Maintenance Immunosuppression With Tacrolimus and Everolimus in Heart Transplantation Compared With the Usual Tacrolimus and Micophenolate Protocol: Results From a Retrospective Registry.

Introduction: Real-life data on the long-term use of a maintenance immunosuppressive protocol in heart transplant patients using delayed Everolimus + Tacrolimus are scarce.

Methods: This is a retrospective study that included all heart transplant patients from 2011 to 2021 in two Spanish hospitals. In Hospital A, the preferred immunosuppressive strategy included Everolimus initiation at 2 months post-transplant combined with Tacrolimus and was compared with the results of Hospital B, where a standard Tacrolimus and Mycophenolate mofetil protocol was used. Incidence of cytomegalovirus infection, cardiac allograft vasculopathy, acute rejection, renal outcomes, infections, and survival were compared.

Results: We studied 101 patients from Hospital A and 136 from Hospital B. Median follow-up was 4 years. We found no differences in the incidence of cytomegalovirus infection (P = .099), but the only two symptomatic cases occurred in Hospital B. No significant differences were found in the incidence of cardiac allograft vasculopathy (P = .322), although there was a trend toward earlier presentation in Hospital B. There was a tendency toward more rejection in patients from Hospital B (P = .051), but patients on Everolimus (Hospital A) had more bacterial infections (P = .013) and higher need for dyalisis or renal transplant (P = .004). 27% of patients on Everolimus required definite discontinuation due to side effects. There was no difference in survival after a median follow-up of 48 months.

Conclusions: Maintenance immunosuppression with delayed initiation of Everolimus in combination with Tacrolimus is considered a valid strategy in heart transplant patients, although discontinuation of Everolimus due to side effects is significant.