Diagnostic Accuracy of a Smartphone-Operated, Single-Lead Electrocardiography Device for Detection of Rhythm and Conduction Abnormalities in Primary Care

• Published in: Annals of family medicine Vol. 17; no. 5; pp. 403 - 411
• Main Authors: Himmelreich, Jelle C.L., Karregat, Evert P.M., Lucassen, Wim A.M., Weert, Henk C.P.M. van, Groot, Joris R. de, Handoko, M. Louis, Nijveldt, Robin, Harskamp, Ralf E.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.09.2019; Annals of Family Medicine; American Academy of Family Physicians
• Series: Annals Journal Club
• Subjects: Arrhythmia; atrial fibrillation; cardiac arrhythmia; cardiac complexes, premature; cardiac conduction system disease; Diagnosis; Electrocardiography; Family Medicine/General Medicine; Health aspects; Internal Medicine; medical device; Methods; Original Research; Primary health care; single-lead; Smart phones; Netherlands; single-lead; atrial fibrillation; cardiac conduction system disease; cardiac arrhythmia; medical device; electrocardiography; cardiac complexes, premature
• ISSN: 1544-1709; 1544-1717; 1544-1717
• DOI: 10.1370/afm.2438

To validate a smartphone-operated, single-lead electrocardiography (1L-ECG) device (AliveCor KardiaMobile) with an integrated algorithm for atrial fibrillation (AF) against 12-lead ECG (12L-ECG) in a primary care population. We recruited consecutive patients who underwent 12L-ECG for any nonacute indication. Patients held a smartphone with connected 1L-ECG while local personnel simultaneously performed 12L-ECG. All 1L-ECG recordings were assessed by blinded cardiologists as well as by the smartphone-integrated algorithm. The study cardiologists also assessed all 12L-recordings in random order as the reference standard. We determined the diagnostic accuracy of the 1L-ECG in detecting AF or atrial flutter (AFL) as well as any rhythm abnormality and any conduction abnormality with the simultaneously performed 12L-ECG as the reference standard. We included 214 patients from 10 Dutch general practices. Mean ± SD age was 64.1 ± 14.7 years, and 53.7% of the patients were male. The 12L-ECG diagnosed AF/AFL, any rhythm abnormality, and any conduction abnormality in 23, 44, and 28 patients, respectively. The 1L-ECG as assessed by cardiologists had a sensitivity and specificity for AF/AFL of 100% (95% CI, 85.2%-100%) and 100% (95% CI, 98.1%-100%). The AF detection algorithm had a sensitivity and specificity of 87.0% (95% CI, 66.4%-97.2%) and 97.9% (95% CI, 94.7%-99.4%). The 1L-ECG as assessed by cardiologists had a sensitivity and specificity for any rhythm abnormality of 90.9% (95% CI, 78.3%-97.5%) and 93.5% (95% CI, 88.7%-96.7%) and for any conduction abnormality of 46.4% (95% CI, 27.5%-66.1%) and 100% (95% CI, 98.0%-100%). In a primary care population, a smartphone-operated, 1L-ECG device showed excellent diagnostic accuracy for AF/AFL and good diagnostic accuracy for other rhythm abnormalities. The 1L-ECG device was less sensitive for conduction abnormalities.