JACC: HF Study
Showcases Economic Value of Earlier Patient Access to Cardiac
Resynchronization Therapy
DUBLIN - Feb. 27, 2017 -
Medtronic plc (NYSE:MDT) today announced an economic analysis of
five-year data showing that patients with mild heart failure who
get cardiac resynchronization therapy (CRT) devices early in their
treatment live longer and that implanting these devices is
cost-effective, compared to optimal medical therapy. Results from
the REVERSE (REsynchronization reVErses Remodeling in Systolic left
vEntricular dysfunction) trial were published in the Journal of the American College of Cardiology: Heart
Failure.
CRT is an established treatment for indicated
patients with heart failure that has been demonstrated to improve
survival and quality of life, and reduce hospitalizations. However,
despite significant clinical evidence and guideline recommendations
in support of CRT, studies have shown the therapy to be
underutilized in eligible patients1.
REVERSE is the largest study to assess the
long-term clinical impact and survival benefit of devices combining
CRT with a defibrillator compared with CRT pacemakers. It is also
the first study to show the cost-effectiveness of CRT when
implanted earlier in the disease state.
"These new data expand upon the current evidence
and guidelines for the treatment of heart failure, by showing that
CRT in patients with mildly symptomatic heart failure is
beneficial, both from a clinical perspective, as well as from a
financial perspective," said Michael R. Gold, M.D., Ph.D., chief of
cardiology, Michael E Assey Professor of Medicine at the Medical
University of South Carolina. "REVERSE confirms that implanting CRT
earlier slows the progression of heart failure, reduces heart
failure-related hospitalizations and deaths, and prolongs life, all
while being very cost-effective."
REVERSE was a prospective, randomized,
double-blind study of 610 patients with mild heart failure (those
designated New York Heart Association Class I/II) from North
America and Europe. All patients were implanted with a
CRT-pacemaker (CRT-P) or -defibrillator (CRT-D) and randomly
assigned (2:1) to either CRT-ON or CRT-OFF.
Previously published REVERSE findings showed a
trend that CRT-ON increased survival by nearly 23 percent (52.5
percent vs. 29.7 percent, p=0.21), leading to an expected survival
rate of 9.76 years for CRT-ON versus 7.5 years for
CRT-OFF2.
Based on these findings, the new analysis shows -
for the first time under the Medicare setting - that CRT is a
cost-effective option for patients with mild heart failure: CRT-ON
yields an incremental cost effectiveness ratio (ICER) of $8,840 per
Quality-Adjusted Life Year (QALY) gained over a patient's lifetime,
compared to CRT-OFF. (ICER is a statistic that summarizes the
cost-effectiveness of a healthcare intervention, and QALY is a
measure of the quantity and quality of life.)
Additionally, REVERSE has shown that CRT-D
provides a significant improvement in survival - 2.77 additional
years of life - compared to CRT-P devices2. This benefit
results in a first-of-its-kind finding that CRT-D is a
cost-effective alternative to CRT-P, yielding an ICER of
$43,678/QALY gained over the patient's lifetime, lower than the
benchmark for therapy cost effectiveness of other serious chronic
conditions that cost at least $50,000 per QALY gained. Thus, while
CRT-D costs more than CRT-P, the added 2.77 years of life justify
the additional cost over a patient's lifetime2.
Finally, these analyses show CRT delays disease
progression, which means that initially implanting a CRT-D is
essentially cost-neutral compared to implanting an ICD and
implanting a CRT-D later, when the disease worsens. With early
CRT-D implantation slowing disease progress and increasing
survival, and without any discounting of future benefits and cost
applied, early CRT-D led to 1.24 years of additional survival,
resulting in an ICER of $1,829 per year of life gained.
"While CRT has long been established as a therapy
that significantly improves outcomes for patients with heart
failure, it is consistently underutilized," said David Steinhaus,
M.D., vice president and general manager of the Heart Failure
business, and medical director for the Cardiac Rhythm and Heart
Failure division of Medtronic. "Not only does REVERSE demonstrate
the clinical benefit of CRT, it also quantifies the economic value
of CRT, providing hospital systems with valuable information to
help make informed decisions about CRT as a treatment option and
the optimal timing of CRT for patients with heart failure.
Ultimately, the goal is to increase value by improving patient
outcomes and optimizing costs."
In collaboration with leading clinicians,
researchers and scientists worldwide, Medtronic offers the broadest
range of innovative medical technology for the interventional and
surgical treatment of cardiovascular disease and cardiac
arrhythmias. The company strives to offer products and services of
the highest quality that deliver clinical and economic value to
healthcare consumers and providers around the world.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, is among the world's largest medical technology, services
and solutions companies - alleviating pain, restoring health and
extending life for millions of people around the world. Medtronic
employs more than 88,000 people worldwide, serving physicians,
hospitals and patients in approximately 160 countries. The company
is focused on collaborating with stakeholders around the world to
take healthcare Further, Together.
Any forward-looking statements
are subject to risks and uncertainties such as those described in
Medtronic's periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from
anticipated results.
-end-
1 Fonarow GC,
Yancy CW, Albert NM, et al. Improving the Use of
Evidence-Based Heart Failure Therapies in the Outpatient Setting:
(IMPROVE HF). Circulation. August
10, 2010;122(6):585-96.
2 Gold MR,
Padhair A, Mealing S, et al. Long-Term Extrapolation of Clinical
Benefits Among Patients With Mild Heart Failure Receiving Cardiac
Resynchronization Therapy: Analysis of the 5-Year Follow-Up from
the REVERSE Study. JACC Heart Fail. 2015 Sep;3(9):691-700.
Contacts:
Tracy McNulty
Public Relations
+1-763-526-2492
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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Source: Medtronic plc via Globenewswire
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