Background: The Mosaic bioprosthesis is a new generation stented porcine valve.
Methods: Between May 1995 and April 1998, this valve was implanted in the aortic position in 98 patients (70 men; mean age, 69.2 years [34.2 to 83.6 years]). Preoperatively 35 patients were in New York Heart Association functional class 3 or 4. Fifty-nine patients underwent concomitant procedures. The mean duration at follow-up in January 1999 was 23.7 +/- 10.2 months (0.3 to 39.4 months) and totaled 193 patient-years. All but one survivor was in New York Heart Association class 1 or 2.
Results: Early complications included 1 death, 3 reoperations for bleeding, greater than mild regurgitation (paravalvar) in 1 patient and thromboembolism in 4 patients. Late complications included four deaths, study-valve endocarditis in 3 patients, more than mild regurgitation or hemolysis in 2, and thromboembolism in 2 patients. Late follow-up echocardiography in all survivors showed a mean transaortic gradient of 13.6 +/- 6.7 mm Hg, and an aortic valve area of 1.80 +/- 0.61 cm2. Valve replacement was followed by a significant and sustained decrease in left ventricular mass for all valve sizes. There has been no primary structural valve failure.
Conclusions: The early experience with the Mosaic valve in the aortic position has been promising.