Implantable Defibrillators Reduce Death by 23 Percent in Landmark Heart Failure Trial

Implantable Defibrillators Reduce Death by 23 Percent in Landmark Heart Failure Trial

NIH study indicates need to more aggressively identify and protect patients at risk for SCA


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New Orleans, LA.–(HISPANIC PR WIRE)–March 8, 2004–People with heart failure live longer when they receive an implantable cardioverter-defibrillator (ICD), according to results of the landmark Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) released today. The 2,521-patient study, the largest ICD trial ever, showed that ICDs reduced death by 23 percent in people with moderate heart failure compared to those who did not receive defibrillators.

“The results of the trial show definitively that simple implantable defibrillator therapy will prolong life in patients with congestive heart failure,” said study director and principal investigator, Gust H. Bardy, M.D., who presented the results at a late-breaking clinical trial session at the 53rd Annual Scientific Session of the American College of Cardiology in New Orleans. “The study also shows that amiodarone, when used as a prophylactic medication, does not improve survival.”

Sudden cardiac arrest (SCA) is the No. 1 killer of Americans. It takes the lives of approximately 450,000 people in the United States each year, more than lung cancer, breast cancer, stroke and AIDS combined. Current medical evidence allows identification of 150,000 of those 450,000 and, with ICDs, protects them from sudden cardiac death.

Implantable defibrillators have been vastly underutilized, even though they are 99 percent effective in preventing sudden cardiac death, and often provide “pain-free” therapy that is typically undetectable by the patient. Despite their proven benefit, approximately 20 percent of U.S. patients currently indicated actually get them. The result has been an epidemic of unnecessary deaths from cardiac arrest.

“The important thing to remember about this trial is that it greatly enhances physicians’ ability to identify and treat heart failure patients at risk for sudden cardiac death,” said Steve Mahle, president of Medtronic Cardiac Rhythm Management.

SCD-HeFT was a placebo-controlled, three-arm trial examining the use of ICD therapy and anti-arrhythmic drug therapy in patients who have moderate heart failure (New York Heart Association Class II or III), plus impaired pumping function of the left ventricle, the heart’s main pumping chamber.

“It’s critical to understand that this trial was aggressively powered to test whether or not ICDs are effective in heart failure patients who are already receiving optimal medical therapy. We achieved that goal,” said Dr. Bardy. “While there are some interesting observations in the major sub-populations, one must be cautious about over-interpreting sub-group analyses. Based on these data, all patients with moderate heart failure, with or without a history of coronary artery disease, should be evaluated for an ICD.”

Background about SCD-HeFT and Heart Failure

One-third of the patients enrolled in the study received an ICD provided by Medtronic. Another third received amiodarone, a medication used to manage fast heart rhythms, and one-third received a placebo. All patients in the trial received optimal conventional heart failure medications when appropriate and tolerated, such as ACE inhibitors, beta-blockers, diuretics, statins and aspirin. Sponsored by the NIH, with funding from Medtronic and Wyeth Pharmaceuticals, patient enrollment began in 1997 and continued through 2001.

Heart failure is a progressive condition affecting at least 5 million Americans that causes the lower chambers of the heart to lose the ability to pump sufficient blood to meet the needs of the circulatory system. Approximately 1 million Americans suffer from the potentially lethal combination of heart failure and a high risk of sudden cardiac arrest. According to the American Heart Association, sudden cardiac arrest occurs six to nine times more frequently in people with heart failure than in the general population.

Medtronic, Inc., headquartered in Minneapolis, is the world’s leading medical technology company, providing lifelong solutions for people with chronic disease. Its website is http://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 Medtronic’s Annual Report on Form 10-K for the year ended April 25, 2003. Actual results may differ materially from anticipated results.

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Implantable Defibrillators Reduce Death by 23 Percent in Landmark Heart Failure Trial