Tratamento anticalcificante de bioprótese: resultado clínico inicial

Clinical results with the use of porcine bioprosthesis are satisfactory from the standpoint of hemodynamic performance, low incidence of thromboembolysm providing adequate quality of life. Calcification and tissue tear remain the major complications of bioprosthesis , mainly in children and young patients. Several stratergies were proposed to control or even to avoid calcification; up to the present, none of them have proved to decrease calcification or to prolong their durability. This controlled clinical study was undertaken based upon the quality of anticalcificant effect of the P.S. treatment obtained in animal implants with the Biocor porcine bioprosthesis; the negative results of toxicological analysis of the treated tissue and the good performance in fatigue testing of the P.S. treated Biocor bioprosthesis. The rational of the P.S. treatment is to obtain covalent bounds of the anticalcificant agent to the tissue, in more durable form. From February/1991 to March/1992, 66 treated bioprosthesis were implanted in 55 patients; there were 28 males and 27 femeles. The age ranged from 11 to 68 years. There were 72.7 ± 11.8 of patients below 30 years of age. Mean age was 26.6. Rheumatic heart disease was the etiological factor in 70.9% ± 12.0. Regular sinus rhythm was present in 70.9%. Preoperative functional class was 40.0% ± 12.0 and 52.7% ± 13.2 respectively, for class III and IV of the NYHA; 55 patients underwent valve replacement namely aortic in 16 patients (29.1% ± 12.0); mitral, 28 patients (50.1% ± 13.21) and double valve replacement 11 patients (20.0% ± 10.6). The surgical technique was the conventional, using bouble oxygenator, crystaloid cardioplegia and U type sutures. There were no complications related to the new bioprosthesis. Hospital mortality was 2 in 55 patients or 3.6%. The majority of the 53 patients are in class functional I and II. The follow up is being done quaterly by clinical, echodopplercardiographical and laboratorial tests (hematological and biochemistry). During this period of 13 months, there were no complications related to the newly treated bioprosthesis.