November 8, 2022 — iRhythm Technologies, Inc., a leading cardiovascular diagnostics and digital healthcare solutions company focused on creating trusted solutions that detect, predict, and prevent disease, announced the results of four clinical studies presented at the American Heart Association’s (AHA) 2022 Scientific Sessions in Chicago, IL. The studies demonstrate health economic and clinical value of the Zio AT and XT product lines across a range of diseases and clinical settings.
“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 mSToPS health economic study, titled “Cost-Effectiveness of AF Screening with Two-Week Patch Monitors: The mHealth Screening to Prevent Strokes Study,” evaluated the cost-effectiveness of screening for atrial fibrillation (AFib) with Zio XT. The 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. Over three years, individuals prescribed Zio XT were more likely than unmonitored individuals to have outpatient visits — including to cardiologists — but less likely to require emergency department visits or hospitalization. The study demonstrated an incremental cost-effectiveness ratio (ICER) of $17,000 per quality-adjusted life year gained — substantially lower than accepted willingness-to-pay thresholds in the U.S. and other healthcare systems — and the authors conclude that screening for AFib using Zio XT provided high value.
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 study sought to determine if extended ambulatory ECG monitoring increased accuracy for estimating burden of PVCs, which require accurate assessments for actionability. The data showed that a 48-hour estimation of PVCs misclassified PVC burden compared to 14-days of ambulatory ECG monitoring. 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. The findings are important, as misclassification could impact clinical decision-making.
The study titled “Near-Real Time Extended Ambulatory ECG Monitoring in Patients With Syncope Unveils a Spectrum of Arrhythmias and High Incidence of Atrial Fibrillation” utilized iRhythm’s proprietary database containing arrhythmia findings of patients prescribed Zio AT mobile cardiac telemetry for the diagnosis of syncope, or loss of consciousness possibly from heart rhythm disorders. The study of over ten thousand patients found not only a high diagnostic yield (79%) with Zio AT, but an unexpectedly high burden of supraventricular arrhythmias (69%) and AFib (9.5%) that are generally not thought to be associated with syncope. Most patients with AFib met criteria for an MD notification, highlighting the value of iRhythm’s mobile cardiac telemetry. A subgroup of syncope-indicated patients had an unexpectedly high AFib burden — potentially requiring a different treatment pathway.
The electronic health record (EHR) integration study, titled “Ascension Health System Experience with Extended Ambulatory Electrocardiographic Monitoring: Implementation of a Novel Integrated Approach to Better Characterize Disparities in Healthcare,” sought to determine the relationship of age, gender, and race for AFib detection in one of the largest private healthcare systems in the U.S. In 6,293 Ascension patients linked to Zio XT data, the study 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 generate tailored care pathways within a healthcare system.
For more information: https://www.irhythmtech.com/