Selection Criteria for Pancreas Transplantation?

Robert J. Stratta, MD

Disclosures

October 17, 2003

Question

What are the current recommendations regarding selection criteria for pancreas transplantation (PTX)?

Response from Robert J. Stratta, MD

Ideally, PTX should be performed before diabetic complications are present and before the need for kidney transplantation. But at present, there are no reliable early markers to predict before the earliest complications appear and which diabetic individuals are at risk for progressive complications. When patients reach the point when they are no longer managing their diabetes because their diabetes is managing them, then either pancreas or islet transplantation is a reasonable option.

Standard eligibility guidelines for PTX include the presence of insulin-requiring diabetes mellitus (usually but not exclusively type 1), the predicted ability to withstand the operative procedure and possible associated complications, the predicted ability to tolerate and comply with the requisite chronic immunosuppression, and the absence of any exclusion criteria. Indications for PTX include:

  1. Presence of insulin-requiring diabetes mellitus

  2. Ability to withstand surgery and immunosuppression (as assessed by pretransplant medical evaluation)

  3. Adequate cardiopulmonary function

  4. Absence of other organ system failure (other than kidney)

  5. Emotional and sociopsychological suitability

  6. Presence of well-defined diabetic complications (any 2):

    • Proliferative retinopathy

    • Nephropathy (with hypertension, proteinuria, or decline in glomerular filtration rate)

    • Symptomatic peripheral or autonomic neuropathy

    • Microangiopathy

    • Accelerated atherosclerosis

    • Glucose hyperlability, insulin resistance, or hypoglycemia unawareness causing a significant impairment in quality of life (with documented frequent episodes of either ketoacidosis, hypoglycemia, or both)

  7. Specific entry criteria based on degree of nephropathy:

    • SKPT: creatinine clearance below 30 mL/min (waiting time accrual begins at a clearance of 20 mL/min or less)

    • Sequential PAKT: creatinine clearance above 40 mL/min

    • PTA: creatinine clearance above 60 mL/min (with some of the newer nonnephrotoxic immunosuppressant drug protocols, however, PTA is being considered for patients with a creatinine clearance in the 40-60 mL/min range)

Absolute contraindications include:

  1. Insufficient cardiovascular reserve, with either coronary angiographic evidence of significant noncorrectable or untreatable coronary artery disease, or recent myocardial infarction

  2. Active infection

  3. History of malignancy treated within the past 2 years (excluding nonmelanoma skin cancer)

  4. Positive HIV serology

  5. Hepatitis B disease with evidence of active viral replication

  6. Active, untreated peptic ulcer disease

  7. Ongoing substance abuse (drug or alcohol)

  8. Major ongoing untreated psychiatric illness

  9. Recent history of medical noncompliance

  10. Inability to provide informed consent

  11. Any systemic illness that would severely limit life expectancy or compromise recovery

  12. Significant, irreversible hepatic or pulmonary dysfunction

  13. Positive lymphocytotoxic cross-match

  14. Morbid obesity (body mass index > 35)

Relative contraindications for PTX include:

  1. Age younger than 18 years or older than 65 years

  2. Recent retinal hemorrhage

  3. Symptomatic cerebrovascular or peripheral vascular disease

  4. Absence of appropriate social support network

  5. Obesity (body mass index > 30)

  6. Active smoking

  7. Severe, untreatable peripheral vascular (aorto-iliac) disease

  8. Hepatitis C disease with evidence of active viral replication and hepatic dysfunction

Comments

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