Advanced Heart Failure: Patient Identification and Treatment Options. Donald Haas, MD, MPH Abington - Jefferson Health Abington, PA

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1 Advanced Heart Failure: Patient Identification and Treatment Options Donald Haas, MD, MPH Abington - Jefferson Health Abington, PA

2 Disclosures I have received honoraria from Thoratec Corporation/St. Jude Medical, manufacturer of Heartmate II and Heartmate 3 left ventricular assist devices I will not discuss any off label products or devices

3 Advanced Heart Failure Considerations Heart failure is associated with extremely high mortality rates

4 Walking Dead Among HF outpatients One year mortality 20% Five year mortality 50% Among HF inpatients One year risk adjusted mortality 30% Chen J. JAMA 2011;306:1669 Donahoe SM. JAMA 2007;298:765

Heart failure is associated with very high mortality rates Among HF outpatients One year mortality 20% Five year mortality One year 50% mortality among

5 Heart failure is associated with very high mortality rates Among HF outpatients One year mortality 20% Five year mortality One year 50% mortality among myocardial infarction patients Among HF inpatients is only 7% One year risk adjusted mortality 30% Chen J. JAMA 2011;306:1669 Donahoe SM. JAMA 2007;298:765

6 Five-year Mortality following Hospitalization for ADHF Shahar E, et al. J Card Fail 2004;10:

7 Percent survival Survival of Stage D Heart Failure Patients with Optimal Medical Therapy

8 Mortality expectation % at One Year Rose EA, et al. Long-term mechanical left ventricular assistance for end-stage heart failure. N Engl J Med Nov 15;345(20): Projected Mortality for Advanced Heart Failure on Par Other Terminal Diseases AIDS Leukemia Lung Cancer Pancreatic Cancer End-stage Heart Failure with Optimal Diagnosis Medical Management

9 Heart Failure: Scope of the Problem Estimated 7 million patients with HF 1 50% have HFpEF or diastolic HF 1,2 (1) Miller LW, Circulation. 2011;123: (2) AbouEzzeddine OF, et al. Congest Heart Fail. 2011;17: (3) Bhatia RS. N Engl J Med. 2006; 355:

10 Pulmonary Hypertension J Am Coll Cardiol 2012 Jan 17;59(3): Heart. 2012; 98(24):

11 Advanced Heart Failure Considerations Heart failure is associated with extremely high mortality rates Generally, advanced heart failure do not receive appropriate therapy

12 Jessup M, Brozena S. N Engl J Med. 2003;348: Stages of Heart Failure

13 Functional Class NYHA Class Class I: no functional impairment Class II: SOB at moderate exertion Class III: SOB at minimal mild exertion Class IV: SOB at rest

14 Why stages? NYHA Class Class I: no functional impairment Class II: SOB at moderate exertion Class III: SOB at minimal mild exertion Class IV: SOB at rest

15 Why stages? NYHA Class Class I: no functional impairment - NYHA Class changes Class II: SOB at moderate exertion Class III: SOB at minimal mild exertion - Inadequate as stand Class IV: SOB at rest alone descriptor of natural history

16 Jessup M, Brozena S. N Engl J Med. 2003;348: Stages of Heart Failure

17 Stage A: high risk for HF without structural heart disease or symptoms Hypertension Atherosclerotic heart disease Diabetes Obesity Metabolic syndrome Cardiotoxins (eg, doxorubicin, EtOH) Family history of cardiomyopathy

18 Jessup M, Brozena S. N Engl J Med. 2003;348: Stages of Heart Failure

19 Stage B: Structural heart disease without the development of HF Prior myocardial infarction Depressed LV ejection fraction Left ventricular hypertrophy Asymptomatic valvular heart disease

20 Jessup M, Brozena S. N Engl J Med. 2003;348: Stages of Heart Failure

21 Stage C: Structural heart disease with current or prior symptoms Needs Lasix Heart Failure Syndrome

22 CARDIOMYOPATHY IS NOT SYNONYMOUS WITH HEART FAILURE

23 Jessup M, Brozena S. N Engl J Med. 2003;348: Stages of Heart Failure

24 Stage D: refractory symptoms requiring special intervention What constitutes refractory symptoms? Repeated HF hospitalizations? Inability to complete activities of daily living? Severe sodium/fluid restriction and high diuretic requirement?

