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.