iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital healthcare solutions company focused on the advancement of cardiac care, announces the results of three clinical research studies presented at The American College of Cardiology’s 71st Annual Scientific Session & Expo (ACC.22). The new clinical evidence:
Further validates the Zio service as a viable solution for the early detection of atrial fibrillation (AF),1 helping undiagnosed populations effectively seek treatment before more serious problems can occur.
- Shows that the Zio service can positively impact hospital resources2 – a crucial benefit during the continued COVID-19 pandemic.
- Supports the need for monitoring post-TAVR discharge in high-risk patient populations.3
“As the healthcare system continues to progress towards value-based medicine, we recognize that providers are increasingly challenged to improve clinical outcomes for patients while controlling costs,” said Dietra Jones, Executive Vice President, Clinical Operations at iRhythm. “We are excited that these new data continue to demonstrate that Zio’s clinical accuracy is beneficial in directing patient care across a variety of settings, while improving clinical workflows and hospital capacity. We are also particularly encouraged to see further evidence of Zio’s ability to support early detection and diagnosis of AF in moderate-risk populations.”
The Syncope study, titled “Syncope Pathway Using Live Ambulatory Monitoring Streamlines ER Patient Disposition,” found that Zio AT was able to monitor and aid in diagnosis of qualified syncope patient candidates in an outpatient setting. Implementation of Zio AT allowed health systems to safely monitor patients upon discharge, avoiding a potential 24-48 hour hospital stay. Additionally, 8.2% of patients had an arrhythmia event triggering an MD notification. Nearly half (46%) of these occurred after 48 hours (longer than atypical inpatient stay) – demonstrating the importance of 14-day monitoring with Zio AT. Finally, it was concluded that use of Zio AT saved the healthcare system an estimated 136 inpatient hospitalization days.
The GUARD-AF study, titled “A Randomized Clinical Trial Of Screening For Atrial Fibrillation With A 14-day Patch Monitor: Analysis Of ECG Recordings From The GUARD-AF Study,” reports the initial findings in 5,713 patients who wore the Zio XT monitor. Among the older primary care population in the study, 4.5% had AF detected within two weeks of monitoring: 0.5% of screened participants had persistent AF and 4% had paroxysmal AF detected.
Lastly, research highlighted in the Rutgers-TAVR study, titled “Ambulatory Electrocardiographic Monitoring Following Transcatheter Aortic Valve Replacement (TAVR) In Different Age Groups,” demonstrates that monitoring with Zio AT post-TAVR discharge can identify AF, high degree atrioventricular block (HAVB), and supraventricular tachycardia (SVT) in patients who are at risk for arrhythmic disorders. During monitoring, in which patients wore the device for up to 14 days, the most common arrhythmias were AF (25%) followed by HAVB (7%) and SVT > 30 secs (6%). The results support the need for monitoring post-TAVR discharge in high-risk patient populations.
Disclaimer: Zio is not intended for critical care patients.
About the Syncope Study
Authors: Bobbi L. Hoppe, Anna Rees, Sonali Parmar, Mike Hsu, Lori Crosson, Katie Lindgren, Cameron Berg, Jeff Vespa, North Memorial Health, iRhythm Technologies
Implementation of an evidence-based syncope pathway (SP) using remote near real-time telemetry monitoring allows health systems to safely monitor appropriate patients upon discharge, avoiding a potential 24-48 hour hospital stay. A SP was developed in which patients were stratified into low, medium, and high-risk groups based on medical history and Canadian Syncope Risk Score. The SP identified appropriate patients for monitoring via Zio AT. 183 patients were discharged with a Zio AT device from the emergency department. 8.2% (15/183) of patients had an arrhythmia event triggering an MD notification (MDN). Average time from Zio AT application to MDN was 89 hours. 62% of the MDNs occurred after the 24-hour period and 46% of MDNs occurred after the 48 hours. The SP using Zio AT was advantageous to hospital workflow, improving hospital capacity by decreasing syncope inpatient hospitalization rates and saving the healthcare system 136 inpatient hospitalization days. Additionally, average time to MDN notification period was well outside the typical window of a hospital stay for syncope.
About the GUARD-AF Study
Authors: Daniel E. Singer, Steven Atlas, Alan S. Go, Renato D. Lopes, Steven Lubitz, David McManus, James H. Revkin, Donna Mills, Lori Crosson, Judith C. Lenane, Ronald S. Aronson, Bristol Myers Squibb
A randomized trial of screening for AF in individuals ≥ 70 years old without AF was done using a Zio XT monitor and compared, 1:1, to usual care. 5,720 participants returned Zio XT monitors (13.9 days median wear time) with analyzable data (98.4% median analyzable time). 255 (4.5%) participants had AF, including 30 (0.5%) with 100% AF. AF was more common in those ages ≥ 80 (1.0%) than among younger participants (0.40%), p < .01. In the 225 participants with paroxysmal AF (PAF), median AF “burden” was 0.48% (0.016-2.5) of time monitoring [78 (3.2, 454) minutes]. In GUARD-AF’s older primary care population, 0.5% of screened participants had persistent AF and 4% had PAF detected within two weeks of monitoring. In those with PAF, average AF burden was low but >25% had an episode of ≥4.6 hours of continuous AF, suggesting increased stroke risk. The need for stroke-preventive interventions (e.g., anticoagulants) for screen-detected PAF remains a critically important research question.
About the Rutgers-TAVR Study
Authors: Alexis K. Okoh, Mike Hsu, Lori Crosson, Alan Wilk, John Kassotis, Leonard Y. Lee, Mark J. Russo
Consecutive patients who underwent TAVR at a single center and discharged home with continuous AECG for 14 days using Zio AT were enrolled into a prospectively maintained database between June 2019 and September 2021. During the 14-day period of monitoring, the most common arrhythmias were AF (25%), followed by high-degree atrioventricular or HAVB (7%) and SVT > 30 secs (6%). The incidence of AF was 29.8% in the < 65-year group and 22.1% and 25.1% in the 65-75 and > 75-year groups respectively [p>0.05]. HAVB was significantly higher in the >75-year (8.1%) group than the 65-75 (5.3%) or < 65 (3.5%) groups (p <0.05). Continuous 14-day AECG monitoring after TAVR showed AF in about one out of every four patients which was similar across all age groups. There was a higher incidence of HAVB in elderly patients than the younger ones. These results not only support AECG monitoring for HAVB during post-TAVR discharge, but also the need for monitoring for AF as the use of TAVR expands to lower risk categories.