Candidate Selection for Long Term VAD

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6th Saudi Heart Failure Symposium Riyadh -

1 6th Saudi Heart Failure Symposium Riyadh - December 9, 2017 Candidate Selection for Long Term VAD AMMAR CHAUDHARY, MBCHB, FRCPC Consultant Cardiologist Advanced Heart Failure Department of Cardiology King Faisal Specialist Hospital & Research Center - Jeddah

2 VAD Candidacy Indications for VAD Contraindications to VAD

3 VAD Candidacy Heart Transplantation is still the gold standard for advanced HF

4 VAD Candidacy Heart Transplantation is still the gold standard for advanced HF Mancini D, et al. J Am Coll Cardiol Jun 16;65(23):

5 VAD Candidacy Indication for heart transplantation?

6 VAD Candidacy Indication for heart transplantation? Contraindication to heart transplantation?

7 VAD Candidacy Indication for heart transplantation? Contraindication to heart transplantation? Contraindication to VAD?

8 VAD Candidacy Indication for heart transplantation? Contraindication to heart transplantation? Contraindication to VAD? Palliation VAD as DT

9 VAD Candidacy Indication for heart transplantation? Contraindication to heart transplantation? Can patient wait for a heart? Contraindication to VAD? Palliation VAD as DT

10 VAD Candidacy Indication for heart transplantation? Contraindication to heart transplantation? Can patient wait for a heart? Contraindication to VAD? Wait list for heart transplant Palliation VAD as DT

11 VAD Candidacy Indication for heart transplantation? Contraindication to heart transplantation? Can patient wait for a heart? Contraindication to VAD? Wait list for heart Contraindication Palliation VAD as DT transplant to VAD?

12 VAD Candidacy Indication for heart transplantation? Contraindication to heart transplantation? Can patient wait for a heart? Contraindication to VAD? Wait list for heart Contraindication Palliation VAD as DT transplant to VAD? Heart Tx or Palliation

13 VAD Candidacy Indication for heart transplantation? Contraindication to heart transplantation? Can patient wait for a heart? Contraindication to VAD? Wait list for heart Contraindication Palliation VAD as DT transplant to VAD? Heart Tx or Palliation VAD as BTT

14 VAD Candidacy % 41% 28% Teuteberg J et al, JACC HF 2013;1:369 78

15 Indications for Heart Transplant Advanced heart failure (stage D)

16 Indications for Heart Transplant Advanced heart failure (stage D) Prognostication

17 Indications for Heart Transplant Advanced heart failure (stage D) Prognostication Multivariable risk score Cardiopulmonary exercise test

18 Indications for Heart Transplant Advanced heart failure (stage D) Prognostication Multivariable risk score Heart Failure Survival Score Seattle Heart Failure Model Cardiopulmonary exercise test

19 Indications for Heart Transplant Advanced heart failure (stage D) Prognostication Multivariable risk score Heart Failure Survival Score Seattle Heart Failure Model Cardiopulmonary exercise test A 1-year survival calculated by SHFM <80% is proposed as a cut-off value for transplant listing, in conjunction with CPET results. Class IIb, LOE: C

20 Post Transplant Outcome

21 Indications for Heart Transplant Advanced heart failure (stage D) Prognostication Multivariable risk score <80% 1 year survival Cardiopulmonary exercise test Peak VO2 14 ml/kg/min (class I, LOE: B)

22 Indications for Heart Transplant Advanced heart failure (stage D) Prognostication Multivariable risk score <80% 1 year survival Cardiopulmonary exercise test Peak VO2 14 ml/kg/min (class I, LOE: B) Peak VO2 12 ml/kg/min (class I, LOE: B)

23 Indications for Heart Transplant Advanced heart failure (stage D) Prognostication Multivariable risk score <80% 1 year survival Cardiopulmonary exercise test Peak VO2 14 ml/kg/min (class I, LOE: B) Peak VO2 12 ml/kg/min (class I, LOE: B) Predicted VO2 55% for age (class IIa, LOE: B)

24 Indications for Heart Transplant Advanced heart failure (stage D) Prognostication Multivariable risk score <80% 1 year survival Cardiopulmonary exercise test RER < 1.05, Peak VO2 14 Peak VO2 12 Predicted VO2 VE/VCO2 slope > ml/kg/min (class ml/kg/min 55% for age I, LOE: B) (class I, LOE: B) (class IIa, LOE: B) 35 (class IIb, LOE: C)

