Maintenance Steroid Avoidance in Pediatric Heart Transplantation is Associated with Excellent Graft Survival

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1 Maintenance Steroid Avoidance in Pediatric Heart Transplantation is Associated with Excellent Graft Survival Scott Auerbach, MD, Jane Gralla, PhD, Shelley Miyamoto, MD, David Campbell, MD, and Biagio Pietra, MD Children s Hospital Colorado and University of Colorado Denver, USA

2 ISHLT 32nd Annual Meeting and Scientific Sessions Prague Convention Center Prague, Czech Republic April 18-21, 2012 I have no financial relationships to disclose within the past 12 months relevant to my presentation

3 Background Historically, the use of maintenance steroids (MS) in heart tx has been routine and the use of steroid-free (SF) regimens remains controversial Several centers have adopted SF regimens in pediatric kidney tx, but SF is less well accepted in heart tx Use of steroids long-term has multiple side effects including HTN, hyperlipidemia, Cushing s syndrome, behavioral abnormalities, osteopenia, diabetes, muscle wasting, obesity and others Strategies to avoid long-term steroid use have potential to improve quality of life by avoiding side effects

4 Purpose To assess the impact of SF maintenance immunosuppression on graft survival in pediatric heart tx Hypothesis: There will be no graft survival disadvantage in patients on SF regimen compared with MS

5 Methods Review of the UNOS database st heart tx in children <18 years, with information on steroid maintenance therapy at discharge Overall and conditional 30 day graft survival were compared based on SF Selection bias may play a role in which recipients were SF We analyzed our center's serial experience with SF protocol in all recipients over the same period.

6 Statistical Methods The probability of treatment for acute rejection was assessed with logistic regression. Kaplan Meier Survival Analysis Multivariable Cox s proportional hazards modeling controlled for univariable risk factors (p<0.1) for graft loss (death or repeat HT). Graft Survival 30 day conditional graft survival-overall Conditional graft survival-early Phase days post-transplant Conditional graft survival-late Phase after 1st year post-transplant

7 Patient Characteristics

8 Patient Characteristics Cont d

9 Immunosuppresion

10 Probability of Treatment for Any Acute Rejection Episode OR 1.16, 95% CI , p=0.15

11 Probability of Treatment for Any Acute Rejection Episode OR 1.16, 95% CI , p=0.15

12 Results: Graft Survival: Overall (p=0.44) Graft Survival: 30 Day Conditional (p=0.004) 3962 (81%) MS, 932 (19%) SF 3694 (82%) MS, 836 (18%) SF % Graft Survival

13

14

15

16 Graft Survival: CHC vs. Other Centers Graft Survival by Center and MS Use (p=0.73) 30 Day Conditional Graft Survival by Center and MS Use (p=0.005) % Graft Survival

17 Limitations Retrospective Registry data Causal relationship cannot be determined Reliant on accurate designation of maintenance immunosuppression. Different methods of PRA reporting Incomplete Data Entry Unable to analyze differences in outcomes based on steroid withdrawal at various times post-transplant. Unable to analyze frequency of rejection

18 Conclusions 1 st multicenter analysis to show graft survival in pediatric heart tx is no worse in SF regimens vs. MS There was a higher risk of graft loss in the MS group in the interval days It may be a surrogate for patients with frequent or resistant rejection and/or poor graft function. This may be related to non-adherence patterns in adolescent patients initially prescribed MS. Or, it may be related MS use itself. Consideration should be given to corticosteroid avoidance protocols, as there does not appear to be a survival benefit to their use and the multiple side effects are well known

19 Future Directions The PHTS has approved a study on SF vs. MS immunosuppression to be analyzed this summer More complete data set Confirm the findings in this analysis Evaluate rejection frequency and severity between MS and SF regimens

All data from Necker Hospital regarding the donors and recipients were extracted from the

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