EARLY OUTCOMES FOR LOW RISK PEDIATRIC HEART TRANSPLANT RECIPIENTS AND STEROID AVOIDANCE: A MULTICENTER COHORT STUDY (CLINICAL TRIALS IN ORGAN TRANSPLANTATION IN CHILDREN - CTOTC-04)

Abstract Background Immunosuppression strategies have changed over time in pediatric heart transplantation (PHT). Thus, comorbidity profiles may have evolved. CTOTC-04 is a multicenter, prospective, cohort study assessing the impact of pre-transplant sensitization on outcomes after PHT. This sub study reports one year outcomes among recipients without pre-transplant donor-specific antibodies (DSA). Methods We recruited consecutive candidates ( Results There were 240 transplants. Subjects for this sub-study (n=186) were non-sensitized (n=108) or had no DSA (n=78). Median age was 6 years, 48.4% male, and 38.2% had congenital heart disease. Patient survival was 94.5% (95% CI: 90.1-97.0). Freedom from any type of rejection was 67.5%. Risk factors for rejection were older age at transplant and presence of non-DSA pre-transplant. Freedom from infection requiring hospitalization/intravenous antimicrobials was 75.4%. Freedom from rehospitalization was 40.3%. New onset diabetes mellitus and post-transplant lymphoproliferative disorder (PTLD) occurred in 1.6% and 1.1% of subjects respectively. There was no decline in renal function over the first year. Corticosteroids were used in 14.5% at 1 year. Conclusions PHT recipients without DSA at transplant, and managed with a steroid avoidance regimen, have excellent short-term survival and low risk of first year diabetes mellitus, and PTLD. Rehospitalization remains common. These contemporary observations allow for improved caregiver/patient counseling and provide the necessary outcomes data to help design future randomized controlled trials.