News | November 12, 2007

Evidence-Based Heart Failure Treatments Vary Significantly

November 13, 2007- There is significant underutilization of many guideline-indicated life-saving medical and device therapies for heart failure (HF) patients, according to the Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF) study.

The study, sponsored by Medtronic Inc., showed substantial variances in the use of all guideline-recommended treatments for HF patients indicated findings from IMPROVE HF presented at Scientific Sessions 2007, the annual congress of the American Heart Association. The study,

According to the baseline results, the use of ACE inhibitors/ARBs
(angiotensin II receptor blockers) and beta-blockers were relatively high in patients eligible for these therapies (80 percent and 86 percent of eligible patients, respectively). However, fewer patients received other life-saving treatments and devices for which they were eligible based on current medical guidelines. These included:

-- Aldosterone antagonists (36 percent of eligible patients)

-- Anticoagulation for atrial fibrillation (69 percent of
eligible patients)

-- Cardiac resynchronization therapy (CRT), including both
CRT-defibrillators (CRT-D) and CRT-pacemaker devices (39
percent of eligible patients)

-- Implantable cardioverter defibrillator (ICD) therapy,
including both ICD-only and CRT-D devices (51 percent of
eligible patients)

-- HF education (61 percent of eligible patients)

"This is the first study of its kind to document the extent in which heart failure patients in the outpatient cardiology practice setting are receiving optimal treatment, as defined by the most recent treatment guidelines," said Gregg C. Fonarow, M.D., co-chair of the IMPROVE HF Scientific Steering Committee and professor of medicine at the University of California at Los Angeles. "The new data demonstrate that alarming treatment gaps exist in the use of evidence-based, guideline recommended therapies in eligible patients with heart failure."

Earlier IMPROVE HF analyses showed:

-- Less than 30 percent of patients assessed at baseline were
being treated with all therapies for which they were eligible.

-- Women were less likely than men to receive an ICD when
indicated, education about their condition, or anticoagulation
treatment for atrial fibrillation.

-- Older patients were less likely than younger patients to
receive certain types of guideline-indicated interventions -
particularly ICD/CRT-D therapy.

The IMPROVE HF study (POSTER #3280/C81: Heart Failure Quality of
Care in the Outpatient Cardiology Practice Setting: A Report from
IMPROVE HF) will be available for viewing from 9 a.m. - 5 p.m. EDT,
and will be presented from 9:30 - 11:30 a.m. EDT Wednesday, Nov. 7, in
West Hall A1/A2.

About IMPROVE HF

IMPROVE HF is the first of its kind, large-scale, prospective
study involving approximately 40,000 HF patients from approximately
150 cardiology practices in the United States.

The study is designed to:

-- Characterize the management of chronic systolic heart failure
(EF less than or equal to 35 percent) in the outpatient care
setting;

-- Assess the effects of practice-specific
performance-improvement measures on patient care;

-- Provide insight into the issues that impede implementation of
HF treatment guidelines, such as the documentation of NYHA
(New York Heart Association) functional class; and

-- Identify methods and tools that will improve the quality of HF
care in the outpatient setting, such as patient education.

The primary objective of the study is to determine if there is a relative 20 percent or greater improvement in the use of at least two of the following seven treatments/study performance measures: ACE inhibitors/ARBs; beta-blockers; aldosterone antagonists; anticoagulation for AF; ICD therapy (ICD-only and CRT-D devices); CRT therapy (CRT-D and CRT only devices); and HF patient education such as smoking cessation, exercising, diet, and restricting salt intake.

Chart reviews were conducted at baseline, and as part of the ongoing study and performance improvement initiative, will be conducted again at six, 12, 18, and 24 months. All study data are being collected and analyzed by an independent clinical research organization.

"Medtronic is firmly committed to advancing patient care through the support of clinical research such as the IMPROVE HF study," said Pat Mackin, senior vice president and president of the Cardiac Rhythm Disease Management business at Medtronic. "We're hopeful that deeper understanding and application of treatment guidelines will ultimately help improve and save more lives."

For more information: www.IMPROVEHF.com

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