Clinical Resource Center

The Clinical Resource Center is where you will find clinical evidence from peer-reviewed publications, educational webinars, and case studies showcasing real-world clinical applications of Zio.

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LARGEST STUDY OF ITS KIND

CAMELOT: NEW REAL-WORLD EVIDENCE

Zio long-term continuous monitoring (LTCM) service can streamline the patient journey and diagnostic odyssey

Featured Publications

Zio monitor AF burden vs. permanent pacemaker AF burden

Eysenck et al., Journal of Interventional Cardiac Electrophysiology, 2019

Zio is as accurate as the gold standard in AF burden detection.

A randomized trial evaluating the accuracy of AF detection by four external ambulatory ECG monitors compared to permanent pacemaker AF detection.

This prospective randomized trial evaluated the accuracy of AF detection by four external ambulatory ECG monitors (ECMs) compared to a permanent pacemaker (industry gold standard).

The study demonstrated that Zio monitors are as accurate as the gold standard in AF burden detection and more accurate than other ECMs at detecting AF burden (including an event monitor and Bardy CAM). In the study, Zio was found to be superior in AF detection.

“Unrestricted research grants received from iRhythm San Francisco, CA, USA, NUUBO Smart Solutions Technologies, SL, Madrid and Bardy Diagnostics Inc., Seattle, WA, USA.”

Hannun et al., Nature Medicine, 2019

AI approach with high diagnostic accuracy and performance.

Cardiologist-level arrhythmia detection and classification in ambulatory electrocardiograms using a deep neural network.

Researchers (Stanford Machine Learning Group & iRhythm Technologies) jointly developed a deep-learned ECG analysis algorithm that leveraged Zio data and sought to demonstrate human, expert-level annotation performance. The researchers stated the following findings:

- “With specificity fixed at the average specificity achieved by cardiologists, the sensitivity of the DNN [deep neural network] exceeded the average cardiologist sensitivity for all rhythm classes.”

- “The DNN appears to recapitulate the misclassifications made by individual cardiologists, as demonstrated by the similarity in the confusion matrices for the model and cardiologists.”

In clinical settings, DNNs could help reduce the amount of misdiagnosed computerized ECG interpretations and improve the efficiency of expert human ECG interpretation by accurately triaging or prioritizing the most urgent conditions.

“iRhythm Technologies, Inc. provided financial support for the data annotation in this work. M.H. and C.B. are employees of iRhythm Technologies, Inc. A.Y.H. was funded by an NVIDIA fellowship. G.H.T. received support from the National Institutes of Health (K23 HL135274). The only financial support provided by iRhythm Technologies, Inc. for this study was for the data annotation. Data analysis and interpretation was performed independently from the sponsor. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.”

Association of burden of atrial fibrillation with risk of ischemic stroke in adults with paroxysmal atrial fibrillation - the KP-RHYTHM study.

The KP-RHYTHM study is a retrospective cohort study that examined 1,965 adults with paroxysmal atrial fibrillation (PAF) across two large integrated healthcare systems who used Zio.

Researchers sought to discover if there was an association between AF burden and the risk of ischemic stroke and other thromboembolism (TE) in adults with PAF. The researchers looked at two measurements for each participant, the percent of analyzable wear time with AF occurrences and the longest duration of AF recorded while monitoring.

A median of 4.4% of monitored time was spent in AF, it was non-normally distributed. The longest continuous episode of AF had a median duration of 171 minutes.

The study discovered that:

- AF burden ≥ 11.4% led to a more than 3x increase of stroke or TE events.

- There was no association between the duration of the longest AF episode and the risk of stroke.

- Standard risk scores (CHA2DS2-VASc) were also not associated with the risk of stroke.

Author affiliations and conflict of interest: Ms. Lenane is an employee of iRhythm Technologies, Inc.

 

Funding: “This study was supported by a research grant from iRhythm Technologies, Inc.”

 

Role of the funder: “The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation or approval of the manuscript; and decision to submit the manuscript for publication. The funder did provide data from the studied Zio XT patches and also participated in reviewing the manuscript.”

 

Additional contributions: “We thank Alda I. Inveiss, MPH, Kaiser Permanente Northern California, and Martha Livingston, CRA, iRhythm Technologies, Inc[.], for their expert technical assistance. These individuals were not compensated specifically for their contributions.”

Barrett et al., American Journal of Medicine, 2014

A head-to-head comparison of Zio vs. Holter monitors.

