Vascularized Composite Bladder Allograft Transplantation

Exclusion Criteria36

• No active co-existing psychosocial problems (i.e., alcoholism, drug abuse).
• Negative crossmatch with donor.
• DONOR: Any potential brain dead donor considered for solid organ transplant.
• DONOR: Age 18-65 years.
• DONOR: Stable, meaning no requirement of excessive vasopressors for maintaining blood pressure.
• DONOR: ABO compatibility.
• DONOR: Negative cross-match with recipient.
• Positive history of one of the following medical co-morbidities:
• Human immunodeficiency virus \[HIV\] (active or seropositive), active hepatitis B or C, viral encephalitis, untreated sepsis, active tuberculosis, viral encephalitis, toxoplasmosis, varicella zoster virus.
• Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications including inherited coagulopathies like hemophilia, Von-Willebrand's disease, protein C and S deficiency, thrombocythemia, thallassemia, sickle cell disease.
• Mixed connective tissue diseases and collagen disorders (can result in poor wound healing after surgery), including:
• Mixed connective tissue disorder
• Severe deforming rheumatoid arthritis
• Infectious, post-infectious, or inflammatory (axonal or demyelinating) neuropathy
• Ehler-Danlos syndrome
• Lipopolysaccharidosis or amyloidosis (effects nerve regeneration).
• Impaired liver function as evaluate by liver function panel, including the presence of hyperbilirubinemia, elevated aspartate aminotransferase/ alanine aminotransferase (AST/ALT), and the presence of secondary coagulopathy, measured by prothrombin, international normalized ratio, and partial thromboplastin time.
• Severe anemia (hemoglobin \< 7 g/dL), leukopenia (WBC \< 3 x 10 \^ 9 cell/L), or thrombocytopenia (platelets \< 20 x10 \^ 9 cells/L).
• Oncology patient specific:
• History of any non-urothelial malignancy within the past 5 years, with the exception of non-melanomatous skin cancer and very-low to low risk prostate cancer on active surveillance.
• History of metastasic malignancy within the past 5 years.
• History of urothelial carcinoma in patients without pre-existing conditions that require immunosuppression and/or without the expected need for immunosuppression in the future.
• Sensitized recipients; panel reactive antibody (PRA) \< 80%, with negative crossmatch to donor and no evidence of donor-specific antibody at time of transplant.
• Patients unable to receive adequate follow-up care and/or unable to receive immunosuppression due to geographic, financial or other reasons.
• Patients with a smoking history who cannot demonstrate smoking cessation for a period of 6 months prior to listing and a desire to abstain from post-operative smoking will be excluded.
• Records of poor medical compliance, documented psychological disorder(s), substance abuse or incomplete psychological clearance.
• Particular attention will be paid to the candidate's compliance and their desire to undergo the offered procedure. While there is no "score" on any particular evaluation that would rule out a patient, certain factors can aid in the identification of patients who for example may not have the ability to comply with the medical directives necessary to care for a genitourinary transplant, or psychologically are not prepared for transplant, or who have unrealistic expectations about the transplant. The decision on eligibility is a team decision. All members of the team will discuss each candidate in a multidisciplinary meeting and reasons for concern over eligibility will be discussed at a Selection Committee Meeting (per University of Southern California Transplant Center Policy). In circumstances where the candidate is considered to be less suitable, they could be given an opportunity to address these issues either through individual counseling or further education and then be reconsidered as a potential candidate. Every effort to prevent a request for allograft removal will be made. Towards these ends, a two-part initial psychiatric consultation will be rendered in addition to psychosocial evaluations already accounted for in the social work and transplantation evaluation prior to listing. The first visit focuses on background history and standard contraindications to transplantation, while the second visit is a more thorough discussion of the challenges ahead for the potential recipient and how these challenges relate to their strengths and vulnerabilities. If at this phase, or any subsequent one, significant psychological need emerges, the patient will be referred to another mental health professional for ongoing treatment with frequent communication between that provider and the transplant psychiatrist. The same psychiatrist responsible for listing and taking part in the protocol will not provide this treatment, given the potentially conflicting obligations involved and the disincentive present for the patient to be completely honest. If a greater than 6 month period of time elapses between listing and transplantation, a follow-up visit with psychiatry and social work will be arranged.
• DONOR: Unresolved sepsis.
• DONOR: Known history of urothelial or prostate cancer/malignancy.
• DONOR: Known history of bladder or prostate surgery.
• DONOR: Abnormal bladder capacity.
• DONOR: Active sexually transmitted disease.
• DONOR: Active cytomegalovirus (CMV), Epstein-Barr virus (EBV), or tuberculosis (TB) infections.
• DONOR: Hepatitis B virus (HBV) core antibody, surface antigen, or DANN positive.
• DONOR: Hepatitis C virus (HCV) antibody or viral load+.
• DONOR: Human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS).