Wrist-worn device combining PPG and ECG can be reliably used for atrial fibrillation detection in an outpatient setting.

ABSTRACT

Aims: The aim was to validate the performance of a monitoring system consisting of a wrist-worn device and a data management cloud service intended to be used by medical professionals in detecting atrial fibrillation (AF). Methods: Thirty adult patients diagnosed with AF alone or AF with concomitant flutter were recruited. Continuous photoplethysmogram (PPG) and intermittent 30 s Lead I electrocardiogram (ECG) recordings were collected over 48 h. The ECG was measured four times a day at prescheduled times, when notified due to irregular rhythm detected by PPG, and when self-initiated based on symptoms. Three-channel Holter ECG was used as the reference. Results: The subjects recorded a total of 1,415 h of continuous PPG data and 3.8 h of intermittent ECG data over the study period. The PPG data were analyzed by the system's algorithm in 5-min segments. The segments containing adequate amounts, at least ~30 s, of adequate quality PPG data for rhythm assessment algorithm, were included. After rejecting 46% of the 5-min segments, the remaining data were compared with annotated Holter ECG yielding AF detection sensitivity and specificity of 95.6 and 99.2%, respectively. The ECG analysis algorithm labeled 10% of the 30-s ECG records as inadequate quality and these were excluded from the analysis. The ECG AF detection sensitivity and specificity were 97.7 and 89.8%, respectively. The usability of the system was found to be good by both the study subjects and the participating cardiologists. Conclusion: The system comprising of a wrist device and a data management service was validated to be suitable for use in patient monitoring and in the detection of AF in an ambulatory setting.Clinical Trial Registration ClinicalTrials.gov/, NCT05008601.