25 Prognosis of Medically-Treated Sickest Patients Rose E, et al. N Engl J Med 2001;345:

26 Spectrum of Illness 1. Critical cardiogenic shock 2. Progressive decline 3. Stable but inotrope dependent 4. Recurrent advanced HF 5. Exertion intolerant 6. Exertion limited 7. Advanced NYHA III

27 Spectrum of Illness 1. Critical cardiogenic shock 2. Progressive decline 3. Stable but inotrope dependent 4. Recurrent advanced HF 5. Exertion intolerant 6. Exertion limited 7. Advanced NYHA III

28 Spectrum of Illness 1. Critical cardiogenic shock 2. Progressive decline 3. Stable but inotrope dependent 4. Recurrent advanced HF 5. Exertion intolerant 6. Exertion limited 7. Advanced NYHA III

29 Inclusion Criteria for HM II as BTT 1. NYHA IV

30 Inclusion Criteria for HM II as BTT 1. NYHA IV 2. Transplant listed: No contraindication for listing as Status 1A or; No contraindication for listing as Status 1B and meet the following hemodynamic criteria (collected within 48 hours of enrolment): PCWP or PAD > 20 mmhg, and Cardiac Index < 2.2 L/min/m2 or systolic blood pressure < 90 mmhg Miller LW, et al. N Engl J Med 2007;357:885-96

31 Baseline Characteristics (BTT Trial)

32 Spectrum of Illness (INTERMACS) 1. Critical cardiogenic shock 2. Progressive decline 3. Stable but inotrope dependent 4. Recurrent advanced HF 5. Exertion intolerant 6. Exertion limited 7. Advanced NYHA III

33 Inclusion Criteria for HM II as DT 1. LVEF < 25% Slaughter M, et al. N Engl J Med 2009;361:

34 Inclusion Criteria for HM II as DT 1. LVEF < 25% 2. Patients with advanced heart failure symptoms (Class IIIB or IV) on OMM, for at least 45 out of the last 60 days and are failing to respond; or treated with ACE inhibitors or beta-blockers for at least 30 days and found to be intolerant. or dependent on intra aortic balloon pump (IABP) for 7 days and/or inotropes for at least 14 days Slaughter M, et al. N Engl J Med 2009;361:

35 Inclusion Criteria for HM II as DT 1. LVEF < 25% 2. Patients with advanced heart failure symptoms (Class IIIB or IV) on OMM, for at least 45 out of the last 60 days and are failing to respond; or treated with ACE inhibitors or beta-blockers for at least 30 days and found to be intolerant. or dependent on intra aortic balloon pump (IABP) for 7 days and/or inotropes for at least 14 days 3. VO2max < 14 ml/kg/min or <50% of predicted VO2 max Slaughter M, et al. N Engl J Med 2009;361:

36 Inclusion Criteria for HM II as DT 1. LVEF < 25% 2. Patients with advanced heart failure symptoms (Class IIIB or IV) on OMM, for at least 45 out of the last 60 days and are failing to respond; or treated with ACE inhibitors or beta-blockers for at least 30 days and found to be intolerant. or dependent on intra aortic balloon pump (IABP) for 7 days and/or inotropes for at least 14 days 3. VO2max < 14 ml/kg/min or <50% of predicted VO2 max 4. Ineligible for cardiac transplant Slaughter M, et al. N Engl J Med 2009;361:

37 Baseline Characteristics (DT Trial)

38 LVAD Trends by INTERMACS Levels Mancini D, et al. J Am Coll Cardiol Jun 16;65(23):

39 LVAD Trends by INTERMACS Levels 20% 80% Mancini D, et al. J Am Coll Cardiol Jun 16;65(23):

40 Outcomes in INTERMACS 4-6 Estep J, et al. JACC VOL. 66, NO. 16, 2015

41 Risks & Contraindications to VAD VAD has less stringent contraindications compared to transplant Transplant in some instances has fewer limitations compared to VAD

42 Risks & Contraindications to VAD 1. Clinical status

43 Survival CF-LVAD 80% 70% Kirklin J, et al. J Heart Lung Transplant 2013;32:

44 Risks & Contraindications to VAD Survival by INTERMACS Level June Dec 2014 Early hazard Level 1 (HR 1.55) n = Kirklin J, et al. J Heart Lung Transplant 2015;34:

