Cardiovascular diagnostics and digital healthcare company iRhythm Technologies is promoting the results of four clinical studies that demonstrate the health, economic, and clinical value of its Zio AT and XT product lines for various diseases and clinical settings.
The results were presented at the American Heart Association’s (AHA) Scientific Sessions in Chicago in 2022.
“The presented studies have important clinical implications,” said Dr. Mintu Turakhia, iRhythm’s chief medical officer and chief scientific officer. “First, screening for atrial fibrillation, based on the mSToPS trial, is cost-effective and can provide high value. Next, extended ambulatory ECG monitoring from our products, compared to shorter monitoring, more accurately estimates the burden of a common type of ventricular arrhythmia, which is clinically consequential to patients and important to get right.”
“We also found that atrial fibrillation was an unexpected and important finding in patients who receive monitoring for loss of consciousness, which we already know benefits from Zio’s 14-days of ambulatory ECG monitoring compared to other diagnostics. Finally, we showed the potential for partnered healthcare system research with EHR integration, in this case for tailored care pathways for diverse populations.”
The four studies were:
The mSToPS health economic study, titled ‘Cost-Effectiveness of AF Screening with Two-Week Patch Monitors: The mHealth Screening to Prevent Strokes Study’. This analysis found that systematic screening for AFib in an at-risk population with the iRhythm Zio XT patch provided high value from a health economic perspective.
The ventricular arrhythmia study, titled ‘Assessing the Optimal Duration of ECG Monitoring Required to Accurately Establish Premature Ventricular Contraction (PVC) Burden in a Large National Database’ was a >10-year study between 2011 and 2022 that analyzed PVC burden in 25,793 patients. The data showed that at least seven days of continuous ambulatory ECG monitoring, which is performed by the Zio AT and XT product lines, was necessary to achieve >95% accuracy in burden categorization.
‘Near-Real Time Extended Ambulatory ECG Monitoring in Patients With Syncope Unveils a Spectrum of Arrhythmias and High Incidence of Atrial Fibrillation’ study of over ten thousand patients found not only a high diagnostic yield with Zio AT, but an unexpectedly high burden of supraventricular arrhythmias and AFib that is generally not thought to be associated with syncope.
The electronic health record (EHR) integration study, ‘Ascension Health System Experience with Extended Ambulatory Electrocardiographic Monitoring: Implementation of a Novel Integrated Approach to Better Characterize Disparities in Healthcare’ found risk of detected AFib was highest in older, white, and male patients; female, diverse patients below age ≤ 65 had the lower risk of detected AFib. The study demonstrated that EHR-linkage is not only feasible but an important step to generating tailored care pathways within a healthcare system.
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