Background: Calcineurin inhibitors (CNI) are essential agents in most orthotopic heart transplantation (OHT) anti-rejection regimens. However, nephrotoxicity limits their use in the immediate post-OHT period, leaving recipients at increased risk of early acute rejection. The aim of this study is to evaluate the efficacy of an OHT induction immunosuppression regimen which includes a third dose of basiliximab on post-operative day (POD) 7 to accommodate delayed initiation or minimization of CNI therapy, a regimen unreported in the literature.

Methods: A retrospective single center study of adults who underwent solitary OHT from January 2011–May 2014 with 1 year post-OHT follow-up was conducted. The primary objective was to compare the 1 year prevalence of biopsy-proven acute rejection (BPAR) grades ≥ 2R per the International Society of Heart and Lung Transplantation (ISHLT) Endomyocardial Biopsy Grading System to the prevalence of acute rejection reported in the literature. Patient and graft survival at 1 year post-OHT, time to initiation of tacrolimus (tac), time to BPAR, and renal function (change from baseline in serum creatinine) and mean tac trough levels at discharge, 6 weeks, 3 months, 6 months, and 1 year were also reported. Results were analyzed using descriptive statistics.

Results: 33 patients were included in the study. Baseline demographics included: 84.8% Caucasian, 84.8% male, median age of 58 years, and mean serum creatinine (SCr) of 1.3 mg/dL. There were no patient deaths or graft failures at 1 year post-OHT. The prevalence of BPAR at 1 year was 51.5%, vs. 35% in the ISHLT 2011 Annual Report. All episodes of BPAR were grade 2R and occurred within the first 6 weeks post-OHT, with a median time to BPAR of POD 16 (7–23). The mean tac trough level at time of BPAR was 5.8±2.5 ng/mL. The median time to tac initiation was POD 4 (1–21). Mean tac trough levels were 7.3±3 ng/mL at discharge, 8.8±4.8 ng/mL at 6 weeks, 9.9±3.8 ng/mL at 3 months, 8±2.6 ng/mL at 6 months, and 6.1±1.8 ng/mL at 1 year post-OHT. Mean change in SCr from baseline was +0.2±0.7 mg/dL at discharge, +0.1±0.5 mg/dL at 6 weeks, +0.1±0.6 mg/dL at 3 months, +0.2±0.4 mg/dL at 6 months, and +0.3±0.4 mg/dL at 1 year post-OHT, resulting in a small increase in mean SCr to 1.6±0.6 mg/dL at 1 year.

Conclusions: A three dose basiliximab regimen may not confer additional protection against early BPAR post-OHT as compared to the 2011 ISHLT report.

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