1. Joseph G. Rogers, MD Professor of Medicine Duke University
Who Should Not Receive a VAD: Pragmatism and Futility in Patient Selection
INTERMACS 9th Annual Meeting
MCSD: Evolution, Expansion, and Evaluation
May 15-16, 2015
Disclosures: None
Joseph G. Rogers, MD
Professor of Medicine
Duke University

2. 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)

3. 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

4. The Impact of Illness Severity on MCS Outcomes
INTERMACS Profile
(% 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
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 2008;27:
Anticipated Survival without VAD X
J Heart Lung Transplant 2011;30:155-23
J Heart Lung Transplant 2013;32:141-56
J Heart Lung Transplant 2014;33:555-64

5. How Old is Too Old? Parameter Estimate SE OR (95% CI) p Value
Age (per 10 yrs)
0.274
0.12
1.32 ( )
0.018
Albumin (per g/dl)
-0.723
0.23
0.49 (
0.002
Creatinine (per mg/dl)
0.740
0.22
2.10 ( )
<0.001
INR (per unit)
1.136
0.32
3.11 ( )
Center Volume < 15
0.807
0.34
2.24 ( )
J Am Coll Cardiol 2013;61:313-21
J Am Coll Cardiol 2011;57:2487–95

6. 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)
General guidelines for nutrition management in LVAS patients have been previously published.(29) Markers of severe malnutrition include a BMI < 20, albumin < 3.2, pre-albumin < 15, total cholesterol < 130, lymphocyte count < 100, and PPD skin test anergy. For patients with a pre-albumin< 15, enteral feedings are often helpful pre-operatively and should be continued post implant until they are taking adequate nutrition. Several recent reports have also shown that patients with a pre-albumin < 15 at 2 weeks post implant are at high risk of death pre-discharge.
J Heart Lung Transplant 2010: (4 Suppl):S1-39. 6

7. Chronic Biscuit Poisoning
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
General guidelines for nutrition management in LVAS patients have been previously published.(29) Markers of severe malnutrition include a BMI < 20, albumin < 3.2, pre-albumin < 15, total cholesterol < 130, lymphocyte count < 100, and PPD skin test anergy. For patients with a pre-albumin< 15, enteral feedings are often helpful pre-operatively and should be continued post implant until they are taking adequate nutrition. Several recent reports have also shown that patients with a pre-albumin < 15 at 2 weeks post implant are at high risk of death pre-discharge.
J Heart Lung Transplant 2010: (4 Suppl):S1-39. 7

8. Uh…. I think that fella is too frail for a VAD. Joseph Rogers, MD
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…
Uh…. I think that fella is too frail for a VAD.
Joseph Rogers, MD
Potter Stewart , Associate Supreme Court Justice

9. The Importance of Frailty in LVAD Patient Selection
Circ Heart Fail 2012;5:286-93

10. Decision-Making in Advanced Heart Failure
Urgency
Malignancy
Infection risk
Renal
insufficiency VT
Right heart
failure
Infection risk
Older
Age
DT VAD
ECTx

11. 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:

12. 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

13. Hepatic Function & Coagulopathy
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, PTT
Platelet count
Platelet aggregation studies
HIT assay (Heparin induced thrombocytopenia, platelet antibody)
Hepatic dysfunction is associated with poor outcomes following LVAD implant. Hepatic dysfunction that is secondary to right heart failure may improve with mechanical support (LVAS or BiVAD), whereas cirrhosis is predictive of poor outcome. Liver dysfunction is associated with greater need for intra- and peri-operative blood transfusion, which can result in worsened right heart function and the need for RVAD. Many centers screen patients with clinical evidence of significant right heart failure or serologic evidence of hepatic dysfunction using hepatic ultrasound or liver biopsy to rule out cirrhosis.
As with renal function, there is evidence that hepatic function improves after implantation of a continuous flow LVAD. In the HeartMate II BTT trial, ALT, AST and total bilirubin values in patients with abnormal baseline parameters improved to normal over 6 months.
Specific management strategies should be initiated to improve hepatic function prior to implant in individuals with abnormal prothrombin time (PT), partial thromboplastin time (PTT), and international normalized ratio (INR). Right heart pressure and pulmonary vascular resistance should be decreased using combinations of pre-load and afterload reducing drugs and/or ultrafiltration. Consideration of an intraaortic balloon pump or a temporary percutaneous assist device to improve systemic blood flow is also warranted.
Supplemental vitamin K may play a beneficial role in repletion of vitamin K-dependent coagulation factors in chronically malnourished patients, those treated with warfarin, or individuals with baseline hepatic insufficiency. Administering vitamin K to normalize INR levels and stopping all anti-coagulant and anti-platelet agents well in advance of surgery are critical to minimizing perioperative bleeding
Clinical Management of Continuous-flow LVADs JHLT 2010: 1-39. 13

14. The Impact of LVAD on Ventricular Arrhythmias
100 consecutive VAD patients
Mean age=51 yrs, 63% ischemic
J Am Coll Cardiol 2005;45:

15. Neurologic, Psychosocial, and Psychiatric Considerations
Assess candidates’ ability to:
Care for equipment
Exercise
Comply
Consider history of psychiatric disorders, drug abuse
Psychosocial support team
Address advanced directives
Patients with neurologic or psychiatric disease that compromises their ability to use and care for external system components, or to ambulate and exercise are poor candidates for LVAS support. All patients with an audible bruit or PAD, diabetes, or age > 60 years old, carotid ultrasound to rule out significant stenosis or the presence of unstable plaque is warranted. Patients with previous stroke also warrant CT or MRI scan to establish a pre-operative baseline study. Psychiatric disorders, drug abuse, and other psychosocial issues must be investigated to assess the patient’s ability to understand and comply with care instructions. Patients with known recent drug abuse and/or a history of non-compliance may not be suitable. Adequate family/caregiver support, housing, and community infrastructure are additional determining factors for potential LVAS candidates. Although not an absolute requirement, LVAS patients should have family or friends nearby to provide supportive care when necessary. Patients must have a reliable means of transportation for follow up visits and a convenient, reliable telephone service to call for medical help in an emergency.
Clinical Management of Continuous-flow LVADs JHLT 2010: 1-39. 15

16. 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