25 Jessup M, Brozena S. N Engl J Med. 2003;348: Stages of Heart Failure

26 Guideline Recommendations: Role of Inotropic Therapy in Patients with Heart Failure The routine use of inotropes as heart failure therapy is not indicated in either the short- or longterm setting The use of inotropes as a treatment of cardiogenic shock, diuretic/ace inhibitor refractory heart failure decompensations, or as a short-term bridge to definitive treatment, such as revascularization or cardiac transplantation, is potentially appropriate Inotropes may be appropriate as a palliative measure in patients with truly end-stage heart failure as part of hospice care

27 COSI* Survival *Continuous Outpatient Support with Inotropes Hershberger RE et al. J Card Fail 2003; 9:

28 IV Inotropic Agents During Hospitalization for Decompensated Heart Failure * without cardiogenic shock Treatment Failure From Adverse Event (48 h) OPTIME-CHF: In-hospital Adverse Events P < P < Sustained Hypotension 3.2 Cuffe MS et al. JAMA. 2002;287: Acute MI P = Afib Milrinone Placebo P = P = Mortality 2.3

29 Guideline Recommendations: Role of Inotropic Therapy in Patients with Heart Failure The routine use of inotropes as heart failure therapy is not indicated in either the short- or longterm setting The use of inotropes as a treatment of cardiogenic shock, diuretic/ace inhibitor refractory heart failure decompensations, or as a short-term bridge to definitive treatment, such as revascularization or cardiac transplantation, is potentially appropriate Inotropes may be appropriate as a palliative measure in patients with truly end-stage heart failure as part of hospice care

30 Stage D: refractory symptoms requiring special intervention Need for inotropes Treatments Transplant MCS/LVAD Hospice

31 Treatment Options for Stage D Heart Failure Patients Transplant Candidate MCS Candidate Hospice

32 Treatment Options for Stage D Heart Failure Patients Transplant Candidate Care as usual MCS Candidate is not an option Hospice

33 Scope of the Problem Estimated 7 million patients with HF 1 50% have HFrEF or systolic HF 1,2 10% have stage D HF Estimates vary between 5-20% 1,2 ~2200 transplants in US annually 6 ~4000 LVAD implants in US % referred to hospice Estimates vary between 12-20% (conservative) 2,3,4,5 (1) Miller LW, Circulation. 2011;123: (2) AbouEzzeddine OF, et al. Congest Heart Fail. 2011;17: (3) Setoguchi S, et al. Am Heart J. 2010;160: (4) Connor SR, et al. J Pain Symptom Manage. 2007;34: (5) Givens JL, et al. Arch Intern Med. 2010;170: (6) Taylor DO, et al. J Heart Lung Transplant. 2009;28: (7) Personal communication, Thoratec, INTERMACS

Scope of the Problem Estimated 7 million patients with HF 1 50% have HFrEF or systolic HF 1,2 10% have stage D HF Estimates vary between 5-20% 1,2 ~2200 transplants in US annually 6 350,000 HFrEF

34 Scope of the Problem Estimated 7 million patients with HF 1 50% have HFrEF or systolic HF 1,2 10% have stage D HF Estimates vary between 5-20% 1,2 ~2200 transplants in US annually 6 350,000 HFrEF Stage D ~4000 LVAD implants in US % referred to hospice Estimates vary between 12-20% (conservative) 2,3,4,5 (1) Miller LW, Circulation. 2011;123: (2) AbouEzzeddine OF, et al. Congest Heart Fail. 2011;17: (3) Setoguchi S, et al. Am Heart J. 2010;160: (4) Connor SR, et al. J Pain Symptom Manage. 2007;34: (5) Givens JL, et al. Arch Intern Med. 2010;170: (6) Taylor DO, et al. J Heart Lung Transplant. 2009;28: (7) Personal communication, Thoratec, INTERMACS

