Key result
Transapical self-expanding mitral valved stents maintain stability and minimal LVOT gradients over 7 days in pigs.
Acute success in porcine model; leaves open durability testing and clinical translation for mitral valved stents.
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.
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Attmann et al. (2011) studied Mitral valve replacement (experimental) (n=30). Self-expanding mitral valved stent was evaluated on Stent function and positioning (including transvalvular and LVOT gradients). Transapical implantation of a self-expanding mitral valved stent in pigs achieved reliable stability and adequate function with minimal transvalvular and LVOT gradients up to 7 days.
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