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Use of sirolimus in pediatric heart transplant patients: A multi-institutional study from the Pediatric Heart
Joseph W Rossano1, John L Jefferies2, Elfriede Pahl3
1Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
Insights
Sirolimus use in pediatric heart transplant patients is uncommon, with no significant differences in survival or adverse events compared to non-users. Further research is needed to fully understand sirolimus
Area of Science:
- Pediatric Cardiology
- Immunosuppression Therapy
- Transplantation Medicine
Background:
- Sirolimus (an mTOR inhibitor) is increasingly used in solid-organ transplantation.
- Limited data exist on sirolimus use in pediatric heart transplant recipients.
- This study describes sirolimus use and its association with outcomes in pediatric heart transplant patients.
Purpose of the Study:
- To describe the utilization of sirolimus in pediatric heart transplant recipients.
- To evaluate the association between sirolimus use and patient survival.
- To assess the impact of sirolimus on secondary outcomes like cardiac allograft vasculopathy, rejection, malignancy, and renal insufficiency.
Main Methods:
- Retrospective review of the Pediatric Heart Transplant Study database (2004-2013).
- Propensity-matched analysis comparing sirolimus-treated vs. non-treated patients at 1 year post-transplant.
- Primary outcome: patient survival; Secondary outcomes: cardiac allograft vasculopathy, rejection, infection, malignancy, renal insufficiency.
Main Results:
- 144 (7%) of 2,080 pediatric heart transplant patients were on sirolimus at 1 year post-transplant.
- Sirolimus-treated and non-treated groups showed similar patient survival and secondary outcomes in overall and propensity-matched analyses.
- Trends observed: increased time to cardiac allograft vasculopathy and decreased time to infection in the overall cohort, but not significant in matched analysis.
Conclusions:
- Sirolimus use is less than 10% at 1 year post-pediatric heart transplant.
- Overall outcomes, including survival and major adverse events, were similar between sirolimus-treated and non-treated pediatric heart transplant patients.
- Further investigation into sirolimus efficacy and safety in this population is warranted.
Background:
Proliferation signal inhibitors, such as sirolimus, are increasingly used in solid-organ transplantation. However, limited data exist on sirolimus-treated pediatric patients. We aimed to describe sirolimus use in pediatric heart transplant patients and test the hypothesis that sirolimus use is associated with improved outcomes.
Methods:
A retrospective review and propensity-matched analysis of the Pediatric Heart Transplant Study database was performed on patients undergoing primary heart transplantation from 2004 to 2013 with at least 1 year of follow-up comparing patients treated vs not treated with sirolimus at 1 year after transplant. The primary outcome of interest was patient survival, with secondary outcomes including cardiac allograft vasculopathy, rejection, malignancy, and renal insufficiency.
Results:
Between 2004 and 2013, 2,531 patients underwent transplantation. At least 1 year of follow-up was available for 2,080 patients, of whom 144 (7%) were on sirolimus at 1 year post-transplant. Sirolimus-treated and non-treated patients had similar survival in the overall cohorts and in the propensity-matched analysis. The secondary outcomes measures were also similar, including a composite end point of all outcome measures. There was a trend toward increased time to cardiac allograft vasculopathy (p = 0.09) and decreased time to infection (p = 0.05) among sirolimus-treated patients in the overall cohort (p = 0.19) but not in the propensity-matched cohort (p = 0.17).
Conclusions:
Sirolimus was used in less than 10% of patients at 1 year post-transplant. Overall outcomes of sirolimus treated and non-treated patients were similar with respect to survival and major transplant adverse events. Further study of sirolimus in pediatric heart transplant patients is needed.
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