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

Mobile Single-Lead Electrocardiogram Technology for Atrial Fibrillation Detection in Acute Ischemic Stroke Patients

“…Ninety-five percent of these single-lead ECGs were of adequate quality for a rhythm decision. Pitman et al reported 89.61% single-lead ECGs to be an adequate quality for a rhythm decision [44]. Although the correlations between extrasystoles and bigeminy were reported by the cardiologist and ECG interpreted by AliveCor algorithm as AF, the observed sensitivity and specificity of KM for AF in the selected high-risk group of AIS patients was 100% and 98.3%, respectively.…”

Prevalence and risk factors for atrial fibrillation in a semi-rural sub-Saharan African population: The hEart oF ethiopia: Focus on Atrial Fibrillation (TEFF-AF) Study

“… 13 However, we reported a limitation of this technology with the inability of the device algorithm to provide a rhythm decision for ∼13% of participants even with repeat tracing. 7 This limitation can be minimized through increased user familiarity and careful execution of the acquisition technique to obtain better-quality ECG signals. One advantage of ECG tracing over plethysmography in low-resource settings is the option of remote manual adjudication by a clinician to enhance diagnostic yield and reduced dependence on automated algorithm performance.…”

“…A multistage protocol for screening was undertaken, which has previously been described. 7 Height and weight measurements were obtained to calculate body mass index (BMI). Blood pressure measurements were undertaken in the seated position (Omron Intellisense T5 automatic monitor; Omron Corporation, Kyoto, Japan), which was repeated when the initial systolic reading exceeded 130 mm Hg.…”

Comparison Between the 24-hour Holter Test and 72-hour Single-Lead Electrocardiogram Monitoring With an Adhesive Patch-Type Device for Atrial Fibrillation Detection: Prospective Cohort Study

“…As a result, there are concerns of over- or under-detection of AF compared to the standard Holter test [ 6 ]. Additionally, the diagnostic performance of single-lead ECG monitoring could be suboptimal due to noisy tracings, frequent ectopic beats, or the coexistence of other tachyarrhythmias [ 7 ]. Although multiple studies have validated the diagnostic performance of single-lead ECG monitoring with APDs for various cardiac arrhythmias [ 6 , 8 - 11 ], evidence of direct comparisons between the Holter test and single-lead ECG monitoring with an APD for AF detection remains limited [ 12 ].…”