HFA- ESC criteria for Advanced HF and US Requirements for Destination Therapy

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3 HFA- ESC criteria for Advanced HF and US Requirements for Destination Therapy ESC- HFA criteria for Adv-HF Severe symptoms of HF (NYHA class III or IV) with episodes of fluid retention and/or peripheral hypoperfusion History of 1 HF hospitalisation in the past 6 months Severe cardiac dysfunction (EF<30%, high PWP/ BNP) Severe impairment of functional capacity (inability to exercise, 6MWTD<300, pvo 2 <12-14) All the previous features despite attempts to optimise therapy, including β-blockers and ACE inhibitors Metra et al. HFA position statement. EJHF 2007; 9:

4 HFA- ESC criteria for Advanced HF and US Requirements for Destination Therapy ESC- HFA criteria for Adv-HF Severe symptoms of HF (NYHA class III or IV) with episodes of fluid retention and/or peripheral hypoperfusion History of 1 HF hospitalisation in the past 6 months Severe cardiac dysfunction (EF<30%, high PWP/ BNP) Severe impairment of functional capacity (inability to exercise, 6MWTD<300, pvo 2 <12-14) Destination therapy coverage Chronic NYHA class IV heart failure Not a candidate for heart transplant LVEF <25%, Severe functional limitation with peak VO 2 <14 ml/k/m unless on IABP or inotropes, or physically unable All the previous features despite attempts to optimise therapy, including β-blockers and ACE inhibitors Did not respond to optimal medical management for days (including β-blockers and ACE inhibitors if tolerated), or IABP for 7 d, or IV inotrope for 14 d Metra et al. EJHF 2007; 9:684; Stewart & Givertz, Circulation. 2012;125:

5 Stages and phenotypes of heart failure At risk for heart failure Heart failure Stage A At high risk for HF but without structural heart disease of symptoms of HF Stage B Structural heart disease but without signs or symptoms of HF Stage C Structural heart disease but prior or current symptoms of HF Stage D Refractory HF e.g. Patients with: Hypertension Diabetes mellitus Obesity Metabolic syndrome Structural OR heart disease Patients: Using cardiotoxins With family history of cardiomyopathy e.g. Patients with: Previous MI LV remodelling including LVH and low EF Asymptomatic valvular disease Development of symptoms of HF e.g. Patients with: Known structural heart disease and HF signs and symptoms Refractory symptoms of HF at rest, despite GDMT e.g. Patients with: Marked HF symptoms at rest Recurrent hospitalisations despite GDMT Advanced heart failure Yancy CW, et al. J Am Coll Cardiol. 2013;62:e

6 Stage D, Advanced Heart Failure Presence of progressive and/or persistent severe signs and symptoms of heart failure despite optimized medical, surgical, and device therapy. It is generally accompanied by frequent hospitalization, severely limited exertional tolerance and poor quality of life and is associated with high morbidity and mortality. The progressive decline should be primarily driven by the heart failure syndrome Fang et al Advanced (Stage D) Heart Failure: A Statement from the Heart Failure Society of America Guidelines Committee, Journal of Cardiac Failure (2015), doi: /j.cardfail

7 Clinical course of HF Allen LA, et al. Circulation 2012; 125:

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9 Advanced & End-stage heart failure ACHF Reduced exercise capacity / poor QoL * Poor outcomes, i.e % 1-year death / hospitalisation Reversible: cardiac function / symptoms End-stage HF Very poor QoL * Very poor outcome, i.e. >30% 1-year death Not reversible Quality of life > important survival * QoL: Quality of Life Metra M, et al. Eur J Heart Fail Jun;9(6-7):

10 Khawaja Afzal Ammar et al. Circulation. 2007;115:

11 Number of AHF Patients potential VAD candidates 300 millions US population HF=2.6% population or 7 millions total 50-55% systolic HF or millions Class IIIB ,000 Class IV ,000 Class IIIB+IV, <75 yrs ,000 pts Theoretical candidates for VAD support Miller LW, Guglin M. J Am Coll Cardiol 2013; 61:

