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. 2022 Jun 23:9:906079.
doi: 10.3389/fcvm.2022.906079. eCollection 2022.

Clinical Validation of Automated Corrected QT-Interval Measurements From a Single Lead Electrocardiogram Using a Novel Smartwatch

Diego Mannhart  1   2 , Elisa Hennings  1   2 , Mirko Lischer  1   2 , Claudius Vernier  1   2 , Jeanne Du Fay de Lavallaz  1   2 , Sven Knecht  1   2 , Beat Schaer  1   2 , Stefan Osswald  1   2 , Michael Kühne  1   2 , Christian Sticherling  1   2 , Patrick Badertscher  1   2
Affiliations

Clinical Validation of Automated Corrected QT-Interval Measurements From a Single Lead Electrocardiogram Using a Novel Smartwatch

Diego Mannhart et al. Front Cardiovasc Med. .

Abstract

Introduction: The Withings Scanwatch (Withings SA, Issy les Moulineaux, France) offers automated analysis of the QTc. We aimed to compare automated QTc-measurements using a single lead ECG of a novel smartwatch (Withings Scanwatch, SW-ECG) with manual-measured QTc from a nearly simultaneously recorded 12-lead ECG.

Methods: We enrolled consecutive patients referred to a tertiary hospital for cardiac workup in a prospective, observational study. The QT-interval of the 12-lead ECG was manually interpreted by two blinded, independent cardiologists through the tangent-method. Bazett's formula was used to calculate QTc. Results were compared using the Bland-Altman method.

Results: A total of 317 patients (48% female, mean age 63 ± 17 years) were enrolled. HR-, QRS-, and QT-intervals were automatically calculated by the SW in 295 (93%), 249 (79%), and 177 patients (56%), respectively. Diagnostic accuracy of SW-ECG for detection of QTc-intervals ≥ 460 ms (women) and ≥ 440 ms (men) as quantified by the area under the curve was 0.91 and 0.89. The Bland-Altman analysis resulted in a bias of 6.6 ms [95% limit of agreement (LoA) -59 to 72 ms] comparing automated QTc-measurements (SW-ECG) with manual QTc-measurement (12-lead ECG). In 12 patients (6.9%) the difference between the two measurements was greater than the LoA.

Conclusion: In this clinical validation of a direct-to-consumer smartwatch we found fair to good agreement between automated-SW-ECG QTc-measurements and manual 12-lead-QTc measurements. The SW-ECG was able to automatically calculate QTc-intervals in one half of all assessed patients. Our work shows, that the automated algorithm of the SW-ECG needs improvement to be useful in a clinical setting.

Keywords: QTc; artificial intelligence; digital health; intelligent ECG; remote patient monitoring (RPM); single-lead ECG; smartwatch.

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Conflict of interest statement

PB received research funding from the “University of Basel“, the “Stiftung für Herzschrittmacher und Elektrophysiologie,” the “Freiwillige Akademische Gesellschaft Basel”, and Johnson & Johnson, all outside the submitted work and reports personal fees from Abbott. SK has received funding of the “Stiftung für Herzschrittmacher und Elektrophysiologie.” CS Member of Medtronic Advisory Board Europe, and Boston Scientitic Advisory Board Europe, received educational grants from Biosense Webster and Biotronik, a research grant from the European Union’s FP7 program and Biosense Webster, and lecture and consulting fees from Abbott, Medtronic, Biosense-Webster, Boston Scientific, Microport, and Biotronik all outside the submitted work. MK reports personal fees from Bayer, personal fees from Böhringer Ingelheim, personal fees from Pfizer BMS, personal fees from Daiichi Sankyo, personal fees from Medtronic, personal fees from Biotronik, personal fees from Boston Scientific, personal fees from Johnson & Johnson, personal fees from Roche, grants from Bayer, grants from Pfizer, grants from Boston Scientific, grants from BMS, grants from Biotronik, and grants from Daiichi Sankyo, all outside the submitted work. BS reports speaker’s bureau for Medtronic. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

FIGURE 1
FIGURE 1
Flowchart showing pathway of pre-analysis data management and acquisition. AI, artificial intelligence.
FIGURE 2
FIGURE 2
Comparison of QT-interval measurements, manually measured QTc on a 12-lead ECG and automated SW-ECG. Measurement Agreement was analyzed using the Bland-Altmann Method. Bias is represented by the solid black line, limit of agreement is represented via d dashed red line. Sections of SW-ECG from outliners are shown in red circles. SW-ECG, Single-Lead Withings Electrocardiogram; QTc, corrected QT-interval; AI, Artificial Intelligence.
See this image and copyright information in PMC

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