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.