35 Most advanced HF patients do not receive stage D therapies 18% of patients receive advanced HF therapies Untreated N =288,300 LVAD N = 3,500 Transplant N = 2,200 Hospice N = 56,000

36 Characteristic Death with HF All deaths (n=160) Outpt deaths (n=80) Inpt deaths (n=80) CHF clinic (mos) CHF duration (yrs) Age (yrs) Male (%) NYHA III (%) NYHA IV (%) ICD (%) CRT (%) EF (%) Deaths from 1/1/00-10/20/03 Teuteberg et al. J Card Fail 2006;12:47

37 HF Patients (%) Cancer Patients (%) Hospice prior to death Died <3 days after hospice enrollment Opiates < 60 days before death Opiates in those dying in hospital Opiates in those dying outside hospital ER visits <30 days before death Hospitalized <7 days before death Hospitalized <30 days before death ICU <30 days before death Adm SNF before death Death in acute care hospital Setoguchi S, et al. Am Heart J. 2010;160:

38 HF Patients (%) Cancer Patients (%) Hospice prior to death Died <3 days after hospice enrollment Opiates < 60 days before death Opiates in those dying in hospital Opiates in those dying outside hospital ER visits <30 days before death Hospitalized <7 days before death Hospitalized <30 days before death ICU <30 days before death Adm SNF before death Death in acute care hospital Setoguchi S, et al. Am Heart J. 2010;160:

39 HF Patients (%) Cancer Patients (%) Hospice prior to death Died <3 days after hospice enrollment Opiates < 60 days before death Opiates in those dying in hospital Opiates in those dying outside hospital ER visits <30 days before death Hospitalized <7 days before death Hospitalized <30 days before death ICU <30 days before death Adm SNF before death Death in acute care hospital Setoguchi S, et al. Am Heart J. 2010;160:

40 Hospitalizations Predict Mortality Russell SD, et al. Congest Heart Fail 2008;14:316-21

41 Russell SD, et al. Congest Heart Fail 2008;14: Hospitalizations Predict Mortality Any heart failure admission is a red flag!!

Impact of Hospitalizations on Mortality J Am Coll Cardiol. 2013;61(12):1209-1221. doi:10.1016/j.jacc.2012.08.

42 Impact of Hospitalizations on Mortality J Am Coll Cardiol. 2013;61(12): doi: /j.jacc Figure Legend: Median Survival Decreases Progressively After Each Hospitalization for HF Hospital admissions not only decrease quality of life, but they are also associated with shorter longevity.

43 Presence of JVD Drazner MH, et al. N Engl J Med 2001; 345:

44 Improvement of Congestion Predicts Survival in Patients With Class IV Symptoms of ADHF 146 Patients hospitalized with class IV HF 80 Assessed 4 to 6 weeks after hospitalization for congestion Patients with persistent orthopnea (n=33) 2-year survival: 38% Patients with resolution of orthopnea (n=113) 2-year survival: 77% (P=.0001) yr survival Orthop No orthop Lucas C et al. Am Heart J. 2000;140:

45 Failure to achieve euvolemia is a poor prognostic sign

46 Persistent Symptoms of Congestion at Discharge in Large Fraction of Patients Admitted for HF ADHERE 1,2 : Patients Discharged From September 1, 2002, to October 30, N=46,218 Asymptomatic 51% Improved (but still symptomatic) 39% No change <1% Not applicable <1% Worse <1% No mention 10% 1. ADHERE Registry. 3 rd Quarter National Benchmark Report Fonarow GC, for ADHERE Scientific Advisory Committee. Rev Cardiovasc Med. 2003;4(suppl 7):S21.

