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