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IN VITRO EVALUATION OF A NEW PERCUTANEOUS MITRAL VALVED STENT DELIVERY SYSTEM
Huangdong Dai, Martin Marczynski-Buehlow, Gunther Fischer, Traudel Hansen, Beke Sarrahs, Anja Metzner, Jochen Cremer, Georg Lutter.
University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.

OBJECTIVE: The complete replacement of the native mitral valve by implantation of a valved stent via catheter technique in an off-pump procedure is still challenging. Though, the outcome will presumably exceed todays percutaneous repair techniques. Here, a newly developed, less-invasive transcatheter mitral valved stent delivery system will be presented.
METHODS: The new stent delivery system combines a percutaneous transapical access with an optional left-transatrial, right-transatrial/transseptal or transfemoral/transseptal access. It consists of three functional units: (1) The first unit establishes the connection line between both accesses with a stiff guide-wire. (2) From antegrade the stent delivery catheter with a Nitinol mitral stent is introduced. (3) An atrial septal occluder system serves as apical stent fixation as well as apical occlusion system.
In vitro system testing was performed on eleven porcine hearts under endoscopic view from atrial side and eleven porcine hearts under x-ray visualization. The hearts were continuously flushed with 37° C warm water throughout the implantation procedure. The new prototype was evaluted with regard to general operability and duration of the implantation procedure from apical puncture to completed stent implantation.
In separated in vitro experiments, tensile tests were conducted on the fixation unit in order to evaluate its suitability to hold the stent in position.
RESULTS: This study showed good operability of the prototype. The overall procedure time took in average 18:59 minutes (range: 13:38 to 22:58 minutes) under endoscopic view and 10:47 minutes (range: 8:00 to 20:25) under x-ray visualization. Both studies revealed a steep learning curve of the physician. In all the 22 hearts, the stent as well as the occluder were precisely positioned. The tensile tests on the fixation unit revealed forces of 9.4 N ± 3.4 N in order to remove it from the myocardium. For the used mitral stent design, this force is estimated to be sufficient holding the stent in position.
CONCLUSIONS: These first in vitro prototype tests showed good results in terms of operability and and mitral stent fixation. The procedure has a great potential to develop to an alternative and less-invasive implantation procedure in contrast to transapical mitral valved stent implantation.


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