Definitive diagnosis. Accelerated Care.

Thousands of physicians and patients count on Zio by iRhythm to monitor heart rhythms for an easy, more accurate diagnosis.

CONCERNED THAT YOUR TRADITIONAL MONITORING DELAYS PATIENT TREATMENT — FREQUENTLY FAILING TO ASSESS TRUE ARRHYTHMIA BURDEN IN A SINGLE TEST?

  • Diagnostic yield is 57% greater with Zio than traditional Holter monitoring.1

  • A definitive diagnosis was achieved in a single testing period to accelerate care in 90% of Zio system uses -- more cost-effectively than other monitoring methods.1

  • The Zio system had a higher diagnostic yield of 63% in low-risk patients discharged from the ED, compared to 15% found with 24-48-hour Holter monitoring in previous studies2.

  • 94% of patients found the Zio patch comfortable to wear -- for high patient compliance leading to increased diagnostic yield.

    1Barrett, P., et al. (2014). Comparison of 24 Hour Holter Monitoring Versus 14 Day Novel Adhesive Patch Electrocardiographic Monitoring. American Journal of Medicine

    2Schreiber, D., et al. (2014). Ambulatory Cardiac Monitoring for Discharged Emergency Department Patients with Possible Cardiac Arrhythmias. Western Journal of Emergency Medicine

CONFIDENCE IN DETECTION

  • 99% analyzable time using the Zio monitor

  • 51% of Zio patients did not experience a symptomatic arrhythmia until they had worn the path for over 48 hours.

    • 47% of patients experienced their first symptomatic episode of atrial fibrillation

    • 37% of patients had their first symptomatic episode with AV block

    • 30% of patients had their first arrhythmia of any type

    Turakhia, M., et al. (2013). Utility of a Novel Leadless Arrhythmia Monitoring Device. The American Journal of Cardiology

Enhanced results from extended continuous ambulatory monitoring with Zio by iRhythm

Longer continuous recording of every beat (14 days compared to 24-hour Holter monitoring) resulted in enhanced detection of arrhythmias: 96 events vs. 61 events.

During a 24-hour period, the Zio monitor and Holter monitor equally identified AFib events and estimated AFib burden. However additional AFib events were identified during the remainder of the Zio wear period, thus changing the documented pattern of AFib in 21 patients, or 28% of studied individuals. Additionally, several malignant arrhythmias were first recorded on the ZIO monitor after 24 hours of monitoring.

Rosenberg, M., et al. (2013). Use of a Noninvasive Continuous Monitoring Device in the Management of Atrial Fibrillation: A Pilot Study. Pacing and Clinical Electrophysiology.

Higher diagnostic yield

The Zio system had a higher diagnostic yield of 63% in low-risk patients discharged from the ED, compared to 15% found with 24-48-hour Holter monitoring in previous studies.

Rosenberg, M., et al. (2013). Use of a Noninvasive Continuous Monitoring Device in the Management of Atrial Fibrillation: A Pilot Study. Pacing and Clinical Electrophysiology.

Clinical publications:

ZIO by iRhythm is the only extended continuous ambulatory monitoring system that is proven in multiple medical research publications to provide a definitive diagnosis and accelerate care.

Persistent but not Paroxysmal Atrial Fibrillation Is Independently Associated With Lower Cognitive Function: ARIC Study. Journal of the American College of Cardiology. Chen, L., et al. (2016)... Read More

Persistent but not Paroxysmal Atrial Fibrillation Is Independently Associated With Lower Cognitive Function: ARIC Study. Journal of the American College of Cardiology. Chen, L., et al. (2016)

Study results showed an association between a high burden of atrial fibrillation (AFib) and lower cognitive function. Previous studies have shown a relationship between AFib, cognitive decline and increased risk of dementia. However, this study demonstrates a correlation between high AFib burden — the percent of time a person has AFib — and cognition.

  • The study was based on 325 participants from the Atherosclerosis Risk in Communities (ARIC) Study who wore the ZIO Patch
  • Compared with participants who did not have AFib, participants with AFib burden of 100% (persistent AFib) had lower Animal Naming (AN), Trail Making Test part B, and Digit Span Backwards (DSB) scores. These are standard cognitive assessment tests.
  • By contrast, participants with an AFib burden of 1% to 6% did not have lower cognitive test scores than those without AFib.
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Incidence and timing of potentially high-risk arrhythmias detected through long term continuous ambulatory electrocardiographic monitoring.BMC Cardiovascular Disorders. Solomon, M., et al. (2016). Read more

Incidence and timing of potentially high-risk arrhythmias detected through long term continuous ambulatory electrocardiographic monitoring. BMC Cardiovascular Disorders. Solomon, M., et al. (2016). BMC Cardiovascular Disorders.

