All Roads Lead to HF. Presenter Disclosure Information. After a Decade of (Almost) Nothing Multiple New Therapies for Heart Failure CAD.

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1 After a Decade of (Almost) Nothing Multiple New Therapies for Heart Failure Larry A. Allen, MD, MHS Director for Advanced Heart Failure October 18, 2016 Presenter Disclosure Information I will not discuss off label use or investigational use in my presentation. I have financial relationships to disclose: Employee of: University of Colorado Consultant for: J&J/Janssen, Novartis, St. Jude, ZS Pharma Stockholder in: None Research support from: NIH / NHLBI, PCORI, AHA Honoraria from: None All Roads Lead to HF Congential Heart Dz CAD HF Valve Dz Hypertension Hypertrophic CM Ideopathic CM

2 4 2010, American Heart Association HF is Largely a Disease of the Aged Population (%) Males Females Median age for hospitalized HF = 77 years US, AHA. Heart Disease and Stroke Statistics 2004 Update Age (yr) 5 Costs of HF in US Hospitalization $ % Total Cost $39.2 billion 11.9% Nursing Home $ % 6.4% 9.7% 8.2% Lost Productivity/ Mortality* $4.1 Home Healthcare $3.8 Drugs/Other Medical Durables $3.2 Physicians/Other Professionals $2.5 Heart Disease and Stroke Statistics 2010 Update: A Report From the AHA Circulation, Feb 2010; 121: e46 - e215.

3 7 Dismal Outcomes in Patients Hospitalized with HF 100 Hospital Readmissions 100 Mortality % 50% % 33% 50% 0 30 Days 6 Months 0 30 Days 12 Months 5 Years Mean Length of Stay: 5 days What do we do? Regardless of HF Type, Diuresis PRN HFrEF (LVEF < 40%) HFpEF (LVEF > 50%) RV Failure Chronic (Stable) Acute (Unstable) Volume Control

4 10 IV diuretics: 90% of HF hospitalizations, 70% only Rx Δ is IV loop diuretic DIURETICS Stroke Volume Ventricular End-Diastolic Pressure Potency Usual 24hr dosing mg mg mg Cost $4/mo $4/mo?? Diuretic Dosing

5 Yancy et al ACCF/AHA Heart Failure Guideline. Start with what we know HFrEF (LVEF < 40%) HFpEF (LVEF > 50%) RV Failure Chronic (Stable) Acute (Unstable)

6 Reverse remodeling Rx for HFrEF: Indicated for nearly all Stage C ACEi ßB NYHA I NYHA II?? NYHA III CRT NYHA IV AA Progress?! 2004 to 2015

7 Since 2015 CardioMEMS PA monitor Cardiac rehabilitation for HFrEF Ivabradine Sacubitril/valsartan CRT refinements SQ-ICD MCS options ARB+NEPi (ARNI) Von Leuder CircHF 2013;594 PARADIGM LCZ bid (valsartan + sacubutril) v. enalapril 10 bid 8441 pts: NYHA II-VI, LVEF <=40% Stopped early at 27 months

8 Outcomes

9 2016 ACC/AHA Guideline Update ARNI Systolic Heart failure treatment with the I f inhibitor ivabradine Trial

10 screened 6558 randomized 3268 to ivabradine 3290 to placebo Excluded: 27 Excluded: analysed 2 lost to follow-up to follow-up3264 analysed 1 lost to followup Median study duration: 22.9 months; maximum: 41.7 months Swedberg K, et al. Lancet. 2010;;376(9744):

11 ACC/AHA Guideline Update Improved survival in HFrEF

12 Challenges Challenge #1: Missed Opportunities Failure to Prescribe

13 Failure to Dose Maximize HEAAL Failure to Monitor Challenge #2: Add-on Therapy

14 The cumulative burden of success 40 Predictors of poor medication adherence Psychological problems, particularly depression Cognitive impairment Asymptomatic disease Inadequate follow-up or discharge planning Side effects to medications Lack of belief in treatment benefit Lack of insight into illness Poor patient-provider relationship Barriers to care or medications Missed appointments Complexity of treatment Cost of medications, copayments, or both Osterberg L, et al. NEJM 2005 Initiation Burden 42

15 Even after transplant Challenge #3: Big Data v. Data Overload

16 The secret of the care for the patient is caring for the patient. Francis Peabody

17 Challenge #4: HFpEF? Gaasch WH et al. Am J Cardio 2009;;104:1413 De Keulenaer GW, Brutsaert DL. Circ 2009;;119:3044 Guidelines HFpEF: radio silence ARB: HFrEF v. HFpEF CHARM Alternative CHARM Preserved I-PRESERVE HFrEF HFpEF

18 MRA for HFpEF: Nope Aldo-DHF TOPCAT Start before it s too late Biggest HF Trials in 2015

19 Biggest HF Trials in 2015 Biggest HF Trials in 2015 Challenge #5: Complex treatment options in complex patients

20 23,435 individuals identified with HF Multimorbidity common addition to HF: 2%: no comorbdity 76%: 3+ co-occurring conditions 52%: 5+ co-occurring conditions HFpEF compared to HFrEF : 53% v. 47% mean 4.5 vs 4.4 comorbidities J Am Geriatr Soc 2013;61:26 33 Re-Conceptualization J Am Geriatr Soc 2013 Death is part of life 60

21 Lanken PN et al. Am J Respir Crit Care Med Summary: Going Forward 1. Rx for HFrEF is where the data is: do it right! ESC 2016 Stage C HFrEF

22 Summary: Going Forward 1. Rx for HFrEF is where the data is: do it right! 2. Future systems of care will need to be: patient-centered longitudinal team-based with clinician and patient decision support Summary: Going Forward 1. Rx for HFrEF is where the data is: do it right! 2. Future systems of care will need to be: patient-centered longitudinal team-based with clinician and patient decision support 3. Expand from Stage C HFrEF to: HFpEF Stage A prevention Stage D end-of life 7 board-certified Advanced Heart Failure & Transplant Cardiologists Gene Wolfel, MD Andreas Brieke, MD (Director MCS) Larry Allen, MD, MHS (Director HF) Amrut Ambardekar, MD (Director Txplt) Natasha Altman, MD Prateeti Khazanie, MD William Cornwell, MD 5 Dedicated Advanced HF NPs 4 MCS Coordinators 4 Advanced Heart Failure RNs 4 Transplant Coordinators 1 HF Clinical Nurse Specialist 4 CT Surgery 18 Fellows, including advanced HF larry.allen@ucdenver.edu Cell

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