David E Albert, founder and chief medical officer of AliveCor, considers the impact of the COVID-19 pandemic on the monitoring and of management of arrhythmias.
As the world continues to fight against the COVID-19 pandemic, healthcare providers and professionals are working around the clock to develop testing solutions, treatments, and vaccines. The USA has reported over one million cases. As the numbers continue to rise, researchers and scientists are digesting an influx of studies and data to better understand how COVID-19 is affecting our bodies and why some are more susceptible than others. Physicians on the front lines are implementing different methods to combat the illness, but rarely are they met without risk.
In an effort to treat COVID-19 patients, some healthcare providers have been prescribing Hydroxychloroquine, a drug principally used for autoimmune diseases, alone or in combination with Azithromycin, an antibiotic commonly used for respiratory infections. These drugs both have a known side effect called QTc prolongation. QTc is the corrected QT interval and is a measurement of the electrocardiogram, usually calculated using Leads II or V5. The QT interval varies with heart rate and must be corrected to the QTc to assess the risk. The QT interval is prolonged at slower heart rates and shortened at faster heart rates. Patients with a prolonged QTc are at greater risk for their hearts going into a potentially dangerous arrhythmia called Torsades de Pointes, which can lead to sudden cardiac arrest and, in some cases, sudden cardiac death. Additionally, this risk is potentially exacerbated in COVID-19 as studies show that those who are diagnosed with COVID-19 may have direct and long-term heart health complications.
With individuals forced to stay at home, patients are facing a new danger: those who once had access to immediate care now find limitations. At the same time, physicians may not have the ability to collect the data normally acquired face-to-face that they need to make patient care decisions. To help solve this issue, the FDA issued new guidance on 20 March, which allowed for expanded use of telehealth devices by healthcare providers to remotely monitor patients. In light of this new guidance, AliveCor’s KardiaMobile 6L was granted Emergency Use for the measurement of a COVID-19 patient’s QTc when taking Hydroxychloroquine with or without Azithromycin. This was implemented as a means of improving patient safety in connection with the use of QTc prolonging medications. KardiaMobile 6L is an FDA-cleared ECG that records Leads I, II, III, aVR, aVL, and aVF and assists in the diagnosis of cardiac arrhythmias.
At AliveCor, we’ve been working on QTc monitoring for a long time. We published our first QTc article in 2016. For the last three years we have collaborated with The Mayo Clinic on the development of a mobile QTc assessment solution based on a Deep Neural Network AI trained on millions of 12-lead ECGs. In 2018 we reached another important milestone in our work with Mayo Clinic on LQTS. In an abstract published at the Heart Rhythm Scientific Sessions conference in Boston, investigators from Mayo Clinic presented research showing that AI using deep neural networks can successfully identify patients with congenital LQTS, despite having a normal QTc on their ECG. As many as 50% of patients with genetically confirmed LQTS have a normal QTc interval on the standard ECG, so identifying these patients who are at increased risk of arrhythmias and sudden cardiac death is crucial for correct diagnosis and treatment. This is especially critical when patients are exposed to medications with known QTc prolonging potential. The deep neural network employed in the study generated an area under the curve of 0.83, with a specificity of 81%, sensitivity of 73%, and an overall accuracy of 79%. Importantly, the results were achieved by applying AI to data from lead I of a 12-lead ECG. Finally, our collaboration resulted in another presentation on our “final” QTc AI solution when AliveCor’s Matthew Schram presented the results of a prospective clinical trial from Michael Ackerman’s Genetic Arrhythmia Clinic at Mayo at the 2018 American College of Cardiology conference.
Today, AliveCor has partnered with Mayo to provide a human expert service enabling physicians to use KardiaMobile 6L ECG recordings and have the QTc measured and returned quickly to facilitate patient management and safety. For patients, KardiaMobile 6L is an affordable option that fits into their pocket and can sync with a smartphone. In just 30 seconds, KardiaMobile 6L can detect atrial fibrillation, bradycardia, tachycardia, and normal heart rhythm. Our goal at AliveCor has always been to deliver clinically-validated, accessible tools to those who need it most, and that mission has been made even more critical during the COVID-19 pandemic.
As the trajectory of the virus remains unclear, what is certain is the lasting impact on the healthcare industry at large. During this crisis, telehealth and remote monitoring services have been a vital tool for healthcare providers and patients, and I think we can expect that trend to continue. This movement comes with many benefits, one of the most important being the ability for patients to take control of their own health from home. For physicians, I have no doubt that telehealth will continue to make practices and hospitals more efficient. Because at-home data collection is likely the only route to safely collect patient data in the near term, it’s crucial that with further adoption, clinical validations remain top of mind as that will ensure that the data collected is accurate. AliveCor’s personal ECG solutions have been clinically validated in over 90 peer-reviewed journal articles. This ensures accuracy and clinical value.
It’s critical that we remain connected and informed as we continue to stay at home. Not only is COVID-19 the healthcare issue that we have to face right now, but health concerns that existed before and during the pandemic will continue long after. Without knowing what the future of our everyday lives will look like, it’s crucial we innovate with both the caregivers and the patients in mind to ensure top quality care.
David E Albert, is a physician and entrepreneur. He is a founder of three technology companies, AliveCor, InnovAlarm and Lifetone Technology, and his previous startups include Corazonix Corp (sold to Arrhythmia Research Technology) and Data Critical (sold to GE). AliveCor is a provider of artificial intelligence (AI)-based, personal ECG technology, including KardiaMobile 6L.