Restrictive Rather Than Routine Use Of Basiliximab For Heart Transplant Induction

Abstract

Introduction The use of immunosuppression induction strategies greatly varies between heart transplant (HT) centers. Clinicians must weigh the risk of allograft rejection with infection and malignancies. Our center stopped routine induction with the Interleukin-2 receptor antagonist basiliximab in 2016 after findings of increased infection, malignancy, and a trend towards higher mortality. Hypothesis We aimed to assess the effect of our protocol change abandoning routine use of basiliximab on survival, allograft rejection, infection, and malignancy. Methods Retrospective single-center analysis of consecutive HT recipients from 2003 to 2015 and 2017-2019. In 2016 the induction protocol was changed, and the adjustment period was excluded. Furthermore, patients bridged to transplant with LVAD, re-transplantation and multi-organ transplants were not included. Results : A total of 398 patients were identified (mean age 55±11, 72% male) and grouped by induction with basiliximab or no induction. There were no clinically significant differences in baseline characteristics between the groups including age, panel reactive antibody % (PRA) and kidney function (Table). One-year mortality was significantly lower in the no-basiliximab group 1.9 vs 6.75% p 0.03 (Figure 1). Multivariate regression for basiliximab, PRA, age, gender, diabetes mellitus, creatinine did not identify independent risk factors for mortality. Significantly more patients in the no-basiliximab group had ≥ 1 rejection (≥ 2R ISHLT 2004) 68 vs 44% with significantly lower rejection free survival (p 0.0001) per log-rank test (Figure 2). There was no longer a significant difference in rates of bacterial and fungal infections as well as CMV-viremia and malignancies during the first-year post-transplant year. Conclusion Restrictive rather than routine use of basiliximab induction is no longer associated with increased infectious and early malignancy but remains associated with inferior survival despite lower incidence of early rejection and comparable immunological risk based on PRA. In the future improved individual immunologic risk profiling might be helpful to better risk stratify transplant candidates, who might benefit from induction. The use of immunosuppression induction strategies greatly varies between heart transplant (HT) centers. Clinicians must weigh the risk of allograft rejection with infection and malignancies. Our center stopped routine induction with the Interleukin-2 receptor antagonist basiliximab in 2016 after findings of increased infection, malignancy, and a trend towards higher mortality. We aimed to assess the effect of our protocol change abandoning routine use of basiliximab on survival, allograft rejection, infection, and malignancy. Retrospective single-center analysis of consecutive HT recipients from 2003 to 2015 and 2017-2019. In 2016 the induction protocol was changed, and the adjustment period was excluded. Furthermore, patients bridged to transplant with LVAD, re-transplantation and multi-organ transplants were not included. : A total of 398 patients were identified (mean age 55±11, 72% male) and grouped by induction with basiliximab or no induction. There were no clinically significant differences in baseline characteristics between the groups including age, panel reactive antibody % (PRA) and kidney function (Table). One-year mortality was significantly lower in the no-basiliximab group 1.9 vs 6.75% p 0.03 (Figure 1). Multivariate regression for basiliximab, PRA, age, gender, diabetes mellitus, creatinine did not identify independent risk factors for mortality. Significantly more patients in the no-basiliximab group had ≥ 1 rejection (≥ 2R ISHLT 2004) 68 vs 44% with significantly lower rejection free survival (p 0.0001) per log-rank test (Figure 2). There was no longer a significant difference in rates of bacterial and fungal infections as well as CMV-viremia and malignancies during the first-year post-transplant year. Restrictive rather than routine use of basiliximab induction is no longer associated with increased infectious and early malignancy but remains associated with inferior survival despite lower incidence of early rejection and comparable immunological risk based on PRA. In the future improved individual immunologic risk profiling might be helpful to better risk stratify transplant candidates, who might benefit from induction.