Mosaic valve international clinical trial: Early performance results

Background. A new third generation porcine bioprosthesis was developed in an attempt to improve on hemodynamic performance and durability of current prostheses. Methods. One thousand, two hundred, sixty patients underwent aortic valve replacement and 366 patients underwent mitral valve replacement between February 1994 and September 2000. The cumulative follow-up was 3,696.3 patient-years for aortic valve replacement and 880.1 patient-years for mitral valve replacement. Follow-up was complete for 95.5% of aortic valve replacement patients and 97.5% of mitral valve replacement patients. Results. For aortic valve replacement, freedom from valve-related adverse events at 1 year was 96.5% +/- 0.5% for antithromboembolic-related hemorrhage and 100% for structural valve deterioration. Freedom from valve-related adverse events at 5 years was 93.8% +/- 2.6% for antithromboembolic-related hemorrhage and 99.3% +/- 0.9% for structural valve deterioration. For mitral valve replacement, freedom from valve-related adverse events at 1 year was 96.0% +/- 1.1% for antithromboembolic-related hemorrhage and 100% for structural valve deterioration. Freedom from valve-related adverse events at 4 years was 92.1% +/- 3.7% for antithromboembolic-related hemorrhage and 100% for structural valve deterioration. Conclusions. These results support the claim that the Mosaic bioprosthetic valve is efficacious and safe, but continued follow-up is mandatory to determine mid- and long-term performance. (C) 2001 by The Society of Thoracic Surgeons.