Data from the Multicenter InSync Randomised Clinical Evaluation, known as MIRACLE, show that cardiac resynchronisation therapy systems helped many patients improve by at least one functional class, resulted in a greater improvement in patient quality of life than for those receiving drug therapy alone and reduced the risk of hospitalisation from worsening heart failure.
Approximately 450,0003 people in the G5 European countries are candidates for cardiac resynchronisation therapy; these patients have moderate-to-severe heart failure and also suffer from ventricular dysynchrony, which occurs when there is a time delay between the beating of the heart's two lower chambers, or ventricles. Cardiac resynchronisation therapy delivers electrical impulses to both sides of the heart to co-ordinate the contractions of the heart's ventricles and improve its efficiency to increase blood flow to the body.
The MIRACLE study was designed to measure therapeutic benefits of the InSync system, as determined by changes in New York Heart Association (NYHA) functional classification, distance walked in six minutes and improvements in quality of life. Findings are based on data from 453 patients with moderate-to-severe heart failure.
Conducted at 45 heart centres in the United States and Canada, the MIRACLE study showed significant improvements in the NYHA functional class, six-minute walk distance, quality of life score and reduction in hospitalisation for patients randomised to cardiac resynchronisation therapy. Specifically, results demonstrated:
· Sixty eight percent of patients receiving cardiac resynchronisation therapy experienced an improvement in NYHA functional status by one or more classes at six months, compared to 38 percent of patients in a control group.
· Improved exercise capacity, as evidenced by an increase in six-minute hall walk distance.
· Patients receiving cardiac resynchronisation therapy reported a greater improvement in quality of life than those receiving drug therapy alone.
· Fifty percent fewer hospitalisations and 77 percent fewer hospital days related to heart failure for patients receiving cardiac resynchronisation therapy than those in the control group.
In addition, when compared with the control group, patients in the resynchronisation group showed improvement in maximal exercise performance, including peak oxygen consumption and total exercise time. Furthermore, cardiac resynchronisation therapy demonstrated a highly favourable effect on the clinical composite heart failure score. At the end of six months, more patients were considered improved (67 percent vs. 39 percent) in the group assigned to treatment than in the control group.
Commenting on this landmark study, Dr Paco Leyva, Consultant Cardiologist, Good Hope Hospital, Sutton Coldfield, UK explained, "The MIRACLE Study clearly shows that patients who received cardiac resynchronisation therapy, using Medtronic's InSync system, experienced a significant improvement in their quality of life. As a result of patients receiving this therapy, there were 50% fewer hospitalisations and 77% fewer hospital days required by CR treated patients when compared to patients receiving drug treatment alone." He concluded, "This demonstrates that cardiac resynchronisation therapy is clinically effective. On the basis of this and other studies, cardiac resynchronisation therapy is likely to revolutionise this treatment for a group of patients with heart failure. From experience, the costs of this treatment is compensated for by reductions in re-admissions and therefore generates cost savings in the long term."
"Publication in the New England Journal of Medicine demonstrates peer-reviewed support for cardiac resynchronisation therapy, confirms existing evidence regarding the effectiveness of this therapy for many heart failure patients, and validates Medtronic's long term commitment in providing physicians with clinical proof, " said Oern Stuge, Vice President, Medtronic Cardiac Rhythm Management in Europe. He continued, "We're encouraged by the positive results of the MIRACLE study, which reinforce and expand MUSTIC4, and look forward to the completion of CARE-HF which will provide additional mortality data".
Heart failure is reaching epidemic proportions and is an increasing burden on healthcare systems in Europe. In Germany, it is estimated to cost $5.4 billion/5.7billion Euros to manage chronic heart failure, with over 55% of this figure associated with hospitalisations alone.5
The InSync system includes a small pulse generator that is implanted beneath the skin in the shoulder region. To monitor the heart and provide the necessary electrical stimulation for heart resynchronisation, three thin insulated wires, called leads, extend from the InSync device to the heart. One lead is placed to touch the inner wall of the right atrium, another to touch the inner wall of the right ventricle and the third lead is manoeuvred through the coronary sinus and inserted in a vein on the exterior wall of the left ventricle (LV lead).
Medtronic was the first company to market a transvenous LV lead in Europe and offers the broadest suite of device-based heart failure products. The InSync system and several models of Attain™ left-heart leads have been commercially available in Europe since 1998; the company obtained FDA approval of the InSync system last year. In Europe, the InSync ICD and InSync III devices are available, and the InSync Marquis is in clinical evaluation.
For more information please visit Medtronic's website at www.medtronic.com
Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Its Internet address is www.medtronic.com.
Any statements made about the company's anticipated financial results and regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in the company's Annual Report on Form 10-K for the year ended April 27, 2001. Actual results may differ materially from anticipated results.
1. Abraham WT et al. Cardiac Resynchronisation in Chronic Heart Failure (MIRACLE). NEJM June 13 2002. 346; (24): 1845-1853.
2. Datamonitor. The Future Decoded, Table 1 Prevalence of chronic heart failure and incidence of acute heart failure in the major markets 2001.
3. Havranek E, et al. Spectrum of heart failure in older patients: results from the National Heart Failure Project. Am Heart J 2002; 143:412-7
4. Cazeau S et al. Effects of Multisite biventricular pacing in patients with heart failure and intraventricular conduction delay (MUSTIC). NEJM March 22 2001. 344 (12) 873-880.
5. Datamonitor. The Future Decoded, Table 13 Healthcare expenditure in the US and Europe due to chronic heart failure.
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