title: Safety and early outcomes using a corticosteroid-avoidance immunosuppression protocol in pediatric heart transplant recipients.
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.
authors.affiliation: Department of Cardiology, Children's Hospital Boston, Boston, Massachusetts 02115, USA. tp.singh@cardio.chboston.org
authors.forename: Tajinder P
authors.initials: TP
authors.lastname: Singh
authors.forename: Carey
authors.initials: C
authors.lastname: Faber
authors.forename: Elizabeth D
authors.initials: ED
authors.lastname: Blume
authors.forename: Sarah
authors.initials: S
authors.lastname: Worley
authors.forename: Christopher S
authors.initials: CS
authors.lastname: Almond
authors.forename: Leslie B
authors.initials: LB
authors.lastname: Smoot
authors.forename: Shay
authors.initials: S
authors.lastname: Dillis
authors.forename: Colleen
authors.initials: C
authors.lastname: Nasman
authors.forename: Gerard J
authors.initials: GJ
authors.lastname: Boyle
mesh_terms: D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage* / Q000009:adverse effects*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D000961:Antilymphocyte Serum; D002423:Cause of Death; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000276:immunology / Q000401:mortality / Q000517:prevention & control; D016027:Heart Transplantation / Q000276:immunology* / Q000401:mortality; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D011183:Postoperative Complications / Q000276:immunology / Q000401:mortality / Q000517:prevention & control; D015996:Survival Rate; D016559:Tacrolimus / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D000911:Antibodies, Monoclonal; D000961:Antilymphocyte Serum; D007166:Immunosuppressive Agents; C512542:thymoglobulin; D016559:Tacrolimus