In vitro hemodynamic assessment of a novel polymeric transcatheter aortic valve

Abstract

Transcatheter aortic valve replacement (TAVR) is a life-saving alternative to surgical intervention. However, the identification of features associated with poor outcomes, including residual paravalvular leakage (PVL), leaflet calcification, and subclinical leaflet thrombosis, are cause to be concerned about valve durablilty (Mylotte and Piazza, 2015a, 2015b; Dasi et al., 2017; Makkar et al., 2015; Kheradvar et al., 2015a). The aim of this study is to optimize the potential of a hyaluronan (HA) enhanced polymeric transcatheter aortic valve (HA-TAV) that has promised to reduce blood damage causing-turbulent flow while maintaining durability. HA-enhanced linear low-density polyethylene (LLDPE) leaflets were sutured to novel cobalt chromium stents, size 26 mm balloon expandable stents. Hemodynamic performance was assessed in a left heart simulator under physiological pressure and flow conditions and compared to a 26 mm Medtronic Evolut and 26 mm Edwards SAPIEN 3. High-speed imaging and particle image velocimetry (PIV) were performed. The HA-TAV demonstrated an effective orifice area (EOA) within one standard deviation of the leading valve, SAPIEN 3.The regurgitant fraction (RF) of the HA-TAV (11.23 ± 0.55%) is decreased in comparison the Evolut (15.74 ± 0.73%) and slightly higher than the SAPIEN 3 (10.92 ± 0.11%), which is considered trace regurgitation according to valve standards. A decreased number of higher principal Reynolds shear stresses were shown for the HA-TAV at each cardiac phase. The HA-TAV is directly comparable and in some cases superior to the leading commercially available prosthetic heart valves in in-vitro hemodynamic testing.