iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital health
company focused on creating trusted solutions that detect, predict,
and prevent disease, recently presented the results of multiple new
studies at the American College of Cardiology’s Annual Scientific
Session Together With the World Congress of Cardiology
(ACC.23/WCC).
The CAMELOT study, titled “Comparative Effectiveness Of
Ambulatory Monitors For Arrhythmia Diagnosis: A Retrospective
Analysis Of Medicare Beneficiaries,” demonstrated that:
- Long-term continuous monitoring (LTCM) with Zio XT is
associated with the highest diagnostic yield and the fastest time
to clinical diagnosis compared to all other ambulatory cardiac
monitors (ACM) when looking at specified arrhythmias.
- Zio XT has the lowest likelihood of retesting compared to all
other ACMs.
- Zio XT is associated with the lowest acute care healthcare
resource utilization compared to all other ACMs.
The CAMELOT study is the largest and most contemporary
real-world, comparative effectiveness analysis1,2 of ambulatory
cardiac monitoring. Using a full (100%) sample of Medicare data,
the study sought to evaluate yield of clinical diagnosis, retesting
rates, and health care utilization across four categories of
ambulatory cardiac monitoring: Holter, long-term continuous
monitoring (LTCM), mobile cardiac telemetry (MCT), and ambulatory
event monitor.
The principal finding is that Zio XT, prescribed for up to 14
days of monitoring, is associated with the highest diagnostic yield
and fastest time to diagnosis, lowest odds of 180-day retesting,
and the lowest risk of emergency department and inpatient
hospitalization compared to Holter, MCT, ambulatory event monitors,
and other LTCM services.
“Ambulatory external ECG monitoring is being widely used in
clinical practice. Providers have choices of various types of ECG
monitors, as well as choice of several vendors. There has
previously been no attempt to determine whether these choices
influence important endpoints such as diagnostic yield or need for
re-testing,” said Suneet Mittal, MD, director of electrophysiology
at Valley Health System and presenting author of the study. “The
CAMELOT study provides real world evidence that these choices
indeed impact these outcomes and may inform how providers make
these choices in clinical practice.”
The presented findings demonstrated that all other monitoring
services (including non-Zio LTCM) had an odds of clinical
arrhythmia diagnosis that was 20%-50% less than Zio XT after
controlling for other variables. All other monitoring services also
had 1.4 to 5.7 greater odds of subsequent retesting compared to Zio
XT.
“This study is an important milestone because it takes what we
already know about our technology, service, clinical experience,
and patient experience — and shows how this translates into
superiority of Zio XT for meaningful clinical outcomes across the
landscape of ambulatory monitoring,” said Mintu Turakhia, MD, MAS,
chief medical officer and chief scientific officer at iRhythm.
“CAMELOT shows how consequential choosing the right monitoring
service can be, from achieving a faster clinical diagnosis leading
to reduced repeated testing all the way to lower emergency and
inpatient health care utilization and lower costs.”
Outside of CAMELOT, other notable studies were presented at
ACC.23/WCC. The Zio monitor post-approval extended wear study,
titled “Initial Real World And Clinical Experience Of The Next
Generation Ambulatory ECG Zio Monitor: Implications For Standard
And Extended Wear Monitoring,” compared Zio XT with the next
generation Zio monitor. It found the Zio monitor demonstrated even
higher compliance, higher ECG analyzable time, increased wear time
and improved signal quality than Zio XT. Post-clearance evaluations
of this next generation ECG monitor showed consistent and even
improved performance compared to Zio XT, with potential to greatly
improve monitoring and decision-making. The Zio monitor was
designed with even greater patient comfort in mind – consisting of
a new wearable biosensor that is 72% smaller and 55% lighter while
also incorporating a new breathable adhesive. It is currently in
limited commercial release in the United States, with a full
commercial launch planned for later in 2023.The results of the VT
prognostic value study, titled “Prevalence And Prognostic Value Of
Ventricular Tachycardia On Ambulatory ECG Monitoring,” found that
non-sustained ventricular tachycardia was independently associated
with increased mortality, and may act as a proxy biomarker for
cardiovascular risk.
Learn more about the CAMELOT study here. To learn more about
iRhythm, please visit the website.
