Joseph G. Rogers, MD Professor of Medicine Duke University

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Presentation transcript:

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

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)

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 Outcomes INTERMACS Profile 2006-2008 (% 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 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;27:1065-72 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

How Old is Too Old? 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) Center Volume < 15 0.807 0.34 2.24 (1.15-4.37) J Am Coll Cardiol 2013;61:313-21 J Am Coll Cardiol 2011;57:2487–95

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

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

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

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

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

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

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

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

The Impact of LVAD on Ventricular Arrhythmias 100 consecutive VAD patients Mean age=51 yrs, 63% ischemic J Am Coll Cardiol 2005;45:1428-34

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

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