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Cardiac resynchronisation
 
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   CARE-HF study shows cardiac resynchronisation therapy saves lives and reduces hospitalisation among many heart failure patients

Results presented by UK professor at US cardiology congress and
published simultaneously by New England Journal of Medicine


ORLANDO, Fla. - 7 March 2005 - Cardiac resynchronisation therapy (CRT) in patients with moderate or severe heart failure and poor heart pumping function saves lives and reduces hospitalisation from cardiovascular cause, according to results of a landmark study presented today by a UK heart failure professor at a major American cardiology congress and concurrently published by The New England Journal of Medicine. Nearly 900,000, or about 1 out of every 70, people in the UK have heart failure, a condition that compromises the heart's ability to pump enough blood to the body.

Presented during a Late-Breaking Clinical Trial session at the American College of Cardiology Annual Scientific Session, the CARE-HF (Cardiac Resynchronisation in Heart Failure) randomised, controlled trial showed that patients who received a Medtronic CRT device and optimal medical therapy experienced:
· a 37 per cent reduction in combined all-cause mortality (death) or unplanned cardiovascular hospitalisation (primary end-point).
· a 36 per cent reduction in all-cause mortality (secondary end-point).
· reduced heart failure hospitalisation and improved heart failure symptoms and quality of life (measured by Minnesota Living with Heart Failure questionnaire patient responses).
Study results were consistent across patient sub-groups.

 University of Hull 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 , UK , commented: "We now have overwhelming evidence that cardiac resynchronisation 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. 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".


Sponsored by Medtronic, CARE-HF is a prospective, multi-centre, randomised clinical study of patients with New York Heart Association (NYHA) Class III or IV heart failure, wide ECG QRS (≥120ms) and poor heart pumping function (low ejection fraction; EF≤35%). Patients studied in the 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 and Scandinavian countries. A Medtronic InSyncÒ or InSyncÒ III CRT device was implanted in 409 patients, and 404 patients were in the control group. Unlike previous trials, CARE-HF enrolled enough patients and followed them long enough to assess the impact of CRT alone on mortality: The devices did not have a defibrillator component.

Steve Mahle, president of Medtronic Cardiac Rhythm Management, commented: "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".

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 US , with approximately 550,000 new patients diagnosed each year. Characterised by frequent hospitalisations, it is the only cardiac condition that is increasing in prevalence and is a major cost and quality of life issue. Heart failure hospitalisations account for nearly £45 billion worldwide in costs each year.



CRT resynchronises the contraction 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 to 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.

More information about the study can be found online at www.care-hf.org. More information about heart failure and its treatment can be found online at www.heart-failure.co.uk.

Founded in 1949, Medtronic is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. UK operations, based in Watford since 1987, began in 1972.

(14/3/05)