿戴式动态ECG记录仪的60 s，ECG检测由AI算法自动判定AF 50例、非AF 61例、无法判断1例。与金标准心电图比较（无法判断为假阳假阴性），穿戴式动态ECG记录仪诊断AF的一致性为97.37%（95%CI 92.21%~99.44%），灵敏度为94.34%（95%CI 84.03%~98.65%），特异度为100%（95%CI 92.91%~100%），阳性预测值为100%（95%CI 91.48%~100%），阴性预测值为95.31%（95%CI 86.57%~98.92%）。运动后，受试者的检测结果同站立位。测试过程中未发生不良事件，无明显的器械缺陷。结论·穿戴式动态ECG记录仪具有较高的特异度及阳性预测值，且操作简便，可提高阵发性AF的检出率。

关键词: 心房颤动, 穿戴式动态心电图记录仪, 心电图, 筛查

Abstract:

Objective·To compare the performance of wearable dynamic electrocardiogram (ECG) recorder and twelve-lead ECG products, and verify the effectiveness and safety of the wearable dynamic ECG recorder in the detection of atrial fibrillation (AF).

Methods·One hundred and fourteen subjects were included and underwent ECG examination simultaneously. Subjects were placed in a supine position and upright positions before and after exercise. Wearable dynamic ECG and twelve-lead ECG were used for ECG collection. Using the twelve-lead ECG as standard, the effectiveness of AF detection results, including consistency, sensitivity, specificity, positive predictive value and negative predictive value for detection of AF, was evaluated.

Results·According to the ECG diagnosis results, the patients were divided into two groups, including 61 patients in the non-AF group and 53 patients in the AF group. The age of the AF group was significantly higher than that of the non-AF group (P=0.000); CHA2DS2-VASc score of the AF group was higher than that of the non-AF group (P=0.001). The proportion of patients with coronary heart disease in the AF group was higher than that in the non-AF group (P=0.014). There were significant differences in the proportion of oral anticoagulants, antiplatelet agents, calcium channel blockers, diuretics, digoxin, and β-blockers between the two groups (all P<0.05). The 60 s-ECG monitoring of the wearable dynamic ECG recorder was automatically determined by the artificial intelligence (AI) algorithm in a supine position: 47 cases of AF, 65 cases of non-AF, and 2 cases not determined. Compared with that of twelve-lead ECG ("unable to judge" as false positive and false negative), the diagnostic consistency of the wearable dynamic ECG recorder for AF was 94.74% (95%CI 88.76%－97.80%). The sensitivity of the wearable dynamic ECG recorder to diagnose AF was 88.68% (95%CI 77.06%－95.07%), and the specific was 100% (95%CI 92.91%－100%). The positive predictive value was 100% (95%CI 90.98%－100%), and the negative predictive value was 91.04% (95%CI 81.48%－96.16%). In an upright position, it was automatically determined by the AI algorithm: 50 AF cases, 61 non-AF cases, and 1 case not determined. Compared with that of the twelve-lead ECG ("unable to judge" as false positive and false negative), the diagnostic consistency of the wearable dynamic ECG recorder for AF was 97.37% (95%CI 92.21%－99.44%). The sensitivity of the wearable dynamic ECG recorder to diagnose AF was 94.34% (95%CI 84.03%－98.65%), and the specific was 100% (95%CI 92.91%－100%). The positive predictive value was 100% (95%CI 91.48%－100%), and the negative predictive value was 95.31% (95%CI 86.57%－98.92%). The results after exercise were the same as that of the standing position. No adverse events occurred throughout the test, and no apparent device defect was found.

Conclusion·The wearable dynamic ECG recorder has higher specificity and positive predictive value. Moreover, the operation is simple, which could increase the detection rate of paroxysmal AF.

Key words: atrial fibrillation, wearable dynamic ECG recorder, electrocardiogram, screening

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