AliveCor , a leading innovator in FDA-cleared personal electrocardiogram (ECG) technology and services, today announced the KardiaMobile® 6L device was found to be superior to single lead devices according to results from the largest study to assess the reliability of the detection of atrial fibrillation (AF) through commercially available personal ECG devices and the first ever study to compare multiple personal ECG devices. The poster, titled “A comparison of over-the-counter available smartwatches and devices for electrocardiogram-based detection of atrial fibrillation” was presented at ESC Congress 2021. 1
In this study, researchers compared the reliability of three personal ECG devices for the detection of atrial fibrillation in 220 consecutive patients with AF presenting for electrical cardioversion (ECV) through a single-center, prospective, non-randomized 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 Dr. Dave Albert, Chief Medical Officer and Founder, AliveCor. “We are continuously advancing our technology and strive to further optimize 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 atrial fibrillation and had double the accuracy when detecting atrial flutter (63% vs 28% and 33% for the Withings and Apple Watches respectively). The authors concluded, “Kardia 6L (is) superior to the single-lead devices.”
About KardiaMobile 6L
The KardiaMobile 6L device is the first and only six-lead personal ECG cleared by the FDA. It detects more arrhythmias than any other personal ECG device. KardiaMobile 6L provides instant detection of Atrial Fibrillation, Bradycardia, Tachycardia, Sinus Rhythm with Supraventricular Ectopy, Sinus Rhythm with Premature Ventricular Contractions, Sinus Rhythm with Wide QRS and Normal Heart Rhythm in an ECG. Cardiologists can also utilize readings from KardiaMobile 6L to measure the QT interval, which is a significant risk factor for a number of medications as well as congenital issues.
About AliveCor
AliveCor, Inc. is transforming cardiological care using deep learning. The FDA-cleared KardiaMobile device is the most clinically validated personal ECG solution in the world. KardiaMobile 6L provides instant detection of Atrial Fibrillation, Bradycardia, Tachycardia, Sinus Rhythm with Supraventricular Ectopy, Sinus Rhythm with Premature Ventricular Contractions, Sinus Rhythm with Wide QRS and Normal Heart Rhythm in an ECG. Kardia is the first AI-enabled platform to aid patients and clinicians in the early detection of atrial fibrillation, the most common arrhythmia and one associated with a highly elevated risk of stroke. AliveCor's enterprise platform allows third party providers to manage their patients’ and customers’ heart conditions simply and profitably using state-of-the-art tools that provide easy front-end and back-end integration to AliveCor technologies. AliveCor protects its customers with stringent data security and compliance practices , achieving HIPAA compliance and SOC2 Type 1 and Type 2 attestations. AliveCor is a privately held company headquartered in Mountain View, Calif. “Consumer” or “personal” ECGs are ECG devices available for direct sale to consumers. For more information, visit alivecor.com .
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1 Abstract title: A comparison of over-the-counter available smartwatches and devices for electrocardiogram based detection of atrial fibrillation