Performance of a Mobile Single-Lead Electrocardiogram Technology for Atrial Fibrillation Screening in a Semirural African Population: Insights From "The Heart of Ethiopia: Focus on Atrial Fibrillation" (TEFF-AF) Study.

ABSTRACT

BACKGROUND: Atrial fibrillation (AF) screening using mobile single-lead electrocardiogram (ECG) devices has demonstrated variable sensitivity and specificity. However, limited data exists on the use of such devices in low-resource countries. OBJECTIVE: The goal of the research was to evaluate the utility of the KardiaMobile device's (AliveCor Inc) automated algorithm for AF screening in a semirural Ethiopian population. METHODS: Analysis was performed on 30-second single-lead ECG tracings obtained using the KardiaMobile device from 1500 TEFF-AF (The Heart of Ethiopia Focus on Atrial Fibrillation) study participants. We evaluated the performance of the KardiaMobile automated algorithm against cardiologists' interpretations of 30-second single-lead ECG for AF screening. RESULTS: A total of 1709 single-lead ECG tracings (including repeat tracing on 209 occasions) were analyzed from 1500 Ethiopians (63.53% [953/1500] male, mean age 35 [SD 13] years) who presented for AF screening. Initial successful rhythm decision (normal or possible AF) with one single-lead ECG tracing was lower with the KardiaMobile automated algorithm versus manual verification by cardiologists (1176/1500, 78.40%, vs 1455/1500, 97.00%; P<.001). Repeat single-lead ECG tracings in 209 individuals improved overall rhythm decision, but the KardiaMobile automated algorithm remained inferior (1301/1500, 86.73%, vs 1479/1500, 98.60%; P<.001). The key reasons underlying unsuccessful KardiaMobile automated rhythm determination include poor quality/noisy tracings (214/408, 52.45%), frequent ectopy (22/408, 5.39%), and tachycardia (>100 bpm; 167/408, 40.93%). The sensitivity and specificity of rhythm decision using KardiaMobile automated algorithm were 80.27% (1168/1455) and 82.22% (37/45), respectively. CONCLUSIONS: The performance of the KardiaMobile automated algorithm was suboptimal when used for AF screening. However, the KardiaMobile single-lead ECG device remains an excellent AF screening tool with appropriate clinician input and repeat tracing. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry ACTRN12619001107112; https//www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378057&isReview=true.