A total and consecutive 291 patients of isolated single mitral valve replacement using the Ionescu-Shiley bovine pericardial xenograft valve operated on between October 1978 and June 1983 were retrospectively studied for the durability of the substitute valves based on the structural degeneration of primary tissue failure which had been proved on their re-replacement surgery. The mean age at the initial surgery was 32.4*12.5 years, and the operative mortality rate was 5.2 %. The early survivors of 276 patients were followed up for a total 1148.3 patient-years[meanulcornerD, 4.16*2.57 years]at the follow-up end of June 1988. They experienced 4 major late complications: 1.045 % thromboembolism/patient-year [pt-yr]; 0.871 % bleeding/pt-yr; 0.610% endocarditis/pt-yr; and 3.309% overall valve failure/pt-yr or 1.655% primary tissue failure/pt-yr. The actuarial survival rates were 89.4*2.2% and 87.7*2.5% at 5 and 10 years after initial surgery respectively. The probabilities of freedom from thromboembolism were 95.1*1.6% and 93.2*2.0% at 5 and 10 years after surgery. Nineteen patients underwent re-replacement of the Ionescu-Shiley valve because of primary tissue failure, and there was no operative mortality. The incidence of primary tissue failure was highest for the patients less than 15 years of age occurring in 9 out of 27 patients [33.3 %] or 8.68 %/pt-yr, while it was 4.0 % or 0.96 %/pt-yr for the rest of patients older than this age. The probabilities of freedom from primary tissue failure were 96.7*1.4 % and 84.2*3.8% at 5 and 9 years after surgery. The freedom from tissue failure increased as the age limits of cumulative younger patients were increased while it decreased as the age limits of cumulative older patients were decreased. Although it is clear that the Ionescu-Shiley valve would degenerate prematurely in young patients, the definite age limit could not be identified when the risk of early failure was significantly high.