Accepted for/Published in: JMIR Formative Research
Date Submitted: Aug 6, 2024
Date Accepted: Nov 20, 2024
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Comparative evaluation of consumer wearable devices for atrial fibrillation detection: A 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 (ECG) and/or photoplethysmography (PPG)-based digital recordings. Despite numerous individual validation studies, a direct inter-device comparison of their performance remains elusive.
Objective:
To evaluate and compare the ability of CWDs to discriminate between sinus rhythm and AF.
Methods:
Patients exhibiting sinus rhythm or AF were enrolled from the cardiology outpatient clinic. Participants were instructed to perform heart rhythm measurements using a handheld six-lead ECG device (KardiaMobile® 6L), a smartwatch-derived single-lead ECG (Apple®Watch), and two PPG-based smartphone applications (FibriCheck® and Preventicus®) in a random sequence, with a simultaneous 12-lead reference ECG.
Results:
Overall, 122 subjects were included (age 69 [61-77] years, 63.9% male, 25.0% with AF, 9.8% without prior smartphone experience, 73.0% without smartwatch experience). 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%) for 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 the Apple®Watch to monitor their heart rhythm over the other devices.
Conclusions:
In this selected population, the discrimination between sinus rhythm and AF using CWDs based on ECG or PPG was highly accurate, with no discernible variations across the examined devices. Clinical Trial: ClinicalTrials.gov NCT06023290.
Citation
