Evaluation of the Accuracy of ECG Captured by CardioChip through Comparison of Lead I Recording to a Standard 12-Lead ECG Recording Device.

Abstract

Remote cardiac rhythm monitoring and recording, using hand-carried electrocardiogram (ECG) device had been widely used in telemedicine. The feasibility and accuracy analysis on the data recorded by a new miniature ECG system-on-chip (SoC) system has not been explored before. This study evaluated the accuracy of the ECG recordings captured by CardioChip - a single-channeled, low-powered, miniature ECG SoC designed for mobile applications; comparing against Philips Pagewriter Trim III - a Food and Drug Administration certified, widely-used standard 12-lead ECG recording device, within Mackay Memorial Hospital in Taiwan. Total of 111 participants, age ranging from 39 to 87years old [mean age: 61.2 ± 13.4, 57 male (51.3%)] were enrolled. Two experienced cardiologists rated and scored the ECG morphology to be the same between the two devices, while CardioChip ECG was more sensitive to baseline noise. R-peak amplitudes measured both devices using single lead information (CardioChip ECG vs. Lead 1 in standard 12-lead ECG) showed statistical consistency. Offline analysis of signal correlation coefficients and coherence showed good correlation with both over 0.94 in average (0.94 ± 0.04 and 0.95 ± 0.04, respectively), high agreement between raters (94% agreement) for detecting abnormal cardiac rhythm with excellent R-peak amplitude (r = 0.98, p < 0.001) and PR interval (r = 0.91, p < 0.001) correlations, indicating excellent correlation between ECG recordings derived from two different modalities. The results suggested that CardioChip ECG is comparable to medical industry standard ECG. The future implementation of wearable ECG device embedded with miniature ECG system-on-chip (SoC) system is ready for clinical use, which will potentially enhance efficacy on identifying subjects with suspected cardiac arrhythmias.