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, o...

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Autores principales:	Robert Kleiman, Borje Darpo, Randy Brown, Todd Rudo, Svetlana Chamoun, David E. Albert, Johan Martijn Bos, Michael J. Ackerman
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	Bland–Altman clinical trials electrocardiogram interval duration measurements QTc remote monitoring Diseases of the circulatory (Cardiovascular) system RC666-701
Acceso en línea:	https://doaj.org/article/3912ef6d96c34b4aad920774d1089bf8
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id	oai:doaj.org-article:3912ef6d96c34b4aad920774d1089bf8
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spelling	oai:doaj.org-article:3912ef6d96c34b4aad920774d1089bf82021-11-12T11:40:14ZComparison of electrocardiograms (ECG) waveforms and centralized ECG measurements between a simple 6‐lead mobile ECG device and a standard 12‐lead ECG1542-474X1082-720X10.1111/anec.12872https://doaj.org/article/3912ef6d96c34b4aad920774d1089bf82021-11-01T00:00:00Zhttps://doi.org/10.1111/anec.12872https://doaj.org/toc/1082-720Xhttps://doaj.org/toc/1542-474XAbstract 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.Robert KleimanBorje DarpoRandy BrownTodd RudoSvetlana ChamounDavid E. AlbertJohan Martijn BosMichael J. AckermanWileyarticleBland–Altmanclinical trialselectrocardiograminterval duration measurementsQTcremote monitoringDiseases of the circulatory (Cardiovascular) systemRC666-701ENAnnals of Noninvasive Electrocardiology, Vol 26, Iss 6, Pp n/a-n/a (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Bland–Altman clinical trials electrocardiogram interval duration measurements QTc remote monitoring Diseases of the circulatory (Cardiovascular) system RC666-701
spellingShingle	Bland–Altman clinical trials electrocardiogram interval duration measurements QTc remote monitoring Diseases of the circulatory (Cardiovascular) system RC666-701 Robert Kleiman Borje Darpo Randy Brown Todd Rudo Svetlana Chamoun David E. Albert Johan Martijn Bos Michael J. Ackerman Comparison of electrocardiograms (ECG) waveforms and centralized ECG measurements between a simple 6‐lead mobile ECG device and a standard 12‐lead ECG
description	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.
format	article
author	Robert Kleiman Borje Darpo Randy Brown Todd Rudo Svetlana Chamoun David E. Albert Johan Martijn Bos Michael J. Ackerman
author_facet	Robert Kleiman Borje Darpo Randy Brown Todd Rudo Svetlana Chamoun David E. Albert Johan Martijn Bos Michael J. Ackerman
author_sort	Robert Kleiman
title	Comparison of electrocardiograms (ECG) waveforms and centralized ECG measurements between a simple 6‐lead mobile ECG device and a standard 12‐lead ECG
title_short	Comparison of electrocardiograms (ECG) waveforms and centralized ECG measurements between a simple 6‐lead mobile ECG device and a standard 12‐lead ECG
title_full	Comparison of electrocardiograms (ECG) waveforms and centralized ECG measurements between a simple 6‐lead mobile ECG device and a standard 12‐lead ECG
title_fullStr	Comparison of electrocardiograms (ECG) waveforms and centralized ECG measurements between a simple 6‐lead mobile ECG device and a standard 12‐lead ECG
title_full_unstemmed	Comparison of electrocardiograms (ECG) waveforms and centralized ECG measurements between a simple 6‐lead mobile ECG device and a standard 12‐lead ECG
title_sort	comparison of electrocardiograms (ecg) waveforms and centralized ecg measurements between a simple 6‐lead mobile ecg device and a standard 12‐lead ecg
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/3912ef6d96c34b4aad920774d1089bf8
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Comparison of electrocardiograms (ECG) waveforms and centralized ECG measurements between a simple 6‐lead mobile ECG device and a standard 12‐lead ECG

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