Purpose: Highly sensitized patients (pts) awaiting heart transplantation remain a significant challenge due to prolonged often prohibitive wait times for suitable organs and increased rejection risk after transplant (tx). Many pts continue to have elevated panel reactive antibodies (PRA) despite attempts at desensitization. This is a first report in heart transplantation of a pilot study evaluating the use of the C5 complement inhibitor eculizumab in a cohort of highly sensitized pts and their post tx outcomes.

Methods: 9 pts underwent treatment with eculizumab infusion perioperatively, weekly for 1 month and biweekly for month 2 post tx. All pts received rabbit anti-thymocyte globulin induction, corticosteroids, tacrolimus and mycophenolate mofetil post transplant. Outcomes determined included 12 month actuarial survival, freedom from antibody mediated rejection (AMR ≥2), cellular rejection (ACR≥2R), any treated rejection (ATR), graft dysfunction and treated infection.

Results: Using the higher limiting HLA Class I or Class II PRA for each pt, the mean PRA for the cohort at tx was 92%±5%. Mean retrospective flow crossmatch (8 pts) was 104±140 median channel shifts (MCS) for T cells (positive>50) and 199±87 MCS for B cells (positive>100). Actuarial survival at 12 months was 88.9% with 1 intraoperative death due to purulent mediastinitis. 12 month freedom from AMR ≥2 was 75%, ACR≥2R 100% and ATR 75%. There were no treated infections and graft function was preserved in all surviving pts.

Conclusion: This pilot study suggests terminal complement inhibition with eculizumab facilitates heart transplantation in high risk highly sensitized pts with acceptable outcomes at 12 months. Further studies are needed to confirm these preliminary results.

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