With an eye toward helping those potentially suffering from COVID-19, Mountain View, Calif.-based Alivecor Inc. said its six-lead electrocardiogram (ECG), known as the Kardiamobile 6L, now is allowed for use in the measurement of a patient's QTc and detection of QT prolongation. The Kardiamobile 6L enables patients to take a six-lead ECG outside a doctor’s office.
The QTc is a heart rate corrected interval that reflects the integrity of the organ’s electrical recharging system. Abnormal prolongation can result from congenital long QT syndrome, certain disease states, electrolyte abnormalities, as well as more than 100 FDA-approved medications. Affected patients face a greater risk of a potentially dangerous arrhythmia called Torsades de Pointes, which can lead to sudden cardiac arrest and SCD.
Of note, Alivecor’s announcement comes after the U.S. FDA issued guidance that allows manufacturers of certain cleared, noninvasive, vital sign-measuring devices to expand their use. As a result, health care providers may use them for remote patient monitoring. The ultimate goal is to keep an eye on individuals needing care while reducing the potential for COVID-19 spread – both to physicians and the patients they treat.
This latest news is timely, as prolonged QTc can lead to drug-induced sudden cardiac death (DI-SCD). And that has particular implications for COVID-19 patients. “This problem is specific to COVID-19 patients who are being treated with medications that have a prolonged QT side effect, including hydroxychloroquine and azithromycin,” David Albert, founder and chief medical officer of Alivecor, told BioWorld. “We don’t, at this time, know how many people are being prescribed these drugs,” he added.
In terms of feedback, the company has seen a number of clinicians ask for help with QTc measurement in the wake of the COVID-19 pandemic. “We do not, however, have any feedback on the efficacy of the medications themselves,” Albert emphasized.
For his part, Michael Ackerman, a genetic cardiologist and director of Mayo Clinic's Windland Smith Rice Genetic Heart Rhythm Clinic and Sudden Death Genomics Laboratory, highlighted the potential for the technology to help in guiding the use of medications for patients. "[T]he patient's QTc can be obtained without exposing ECG technicians to affected patients, which helps to conserve personal protection equipment (PPE) and thereby expand the capacity of our strained medical resources. We are encouraged by the progress being made by regulatory authorities in allowing us to rapidly respond to the COVID crisis."
Albert added that Kardiamobile 6L will help conserve strained medical resources and reduce the load on the already burdened health care infrastructure.
Alivecor expects to add in the near term a professional QTc monitoring service that aims to provide a more seamless workflow with no on-premise calculations required.
The company gained clearance for this first six-lead personal ECG in 2019. It was slated to complement the one-lead product Kardiamobile, which was starting to face competition with single-lead ECG watch products from Apple Inc. and Verily Life Sciences LLC.
According to the company, the Kardiamobile 6L is the only personal ECG to provide data from lead II. This is unavailable from smartwatch-based ECGs. As a result, doctors, nurses and other medical professionals will now have the power to monitor QTc in patients receiving what will hopefully be lifesaving treatment for COVID-19 – both at the hospital and at home.
Smartwatches looking to help
A number of technology and medical device companies have stepped up during the COVID-19 outbreak, including smartwatch developers. One interesting approach has been launched by Vagus Health Ltd., which has unveiled a crowdsourcing, open data study to collect as much ECG data as possible from those who might have been infected by COVID-19.
Specifically, it will aim to collect ECG data from those who have not yet been infected by COVID-19 but might be during the course of the data-collection. Data also will be collected on those who develop another viral or bacterial condition. The company has hypothesized that the data could provide important information related to the progress of disease and help identify early detection and monitoring methods for cardiac-respiratory infections, including COVID-19.
Vagus Health also emphasized that this data collection is not a formal clinical disease detection study. Rather, it will provide a platform for voluntary data collection and distribution and potentially help in the development of better early COVID-19 detection and disease progress diagnostics.