Duke Heart Center Who Should Not Receive a VAD: Pragmatism and Futility in Patient Selection Joseph G. Rogers, MD Professor of Medicine Duke University.

Duke Heart Center

Who Should Not Receive a VAD: Pragmatism and Futility in Patient Selection

Joseph G. Rogers, MDProfessor of MedicineDuke University

INTERMACS 9th Annual MeetingMCSD: Evolution, Expansion, and Evaluation

May 15-16, 2015

Disclosures: None

Duke Heart Center

Contraindications to VAD Therapy: Clinical Trial Definitions

• Mechanical aortic valve without plan to replace or close• Thrombocytopenia• Other condition that limits survival to < 24 months• Uncontrolled, systemic infection• Recent stroke or cerebrovascular disease that increases risk

for intra-operative CVA• Contraindication to systemic anticoagulation or antiplatelet

therapy• Significant right heart failure• Psychosocial instability (ongoing substance abuse, lack of

care giving plan, non-compliance)

Duke Heart Center

Who is (or is not) a VAD Candidate?Duke Criteria

• Sick but not too sick• Not too old• Not too much right heart failure• Not too much renal dysfunction• Not too malnourished• Not too septic• Not supported on mechanical ventilation for too long• Not too crazy

The Impact of Illness Severity on MCS OutcomesThe Impact of Illness Severity on MCS Outcomes

J Heart Lung Transplant 2008;27:1065-72

J Heart Lung Transplant 2014;33:555-64

INTERMACS Profile2006-2008

(% Pts)2012

(% Pts)

1 Critical cardiogenic Shock

34.7 16.6

2 Progressive decline

40.2 36.7

3 Stable on Inotropes

13.0 27.4

% intensely ill 87.9 80.7

4 Recurrent advanced heart failure

8.4 13.0

5 Exertion intolerant 1.3 3.0

6 Exertion limited 1.0 1.5

7 Advanced Class III 1.4 0.8

J Heart Lung Transplant 2011;30:155-23J Heart Lung Transplant 2013;32:141-56

X Anticipated Survival without VAD

How Old is Too Old?How Old is Too Old?

J Am Coll Cardiol 2013;61:313-21J Am Coll Cardiol 2011;57:2487–95

Parameter Estimate SE OR (95% CI) p Value

Age (per 10 yrs) 0.274 0.12 1.32 (1.05-1.65) 0.018

Albumin (per g/dl) -0.723 0.23 0.49 (0.31-0.76 0.002

Creatinine (per mg/dl) 0.740 0.22 2.10 (1.37-3.21) <0.001

INR (per unit) 1.136 0.32 3.11 (1.66-5.84) <0.001

Center Volume < 15 0.807 0.34 2.24 (1.15-4.37) 0.018

Duke Heart CenterDuke Heart Center

Issues of Nutrition (Low)Issues of Nutrition (Low)

Markers of Poor Nutrition•BMI < 20 kg/m2

•Pre-albumin < 15 mg/dl•Transferrin > 250 mg/dl•Total Cholesterol < 130 mg/dl•Lymphocyte Count < 100 Strategies•PO supplements•Enteral nutrition•TPN (last resort)

J Heart Lung Transplant 2010: (4 Suppl):S1-39.

Duke Heart CenterDuke Heart Center

Chronic Biscuit Poisoning Chronic Biscuit Poisoning

J Heart Lung Transplant 2010: (4 Suppl):S1-39.

Obesity not a contraindication•Devices may provide adequate support•Has not impacted outcomes•May be contraindication for transplant•Patients not losing weight on VAD support

I shall not attempt to further define the kinds of material I understand to be embraced within the short-hand description of hard-core pornography and perhaps I should never succeed in intelligibly doing so. But I know it when I see it…

Potter Stewart , Associate Supreme Court Justice

Uh…. I think that fella is too frail for a VAD.Joseph Rogers, MD

Duke Heart CenterDuke Heart Center

The Importance of Frailty in LVAD Patient SelectionThe Importance of Frailty in LVAD Patient Selection

Circ Heart Fail 2012;5:286-93

Duke Heart Center

UrgencyMalignancyInfection riskRenal insufficiency

VTRight heart failureInfection risk

Older Age

DT

VA

D EC

Tx

Decision-Making in Advanced Heart Failure

Duke Heart Center

The Importance of RV Function in MCS

Pre-implant diagnosis is challenging Definition

Need for inotropic support > 14 days

Need for RVAD Limits device function by reducing

pre-load Associated with end-organ

dysfunction and prolonged LOS Important cause of post-implant

morbidity and mortality MSOF

New description of “late” RV failure, etiology unknown

J Thorac Cardiovasc Surg 2010;139:1316-24

Duke Heart Center

Predictors of Post-LVAD RV Failure

Clinical

–Pre-implant mechanical ventilation

–Pre-implant renal or hepatic dysfunction

–Need for vasopressors

Hemodynamic

–High RA, low PA

–CVP:PCWP pressure > 0.63

–RVSWI < 300 mmHgxml/m2

Echocardiographic

–RV size and function

–Tricuspid insufficiency

–TAPSE

–RV Strain

Duke Heart Center

Hepatic Function & Coagulopathy

Clinical Management of Continuous-flow LVADs JHLT 2010: 1-39.

Determine etiology of hepatic dysfunction• LFT’s• Serologies• Liver biopsy to r/o cirrhosis• If labs are normal the liver disease may be well compensated

The minimum screen for coagulation abnormalities should include:

PT/INR, PTTPlatelet countPlatelet aggregation studiesHIT assay (Heparin induced thrombocytopenia,

platelet antibody)

Duke Heart CenterDuke Heart Center

The Impact of LVAD on Ventricular The Impact of LVAD on Ventricular ArrhythmiasArrhythmias

• 100 consecutive VAD patients• Mean age=51 yrs, 63% ischemic

J Am Coll Cardiol 2005;45:1428-34

Duke Heart Center

Neurologic, Psychosocial, and Psychiatric Considerations

Clinical Management of Continuous-flow LVADs JHLT 2010: 1-39.

Assess candidates’ ability to:• Care for equipment• Exercise• Comply

Consider history of psychiatric disorders, drug abuse

Psychosocial support team

Address advanced directives

Duke Heart Center

Who Should not be Treated with a VAD

• It is often not evidence-based or entirely clear.

• Be mindful of – The aged and frail– The under- and over-nourished– Those with VT– Those with right heart failure– Those with primary coagulopathy and liver

disease– The crazy people whose mothers don’t love them