12 Survival curves according to HF stage Khawaja Afzal Ammar et al. Circulation. 2007;115:

13 Survival Analysis for LVAD and : INTREPID Trial Roigers et al. JACC Volume 50, Issue 8, 2007,

14 Fig. 1 Assessment domains in advanced HF Journal of Cardiac Failure , DOI: ( /j.cardfail )

15 INTERMACS stages for patienst with advanced heart failure Ponikowski et al. Eur J Heart Fail 2016;

16 Cowger et al. J Am Coll Cardiol. 2013;61(3):

17 The HeartMate Risk Score Identifies Patients With Similar Risk of 1-year Mortality Across All INTERMACS Profiles Adamo et al JCHF. Published online September 07, doi: /j.jchf

18 Fig. 2 Clinical approach to advanced HF Journal of Cardiac Failure , DOI: ( /j.cardfail )

19 Probability of an HF event for 261 patients during a 6-month period in relation to chronic daily epad Stevenson, L. W. et al. Circ Heart Fail 2010;3:

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21 Predictors of 180 days mortality by baseline variables in the PROTECT trial This reflects a particularly poor outcome in patients with a disproportionately high urea compared with creatinine. Cleland et al. Circulation Heart Fail 2014; 7:76

22 Therapeutic algorithm for a patient with symptomatic HFrEF Ponikowski et al. Eur J Heart Fail 20 MAY 2016 DOI: /ejhf.592

23 Poor Diuretic Response (DR) but not Worsening Renal Function (WRF) identify patients at high risk of events. RELAX-AHF Trial Voors et al. Eur J Heart Fail Accepted for publication

24 Dual Angiotensin Receptor and Neprilysin inhibition (ARNI) as an alternative to ACE inhibition in patients with chronic systolic HF. Design of the PARADIGM HF Trial Aged > 18 years NYHA II-IV LVEF < 40% BNP/NTpro BNP > 150 / 600 pg/ml McMurray et al. European Journal of Heart Failure; 15:

25 McMurray et al. Eur J Heart Fail 2015

26 Effect of Angiotensin Receptor Neprilysin Inhibitor on Clinical Outcomes: The MAGGIC Risk Score Category Simpson et al. J Am Coll Cardiol. 2015;66(19):

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28 Mentz et al. Am Heart J 2014;168:

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32 Comparative Effectiveness of LVAD and Optimal Medical Management (OMM) in Ambulatory HF Patients: ROADMAP Study Estep et al. J Am Coll Cardiol. 2015;66(16):

33 Comparative Effectiveness of LVAD and Optimal Medical Management (OMM) in Ambulatory HF Patients: ROADMAP Study Estep et al. J Am Coll Cardiol. 2015;66(16):

34 Heart Transplant and LVAD Implant Numbers in the United States 2006 to 2010 Miller LW, Guglin M.. J Am Coll Cardiol. 2013;61(12):

35 Use of MCS Devices Between 2004 and 2011 Stretch et al. J Am Coll Cardiol. 2014;64(14):

36 Mortality Rate Associated With Short-Term Mechanical Circulatory Support (2004 to 2011) Stretch et al. J Am Coll Cardiol. 2014;64(14):

37 Indications for Mechanical Circulatory Support Ponikowski et al. Eur J Heart Fail 2016;

38 Progressive Improvement in Outcomes of Patients Supported With CF-LVADs for Advanced Heart Failure Uriel, Adatya, Mehra. J Am Coll Cardiol. 2015;66(23): doi: /j.jacc

39 Patients potentially eligible for LVAD implantation Ponikowski et al. Eur J Heart Fail 2016;

40 Recommendations for LVAD implantation Rose et al. N Engl J Med 2001; 345: ; Slaughter et al. N Engl J Med 2009; 361: ; Estep et al. J Am Coll Cardiol 2015; 66: Ponikowski et al. Eur J Heart Fail 2016;

41 Indications to heart transplantation Ponikowski et al. Eur J Heart Fail 2016;

42 Temporal trends in downloads and time (July to August 2010) when Vice President Cheney underwent LVAD implantation (arrow) LVAD-related videos uploaded on YouTube LVAD-related messages on Twitter Pandey, Abdullah, Drazner. Am J Cardiol 2014; 113:

43 Temporal trends in Google search interest and Vice President Cheney health Pandey, Abdullah, Drazner. Am J Cardiol 2014; 113: