A smartphone-operated, single-lead electrocardiography (1L-ECG) device has excellent diagnostic accuracy for atrial fibrillation (AF) and atrial flutter (AFL) when compared against a traditional 12L-ECG, according to study results published in the Annals of Family Medicine.

Visual assessment of the IL-ECG by cardiologists also resulted in good diagnostic accuracy for other nonatrial fibrillation abnormalities; however, the device was less accurate in detecting conduction abnormalities, the authors said.

This was the first multicenter study to directly compare the 1L-ECG (KardiaMobile) to traditional 12L-ECG in a primary care setting. In the Dutch study, ECGs were performed simultaneously on patients with nonacute symptoms, using both the handheld 1L-ECG and a 12-L ECG.

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Of the 214 participants (mean age, 64.1 years; 53.7% men), the 12L-ECG diagnosed AF or AFL in 23 patients, rhythm abnormality in 44 patients, and conduction abnormality in 28 patients. Cardiologist-assessed 1L-ECG resulted in 100% sensitivity and specificity for AF and flutter. In contrast, the device’s AF detection algorithm was reported to have an 87.0% and 97.9% sensitivity and specificity, respectively. In addition, the sensitivity and specificity for any rhythm abnormality using the IL-ECG were 90.0% and 93.5%, respectively. For any conduction abnormality, sensitivity was 46.4% and specificity was 100%, respectively.

The findings are highly relevant for nurse practitioners and physician assistants because the smartphone-operated ECG device allows for immediate assessment during a symptomatic episode, the authors noted. The device can also be used at home by patients.

“Our primary care–based study provides important insights for physicians who are in need of a point-of-care ECG device that can lower the logistical threshold for performing ECG to improve diagnostic gain,” they wrote.

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“Further study is required to evaluate the safety and efficacy of the 1L-ECG device in the hands of primary care physicians instead of cardiologists, particularly for detecting [atrial fibrillation or atrial flutter],” noted the authors. “Moreover, future studies are warranted to determine whether the availability of 1L-ECG changes the use of 12L-ECG, diagnosis, and/or patient management.”

The authors reported no financial ties to the manufacturer of the device.


Himmelreich JCL, Karregat EPM, Lucassen WAM, et al. Diagnostic accuracy of a smartphone-operated, single-lead electrocardiography device for detection of rhythm and conduction abnormalities in primary care. Ann Fam Med. 2019;17(5):403-411.