Handheld ECG Tracking of in-hOspital Atrial Fibrillation (HECTO-AF): A Randomized Controlled Trial

Abstract

Background. Atrial fibrillation (AF) is frequent and causes substantial morbidity through AF-related strokes. Given the increasing prevalence of AF, screening methods are of interest given the potential to initiate timely appropriate anticoagulation. The HECTO-AF trial aims to determine the efficacy of AF screening with a single-lead electrocardiogram (ECG) handheld device in naïve in-hospital patients.Methods. The HECTO-AF is a single-centre, open label, randomized controlled trial. Patients admitted to the general medicine ward of the University and Hospital Fribourg without previous diagnosis of AF were invited to participate in a screening program with a 1:1 allocation to either the screening group with intermittent single-lead handheld ECG recordings vs. a control group undergoing detection of AF as per routine clinical practice. Primary outcome was prevalence of newly diagnosed AF. Enrolment was terminated for poor patient recruitment and apparent futility before a sufficient sample for powered efficacy comparisons was enrolled. Results. A total 804 patients were included of whom 381 were allocated to the intervention and 423 to the control group. Mean age was 65±16 and 464 (58%) were male. Median CHA2DS2-VASc score was 3 (13% heart failure, 57% hypertension, 19% diabetes mellitus, 14% prior stroke/transient ischemic attack, 29% arterial disease) and all CHA2DS2-VASc risk factors were equally distributed between groups. Seven patients (1.8%) were diagnosed with AF in the intervention group versus 3 (0.7%) in the control group (p-value=0.20). Conclusion. There was a trend towards a higher AF detection in the intervention group, but a definitive conclusion cannot be drawn due to the early termination of the present study. Systematic screening for AF in the hospital setting is resource-consuming, and of uncertain clinical benefit. The interpretation of single-lead handheld ECG is challenging and may result in inaccurate AF diagnosis. Trial registration. ClinicalTrials.gov, ID: NCT03197090.