45 Risks & Contraindications to VAD Freedom from severe RHF requiring RVAD at time of LVAD by INTERMACS n = Kirklin J, et al. J Heart Lung Transplant 2015;34:

46 Survival CF-LVAD 80% 70% Kirklin J, et al. J Heart Lung Transplant 2013;32:

47 VAD Utilization by INTERMACS Level 20

48 20% 80% Mancini D, et al. J Am Coll Cardiol Jun 16;65(23):

49 Risks & Contraindications to VAD 1. Clinical status 2. Age

50 Risks & Contraindications to VAD Survival by age group June June 2012 n = 5436 Kirklin J, et al. J Heart Lung Transplant 2013;32:141 1

51 Risks & Contraindications to VAD 2013 INTERMACS report: HR 1.69

52 Risks & Contraindications to VAD 2013 INTERMACS report: HR INTERMACS report: HR 1.03

53 Risks & Contraindications to VAD 2013 INTERMACS report: HR INTERMACS report: HR 1.03 Advance age in itself does not constitute a contraindication to MCS - ISHLT 2013 Guidelines

54 Risks & Contraindications to VAD 2013 INTERMACS report: HR INTERMACS report: HR 1.03 Advance age in itself does not constitute a contraindication to MCS - ISHLT 2013 Guidelines Oldest reported patient supported by VAD 88 years

55 Exclusion Criteria for LVAD vs Tx Tx LVAD Age, yrs >70 None

56 Risks & Contraindications to VAD 1. Clinical status 2. Age 3. PVR

57 Risks & Contraindications to VAD N = 6 DeBakey LVAD Fixed pulmonary HTN Mean PVR 398 [5 WU] (501 [6 WU] 305) to 167 [2 WU] (74 216) dyne*s*cm-5 in 6 wks Salzberg SP, et al. Eur J Cardiothoracic Surgery 27 (2005)

58 Risks & Contraindications to VAD N = 6 DeBakey LVAD Fixed pulmonary HTN No ISHLT recommendation for PVR Mean PVR 398 [5 WU] (501 [6 WU] 305) to 167 [2 WU] (74 216) dyne*s*cm-5 in 6 wks Salzberg SP, et al. Eur J Cardiothoracic Surgery 27 (2005)

59 Exclusion Criteria for LVAD vs Tx Transplant LVAD Age, yrs >70 None PVR, WU > 3 > 8

60 Risks & Contraindications to VAD 1. Clinical status 2. Age 3. PVR 4. Size & weight

61 Risks & Contraindications to VAD BMI > 40 exclusion criterion for VAD in clinical trials

62 Risks & Contraindications to VAD BMI > 40 exclusion criterion for VAD in clinical trials Risk of driveline infections

63 Risks & Contraindications to VAD BMI > 40 exclusion criterion for VAD in clinical trials Risk of driveline infections n = 58 HM II & XVE BMI < 30 vs. >30 Mean BMI 24 ± 3 vs 35 ± 6 1-year survival 63 vs. 65% Coyle LA, et al. Artif Organs Feb;34(2):93-7

64 Risks & Contraindications to VAD BMI > 40 exclusion criterion for VAD in clinical trials Risk of driveline infections Recommendations for Obesity: Class I, LOE: B Obesity (BMI kg/m2), in and of itself, is not a contraindication to MCS, but surgical risk and attendant comorbidities must be carefully considered prior to MCS in the morbidly obese (BMI 35 kg/m2). Pamboukian S, et al. ISHLT 2013 VAD Guidelines

65 Exclusion Criteria for LVAD vs Tx Transplant LVAD Age, yrs >70 None PVR, WU > 3 > 8 BMI, kg/m2 > 35 > 45

66 Risks & Contraindications to VAD BSA < 1.5 m2 contraindication in DT trial for HM I (1.25 kg)

67 Risks & Contraindications to VAD BSA < 1.5 m2 contraindication in DT trial for HM I (1.25 kg) BSA < 1.2 m2 contraindication in BTT & DT trials for HMII (390 g) & HVAD (160 g)

68 Exclusion Criteria for LVAD vs Tx Transplant LVAD Age, yrs >70 None PVR, WU > 3 > 8 BMI, kg/m2 > 35 > 45 BSA, m2 None < 1.2