Kaiser researchers examined 128,401 episodes of monitoring between October 2011 and 2013 using iRhythm’s Zio Service for which the average monitor wear time was nearly 10 days and more than one quarter were worn for 14 days.

  • 18.3% of recordings had at least one episode of non-sustained ventricular tachycardia (NSVT), 0.2% with sustained VT, 1.4% with a sinus pause >3 seconds (SP), 0.4% with a pause during atrial fibrillation >5 seconds (AFP), and 1.2% with high-grade heart block (HGHB)
  • Median time to first arrhythmia: 74 hours for NSVT, 22 hours for sustained VT, 22 hours for SP, 31 hours for AFP, and 40 hours for HGHB.
  • A significant percentage of potentially high-risk arrhythmias were not identified within 48-hours of ambulatory ECG monitoring. Longer-term continuous ambulatory ECG monitoring provides incremental detection of these potentially clinically relevant events.
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Cost Analysis and Clinical Outcomes of ambulatory Care Monitoring in Medicare Patients: Describing the Diagnostic Odyssey.Journal of Health Economics and Outcomes Research. Renée, J. and Layton A. (2015)... Read More

Cost Analysis and Clinical Outcomes of ambulatory Care Monitoring in Medicare Patients: Describing the Diagnostic Odyssey.Journal of Health Economics and Outcomes Research. Renée, J. and Layton A. (2015).

Claims analysis performed using a 5% random sample of Medicare beneficiaries’ claims from Fee-for-Service Standard Analytic Files (SAF). The analysis was limited to patients with full benefits for 1 year prior and 2 years post the index Holter event, with no prior arrhythmia or Holter.

  • Clinicians were unable to rule in or rule out arrhythmias in 11.1% of the claims evaluated, even after repeated Holter monitoring.
  • In spite of this failure, there was a total allowed charge of more than $45 million, which calculates to more than $23,000 per involved patient.
  • When extrapolated over the entire Medicare Fee-for-Service population, this category was estimated to have cost more than $900 million over the 2-year study period.
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For a complete list of peer-reviewed publications demonstrating the clinical validity and utility of the Zio by iRhythm system, please download our clinical summaries.

 

Ongoing Clinical Studies With ZIO

For a list of ongoing clinical trials information involving the Zio System, please visit ClinicalTrials.gov.

Zio benefits extend beyond Cardiology and Electrical Physiology

Medical specialties including Neurology, Emergency Medicine, Internal Medicine and Family Practice have demonstrated effective application of the Zio by iRhythm system with their patients.

 

Neurology

Steinhubl, S., et al. Rationale and design of a home-based trial using wearable sensors to detect asymptomatic atrial fibrillation in a targeted population: The mHealth Screening To Prevent Strokes (mSToPS) trial. American Heart Journal, 2016... Read more

Steinhubl, S., et al. Rationale and design of a home-based trial using wearable sensors to detect asymptomatic atrial fibrillation in a targeted population: The mHealth Screening To Prevent Strokes (mSToPS) trial. American Heart Journal, 2016

Researchers at the Scripps Translational Science Institute (STSI) have launched a home-based clinical trial using the ZIO Service to identify patients with asymptomatic atrial fibrillation (AFib).

  • The mSToPS clinical trial aims to determine whether screening select individuals in their homes using wearable sensor technology can detect asymptomatic AFib more efficiently than routine care, such as primary care visits.
  • To conduct the study, STSI has teamed with iRhythm, Aetna’s Innovation Labs and Healthagen Outcomes units, Janssen Pharmaceuticals and Amiigo consumer heart rate tracker.
  • 2,100 active monitoring participants will be compared to 4,000 usual care beneficiaries.
  • Participants will undergo continuous single-lead ECG monitoring using the Zio monitor for the first two weeks and last two weeks of the four-month monitoring period. Read less
 

Emergency Medicine

Schreiber, D., et al. Ambulatory Cardiac Monitoring for Discharged Emergency Department Patients with Possible Cardiac Arrhythmias. Western Journal of Emergency Medicine, 2014... Read more

Schreiber, D., et al. Ambulatory Cardiac Monitoring for Discharged Emergency Department Patients with Possible Cardiac Arrhythmias. Western Journal of Emergency Medicine, 2014

In a retrospective study of 174 adult ED patients with symptoms of possible cardiac arrhythmia that were discharged with a Zio patch from one of 3 academic EDs in the US, the aim was to determine the diagnostic yield of the Zio system and the value of prolonged monitoring of these patients.

