Ten-year results of aortic valve replacement with first-generation Mitroflow bioprosthesis: Is early degeneration a structural or a technical issue?

Abstract

OBJECTIVES: Concerns have been raised about the durability of the first-generation Mitroflow aortic bioprosthesis (model 12 A-LX) due to the lack of anticalcification treatment. This study reflects a 10-year experience with this prosthesis for aortic valve replacement. METHODS: From June 2003 to May 2012, the Mitroflow prosthesis was used for aortic valve replacement in 510 patients, of whom only 467 with complete clinical follow-up were included for analysis. Study end-points were survival and incidence of structural valve degeneration (SVD). Analysis of SVD was based on cumulative incidence function and competing-risk Cox regression. RESULTS: The mean patient age was 76.4 ± 6.1 years. Valve sizes from 23 to 25 were used in 70.4%, whereas sizes from 19 to 21 were used in only 19.2%, thereby avoiding patient-prosthesis mismatch in 89.1%. Within a median follow-up time of 6.6 years (interquartile range 4.4), a cumulative 2375 patient-years, the survival rate was 86.2%, 67.3% and 33.3% at 1, 5 and 10 years, respectively. The cumulative incidence of SVD, with death as a competing risk, was 0%, 0.7% and 6.2% at 1, 5 and 10 years, respectively. Only age < 75 years tended to affect the late hazard of SVD (hazard ratio 0.50, 95% confidence interval 0.23-1.08, P = 0.08), regardless of valve-specific issues. CONCLUSIONS: The data do not support the concerns about early accelerated structural degeneration of the first-generation Mitroflow bioprosthesis used for aortic valve replacement in patients older than 75 years. We postulate that limiting the number of small prostheses using a proper implantation technique has enhanced the reduction in risk of significant patient-prosthesis mismatch as the main determinant of early SVD.