Press Release

Landmark IMPROVE HF Trial Shows Evidence-Based Programs Result in Improvements in Heart Failure Patients Regardless of Race, and Improves Survival

Medtronic-Supported Study is one of First to Evaluate Improvements, by Race, in the Use of Heart Failure Therapies in the Outpatient Setting

MINNEAPOLIS – August 30, 2012 – Medtronic, Inc. (NYSE: MDT) today announced new findings from the landmark IMPROVE HF (Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting) trial, which showed equivalent improvements in the care of heart failure patients across all races and ethnicities when evidence-based, performance improvement interventions were applied in outpatient settings. The performance improvement interventions included clinical-decision support tools, structured improvement strategies (including patient assessment and management forms, and patient education materials) and patient chart reviews with performance feedback.  

The majority of baseline differences in care among race groups studied were reduced or eliminated at 24 months, post-intervention. Funded by Medtronic and recently published in the Journal of the National Medical Association, the study is among the first to assess improvements in the use of clinical guideline-recommended heart failure therapies by race in the outpatient cardiology practice setting.

“While African Americans are at greater risk for developing heart failure at an earlier age and at increased risk for disease-related complications and death, studies show that these patients are less likely to receive guideline-recommended medication and device therapies to treat their debilitating condition,” said Clyde W. Yancy, M.D., co-chair of the IMPROVE HF steering committee and chief of the Division of Cardiology at Northwestern Memorial Hospital and Northwestern University Feinberg School of Medicine, Chicago. “These new findings from the IMPROVE HF registry are provocative, as they demonstrate that physician education initiatives have the potential to help eradicate disparities in care and therefore greatly improve overall clinical outcomes for heart failure patients of all races.”

Seven quality measures were analyzed in the IMPROVE HF study, including use of drug therapy (ACE inhibitors or angiotensin receptor blockers, beta-blockers, aldosterone antagonists and anticoagulants for atrial fibrillation); use of implantable device treatments such as implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) with a defibrillator or pacemaker; and heart failure patient education. Following implementation of the IMPROVE HF physician-based performance interventions, statistically significant improvements in the use of CRT device therapy, aldosterone antagonist drugs and heart failure education were observed across all race groups studied.

As confirmed in this study, many physicians do not document race or ethnicity in the outpatient medical chart. However, results from IMPROVE HF demonstrate that improvements in outpatient care and overall treatment adherence were achieved regardless of whether the patient race was African American, Caucasian or undocumented. Of the 7605 patients analyzed in the retrospective study, 9 percent were African American, 42.6 percent were Caucasian and 46.5 percent were undocumented in terms of race. Specifically, at 24-months post-intervention:

  • CRT devices were used in 67.3 percent of African Americans (25.7 percent change from baseline, p <.001), 71.3 percent of Caucasians (29.3 percent change from baseline, p <.001) and 65.6 percent of race undocumented patients (25.4 percent change from baseline, p <.001).
  • Aldosterone antagonists were used in 76 percent of African Americans (24.8 percent change from baseline, p <.001), 59 percent of Caucasians (24 percent change from baseline, p <.001) and 58.2 percent of race undocumented patients (28.1 percent change from baseline).
  • Heart failure educational tools were applied with 78.4 percent of African Americans (15.2 percent change from baseline, p <.001), 72.5 percent of Caucasians (12.4 percent change from baseline, p <.001) and 67.8 percent of race undocumented patients (9.1 percent change from baseline, p <.001).

“This research represents a significant milestone demonstrating our commitment to innovation in identifying the best, most clinically advanced solutions for ensuring patient quality of care,” said David Steinhaus, M.D., Vice President and General Manager, Heart Failure, and Medical Director for the Cardiac Rhythm Disease Management business at Medtronic. “Current guidelines recommend the use of evidence-based medication and device therapy for heart failure patients of all races and ethnicities, and through implementation of IMPROVE HF performance improvement interventions, this could ultimately be achieved.”

Additional IMPROVE HF Findings Show Survival Benefit
In addition to the racial disparities findings described above, other data recently published from the IMPROVE HF trial demonstrated that individual and incremental use of evidence-based, guideline- recommended heart failure therapies result in a significant increase in patient survival over the course of 24 months, according to an article recently published in the Journal of the American Heart Association.

Cardiac resynchronization therapy (CRT) and beta blockers demonstrated the strongest 24-month survival benefit when used individually (56 percent lower adjusted-odds ratio for death using CRT; 58 percent lower adjusted-odds ratio for death using beta blockers). ACE inhibitors/angiotensin receptor blockers, ICDs, heart failure education, and anticoagulation for atrial fibrillation were also independently associated with decreased mortality odds.  In addition, patients who received a greater number of guideline- recommended treatments at baseline were more likely to be alive at 24 months, with this benefit plateauing after use of four-to-five therapies.

“The clinical effectiveness of each guideline-recommended heart failure treatment – when used alone in absence of other therapies and when applied incrementally as an additive to a subsequent therapy – has not been well studied in the past,” said Gregg C. Fonarow, M.D., co-chair of the IMPROVE HF Scientific Steering Committee and Professor of Cardiovascular Medicine at the University of California at Los Angeles. “Our findings add to the growing body of evidence supporting the comparative effectiveness of evidence-based treatment for heart failure patients in the real-world clinical setting, and also suggest that there may be incremental benefits to the application of these therapies in the outpatient setting.”

About IMPROVE HF
IMPROVE HF is a first-of-its-kind, prospective study involving approximately 35,000 heart failure patients from 167 U.S. cardiology practices. Using a process improvement intervention and chart reviews at baseline, six, 12, 18 and 24 months, IMPROVE HF was designed to quantify and improve quality of care for heart failure patients (who were determined eligible for treatment according to current guidelines) by promoting the use of evidence-based, guideline-recommended therapies. All study data were collected and analyzed by an independent clinical research organization.

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 periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

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Medtronic Media Contacts:
Kathleen Janasz, Public Relations, 763-526-3676
Jeff Warren, Investor Relations, 763-505-2696
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