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...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2021-11-01
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| Series: | Annals of Noninvasive Electrocardiology |
| Subjects: | |
| Online Access: | https://doi.org/10.1111/anec.12872 |
| _version_ | 1818931155333808128 |
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| 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 |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-12-20T04:12:06Z |
| format | Article |
| id | doaj.art-3912ef6d96c34b4aad920774d1089bf8 |
| institution | Directory Open Access Journal |
| issn | 1082-720X 1542-474X |
| language | English |
| last_indexed | 2024-12-20T04:12:06Z |
| publishDate | 2021-11-01 |
| publisher | Wiley |
| record_format | Article |
| series | Annals of Noninvasive Electrocardiology |
| spelling | doaj.art-3912ef6d96c34b4aad920774d1089bf82022-12-21T19:53:53ZengWileyAnnals of Noninvasive Electrocardiology1082-720X1542-474X2021-11-01266n/an/a10.1111/anec.12872Comparison of electrocardiograms (ECG) waveforms and centralized ECG measurements between a simple 6‐lead mobile ECG device and a standard 12‐lead ECGRobert Kleiman0Borje Darpo1Randy Brown2Todd Rudo3Svetlana Chamoun4David E. Albert5Johan Martijn Bos6Michael J. Ackerman7eResearch Technology Inc Philadelphia PA USAeResearch Technology Inc Philadelphia PA USAPPD Inc Wilmington NC USAeResearch Technology Inc Philadelphia PA USAeResearch Technology Inc Philadelphia PA USAAliveCor Corporation San Francisco CA USAWindland Smith Rice Comprehensive Sudden Cardiac Death Program Divisions of Heart Rhythm Services and Pediatric Cardiology Departments of Cardiovascular Medicine, Pediatric and Adolescent Medicine, and Molecular Pharmacology & Experimental Therapeutics Mayo Clinic Rochester MN USAWindland Smith Rice Comprehensive Sudden Cardiac Death Program Divisions of Heart Rhythm Services and Pediatric Cardiology Departments of Cardiovascular Medicine, Pediatric and Adolescent Medicine, and Molecular Pharmacology & Experimental Therapeutics Mayo Clinic Rochester MN USAAbstract 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.https://doi.org/10.1111/anec.12872Bland–Altmanclinical trialselectrocardiograminterval duration measurementsQTcremote monitoring |
| spellingShingle | 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 Annals of Noninvasive Electrocardiology Bland–Altman clinical trials electrocardiogram interval duration measurements QTc remote monitoring |
| 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_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_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_sort | comparison of electrocardiograms ecg waveforms and centralized ecg measurements between a simple 6 lead mobile ecg device and a standard 12 lead ecg |
| topic | Bland–Altman clinical trials electrocardiogram interval duration measurements QTc remote monitoring |
| url | https://doi.org/10.1111/anec.12872 |
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