Reliability and validity of a novel single-lead portable electrocardiogram device for pregnant women: a comparative study.

Abstract

Background: WenXinWuYang, a novel portable Artificial Intelligence Electrocardiogram (AI-ECG) device, can detect many kinds of abnormal heart disease and perform a single-lead ECG, but its reliability and validity among pregnant women is unclear. The aim of this study was to assess the reliability and validity of heart rate, ECG measurements and diagnostic results by compared the portable device with a clinical 12-lead ECG among pregnant women.

Methods: We conducted a clinical study at a municipal-level maternal and child health care hospital. The pregnant women who visited the ECG room for ECG examination were invited to participate in this study. Each participant underwent three ECG recordings: one with conventional 12-lead ECG and two with WenXinWuYang ECG. The first WenXinWuYang ECG was recorded simultaneously with the 12-lead ECG. We collected heart rate, ECG measurements, and diagnostic results related to arrhythmias from both ECG devices. The data were then analyzed using Spearman rank correlation coefficients, consistency analyses, and Bland-Altman plots.

Results: The study included 287 ECG recordings from 99 pregnant women, with a balanced distribution across different stages of pregnancy. We observed strong to moderate correlations between the two WenXinWuYang measurements for heart rate (r = 0.847), PR interval (r = 0.728), QRS duration (r = 0.636), QT interval (r = 0.836), and QTc interval (r = 0.648), with a diagnostic consistency rate exceeding 90.0%. When compared with the 12-lead ECG, the mean differences for heart rate, PR interval, QRS duration, QT interval, and QTc interval were - 0.4 ± 3.1 bpm (r = 0.957), 14.6 ± 12.4 ms (r = 0.537), 7.0 ± 8.9 ms (r = 0.136), 2.1 ± 12.0 (r = 0.774), and 6.6 ± 16.5 (r = 0.663), respectively. Although the correlation coefficient was low in QRS duration, Bland-Altman results showed moderate to strong agreement between these intervals. Sinus rhythm recognition was fully consistent with the 12-lead ECG, with higher validity in detecting arrhythmias (sensitivity 84.2%, specificity 97.5%). Similar trends existed among different stages of pregnancy.

Conclusion: WenXinWuYang demonstrated acceptable reliability and validity in measuring heart rate, ECG measurements, and detecting arrhythmias among pregnant women.