69 Risks & Contraindications to VAD 1. Clinical status 2. Age 3. PVR 4. Size & weight 5. Comorbidities

70 Risks & Contraindications to VAD Renal function: Creatinine early hazard (HR 1.03), dialysis (HR 2.34) Creatinine > 3.5 mg /dl (300 mmol/l) exclusion criterion from DT trials

71 Risks & Contraindications to VAD Renal function: Creatinine early hazard (HR 1.03), dialysis (HR 2.34) Creatinine > 3.5 mg /dl (300 mmol/l) exclusion criterion from DT trials Recommendation for Renal Function: Class III, LOE: C Permanent dialysis is a contraindication to LVAD Pamboukian S, et al. ISHLT 2013 VAD Guidelines

72 Risks & Contraindications to VAD Pulmonary Hepatic Malignancy

73 Risks & Contraindications to VAD Pulmonary Mod-severe restrictive lung disease (FEV1/FVC < 0.7, or FEV1 <50% predicted) Hepatic Malignancy Pamboukian S, et al. ISHLT 2013 VAD Guidelines

74 Risks & Contraindications to VAD Pulmonary Mod-severe restrictive lung disease (FEV1/FVC < 0.7, or FEV1 <50% predicted) Hepatic Primary liver cirrhosis (Bx, high MELD score) Malignancy Pamboukian S, et al. ISHLT 2013 VAD Guidelines

75 Risks & Contraindications to VAD Pulmonary Mod-severe restrictive lung disease (FEV1/FVC < 0.7, or FEV1 <50% predicted) Hepatic Primary liver cirrhosis (Bx, high MELD score) Malignancy Active cancer with expected survival < 2yrs (Class IIa, LOE: C) Pamboukian S, et al. ISHLT 2013 VAD Guidelines

76 Exclusion Criteria for LVAD vs Tx Transplant LVAD Age, yrs >70 None PVR, WU > 3 > 8 BMI, kg/m2 > 35 > 45 BSA, m2 None < 1.2 Creat/GFR < 30 > 300 Pulmonary Mild-mod Mod-severe Malignancy <5 yrs free of disease Active cancer < 2 yrs expected survival

77 Risks & Contraindications to VAD 1. Clinical status 2. Age 3. PVR 4. Size & weight 5. Comorbidities 6. Intolerance to anticoagulation

78 Exclusion Criteria for LVAD vs Tx Transplant LVAD Age, yrs >70 None PVR, WU > 3 > 8 BMI, kg/m2 > 35 > 45 BSA, m2 None < 1.2 Creat/GFR < 30 > 300 Pulmonary Mild-mod Mod-severe Malignancy 5 yrs free of disease Active < 2 yrs expected survival Intolerance to anticoagulation No Yes

79 Risks & Contraindications to VAD 1. Clinical status 7. Restrictive cardiomyopahy 2. Age 3. PVR 4. Size & weight 5. Comorbidities 6. Intolerance to anticoagulation

80 Exclusion Criteria for LVAD vs Tx Transplant LVAD Age, yrs >70 None PVR, WU > 3 > 8 BMI, kg/m2 > 35 > 45 BSA, m2 None < 1.2 Creat/GFR < 30 > 300 Pulmonary Mild-mod Mod-severe Malignancy 5 yrs free of disease Active < 2 yrs expected survival Intolerance to anticoagulation No Yes Restrictive CMO No Yes

81 Risks & Contraindications to VAD 1. Clinical status 7. Restrictive cardiomyopahy 2. Age 8. RV dysfunction 3. PVR 4. Size & weight 5. Comorbidities 6. Intolerance to anticoagulation

82 Risks & Contraindications to VAD RV dysfunction is a risk factor for early and late mortality Need for RVAD (HR 3.73) Miller LW, et al. J Am Coll Cardiol Mar 26;61(12):

83 Risks & Contraindications to VAD RV dysfunction is a risk factor for early and late mortality Need for RVAD (HR 3.73) Severe RV dysfunction seen in ~10 % of LVADs More likely in non-ischemic cardiomyopathy Mechanisms: Higher venous return, changed geometry Miller LW, et al. J Am Coll Cardiol Mar 26;61(12):

84 Risks & Contraindications to VAD Predictors of RV dysfunction PVR is not predictive Serum creatinine, bilirubin, transaminases, inotrope support

85 Risks & Contraindications to VAD Predictors of RV dysfunction PVR is not predictive Serum creatinine, bilirubin, transaminases, inotrope support Lower pre-op PASP [PASP < 50 mmhg] (Fukamachi, Dang, Mathews, 2008, Fitzpatrick, 2008) n = 671

