Immunosuppression Protocol
Our immunosuppressive protocol has been based on triple therapy: corticosteroids, a calcineurin inhibitor, and an antiproliferative agent. Induction therapy consisted of intravenous thymoglobulin (1.5 mg/kg/day) during the first five postoperative days and was preceded by acetaminophen, methylprednisolone, and chlorphenamine. Thymoglobulin dose was decreased (1 mg/kg/day) if leukocytes <3000 cells/mm3 or platelets <75000 cells/mm3, and discontinued if leukocytes <2000 cells/mm3 or platelets <50000 cells/mm3. Basiliximab (20 mg) is also administrated, one drug regimen two hours preoperatively, and another on the fourth postoperative day. The corticosteroid regimen started with intravenous methylprednisolone (500 mg) in the preoperative period and upon release of the aortic clamp, and 125 mg 3 times daily on the first postoperative day. Prednisone (1 mg/kg/day) was continued twice daily, with the dose being decreased 5 mg every three days until reaching approximately 0.2 mg/kg/day by the sixth week. After six months of treatment, it was tapered at 5 mg/day. Our institute currently employs oral tacrolimus (0.05 – 0.1 mg/kg/day) twice daily as a calcineurin inhibitor and adjusted according to renal function. It is titrated to achieve a serum level between 15 ng/mL and 20 ng/mL for the first month, between 10 ng/mL and 15 ng/mL from months one to nine, and between 5 ng/mL and 10 ng/mL after nine months from transplantation. Cyclosporine is only considered in the presence of tacrolimus intolerance. As an antiproliferative agent, we considered mycophenolate mofetil 1g pre-transplant if there was no induction therapy and 1g twice on the first day. Then it is tapered from 0.5g to 2g twice daily. Indications for discharge consisted of oral prednisone twice daily in descending doses of 5mg every three days until reaching 10 mg/day, oral tacrolimus twice daily with serum controls at regular time intervals, mycophenolate mofetil twice daily, and, eventually, everolimus. Endomyocardial biopsies were performed before discharge, in the second month, the third month, the sixth month, and one year after transplantation.