DUBLIN, March 2, 2021 /PRNewswire/ -- Medtronic plc
(NYSE:MDT), the global leader in medical technology, today
announced new results from the landmark REVERSE trial, evaluating
outcomes of cardiac resynchronization therapy (CRT) for patients
with mild heart failure (HF). This new analysis of the REVERSE
(REsynchronization reVErses Remodeling in Systolic left vEntricular
dysfunction) clinical trial shows that patients whose heart failure
stabilizes with CRT live longer, similar to patients whose
condition improves with CRT. The manuscript was recently published
in the Journal of American College of Cardiology: Clinical
Electrophysiology.
Heart failure impacts more than 6.5 million people in the U.S.;
as a progressive disease, it worsens over time, leading to a
reduced quality of life, greater risk of complications and death.
CRT is an established treatment for select patients with heart
failure and has been demonstrated to improve survival and quality
of life and reduce heart failure-related hospitalizations.
"It is commonly stated within the cardiology community that
about a third of patients do not respond to CRT," said Michael R. Gold, M.D., Ph.D., Michael E. Assey
Professor of Medicine at the Medical
University of South Carolina, Charleston. "However,
REVERSE shows that with mild heart failure, patient stability is a
long-term benefit of CRT, similar to patient improvement. Our
current classifications do not give us the full picture of how
patients benefit from CRT. We need to redefine our current
understanding of CRT response to include stability as a favorable
outcome for this patient population."
The progression of heart failure can be measured in a number of
ways. Clinical Composite Score (CCS) is used to categorize patient
outcomes as improved, unchanged (stabilized), or worsened, which is
determined using clinical measures, heart failure status and
patient symptoms. Similarly, left ventricular end systolic volume
index (LVESVi) assesses the amount of blood remaining in the left
ventricle after contracting to determine the heart's effectiveness
at pumping blood to meet the body's needs. Since survival decreases
as LVESVi rises, this measure has been shown to be an important
predictor of long-term outcomes in patients.
Using the CCS (406 patients), more than half (56%) of patients
with mild heart failure improved at one year, 30% remained
unchanged (or stabilized), and 14% worsened; five-year mortality
for improved or stabilized patients was 10% compared to 21% for
worsened patients, p=0.01. Using the LVESVi measure (353 patients),
there was a 73% decrease in the risk of dying at five years for CRT
patients who stabilized or improved, compared to those whose
condition worsened (i.e., five-year mortality for improved or
stabilized patients was 8% compared to 30% for worsened patients,
p<0.01). Results of the trial showed a greater percentage of
patients with mild heart failure benefited from CRT therapy,
compared to current classifications.
"As we look for innovative solutions to reduce the burden of
heart failure, the REVERSE analysis underscores that our CRT
devices provide benefits for a larger number of patients than we
previously understood," said Rob
Kowal, M.D., Ph.D., chief medical officer of Cardiac Rhythm
Management, which is reported as part of the Cardiac and Vascular
Group at Medtronic. "REVERSE reinforces the strong clinical
evidence supporting CRT, and the value of CRT as an option to slow
the progression of this debilitating disease. Time and again,
the landmark CRT trials have demonstrated a range of patient
stabilization or improvement with the application of cardiac
resynchronization therapy."
Optimized Implementation of Cardiac Resynchronization
Therapy: A Call for Action for Referral and Optimization of
Care, a recent position statement issued by the European
Society of Cardiology and its partners, similarly concluded that "a
slowing of a progressive disease [such as heart failure] is a
positive outcome," and "therefore 'stability' is seen as a positive
outcome."
The REVERSE trial was the first, large scale, global,
randomized, double-blind study to evaluate the benefits of CRT for
patients with mild HF – those designated as New York Heart
Association Class I/II. The trial included 73 sites worldwide,
including those in the U.S. Western
Europe, and Canada.
The Medtronic portfolio of therapies, diagnostic tools and
services for patients suffering from heart failure includes CRT
devices, including MR-conditional CRT-defibrillators and
CRT-pacemakers; mechanical circulatory support therapy for advanced
heart failure patients; heart failure diagnostics; and meaningful
expert analysis through Medtronic Care Management Services.
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 90,000 people worldwide, serving physicians,
hospitals and patients in more than 150 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.
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SOURCE Medtronic plc