The Withings smartwatch algorithm accurately detected atrial fibrillation, achieving a sensitivity of 96.3% and a specificity of 100% when compared to a 12-lead reference ECG.
Observational (n=262)
Yes
Does an automatic AF detection algorithm using a single-lead ECG from an analog smartwatch accurately detect AF compared to a 12-lead reference ECG?
The Withings smartwatch algorithm demonstrated high sensitivity and specificity for detecting atrial fibrillation compared to a standard 12-lead ECG.
Absolute Event Rate: 96.3% vs 100%
BACKGROUND Atrial Fibrillation (AF) affects one to 4% of the World’s population and is one of the major causes of stroke, heart failure, sudden death, and cardiovascular morbidity. It can be difficult to diagnose when asymptomatic or in the paroxysmal stage, and its natural history is not well understood. New wearables and connected devices offer an opportunity to improve on this situation. OBJECTIVE To validate an algorithm for the automatic detection of AF from a single-lead electrocardiogram (ECG) taken with an analog watch. METHODS Eligible patients were recruited from 4 sites in Paris and its suburb area. Simultaneous 1-lead ECG captured by Withings smartwatch with embedded algorithm were recorded with 12-lead reference ECG. Automatic AF detection performance and algorithm-generated 1-lead ECG quality (visibility, polarity, interval durations, heart rate) were assessed. Sensitivity and specificity of the algorithm to detect AF and to discriminate if from normal sinus rhythm (NSR) were calculated. RESULTS Two hundred and sixty two patients were included in the final analysis: 100 AF, 113 NSR, 45 Other arrhythmia, 4 presented unreadable ECGs. Mean age was of 74.3 years ± 12.3 in the AF group versus 61.8 years old ± 14.3 and 66.9 years old ± 15.2 in the NSR and other arrhythmia groups respectively. 6.9% (18/262) were classified as “Noise” by the algorithm. Excluding “Other” arrhythmia and “Noise”, the sensitivity to detect AF was of SeAF/NSR = 0.963 (0.894), and specificity of SpAF/NSR = 1.000 (0.967). Visibility and polarity accuracies (1-lead ECG vs 12-lead ECG) were of: P-waves: 96.9%/100%, QRS-complexes: 99.2%/98.8%, and T-waves: 91.2%/99.5% respectively. P-wave visibility accuracy was of 99% (99/100) in AF patients and of 95.7% (155/162) when excluding AF patients. Except for QT, mean difference absolute values for difference in PR duration and QRS width were below 3ms and more than 97% of these differences were below 40ms. Difference between HR calculated by the algorithm and device 1-lead ECG read by cardiologists being of 0.55 bpm ± 6.46. CONCLUSIONS Withings algorithm demonstrated great diagnostic performance for AF detection. 1-lead generated ECG also demonstrated good quality for physician use in daily routine care. CLINICALTRIAL ClinicalTrials.gov registration number: NCT04351386
Valery Élie (Mon,) conducted a observational in Atrial Fibrillation (n=262). Withings smartwatch with embedded algorithm (1-lead ECG) vs. 12-lead reference ECG was evaluated on Sensitivity and specificity of the algorithm to detect AF and discriminate it from normal sinus rhythm. The Withings smartwatch algorithm accurately detected atrial fibrillation, achieving a sensitivity of 96.3% and a specificity of 100% when compared to a 12-lead reference ECG.