Midterm stability and hemodynamic performance of a transfemorally implantable nonmetallic, retrievable, and repositionable aortic valve in XXXX with severe @entity472 . Up to 2-year follow-up of the direct-flow medical valve: a pilot study.

@entity1 @entity472 @entity337
BACKGROUND: Misplacement during percutaneous aortic valve implantation can be associated with severe complications. The direct flow medical (DFM) valve is repositionable and retrievable; however, the nonmetallic inflatable and conformable design of the valve results in less radial force, which may have an impact on stability and valve function over time. We, therefore, analyzed the midterm stability of the position, shape, and hemodynamic performance of the DFM percutaneous aortic valve. METHODS AND RESULTS: Sixteen symptomatic high-risk for surgery @entity1 with @entity472 and a logistic EuroSCORE >20 underwent implantation and were the subject of this analysis. Clinical, echocardiographic, and dual-source multislice computed tomography data were obtained during 2-year follow-up. The 1- and 2-year survival rates were 81% and 69%, respectively. The dual-source multislice computed tomography follow-up indicated no changes in position, diameter, and orifice area of the DFM valve over time. Echocardiography revealed a significant decrease of the mean gradient from baseline (50.1  11.3 mm Hg) to 30 days (19.6  5.7 mm Hg, P<0.001), which remained stable over 2 years. The aortic valve area increased from 0.57  0.15 cm(2) at baseline to 1.47  0.35 cm(2) at 30 days (P<0.001) and did not significantly change during 2-year follow-up. Of the @entity1 , 73% had no @entity337 ( @entity337 ) and 27% had minimal @entity337 . CONCLUSIONS: In this preliminary series, the 2-year follow-up data of @entity1 , in whom the nonmetallic, repositionable, and retrievable DFM valve was successfully implanted, show stability of the position, shape, and hemodynamic performance, with no @entity337 in most @entity1 .
