Major Medical Decisions in Advanced Heart Failure

1. Major Medical Decisions in Advanced Heart Failure G. Michael Felker, MD, MHS, FACC, FAHA Chief, Heart Failure Section Duke University School of Medicine

2. Disclosures • Grant Support and/or Consulting • NIH/NHLBI • Novartis • Amgen • Trevena • Roche Diagnostics • Otsuka • Celladon • St Judes • Singulex

4. Allen, LA et al. Circulation, 2012

5. Variable Clinical Course of Heart Failure Allen L A et al. Circulation 2012

6. Defining Options • Medical decision making is not a menu where the patient choses from among all available treatment options • Clinicians are responsible for defining the range of medically appropriate options. • Presentation of options should include: • alternative approaches • range of anticipated outcomes, including QoL • “what if?” scenarios

7. Typical Medical Decisions in Advanced Heart Failure • Should we place an ICD? • Should we list for heart transplant? • Should we place a ventricular assist device as destination therapy? • Should we involve palliative care?

8. ICDs in Chronic HF P=0.007 P=0.016 P=0.004 P=0.065

9. Device Therapy for Stage C HFrEF I I IIa IIa IIb IIb III III A B ICD therapy is recommended for primary prevention of SCD to reduce total mortality in selected patients with nonischemic DCM or ischemic heart disease at least 40 days post-MI with LVEF of 35% or less, and NYHA class II or III symptoms on chronic GDMT, who have reasonable expectation of meaningful survival for more than 1 year. ICD therapy is recommended for primary prevention of SCD to reduce total mortality in selected patients at least 40 days post-MI with LVEF less than or equal to 30%, and NYHA class I symptoms while receiving GDMT, who have reasonable expectation of meaningful survival for more than 1 year.

10. Device Therapy for Stage C HFrEF I IIa IIb III B *Counseling should be specific to each individual patient and should include documentation about the potential for sudden death and non-sudden death from HF or non-cardiac conditions. Information should be provided about the efficacy, safety, and potential complications of an ICD and the potential for defibrillation to be inactivated if desired in the future, notably when a patient is approaching the end of life. The usefulness of implantation of an ICD is of uncertain benefit to prolong meaningful survival in patients with a high risk of nonsudden death as predicted by frequent hospitalizations, advanced frailty, or comorbidities such as systemic malignancy or severe renal dysfunction.

11. Primary Prevention ICD in context • Out of 100 patients with an ICD implanted for primary prevention and followed for 4 years: • 70 will never receive a shock • Of the 30 who do receive a shock, 13 of those shocks will be inappropriate • 17 will have an appropriate shock that prevents SCD • 10 of those pts will go onto die of something else • 7 lives will be saved by implanting an ICD • 14 ICD’s will be implanted to save 1 life (NNT = 14) Extrapolated from SCD-HeFT results

12. ICD Take Home Message • ICD clearly improve survival in well defined groups of patients with heart failure • Data on ICD therapy in patients with more advanced HF is very limited • Important limitations of ICD therapy • ICDs do not improve symptoms or QOL • ICDs may decrease QOL (frequent shocks) • ICDs are designed to identify and treat a specific type of mortal event (ventricular tachy-arrhythmias)

13. Typical Medical Decisions in Advanced Heart Failure • Should we place an ICD? • Should we list for heart transplant? • Should we place a ventricular assist device as destination therapy? • Should we involve palliative care?

16. I IIa IIb III Cardiac Transplantation Evaluation for cardiac transplantation is indicated for carefully selected patients with stage D HF despite GDMT, device, and surgical management.

