Use of Proven Heart Failure Therapies Not Standardized in the United States

New Findings Released From the Country’s Largest Study of Treatment for Outpatient Heart Failure Patients

MINNEAPOLIS – New analysis from the largest outpatient study of heart failure patients in the United States shows they are receiving inconsistent care. These findings from the Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF), sponsored by Medtronic, Inc. (NYSE:MDT), are being presented this week as posters at the 12th Annual Scientific Meeting of the Heart Failure Society of America (HFSA) in Toronto. IMPROVE HF was designed to quantify and improve quality of care for heart failure patients by promoting the use of evidence-based, guideline-recommended therapies.

“These new data represent novel observations obtained in the outpatient environment and demonstrate that patients suffering from heart failure are not receiving consistent care in accordance with recommended evidence-based guidelines,” said Clyde Yancy, M.D., 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. “Previously we could only speculate on the quality of heart failure care in the outpatient arena. Now we know and there are reasons for concern.”

Specifically, the new data demonstrate several gaps in heart failure guideline adherence:

1. Use of device and drug therapy – Heart failure patients without implantable cardiac devices (implantable cardioverter-defibrillators (ICDs) or cardiac resynchronization therapy-defibrillators (CRT-Ds) versus those with devices were less likely to receive the appropriate evidence-based therapies. Patients with ICD/CRT-D devices were significantly more likely than those without devices to receive ACE inhibitors (ACEI) /angiotensin-receptor blockers (ARB) (82.7 percent versus 78.6 percent) or beta blockers (BB) (90.6 percent versus 84.2 percent). Patients with CRT/CRT-D devices were significantly more likely to receive aldosterone antagonists (40.3 percent versus 34.1 percent) than patients without devices.
2. Impact of dedicated heart failure clinics on care – Clinics with two or more devoted heart failure nurses or physician’s assistants (PAs) were independently associated with improved quality of care in three of the seven quality measures that were assessed in the study. Notably, outpatient cardiology practices with at least two heart failure dedicated nurses/PAs were shown to be associated with increased adherence to ACEI/ARB and ICD/CRT-D interventions as well as the delivery of heart failure education. This evidence suggests a heart failure disease management program and/or a team model may positively influence the quality of care. However, the benefit was not demonstrated across all heart failure care measures reviewed in this study.
3. Variations in adjunct care – Gaps and variations among cardiology practices in documented care for certain guideline-recommended adjunctive therapies were revealed. Notably, on average, only 7.3 percent of eligible African Americans received the recommended medications to lower blood pressure and relax veins and arteries.

“These results send a clear message that cardiology practices need to have systematic methods to employ the best evidence-based care for heart failure,” 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. “IMPROVE HF is an important study to document the need for more stringent practice patterns and to improve the care and outcomes for heart failure patients.”

“Supporting this type of research is critical to helping improve the quality of care for the 22 million heart failure patients worldwide,” said Pat Mackin, senior vice president and president of the Cardiac Rhythm Disease Management business at Medtronic. “We’re confident that a deeper understanding and application of treatment guidelines will promote more consistent care for all heart failure patients.”

An earlier analysis of IMPROVE HF baseline data demonstrated inconsistencies in care and underutilization of lifesaving device therapies for heart failure patients. Specifically, only 39 percent of eligible patients received a CRT device and only 51 percent who were eligible received ICD therapy.

About IMPROVE HF

IMPROVE HF is the first of its kind, large-scale, prospective study involving approximately 40,000 heart failure patients from approximately 160 cardiology practices in the United States. This new release of baseline data includes 15,381 patients and 167 clinics. The study is assessing seven performance measures including four on drug therapy, three on device therapy and heart failure education.

Chart reviews were conducted at baseline, and then again at six, 12, 18 and 24 months as part of the ongoing study and performance improvement initiative. 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 a.m. to 7 p.m. EDT, and will be presented from 5:45 to 6:45 p.m. EDT on Monday, Sept. 22, and Tuesday, Sept. 23, in the Exhibit Hall:

* POSTER #327: Influence of Advance Practice Nurse and Dedicated Heart Failure Clinics on Delivery of Recommended Therapies In Outpatient Cardiology Practices: IMPROVE HF Findings (Sept. 22)
* POSTER #281: Significant Gaps in Adherence to Guideline Recommended Adjunctive Heart Failure (Sept. 22)
* POSTER #304: Comparison of Medical Treatment in Outpatients receiving Device Therapy for Systolic Dysfunction: A Report from IMPROVE HF (Sept. 23)

Editor’s Note: Findings from IMPROVE HF were recently published in the July Circulation journal titled

“Heart Failure Care in the Outpatient Cardiology Practice Setting: Findings from IMPROVE HF”.

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 forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 25, 2008. Actual results may differ materially from anticipated results.