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
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.
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 studies1,2, 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
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 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.
Investor Relations ContactLynn Pieper Lewis orLeigh Salvo (415) 937-5404 investors@irhythmtech.com Media ContactAaron Murphy (415) 229-3331 media@irhythmtech.com