Cardiac resynchronization therapy saves lives and reduces
hospitalisations in heart failure patients
7 March 2005
Cardiac resynchronization therapy (CRT) in patients with moderate or
severe heart failure and poor heart pumping function saves lives and reduces
cardiovascular hospitalization, according to results of a landmark study
announced by Medtronic, Inc. (NYSE:MDT). Findings from the CARE-HF (Cardiac
Resynchronization in Heart Failure) randomized, controlled trial were
presented during a Late-Breaking Clinical Trial session at the American
College of Cardiology Annual Scientific Session and concurrently published
in The New England Journal of Medicine.
Study results, which were consistent across patient sub-groups, showed
the following outcomes for patients who received a Medtronic CRT pacemaker
and optimal medical therapy:
- A 37% reduction in combined all-cause mortality (death) or unplanned
cardiovascular hospitalization (primary end-point).
- A 36% reduction in all-cause mortality (secondary end-point).
- Reduced heart failure hospitalizations and improved heart failure
symptoms and quality of life (measured by Minnesota Living with Heart
Failure questionnaire patient responses).
"We now have overwhelming evidence that cardiac resynchronization therapy
saves lives, slows the progression of heart failure, and improves symptoms
and morbidity in many heart failure patients; these results add to previous
study results demonstrating improvement in heart failure symptoms and
quality of life with CRT," said Professor John Cleland, chairman of the
CARE-HF steering committee and head of the Department of Cardiology, Castle
Hill Hospital, Kingston-upon-Hull, United Kingdom. "The presentation of
CARE-HF findings and publication in The New England Journal of Medicine
provide further validation that CRT should be considered as a routine
therapy for people with advanced heart failure and cardiac dysynchrony."
The CARE-HF study, sponsored by Medtronic, is a prospective,
multi-center, randomized study of patients with NYHA Class III or IV heart
failure, wide QRS (QRS greater than or equal to 120ms) and poor heart
pumping function (low ejection fraction or EF less than or equal to 35%).
Patients studied in this trial had a poorly functioning left ventricle, the
heart's main pumping chamber, and received optimal heart failure medical
therapy (i.e., ACE inhibitors and beta blockers). For an average of 29
months, CARE-HF investigators followed 813 patients at 82 clinical centers
in 12 European countries. A Medtronic InSync(R) or InSync(R) III CRT device
was implanted in 409 patients, and 404 patients were in the control group.
Unlike previous trials, CARE-HF was of sufficient patient sample size and
duration to assess the impact of CRT alone (no defibrillator component) on
mortality.
"I expect these impressive CARE-HF findings — which demonstrate
significant advantages distinct from the important lifesaving benefits of
defibrillation therapy in these patients — will increase the use of both CRT
and CRT defibrillator systems in the treatment of many patients suffering
from heart failure," said Steve Mahle, President of Medtronic Cardiac Rhythm
Management.
Mahle added, "More than 13 years ago, Medtronic set out to lead the way
to improve treatment options and clinical outcomes for the millions of
people worldwide who suffer from heart failure symptoms and have a poor
prognosis despite optimal drug therapy. The company has supported more than
20 heart failure clinical studies following more than 9,000 patients
worldwide to evaluate the potential of device-based therapies to treat heart
failure. CARE-HF, together with studies such as Sudden Cardiac Death in
Heart Failure Trial (SCD-HeFT), demonstrates Medtronic's leadership in and
commitment to heart failure clinical research to improve and save patient
lives."
Other major clinical trials supported by Medtronic such as MUSTIC,
MIRACLE and MIRACLE ICD have shown dramatic benefits of CRT for many heart
failure patients, including improved exercise capacity, quality of life and
clinical symptoms.
Heart failure affects more than 22 million people worldwide, including 6
million in Europe and 5 million in the United States, with approximately
550,000 new patients diagnosed each year. It is the only cardiac condition
that is increasing in prevalence and is a major cost and quality of life
issue, characterized by frequent hospitalizations. Heart failure
hospitalisations account for nearly $80 billion worldwide in costs each
year.
CRT resynchronizes the contractions of the heart's ventricles by sending
tiny electrical impulses to the heart muscle, which can help the heart pump
blood throughout the body more efficiently. It has become an increasingly
important therapeutic option for patients with moderate and severe heart
failure since Medtronic first began clinical evaluation of the InSync system
in Europe in 1997. Today, more than 200,000 heart failure patients worldwide
have been treated with a CRT device or CRT defibrillator (all
manufacturers).
Medtronic plans to submit results of the CARE-HF study to various
regulatory agencies worldwide to request an expanded labeling for its CRT
devices.
The CARE-HF study objectives, design and end-points can be referenced in
the European Journal of Heart Failure, 3 (2001): 481-489.
A description of the baseline patient characteristics and the impact of
CRT on health-related quality of life were published in the European
Journal of Heart Failure, 7 (2005): 205-214; 243-251.
Additional information about the study can be found at
www.care-hf.org
Source: Medtronic
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