The following criteria for the risk-assessment and prophylaxis strategies for allosensitized heart transplant candidates are as follows:
- Class IIa:
- A complete sensitization history, including previous PRA (panel reactive antibody) determinations, blood transfusions, pregnancies, implant of homograft materials, previous transplantation, and use of a VAD is required to assess the risk of heart allograft anti-body-mediated rejection; and
- A PRA greater than or equal to 10% indicates significant allosensitization and it should raise the question of whether therapies aimed at reducing allosensitization should be instituted to minimize the need for a prospective donor/recipient crossmatch; and
- The results of the retrospective donor recipient crossmatch may be considered to make decisions regarding immunosuppressive therapy.
- Class IIb:
- Desensitization therapy should be considered when the calculated PRA is considered by the individual transplant center to be high enough to significantly decrease the likelihood for a compatible donor match or to decrease the likelihood of donor heart rejection where unavoidable mismatches occur; and
- Choices to consider as desensitization therapies include IV immunoglobulin (Ig) infusion, plasmapheresis, either alone or combined, rituximab (Rituxan®), and in very selected cases, splenectomy.
Plasmapheresis may be considered medically necessary as a desensitization therapy for kidney or heart transplantation if the following are met:
- Prior to solid organ transplant, treatment of individuals at high risk of antibody-mediated rejection, including highly sensitized patients, and those receiving an ABO incompatible organ; and
- Following solid-organ transplant, treatment of antibody-mediated rejection.
The use of a desensitization treatment protocol that does not meet these criteria or for any other transplant other than heart or renal is considered experimental/investigational, and therefore, non-covered. Scientific evidence does not support the use of desensitization for other types of transplant.