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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 -- 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 NYSE

See: New York Stock Exchange
:MDT MDT
abbr.
Mountain Daylight Time


MDT (in the US and Canada) Mountain Daylight Time

MDT n abbr (US) (= mountain daylight time) →
).

"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 The University of California has a combined student body of more than 191,000 students, over 1,340,000 living alumni, and a combined systemwide and campus endowment of just over $7.3 billion (8th largest in the United States).  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 Baylor University Medical Center (BUMC) is located at 3500 Gaston Avenue in east Dallas, Texas (USA). Its medical services are often listed in the annual U.S. News & World Report compilation of Best Hospitals. , 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 angiotensin II
n.
An octapeptide that is a potent vasopressor and a powerful stimulus for production and release of aldosterone from the adrenal cortex.
 receptor blockers) (67.9-90.4%)

* Beta-blockers (72.3-94.4%)

* Aldosterone antagonists (7.1-63%)

* Cardiac resynchronization therapy (CRT (1) (C RunTime) See runtime library.

(2) (Cathode Ray Tube) A vacuum tube used as a display screen in a computer monitor or TV. The viewing end of the tube is coated with phosphors, which emit light when struck by electrons.
), including both CRT-Defibrillation and CRT-Pacing only devices (0-80%)

* Implantable cardioverter defibrillator defibrillator, device that delivers an electrical shock to the heart in order to stop certain forms of rapid heart rhythm disturbances (arrhythmias). The shock changes a fibrillation to an organized rhythm or changes a very rapid and ineffective cardiac rhythm to a  (ICD ICD International Classification of Diseases (of the World Health Organization); intrauterine contraceptive device.

ICD
abbr.
) therapy, including both ICD only and CRT-D CRT-D Cardiac Resynchronization Therapy - Defibrillators  devices (26.3-76.2%)

* Patient education (29.1-88.9%)

* Anticoagulation for atrial fibrillation atrial fibrillation

Irregular rhythm (arrhythmia) of contraction of the atria (upper heart chambers). The most common major arrhythmia, it may result as a consequence of increased fibrous tissue in the aging heart, of heart disease, or in association with severe infection.
 (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 New York, state, United States
New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of
 Heart Association (NYHA NYHA New York Heart Association ) 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<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 >76 years

* 57.2% in patients >64 to [?]76 years

* 52% in patients [?]64 years; p<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 systolic heart failure Cardiology Heart failure with a severely reduced systolic function–LV ejection fraction of ≤35%. Cf Diastolic heart failure.  (EF [?]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 EDT
abbr.
Eastern Daylight Time


EDT Eastern Daylight Time

EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York

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 coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue.  (CAD), hypertension, and valvular valvular /val·vu·lar/ (val´vu-ler) pertaining to, affecting, or of the nature of a valve.

val·vu·lar
adj.
Relating to, having, or operating by means of valves or valvelike parts.
 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 The American College of Cardiology (ACC) is a nonprofit medical association established in 1949 to educate, research and influence health care public policy. The president for the 2006–2007 year is Steven E. Nissen. [1] The organization has 39 chapters in the U.S.  and American Heart Association American Heart Association (AHA),
n.pr a national voluntary health agency that has the goal of increasing public and medical awareness of cardiovascular diseases and stroke, and thereby reducing the number of associated deaths and disabilities.
 (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 HFSA Heart Failure Society of America (also seen as HFSOA)
HFSA Hungarian Financial Supervisory Authority
HFSA Health Flexible Spending Account
HFSA Hispanic Faculty Staff Association
HFSA Health Flexible Spending Arrangement
) 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.
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Date:Sep 17, 2007
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