Does stentless aortic valve implantation increase perioperative risk? A critical appraisal of the literature and risk of bias analysis

Stentless aortic valve replacement has potential benefits in terms of valve hemodynamics and clinical outcomes, although these may be offset by greater technical complexity of implantation with longer cardiopulmonary bypass and cross-clamp times compared with stented valves. Meta-analyses of the small number of published randomized trials have been limited by their lack of critical synthesis of the literature, including evaluation of the Risk of Bias. Our objective was to determine whether stentless aortic valves increase perioperative risk of mortality. We also examined secondary clinical outcomes of neurological, renal and respiratory complications as well as hemodynamic changes reported by studies following implantation of the two types of aortic prosthesis. The methodology used to answer this question was a rigorous meta-analysis of randomized controlled trials, using bias-assessment techniques designed to address limitations of conventional meta-analysis. Our findings show that many of the existing randomized trials have a high or uncertain risk of bias. Analysis of studies with low risk of bias reveals that stentless valves do not increase perioperative risk in terms of 30-day mortality and morbidity though neither do they exhibit benefits in hemodynamics or clinical outcomes compared with stented valves. Larger, more stringent randomized studies would be required to identify any robust clinical difference.