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Item type:Publication, Access status: without files , Transapical mitral valved stent implantation: Computed tomographic evaluation of different prototype designsAims: The evaluation of in vivo shaping of mitral valved stent prototypes using cardiac computed tomography (CT) was the focus of this study. Methods and results: Twelve pigs received a self-expanding mitral valved stent, composed of an atrial element connected to a tubular ventricular body at a modified angle (45°, 90°, 110°) resulting in three designs. Cardiac CT was performed three weeks after implantation, with focus placed on stent design-related parameters: possible left ventricular outflow tract obstruction and stent shaping. CT was successfully conducted in 11/12 animals showing correct stent position within the mitral annulus and no obstruction of the left ventricular outflow tract in 9/11 animals. Minor radial deformations of the stent body were detected. At the atrioventricular junction, deformations of the stent structure were observed in all cases. Stents with a 45° angle exhibited the greatest deflection (≤56.4°±14.5°). Conclusions: The effectiveness of cardiac computed tomography in the development process of valved stents to provide essential information and quantitative data about the in vivo stent geometry was demonstrated. The in vivo mechanical deformations of the stent were quantified, identifying critical design areas: a larger preset angle leads to less deflection and improved alignment and hence reduces the mechanical load.Publicationtype: Journal Article179 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Access status: without files , Transapical mitral valved stent implantation : comparison between circular and D-shaped design(Europa Group, 2014-07); ; ; Aims: In this study two designs of a self-expanding valved stent were compared after off-pump implantation into the mitral valve to identify the superior one. Methods and results: Two designs of a mitral valved stent were tested. The first design is composed of a circular atrial element connected to a tube-shaped ventricular element. In the second design, the atrial element is D-shaped to achieve better anatomical alignment. Prior to in vivo testing, the area with the highest risk of PVL was identified in a hydrostatic in vitro set-up. Subsequently, eight pigs received stents (circular, n=5; D-shaped, n=3) via apical access in the beating heart. Positioning and haemodynamics were evaluated by TEE and invasive pressure measurement pre-implantation, after 1 hr, and at two and four weeks. In vitro testing showed less PVL in the anteromedial region in D-shaped design stents (p<0.001). All stents were successfully deployed in vivo and six animals maintained normal haemodynamics for two weeks or longer. Rotational reorientation of all stents with D-shaped elements was observed. Both groups indicated no clinically relevant gradients over the mitral valved stent. Conclusions: This study demonstrates that the circular design was superior to the D-shaped model after rotational reorientation of the latter occurred.Publicationtype: Journal Article3