Results of orthotopic heart transplantation with and without the use of maintenance steroids.

From March 1984 to June 1987, 51 patients underwent primary orthotopic heart transplantation at the Second University Department of Surgery, Vienna. Recipients were immunosuppressed with a combination of either ciclosporine and azathioprin (double drug regimen = DD, 10 patients), or ciclosporine, azathioprin and low-dose steroids (triple drug regimen = TD, 33 patients). Four patients who died intra- or perioperatively and 4 who were switched to conventional therapy were excluded from analysis. In both groups, ciclosporine was administered to obtain whole blood HPLC trough levels of 200-400 ng/ml in the 1st month, 150-250 ng/ml from the 2nd to the 6th and 100-150 ng/ml after the 6th month. Azathioprin 2 mg/kg per day was given, and in TD patients, an additional 0.2 mg/kg per day of prednisolon: all patients received prophylactic antithymocyte globulin for 7-10 days postoperatively. Five deaths from acute rejection in the DD group contrasted with none in the TD group. The high incidence of fatal rejection episodes was reflected in a 40% Kaplan-Meier 1-year survival for DD vs 84% for TD (p less than 0.0001). Analysis of endomyocardial biopsies (DD vs TD) demonstrated 20.4% vs 57.0% absent, 46.0% vs 29.5% mild, 31.2% vs 12.4% moderate and 2.4% vs 1.1% severe rejection. Fatal and nonfatal infections and toxic side effects occurred with the same frequency in both protocols. Calculation of mean ciclosporine levels resulted in 249.7 ng/ml (TD) and 206.0 ng/ml (DD) in the 1st month (p less than 0.05). Consequently, adjunctive maintenance low-dose steroids combined with increased ciclosporine levels in the early posttransplant course are considered responsible for the improved results.