About the “CAMELOT: Comparative Effectiveness Of
Ambulatory Monitors For Arrhythmia Diagnosis: A Retrospective
Analysis Of Medicare Beneficiaries” studyAuthors: Matthew
R. Reynolds, MD, MSc; Rod S. Passman, MD; Jason P. Swindle, PhD;
Iman Mohammadi, PhD; Eric Hillson, PhD; Brent Wright, DrPHc;
Kenneth Boyle, DC; Mintu Turakhia, MD, MAS; Suneet Mittal, MD
Using claims data from the full Medicare fee-for-service
database (inclusive of part A, part B, and part D claims), the
authors performed a retrospective analysis of patients with
first-time ambulatory cardiac monitoring (ACM) in 2017-2018. Within
long-term continuous monitoring (LTCM), they identified use of the
Zio XT monitor from National Provider Identifier codes. The authors
evaluated 90-day diagnostic yield (arrhythmia diagnosis), 180-day
retest (another ACM) and 90-day health care utilization. The cohort
included 287,789 patients [age 76 ±7 years, 61% female; 10% AEM,
54% Holter, 13% LTCM, 23% mobile cardiac telemetry (MCT)]. Patients
with Zio XT had the highest diagnostic yield (adjusted odds ratio
versus Holter: 1.95 [1.90-2.00, p < 0.001]) and lowest retest
(adjusted odds ratio versus Holter 0.74 [0.72-0.77, p < 0.001]),
even when compared to other LTCM or MCT. Fewer patients with LTCM
had 90-day emergency room visits (12% versus 15%-16% other ACMs, p
< 0.001) and hospitalization (8% versus 13%-14% AEM or MCT, p
< 0.001).
About the “Initial Real World And Clinical Experience Of
The Next Generation Ambulatory ECG Zio Monitor: Implications For
Standard And Extended Wear Monitoring” studyAuthors: Jay
H. Alexander, MD; Mike Hsu, PhD; Jeffrey Ellis, PhD; Adina Muresan,
BS; Charlotte Bame, RN; Alan Wilk, BS; Lori Crosson, PhD; Kevin
Clarkson, MS; Mark Day, PhD; Mintu Turakhia, MD, MAS; Judith C.
Lenane, RN BSN
This report details the first wear and clinical experience of
the Zio monitor, a smaller, lighter and more patient-friendly next
generation electrocardiogram (ECG) monitor (compared to existing
Zio XT and AT monitors) cleared by the FDA in May 2021. Commercial
data were analyzed from 673 monitors prescribed by 75 US
physicians. Additionally, 30 subjects enrolled in an IRB-approved,
extended-wear validation study of safety and feasibility of 30-day
wear. Zio monitors demonstrated high compliance and high-quality
ECG. Wear metrics and analyzable ECG were compared to national Zio
XT prescriptions. Arrhythmia yield was 77.1% for Zio XT and 80.9%
(p=0.0168) for the Zio monitor. Thirty-day clinical data
demonstrated high compliance and high analyzable ECG with no
clinically significant skin irritation. Extended wear monitoring
yielded additional clinical findings beyond 14 days. Post-clearance
evaluations of this next generation ECG monitor showed consistent
and even improved performance compared to Zio XT, with potential to
greatly improve monitoring and decision-making in complex
patients.
About the “Prevalence And Prognostic Value Of
Ventricular Tachycardia On Ambulatory ECG Monitoring”
studyAuthors: Krishna Pundi, MD; Jun Fan; Natasha Din, MD;
Alex Sandhu, MD; Paul A. Heidenreich, MD; Mintu Turakhia, MD,
MAS
The authors performed a retrospective cohort study using data
from the Veterans Health Administration, including individuals who
received a Zio XT monitor between 2011 to 2020. They analyzed
134,142 patients. There were 58,495 (44%) patients with
non-sustained ventricular tachycardia (NSVT) and 443 (0.3%)
patients with sustained VT; 2.4% of patients had symptom triggers
with VT. There was an increased risk of death after NSVT (hazard
ratio (HR) 1.25 [95% CI: 1.20-1.29], p<0.0001) and sustained VT
(HR 1.39 [95% CI: 1.09-1.77], p<0.0087). Heart failure, coronary
artery disease, atrial fibrillation, history of VT/ICD, and left
ventricular ejection fraction < 40% were all independently
associated with an increased risk of NSVT. The authors conclude
that NSVT was highly prevalent on long-term continuous monitoring
and represents an opportunity for refined risk stratification to
identify patients for further diagnostic evaluation or
treatment.
About iRhythm Technologies, Inc.iRhythm is a
leading digital health care company that creates trusted solutions
that detect, predict, and prevent disease. 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 deliver better data, better
insights, and better health for all.
Investor Relations Contact:Stephanie
Zhadkevich(919) 452-5430investors@irhythmtech.com
iRhythm Media Contact:Morgan Mathis(310)
528-6306irhythm@highwirepr.com
1 Reynolds et al. Comparative effectiveness of ambulatory
monitors for arrhythmia diagnosis: A retrospective analysis of
Medicare beneficiaries managed with ambulatory cardiac monitors
between 2017 and 2019. Accepted for ACC.23 presentation, presented
in New Orleans, LA.2 Data on file. iRhythm Technologies, 2023.
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