Four hundred seventy-six patients underwent isolated mitral valve replacement (MVR) with the glutaraldehyde-preserved porcine Hancock bioprosthesis from March, 1970, through December, 1981. There were 312 female and 164 male patients ranging in age at operation from 9 to 68 years (average, 53 years). Associated surgical procedures were performed in 35 patients. Hospital mortality was 13%, the main cause of death being low-output syndrome. The survivors were followed from 1.6 to 13.2 years (mean, 5.2 years). Cumulative duration of follow-up is 2,180 patient-years and is 97% complete. Overall late mortality is 3.1 +/- 0.3% per patient-year, and actuarial survival is 73.8 +/- 3.4% at 13 years. Embolic accidents occurred in 45 patients and were fatal in 13; the linearized incidence of postoperative systemic thromboemboli is 2.1 +/- 0.3% per patient-year. Reoperation was necessary in 49 patients: in 4 because of valve endocarditis, with 3 deaths; in 6 because of perivalvular leak, with no deaths; in 2 because of left atrial thrombosis; and in 37 because of valve dysfunction due to primary tissue failure, caused mainly by calcific degeneration of the tissue, with 5 operative deaths. Actuarial freedom from primary tissue failure is 58 +/- 6.6% at 13 years. Extended follow-up after MVR with the Hancock bioprosthesis confirms the satisfactory performance and low thrombogenicity of this device up to 13 years after operation.(ABSTRACT TRUNCATED AT 250 WORDS)