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Acute Decompensated Heart Failure - Medical Management or Device? Timothy M. Hoffman, MD, FACC, FAHA Medical Director, Heart Transplant and Heart Failure Program Associate Medical Director, Division of Cardiology Professor of Pediatrics ………………..…………………………………………………………………………………………………………………………………….. Presenter Disclosure Information Session: Heart Failure/Transplant Presenter: Timothy M. Hoffman, MD Title: Acute Decompensated Heart Failure - Medical Management or Device? Financial Disclosure: There are no relationships that exist related to this presentation ………………..…………………………………………………………………………………………………………………………………….. How Do We Answer the Question? Describe Acute Decompensated Heart Failure in Pediatrics Review Adult and Pediatric Guidelines Review Care Algorithms and Collective Experiences What Don’t We Know • What are the pathophysiological differences (if any) between acute and chronic HF? • What is the difference (if any) between acute decompensated HF versus acute on chronic HF? Adapted from Gheorghiade M, et al. Circulation 2005;112:3958-3968 What Don’t We Know • What is the contribution of different organs or systems to the pathophysiology of acute HF? – Kidney – Liver – Peripheral vasculature • What is unique to the pediatric patient population? Adapted from Gheorghiade M, et al. Circulation 2005;112:3958-3968 Kantor PF, et al. Can J Cardiol 2013;29:1535-1552 Acute Changes & Incomplete Compensation Mancini D, et al. Circulation 2005;112:438-448 Goal of Medical or Device Therapy Mancini D, et al. Circulation 2005;112:438-448 Adult and Pediatric Guidelines Yancy CW, et al. Circulation 2013;28:e240-e327 Treatment of Stages A to D Adult Guidelines Inotropic Support Inotropic Support I IIa IIb III Until definitive therapy (e.g., coronary revascularization, MCS, heart transplantation) or resolution of the acute precipitating problem, patients with cardiogenic shock should receive temporary intravenous inotropic support to maintain systemic perfusion and preserve end-organ performance. I IIa IIb III Continuous intravenous inotropic support is reasonable as “bridge therapy” in patients with stage D refractory to GDMT and device therapy who are eligible for and awaiting MCS or cardiac transplantation. Inotropic Support (cont.) I IIa IIb III I IIa IIb III Short-term, continuous intravenous inotropic support may be reasonable in those hospitalized patients presenting with documented severe systolic dysfunction who present with low blood pressure and significantly depressed cardiac output to maintain systemic perfusion and preserve end-organ performance. Long-term, continuous intravenous inotropic support may be considered as palliative therapy for symptom control in select patients with stage D despite optimal GDMT and device therapy who are not eligible for either MCS or cardiac transplantation. Inotropic Support (cont.) I IIa IIb III Harm I IIa IIb III Harm Long-term use of either continuous or intermittent, intravenous parenteral positive inotropic agents, in the absence of specific indications or for reasons other than palliative care, is potentially harmful in the patient with HF. Use of parenteral inotropic agents in hospitalized patients without documented severe systolic dysfunction, low blood pressure, or impaired perfusion, and evidence of significantly depressed cardiac output, with or without congestion, is potentially harmful. All Cause Mortality Elkayam U, et al. Am Heart J 2007;153:98-104 Treatment of Stages A to D Adult Guidelines Mechanical Circulatory Support Mechanical Circulatory Support I IIa IIb III MCS use is beneficial in carefully selected* patients with stage D HFrEF in whom definitive management (e.g., cardiac transplantation) or cardiac recovery is anticipated or planned. I IIa IIb III Nondurable MCS, including the use of percutaneous and extracorporeal ventricular assist devices (VADs), is reasonable as a “bridge to recovery” or a “bridge to decision” for carefully selected* patients with HFrEF with acute, profound hemodynamic compromise. I IIa IIb III Durable MCS is reasonable to prolong survival for carefully selected* patients with stage D HFrEF. McMurray J, et al. Eur J Heart Fail 2012;14:803-869 Pediatric Guidelines ISHLT Practice Guidelines Inotropic Support All recommendations LOE C • Class I: – Inotropic support can be used in AHF presenting as cardiogenic shock (poor perfusion) • Class IIa: – Inotropic support may be temporarily used in AHF with hypotension and low cardiac output Kirk R, Dipchand AI, Rosenthal D, et al. ISHLT Monograph Series 2014 ISHLT Practice Guidelines • Class IIa: – Inotropic support choice depends on clinical presentation. Milrinone and/or dobutamine can be used as first-line rescue therapy with epinephrine playing a role in refractory hypotension • Class IIb: – Levosimendan may be considered in AHF unresponsive to traditional inotropic support Kirk R, Dipchand AI, Rosenthal