Randomized trial of the Carpentier-Edwards supra-annular prosthesis versus the Medtronic Mosaic aortic prosthesis: 10-year results.

Objectives: We performed a prospective randomized study comparing the clinical performance of the Carpentier-Edwards supra-annular valve (CE-SAV) (Edwards Lifesciences, Irvine, CA, USA) and the newer Mosaic (Medtronic Corporation, Minneapolis, MN, USA) porcine bioprostheses in the aortic position over a 10-year period.

Methods: Between January 2001 and March 2005, 394 patients undergoing bioprosthetic aortic valve replacement were randomized to receive either the CE-SAV (n = 191) or the Mosaic (n = 203) prosthesis. The preoperative demographics, EuroSCORE and intraoperative characteristics concerning cardiopulmonary bypass of the 2 groups were comparable. All patients were followed annually for 10 years.

Results: There were 77 (40.3%) deaths in the CE-SAV group and 93 (45.8%) deaths in the Mosaic group. The 10-year survival rate in the 2 groups was 59.7% and 54.2%, respectively (P = 0.27). There were no statistically significant differences between the 2 groups in terms of structural valve deterioration (P = 0.08), endocarditis (P = 0.95), thromboembolism (P = 0.06) and major bleeds (P = 0.09). However, the incidence of paravalvular leaks and valve-related reoperations were higher in the Mosaic group, with 5 leaks and 6 reoperations when compared to none in the CE-SAV group, (P = 0.02) and (P = 0.01) respectively.

Conclusions: At 10 years after implantation, freedom from reoperation was greater in the CE-SAV group with no incidences of paravalvular leaks. There were no other statistically significant differences between CE-SAV and Mosaic aortic prostheses.

Clinical Trial Registration: clinicaltrial.gov ID 1301 (NCT03346044).