Diagnostic Performance of a Smart Device With Photoplethysmography Technology for Atrial Fibrillation Detection: Pilot Study (Pre-mAFA II Registry) (Preprint)

Abstract

Background: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. The asymptomatic nature and paroxysmal frequency of AF lead to suboptimal early detection. A novel technology, photoplethysmography (PPG), has been developed for AF screening. However, there has been limited validation of smartphone and smart band applications with PPG compared to 12-lead electrocardiograms (ECG). Objective:We investigated the feasibility and accuracy of a smartphone-and smart band-based algorithm (PRO AF PPG) for AF detection using pulse data measured by PPG. Methods:One hundred twelve consecutive inpatients were recruited from the Chinese PLA General Hospital from 15 March to 1 April 2018. Participants were simultaneously tested with smartphones (HUAWEI Mate 9, HUAWEI Honor 7X), smart bands (HUAWEI Band 2), and 12-lead ECG for 3 minutes. Results:One hundred eight patients (56 with normal sinus rhythm, 52 with persistent AF) were enrolled in the final analysis after excluding 4 patients with unclear cardiac rhythms. The corresponding sensitivity and specificity of the smart band PPG were 95.36% (95% confidential interval, CI 92.00-97.40%) and 99.70% (95% CI 98.08-99.98%), respectively. The positive predictive value of the smart band PPG was 99.63% (95% CI 97.61-99.98%), the negative predictive value was 96.24% (95% CI 93.50-97.90%), and the accuracy was 97.72% (95% CI 96.11-98.70%). Moreover, the diagnostic sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of smartphones with PPG for AF detection were over 94%. There was no significant difference after further statistical analysis of the results from the different smart devices compared with the gold-standard ECG (P=.999). Conclusions:The algorithm based on smartphones and smart bands with PPG demonstrated good performance in detecting AF and may represent a convenient tool for AF detection in at-risk individuals, allowing widespread screening of AF in the population.