Comparative Evaluation of Consumer Wearable Devices for Atrial Fibrillation Detection: Validation Study.

Abstract

Background: Consumer-oriented wearable devices (CWDs) such as smartphones and smartwatches have gained prominence for their ability to detect atrial fibrillation (AF) through proprietary algorithms using electrocardiography or photoplethysmography (PPG)-based digital recordings. Despite numerous individual validation studies, a direct comparison of interdevice performance is lacking.

Objective: This study aimed to evaluate and compare the ability of CWDs to distinguish between sinus rhythm and AF.

Methods: Patients exhibiting sinus rhythm or AF were enrolled through a cardiology outpatient clinic. The participants were instructed to perform heart rhythm measurements using a handheld 6-lead electrocardiogram (ECG) device (KardiaMobile 6L), a smartwatch-derived single-lead ECG (Apple Watch), and two PPG-based smartphone apps (FibriCheck and Preventicus) in a random sequence, with simultaneous 12-lead reference ECG as the gold standard.

Results: A total of 122 participants were included in the study: median age 69 (IQR 61-77) years, 63.9% (n=78) men, 25% (n=30) with AF, 9.8% (n=12) without prior smartphone experience, and 73% (n=89) without experience in using a smartwatch. The sensitivity to detect AF was 100% for all devices. The specificity to detect sinus rhythm was 96.4% (95% CI 89.5%-98.8%) for KardiaMobile 6L, 97.8% (95% CI 91.6%-99.5%) for Apple Watch, 98.9% (95% CI 92.5%-99.8%) for FibriCheck, and 97.8% (95% CI 91.5%-99.4%) for Preventicus (P=.50). Insufficient quality measurements were observed in 10.7% (95% CI 6.3%-17.5%) of cases for both KardiaMobile 6L and Apple Watch, 7.4% (95% CI 3.9%-13.6%) for FibriCheck, and 14.8% (95% CI 9.5%-22.2%) for Preventicus (P=.21). Participants preferred Apple Watch over the other devices to monitor their heart rhythm.

Conclusions: In this study population, the discrimination between sinus rhythm and AF using CWDs based on ECG or PPG was highly accurate, with no significant variations in performance across the examined devices.