AliveCor has announced that its KardiaMobile 6L is now allowed for use in the measurement of a patient’s QTc and detection of potentially dangerous QT prolongation. A prolonged QTc can lead to a potentially fatal side effect of drug-induced sudden cardiac death (DI-SCD) that is associated with the use of several medicines now being used in the treatment of COVID-19. This news comes following guidance from the US Food and Drug Administration (FDA) to help expand the availability of non-invasive remote monitoring devices during the COVID-19 pandemic.
AliveCor is a provider of artificial intelligence (AI)-based, personal ECG technology, including KardiaMobile 6L, which it describes in a press release as the world’s only six lead personal ECG.
The QTc is a heart rate corrected interval that reflects the integrity of the heart’s electrical recharging system. Abnormal prolongation of the QTc can stem from congenital long QT syndrome, many disease states, electrolyte abnormalities, and >100 FDA-approved medications that have the potential for unwanted QT prolongation. Patients with a prolonged QTc are at greater risk of the potentially dangerous arrhythmia Torsades de Pointes, which can lead to sudden cardiac arrest and SCD. Several drugs being used off-label to treat COVID-19, such as antidepressants and antibiotics and including hydroxychloroquine and azithromycin, have the potential for unwanted QT prolongation and DI-SCD.
In a press release from the company, AliveCor CEO Priya Abani says: “At AliveCor, we are committed to providing life-saving cardiological services to those who need them most. The benefits of remote, personal ECG measurements have never been clearer. We are thankful to the FDA for issuing timely guidance to help expand the availability of our device to assist in the treatment of COVID-19 during this global health emergency.”
Michael J Ackerman (genetic cardiologist and director of Mayo Clinic’s Windland Smith Rice Genetic Heart Rhythm Clinic and Sudden Death Genomics Laboratory, Rochester, USA) says in the company statement: “AliveCor’s KardiaMobile 6L technology can play a key role in obtaining the patient’s QTc as a vital sign to help guide the rapid and safe use of these drugs. In addition, the 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.”
Beginning in 2017, AliveCor and Mayo Clinic have collaborated to develop advanced QT measurement technology.
Healthcare professionals will now be able to use KardiaMobile 6L to collect a six-lead ECG (Lead I, II, III, aVR, aVL, aV), use manual tools to calculate QT duration, and then make assessments with respect to patient medication. According to AliveCor, the KardiaMobile 6L is the only personal ECG to provide data from Lead II, which is simply unavailable from smart watch based ECGs and is critical for the detection and monitoring for potentially life threatening QT prolongation. This gives doctors, nurses, and other medical professionals the power to monitor QTc in patients receiving what will hopefully be life-saving treatment for COVID-19, whether in the hospital, or at-home.
AliveCor says it expects to soon add a professional QTc monitoring service which would quickly provide the actual QTc value to health professionals. This will facilitate a more seamless workflow with no on-premise measurement required.