Prospective randomized evaluation of stentless vs. stented aortic biologic prosthetic valves in the elderly at five years

Abstract

Randomized trials comparing stentless to stented bioprostheses for aortic valve replacement in elderly are scarce. The aim of this study was early and mid-term evaluation of these bioprostheses, with regards to clinical outcome and hemodynamic performance. Between September 1999 and January 2001, 40 patients with aortic stenosis, over the age of 75 years, were randomly assigned to receive either the stented Perimount (n=20) or the stentless Prima Plus (n=20) bioprosthesis. Clinical outcomes, left ventricular mass regression, effective orifice area, ejection fraction and mean gradients were evaluated at discharge, six months, one year and five years after surgery. At five years, there were 5/20 (25%) deaths in the stentless group and 6/20 (30%) deaths in the stented group (all non-valve-related). There was one case of endocarditis in each group, early postoperatively. Overall, a significant decrease in left ventricular mass was found five years postoperatively. However, there was no significant difference in the rate and completeness of LV-mass regression between the groups (LV mass index 114+/-34.1 vs. 120+/-27.2). Furthermore, hemodynamic performance of the valves (mean gradient of 9.9+/-4.8 mmHg vs. 10.2+/-4.2 mmHg) did not differ significantly between the groups. At five years, stentless valves were not superior to the stented valves, with regards to hemodynamic performance, regression of left ventricular mass and clinical outcome.