Comparison of 24-hour Holter monitoring with 14-day novel adhesive patch electrocardiographic monitoring.

In this prospective head-to-head comparison study of 14-day Zio monitor vs. 24-hour Holter monitors, 146 patients wore both types of monitors simultaneously. The findings were as follows:

- Over the total wear time of both devices, Zio monitors detected 57% more arrhythmias than Holter monitors (96 arrhythmia events vs. 61 arrhythmia events).

- More physicians reported that Zio achieved a definitive diagnosis compared to Holter (90% vs. 64%).

- A total of 81% of patients preferred Zio over Holter monitors, which may account for the longer wear time and improved arrhythmia detection (11.1 days vs. 24 hours).

“This study was supported in part by Clinical and Translational Science Award funding to the Scripps Translational Science Institute (National Institutes of Health/National Center for Advancing Translational Sciences UL1 TR000109) and iRhythm Technologies.”

Turakhia et al., The American Journal of Cardiology, 2013

Over 50% of symptomatic arrhythmias occurred > 48 hours after start of monitoring.

Diagnostic utility of a novel leadless arrhythmia monitoring device.

This retrospective study evaluated patient compliance, timing to arrhythmia, analyzable time, detection, and diagnostic yield of Zio monitors in 26,751 patients.

Arrhythmias were detected in over 60% of patients. Over half of patients had their first symptomatic arrhythmia occur beyond the initial 48 hours of monitoring. Data showed that median analyzable time of Zio monitors was 99% of total wear time and diagnostic yield increased significantly after 48 hours.

Author affiliations: “Dr. Kumar is the founder and former chief medical officer of iRhythm Technologies, Inc. (San Francisco) and retains a significant equity share in the company.”

 

Funding: “This project was supported by a grant from iRhythm Technologies, Inc. (San Francisco, CA). Dr. Turakhia is supported by Veterans Health Services Research and Development Career Development Award CDA09027-1 (Washington, DC) and American Heart Association National Scientist Development grant 09SDG2250647 (Dallas, Texas).”

Rosenberg et al., Pacing and Clinical Electrophysiology, 2013

Simultaneous monitoring study demonstrated improved diagnostic accuracy of Zio vs. Holters.

Use of a noninvasive continuous monitoring device in the management of atrial fibrillation: A pilot study.

In this prospective head-to-head comparison study of Zio monitors vs. 24-hour Holter monitors, Zio monitors identified AF events in 18 additional individuals and the clinical classification of AF (persistent or paroxysmal) changed in 21 patients after Zio monitoring. Clinically actionable arrhythmias were first recorded on the Zio monitor after 24 hours of monitoring (outside of the Holter monitoring window).

Longer continuous monitoring with Zio resulted in a meaningful change in clinical management, including changes in cardiovascular medications, devices, or procedures, for 28.4% of patients.

 “The research reported in this article was supported by a restricted research grant from iRhythm Technologies, Inc., San Francisco, CA.”

Webinar Library

Hear first-hand experiences from physicians using Zio, and how it has impacted patient care and their practices. Each physician brings their unique perspective of clinical use cases. Webinar recordings are available on demand.

AI and the power of data

RECORDED AUGUST 31, 2022

Mark J. Day, PhD

Chief Technology Officer, iRhythm Technologies

Run Time: 44 Minutes

Webinar speakers

Lindsey Valenzuela, PharmD, APh, BCACP 

Associate Vice President of Population Health Integration, Desert Oasis Healthcare

 

Judy Lenane, RN, MHA

Chief Clinical Officer and Executive Vice President of Products, iRhythm Technologies

 

Brent Wright, DrPHc 

Director of Health Economics and Outcome Research, iRhythm Technologies

 

Run Time: 58 minutes

Case Studies

Hear first-hand experiences from physicians using Zio, and how it has impacted patient care and their practices. Each physician brings their unique perspective of clinical use cases. Webinar recordings are available on demand.


- Increased patient throughput by approximately 5x

- Expanded telehealth program

- Improved patient compliance

- Reduced time to treatment by 90%

- Grew pacemaker implants by 78%

- Cut appointment times in half

- Doubled monitoring clinic access

- Better diagnostic yield

- Reduced labor utilization per patient

- Achieved definitive diagnosis with first test

- Improved report turnaround time

- Saved over 90 minutes of labor costs per monitor over Holter monitoring

- 2x faster diagnosis

- Increased efficiency and patient access

- Reduced labor costs of monitoring program
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