Personal ECG technology player AliveCor has announced its six-lead product KardiaMobile 6L is allowed for use in the measurement of a patient’s QTc and detection of potentially dangerous prolongation.
A prolonged QTc can lead to a potentially fatal side effect, called drug-induced sudden cardiac death (DI-SCD), associated with the use of several medicines now being used in the treatment of COVID-19.
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 over 100 FDA-approved medications that have the potential for unwanted QT prolongation. Patients with a prolonged QTc are at greater risk for their hearts to go into a potentially dangerous arrhythmia called Torsades de Pointes which can lead to sudden cardiac arrest and even worse, SCD. Several drugs being used off-label to treat COVID-19 include Hydroxychloroquine and Azithromycin, have the potential for unwanted QT prolongation and worse, DI-SCD.
Priya Abani, AliveCor CEO, said: "At AliveCor, we are committed to providing life-saving cardiological services to those who need them most. The benefits of remote, personal ECG measurement 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."
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. The KardiaMobile 6L provides data from Lead II, which is unavailable from smart watch-based ECGs and is critical for the detection and monitoring for potentially life-threatening QT prolongation.
Michael J Ackerman, genetic cardiologist and director of Mayo Clinic's Windland Smith Rice Genetic Heart Rhythm Clinic and Sudden Death Genomics Laboratory, said: "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."
