Randomized trial of carpentier-edwards supraannular prosthesis versus mosaic aortic prosthesis: 6 year results.

BACKGROUND: This study prospectively compares the clinical performance of 2 stented porcine aortic bioprostheses: the Carpentier-Edwards supraannular aortic valve (CE-SAV) from Edwards Lifesciences (Irvine, CA) and the Mosaic valve from Medtronic Corp (Minneapolis, MN). We believe it is the only study of this kind.

METHODS: Four hundred three patients undergoing bioprosthetic aortic valve replacement (AVR) between January 2001 and March 2005 were prospectively randomized to receive either the CE-SAV (n = 197) or the Mosaic (n = 206) prosthesis. All patients are being followed annually.

RESULTS: The patients in the 2 groups were comparable with respect to their preoperative demographics, EuroSCORE, and their intraoperative characteristics concerning cardiopulmonary bypass. The mean follow-up period was 6 ± 0.25 years, with a total follow-up of 2,418 patient-years. There have been a total of 64 (32.5%) deaths in the group receiving CE-SAV valves and 85 (41.3%) deaths in the group receiving Mosaic valves. The 5-year survival in the 2 groups was 77.7 % and 73.3%, respectively (p = 0.36). There were no statistically significant differences between the 2 groups in terms of structural valve deterioration (SVD) (p = 0.16), paraprosthetic leak (p = 0.13), thromboembolism (p = 0.25), endocarditis (p = 0.68), and freedom from reoperation at 5 years (p = 0.27). Echocardiographic data suggests a trend for lower valve gradients across the 23-mm CE-SAV prostheses compared with similar-sized Mosaic prostheses.

CONCLUSIONS: There were no statistically significant differences in the clinical performance between CE-SAV and Mosaic aortic prostheses at 6 years after implantation.