Abstract
Background: Randomized control trials (RCT) of immunosuppression are needed in pediatric heart transplantation. However, variations in clinical practice could confound results. We surveyed centers to describe practice variations and understand willingness to modify protocols for the purpose of a RCT. Hypothesis: We hypothesized that though variability in practice exists, there would be a willingness to change protocols as part of a RCT. Methods: Pediatric heart transplant centers were identified based on participation in the Pediatric Heart Transplant Study. One member from each institution was sent an electronic request to complete a survey using a customized Qualtrics tool. Simple descriptive statistics were used. Results: The response rate was 72% (40 responses from 52 contacted centers, 37 complete). Respondents were from the United States (36, 90%), Great Britain (2, 5%), Canada (1, 2.5%), and Brazil (1, 2.5%). Mean center volume was 10 transplants/year (range of 1 to 25). A majority of centers use tacrolimus (36, 95%) and mycophenolate mofotil (36, 95%) as maintenance therapy. Other immunosuppression was cyclosporine (7, 18%), everolimus or sirolimus (3, 8%), and azathioprine (2, 5%). Responses for most clinical practices were over 70% similar except for steroid use and biopsy frequency (Table). Overall, willingness to change clinical practice was greater than 70%. A majority of respondents, 97% (36/37) responded that they would be willing to participate in a RCT and 100% (37/37) said they would be willing to participate in a RCT investigating everolimus or sirolimus. Conclusion: Though practice variations exist between pediatric heart transplant centers, most major components of clinical practice protocols are similar. Importantly, a majority of centers are willing to adopt a common protocol for a RCT and practice variations should not be considered a barrier to trial design. There is overwhelming support for a trial involving everolimus or sirolimus.
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