Pledget-Armed Sutures Affect the Haemodynamic Performance of Biologic Aortic Valve Substitutes: A Preliminary Experimental and Computational Study.

Surgical aortic valve replacement is the most common procedure of choice for the treatment of severe aortic stenosis. Bioprosthetic valves are traditionally sewed-in the aortic root by means of pledget-armed sutures during open-heart surgery. Recently, novel bioprostheses which include a stent-based anchoring system have been introduced to allow rapid implantation, therefore reducing the duration and invasiveness of the intervention. Different effects on the hemodynamics were clinically reported associated with the two technologies. The aim of this study was therefore to investigate whether the differences in hemodynamic performances are an effect of different anchoring systems. Two commercially available bio-prosthetic aortic valves, one sewed-in with pledget-armed sutures and one rapid-deployment, were thus tested in this study by means of a combined approach of experimental and computational tools. In vitro experiments were performed to evaluate the overall hydrodynamic performance under identical standard conditions; computational fluid dynamics analyses were set-up to explore local flow variations due to different design of the anchoring system. The results showed how the performance of cardiac valve substitutes is negatively affected by the presence of pledget-armed sutures. These are causing flow disturbances, which in turn increase the mean pressure gradient and decrease the effective orifice area. The combined approach of experiments and numerical simulations can be effectively used to quantify the detailed relationship between local fluid-dynamics and overall performances associated with different valve technologies.