Long-term evaluation of the Ionescu-Shiley pericardial xenograft bioprosthesis in the aortic position.

From August 1977 through October 1984, 241 patients underwent aortic valve replacement with the Ionescu-Shiley pericardial valve. There were 130 males and 11 females in this series with an average age of 50.8 years (range 15 to 78 years). Isolated aortic valve replacement was performed in 121 patients (50.2%) and associated cardiac surgery in 120 (49.8%). Valve size was 21 mm or smaller in 107 cases (50.2%). Cumulative duration of follow-up was 1,260 patient-years with a mean follow-up of 5.16 years per patient. Five patients were lost to follow-up. Maximum follow-up was 10.5 years. There were 26 hospital deaths and 15 late deaths (1.19% per pt-yr). The expected 10.5 year actuarial survival rate is 82% +/- 2.9%. Twelve thromboembolic episodes occurred in seven patients--seven central and five peripheral events. The thromboembolic rate was 0.95% per patient-year--32% for patients with isolated aortic valve replacement and 0.63% for patients with concomitant surgery. Freedom from thromboembolic episodes at 10.5 years is 73% +/- 12%. Structural valve deterioration was found in 24 patients (1.9% per pt-yr) with an actuarial freedom from primary tissue failure of 77.5% +/- 5.4% at 10.5 years. Reoperation was required in 39 cases (3.09% per pt-yr)--primary tissue failure (n = 24), paravalvular leak (n = 7), infective endocarditis (n = 6), and valve thrombosis (n = 2).