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 cross-match) 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 [SHLT] grade 2R/3A or antibody-mediated rejection). Results The median age at transplant was 7.1 years (range 2 weeks–22 years) and median follow-up 19 months (range 2–46 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.

609 Steroid Avoidance in Pediatric Heart Transplantation Results in Excellent Graft Survival

“…The successful use of SF maintenance immunosuppression in our analysis is consistent with single-center and dual-center reports of SF maintenance immunosuppression in heart, liver, and renal transplantation (2,3,11,12). While there are no other studies in pediatric HT directly comparing graft survival in patients with and without MS use, multiple single-center studies of pediatric HT have reported outcomes with an SF maintenance immunosuppression protocol with excellent results (2,8,(13)(14)(15)(16). Our propensity matching addresses the limitations of those reports by creating two groups with similar baseline characteristics and comparing MS and SF groups directly.…”

“…Other explanations for the worse univariable outcomes in the MS group indude a higher proportion of African Americans, a higher proportion of patients who underwent transplantation in the earlier era, and a higher proportion of patients with a previous sternotomy, all of which have been associated with a higher risk of graft loss (1,9,10). The successful use of SF maintenance immunosuppression in our analysis is consistent with single-center and dual-center reports of SF maintenance immunosuppression in heart, liver, and renal transplantation (2,3,11,12). While there are no other studies in pediatric HT directly comparing graft survival in patients with and without MS use, multiple single-center studies of pediatric HT have reported outcomes with an SF maintenance immunosuppression protocol with excellent results (2,8,(13)(14)(15)(16).…”

“…Despite the side effects associated with maintenance steroid (MS) use, the International Society for Heart and Lung Transplantation registry reports that 63% of pediatric HT recipients received MS at 1 year after HT and univariable conditional 1-year survival analysis showed better survival in patients not taking MS (1). Single-and dual-center reports of pediatric HT protocols that avoid MS have shown survival equivalent to what has been published in registry reports and an acceptable incidence of rejection (1)(2)(3). However, none of these studies have directly evaluated a survival advantage based on MS use.…”

Cardiac Allograft Function During the First Year after Transplantation in Rejection-Free Children and Young Adults

“…Current clinical immune suppression protocols are associated with a lower incidence of rejection in pediatric HT recipients compared with earlier eras 7,8 and may have contributed to improved early survival in the pediatric HT population. 9 A larger pool of rejection-free recipients in clinical practice has created an opportunity to study the physiology of allograft recovery, in particular, recovery of ventricular function, in such recipients with more precision than was previously possible.…”

Análise clínica evolutiva do uso do tacrolimus como droga imunossupressora em transplante cardíaco pediátrico

“…Entretanto, seu uso por tempo prolongado está associado a efeitos adversos, particularmente na faixa etária pediátrica, como: distúrbios do crescimento, hipertensão arterial sistêmica, dislipidemia, diabetes melito e aumento da incidência de infecções 16 .…”