A prospective randomized comparison of Medtronic Mosaic and Carpentier-Edwards-SAV in the aortic position: an interim report.

BACKGROUND AND AIM OF THE STUDY: The study aim was to compare prospectively the clinical performance and long-term durability of the Medtronic Mosaic and Carpentier-Edwards porcine (CE-SAV) bioprostheses in the aortic position over 10 years. METHODS: Between January 2001 and July 2003, a total of 242 patients undergoing bioprosthetic aortic valve replacement (AVR) were prospectively randomized to receive either Medtronic Mosaic (n = 126) or CE-SAV (n = 116) valves, and followed up annually. RESULTS: The mean follow up period was 1.7 +/- 0.8 years; total follow up was 411 patient-years. Early mortality and 40-month actuarial survival were 5.5% and 93 +/- 1% for the Mosaic valve, and 2.6% and 90 +/- 1% for the CE-SAV. Among patients, 78% showed symptomatic improvement in their NYHA functional class after AVR. To date there have been no structural failures, and one patient required reoperation for prosthetic valve (Mosaic) endocarditis. Early thromboembolic events occurred in 2.9% of patients (two Mosaic, five CE-SAV). Echocardiographic evaluations between the two valves demonstrated comparable hemodynamic performance for a given size at one year after surgery. CONCLUSION: At this stage of the study there were no differences in clinical or hemodynamic outcome in patients undergoing AVR using either the Mosaic or CE-SAV porcine xenograft.