Diagnostic Accuracy of a Smartphone-Operated Electrocardiography Device

AliveCor’s smartphone-operated ECG device demonstrated excellent diagnostic accuracy for atrial fibrillation and atrial flutter in a primary care population.

For many patients experiencing symptoms of cardiac arrhythmias, the primary care physician is their first point of contact. Performing a 12-lead ECG is necessary if a patient presents with symptoms of cardiac arrhythmias. But in some primary care practices, 12-lead ECG machines may not be available. Performing 12-lead ECG tests may be too cumbersome and are also impractical for house visits.

A research study published in The Annals of Family Medicine compared the diagnostic accuracy of AliveCor’s smartphone-operated ECG device with that of a 12-lead ECG machine. The validity of AliveCor’s ECG device was determined by recording ECG readings simultaneously using both the smartphone-based and the 12-lead ECG devices.

The study recruited consecutive participants who were assigned to 12-lead ECGs for any non-acute indication. For each participant, the authors measured the different readings: (1) the one-lead ECG captured by AliveCor’s smartphone-operated ECG device and assessed by its algorithm, (2) AliveCor’s one-lead ECG read by blinded cardiologists, and (3) standard 12-lead ECG read by cardiologists in random order. The standard 12-lead ECG readings were used as a reference standard and were simultaneously measured with the one-lead ECGs.

The study results reported AliveCor’s smartphone-based ECG device was able to correctly classify 20 of the 23 atrial fibrillation cases among the sample population with a

● sensitivity of 87.0% (95% CI: 85.2–100%),

● and specificity of 97.9% (95% CI: 94.7–99.4%).

The interpretation of the ECG readings by AliveCor’s smartphone-operated algorithm was less robust for detecting other rhythm abnormalities (sensitivity, 90.9%; specificity, 93.5%) and conduction abnormalities (sensitivity, 46.4%; specificity, 100%).

Conclusion: AliveCor’s smartphone-operated ECG device showed high diagnostic accuracy in the detection of atrial fibrillation and atrial flutter. This finding may have important implications for the primary care practices as such smartphone-based ECG devices can serve as a point-of-care test and allow for immediate medical-grade heart rhythm assessment during a symptomatic episode.

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