1. Effects of Multidisciplinary Care of Heart Failure Patients at High Risk for Hospital Admission S. Scott Sutton, Pharm.D. Associate Clinical Professor South Carolina College of Pharmacy University of South Carolina & Medical University of South Carolina WJB Dorn Veterans Administration Medical Center Columbia, South Carolina

2. Objectives SCSHP Program agenda: Identify Characteristics of heart failure patients and common factors that lead to hospitalization of patients.

3. Research Team S. Scott Sutton, Pharm.D. Meg Franklin, Pharm.D., Ph.D. C.E. (Gene) Reeder, RPh, Ph.D. Frank Laws, M.D. HF Research - Abstracts / Posters & PublicationsHF Research - Abstracts / Posters & Publications: –Effects of Multidisciplinary Care of Heart Failure Patients at High Risk for Hospital Admission American Heart Association University of South Carolina School of Medicine / Palmetto Health Biomedical Research Program Drug Benefit Trends 2008;20:54-59 –Economic Evaluation of a Multidisciplinary Approach to Heart Failure Management International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 11 th Annual International Meeting –Predicting Heart Failure Related Events in Patients Enrolled in an Outpatient Specialty Clinic in the VA System In progress

4. Heart Failure Key ConceptsKey Concepts –Complex clinical syndrome Dyspnea Fatigue –Proven treatments Decrease morbidity and mortality Decrease health care expenditures –Angiotension converting enzyme inhibitors –Beta-blockers –Multidisciplinary care –Pharmacist Circulation 2005;112:1825-1852 NEJM 2003;348:2007-2018 Arch Intern Med 1999;159:1939-1945 Can J Cardiol 2004;20:1205-1211

5. Heart Failure Key ConceptsKey Concepts –Complex clinical syndrome Dyspnea Fatigue –Proven treatments Decrease morbidity and mortality Decrease health care expenditures –Angiotension converting enzyme inhibitors –Beta-blockers –Multidisciplinary care –Pharmacist 11,000 patients –ACEI and BB 62 and 37% Suboptimal treatment may lead to: Increased mortality Increased healthcare expenditures Circulation 2005;112:1825-1852 NEJM 2003;348:2007-2018 Arch Intern Med 1999;159:1939-1945 Can J Cardiol 2004;20:1205-1211

6. New York Heart Classification Class I: –no limitation is experienced in any activities; there are no symptoms from ordinary activities. Class II: –slight, mild limitation of activity; the patient is comfortable at rest or with mild exertion. Class III: –marked limitation of any activity; the patient is comfortable only at rest. Class IV: –any physical activity brings on discomfort and symptoms occur at rest. Circulation 2005;112:1825-1852 NEJM 2003;348:2007-2018

7. American College of Cardiology American Heart Association Stage AStage A: –a high risk HF in the future but no structural heart disorder; Stage BStage B: –a structural heart disorder but no symptoms at any stage; Stage CStage C: –previous or current symptoms of heart failure in the context of an underlying structural heart problem, but managed with medical treatment; Stage DStage D: –advanced disease requiring hospital-based support, a heart transplant or palliative care Circulation 2005;112:1825-1852 NEJM 2003;348:2007-2018

8. Heart Failure Common model of treatment –Reactive Patient perceives problem and makes appointment with clinician. Ideal model provides continuous care coordination and support –Current HF Treatment Model 12-15 million office visits 6.5 million hospital bed days More Medicare dollars than other single diagnosis 27.9 billion in direct and indirect Circulation 2005;112:1825-1852 NEJM 2003;348:2007-2018 Heart 2005;91:849-850

9. HF - Pharmacologic Management Angiotension Converting Enzyme InhibitorsAngiotension Converting Enzyme Inhibitors –CONCENSUS Enalapril versus placebo – NYHA IV –SOLVD Enalapril versus placebo – NYHA II-IV –ATLAS Low dose versus high dose lisinopril – NYHAII-IV NEJM 1987;316;1429-35 NEJM 1991;325:293-302 Circulation 1999;100:2312-8

10. HF - Pharmacologic Management Angiotension Converting Enzyme InhibitorsAngiotension Converting Enzyme Inhibitors –Heart Failure – NYHA I-II ACE Inhibitor x 1 year 100 treated to prevent 1 death (number needed to treat - NNT) –Heart Failure – NYHA IV ACE Inhibitor x 1 year 6 treated to prevent 1 death (NNT) –Heart Failure – post MI ACE Inhibitor 18 treated to prevent 1 death (NNT) NEJM 1987;316;1429-35 NEJM 1991;325:293-302 Circulation 1999;100:2312-8 Bandolier

11. HF - Pharmacologic Management Beta-Blockers -Beta-Blockers - (Number needed to treat 14-22) –CIBIS-II Bisoprolol versus placebo – NYHA III-IV –US Carvedilol Heart Failure Study Carvediolol versus placebo – NYHA II-IV –Merit-HF Metoprolol XL versus placebo – NYHA II-IV –COMET Carverdilol versus metoprolol tartrate – NYHA II-IV –Only compared to immediate release metoprolol Lancet 1999;353:9-13 NEJM 1996;334:1349-55 Lancet 1999;353:2001-7 Lancet 2003:362:7-13