47 Diuretics and Mortality 100% KM Survival - Daily Diuretic Dose mg/kg 75% 50% 25% <0.5 mg/kg mg/kg 1-2 mg/kg 2-3 mg/kg 3-4 mg/kg 4+ mg/kg p< % Years Levy W, Mozaffariun D, Linker D, et al. The Seattle heart failure model. Circulation. 2006;113:

48 Predictors of Acute Mortality for Patients Admitted with Acute CHF Less than 2.68% n=25,122 BUN 43 mg/dl N=33,046 Greater than or equal to 8.98% n=7202 Less than SBP 115 mm Hg n=24, % n= % n=20,834 Greater than or equal to Less than 15.28% n=2048 SBP 115 mm Hg n= % n=5102 Greater than or equal to Fonarow GC et al. JAMA 2005;293: Less than 12.42% n=1425 SCr 2.75 mg/dl n= % n=620 Greater than or equal to

$from serum creatinine, LVEF=left ventricular ejection fraction Hillage HL et al.$

49 Proportion survival Proportion survival Diagnostic Value of Glomerular Filtration Rate in Patients With Heart Failure Days 0.0 GFR (ml/min) LVEF (%) > <44 > <20 GFRc=glomerular filtration rate estimated from serum creatinine, LVEF=left ventricular ejection fraction Hillage HL et al. Circulation 2000; 102:

50 Russell SD, et al. Congest Heart Fail 2008;14: Clues to Identifying the Potential Stage D Heart Failure Patient Two or more HF hospitalizations in 6 months Intolerant of ACE-I/ARB/Beta blocker Unable to walk 1 block or 1 flight of stairs without dyspnea (< 300 m 6MWT) Renal insufficiency (especially BUN) Increasing diuretic requirement

ACE/ARB Beta Blockers Aldosterone antagonists

Congest Heart Fail 2008;14:316-21 Clues to

Patient Two or more HF hospitalizations in 6

diuretics Metolazone Unable to walk 1 block or 1

51 ACE/ARB Beta Blockers Aldosterone antagonists Russell SD, et al. Congest Heart Fail 2008;14: Clues to Identifying the Potential Stage D Heart Failure Patient Two or more HF hospitalizations in 6 months Intolerant of ACE-I/ARB/Beta blocker Loop diuretics Metolazone Unable to walk 1 block or 1 flight of stairs without dyspnea (< 300 m 6MWT) No clinical improvement with CRT or no CRT and QRS > 140ms

52 Triggers for Referral to Advanced HF Program J Am Coll Cardiol. 2014;63(7): Swedish HF Registry ~10000 patients NYHA III-IV (~9000 NYHA II) Age < 80 years SBP <90 mmhg Creatinine >1.8mg/dL Hemoglobin <12 g/dl No beta blocker No RAS antagonist Figure Legend: NYHA III-IV NYHA II

53 Triggers for Referral to Advanced HF Program J Am Coll Cardiol. 2014;63(7): Figure Legend: NYHA III-IV NYHA II

54 Advanced Heart Failure Considerations Heart failure is associated with extremely high mortality rates Generally, advanced heart failure do not receive appropriate therapy The crucial role of RHC in the management of heart failure

55 Low Perfusion at Rest No Yes Rapid Assessment of Hemodynamic Status Congestion at Rest No Warm & Dry Cold & Dry Yes Warm & Wet Cold & Wet Signs/symptoms of congestion Orthopnea/PND JV distension Ascites Edema Rales (rare in chronic HF) Possible evidence of low perfusion Narrow pulse pressure Sleepy/obtunded Low serum sodium PND = paroxysmal nocturnal dyspnea; JV = jugular venous. Stevenson LW. Eur J Heart Fail. 1999;1: Cool extremities Hypotension with ACE inhibitor Renal dysfunction (one cause)

