The Who, How and When of Advanced Heart Failure Therapies. Disclosures. What is Advanced Heart Failure?

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1 The Who, How and When of Advanced Heart Failure Therapies 9 th Annual Dartmouth Conference on Advances in Heart Failure Therapies Dartmouth-Hitchcock Medical Center Lebanon, NH May 20, 2013 Joseph G. Rogers, M.D. Associate Professor of Medicine Senior Vice Chief for Clinical Affairs, Division of Cardiology Medical Director, Cardiac Transplant and Mechanical Circulatory Support Program Duke University Disclosures Consultant: Thoratec Corporation Principal Investigator, HeartWare ENDURANCE trial What is Advanced Heart Failure? European Society of Cardiology Committee on Heart Failure NYHA class III-IV symptoms Clinical signs of fluid retention and/or peripheral hypoperfusion Objective evidence of severe LV dysfunction LVEF 0.30 Pseudonormal or restrictive mitral inflow pattern by Doppler High left and/or right-sided filling pressures Elevated b-type natriuretic peptide Severe reduction in exercise capacity 6 minute walk distance < 300 meters Peak VO2 < ml/kg/min > 1 hospitalization in the past 6 months Presence of above despite optimal medical management Eur J Heart Failure 2007; 9:684-94

2 Heart Failure Risk Stratification Defining the patient who is in trouble Signs, symptoms, and clinical course Ventricular structure and function Medication use and intolerance End-organ dysfunction Functional limitations Biomarkers Right heart function Prognostic Importance of Symptoms 100 Cumulative Survival (%) Class II and III Class IV Months Circulation 1987;75(suppl IV):IV11-IV19 NYHA Functional Class is Insensitive to Mortality Sub-stratification using Seattle HF Score 100% 90% 80% 70% SHFS 0 SHFS 1 SHFS 2 1 Year Survival 60% 50% 40% 30% SHFS 3 SHFS 4 20% 10% 0% NYHA 2 NYHA 3 NYHA 3B NYHA 4 * Seven Subjects Levy W: Can the Seattle Heart Failure Model Be Used to Risk Stratify Heart Failure Patients for Potential LVAD Therapy? J Heart Lung Transplant 2009

Freedom From Congestion Predicts Survival Despite Previous Class IV Symptoms of HF 146 patients

of the CHARM Trial Circulation 2007; 116: 1482-7 Heart Failure Risk Stratification: Cardiac Structure

3 Freedom From Congestion Predicts Survival Despite Previous Class IV Symptoms of HF 146 patients hospitalized with class IV heart failure Assessed 4 to 6 weeks after hospitalization for congestion Am Heart J. 2000;140: The Impact of Heart Failure Hospitalization on Mortality Risk A retrospective analysis of the CHARM Trial Circulation 2007; 116: Heart Failure Risk Stratification: Cardiac Structure and Function Hazard ratio 3 Mortality vs EF in CHARM All-cause mortality Subgroup Analysis from SAVE Ejection fraction Eur Heart J 2006;27:65-75 Circulation 1994;89:68-75

4 Importance of RV Function on VAD Outcomes Post-VAD RV failure contributes to: Hepatic congestion Renal failure Bleeding Prolonged mechanical ventilation MSOF Prolonged LOS No RV Failure RV Failure J Thorac Cardiovasc Surg 2006; 131: J Thorac Cardiovasc Surg 2010;139: Predictors of RV failure during LVAD support J Thorac Cardiovasc Surg 2010;139: Kormos, R. Thoracic Cardiovascular Surg 2010;139: Evaluating Right Heart Function Parameter Desirable Value RVSWI [(mpa-mcvp) x SV/BSA] > 300 mmhg ml/m 2 CVP Presence of tricuspid regurgitation PVR and TPG <15 mmhg Minimal to moderate PVR <4 Woods Units and TPG <15 mmhg RV size Need for preoperative ventilator support RVEDV <200 ml and RVESV <177 ml None Clinical Management of Continuous-flow LVADs JHLT 2010: 1-39.

