AliveCor has announced the results of what it describes as the largest study to assess the reliability of the detection of atrial fibrillation (AF) through commercially available personal ECG devices, in which its KardiaMobile 6L device was found to be superior to single lead devices.
Results of the study were presented as a poster presentation, titled “A comparison of over-the-counter available smartwatches and devices for electrocardiogram-based detection of atrial fibrillation” at the European Society of Cardiology’s 2021 congress (ESC 2021, 27–30 August, virtual).
In this study, researchers compared the reliability of three personal electrocardiogram (ECG) devices for the detection of AF in 220 consecutive patients with AF presenting for electrical cardioversion (ECV) through a single-centre, prospective, non-randomised and adjudicator-blinded study.
The authors collected standard 12-lead ECG recordings immediately followed by four times 30 seconds of ECG recordings from three different devices, including the Withings Move ECG, Apple Watch Series 5 and the KardiaMobile 6L, for every patient prior to the ECV. Standard 12L-ECGs were interpreted by a cardiologist. Sensitivity and specificity were determined for each AF detection algorithm and for the interpretation of the data from each device by a cardiologist.
“We are excited to see our KardiaMobile 6L device is superior to other commercially-available personal ECGs in this first-of-its-kind study,” said Dave Albert, chief medical officer and founder, AliveCor. “We are continuously advancing our technology and strive to further optimise the specificity of our KardiaMobile technology.”
The results demonstrate the sensitivity/specificity were similar overall for the AF algorithms used on all three devices (Withings 98%/95%, Apple 94%/98%, Kardia 99%/91%, p>0.05 for all), but the KardiaMobile 6L device was the most sensitive test with the highest proportion of suspected AF (57%). All devices in the study shared a comparable proportion of uninterpretable ECGs (p>0.05 for all).
Despite removing the watches from the wrist and recording Lead II in addition to Lead I, cardiologist interpretation of the KardiaMobile 6L was the best with a sensitivity of 99%/97% for AF and had double the accuracy when detecting atrial flutter (63% vs 28% and 33% for the Withings and Apple Watches respectively), AliveCor said in its press release. The authors concluded, “Kardia 6L (is) superior to the single-lead devices.”