From 1981 to 1987, 189 patients underwent isolated aortic valve replacement with the Carpentier-Edwards bovine pericardial bioprosthesis. There were 9 early deaths (30-day mortality of 4.8%) and 18 late deaths (3.3% pt-yr). After 5 years, the actuarial survival rate was 81.9%. All patients but one were followed for an average of 37 months after operation, and follow-up totaled 551 patient-years. Valve-related complications included 12 thromboembolic episodes (2.2%/pt-yr), 7 endocarditis (1.3%/pt-yr), 2 hemorrhages due to anticoagulation (0.4%/pt-yr), and 3 reoperations (0.5%/pt-yr). After five years, freedom from thromboembolic events was 91%, that from reoperation was 98%, and 87% for all valve-related complications. There was no primary tissue failure of the valve. Before operation, 55% of the patients were in functional Class III or IV, 97% of the survivors were in Class I or II after valve replacement. Hematological evaluation of 77 patients, an average of 18 months postoperatively, showed no clinically significant hemolysis. Postoperative hemodynamic studies in 28 patients showed mean aortic pressure gradients across the prosthesis at rest ranging from 24 mmHg with the smaller (19 mm) to 11 mmHg with the larger (25 mm and more) valves, and effective orifice areas ranging from 1.0 to 1.9 cm2, respectively. Thus, the Carpentier-Edwards pericardial bioprosthesis appears to be a reliable and hemodynamically effective substitute for replacement of the aortic valve.