Retrospective study of 174 adult ED patients with symptoms of possible cardiac arrhythmia who were discharged with a ZIO Patch from one of 3 academic EDs in the US. Study aimed to determine the diagnostic yield of the ZIO Service and the value of prolonged monitoring of these patients.

  • The Zio system had a higher diagnostic yield of 63% in low-risk patients discharged from the ED, compared to 15% found with 24-48-hour Holter monitoring in previous studies.
  • 53% of patients with symptoms, as noted by depressing the Zio patch event button, did not have an arrhythmia present at the time. This symptom-rhythm correlation is helpful when “Ruling Out” the presence of arrhythmia when symptoms are noted.
  • The median time to the first triggered arrhythmia for potentially serious arrhythmias (ventricular tachycardia and pauses >3 seconds) was 3.1 and 4.2 days, outside of the detection window of traditional Holter monitoring.
  • Ease of use with the Zio monitor was demonstrated by 100% of participants successfully returning the device.
  • The Zio system is clinically useful in an ED setting as it provides relatively prompt diagnoses of both normal sinus rhythm in symptomatic patients as well as serious asymptomatic arrhythmias in others.

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Internal Medicine and Family Practice

Turakhia, M., et al. Feasibility of Extended Ambulatory Electrocardiogram Monitoring to Identify Silent Atrial Fibrillation in High-Risk Patients: The Screening Study for Undiagnosed Atrial Fibrillation (STUDY-AF). Clinical Cardiology Journal, 2015... Read more

Turakhia, M., et al. Feasibility of Extended Ambulatory Electrocardiogram Monitoring to Identify Silent Atrial Fibrillation in High-Risk Patients: The Screening Study for Undiagnosed Atrial Fibrillation (STUDY-AF). Clinical Cardiology Journal, 2015

Prospective study of 75 male patients screened using ZIO Patch detected atrial fibrillation (AFib) and atrial tachycardia (AT) in 11% of asymptomatic patients (silent AFib) with known risk factors.

  • Inclusion criteria were age ≥55 years and ≥2 of the following risk factors: coronary disease, heart failure, hypertension, diabetes, sleep apnea. Patients were excluded with prior AFib, stroke, transient ischemic attack, implantable pacemaker or defibrillator, or palpitations or syncope in the prior year.
  • AFib was detected in 4 subjects (5.3%; mean AFib burden 28%).
  • AT ≥60 seconds was present in 5 subjects (6.7%).
  • The combined diagnostic yield of sustained AT/AFib was 11%.
  • Found a high prevalence of asymptomatic AT and frequent supraventricular ectopic complexes, which may be relevant to development of AFib or stroke.
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TESTIMONIALS FROM LEADING PHYSICIANS

I have been in cardiology for 29 soon to be 30 years and over those years I have used many different monitors to decipher patients with rhythm disturbances. The majority of times the results would show benign rhythms with the occasional SVT. I have been using the ZIO Patch for quite a few years now and in studying the results we have found non sustained V Tach over 100 times, we have found pauses that have called for pacemakers, long runs of SVT at over 190bpm, two of those patients had worn a variety of other monitors with no abnormal results. I could go on and on but I will say this, I will not use another type of monitor than the ZIO Patch, it has caused very ill patients to receive the proper treatment.

Joanna C. Sima, RDCS - Physician
 

Nobody knew I was wearing the patch. I could do my work, perform my daily routine without catching wires and I could shower. I was relieved to be able to resume my active family, work and recreational activities. I urge other patients who suspect AFib or are at increased risk to see their doctors promptly. I felt like a normal human being with ZIO® XT Patch. I didn’t have to explain myself to people. You get scared because it’s your heart, but it’s curable. The technology is so far advanced today. People should not have to suffer, especially if they know to get to the doctor quickly.

Gregory Fisher - Patient
 

Physicians need to know if stroke or TIA patients have an underlying cardiac arrhythmia which may have caused their neurological event, as this will impact treatment to help prevent a recurrence. Continuous long-term cardiac monitoring is essential to detect AFib, which may occur infrequently and often has no symptoms. However, many of the available monitoring options do not capture enough data or record for a long enough period of time, are burdensome for patients to wear or are too expensive.

Dr. Hooman Kamel - Physician
 

As an active mid-fifties woman with a busy athletic life-style, being diagnosed with serious AFib needing continuous monitoring was a huge blow to me. When ZIO® XT Patch came along as a viable substitute to my prior monitoring system, I was thrilled that I could now exercise, shower, and engage socially without the visible stigma. I felt I was reclaiming some of my life back.

KC Branscomb Kelley - Patient
 

Now, with Zio by iRhythm, you can combine innovative cardiac analysis and a simplified patient experience. A shorter path to what you and your patient both need — answers.