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 mobile 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.