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Abstract
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.