Development and performance testing of a novel transcatheter tricuspid valve interventional device
Objective To develop a novel transcatheter tricuspid valve replacement device and test its performance.Methods The transcatheter tricuspid valve stent consisted of double-layer self-expanding nitinol stent,biotissue-derived bovine pericardial leaflets,and PTFE woven.The delivery system,mainly consisting of a handle control unit and a delivery sheath,was sent to the correct position via right atrium or jugular vein.The sheath had a visualization feature,and the handle control unit could realize the functions of stable release and partial recovery of the interventional valve.In addition,this study performed animal survival experiments on the basis of in vitro experiments.A large-white pig was used as the experimental animal.Cardiopulmonary bypass was established through median thoracotomy,then the right atrium was opened,and the interventional valve was released under direct vision without cardiac arrest.Approximately 1 month after interventional valve implantation,the maneuverability and stability of the interventional tricuspid device were evaluated by autopsy.Results Through the animal experiment,the interventional valve was successfully released,and the anchoring was satisfactory.Postoperative transthoracic echocardiography showed that the interventional valve opened and closed well,the flow rate of tricuspid valve was 0.6 m/s,and there was no obvious tricuspid regurgitation.One month after the operation,we dissected the large-white pig and found the interventional valve was not deformed or displaced,the leaflets were well aligned,and there was thrombus attachment in the groove between the inner and outer layers of the interventional valve.Conclusion Animal experiment shows that the novel device can stably and firmly attach to the tricuspid annulus,with good anchoring effect,and effectively reduce paravalvular leakage.
NETL
NSTL
万方数据