Heart Failure Risk Stratification Circulatory-Renal Limitations to Therapy J Am Coll Cardiol 2003;41:2029-35 Prognosis on Chronic Dobutamine or Milrinone Infusions Gorodeski EZ et al.

5 Heart Failure Risk Stratification Circulatory-Renal Limitations to Therapy J Am Coll Cardiol 2003;41: Prognosis on Chronic Dobutamine or Milrinone Infusions Gorodeski EZ et al. Circulation:Heart Failure, The Prognostic Value of Functional Limitations VO 2 max = (Ao 2 Vo 2 ) x CO 100 Cumulative Survival (%) VO 2 > 14 ml/kg/min VO 2 14 ml/kg/min (listed)* VO 2 14 ml/kg/min (not listed)* * p<0.005 for VO2 14 vs > Duration of Follow-up (Mo) Circulation 1991;83:

6 Is Physician Gestalt Important? ESCAPE Registry included 439 patients not randomized in trial but received a PAC No difference in hemodynamics except higher SVO2 and CI in Trial patients Trial Registry (n=433) (n=439) p LOS, days 6 (3-8) 13 (7-26) < Month Mortality (%) <0.001 LOS given as median (interquartile range). ESCAPE, Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness; LOS, length of stay for index hospitalization; PAC, pulmonary artery catheter. J Cardiac Failure 2008;14:661-9 What Is a Biomarker? A characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or the response to a therapeutic intervention. Atkinson et al, Clin Pharmacol Ther 2001 If it costs less than 10 bucks it s a lab test. If it costs more, it s a biomarker. Alan Maisel Common Biomarkers Useful in Risk Stratification Natriuretic peptides serum sodium BUN creatinine Hemoglobin RDW albumin

7 Physiology of BNP S P K M V Cardiac D R I S SS M S K G R L G G F C S S C K V L R RH G Q G S lusitropic antifibrotic anti-remodeling Hemodynamic (balanced vasodilation) veins arteries coronary arteries Neurohumoral aldosterone endothelin norepinephrine Renal diuresis natriuresis GFR Heart Failure Risk Stratification: Biomarkers Circulation 2003;107: Anemia in Heart Failure Am J Med 2003;114:

Diagnostic Value of Glomerular Filtration Rate in Patients With Heart Failure 4.0 1.0 Proportion survival 0.9 0.8 0.7 0.6 0.

$LVEF=left ventricular ejection fraction Hillage HL et al. Circulation 2000; 102:203-210.$ Heart Failure Risk Stratification: Multivariable Models Seattle Heart Failure Model Levy, Seattle Heart Failure Model Who Should Be

Heart Failure Risk Stratification: Multivariable Models Seattle Heart Failure Model Levy, Seattle Heart Failure Model Who Should Be

8 Diagnostic Value of Glomerular Filtration Rate in Patients With Heart Failure Proportion survival Proportion survival Days 0.0 GFR (ml/min) > <44 LVEF (%) > <20 N=196 GFRc=glomerular filtration rate estimated from serum creatinine, LVEF=left ventricular ejection fraction Hillage HL et al. Circulation 2000; 102: Heart Failure Risk Stratification: Multivariable Models Seattle Heart Failure Model Levy, Seattle Heart Failure Model Who Should Be Referred for Advanced Heart Failure Therapies? Heart failure hospitalization and hypotension Failing standard medical and electrical therapies Resistant to diuretics Inability to walk > 1 block Severe LV dysfunction Kidney dysfunction (particularly BUN)

Right Ventricular Failure: Prediction, Prevention and Treatment

Right Ventricular Failure: Prediction, Prevention and Treatment 3 rd European Training Symposium for Heart Failure Cardiologists and Cardiac Surgeons University Hospital Bern June 24-25, 2016 Disclosures: