(NASDAQ:IRTC) today announced that the results from the
Cardiac
Ambulatory
Monitor
Eva
Luation of
Outcomes and
Time to Events
(CAMELOT) study have been published in the American Heart Journal
(AHJ).
The peer-reviewed manuscript, titled “Comparative Effectiveness
and Healthcare Utilization for Ambulatory Cardiac Monitoring (ACM)
Strategies in Medicare Beneficiaries,” reveals that the Zio
long-term continuous monitoring service (LTCM), which features up
to 14 continuous days of monitoring, was independently associated
with the highest yield of clinical arrhythmia encounter diagnosis
and lowest likelihood of retest. The retrospective study of almost
300,000 patients makes CAMELOT the largest published real-world
comparative effectiveness analysis of ambulatory cardiac
monitoring.
“Our findings reveal significant variation in selection of
monitoring devices, which can be influenced by patient
characteristics and other factors. However, long-term continuous
monitoring — and iRhythm’s Zio LTCM in particular — was
independently associated with a higher probability of an arrhythmia
diagnosis being documented and a lower probability of repeat
testing," said Matthew Reynolds, MD, MSc, a cardiac
electrophysiologist at Lahey Hospital & Medical Center and the
study's lead author. “LTCM also minimized subsequent health care
spending, compared to traditional Holter monitors or non-continuous
event monitors. We believe these findings may be useful for
clinicians in choosing the best type of monitor for different
clinical scenarios.”
Higher Diagnostic Yield and Lower Likelihood of
Retest
The investigators sought to determine the impact of choice of
monitoring service and strategy on a range of clinical and health
economic outcomes. Using the full (100%) sample of Medicare
beneficiaries, the investigators identified 287,789 patients who
had previously not received cardiac monitoring or arrhythmia
diagnosis in the 12 months prior to the index date (baseline
period).
The study found that in diagnostic-naïve Medicare patients, Zio
LTCM was associated with a higher diagnostic yield, ascertained by
medical claims, compared to all other ACMs when looking at
specified arrhythmias. The presence of an encounter diagnosis of an
arrhythmia within the first 90 days was highest for the LTCM
(33.8%) followed by the mobile cardiac telemetry (MCT) (27.1%),
external ambulatory event monitoring (AEM) (24.6%), and Holter
(22.7%). Holter, AEM, MCT, and non-iRhythm LTCM were 50%, 42%, 33%,
and 23% less likely to achieve clinical arrhythmia encounter
diagnosis compared to the Zio LTCM service, respectively.
The study also found that in diagnostic-naïve Medicare patients,
the Zio LTCM had a lower adjusted odds of retesting within 180 days
compared to other ACM modalities, including LTCMs from other
service providers in the same extended monitoring category.
Non-iRhythm LTCMs were 3.7 times more likely to result in a retest
than the Zio LTCM service. Zio LTCM also outperformed other ACM
categories: even after accounting for baseline patient differences,
Holter, MCT monitoring and AEM were 1.4, 3.0, and 4.3 times more
likely to result in retesting as compared to the Zio LTCM,
respectively.
“These are really important findings to consider when we
recommend cardiac monitoring to our patients. We now have clear
evidence that the short-term Holter monitors still used by many are
less likely to provide a diagnosis and more likely to require
repeat testing — both of which impact patient care,” said Rod
Passman, MD, MSCE, cardiac electrophysiologist and professor of
medicine at Northwestern University. “We also learned that not all
LTCMs are equivalent and choosing the right device can make a big
difference in how we find and treat abnormal cardiac rhythms.”
Lower Increase in Health Care Utilization and
Costs
The study also found that LTCM were associated with the lowest
increase in health care resource utilization and costs — including
fewer emergency department visits. AEM and MCT monitoring services
were associated with statistically significantly higher costs of
$1,317 and $2,372 more per patient, respectively.
“These real-world findings show how our innovation — including
the patient experience with a single uninterrupted 14-day monitor,
the clinician experience with our integrated tools, along with our
advanced AI and ECG technicians — all translate into superior
clinical outcomes,” said Mintu Turakhia, MD, MAS, chief medical
officer, chief scientific officer and executive vice president,
product innovation at iRhythm. “CAMELOT unequivocally shows that
all monitoring is not the same. Compared to the field, long-term
continuous monitoring with the Zio service is more likely to
prevent retesting and get to a diagnosis — which is important for
patients, clinicians, health systems and payers.”
To access the manuscript, go to the “Comparative Effectiveness
and Healthcare Utilization for Ambulatory Cardiac Monitoring (ACM)
Strategies in Medicare Beneficiaries” published in the AHJ.
The research reinforces the findings of the National Association
of Managed Care Physicians (NAMCP), which, in an independent
third-party review, found that Zio LTCM service value proposition
claims are credible and objective and demonstrate high value around
clinical utility and payer economics, noting that iRhythm is the
first manufacturer of cardiac monitors that have conducted and
published real-world comparative economic and outcome data. Since
the CAMELOT study presentation at the American College of
Cardiology's 2023 Annual Scientific Sessions, these data have
resulted in several health insurers updating their respective
policies, ultimately removing access barriers for patients and
prescribers — updates that could positively impact nearly 17
million covered lives in the US.
Visit iRhythmTech.com to learn more about iRhythm and its
portfolio of Zio products and services.
About the CAMELOT StudyAuthors: Matthew R.
Reynolds MD MSc, Rod Passman MD, Jason Swindle PhD, Iman Mohammadi
PhD, Brent Wright RN DrPH, Kenneth Boyle DC, Mintu P. Turakhia MD
MS, Suneet Mittal MD
Objective data comparing the diagnostic capabilities and
subsequent outcomes of various ACMs has been lacking.
The CAMELOT study aimed to fill the void by assessing variations
in monitoring strategies, clinical outcomes, and health care
utilization among patients undergoing ambulatory monitoring without
a pre-existing arrhythmia diagnosis, and to provide critical
insights that could significantly impact cardiac care and
diagnostic precision.
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 ACM in 2017-2018. Within LTCM, they identified use of
the Zio LTCM service from National Provider Identifier codes. The
authors evaluated 90-day diagnostic yield (arrhythmia diagnosis),
180-day retest (use of an additional 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 LTCM service 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. As a category, LTCM was associated with the
lowest one-year incremental health care expenditures (mean
Δ$10,159), followed by Holter ($10,755), AEM ($11,462), and MCT
($12,532).
The CAMELOT study was funded by iRhythm Technologies, Inc;
statistical analysis was independently performed by Inovalon. The
manuscript and supplemental materials, which includes the full list
of specified arrhythmias ascertained, can be accessed here.
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:Saige Smith(262)
289-7065irhythm@highwirepr.com
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