Impact of Donor Specific Anti-HLA Antibody on Cardiac Hemodynamics and Graft Function 3 years after Pediatric Heart Transplantation: First Results from the CTOTC-09 Multi-Institutional Study.

2023

08/2023

1600-6143

The aim of this study (CTOTC-09) was to assess the impact of 'preformed' (at transplant) donor-specific anti-HLA antibody (DSA) and first year newly-detected DSA (ndDSA) on allograft function at 3-years after pediatric heart transplantation (PHTx). We enrolled children listed at 9 North American centers. The primary endpoint was pulmonary capillary wedge pressure (PCWP) at 3-years post-transplant. Of 407 enrolled subjects, 370 achieved PHTx (mean age 7.7 years, 57% male). Pre-PHTx sensitization status was: non-sensitized (n=163, 44%), sensitized/no DSA (n=115, 31%), sensitized/DSA (n=87, 24%) and 5 (1%) insufficient DSA data; 131 (35%) subjects developed ndDSA. Subjects with any DSA had comparable PCWP at 3 years to those with no DSA. There were also no significant differences overall between the two groups for: other invasive hemodynamic measurements, systolic graft function by echocardiography, and serum brain natriuretic peptide. However, in the multivariable analysis, persistent first year DSA was a risk factor for 3-year abnormal graft function. Graft and patient survival did not differ between groups. In summary, overall, DSA status was not associated with worse allograft function or inferior patient and graft survival at 3 years, but persistent first year DSA was a risk factor for late graft dysfunction.

10.1016/j.ajt.2023.08.006

Am J Transplant

37579817

Use of sirolimus in pediatric heart transplant patients: A multi-institutional study from the Pediatric Heart Transplant Study Group.

2016

2016 Oct 04

1557-3117

<p><strong>BACKGROUND: </strong>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.</p>

<p><strong>METHODS: </strong>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.</p>

<p><strong>RESULTS: </strong>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).</p>

<p><strong>CONCLUSIONS: </strong>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.</p>

10.1016/j.healun.2016.09.009

J. Heart Lung Transplant.

28029575