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Devices Cardiology

 News Release - September 17, 2007

Study Data Shows Gaps and Variation in the Use of Evidence-Based Treatments and Guidelines for Chronic Heart Failure

Ongoing Process Improvement Study Underscores Importance of Optimal Medical Care, Including Treatment with Life-Saving Medical and Device Therapy

MINNEAPOLIS--(HSMN NewsFeed)--Baseline data from the largest study of United States-based heart failure (HF) patients in the outpatient setting demonstrate significant gaps and variation in medical care, particularly for women and the elderly. Findings from the Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF) study were presented today in a poster session at the Heart Failure Society of America Annual Scientific Meeting. The study is sponsored by Medtronic, Inc. (NYSE:MDT ).

"This is the first study of its kind to document the extent to which heart failure patients in the outpatient setting are receiving optimal treatment, as defined by the most recent treatment guidelines," said Gregg C. Fonarow, MD, Co-Chair of the IMPROVE HF Scientific Steering Committee and Professor of Medicine at the University of California at Los Angeles.

"The IMPROVE HF data represents real-world management of heart failure patients in a variety of outpatient cardiology practices from all regions of the United States. It shows us that there are gaps and significant variation across these practices in the use of evidence-based, guideline-recommended therapies in eligible patients, especially female and elderly patients," added Fonarow.

"These data signal an opportunity for the medical community to improve the quality of care for the country's five million heart failure patients," said Clyde Yancy, MD, Co-Chair of the IMPROVE HF Scientific Steering Committee and Medical Director, at the Baylor Heart and Vascular Institute, Baylor University Medical Center, in Dallas, Texas.

Key baseline results from IMPROVE HF include:
  • Substantial variation exists across outpatient cardiology practices in the type of treatment provided to heart failure patients. Conformity with performance measures (in eligible patients only) for practices (10th-90th percentiles) was:
  • ACE inhibitors/ARB (angiotensin II receptor blockers) (67.9-90.4%)
  • Beta-blockers (72.3-94.4%)
  • Aldosterone antagonists (7.1-63%)
  • Cardiac resynchronization therapy (CRT), including both CRT-Defibrillation and CRT-Pacing only devices (0-80%)
  • Implantable cardioverter defibrillator (ICD) therapy, including both ICD only and CRT-D devices (26.3-76.2%)
  • Patient education (29.1-88.9%)
  • Anticoagulation for atrial fibrillation (AF) (44.4-87.5%)
  • Less than 30 percent (27.5%) of patients assessed at baseline were being treated with all therapies for which they were eligible.
  • Eligibility for certain treatments is based upon documented medical information such as New York Heart Association (NYHA) functional class; yet, only 31 percent of records documented NYHA class.
  • Women were less likely than men to receive an implantable cardioverter defibrillator (ICD) when indicated (43.1% vs. 53%; p less than 0.001), education about their condition (59.7% vs. 61.9%; p=0.026), or anticoagulation treatment for atrial fibrillation (64.8% vs. 70.6%; p=0.004).
  • Older patients were less likely than younger patients to receive certain types of guideline-indicated interventions - particularly ICD/CRT-D therapy.
  • 43% in patients greater than 76 years
  • 57.2% in patients greater than 64 to less than or equal to 76 years
  • 52% in patients less than or equal to 64 years; p less than 0.001
"Medtronic is firmly committed to advancing patient care through the support of clinical research such as the IMPROVE HF study," said James P. Mackin, Senior Vice President and President, Cardiac Rhythm Disease Management at Medtronic. "We're hopeful that deeper understanding and application of treatment guidelines will ultimately help save more lives."

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 U.S. 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
  • 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 a relative 20 percent or greater improvement in at least two of the following seven performance measures is possible:

1. ACE inhibitors/ARB (angiotensin II receptor blockers)

2. Beta-blockers

3. Aldosterone antagonists

4. Anticoagulation for atrial fibrillation

5. ICD therapy - including both ICD only and CRT-D devices

6. CRT therapy - including both CRT-D and CRT-P only devices

7. Heart failure 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 is being collected and analyzed by an independent clinical research organization.

The following IMPROVE HF posters will be available for viewing from 9:00 am-7:00 pm EDT, and will be presented from 5:45-6:45 pm EDT on Monday, September 17, in Exhibit Hall A:
  • POSTER #283: Variation in HF Quality of Care among US Outpatient Practices: Analysis of 131 Cardiology Practices in IMPROVE HF
  • POSTER #290: Are Patient Age and Gender Associated with Delivery of Recommended HF Therapies?
  • POSTER #356: Outpatient Documentation of NYHA Functional Class and/or Activity Level in HF Patients: A Report from IMPROVE HF
Additional information about the IMPROVE HF study is available at: www.IMPROVEHF.com.

About Heart Failure and Treatment Guidelines

Heart failure is typically a late manifestation of one or more other cardiovascular diseases, including coronary artery disease (CAD), hypertension, and valvular disease. Chronic heart failure occurs when the heart is unable to pump enough blood to sustain adequate circulation in the body's tissues. Approximately 5.2 million Americans suffer from HF and more than 550,000 new cases are estimated to develop each year. Heart failure is the most costly cardiovascular disease in the U.S., at an estimated $40 billion per year. Estimates for the global population (22 million) are near $80 billion.

In 2001, the American College of Cardiology and American Heart Association (ACC/AHA) published the first guidelines for the evaluation and management of chronic heart failure in adults. The ACC/AHA published updated HF treatment guidelines in 2005. In 2006, the Heart Failure Society of America (HFSA) released guidelines for living with and treating HF, which complement the ACC/AHA guidelines that recommend device therapy as standard of care for HF patients already on optimal medical therapy who meet CRT and/or ICD indications. The use of published HF treatment guidelines has been shown to reduce the risk of death by up to 77 percent.

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.

Any statements made about anticipated regulatory review or approval 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 27, 2007. Actual results may differ materially from anticipated results.


Source: Medtronic

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