Allosensitization is a risk factor for rejection, vasculopathy and graft loss. CTOTC-04 is a prospective study assessing the impact of sensitization on a composite of death, retx and rejection with hemodynamic compromise. We report sensitization status of enrolled candidates and explore associations with pt characteristics. We prospectively recruited consecutive listed children at 8 centers. Serial protocol blood draws for core lab assessment of anti-HLA antibody (Ab) was performed. Sensitization was defined as positive Luminex® screen with ≥1 anti-HLA Ab at ≥1000 MFI confirmed using single antigen beads. Univariate associations of sensitization with pt characteristics were sought. Of 318 screened candidates, 291 were enrolled. Age at listing was 6.7 yrs (2 d-20.0 yrs) and weight 27.6 kg (2.4-133.0 kg); 55% were male, 58% white & 20% black. Diagnoses were CHD in 50% & cardiomyopathy in 48%. At least 1 prior sensitizing event was present in 73% (prior heart surgery 57%, transfusion 57%, VAD/ECMO 29%, homograft 16%, prior HT 6%, pregnancy 0.3%). 240 received HT. By local evaluation, 143/240 (60%) were sensitized. At HT, 16 had a positive CDC crossmatch. Core lab Ab was available in 237/240; 122 (51%) were sensitized. Among sensitized pts, 48% had Ab with maximum MFI at 1000-3999, 17% at 4000-7999, and 34% at >8000. Univariate analyses showed sensitization associated with CHD (53 vs. 35%, p=0.004), prior heart surgery (66 vs. 43%, p<0.001), transfusion (60 vs 46%, p=0.034), homograft placement (25 vs 6%, p<0.001), HT (10 vs 2%; p=0.008), and male gender (64 vs 42%, p<0.001). Using solid phase assay, pre-HT sensitization is very common in children, even those without CHD. Risk factors traditionally associated with sensitization persist. Long-term follow-up offers a unique opportunity to understand the role played by Ab on late outcomes.

CITATION INFORMATION: Zuckerman W, Feingold B, Zeevi A, Bentlejewski C, Addonizio L, Blume E, Canter C, Dipchand A, Hsu D, Shaddy R, Mahle W, Much K, Armstrong B, Ikle D, Diop H, Odim J, Webber S. Solid Phase Assay Demonstrates High Rates of Allosensitization in Pediatric Heart Recipients. Am J Transplant. 2016;16 (suppl 3).

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