Diagnostic validation of smart wearable device embedded with single-lead electrocardiogram for arrhythmia detection.

Objective: To validate a single-lead electrocardiogram algorithm for identifying atrial fibrillation, atrial premature beats, ventricular premature beats, and sinus rhythm.

Methods: A total of 656 subjects aged 19 to 94 years were enrolled. Participants were simultaneously tested with a wristwatch (Huawei Watch GT2 Pro, Huawei Technologies Co., Ltd, Shenzhen, China) and a 12-lead electrocardiogram for 3 minutes. A total of 1926 electrocardiogram signals from 628 subjects (282 men and 346 women) aged 19 to 94 years (median 64 years) were analyzed using an algorithm.

Results: The numbers of subjects with atrial fibrillation, atrial premature beats, ventricular premature beats, and sinus rhythm were 129, 141, 107, and 251, respectively, and together they had a total of 1926 electrocardiogram signals. For the three-class classification system, the recall, precision, and F1 score were 97.6%, 96.5%, 97.0% for sinus rhythm; 96.7%, 96.9%, 96.8% for atrial fibrillation; and 92.8%, 94.2%, 93.5% for ectopic beats, respectively. The macro-F1 score of the three-class classification system was 95.8%. For the four-class classification system, the recall, precision, and F1 score were 97.6%, 96.5%, 97.0% for sinus rhythm; 96.7%, 96.9%, 96.8% for atrial fibrillation; 90.5%, 89.4%, 89.9% for atrial premature beats; and 86.1%, 89.6%, 87.8% for ventricular premature beats, respectively. The macro-F1 score of the four-class classification system was 92.9%.

Conclusions: The single-lead electrocardiogram algorithm embedded into smart wearables demonstrated good performance in detecting atrial fibrillation, atrial/ventricular premature beats, and sinus rhythm, and thus would facilitate atrial fibrillation screening and management.