Medtronic supports new European guidelines on use of ICDs and CRT as heart failure therapies

29 May 2005

Tolochenaz, Switzerland. Medtronic, Inc. announced its support for the new guidelines for the treatment of heart failure (HF) issued by the European Society of Cardiology (ESC).

Under the new ESC heart failure guidelines, implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) have been designated Class I for indicated heart failure patients, which means they are recognized as standard-of-care treatments for many heart failure patients already on optimal medical therapy. The guidelines stipulate that:

  • ICDs are recommended for indicated HF patients with reduced ejection fraction to decrease sudden cardiac arrest (SCA);
  • CRT is recommended in HF patients with reduced ejection fraction and cardiac dyssynchrony to improve symptoms and reduce mortality and hospitalizations.

"Based on several clinical trials, ICDs are now proven to effectively reduce sudden death among patients with heart failure and reduced systolic dysfunction. It is now up to the medical community to define which patients should be treated in clinical practice," said Prof. Karl Swedberg, Sahlgrenska University Hospital at Ostra, Gotenborg, Sweden.

"We are very pleased that the European Society of Cardiology is recommending routine use of defibrillators and CRT for heart failure patients with systolic dysfunction," said Peter Steinmann, vice president of Medtronic Cardiac Rhythm Management in Western Europe. "ICDs can correct deadly fast heart rhythms, the leading cause of mortality in heart failure patients. These implantable devices will protect thousands of patients from sudden cardiac death."

The chance to SCA is approximately 5 percent. Defibrillation therapy is the only treatment option with the potential to reverse SCA and thereby reduce mortality in HF patients who suffer a lethal heart rhythm.

When considering heart failure patients with ventricular dyssynchrony, a disruption in the synchronous beating of the heart's lower chambers, Prof. Swedberg stated, "Along with optimal medical therapy, CRT is a very impressive new therapy that can improve patient's lives and can reduce mortality and hospitalizations."

Extensive recent scientific evidence demonstrates that ICDs prolong lives when used in conjunction with optimal drug therapy in indicated heart failure patients.

The Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), published in the Jan. 20, 2005 issue of The New England Journal of Medicine, showed ICDs increased survival by 23 percent. The Medtronic-supported study compared the lifesaving benefits of ICDs and amiodarone, a commonly used heart medication, in 2,521 patients with moderate heart failure and poor heart pumping function who had not experienced a prior episode of SCA. In addition, economic data from SCD-HeFT indicate that ICDs are a cost-effective therapy in this population.

Results from the recent Medtronic-sponsored CARE-HF (Cardiac Resynchronization in Heart Failure) study, published in the April 14, 2005 issue of The New England Journal of Medicine, contributed to the ESC decision to designate CRT as Class I therapy for heart failure patients. In addition to previously reported CRT benefits in quality of life, long-term CARE-HF data showed CRT's impact in significantly improving survival and reducing hospitalization.

A combined CRT-ICD device is recommended by ESC for patients considered for CRT and in whom the risk of SCA remains high despite optimal medical treatment.

Heart failure, a chronic, relentless condition that robs patients of their energy, mobility and independence, affects approximately 22 million people worldwide, including six million in Europe and five million in the United States. It is the only cardiac condition increasing in prevalence and is a major cost and quality of life issue, characterized by frequent hospitalizations. Heart failure is responsible for one million hospitalizations a year in Europe.

Implantable defibrillators have been approved for use since the late 1980s, but primarily for the 5 percent of people who had already survived an episode of SCA. Recent studies have demonstrated that ICDs can be used as a preventive therapy to save lives from SCA in many heart failure patients, even if they haven't previously experienced SCA.

The new ESC guidelines for the diagnosis and treatment of chronic heart failure are available online at: 

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