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

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 semiautomated 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.

Non-continuous mobile electrocardiogram monitoring for post-transcatheter aortic valve replacement delayed conduction disorders put to the test

“…This device has three electrodes that allow simultaneous recordings of all limbs leads by holding the device with both hands and applying the rear electrode against the left leg, and for this device, mean ECG interval duration measurements have been demonstrated to be comparable to supine standard 12-lead ECGs. 22 …”

The Relationship between Body Composition and ECG Ventricular Activity in Young Adults

“…The BIA method is widely used in research that uses body fat monitors to quickly determine body composition. Instead, the portable ECG with six leads, with smartphone applications, has recently appeared on the market and has been less used for studies on the electrical intervals of the heart [ 34 ]. Moreover, the use of both types of assessment for the assumed objectives of the research is a novelty.…”

“…Several companies have proposed portable ECG devices with a smartphone interface that allow simultaneous recording on six leads. Preliminary data indicate that the measured electrical intervals are close enough to allow the detection of clinically meaningful abnormalities [ 34 ]. These devices have good accuracy for reliable QT and QTc interval determination and, therefore, can be used in clinical trials [ 35 ].…”

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“…Es konnten eine Sensitivität von 98,5 % und eine Spezifität von 91,4 % gezeigt werden [21]. Durch Erweiterung um eine dritte Elektrode auf der Rückseite der Platte, die auf das linke Bein aufgelegt wird, kann ein 6-Kanal-EKG abgeleitet werden [20].…”