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VAD Therapy Changing the Treatment for Heart Failure. Decision Tree For Heart Failure Treatments1 (Consistent with ESC Guidelines) Diuretics to relieve symptoms/signs of congestion + ACE inhibitor (or ARB if not tolerated) ADD a beta blocker Still NYHA class II-IV? Yes No Add a MR antagonist Still NYHA class II-IV? Yes No LVEF ≤ 35%? Yes No Sinus rhythm and HR ≥ 70 beats/min? No Yes Add ivabradine Still NYHA class II-IV? and LVEF ≤ 35%? No Yes QRS duration ≥ 120 ms? No Yes Consider CRT-P/CRT-D Consider ICD Still NYHA class II-IV? Yes No Consider digoxin and/or H-ISDN if end stage, consider LVAD and/or transplantation No further specific treatment Continue in disease-management programme ESC Criteria for VAD-Eligible Patients1 Patients with >2 months of severe symptoms despite optimal medical and device therapy and more than one of the following: • LVEF<25% and, if measured, peak VO2 <12mL/kg/min • ≥3 HF hospitalizations in previous 12 months without an obvious precipitating cause. • Dependence on IV inotropic therapy • Progressive end-organ dysfunction (worsening renal and/or hepatic function) due to reduced perfusion and not to inadequate ventricular filling pressure (PCWP ≥20 mmHg and SBP ≤ 80-90mmHg or CI ≤ 2 L/min/m2). • Deteriorating right ventricular function LVEF = Left ventricular ejection fraction VO2 = Maximal oxygen consumption PCWP = Pulmonary capillary wedge pressure CI = Cardiac index IV = Intravenous ESC HF Guideline 2012 Recommendation – LVADs in Patients with Systolic Heart Failure1 • Recommended in selected patients with end-stage heart failure despite optimal pharmacological and device treatment and who are otherwise suitable for heart transplantation. • Class: I Level: B • Should be considered in highly selected patients who have end-stage heart failure despite optimal pharmacological and device therapy and who are not suitable for heart transplantation, but are expected to survive >1 year with good functional status.. • Class: IIa Level: B Improve symptoms Risk of heart failure hospitalization Risk of premature death ESC HF Guidelines 2012 Definitions1 Classes of Recommendations Definitions Suggested Wording to Use Class I Evidence and / or general agreement that a given treatment or procedure is beneficial, useful, effective “Is recommended / is indicated” Class IIa Weight of evidence / opinion is in favor of usefulness / efficacy “Should be considered” Levels of Evidence Definition B Data derived from a single randomized clinical trial or large non-randomized studies. 1. McMurray, J, et al. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012 European Heart Journal. 2012;33:1787-847. HEARTWARE, CHOICE, HVAD, and the HEARTWARE logo are trademarks of HeartWare, Inc. © 2015 HeartWare, Inc. INTL1044 Rev01 02/16 HeartWare, Inc. 14400 NW 60th Avenue Miami Lakes, FL 33014 USA www.heartware.com