Indications, tolerance and complications of a sirolimus and calcineurin inhibitor immunosuppression regimen: intermediate experience in pediatric heart transplantation recipients.

Although SRL has been used in adults, few studies are reported in pediatric Htx recipients. Retrospective chart review of all Htx patients on SRL. We evaluated Cr at Htx and years 1, 3, 5, 7, 9, 11, 13, and 15 post-Htx. GFR was calculated (Schwartz). BMI, Hgb, lipid profiles, and complications were compared to 59 controls, and a matched case-control group used to compare GFR to SRL cohort. Twenty-one patients were converted to SRL 1-2 mg/day (target 4-8 ng/mL) and analyzed. Reasons for conversion: re-transplantation/TCAD (8), renal (7), rejection (5), other (1). Cr was higher (p = 0.004) and GFR lower (p = 0.025) in SRL group than controls at Htx. Patients began SRL a median of 3.6 yr (0.1-16.2) post-Htx at 15.2 yr of age (4.4-24.4), with follow-up 0.5-4.6 yr. SRL was well tolerated with no increase in hyperlipidemia, rejection or mortality. None required SRL discontinuation. SRL was well tolerated in pediatric Htx patients. Kidney function remained stable; subjects had no increase in mortality, rejection or PTLD. Multicenter studies using renal sparing protocols are needed to determine whether SRL should be used routinely in children.