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Update on Mitral Valved-Stent Implantation with an Apically Tethered Valve
Saskia Pokorny1, Katharina Huenges1, Martin Marczynski-Bühlow1, Telse M. Bähr1, Huangdong Dai1, Jan-Paul Gundlach1, Lucian Lozonschi2, Georg Lutter1.
1Department of Cardiovascular Surgery, Christian-Albrechts-University of Kiel, School of Medicine, Kiel, Germany, 2Department of Cardiothoracic Surgery, University of Wisconsin, School of Medicine and Public Health, Madison, WI, USA.
OBJECTIVE:
To date, minimally invasive off-pump treatment of mitral valve disease is limited to repair techniques. This study investigates the outcomes of a novel mitral valved-stent using the off-pump technique one and two months after implantation.
METHODS:
Eight pigs received a self-expanding nitinol valved-stent into the mitral position via a transapical approach. Hemodynamic stability, stent function and positioning were assessed before (n=8) and 1h after implantation (n=7), at one month (n=6) and two months (n=1) using transesophageal echocardiography (TEE), ventriculography and cardiac computed tomography.
RESULTS:
One animal died of cardiac fibrillation during the implantation procedure and one animal died due to unrecognized inadequate valved stent positioning 4 days after implantation. Reliable stent stability and good positioning was achieved in all other animals. No arrhythmias were sustained in the six remaining pigs. TEE examination showed no significant mitral regurgitation, no left ventricular outflow tract (LVOT) obstruction and minimal gradients across the new valve and the LVOT. Gross evaluation of the six pigs demonstrated correct stent positioning and no thrombus formation. The atrial elements were covered with 50% / 70% tissue ingrowths within the anatomically structures of the left atrium 4 weeks and 8weeks after implantation, respectively.
CONCLUSIONS:
Reliable stent stability, minimal gradients and adequate stent function were seen throughout the study at a high degree of reproducibility, over a post-operative period of up to two months. The prospective focus will pertain to stent design, aiming at enhanced durability of the valved-stent components and studying the effects of anchorage to native heart tissue.
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