The Carpentier-Edwards porcine valve bioprosthesis was implanted in 299 patients (325 prostheses) from April 1976 to April 1982. The series consisted of aortic valve replacement in 150 patients, mitral valve replacement in 120, multiple valve replacement in 26, pulmonary valve replacement in 2 and tricuspid valve replacement in 1 patient. The postoperative follow-up was 100% complete. The total accumulated follow-up was 1956 patient-years. The early mortality was 6.4% (20 patients) and the late mortality was 22% (62 patients). Valve-related mortality was seen in 8 patients (2.7%): 1 paravalvular leak during the 1st 30 postoperative days and 7 late mortalities (1 endocarditis, 2 paravalvular leaks and 4 deaths during reoperation). Three operative deaths (1.5%) occurred. The overall patient survival including operative deaths was 78.5% +/- 5% at 5 years and 66% +/- 4% at 10 years. The incidence of the different complications were: thromboembolism in 5 patients (1.7%) with a risk of 0.3%, haemorrhage in 1 (0.3%) with a risk of 0.05%, endocarditis in 2 (0.7%) with a risk of 0.1%, and paravalvular leak in 11 patients (3.7%) with a risk of 0.6%. There was a high incidence of tissue failure during the last 6 years which occurred in 54 patients (18%) with a risk of 2.7%. Sixty-seven patients (22.5%) were reoperated upon during the 11 years with an annual risk of 3.4% and the main cause of reoperation was primary tissue failure. The Carpentier-Edwards biological valve was shown to be efficient during the first 5 years of implantation after which the incidence of tissue failure increased.(ABSTRACT TRUNCATED AT 250 WORDS)