OBJECTIVES: 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. METHODS: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. RESULTS: 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. CONCLUSIONS: 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.
RCT Entities:
OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
Authors: Blake N Shultz; Tomasz Timek; Alan T Davis; John Heiser; Edward Murphy; Charles Willekes; Robert Hooker Journal: J Cardiothorac Surg Date: 2017-05-31 Impact factor: 1.637