To date, transcatheter valve implantation is limited to the replacement of pulmonary and aortic valves. The aim of this study was to analyze a valved stent for minimally invasive implantation in the mitral position. A self-expanding mitral valved stent was designed for transapical implantation. Thirty pigs underwent off-pump mitral valved stent implantation with follow-up times of 60 minutes (n = 17) and seven days (n = 13). Transesophageal echocardiography and computed tomography were used to evaluate stent function and positioning. After valved stent deployment, accurate adjustment of the intra-annular position reduced paravalvular leakage in all animals. Accurate positioning was established in all but five animals. The average mean transvalvular gradient across the mitral valve and the left ventricular outflow tract recorded immediately after deployment, six hours and one week were 1.85 ± 0.95 mmHg, 3.45 ± 1.65 mmHg, 4.15 ± 2.3 mmHg and 1.35 ± 1.35 mmHg, 1.45 ± 0.7 mmHg, 1.9 ± 0.65 mmHg, respectively. No valved stent migration, embolization, systolic anterior movement or left ventricular outflow tract obstruction was observed. The mitral valved stent can be deployed in a reproducible manner to achieve reliable stent stability, minimal gradients across the left ventricular outflow tract and adequate stent function in acute and short term experimental settings.
This study indicates a sufficient annular fixation force of the tested transcatheter mitral valve implantation valved stent prototypes. Therefore, these mitral valved stents demonstrate a new type of mitral valved stent design.
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