Heart valve replacement with the Björk-Shiley Monostrut valve: early results of a multicenter clinical investigation.

To evaluate the clinical performance of the Björk-Shiley Monostrut prosthesis, five centers combined their early experience. Between May, 1982, and June, 1985, 537 prostheses were implanted in 486 patients at these centers: 246 patients had aortic valve replacement (AVR), 163 underwent mitral valve replacement (MVR), and 47 had double-valve replacement (DVR). Thirty patients underwent other, more complex procedures. Concomitant cardiac procedures were performed in altogether 25%. Overall hospital (30 days) mortality was 5.1% (3.6% for AVR, 4.3% for MVR, 8.3% for DVR, and 16.6% for other procedures). The patients were followed up at 6- to 9-month intervals from 6 to 48 months (mean follow-up, 33 months). Follow-up was 99.6% complete. Late mortality was 7.2%. The three-year survival rate was 91.0% for AVR, 92.3% for MVR, and 76.2% for DVR. There was no structural failure of the prosthesis. No instances of valve thrombosis and fatal thromboembolism occurred in anticoagulated patients. The three-year incidence of freedom from thromboembolic events (including TIA) was 89.8% for AVR, 94.9% for MVR, and 90.2% for DVR. Preoperative and postoperative data for the assessment of mechanical hemolysis was available in 60% of the patients. The degree of mechanical hemolysis was low and did not change with time. Although the follow-up is still short, the Björk-Shiley Monostrut prosthesis appears to represent an improvement over previous Björk-Shiley models, particularly with regard to durability.