D, et al. ISHLT Monograph Series 2014 ISHLT Practice Guidelines Mechanical Circulatory Support All recommendations LOE C • Class IIa: – For a child in cardiac arrest/cardiogenic shock with pulmonary compromise, ECMO should be considered – For a child with AHF that is believed to be reversible, either ECMO or a temporary VAD may be considered as a temporizing measure. Kirk R, Dipchand AI, Rosenthal D, et al. ISHLT Monograph Series 2014 ISHLT Practice Guidelines • Class IIa: – For a child with cardiogenic shock that is not believed to be due to a reversible underlying cause, consideration should be given to use of a temporary VAD or ECMO for resuscitation of end organ function rather than directly implanting a chronic VAD system Kirk R, Dipchand AI, Rosenthal D, et al. ISHLT Monograph Series 2014 Kantor PF, et al. Can J Cardiol 2013;29:1535-1552 Kantor PF, et al. Can J Cardiol 2013;29:1535-1552 Kantor PF, et al. Can J Cardiol 2013;29:1535-1552 ∙ Circulatory support Kantor PF, et al. Can J Cardiol 2013;29:1535-1552 Care Algorithms and Collective Experiences Can We Predict the Outcome? ADHERE Trial Analysis Yancy CW, et al. J Am Coll Cardiol 2006;47:76-84 Seattle Heart Failure Score Levy W C et al. Circulation. 2006;113:1424-1433 Copyright © American Heart Association, Inc. All rights reserved. Seattle Heart Failure Score Levy W C et al. Circulation. 2006;113:1424-1433 Copyright © American Heart Association, Inc. All rights reserved. Predicted Effects on Survival Levy W C et al. Circulation. 2006;113:1424-1433 Copyright © American Heart Association, Inc. All rights reserved. REMATCH Trial: Subset Analysis Stevenson L W et al. Circulation. 2004;110:975-981 Copyright © American Heart Association, Inc. All rights reserved. Improvement in Minnesota Living with Heart Failure Score Stevenson L W et al. Circulation. 2004;110:975-981 Copyright © American Heart Association, Inc. All rights reserved. LVAD survival benefit Stevenson L W et al. Circulation. 2004;110:975-981 % of Patients with VAD as BTT Blume E D et al. Circulation. 2006;113:2313-2319 Copyright © American Heart Association, Inc. All rights reserved. How Many Recovered? Blume E D et al. Circulation. 2006;113:2313-2319 Copyright © American Heart Association, Inc. All rights reserved. Device Types Peura J L et al. Circulation. 2012;126:2648-2667 Copyright © American Heart Association, Inc. All rights reserved. Device Selection Flow Chart Peura J L et al. Circulation. 2012;126:2648-2667 Copyright © American Heart Association, Inc. All rights reserved. Optimal Timing for MCS Peura J L et al. Circulation. 2012;126:2648-2667 Copyright © American Heart Association, Inc. All rights reserved. Optimal Timing for MCS Peura J L et al. Circulation. 2012;126:2648-2667 Copyright © American Heart Association, Inc. All rights reserved. Optimal Timing for MCS Peura J L et al. Circulation. 2012;126:2648-2667 Copyright © American Heart Association, Inc. All rights reserved. Device Types Peura J L et al. Circulation. 2012;126:2648-2667 Copyright © American Heart Association, Inc. All rights reserved. Bridge to Recovery Simon MA, et al. Circulation 2005;112[suppl I]:I-32-I-36 Bridge to Recovery Simon MA, et al. Circulation 2005;112[suppl I]:I-32-I-36 Ejection Fraction Bridge to Recovery = non-ischemic CM Simon MA, et al. Circulation 2005;112[suppl I]:I-32-I-36 Clinical Scenario • 8 year old (25 kg, BSA 0.97 m2) – Bone sarcoma • Doxorubicin 450 mg/m2 cumulative dose – SF 15%, EF 25% • Inotropic and mechanical ventilatory support • Ongoing deterioration – 149 device days total • 90 days in hospital Cavigelli-Brunner A, et al. Pediatrics 2014;134:e894 Catheterization/Balloon Occlusion of Outflow Graft Cavigelli-Brunner A, et al. Pediatrics 2014;134:e894 HeartWare Cavigelli-Brunner A, et al. Pediatrics 2014;134:e894 Impella Recover LVAD Siegenthaler MP, et al. J Thorac Cardiovasc Surg 2004;127:812-22 Impella Recover LVAD Acute Decompensated Heart Failure - Medical Management or Device? • Answer is … – Interpreting the current guidelines and reviewing the collective experiences… – Optimal medical management is acceptable as initial therapy for most patients – For fulminant myocarditis, early device use is acceptable as a bridge to decision Acute Decompensated Heart Failure - Medical Management or Device? • The decision to implant a device takes into account: – Disease process (reversibility, pathophysiology) – Patient size – Available devices – Program experience and infrastructure • What works best within the program’s system Future Directions • Can we predict outcome in acute heart failure in children? • Can device technology improve in pediatrics for specific clinical scenarios? • Can we develop practice models for pediatric heart failure? Future Directions Paradigm ISHLT Workforce Targeted Therapies AHA CVDY Committee National Registry Develop practice models Link phenotype and genotype data ………………..……………………………………………………………………………………………………………………………………..