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

Abstract
From March 1984 to June 1987, 51 patients underwent primary orthotopicheart transplantation at the Second University Department of Surgery,Vienna. Recipients were immunosuppressed with a combination of eitherciclosporine and azathioprin (double drug regimen = DD, 10 patients), orciclosporine, azathioprin and low-dose steroids (triple drug regimen = TD,33 patients). Four patients who died intra- or perioperatively and 4 whowere switched to conventional therapy were excluded from analysis. In bothgroups, ciclosporine was administered to obtain whole blood HPLC troughlevels of 200-400 ng/ml in the 1st month, 150-250 ng/ml from the 2nd to the6th and 100-150 ng/ml after the 6th month. Azathioprin 2 mg/kg per day wasgiven, and in TD patients, an additional 0.2 mg/kg per day of prednisolon:all patients received prophylactic antithymocyte globulin for 7-10 dayspostoperatively. Five deaths from acute rejection in the DD groupcontrasted with none in the TD group. The high incidence of fatal rejectionepisodes 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 infectionsand toxic side effects occurred with the same frequency in both protocols.Calculation of mean ciclosporine levels resulted in 249.7 ng/ml (TD) and206.0 ng/ml (DD) in the 1st month (p less than 0.05). Consequently,adjunctive maintenance low-dose steroids combined with increasedciclosporine levels in the early posttransplant course are consideredresponsible for the improved results.

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