Clinical value of portable 12-lead electrocardiography devices in patients with heart disease: A validation study.

Abstract

Objective: The present study was conducted to assess the accuracy and reliability of portable 12‑lead electrocardiography (ECG) devices in patients with heart disease.

Materials and methods: This single-center, prospective, blinded study enrolled 62 patients between September and October 2023 from the Heart Center of a Class III hospital. In sequential tests on each patient, heart rate (HR) and the PR, QT, QTc and QRS intervals of ECG recordings obtained with a portable 12‑lead device (Weheal, CN) were compared with those obtained via conventional 12‑lead ECG. ECG parameters were read in batches by 3 blinded electrophysiologists. Two-tailed paired t-tests were used to compare the continuous variables. Agreement was evaluated via Bland-Altman plots.

Results: Sixty-two patients were included. HR and the QT, QTc and QRS intervals from the portable 12‑lead electrocardiogram recordings were essentially the same as those obtained via conventional ECG. Bland-Altman analysis revealed no significant differences in these values, indicating suitable agreement between the 2 measurements. The PR interval was 176.89 ± 29.53 ms in the portable group and 161.56 ± 17.78 ms in the standard group, which was statistically (p < 0.001) but not clinically significant.

Conclusions: ECG recordings obtained with a portable 12‑lead device (Weheal, CN) allow for accurate HR, PR, QT, QTc and QRS assessments. Considering its simplicity, this approach has advantages over conventional ECG and can provide an alternative for evaluating patients outside the hospital. How to improve patients' acceptance of portable ECG machines still needs further research.