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

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.