Patient Driven EKG Device Performance in Adults with Fontan Palliation

Abstract Objectives The aim of this study was to evaluate the accuracy of the KardiaMobile (KM) device in adults with a Fontan palliation, and to assess the KM function as a screening tool for atrial arrhythmias.Background While patient driven electrocardiogram (EKG) devices are becoming a validated way to evaluate cardiac arrhythmias, their role for patients with congenital heart disease is less clear. Patients with single ventricle Fontan palliation have a high prevalence of atrial arrhythmias and represent a unique cohort that could benefit from early detection of atrial arrhythmias.Methods This single center prospective study enrolled adult patients with Fontan palliation to use the KM heart rhythm monitoring device for both symptomatic episodes and asymptomatic weekly screening over a 1-year period. Accuracy was assessed by comparing the automatic KM to physician overread and traditional EKG.Results Fifty patients were enrolled and 510 follow up transmissions were received. The sensitivity and specificity of enrollment KM-auto compared to EKG was 65% and 100%, respectively. The sensitivity and specificity of enrollment automated KM interpretations (KM-auto) compared to the electrophysiologist interpretation (KM-EP) was 75% and 96%, respectively.Conclusion In the adult Fontan palliation, the accuracy of the KM device to detect a normal rhythm was reliable and best with a physician overread. Abnormal or uninterpretable KM device interpretations, symptomatic transmissions, and any transmissions with a high heart rate compared to a patient’s normal baseline should warrant further review.