12. HF - Pharmacologic Management Outcome# of trialsBeta- blocker ControlRelative risk (95% CI) NNT (95% CI) Mortality 14443/5366682/48670.62 (0.55- 0.69) 17 (14-22) Mortality or Hospital admission 91401/50351655/46100.81 (0.76- 0.86) 12 (10-16) Hospital admission 13613/5301833/48270.67 (0.61- 0.74) 17 (14-23) Beta-Blockers Bandolier - http://www.jr2.ox.ac.uk/bandolier/booth/AF/betamort.html

13. HF - Pharmacologic Management Aldosterone AntagonistsAldosterone Antagonists –RALES Spironolactone versus placebo – NYHA III-IVSpironolactone versus placebo – NYHA III-IV NNT (all-cause mortality) 10NNT (all-cause mortality) 10 –EPHESUS Eplerenone versus placebo – acute MI with LV dysfunction NNT (all-cause mortality) 44 NEJM 1999;341(10):709-17 NEJM 2003;348:1309-21

14. HF non-Pharmacologic Management Multidisciplinary ClinicsMultidisciplinary Clinics –Decrease mortality Rates Mortality rate similar to that of ACE Inhibitors –Reduce hospital admission rates All cause hospital admission – 13% HF admissions by 30% –Decrease use of health-care resources Heart 2005;91:899-906 Chest 2005;127:173:40-45

15. HF non-Pharmacologic Management Home-based interventions –Decreased: All cause-admission HF related admission Mean days in the hospital Telephone-based interventions –Decreased: Mortality HF admissions Heart 2005;91:899-906

16. HF non-Pharmacologic Management Randomized clinical trials based upon self-care: –Decreased: Readmission Hospitalization days Cost of care 2 key components –1-to-1 patient education –Self-management recommendations Heart 2005;91:899-906

17. Effects of Multidisciplinary Care Multidisciplinary Care TrialsPatientsIntervention (% having event) Control (% having event) Relative Risk (95% CI) Number needed to Treat (95% CI) All-cause mortality 12212917240.7 (0.6-0.9)17 (11-38) All-cause Admission 14227341510.8 (0.7-0.9)10 (7-16) HF Admission 9141627380.7 (0.6-0.8)9 (6-17) Journal American College of Cardiology 2004;44:810-819 American Journal of Medicine 2001;110:378-84

18. Effects of Multidisciplinary Care of Heart Failure Patients at High Risk for Hospital Admission S. Scott Sutton, Pharm.D. Meg Franklin, Pharm.D., Ph.D. C.E. (Gene) Reeder, RPh, Ph.D. Frank Laws, M.D. Drug Benefit Trends 2008;20:54-59 (publication) American Heart Association (abstract / poster presentation)

19. Advanced Heart Failure Program (AHFP) Target PatientsTarget Patients –High readmission rates –Risks are identified Intervention DescribesIntervention Describes –Strategy to improve outcomes of patients with chronic HF at the Dorn Veterans Administration Medical Center in Columbia, South Carolina Drug Benefit Trends 2008;20:54-59

20. Advanced Heart Failure Program (AHFP) Developed to provide comprehensive multidisciplinary management to persons with advanced HF. Inclusion criteria: –ACC/AHA stage C/D or NYHA III/IV –Hospitalized 2 or more times in 1-year period Drug Benefit Trends 2008;20:54-59

21. Advanced Heart Failure Program (AHFP) Goals: –Decrease hospital admission & readmission –Decrease health-care expenditures –Improve quality of life AHFP Team: Cardiologist Internal Medicine Specialist Nurse Practitioner Nurse Case Managers Physician assistants Pharmacists Clinical Researchers Drug Benefit Trends 2008;20:54-59

22. AHFP HF Patients NYHA Class III/IV or AHA Class C/D Enroll in HF Clinic Initial Visit Every 2 Weeks for 2 Months, Then Monthly Thereafter Patient Monitoring Weight Blood Pressure Peak Flow Daily symptoms Clinic Monitoring Labs BNP ICG PRN Infusion Clinic Episodic Management in Clinic Emergency Department/ Readmission

23. Advanced Heart Failure Program (AHFP) Once enrolled into AHFP –Patients presented every 2 weeks for first 2 months Monthly thereafter Initial Visit –Extensive evaluation Physical Diagnostic Laboratory Medication Quality of Life Evaluation Drug Benefit Trends 2008;20:54-59

24. Initial Visit $1051.92 Subsequent visits $141.73 50 Week Cost $3036.14 AHFP Costs

25. Advanced Heart Failure Program (AHFP) Once enrolled into AHFP –Patients presented every 2 weeks for first 2 months Monthly thereafter Initial Visit –Extensive evaluation Physical Diagnostic Laboratory MedicationMedication Quality of Life Evaluation Drug Benefit Trends 2008;20:54-59 Medication Evaluation AHFP Medications (pending indications) Lisinopril Furosemide Carvedilol Spironolactone Other medications potentially utilized Digoxin Valsartan Potassium Chloride

26. Patient Population Local versus National PREVALENCEPREVALENCE

27. Drug Benefit Trends 2008;20:54-59 AHFP - Results Baseline Characteristics Hospital Readmission Rates per Patient

28. Drug Benefit Trends 2008;20:54-59

29. Objectives SCSHP Program agenda: Identify Characteristics of heart failure patients and common factors that lead to hospitalization of patients. Implications to clinicians