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, Kingston-upon-Hull, UK.

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 cost-effective.
  • 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 cost-effective treatment."

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.

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