17. Cardiac Transplantation Evaluation • Complete history and physical examination • CBC, BMP, LFT, coags, UA • Serologic testing for syphilis, HIV, hepatitis B & C, CMV,EBV, VZV, toxo • Tb skin testing • ABO, HLA typing, panel reactive antibody screening • 12 lead ECG • Echocardiogram • Chest xray • Cardiopulmonary exercise testing • Right heart catheterization with vasodilator challenge if appropriate • Age appropriate cancer screening • PFTS • Carotid ultrasound • VQ scan • Dental evaluation • Psychosocial evaluation • Social work evaluation • Nutrition consult • Financial Evaluation

18. Transplant is Epidemiologically Trivial 300 million 2.6% w/ HF (7 milllion) 50% sys HF 25% NYHA III 10% NYHA IIIB (300-350K) 5% NYHA IV (150-200K) IIIB+IV (250-300K) [<75 yrs] ~2300 transplant/year Miller LW. Circulation 2011

19. Typical Medical Decisions in Advanced Heart Failure • Should we place an ICD? • Should we list for heart transplant? • Should we place a ventricular assist device as destination therapy? • Should we involve palliative care?

20. Improving Survival with Continuous Flow LVAD

21. Improvement in Functional Capacity with Mechanical Support Rogers, JG et al. JACC 2010

22. Changing Landscape of Mechanical Support Stewart and Stevenson. Circulation 2011;123:1559-68.

23. Landscape of potential VAD patients AHA/ACC classification Stage C Stage D NYHA classifications Class III Class IIIb/IV Class IV 7 6 5 4 3 2 1 INTERMACS Profiles Range of HM II DT Approval and CMS Coverage Approved General Range of Market Adoption Not Broadly Adopted Generally Accepted Ambulatory Class IIIB and IV INTERMACS 6: Walking Wounded INTERMACS 5: Exertion intolerant Less Sick Sick INTERMACS 4: Resting symptoms on oral therapy at home ROADMAP

24. Limitations of of LVAD Therapy • Right heart failure • Pump thrombosis • Stroke • Recurrent GI bleeding • Arrhythmias • Aortic insufficiency • Drive line infections

25. I I I IIa IIa IIa IIb IIb IIb III III III Mechanical Circulatory Support 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. 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. Durable MCS is reasonable to prolong survival for carefully selected* patients with stage D HFrEF. B B B

26. Re-hospitalizations after LVAD Total Readmissions Hospital Days Smedira, N. et al. JACC-Heart Failure, 2013

27. The Importance of Frailty Patient Selection for Advanced Heart Failure Therapy Flint, KM. CircHeart Fail 2012;5:286-93

28. “…it is challenging to locate the intersection of patients who face high mortality without LVAD and yet can look forward to good outcomes with LVAD.” Stewart and Stevenson. Circulation 2011.

29. LVAD Take Home • Destination LVAD therapy can provide substantial improvement in survival and functional capacity in selected patients with advanced heart failure • It is also associated with a multiple major morbidities and a high risk of unplanned rehospitalization • Patient selection with attention to those comorbidities likely to be improved by VAD therapy vs. those not is key

30. Other Important Considerations • Even non-cardiac procedures may lead to progressive heart failure and cardiogenic shock • Many ‘temporary’ forms of support may be associated with failure to wean and ‘dependence’ • Cardiopulmonary bypass • Inotropic therapy • IABP • Mechanical Ventilation • Need for discussion of “what if” outcomes where feasible in advance

31. Typical Medical Decisions in Advanced Heart Failure • Should we place an ICD? • Should we list for heart transplant? • Should we place a ventricular assist device as destination therapy? • Should we involve palliative care?

32. Palliative Care is: • Specialized medical care for people with serious illness • Relief from symptoms, pain and stress – whatever the diagnosis • Improve quality of life for both patient and family • Ateam that provides an extra layer of support • Appropriate at any age and at any stage of illness • Can be provided together with curative treatment

33. Medicare Hospice Benefit Life Prolonging Care Life Prolonging New Hospice Care Care Bereavement Palliative Care Palliative Care Models Diagnosis of Serious Illness End of Life Old

34. Shared Decision Making “The process through which clinicians and patients share information with each other and work toward decisions about treatment chosen from medically reasonable options aligned with patients’ values, goals, and preferences.”