A total of and consecutive 291 patients underwent isolated mitral valve replacement using the Ionescu-Shiley bovine pericardial xenograft valve during the 5-year period between October 1978 and June 1983. Thirty-two patients were the children under 15 years of age. There were 15 deaths within 30 days after surgery [operative mortality, 5.2%]. All early survivors except 6 children were placed on the long-term oral anticoagulation longer than postoperative 3 months. A total follow-up period extended for 398.2 patient-years, and 12 patients died [late mortality, 4.1%, or 3.0%/patient- year]. Ten patients experienced the thromboembolic complication [2.51%/patient-year], occurring in 8 patients within the first 3 postoperative months, and 4 died. Three patients had the late prosthetic valve endocarditis [0.75%/patient-year] and 2 died. The incidence of overall valve failure according to the criteria was 3.01%/patient-year, or 12 patients, and 2 had replacement of the failed bioprostheses [primary tissue failure, 0.5%/patient-year]. The long-term survival rate was 87.8%ulcorner2.6% at 5 years postoperatively, and 84% of the late survivors were in NYHA Class I at the end of the follow- up. The probability remaining free from thromboembolism and overall valve failure was 89.8%ulcorner6.3% and 81.2%ulcorner.8% at 5 years respectively. These clinical results confirm the safety of mitral valve replacement. The only remaining clinical problem is the structural and functional durability of the bovine pericardial xenograft valve, and its use in young patients may be stopped in preference to the mechanical prosthetic valves.