Incidence of primary tissue valve failure with the Ionescu-Shiley pericardial valve. Preliminary results.

This report provides retrospective follow-up data on 88 patients who received an Ionescu-Shiley bovine pericardial valve in the aortic position between August, 1977, and June. 1980. Seven instances of primary tissue degeneration occurred in seven of the 65 patients followed up until June, 1984. Cumulative duration of follow-up was 335.5 patient-years. The linearized incidence of primary tissue failure was 2.08% per patient-year. The actuarial rate of freedom from valve failure for patients with an Ionescu-Shiley valve in aortic position was 79% +/- 8% at 7 years of follow-up. This series shows a higher incidence of primary tissue failure with this prosthesis than with the glutaraldehyde-preserved porcine xenograft in the aortic position at 7 years' follow-up.