Abstract 13757: A Nationwide Trial of Screening for Undiagnosed Atrial Fibrillation in an At-Risk Population Using a Self-Applied ECG Recording Patch Sensor: Results of the Randomized Component of the mHealth Screening to Prevent Strokes (mSToPS) Trial
Introduction: Undiagnosed atrial fibrillation (AF) can lead to strokes, the majority of which could be prevented through use of oral anticoagulants. Therefore, guidelines recommend opportunistic screening for AF; this is rarely done, however, due to challenges in implementation.
Hypothesis: Novel mobile health (mHealth) technologies can allow for the study of pragmatic solutions in large scale screening programs for undiagnosed AF.
Methods: 102,553 eligible Aetna members without a diagnosis of AF and meeting all inclusion/exclusion criteria were invited to participate, consent, and enroll via a web-based platform. 2,820 individuals who signed the informed consent were randomized to either immediate monitoring with an iRhythm Zio patch, or delayed monitoring to be initiated 4 months after consent. The primary endpoint in this pragmatic randomized trial was the incidence of newly diagnosed AF, either clinically or through monitoring in the immediate cohort, or clinically only in the delayed cohort.
Results: A total of 1,739 individuals with a mean age of 73.7 and median CHA2DS2-VASc of 3.0 wore the Zio patch and are included in this analysis. Of the 908 randomized to immediate monitoring, 46 (5.1%) were newly diagnosed with AF during their monitoring period compared to 5 (0.6%) of 831 individuals in the delayed cohort (OR 8.8 [95% CI 3.5, 22.3], p<0.01). (Figure)
Conclusions: Through a patient-centric, nationwide, and completely remote digital research screening program we were able to improve the diagnosis of previously undiagnosed AF ~9-fold relative to clinical diagnosis only in a randomized cohort.
Author Disclosures: S.R. Steinhubl: Research Grant; Modest; Janssen Pharmaceuticals, Qualcomm Foundation. Consultant/Advisory Board; Modest; Novartis. J. Waalen: None. A.M. Edwards: Employment; Significant; Aetna. R.R. Mehta: Employment; Significant; Aetna. L. Ariniello: None. G. Ebner: None. K. Baca-Motes: None. C. Carter: Employment; Significant; Janssen. E. Felicione: Employment; Significant; Janssen. T. Sarich: Employment; Significant; Janssen. E.J. Topol: None.
- © 2017 by American Heart Association, Inc.