Safety and early outcomes using a corticosteroid-avoidance immunosuppression protocol in pediatric heart transplant recipients

J Heart Lung Transplant. 2010 May;29(5):517-22. doi: 10.1016/j.healun.2009.11.601. Epub 2010 Jan 12.

Abstract

Background: Long-term oral corticosteroids have been a mainstay of maintenance immunosuppression in pediatric heart transplantation. In this study, we report early clinical outcomes in a cohort of pediatric heart transplant recipients managed using a steroid-avoidance protocol.

Methods: Of the 70 patients who underwent heart transplantation during the study period, 55 eligible recipients, including 49 non-sensitized and 6 sensitized (all 55 with negative crossmatch) patients, entered a steroid-avoidance immunosuppression protocol consisting of thymoglobin induction followed by a 2-drug, tacrolimus-based, corticosteroid-free regimen. The primary outcome variable was freedom from moderate rejection (International Society for Heart and Lung Transplantation [ISHLT] Grade 2R/3A or antibody-mediated rejection).

Results: The median age at transplant was 7.1 years (range 2 weeks to 22 years) and median follow-up was 19 months (range 2 to 46 months). Fifty patients survived to discharge after transplantation. Of these patients, 2 (4%) were discharged on steroids and 8 (16%) started on maintenance steroids at follow-up. Rejection was diagnosed in 8 patients (Grade 2R cellular rejection in 3 and antibody-mediated rejection in 5). Freedom from rejection was 92% at 6 months (95% confidence interval [CI] 80% to 97%) and 87% at 1 year (CI 73% to 94%). Post-transplant survival was 91% at 6 months (CI 79% to 96%) and 88% at 12 and 24 months (CI 75% to 95%). There was 1 death due to rejection (antibody-mediated) 8 months after transplantation.

Conclusions: An immunosuppression protocol consisting of induction followed by corticosteroid avoidance appears to achieve acceptable rejection rates during the first year post-transplant in pediatric heart transplant recipients.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adrenal Cortex Hormones / administration & dosage*
  • Adrenal Cortex Hormones / adverse effects*
  • Antibodies, Monoclonal / administration & dosage*
  • Antibodies, Monoclonal / adverse effects
  • Antilymphocyte Serum
  • Cause of Death
  • Child
  • Child, Preschool
  • Cohort Studies
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Graft Rejection / immunology
  • Graft Rejection / mortality
  • Graft Rejection / prevention & control
  • Heart Transplantation / immunology*
  • Heart Transplantation / mortality
  • Humans
  • Immunosuppressive Agents / adverse effects
  • Immunosuppressive Agents / therapeutic use*
  • Infant
  • Infant, Newborn
  • Male
  • Postoperative Complications / immunology
  • Postoperative Complications / mortality
  • Postoperative Complications / prevention & control
  • Survival Rate
  • Tacrolimus / administration & dosage*
  • Tacrolimus / adverse effects
  • Young Adult

Substances

  • Adrenal Cortex Hormones
  • Antibodies, Monoclonal
  • Antilymphocyte Serum
  • Immunosuppressive Agents
  • thymoglobulin
  • Tacrolimus