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.
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.
“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.