56 How do you diagnose shock? Who needs an inotrope?

57 How do you diagnose shock? Who needs an inotrope? PA catheter

58 How do you diagnose shock? Who needs an inotrope? PA ESCAPE catheter

59 Clinical Outcomes in ESCAPE Six-month end points Days dead or hospitalized (mean) PAC, n=215 (%) Clinical, n=218 (%) Mortality Rehospitalizations/ patient (mean) Days in hospital (median) *No significant differences PAC=pulmonary artery catheterization; clinical=clinically guided therapy only

60 Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness: The ESCAPE Trial 26 experienced transplant cardiology centers Study of decongestion Exclusion included creatinine >3.5 mg/dl Prior use of dobutamine, milrinone Inotropes discouraged Sick cohort BP 105 EF < 30% JAMA. 2005;294(13):

61 O2 consumption [hgb][13.6][ao sat PA sat]

62 O2 consumption [hgb][13.6][ao sat PA sat] What is the O2 consumption? 108 consecutive patients Mean : 126 ml/min/m2 Wide variability: ml/min/m2 Dehmer, GJ, et al. Clin Cardiol 1982; 5:

63 CO 6, HGB 15, PA sat 70%

64 CO 6, HGB 15, PA sat 70% CO 6, HGB 10, PA sat 60%

65 CO 6, HGB 15, PA sat 70% CO 6, HGB 10, PA sat 60% CO 3, HGB 15, PA sat 50%

66 CO 6, HGB 15, PA sat 70% CO 6, HGB 10, PA sat 60% CO 3, HGB 15, PA sat 50% CO 3, HGB 10, PA sat 40%

67 Destination Therapy survival improvement over time 1 1. Jorde UP, Khushwaha SS, Tatooles AJ, et al. Two-Year Outcomes in the Destination Therapy Post-FDA-Approval Study with a Continuous Flow Left Ventricular Assist Device: A Prospective Study Using the INTERMACS Registry. Presented at the ISHLT annual meeting, April 25, 2013.

69 INTERMACS PROFILES INTERMACS PROFILES AND OTHER CLASSIFICATION SYSTEMS Profile # Description NYHA Class Time to MCS therapy INTERMACS 1 INTERMACS 2 INTERMACS 3 INTERMACS 4 INTERMACS 5 INTERMACS 6 INTERMACS 7 AHA/ACC Stage Crashing and burning IV Within hours D Progressive decline on inotropic support IV Within a few days D Stable but inotrope dependent IV Within a few weeks D Recurrent advanced heart failure; resting symptoms at home on oral therapy Ambulatory IV Within weeks to months Exertion intolerant Ambulatory IV Variable D Exertion limited or walking wounded Ambulatory IV Variable C-D Advanced NYHA III IIIB Variable C D Stevenson LW, Pagani FD, Young JB, et al. INTERMACS profiles of advanced heart failure: the current picture. J Heart Lung Transplant. 2009;28:

70 Interaction of Age and INTERMACS Level on Survival following CF-LVAD Implantation Source: The Journal of Heart and Lung Transplantation 2013; 32: (DOI: /j.healun ) Copyright 2013 International Society for Heart and Lung Transplantation Terms and Conditions

71 Clinical Outcomes Based on INTERMACS Profile Length of Stay Post-VAD Actuarial Survival Post-VAD Less acutely ill, ambulatory patients in INTERMACS profiles 4-7 had better survival and reduced length of stay compared to patients who were more acutely ill in profiles 1-3. Boyle, Ascheim, Russo, et.al. JHLT. 30:4, 2011.

72 It s better to refer a month too early than a week too late Transplant LVAD Hospice

73 End Stage Cancer

74 End Stage Heart Failure 74% receive ICD shock within days of death ADLER ED 2010

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Ventricular Assist Device: Are Early Interventions Superior? Hamang Patel, MD Section of Cardiomyopathy & Heart Transplantation

Ventricular Assist Device: Are Early Interventions Superior? Hamang Patel, MD Section of Cardiomyopathy & Heart Transplantation Objectives Current rationale behind use of MCS Patient Selection Earlier?