FIBRIN SEALANT, APROTININ, AND IMMUNE-RESPONSE IN CHILDREN UNDERGOINGOPERATIONS FOR CONGENITAL HEART-DISEASE

Objective: Most commercially available fibrin sealants contain aprotin in in doses of 1500 kallikrein inactivator units per milliliter. They are used in many operative disciplines. An elevated risk of hypersensi tivity reactions exists at reexposure to aprotinin. Our aim was to exa mine the immunogenic potency of aprotinin as a fibrin sealant content. Methods: We investigated 49 children with operatively treated congeni tal heart disease. All patients received aprotinin only topically as c ontained in fibrin sealant. Serum samples were drawn preoperatively, 1 week, 2 weeks, 6 weeks, and approximately 1 year after operation. The y were analyzed for aprotinin-specific immunoglobulin G antibodies wit h a standard enzyme-linked immunosorbent assay and a fluorescence enzy me immunoassay for aprotinin-specific immunoglobulin E antibodies. Res ults: At 1 week, 2 weeks, 6 weeks, and 1 year, we found prevalences of 8% (2 of 26), 8% (2 of 24), 6% (3 of 49), and 0% for aprotinin-specif ic Immunoglobulin E, and for aprotinin-specific immunoglobulin G 8% (2 of 26), 17% (4 of 24), 39% (19 of 49), and 12% (5 of 41). The doses o f aprotinin given did not differ significantly in antibody-negative an d antibody-positive patients; no significant factors could predict the immune response. Conclusions: Our findings show the existence of a su bgroup of patients who had aprotinin-specific antibodies develop after topical aprotinin application. Any use of aprotinin must be carefully documented. If aprotinin use is planned in patients who previously un derwent a surgical procedure, preexposure to aprotinin in any form mus t be sought to avoid unexpected anaphylactic reactions. The necessity itself and alternatives for aprotinin as a stabilizing agent in fibrin sealants merit consideration.