Disclosures

1. Quality of Care of and Outcomes forAfrican Americans Hospitalized With Heart Failure: Findings From OPTIMIZE-HF (Organized Program To Initiate life-saving treatMent In hospitaliZEd patients with Heart Failure) Clyde W. Yancy MD, FACC, William T. Abraham MD, FACC, Nancy M. Albert PhD, RN, Robert Clare, MS, Wendy Gattis Stough PharmD, Mihai Gheorghiade MD, FACC, Barry H. Greenberg MD, FACC, Christopher M. O'Connor MD, FACC, Jie Lena Sun MS, James B. Young MD, FACC and Gregg C. Fonarow MD, FACC for the OPTIMIZE-HF Investigators and Hospitals

2. Disclosures • Funding Support • GlaxoSmithKline funded the OPTIMIZE-HF registry under the guidance of the OPTIMIZE-HF Steering Committee and funded data collection and management by Outcome Sciences, Inc (Cambridge, MA) and analysis of registry data at Duke Clinical Research Institute (Durham, NC) • Individual author disclosures are listed in the manuscript

3. Quality of Care of and Outcomes forAfrican American with HF • Heart failure in African Americans is characterized by variations in natural history, lesser response to evidence based therapies, and disparate health care. • We hypothesized that a performance improvement program will achieve similar adherence to quality measures in African Americans admitted with HF compared with non–African Americans.

4. HF in African American Patients • African Americans have a greater prevalence of HF and a higher rate of HF hospitalization and mortality than the general population1 • HF in African Americans presents at an earlier age, with more advanced LVSD and worse clinical class at the time of diagnosis2 • A-HeFT has suggested that among African American patients with HF and LVSD there is frequently a nonischemic etiology with a high prevalence of obesity and hypertension2,3 • African American patients may be less likely to receive guideline-recommended, evidence-based therapies due to less access to care4 or due to misconceptions from clinical trials5 that therapy is less effective in this population 1. American Heart Association. 2007 Heart and Stroke Disease Statistical Update. Dallas, Tex: American Heart Association; 2007. 2. Yancy C. Ethn Dis. 2002;12:S1S26. 3. Taylor AL, et al. N Engl J Med. 2004;351:20492057. 4. Yancy CW, Sica DA. J Clin Hypertens (Greenwich). 2004;6:5458. 5. Shekelle O. J Am Coll Cardiol. 2003;4141:1529-1538.

5. Study Objective • We sought to examine the characteristics, quality of care, and clinical outcomes for a large cohort of African-American patients hospitalized with heart failure (HF) in centers participating in a quality improvement initiative.

6. OPTIMIZE-HF Program Objectives • OPTIMIZE-HF is a national performance improvement initiative to improve guidelines adherence in patients hospitalized with HF • Overall OPTIMIZE-HF program objectives: • Improve medical care and education of patients hospitalized with HF • Accelerate initiation of HF evidence-based, guideline-recommended therapies by starting these therapies before hospital discharge in appropriate patients without contraindications • Increase understanding of barriers to use of ACEIs, -blockers, and other guideline-recommended therapies in eligible HF patients

7. OPTIMIZE-HF Process-of-Care Intervention and Registry • “Process-of-care” intervention • Enhanced inpatient HF care and education • Enhanced discharge planning • Care maps, pathways, and standardized order sets that encouraged adoption of evidence-based therapies • ACEI and -blocker initiation before discharge • JCAHO performance indicators • Educational programs to encourage adoption by providers • Web-based registry • Tracks treatment rates and changes following performance interventions • Captures JCAHO/ORYX Quality of Care indicators • Benchmarks comparisons between institutions • Enhances understanding of barriers to uptake

8. OPTIMIZE-HF Performance Improvement Registry Protocol • Eligibility • Adults hospitalized for episode of new or worsening HF as primary cause of admission, or with significant HF symptoms that develop during hospitalization when the initial reason for admission was not HF • Includes patients with systolic dysfunction and/or isolated diastolic dysfunction (HF with preserved systolic function) • Any admission satisfying JCAHO HF core measure criteria • Prespecified subgroup (10%) with 60–90-day follow-up data • Survival, readmissions, and medical regimen • Informed consent required for follow-up • The registry coordinating center was Outcome Sciences, Inc

9. OPTIMIZE-HF Hospital Characteristics * N=246, n=88; † N=245, n=88; ‡ N=255, n=90. CABG/PCI = coronary artery bypass graft/percutaneous coronary intervention.

10. OPTIMIZE-HF Patient Characteristics

11. HF Etiology by Race Hypertensive Etiology Other* Ischemic Etiology *Other etiologies include postpartum, valvular, familial, alcohol/other drug, other, chemotherapy, unknown/idiopathic, and viral. P.0001 between both groups for each etiology.

12. Patient Characteristics by Race

13. Patient Lab and Exam Findings by Race

14. Diagnostic Studies and Procedures by Race

15. HF Measures at Hospital Discharge by Race African American NonAfrican American P=.0003 P<.0001 P<.0001 P.0001 Smoking Cessation Advice Complete Discharge Instructions LVEF Assessed Discharge ACEI

16. Use of Evidence-Based HF Therapy at Discharge by Race African American P<.0001 NonAfrican American P=.2250 P=.1178 P<.0001 P=.6744 P<.0001 P=.0001 P<.0001 Hydralazine/Isosorbide Dinitrate ACEI/ARB -Blocker Statin Aldosterone Antagonist Warfarin Hydralazine Nitrate ACEI/ARB, β-blocker, aldosterone antagonist, hydralazine, and nitrate use in eligible patients with LVSD; statin in coronary artery disease, cerebrovascular accident/transient ischemimc attack, diabetes, hyperlipidemia, and/or peripheral vascular disease; and warfarin use in patients with atrial fibrillation.

17. Independent Association of African American Race and Quality of Care

18. In-Hospital and Follow-Up Outcomes in HF Patients With LVSD by Race African American NonAfrican American P=.0164 P=.0025 P<.0001 Patients (%) P=.0549 93/4,212 670/15,365 191/560 616/2,133 183/2,060 35/553 60- to 90-Day Rehospitalization 60- to 90-Day Mortality Length of Stay (days) In-Hospital Mortality (%)

19. In-Hospital and Follow-Up Outcomes in HF Patients Without LVSD by Race African American NonAfrican American P=.1166 P=.2532 Patients (%) P<.0001 P=.2918 49/3,187 539/17,283 93/360 603/2,015 23/353 159/1,947 Length of Stay (days) In-Hospital Mortality (%) 60- to 90-Day Rehospitalization 60- to 90-Day Mortality

20. Multivariable Mortality Analyses by Race

21. Limitations • The present observations include only hospitalized patients with HF, a population known to be at increased risk of adverse outcomes • Race was not a self-reported variable but rather was determined as that documented in the medical record, thus errors in racial determination could have occurred. • Follow-up data were collected only from a pre-specified subset of patients and extended only 60 to 90 days • Despite extensive covariate and propensity adjustment, residual confounding cannot be excluded, thus may only be demonstrating associations, rather than cause-and-effect relationships

22. Conclusions • African-American HF patients, when exposed to a process-of-care improvement initiative, had better-than-previously observed treatment with evidence-based therapies. • African-American HF patients when treated according to guidelines had similar or better outcomes compared with non–African-American patients. • The OPTIMIZE-HF program suggests that an in-hospital process-of-care improvement program might help to achieve similar conformity with quality measures for African Americans with HF.