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
- 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
"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
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
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
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: