Pancreas or Kidney/Panc Eval

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Policy: Kidney/Pancreas Pre-Transplant: Pancreas Transplant Candidate Selection Criteria

Statement: Activation date: 1/28/03

Affected Department: Emory Kidney/Pancreas Transplant Program

Vision Strategy: Patient Care

Policy Statement: Determination of candidacy for pancreas transplant is based upon specific program selection criteria. Candidates must have Type I diabetes mellitus (DM I) and desire a pancreas transplant. Candidates are considered based on 1) their overall health status, 2) sufficient family and social support systems, 3) an ability to obtain transportation to and from the transplant center, and 4) an ability to purchase and take prescribed medications after transplant, to be reasonably assured s/he can successfully manage the post-transplant treatment regime. There are no absolute age criteria. Patients with chronic renal failure (CRF) or end-stage renal disease (ESRD) may be referred and evaluated for a combined simultaneous renal/pancreas transplant; however a candidate must be dialysis dependent or have a creatinine clearance of < 30cc/min before he/she will be placed on the UNOS active waiting list for this procedure.

Basis: This procedure is necessary to ensure that effective and efficient care is provided to all patients who are referred to the Emory Transplant Center’s Kidney/Pancreas Transplant Department for a potential pancreas transplant.

Administrative Responsibility: Section heads, physicians, practitioners, and staff are responsible for compliance with this policy.

Scope/Procedure:

The Emory Kidney/Pancreas Transplant Program will evaluate candidates who meet the required criteria. Each candidate will be considered and if necessary, referred to UNOS for assistance with referral to other centers with expertise in the treatment of specific cases not currently treated by our team.

Selection Criteria:

Absolute Contraindications

There are many situations in which kidney and/or pancreas transplantation may not be appropriate. The following list is meant only as a guide. The transplant team will always be willing to perform an initial review on any patient if there is a doubt as to candidacy. Absolute contraindications to immediate transplant or active listing for transplant include:

1- Active infection. This may include bacterial, viral, and fungal infections.

2- Previous aortofemoral graft reconstruction for peripheral vascular disease.

3- Severe mental disability without adequate social support to manage post transplant regime.

4- Severe irreversible extra non-renal and organ disease, such as respiratory disease, cardiac disease and hepatic disease.

5- Severe active vasculitis or other autoimmune disorders.

6- Current untreated malignancy other than non-melanoma skin cancer.

7- General medical condition and/or functional status that makes the risk of transplant greater than the potential benefit

Relative Medical Contraindications

The following list serves as a guideline. Every candidate referral with a relative contraindication will be reviewed with the transplant team before a final candidacy decision is made.

1- Serious medical problems that may be reversible.

2- Organic neurological disorders, psychiatric disorders, and/or drug addiction that will, in our opinion, significantly impair the candidate’s ability to manage the post transplant regime.

3- Severe peripheral vascular disease.

4- Malignancy within the last two to five years other than non-melanoma skin cancers. Every candidate with a previous malignancy will be evaluated individually based on surgery notes, pathology reports, and cancer treatment records.

5- Moderately severe or severe cardiac disease, including ischemic myocardial disease, congestive heart failure, valvular disease and myopathies.

6- Chronic active inflammatory or infectious diseases.

7- Obesity or malnutrition to the extent that this factor significantly impacts surgical risk and life expectancy.

8- Chronic upper respiratory disease.

9- Uncorrected lower urinary tract abnormalities.

Additional Information

Candidates must be determined to have Type I diabetes to receive a pancreas transplant. To confirm this diagnosis we require the potential recipient to: (1) have an undetectable c-peptide level; (2) have a BMI of 30 or less; (3) have a daily insulin requirement of 1 unit per kilogram body weight or less per day. Candidates that have an indeterminate diagnosis of Type I vs. Type II diabetes will be evaluated by the Emory endocrinologist that works closely with the pancreas transplant team. If the endocrinologist determines the patient to have predominately a

Type 1 diabetes then they will be a candidate for this procedure from this perspective.

Pancreas transplantation may be performed simultaneously with a kidney transplant (SPK), after a kidney transplant

(PAK) of prior to the need for a kidney transplant (PTA). Candidates for a SPK will have DM I and CRF or ESRD.

They will be on renal replacement therapy or have a measured or calculated creatinine clearance of 30 ml/min or less. Candidates for PAK will have had a previous renal transplant and have good function of the transplant as determined by a measured or calculated creatinine clearance of 40 ml/min or greater. Candidates for PTA should have good function of their native kidneys (creatinine clearance of 40 ml/min or greater) and be experiencing significant short risk of risk of morbidity or mortality from the DM I despite excellent compliance with an optimized insulin regimen under the care of an endocrinologist. An example would be a patient that is experiencing frequent episodes of hypoglycemic unawareness.

Relative Non-Medical Contraindications

The following list serves as a guideline. Every candidate referral with a relative contraindication will be reviewed with the transplant team before a final candidacy decision is made.

1. Inability to provide adequate psychosocial support plan

2. Inability to provide adequate financial plan for provision of medications and the cost associated with post-transplant care per policy

3. Failure to follow No Show/Cancellation policy

4. Failure to complete required testing/transplant plan within program

Guidelines

5. Gross non-compliance

6. Recipient candidate does not desire a transplant

7. Failure to maintain contact with the transplant center

Approval Dates: 8/5/06, 12/15/06 , 2/6/08 , 2/1/2012

Revision Date: 3/15/11, 6/30/2011, 2/1/2012

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