HER Lab, Department of Civil, Environmental, and Architectural Engineering, University of Padova, Padua, Italy.
Department of Civil, Environmental And Architectural, University of Padova, Via Loredan, 20, 35131, Padua, Italy.
J Cardiovasc Transl Res. 2019 Dec;12(6):551-559. doi: 10.1007/s12265-019-09902-4. Epub 2019 Jul 30.
This study aims at achieving a proof-of-concept for a novel device designed to occlude the orifices that may form between transcatheter valves and host tissues after TAVI. The device effect on the performance of a SAPIEN XT with a paravalvular gap was assessed into an in vitro and ex vivo pulse duplicator. The in vitro tests were performed complying with the standard international regulations, measuring the trasvalvular pressure and regurgitant volumes with and without the paravalvular gap, and with the occluder correctly positioned into the gap. In the second series of tests, the leakage reduction due to the presence of the occluder was assessed for the same setup, into a beating swine heart. The occluder implantation decreased the regurgitant fraction of about 50% for the in vitro assessment and 75% for the ex vivo test, under rest operating conditions. These results suggest that suitably designed occluders can lead to important benefit in the PVL treatment.
本研究旨在验证一种新型装置的概念验证，该装置旨在阻塞经导管主动脉瓣置换术（TAVI）后可能在经导管主动脉瓣和宿主组织之间形成的孔口。该装置对具有瓣周漏的 SAPIEN XT 瓣膜性能的影响在体外和离体脉动复制器中进行了评估。体外测试符合国际标准规定，测量有和无瓣周漏以及瓣周漏正确定位到瓣周漏时的跨瓣压和反流容积。在第二系列测试中，评估了在相同设置下，由于存在封堵器而导致的漏出减少，采用搏动猪心。在休息操作条件下，封堵器植入使体外评估的反流分数降低约 50%，使离体试验的反流分数降低约 75%。这些结果表明，设计合理的封堵器可在治疗 PVL 方面带来重要益处。
