Cardiac resynchronization therapy saves many lives cost-effectively
13 September 2005
Stockholm, Sweden. Three new studies of cardiac resynchronization therapy
(CRT) in patients with moderate or severe heart failure and poor heart
pumping function, based on its lifesaving, clinical and economic benefits,
were presented at the European Society of Cardiology (ESC) Congress 2005 in
Stockholm last week.
The new findings from the CARE-HF (Cardiac Resynchronization in Heart
Failure) clinical trial, supported by Medtronic, Inc., further advocate the
use of CRT as a routine therapy in this heart failure population. The
steering committee for the CARE-HF trial was chaired by Professor John
Cleland, head of the Department of Cardiology, Castle Hill Hospital,
The findings show that CRT offers sustained all-cause mortality
improvements through an extended follow-up period, is a cost-effective
therapy and improves heart pumping function. These results, detailed below,
add to previous compelling CARE-HF data that showed CRT improves symptoms,
slows the progression of heart failure, reduces hospitalisations and saves
lives in many heart-failure patients.
- A presentation on CARE-HF mortality data incorporating an additional
seven months of patient follow up, or an average of 36.4 months, showed
a 40% reduction in all-cause mortality for patients who received a
Medtronic CRT pacemaker and optimal medical therapy. Data previously
presented based on the original 29-month follow-up period indicated a
36% reduction in all-cause mortality in these patients.
- During the 2.5 years of follow up, CRT was associated with a
measurable improvement in quality of life (quality adjusted life years —
QALYs — improved 0.22 units). An economic analysis of CARE-HF showed
that CRT, on top of optimal medical therapy, reduced costly
cardiovascular hospitalizations by 52% while prolonging and improving
patient quality of life. These findings together show CRT to be highly
cost effective at £13,142 per QALY (19,416 Euros or $24,198 USD).
Typically, treatments under £30,000 per QALY gained are considered to be
- Data presented based on echocardiographic recordings taken at the end
of the 29-month follow-up period showed that CRT restores pumping
efficiency in the heart's ventricles. CRT improved left ventricular end
systolic volumes by 55 ml, improved absolute ejection fraction by seven
percent and led to reduced mitral regurgitation at three months by 21%,
a level which was sustained over time. CARE-HF clearly demonstrated the
reverse remodeling effect of the therapy.
"The results of the extension phase of CARE-HF reinforce the view that
CRT should be part of the routine, standard care for patients who have
cardiac dyssynchrony and persistent moderate or severe symptoms of heart
failure despite appropriate pharmacological therapy, as advocated in the
recently published ESC guidelines on heart failure." said Professor John G.
F. Cleland, chairman of the CARE-HF steering committee and head of the
Department of Cardiology, Castle Hill Hospital, Kingston-upon-Hull, United
Kingdom. "Few other treatments for heart failure have had such a large and
comprehensive range of effects, including striking effects on prognosis,
symptoms, quality of life and cardiac function. This is a very
The CARE-HF study is a prospective, multi-centre, 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 (ie ACE inhibitors and beta blockers).
For an average of 29 months, CARE-HF investigators followed 813 patients at
82 clinical centres 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. Findings from CARE-HF were presented in March
2005 at the American College of Cardiology Annual Scientific Session and
concurrently published in The New England Journal of Medicine. Additional
information about the study can be found at
The 2005 ESC heart failure guidelines also recommend the use of CRT
defibrillators and implantable cardioverter-defibrillators (ICDs) for many
heart failure patients.
"We expect that the new CARE-HF findings should contribute to greater
physician awareness of the benefits of CRT and increased use of both CRT and
CRT defibrillators for appropriate heart failure patients. Today, less than
20% of patients who could have their lives saved and improved with these
cost-effective therapies are getting them. CARE-HF helps reinforce the
importance of better worldwide patient access to proven device therapies,"
said Steve Mahle, president of Medtronic Cardiac Rhythm Management.
Heart failure affects more than 22 million people worldwide and accounts
for nearly 64 billion Euros or $80 billion USD worldwide in cost each year.
Approximately 40% of these patients could benefit from CRT, CRT
defibrillators or ICDs.
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. CRT defibrillators also
incorporate additional lifesaving therapy to quickly terminate an abnormally
fast, life-threatening heart rhythm. CRT and CRT defibrillators have become
increasingly important therapeutic options for patients with moderate and
severe heart failure since Medtronic first began clinical evaluation of its
CRT systems in 1997.