Feasibility of Mobile Single-Lead Electrocardiogram Screening for Atrial Fibrillation: Multicenter Cross-Sectional Study

Abstract Background Atrial fibrillation (AF) is a major contributor of thromboembolic stroke. However, early detection remains challenging and is severely hindered by structural limitations in health care infrastructure. While current clinical guidelines recognize a 30-second single-lead electrocardiogram (ECG) as a standard diagnostic tool, the actual deployment and real-world utility of mobile screening technologies across health care settings remain poorly understood. Objective The primary objective of this study was to evaluate the real-world feasibility of a mobile single-lead ECG for the detection of AF in routine inpatient and outpatient settings. Feasibility was evaluated by the proportion of successfully completed recordings, patient acceptance, and the occurrence and characteristics of technical challenges during deployment. Methods This multicenter, cross-sectional pragmatic implementation study enrolled patients across 3 university hospitals and 3 primary care practices. Screening was performed using an US Food and Drug Administration (FDA)–approved single-lead ECG device (AliveCor KardiaMobile). Patients with an automated device reading indicating “Possible AF” and no prior diagnosis of AF underwent a confirmatory 12-lead ECG. Patient awareness and acceptance were evaluated using an exploratory, descriptive questionnaire. Results A total of 237 patients were enrolled (194 inpatients and 43 outpatients). The device algorithm provided an automatic interpretation in 95.3% (41/43) of the outpatients and 85.6% (166/194) of inpatients, resulting in an overall automated detection of AF in 21.5% (51/237) of the cohort. The algorithm identified newly suspected AF in 1.7% (4/237) of patients without a prior AF diagnosis. Of these, 1 case underwent same-day confirmatory 12-lead ECG and was confirmed as AF. Technical challenges occurred in 16.0% (38/237) of all recordings, with a numerical higher rate observed in the inpatient setting (34/194, 17.5% vs 4/43, 9.3% in outpatients; P =.25). Only 6.3% (15/237) of patients reported regular use of telemedicine applications. Conclusions Mobile single-lead ECG screening is feasible in routine inpatient and outpatient settings and identified a substantial prevalence of AF, which increased with age. The high detection rate underscores the potential of wearable ECG devices to facilitate early detection of AF. However, the absence of systematic confirmatory ECG testing and limited patient engagement with telemedicine applications highlight challenges in real-world implementation.