86 Risks & Contraindications to VAD Predictors of RV dysfunction PVR is not predictive Serum creatinine, bilirubin, transaminases, inotrope support Lower pre-op PASP [PASP < 50 mmhg] (Fukamachi, Dang, Mathews, 2008, Fitzpatrick, 2008) n = 671 Higher RA Pressure [> 15 mmhg] (Dang, Fitzpatrick, Dracos, Kormos, 2010) n = 1033

87 Risks & Contraindications to VAD Predictors of RV dysfunction RVSWI = SVi x (mpap - RAP) x [< 250 mm Hg x ml/m2] (Fukamachi, Kavarana, Ochlal, Mathews, Fitzpatick, Kormos, 2010) n = 1361

88 Risks & Contraindications to VAD Predictors of RV dysfunction RVSWI = SVi x (mpap - RAP) x [< 250 mm Hg x ml/m2] (Fukamachi, Kavarana, Ochlal, Mathews, Fitzpatick, Kormos, 2010) n = 1361 RA/PCWP [> 0.65], RVEDD/LVEDD [>0.72], TAPSE [<40%]

89 Risks & Contraindications to VAD Predictors of RV dysfunction RVSWI = SVi x (mpap - RAP) x [< 250 mm Hg x ml/m2] (Fukamachi, Kavarana, Ochlal, Mathews, Fitzpatick, Kormos, 2010) n = 1361 RA/PCWP [> 0.65], RVEDD/LVEDD [>0.72], TAPSE [<40%] PAPi = (PASP - PADP)/RA [<2.0] (Kang, JHLT. 2016) [<1.8] C-statistic 0.94 (Morine, JCF, 2016)

90 Exclusion Criteria for LVAD vs Tx Transplant LVAD Age, yrs >70 None PVR, WU > 3 > 8 BMI, kg/m2 > 35 > 45 BSA, m2 None < 1.2 Creat/GFR < 30 > 300 Pulmonary Mild-mod Mod-severe Malignancy 5 yrs free of disease Active < 2 yrs expected survival Intolerance to anticoagulation No Yes Restrictive CMO No Yes RV dysfunction No Yes

91 Risks & Contraindications to VAD 1. Clinical status 7. Restrictive cardiomyopahy 2. Age 8. RV dysfunction 3. PVR 9. Psychosocial 4. Size & weight 5. Comorbidities 6. Intolarance to anticoagulation

92 Risks & Contraindications to VAD Psychosocial requirements Class IIb, LOE C: Significant caregiver burden or lack of any caregiver is a relative contraindication to patient s MCS implantation

93 Risks & Contraindications to VAD Psychosocial requirements Class IIb, LOE C: Significant caregiver burden or lack of any caregiver is a relative contraindication to patient s MCS implantation Class I, LOE C: The social worker may need to develop a formal social contract with the patient s social network and/or caregiver(s) that outlines their commitment and responsibilities to ensure they are prepared to assist patients with device and driving needs

94 Risks & Contraindications to VAD Psychosocial requirements Class IIb, LOE C: Significant caregiver burden or lack of any caregiver is a relative contraindication to patient s MCS implantation Class I, LOE C: The social worker may need to develop a formal social contract with the patient s social network and/or caregiver(s) that outlines their commitment and responsibilities to ensure they are prepared to assist patients with device and driving needs Class I, LOE C: An uninterrupted supply of electricity to continuously power the MCSD must be ensured

95 Risks & Contraindications to VAD Psychosocial requirements Class IIb, LOE C: Significant caregiver burden or lack of any caregiver is a relative contraindication to patient s MCS implantation Class I, LOE C: The social worker may need to develop a formal social contract with the patient s social network and/or caregiver(s) that outlines their commitment and responsibilities to ensure they are prepared to assist patients with device and driving needs Class I, LOE C: An uninterrupted supply of electricity to continuously power the MCSD must be ensured Class IIa, LOE C: Equipment at home should be placed in a configuration that minimizes the risk of falls, allows family members to hear alarms. Lighting should be adequate. The bathroom should be safe for showering with a shower chair, toilet seat, or any other necessary physical aids

96 Risk Assessment Tools Leitz-Miller score HeartMate II Risk Score (HMRS) Destination Therapy Risk Score (DTRS) MELD Seattle Heart Failure Model (SHFM)

