On December 2, 2020, the UK’s National Institute for Health and Care Excellence (NICE) positively recommended the Zio XT service, by iRhythm Technologies, as an option for those with suspected cardiac arrhythmias who would benefit from electrocardiograph (ECG) monitoring for more than 24 hours.
Cardiac rhythm abnormalities, also known as cardiac arrhythmias, are a common occurrence, affecting millions of people worldwide. While arrhythmias can sometimes be benign, they can also lead to serious, life-threatening complications including heart failure, cognitive impairment, and stroke in some cases.
Electrocardiographs (ECGs) are often used to detect and diagnose cardiac arrhythmias in order to determine proper treatment and prevention of possible complications. In some cases, continuous ECG monitoring is required to make a diagnosis. The most-established device used for continuous ECG monitoring is the Holter monitor; this non-invasive wearable device typically records a patient’s ECG for 24 to 48 hours or sometimes for up to two weeks. For longer monitoring or for arrhythmias that are more difficult to diagnose, implantable loop recorders (ILRs) are sometimes used. These are small devices that are implanted subcutaneously in the patient and can monitor a patient’s heart for a much longer time period (many years).
The Zio XT service from iRhythm Technologies offers substantial improvements over these devices in multiple arenas. The Zio monitor itself is a small, discreet patch—much more comfortable than a bulky Holter monitor and less invasive than an ILR—leading to higher patient compliance. The Zio service combines ambulatory ECG readings from these small patches with a deep-learning algorithm that helps physicians make accurate diagnoses much faster and more easily. These improvements are especially important during the COVID-19 pandemic, when care at home is preferable to care at the hospital; to this end, iRhythm Technologies has established a home enrollment workflow that allows patients to receive and apply their Zio patch at home, rather than at a clinic. Given the trend of people with heart problems avoiding hospitals out of fear of the COVID-19 virus that has been observed in many countries, this type of at-home solution could significantly benefit the health of many people who might otherwise develop serious complications due to undiagnosed arrhythmias.
GlobalData estimates the US market value of ILRs to be just over $500M in 2020, which represents a significant decline from 2019 due to the COVID-19 pandemic, since hospitals have been delaying and cancelling non-essential, invasive procedures. Much of this lost market value is likely being taken up by devices such as iRhythm’s Zio XT, which are non-invasive and easy to use. After the COVID-19 pandemic, the market will likely shift back to more common usage of ILRs, since ILRs are still usable for a much longer time period than non-invasive monitors such as the Zio XT. However, the regulatory recommendation of the Zio XT paves the way for other manufacturers to incorporate deep learning into their cardiac monitors to improve future devices.