05-22-2023 | NEAR: IRTC | Press Release iRhythm Technologies Inc. (2023)

The clinical studies presented at Heart Rhythm 2023 build on the body of clinical evidence that continues to highlight the value of iRhythm's Zio products and services in a wide range of patient populations.

SAN FRANCISCO, May 22, 2023 (GLOBE NEWSWIRE) --Rhythm Technologies, Inc.(NASDAQ:IRTC), a leading digital health company focused on creating trusted solutions that detect, predict and prevent disease, today announced the presentation of four studies at the Heart Rhythm Society Annual Meeting, Heart Rhythm 2023, in New Orleans, THERE. These new data strengthen the body of clinical evidence that long-term ambulatory cardiac monitoring of up to 14 days with Zio®XT increases diagnostic throughput and improves diagnostic accuracy of ventricular arrhythmias in a wide range of patient populations.

This new scientific data from iRhythm builds on the body of clinical evidence – including real-world comparative effectiveness and comparative studies – that continues to highlight the value of iRhythm's Zio products and services.

Life-threatening ventricular arrhythmias, especially ventricular tachycardia and ventricular fibrillation, cause approx.300,000 deaths per year in the USand is responsible for nearly half of deaths from cardiac causes. Early detection and diagnosis are essential to treat these arrhythmias and prevent adverse health outcomes.

"These studies thematically demonstrate the value of iRhythm's Zio products and services - particularly in identifying ventricular arrhythmias for risk stratification and disease management," said Mintu Turakhia, MD, MAS, Chief Medical Officer, Chief Scientific Officer and Executive Vice President of iRhythm Product Innovation "The results have important clinical and scientific implications and further demonstrate the power of our technology across the full range of clinical arrhythmias."

Extended ambulatory ECG monitoring improves identification of high-risk patients with hypertrophic cardiomyopathy

The EXAMINE-HCM study showed that in patients with hypertrophic cardiomyopathy (HCM) -a heart condition that affects 1 in 500 people in the United States.which can lead to an increased risk of sudden cardiac death – long-term monitoring of up to 14 days with the Zio XT service significantly improves the diagnostic yield of non-sustained ventricular tachycardia (NSVT). This can be of great importance to assess the risk of arrhythmias and define treatment options in these patients.

Main conclusions:

• The diagnostic yield for detecting NSVT was significantly increased using 14 days of surveillance, with 48 hours of surveillance missing nearly two-thirds of patients with high-risk NSVT episodes, which may influence risk stratification and treatment.
• The diagnostic yield of NSVT detection was 18% during the first 48 hours of monitoring, compared to 48% after 14 days, with 63% of initial episodes of NSVT occurring after the first 48 hours.
• The diagnostic yield of detecting high-risk NSVT episodes was 8% during the first 48 hours compared to 24% at 14 days, with 64% of the initial high-risk NSVT runs occurring after the first 48 hours.
  

The PVC Load Analysis Study: Premature Ventricular Complexes (PVC): Evaluation of Load Density in a Large National Cohort Population to Better Define the Optimal Duration of ECG Monitoring

The PVC Burden Analysis Study of 106,705 patients shows that increased monitoring for at least seven to 10 days in duration is associated with greater accuracy in categorizing patients by level of PVC burden. The results are important, as classification errors can affect clinical decision-making.

Main conclusions:

• An estimate of 48 hours of PVC misclassified PVC burden compared with 14 days of ambulatory ECG monitoring.
• At least seven days of continuous ambulatory ECG monitoring performed by the Zio service were required to achieve >95% accuracy in load categorization.

The prognostic study of non-sustained VT: practical variation after ambulatory ECG detection of non-sustained ventricular tachycardia in the non-cardiac patient

In the Nonsustained VT Prognosis Study, a retrospective study by the Veterans Health Administration, the largest integrated health care system in the United States, nearly one-third of the 58,279 patients who received long-term ambulatory ECG monitoring for up to 14 days with Zio had NSVT . The results highlight the possibility of creating risk models and integrated treatment pathways after ambulatory ECG monitoring.