97 HMRS HMRS variables: age, INR, albumin, creatinine, center volume Adamo L, et al. J Am Coll Cardiol HF 2016;4:950 8

98 HMRS vs DTRS vs MELD AUC 0.71, C-statistic 0.62 for 90 day mortality, 0.60 for 1 yr mortality Ravichandran A, et al. J Thorac Dis 2015;7(12):

99 HMRS HMRS variables: age, INR, albumin, creatinine, center volume AUC day mortality: Low (8%), intermediate (12%), high (32%) Predicts morbidity: GI bleed, length of stay Adamo L, et al. J Am Coll Cardiol HF 2016;4:950 8

100 HMRS Reclassifies Clinical Risk Adamo L, et al. J Am Coll Cardiol HF 2016;4:950 8

101 HMRS Reclassifies Clinical Risk Adamo L, et al. J Am Coll Cardiol HF 2016;4:950 8

102 Bayesian Network - The Next Frontier Loghmanpour N, et al. J Am Coll Cardiol HF 2016;4:711 21

103 Bayesian Network - The Next Frontier Loghmanpour N, et al. J Am Coll Cardiol HF 2016;4:711 2

104 Bayesian Network - The Next Frontier Loghmanpour N, et al. J Am Coll Cardiol HF 2016;4:711 21

105 Bayesian Network - The Next Frontier Loghmanpour N, et al. J Am Coll Cardiol HF 2016;4:711 2

106 Summary Indications & contraindications for VAD are determined by implant strategy VAD-specific contraindications should be considered Tools for risk stratification are still a work in progress. Predicting outcomes and candidacy is more of an art, relying heavily on clinical judgement

107 Prediction Tools HM II Risk Score SHFM MELD Score

108

109 GDMT for LV Systolic Dysfunction 1. RAASi: ACEi/ARB (~17%), spironolactone/eplerenone (~30%), ARNI (~30%)

110 GDMT for LV Systolic Dysfunction 1. RAASi: ACEi/ARB (~17%), spironolactone/eplerenone (~30%), ARNI (~30%) 2. Beta blockers (~34%)

111 GDMT for LV Systolic Dysfunction 1. RAASi: ACEi/ARB (~17%), spironolactone/eplerenone (~30%), ARNI (~30%) 2. Beta blockers (~34%) 3. Hydralazine & nitrates (~44%)

112 GDMT for LV Systolic Dysfunction 1. RAASi: ACEi/ARB (~17%), spironolactone/eplerenone (~30%), ARNI (~30%) 2. Beta blockers (~34%) 3. Hydralazine & nitrates (~44%) 4. ICD/CRT (~25%)

113 GDMT for LV Systolic Dysfunction 1. RAASi: ACEi/ARB (~17%), spironolactone/eplerenone (~30%), ARNI (~30%) 2. Beta blockers (~34%) 3. Hydralazine & nitrates (~44%) 4. ICD/CRT (~25%) 5. Appropriate diuretics (?)

114 GDMT for LV Systolic Dysfunction 1. RAASi: ACEi/ARB (~17%), spironolactone/eplerenone (~30%), ARNI (~30%) 2. Beta blockers (~34%) 3. Hydralazine & nitrates (~44%) 4. ICD/CRT (~25%) 5. Appropriate diuretics (?), cardiac rehab (~30%)

115 GDMT for LV Systolic Dysfunction 1. RAASi: ACEi/ARB (~17%), spironolactone/eplerenone (~30%), ARNI (~30%) 2. Beta blockers (~34%) 3. Hydralazine & nitrates (~44%) 4. ICD/CRT (~25%) 5. Appropriate diuretics (?), cardiac rehab (~30%) ivabridine, iron therapy, mitraclip

116 What is not in prognostic models Cardiac output / index Filling pressures (PCWP, RA) BNP Severe MR Rehospitalizations

Relationship between pvo2 & EF 30 pvo2 20

117 Relationship between pvo2 & EF 30 pvo N =150 EF<45% 0 10% 20% 30% 40% 50% EF

118 Normal values in 35 year old male VO2 Values

119 VO2 Values Normal values in 35 year old male Rest 6L x 0.04 = 0.24 L O2 per minute (3.5 ml/min/kg) Peak effort: 18 L x 0.17 = 3.06 L/min (40 ml/min/kg)

