Medical Device Daily Senior

Evidence-based performance improvement interventions have the potential to eliminate disparities in care for heart failure patients across different race groups, according to new findings from Medtronic's (Minneapolis) landmark IMPROVE HF.

IMPROVE HF is a first-of-its-kind, prospective study involving roughly 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.

According to the latest findings, IMPROVE HF 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, structure 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, Medtronic reported. The study, published recently in the Journal of the National Medical Association, 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 Yancy, MD, 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.“

Yancy told Medical Device Daily that an important observation from these findings is that the positive impact of these measures were observed in a broad population, not just in a refereed clinical trial population as is often the case with clinical studies.

“It shows that doing the right thing works,“ he said. “So many times a clinical trial will suggest what should be done“ but getting the medical community to adhere to those measures outside of the trial is often a challenge.

“What we're demonstrating is that indeed the answer is yes, there are some differences at baseline, and that is not a new observation,“ Yancy said. “But the new observation is that when you apply performance improvement strategy there is broad adherence to these measures.“

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, the researchers noted.

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 7,605 patients analyzed in the retrospective study, 9% were African American, 42.6% were Caucasian and 46.5% were undocumented in terms of race. Specifically, at 24-months post-intervention:

• CRT devices were used in 67.3% of African Americans (25.7% change from baseline), 71.3% of Caucasians (29.3% change from baseline), and 65.6% of race undocumented patients (25.4% change from baseline).

• Aldosterone antagonists were used in 76% of African Americans (24.8% change from baseline), 59% of Caucasians (24% change from baseline) and 58.2% of race undocumented patients (28.1% change from baseline).

• Heart failure educational tools were applied with 78.4% of African Americans (15.2% change from baseline), 72.5% of Caucasians (12.4% change from baseline) and 67.8% of race undocumented patients (9.1% change from baseline).

“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, MD, VP and general manager of 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.“

In addition to the racial disparities findings, 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.

CRT and beta blockers demonstrated the strongest 24-month survival benefit when used individually (56% lower adjusted-odds ratio for death using CRT; 58% 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.

“This approach has characteristics that will allow it to modify in a favorable way the use of quality measures, regardless of the kind of measure it is,“ Yancy said. “I don't know that we've been able to say that definitively in the past. That, I think, is exemplary.“

“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 Fonarow, MD, 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.“

Amanda Pedersen, 912-660-2282;
amanda.pedersen@ahcmedia.com