FDA Approves COVID-19 Guidelines for ECG Use to Measure QTc

The US Food and Drug Administration (FDA) has provided guidance for the use of KardiaMobile 6L, a six-lead personal ECG to measure a patients QTc and potential detect dangerous QT prolongation, which can lead to drug-induced sudden cardiac death (DI-SCD) associated with several medicines used to treat the novel coronavirus (COVID-19).

The QTc is a heart rate correct interval that reflects the integrity of the heart’s electrical recharging system.

Abnormal prolongation stems from congenital long QT syndrome, several 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 a greater risk of a potentially dangerous arrhythmia called Torsades de Pointes, which can also lead to sudden cardiac arrest and sudden cardiac death (SCD).

Several drugs are currently being used off-label to treat COVID-19, including Hydroxychloroquine and Azithromycin.

The approval allows medical personnel 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.

KardiaMobile 6L was developed by AliveCor.

"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," Michael J. Ackerman, MD, PhD, genetic cardiologist and director of Mayo Clinic's Windland Smith Rice Genetic Heart Rhythm Clinic and Sudden Death Genomics Laboratory, said in a statement. "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."

The amount of COVID-19 cases is rapidly increasing worldwide, with major outbreaks seen in Spain, Italy, China, and the US.