Objective: The purpose of this study was to prospectively evaluate the clinical and hemodynamic performance of the Mosaic bioprosthesis (Medtronic, Inc, Minneapolis, Minn).
Methods: The stented porcine bioprosthesis combines the amino-oleic acid antimineralization treatment and the zero-pressure differential fixation technique for improved tissue durability. From February 1994 to May 1999, a total of 561 patients underwent valve replacement with the Mosaic bioprosthesis at 5 centers in Europe: 461 in the aortic and 100 in the mitral position. There were 261 women and 300 men; mean age at implantation was 70 years (range, 23-89 years). Mean follow-up was 2.9 years (range, 0-6.2 years), with a total follow-up of 1710.1 patient-years.
Results: Postoperative mortality was 4.2% per patient-year, including a valve-related mortality of 0.4% per patient-year. The freedom from event rates in the aortic position at 5 years and in the mitral position at 4 years were, respectively, 96.6% +/- 1.1% and 94.9% +/- 3.3% for primary thromboembolism, 96.4% +/- 5.0% and 87.1% +/- 4.8% for antithromboembolic-related hemorrhage, 99.1% +/- 0.5% and 100% for thrombosed prosthesis, 98.8% +/- 1.2% and 100% for structural valve deterioration, 98.8% +/- 0.7% and 100% for nonstructural dysfunction, 98.4% +/- 0.6% and 94.4% +/- 3.8% for endocarditis, and 95.4% +/- 1.6% and 95.3% +/- 3.7% for explant and reoperation. Mean pressure gradient values at 5 years ranged from 7.5 to 15.9 mm Hg in the aortic position and at 4 years from 2.0 to 6.9 mm Hg in the mitral position across all valve sizes.
Conclusions: Clinical and hemodynamic performance of the Mosaic bioprosthesis were very satisfactory during the first 6 years after clinical introduction.