New Study Confirms Extended Continuous Cardiac Monitoring is More Efficient than Holter Monitoring for Cryptogenic Stroke Patients

SAN FRANCISCO, May 18, 2017 -- iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital health care solutions company focused on the advancement of cardiac care, today announced study results presented during the European Stroke Organisation Conference in Prague. Findings reveal that Zio^® by iRhythm extended continuous ambulatory monitoring is more efficient for the detection of arrhythmias, such as atrial fibrillation, than Holter monitors in patients who have recently experienced cryptogenic strokes or transient ischemic attacks (TIA). 

The study, “Randomized Clinical Trial of Early Prolonged Ambulatory Cardiac Monitoring After Stroke (EPACS),” is reporting results of 116 subjects who experienced a cryptogenic stroke or TIA. Within three days of the index event, patients underwent ECG monitoring to detect paroxysmal atrial fibrillation (PAF). Patients were randomized by a computer with half wearing a Zio monitor for up to 14 days. The remaining patients formed the control group and wore a traditional Holter monitor for 24 hours. In statistically significant findings, PAF was detected in 16.3% patients using a Zio monitor compared to only 2.1% of patients using a Holter monitor.

PAF is a preventable cause of cryptogenic stroke or TIA. However, due to the transient nature of the arrhythmia, a considerable proportion of cases are likely missed by short term Holter monitors, the current standard of care in the United Kingdom and United States. Alternative options for long-term cardiac monitoring, such as event-triggered or implanted loop recorders, have notable limitations including reduced patient compliance, barriers to monitoring access, and invasive surgical procedures.   

“We know with PAF, detection is key to preventing subsequent cryptogenic stroke or transient ischemic attacks. However, since PAF is temporary, many events fall outside the 24-hour monitoring period of Holters,” said the chief investigator, Dr. James T.H. Teo, Consultant Neurologist, Kings College Hospital, London. “Extended continuous cardiac monitoring is a superior solution after initial stroke or TIA as Zio by iRhythm extends the monitoring window to up to 14 days, detecting PAF events that may have otherwise gone unnoticed and allowing us to more promptly treat and protect these vulnerable patients.”

“In demonstrating traditional Holter ECG monitoring’s shortcomings in detecting paroxysmal atrial fibrillation as compared to Zio’s patch-based system, the results in this study are consistent with the FIND-AF and EMBRACE studies^1,2,” added Dr. Teo. “Patch-based monitoring may also offer a less invasive more convenient alternative compared to implantable loop recorders as used by the CRYSTAL-AF study³.”

“This research adds to the growing body of scientific evidence establishing that Zio by iRhythm is an efficient first line diagnostic tool for cryptogenic stroke and TIA populations, reliably detecting arrhythmias in a single monitoring period to accelerate care,” said Judy Lenane, RN, MHA, Executive Vice President of Operations and Chief Clinical Officer of iRhythm.  

Zio by iRhythm is the first ambulatory cardiac monitoring system proven with extensive clinical data to enable diagnosis earlier in the clinical pathway, which may improve patient outcomes. Zio is readily available for providers to apply at the point of care, expediting and simplifying the process for cardiac monitoring at discharge.

About iRhythm Technologies, Inc.
iRhythm is a leading digital health care company redefining the way cardiac arrhythmias are clinically diagnosed. The company combines wearable biosensor devices worn for up to 14 days and cloud-based data analytics with powerful proprietary algorithms that distill data from millions of heartbeats into clinically actionable information. The company believes improvements in arrhythmia detection and characterization have the potential to change clinical management of patients.

¹Wachter R, Weber-krüger M, Seegers J, et al. Age-dependent yield of screening for undetected atrial fibrillation in stroke patients: the Find-AF study. J Neurol. 2013;260(8):2042-5.

²Gladstone DJ, Spring M, Dorian P, et al. Atrial fibrillation in patients with cryptogenic stroke. N Engl J Med. 2014;370(26):2467-77.

³Sanna T, Hans-Christopher D, Passman RS, et al. Cryptogenic Stroke and Underlying Atrial Fibrillation. N Engl J Med 2014;370:2478-86.

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