OBJECTIVE: Cryopreserved allograft tissue used in the Norwood procedure for infants with hypoplastic left heart syndrome causes profound immunologic sensitization, which may complicate future transplantation. Intravenous immunoglobulin has been shown to reduce sensitization after it has developed, allowing successful transplantation. The purpose of this pilot trial was to determine whether intravenous immunoglobulin given before and after the procedure could prevent sensitization to cryopreserved allograft patches used in the initial repair of hypoplastic left heart syndrome. METHODS: Intravenous immunoglobulin (2 g/kg) was given preoperatively, 3 weeks postoperatively, and 4 months postoperatively to 7 infants undergoing the Norwood procedure. Panel-reactive antibodies were measured with flow cytometry preoperatively and at 1, 4, 6, and 12 months postoperatively and compared with values from a contemporary cohort of 12 infants undergoing the Norwood procedure who did not receive intravenous immunoglobulin. RESULTS: The groups were well matched for length and weight at time of surgery. Control infants were somewhat younger than the cohort receiving intravenous immunoglobulin (8 +/- 5 vs 17 +/- 14 days, P = .021). There were no differences in transfusion requirements. There was no difference in the degree of sensitization between control and intravenous immunoglobulin groups at 1 month (class I panel-reactive antibodies 20% +/- 30% vs 4% +/- 9%, P = .443, class II panel-reactive antibodies 17% +/- 27% vs 20% +/- 17%, P = .400), 4 months (class I panel-reactive antibodies 62% +/- 40% vs 73% +/- 41%, P = .813, class II panel-reactive antibodies 49% +/- 42% vs 54% +/- 41%, P = .706), and 12 months (class I panel-reactive antibodies 49% +/- 42% vs 58% +/- 39%, P = .686, class II panel-reactive antibodies 44% +/- 36% vs 49% +/- 42%, P = .651). CONCLUSION: Despite studies showing intravenous immunoglobulin to reduce sensitization, we were unable to demonstrate that intravenous immunoglobulin prevented sensitization after exposure to allograft tissue in neonates undergoing congenital cardiac surgery.
OBJECTIVE: Cryopreserved allograft tissue used in the Norwood procedure for infants with hypoplastic left heart syndrome causes profound immunologic sensitization, which may complicate future transplantation. Intravenous immunoglobulin has been shown to reduce sensitization after it has developed, allowing successful transplantation. The purpose of this pilot trial was to determine whether intravenous immunoglobulin given before and after the procedure could prevent sensitization to cryopreserved allograft patches used in the initial repair of hypoplastic left heart syndrome. METHODS: Intravenous immunoglobulin (2 g/kg) was given preoperatively, 3 weeks postoperatively, and 4 months postoperatively to 7infants undergoing the Norwood procedure. Panel-reactive antibodies were measured with flow cytometry preoperatively and at 1, 4, 6, and 12 months postoperatively and compared with values from a contemporary cohort of 12 infants undergoing the Norwood procedure who did not receive intravenous immunoglobulin. RESULTS: The groups were well matched for length and weight at time of surgery. Control infants were somewhat younger than the cohort receiving intravenous immunoglobulin (8 +/- 5 vs 17 +/- 14 days, P = .021). There were no differences in transfusion requirements. There was no difference in the degree of sensitization between control and intravenous immunoglobulin groups at 1 month (class I panel-reactive antibodies 20% +/- 30% vs 4% +/- 9%, P = .443, class II panel-reactive antibodies 17% +/- 27% vs 20% +/- 17%, P = .400), 4 months (class I panel-reactive antibodies 62% +/- 40% vs 73% +/- 41%, P = .813, class II panel-reactive antibodies 49% +/- 42% vs 54% +/- 41%, P = .706), and 12 months (class I panel-reactive antibodies 49% +/- 42% vs 58% +/- 39%, P = .686, class II panel-reactive antibodies 44% +/- 36% vs 49% +/- 42%, P = .651). CONCLUSION: Despite studies showing intravenous immunoglobulin to reduce sensitization, we were unable to demonstrate that intravenous immunoglobulin prevented sensitization after exposure to allograft tissue in neonates undergoing congenital cardiac surgery.