Patient Driven EKG Device Performance in Adults with Fontan Palliation

Area of Science:

• Cardiology
• Medical Devices
• Congenital Heart Disease

Background:

• Patient-driven electrocardiogram (EKG) devices are increasingly validated for arrhythmia detection.
• The utility of these devices in congenital heart disease (CHD) populations remains less clear.
• Adults with single ventricle Fontan palliation have a high prevalence of atrial arrhythmias, necessitating effective screening tools.

Purpose of the Study:

• To evaluate the accuracy of the KardiaMobile (KM) device in adults with Fontan palliation.
• To assess the KM's function as a screening tool for atrial arrhythmias in this cohort.

Main Methods:

• A single-center prospective study enrolled 50 adult patients with Fontan palliation.
• Patients used the KM device for symptomatic episodes and weekly asymptomatic screening over 1 year.
• Accuracy was determined by comparing KM interpretations (automatic and electrophysiologist-overread) against traditional EKG.

Main Results:

• The study received 510 follow-up transmissions.
• KM automatic interpretation sensitivity and specificity versus EKG were 65% and 100%.
• KM automatic interpretation sensitivity and specificity versus electrophysiologist overread were 75% and 96%.

Conclusions:

• The KM device is reliable for detecting normal rhythms in adult Fontan patients, especially with physician overread.
• Abnormal, uninterpretable, symptomatic, or high heart rate KM transmissions warrant further investigation.
• KM shows potential as a screening tool for atrial arrhythmias in the Fontan population.