ITEM 2015 JBC APPROVED WORDING PROPOSED REVISIONS TO THE CRITERIA SPECIALIST WORKING GROUP RATIONALE FOR ADDITIONS/CLARIFICATIONS Condition Name Solid organ transplantation (other than kidney) Solid organ transplantation (other than kidney) Unchanged Specialty Transplantation Transplantation Unchanged Category Emerging therapeutic role Emerging therapeutic role Unchanged Specific Conditions • Heart • Lung • Heart & Lung • Liver • Heart kidney • Heart liver • Liver kidney • Pancreas • Small intestine Heart • Lung • Heart & Lung • Liver • Heart kidney • liver • Liver kidney • Pancreas • Small intestine Unchanged Level of Evidence Small case studies only; insufficient data (Category 4a) Insufficient data (Category 4a) Unchanged Justification for Evidence Category Jordan et al (1998) combined data from seven renal transplant recipients and three heart transplant recipients with steroid-resistant combined (AbMR) and cellular rejection. All patients in this series were successfully treated with high-dose IVIg. Findings from an International Consensus Conference in 2011 noted that IVIg has never been systematically Ig therapy plays an important immunomodulatory role in incompatible organ transplantation with proven benefit (Level 1 evidence) for of highly sensitised patients to improve transplant rates and clinical outcomes (Jordan, 2004). For desensitisation, trials have demonstrated improved outcomes when IVIg is used in association with Rituximab and/or other immunosuppressant agents. This section has been strengthened to include supporting evidence for desensitisation and additional literature related to antibody mediated rejection.
Post-transplant - acute anti-body mediated rejection with clinical evidence of graft dysfunction Treatment or prevention of graft rejection where conventional immunosuppressive therapies is contraindicated or pose a threat to the graft or patient Treatment or prevention of graft rejection where conventional immunosuppressive therapies is contraindicated or pose a threat to the graft or patient The second indication has been amended to more accurately reflect the fact that clinical evidence of graft dysfunction is not always required - a one-off request may be approved in the early period of rejection where there is a high clinical suspicion. The criteria themselves have not changed and this change is consistent with Kidney transplantation. Description and Diagnostic Criteria Transplant rejection occurs when a recipient’s immune system attacks a transplanted organ or tissue. Despite the use of immunosuppressants, one or more episodes of rejection can occur after transplantation. Both cellular and humoral (antibody-mediated) effector mechanisms can play a role. The presence and pattern of rejection need to be established by biopsy. Laboratory tests to assess the presence and strength of antibodies to the donor antigens can provide additional useful information. Clinical assessment, blood tests, ultrasound and nuclear imaging are used primarily to exclude other causes of organ dysfunction. Acute cellular rejection occurs in of organ transplants and is responsive to steroids in more than 90% of cases. When rejection is steroid In heart transplant, the approach to desensitise patients is reasonably common because of the increasing use of device technology (and exposure to blood transfusion), so there is an increasing population of sensitised patients that would not be considered for transplant without this approach. Desensitisation is only an occasional occurrence in lung transplantation. Transplant rejection occurs when a recipient’s immune system attacks a transplanted organ or tissue. Despite the use of immunosuppressants, one or more episodes of rejection can occur after transplantation. Both cellular and humoral (antibody-mediated) effector mechanisms can play a role. The presence and pattern of rejection need to be established by biopsy. Laboratory tests to assess the presence and strength of antibodies to the donor antigens can provide additional useful information. Clinical assessment, blood tests, A short description relating to desensitisation has been added.