Main conclusions:

• There was wide local variation in diagnostic tests and treatment in the VA Health Care System after detection of NSVT, such as in the proportion of patients with echocardiograms, coronary angiograms, stress tests, cardiologic treatment, and use of cardiovascular medications in the 90-day post-follow-up period outpatient.
  

Flec-ARVC Trial: Randomized Placebo-Controlled Trial of Flecainide in Patients with Arrhythmogenic Right Ventricular Cardiomyopathy

The Flec-ARVC study, conducted at the University of Rochester, the Johns Hopkins ARVC Program and at other institutions outside of iRhythm, is the first randomized clinical trial evaluating flecainide in arrhythmogenic right ventricular cardiomyopathy (ARVC). ARVC is an inherited heart disease that carries a high risk of ventricular tachycardia and sudden death, often in young people. Although implantable cardioverter defibrillators (ICDs) can prevent sudden cardiac death, recurrent ventricular arrhythmias can be a significant clinical challenge, and there is limited data from studies on the effectiveness of antiarrhythmic therapy for suppression of ventricular arrhythmia. Using Zio Services highlights Zio's PVC load measurement capabilities and, more generally, the ability to use Zio Service in clinical trials and research.

Main conclusions:

• In this randomized, placebo-controlled, crossover study of 41 patients who received Zio XT ambulatory ECG monitoring for seven days, Flecainide significantly reduced CVP burden.
  

About the study "Extended ambulatory ECG monitoring improves identification of high-risk patients with hypertrophic cardiomyopathy"
Forfater: Ethan J. Rowin, MD; Gaurav Das, MD; Christopher Madias, MD; Mike Hsu, PhD; Lori Crosson, PhD; Barry J. Maron, MD; Mintu P. Turakhia, MD, MAS; Martin S. Maron, MD

Study authors evaluated 236 patients with hypertrophic cardiomyopathy (HCM) (49 ± 12 years; 72% male) without a primary prevention implantable cardioverter-defibrillator previously assessed as having low or intermediate risk of sudden death (SD) with continuous ambulatory monitoring of 14 days Zio XT . NSVT episodes were evaluated during the first 48 hours of monitoring and compared with NSVT identified in the subsequent two to 14 days. NSVT episodes with ≥1 of the following criteria were considered higher risk as a marker of DS: ≥ 200 beats per minute, ≥ eight beats, ≥ three runs in a consecutive 48-hour period. Among the 236 patients, 114 (48%) had ≥ one cycle of NSVT, with a median of two cycles (IQR: 1-4) during the entire monitoring period, including 86 patients with ≤ four cycles (36%), 13 with five to nine runs (6%) and 15 with ≥10 runs (7%). The diagnostic yield of NSVT detection was 18% during the first 48 hours of monitoring compared to 48% after 14 days, with 63% of initial NSVT episodes occurring after the first 48 hours (72 of 114). Likewise, the diagnostic yield of detecting high-risk NSVT episodes was 8% during the first 48 hours compared to 24% at 14 days, with 64% of the initial runs of high-risk NSVT occurring after the first 48 hours. hours (36 out of 56).

Om "Premature Ventrikulære Complexes: Assessing loading density in a large national cohort population to better define the optimal duration of ECG monitoring" undersøgelse
Forfater: Andrew Krumerman, MD; Luigi Di Biase, MD, PhD; Jay J. Chudow, MD; Ardit Kacorri, MD; Lori Crosson, PhD; Alan Wilk, BS; Kevin J. Ferrick, MD

Patients with a PVC burden ≥5%, age ≥18, and a period of use of ≥13 days were analyzed between June 2011 and April 2022. Patient demographics were reported and the mean absolute error in PVC burden was calculated at baseline (<10 sec.), 24 hours, 48 ​​hours, and daily for 14 days. The load at the end of the wear period was taken as the true value for the PVC load. The measured error was described for each subinterval (mean, SD, median, IQR). PVC loading accuracy was evaluated at monitoring durations at thresholds of 10% (low), 15% (moderate), and 20% (high). 106,705 patients were analyzed. PVC density was more frequent in men than in women, 66:34, and in those over 65 years old, respectively. Mean absolute error for CVP load was calculated at baseline (<10 sec), 24 hours, 48 ​​hours, seven days, and 13 days (Figure 1). When comparing PVC load densities of less than and greater than 20% at 24 hours and 7 days, the data showed a decrease in mean absolute error from 2.78% and 3.97% at 24 hours to 1.27% and 1. 75% after seven days. Furthermore, the accuracy in classifying the PVC load within a 15% threshold increased from 89.2% after 24 hours to 95.1% after seven days.

About the study "Practical variation after ambulatory ECG detection of non-sustained ventricular tachycardia in non-cardiac patients"
Author: Krishna Pundi, MD; June Fan, MS; Natasha Dean, MBBS, MA; Alex T. Sandhu, MD, MS; Paul A. Heidenreich, MD, MS; Mintu Turakhia MD, MAS

The authors conducted a retrospective cohort study using data from the Veterans Health Administration, the largest integrated health care system in the United States. They included patients who received a Zio XT monitor between 11/18/2011 and 6/23/2020 and excluded patients with a history of arrhythmias, atherosclerotic disease, or heart failure. The authors defined NSVT as at least one VT episode ≥3 beats but <30 seconds in duration. They determined healthcare utilization and drug prescriptions within 90 days of the Zio monitor and examined variation in treatment at the site level. The authors analyzed 58,279 patients with no known heart disease, of which 18,792 (32.2%) had NSVT. They matched 18,263 NSVT patients (97.2%) at 89 unique sites for site-level analysis. There was considerable local variation in the proportion of patients with echocardiograms, coronary angiograms, stress tests, cardiologic treatment, and prescriptions filled within 90 days of monitoring. After adjusting for baseline characteristics and medications, the authors found only significant associations between the Charlson comorbidity index and the use of echocardiography (odds ratio [OR]: 0.95, 95% confidence interval [CI]: 0, 91-0.99, p=0.008), age and stress test (OR 0.92, 95% CI: 0.88-0.95, p<0.0001) and high-volume sites and cardiac treatment (OR 1.83, 95% CI: 1.16-2.89, p=0.01).

About the Study "Randomized Placebo-Controlled Trial of Flecainide in Patients with Arrhythmogenic Right Ventricular Cardiomyopathy"
Forfattere: Wojciech Zareba, MD, PhD; Crystal Tichnell, MS; Spencer Z. Rosero, MD; marineCerrone , MD ; Matthew M. Zipse, MD; Francis E. Marchlinski, MD; Albert Y. Sun, PhD; Julia H. Indick, MD, PhD; Cynthia A. James, PhD; Luisa Mestroni, MD; Kristina Cutter; Derick R. Peterson, PhD; Scott McNitt, MS; Bronislava Polonsky, MS; James P. Daubert, MD; Mark C. Haigney, MD; Matthew Needleman, MBA; David Oakes, PhD; Mario Delmar, MD, PhD; Hugh Calkins, physician

Study authors conducted an NIH-funded pilot clinical trial hypothesizing that administration of flecainide is more effective than placebo in reducing the burden of ventricular premature beats (VPBs) in patients with ARVC. The study was designed as a randomized, double-blind, placebo-controlled crossover study in patients with ARVC given flecainide 100 mg twice daily or matching placebo for four weeks each with a washout period. The primary specific objective was to determine whether flecainide administration is associated with a significant reduction in BPVs compared with placebo, as measured by 7-day Zio patch monitoring. The mean and median number of BPVs/day were significantly lower with flecainide than with placebo. A reduction of at least 50% in BPVs/day was seen in 79% and a reduction of at least 75% in 53% of patients. The primary analysis showed that flecainide reduced the rate of BPV by 72% (p < 0.0001, 95% CI: 56–82%), adjusted for period effect. The study concluded that flecainide significantly reduced the BPV rate and the NSVT/VT/VF rate, supporting the clinical use of this medication in patients with ARVC.

To learn more about iRhythm, including its portfolio of Zio products and services, visitirhythmtech.com.

Om iRhythm Technologies, Inc.
iRhythm is a leading digital health company that creates trusted solutions that detect, predict and prevent disease. By combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm's vision is to provide better data, better insights and better health for all.

Investor Relations Contact:
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