US and UK health organizations recognize iRhythm's Zio as key diagnostic cardiac monitoring system

Apr 13 2017

Zio system becoming standard of care for diagnosis and management of arrhythmias; could be more efficient and accurate than legacy monitors in arrhythmia detection

iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital health care solutions company focused on the advancement of cardiac care, announced the recent publication of two documents in support of extended continuous ambulatory monitoring for arrhythmia detection. The American College of Cardiology (ACC), the American Heart Association (AHA) and the Heart Rhythm Society (HRS) issued new guidelines that recommend the use of cardiac monitors such as Zio by iRhythm when evaluating patients with syncope (fainting).

Additionally, the National Institute for Health and Care Excellence (NICE) in the UK issued a Medtech Innovation Briefing (MIB) citing evidence of the low diagnostic yield of Holter monitors and highlighting studies that demonstrate the high diagnostic yield of the Zio system. NICE also noted that extending monitoring up to 14 days with Zio by iRhythm could reduce both hospital inpatient and outpatient admissions and associated costs to the National Health Service (NHS).

The comprehensive continuous monitoring approach provided by Zio by iRhythm combines an easy-to-wear ambulatory biosensor patch and cloud-based technology to record and analyze up to 14 days of a patient’s heartbeats. The Zio diagnostic support services deliver clear, clinically actionable information to physicians in the form of a comprehensive report.

2017 ACC/AHA/HRS Guideline for the Evaluation and Management of Patients with Syncope

Syncope is the abrupt, temporary loss of consciousness, or fainting, which may be caused by cardiac arrhythmia. The "2017 ACC/AHA/HRS Guideline for the Evaluation and Management of Patients with Syncope," was published in the March editions of Circulation, the Journal of the American College of Cardiology and Heart Rhythm. The guideline recommends the use of external cardiac monitors to diagnose the cause of syncope based on the nature and frequency of syncope events. External patch recorders, such as Zio by iRhythm, were classified as a unique category of monitor able to continuously record and store data for up to 14 days and offer an accurate means for assessing arrhythmias including atrial fibrillation burden. External patch recorders are noted to be more comfortable and less cumbersome than external loop recorders, potentially improving patient compliance.

“It can be hard to diagnose the cause of syncope as symptoms often occur sporadically," said Nora Goldschlager, M.D., F.A.C.C., Chief of Clinical Cardiology, San Francisco General Hospital of the University of California San Francisco. "This guideline confirms the significant role long-term continuous cardiac rhythm monitoring can play in diagnosing causes of unexplained syncope, especially in such a broad and diverse patient population. Through its extended wear time, easy and therefore improved patient compliance, and ability to record and store every heartbeat for later analysis, the Zio system provides accurate, insightful heart rhythm information which may accelerate correct and appropriate diagnosis and treatment.”

National Institute for Health and Care Excellence Medtech Innovation Briefing

The Medtech Innovation Briefing issued in the UK by NICE is designed to support NHS and social care commissioners and staff who are considering using new medical devices and other medical or diagnostic technologies. It states that the Zio system may save health care costs in the UK by increasing diagnosis rates after a single test and thereby avoiding repeat hospital inpatient and outpatient admissions. Clinical experts agreed that Zio by iRhythm is an innovative technology that may improve the detection of infrequent arrhythmias, including atrial fibrillation, compared to Holter monitoring.

“It is vitally important, especially with the high number of emergency department visits and hospital admissions due to syncope, that diagnosis is made as quickly as possible thereby reducing unnecessary visits and admissions,” said Trudie C. A. Lobban MBE, Founder and CEO of the international patient advocacy organizations Arrhythmia Alliance, Atrial Fibrillation Association and Syncope Trust and Reflex anoxic Seizures (STARS). “With Holter monitors patients often face long delays for referral to have a Holter monitor fitted. The Zio monitor can be fitted by the local general physician, reducing visits to the hospital and further delays to diagnosis.”  

“Patients find the Zio monitor easy to wear and non-intrusive as there are no wires. In fact it is just like wearing a large band-aid, and they can still shower or go to the gym,” said Mrs. Lobban, whose organizations aim to reduce atrial fibrillation related strokes and ensure that arrhythmia patients are diagnosed and receive therapy sooner. “Monitoring with Zio by iRhythm increases the chance of recording an event and therefore leads to a potentially quicker diagnosis.”

“There is a growing recognition of the advantages of the Zio monitoring system for patients compared to traditional cardiac monitoring,” said Kevin King, Chief Executive Officer of iRhythm Technologies, Inc. “Both the new US societies’ guideline and the MIB publication in the UK confirm the effectiveness of Zio by iRhythm and will allow for broader patient access to this technology, hastening the answers they need.”