The Björk-Shiley Monostrut valve. Clinical experience in 647 patients

A total of 647 consecutive patients underwent valve replacement with a Björk-Shiley Monostrut valve (Shiley, Inc., Irvine, Calif.) from January 1, 1984, through December 31, 1988. A total of 135 patients (20.8%) had had a previous cardiac correction. Overall hospital mortality was 6.8%. Preoperative functional class, cardiopulmonary bypass time, aortic crossclamping time, and cause of valve replacement influenced in-hospital mortality significantly (univariate analysis). The median follow-up was 30 months. Overall actuarial survival was 81% +/- 4% at 6 years. Univariate and multivariate regression analysis showed that preoperative functional class, total cardiopulmonary bypass time, size of mitral prosthesis, and pure mitral insufficiency significantly influenced total mortality after valve replacement. Additional coronary bypass grafting and redo valve replacement did not. The actuarial rate of freedom from thromboembolism was 86% +/- 4% at 6 years. There were no cases of valve thrombosis. Patients having a thromboembolic event showed a higher probability of late death after native valve replacement.