120 VO2 Values Normal values in 35 year old male Rest 6L x 0.04 = 0.24 L O2 per minute (3.5 ml/min/kg) Peak effort: 18 L x 0.17 = 3.06 L/min (40 ml/min/kg) Olympic cyclist: 30 : x 0.19 = 5.7 L/min (87 ml/min/kg)

121 VO2 Values Normal values in 35 year old male Rest 6L x 0.04 = 0.24 L O2 per minute (3.5 ml/min/kg) Peak effort: 18 L x 0.17 = 3.06 L/min (40 ml/min/kg) Cyclist (athlete): 30 : x 0.19 = 5.7 L/min (87 ml/min/kg) EPO doped cyclist: 30 L x 0.21 = 6.2 L/min (95 ml/min/kg)

122 VO2 Values Normal values in 35 year old male Rest 6L x 0.04 = 0.24 L O2 per minute (3.5 ml/min/kg) Peak effort: 18 L x 0.17 = 3.06 L/min (40 ml/min/kg) Cyclist (athlete): 30 : x 0.19 = 5.7 L/min (87 ml/min/kg) EPO doped cyclist: 30 L x 0.21 = 6.2 L/min (95 ml/min/kg) Effect of training: increase pvo2 by 30-40%

123 Indications for Heart Transplant Advanced heart failure (stage D) Severe symptoms of heart failure at rest or with minimal exertion (NYHA III or IV)

124 Indications for Heart Transplant Advanced heart failure (stage D) Severe symptoms of heart failure at rest or with minimal exertion (NYHA III or IV) Episodes of fluid retention or low cardiac output at rest

125 Indications for Heart Transplant Advanced heart failure (stage D) Severe symptoms of heart failure at rest or with minimal exertion (NYHA III or IV) Episodes of fluid retention or low cardiac output at rest Objective evidence of severe cardiac dysfunction (LVEF <30%, mean PCWP > 16mmHg, high BNP or NT-pro BNP plasma levels)

126 Indications for Heart Transplant Advanced heart failure (stage D) Severe symptoms of heart failure at rest or with minimal exertion (NYHA III or IV) Episodes of fluid retention or low cardiac output at rest Objective evidence of severe cardiac dysfunction (LVEF <30%, mean PCWP > 16mmHg, high BNP or NT-pro BNP plasma levels) Severe impairment of functional capacity (inability to exercise, 6-minute walk distance < 300 m, peak VO2 <12 ml/kg/min)

127 Indications for Heart Transplant Advanced heart failure (stage D) Severe symptoms of heart failure at rest or with minimal exertion (NYHA III or IV) Episodes of fluid retention or low cardiac output at rest Objective evidence of severe cardiac dysfunction (LVEF <30%, mean PCWP > 16mmHg, high BNP or NT-pro BNP plasma levels) Severe impairment of functional capacity (inability to exercise, 6-minute walk distance < 300 m, peak VO2 <12 ml/kg/min) At least one HF hospitalization in prior 6 months

128 Indications for Heart Transplant Advanced heart failure (stage D) Severe symptoms of heart failure at rest or with minimal exertion (NYHA III or IV) Episodes of fluid retention or low cardiac output at rest Objective evidence of severe cardiac dysfunction (LVEF <30%, mean PCWP > 16mmHg, high BNP or NT-pro BNP plasma levels) Severe impairment of functional capacity (inability to exercise, 6-minute walk distance < 300 m, peak VO2 <12 ml/kg/min) At least one HF hospitalization in prior 6 months Presence of all above features despite attempts to optimize to Goal Directed Medical Therapy (GDMT)

129 Heart Tx Survival by pre-tx Support

130 Impact of age on 1-year Tx Mortality

131 Post Tx Survival by Age

132 Risk Factors for VAD vs. Tx Heart Tx Survival by BMI

133 Risks & Contraindications to VAD Survival by INTERMACS Level June June 2012 n = 5436

134 Risks & Contraindications to VAD Early hazard with older age for VAD (HR 1.69) in 2013, (HR 1.03) in 2015 No official upper age limit for VADs. Advance age in itself does not constitute a contraindication to MCS - ISHLT 2013 Guidelines Oldest reported patient supported by VAD 88 years Recommendation for Age: Class IIb, LOE: C Patients >60 years old should undergo thorough evaluation for the presence of other clinical risk factors that

135 Risks & Contraindications to VAD PVR > 8 exclusion criterion in LVAD trials

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

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