Prolonged ECG with a novel recorder utilizing electrode belt and mobile device in patients with recent embolic stroke of undetermined source: A pilot study

Abstract

Background

Paroxysmal atrial fibrillation (pAF) is a major risk factor for ischemic stroke, but challenging to detect with routine short‐term monitoring methods. In this pilot study, we present a novel method for prolonged ECG and screening for pAF in patients with a recent embolic stroke of unknown source (ESUS).

Methods

Fifteen patients aged ≥ 50 years with a recent ESUS were assigned to wear an external electrode belt‐based 1‐lead ECG device (Beat2Phone) continuously for 2 weeks (wear time). The device was operated via a mobile phone application in nonhospital conditions. The primary outcome was patient adherence to monitoring. Secondary outcomes were incidence of new pAF, quality‐wise comparison to Holter, and usability of the novel ECG monitoring method with Systems Usability Scale (SUS). We also performed a 24‐ to 48‐hr comparison between simultaneous Beat2Phone ECG and a standard Holter in 6 patients.

Results

Wear time of Beat2Phone device was over 80% in 5 (33.3%) patients, 50%–80% in 7 (46.6%) patients, and less than 50% in 3 (20%) patients. We detected pAF ≥ 30 s in 1 patient (6.7%). In the simultaneous monitoring with Beat2Phone and Holter, there were a total of 817 (out of 1979) analyzable periods of sinus rhythm or premature atrial or ventricular beats (Cohen's Kappa coefficient 0.92 ± 0.02 between Beat2Phone and Holter), and no pAF events. Beat2Phone ECG showed remarkable SUS scores in user evaluations (average score: 81.4 out of 100 on SUS).

Conclusions

Beat2Phone device was easy to use among ESUS patients and in optimal conditions provided high‐quality 1‐lead ECG signal for diagnosing pAF.

Clinical trial registration

The study was not registered, as it was a nonrandomized single‐arm pilot study.