Earlier this month, Eko Devices, Inc. announced the results of a study report published in The Lancet that shows the AI-powered Eko Duo ECG + Digital Stethoscope can screen patients for heart failure.
In 2018 we wrote about Eko’s collaboration with the Mayo Clinic to develop an algorithm to help physicians screen for low ejection fraction. After the Eko Duo’s FDA Breakthrough Device designation in 2019 and FDA Clearance in 2020, in 2021 Eko announced the next generation Duo platform with FDA-cleared deep learning algorithms for physician use in non-clinical settings. In this latest technology advance, Eko and the Mayo Clinic developed the ELEFT algorithm to screen patients with weak heart pumps.
Researchers at the Imperial College of London conducted the latest study and published the results. The study involved 1,050 National Health Service patients. In the study 945 patients had left ventricular ejection fraction (LVEF) of at least 40% or higher and 105 patients had LVEF of 40% or lower. Ejection fraction is a quantitative measure of the heart’s ability to pump blood. LVEF of 40% or lower is the threshold for a diagnosis of reduced ejection fraction, a symptom common to most patients who have heart failure, according to Eko. Each patient had their ejection fraction measured in four positions with a single-lead ECG and in one handheld position with the Eko ECG-enabled Duo digital stethoscope. The researchers analyzed data from both devices using AI-ECG, a previously-validated algorithm for detecting reduced LVEF. In addition, the researchers tested the subjects by transthoracic echocardiogram, the current gold standard for measuring ejection fraction.
The study reported that the single lead ECG and the Eko Duo were able to detect LVEF of 40% or lower. The results of the single-lead ECG varied by the reading positions, but when the researchers combined the optimal combination of the best single-lead ECG position and the handheld position, the devices had 91.9% sensitivity (true positive reading) and 80.2% specificity ( true negative reading). The report noted the platform’s potential for inexpensive, non-invasive, point-of-care screening to aid earlier diagnosis.
The Eko Duo ECG + Digital Stethoscope with ELEFT does not have FDA clearance for detecting heart failure at this time. The collaboration plans to submit the algorithm under Breakthrough Designation review for possible clearance later in 2022. The Eko Duo ECG + Digital Stethoscope is available for purchase on the Eko Health website for $399. Purchase is restricted to physicians and patients with a prescription for previously approved functions.
We asked an Eko representative if the company has protocol for telemedicine applications with remote patient monitoring. We were curious if there are circumstances when patients self-test with the Duo and transmit their test results from the mobile app to their care team. Eko responded, “We have health system partners who do use the DUO for clinician-directed at-home care, using telehealth, but these protocols tend to be customized based on the telehealth solutions the specific health partner has in place.” Eko also included a link to this video about at-home telemedicine. Perhaps with future clearance for OTC use in the U.S., we can look forward to patient-directed protocols.
