Comparison of electrocardiograms (ECG) waveforms and centralized ECG measurements between a simple 6-lead mobile ECG device and a standard 12-lead ECG

Robert Kleiman, Borje Darpo, Randy Brown, Todd Rudo, Svetlana Chamoun, David E Albert, Johan Martijn Bos, Michael J Ackerman, Robert Kleiman, Borje Darpo, Randy Brown, Todd Rudo, Svetlana Chamoun, David E Albert, Johan Martijn Bos, Michael J Ackerman

Abstract

Background: Interval duration measurements (IDMs) were compared between standard 12-lead electrocardiograms (ECGs) and 6-lead ECGs recorded with AliveCor's KardiaMobile 6L, a hand-held mobile device designed for use by patients at home.

Methods: Electrocardiograms were recorded within, on average, 15 min from 705 patients in Mayo Clinic's Windland Smith Rice Genetic Heart Rhythm Clinic. Interpretable 12-lead and 6-lead recordings were available for 685 out of 705 (97%) eligible patients. The most common diagnosis was congenital long QT syndrome (LQTS, 343/685 [50%]), followed by unaffected relatives and patients (146/685 [21%]), and patients with other genetic heart diseases, including hypertrophic cardiomyopathy (36 [5.2%]), arrhythmogenic cardiomyopathy (23 [3.4%]), and idiopathic ventricular fibrillation (14 [2.0%]). IDMs were performed by a central ECG laboratory using lead II with a semi-automated technique.

Results: Despite differences in patient position (supine for 12-lead ECGs and sitting for 6-lead ECGs), mean IDMs were comparable, with mean values for the 12-lead and 6-lead ECGs for QTcF, heart rate, PR, and QRS differing by 2.6 ms, -5.5 beats per minute, 1.0 and 1.2 ms, respectively. Despite a modest difference in heart rate, intervals were close enough to allow a detection of clinically meaningful abnormalities.

Conclusions: The 6-lead hand-held device is potentially useful for a clinical follow-up of remote patients, and for a safety follow-up of patients participating in clinical trials who cannot visit the investigational site. This technology may extend the use of 12-lead ECG recordings during the current COVID-19 pandemic as remote patient monitoring becomes more common in virtual or hybrid-design clinical studies.

Keywords: Bland-Altman; QTc; clinical trials; electrocardiogram; interval duration measurements; remote monitoring; virtual trials.

Conflict of interest statement

RK, TR, and SC are employees of ERT, a company that offers centralized ECG reading services to the biopharmaceutical industry. BD is a consultant for ERT and owns stock and is eligible for stock options with the company. MJA and Mayo Clinic have a potential equity/royalty relationship with AliveCor.

© 2021 The Authors. Annals of Noninvasive Electrocardiology published by Wiley Periodicals LLC.

Figures

FIGURE 1
FIGURE 1
Panel a shows the top and bottom of the AliveCor KardiaMobile 6L. Panel b illustrates a patient positioning the device to record a 6‐lead ECG, with the electrode on the back of the device placed on the left knee or left ankle
FIGURE 2
FIGURE 2
Lead II waveforms with annotated caliper placements from 12‐lead (panel a, unfiltered) and 6‐lead (panel b, with filtering) ECGs recorded from the same subject
FIGURE 3
FIGURE 3
12‐lead (panel a) and 6‐lead (panel b) ECGs from the same subject with more prominent ST and T‐wave findings on the 6‐lead recording
FIGURE 4
FIGURE 4
Bland–Altman and bias assessment plots for heart rate (HR). The solid horizontal red line represents the mean difference, and the hashed red line represents the 95% confidence bounds for the measurement pairs. The horizontal green lines represent the limits of agreement
FIGURE 5
FIGURE 5
Bland–Altman and bias assessment plots for QTcF. The solid horizontal red line represents the mean difference, and the hashed red line represents the 95% confidence bounds for the measurement pairs. The horizontal green lines represent the limits of agreement
FIGURE 6
FIGURE 6
12‐lead (panel a) and 6‐lead (panel b) ECGs for subject with a 62 ms difference between QTcF measurements. The 12‐lead ECG was recorded while the T waves in the measurement lead were upright, while the 6‐lead ECG recorded 24 min later had inverted T waves in the measurement lead
FIGURE 7
FIGURE 7
Bland–Altman and bias assessment plots for the PR interval. The solid horizontal red line represents the mean difference, and the hashed red line represents the 95% confidence bounds for the measurement pairs. The horizontal green lines represent the limits of agreement
FIGURE 8
FIGURE 8
Bland–Altman and bias assessment plots for QRS. The solid horizontal red line represent the mean difference, and the hashed red line represents the 95% confidence bounds for the measurement pairs. The horizontal green lines represent the limits of agreement

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Source: PubMed

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