Ultrasound-Guided Delivery System for Accurate Positioning/Repositioning of Transcatheter Aortic Valves

项目摘要 拟议的项目旨在开发和测试一种新型的超声引导输送系统， 经导管主动脉瓣这项新技术将使精确定位和重新定位的 在植入过程中使用器械，以确保瓣膜功能，并避免瓣周漏和冠状动脉口 梗阻 目前，实时荧光透视成像不足以准确地识别微血管中的最佳部署区域。 主动脉解剖植入不当可能导致植入瓣膜阻塞冠状动脉口，或 高度钙化的瓣膜中有碎片脱位经食管超声心动图（TEE）已被研究 作为TAVR手术的补充成像模式;然而，TEE的分辨率较低， 导致严重的并发症，并且对大多数患者来说是不舒服的。此外，TEE要求一般 手术过程中的麻醉，并且正在推动仅在清醒镇静下进行TAVR， 这将不允许在长时间段内使用TEE。本项目旨在将联合收割机 超声（IVUS）已成功用于最佳定位冠状动脉支架，我们的 用于TAVR手术的可重新定位/可回收输送导管。我们假设IVUS将有助于 主动脉瓣环和根部的准确成像，允许改进TAVR植入手术 与常规TEE引导手术相比。我们将在这一范围内实现以下具体目标 奖项为期两年： 具体目标1：设计和构建一个集成的超声引导输送系统， 经导管主动脉瓣的定位/重新定位。 具体目标2：通过输送瓣膜证明IVUS引导下瓣膜植入的临床可行性 在绵羊模型中（在先前植入的钙化聚合物主动脉瓣内）并测试其功能。 然后将该手术的结果变量与常规TEE引导植入进行比较 程序.

PROJECT SUMMARY The proposed project aims to develop and test a novel ultrasound-guided delivery system for implanting transcatheter aortic valves. This new technology will enable accurate positioning and repositioning of the device during implantation to ensure valvular competency, and avoid paravalvular leakage and coronary ostia obstruction. Currently, real-time fluoroscopy imaging is insufficient to accurately identify optimal deployment areas in the aortic anatomy. Improper implantation may result in obstruction of coronary ostia by the implanted valve, or debris dislocation in a highly calcified valve. Transesophageal Echocardiography (TEE) has been investigated as a complementary imaging modality for TAVR procedures; however, TEE operates at a lower resolution, can result in significant complications, and is uncomfortable for most patients. Additionally, TEE requires general anesthesia during the procedure, and a push is being made to perform TAVR solely under conscious sedation, which would not allow the use of TEE over long time periods. This project aims to combine intravascular ultrasound (IVUS), which has been used successfully to optimally position coronary artery stents, with our repositioning/retrievable delivery catheter for TAVR procedure. We hypothesize that IVUS will assist in accurate imaging of the aortic annulus and root, allowing for an improved TAVR implantation procedure compared to conventional TEE-guided procedures. We will accomplish the following specific aims within this award's two-year duration: Specific Aim 1: Design and construct an integrated ultrasound-guided delivery system for accurate positioning/repositioning of transcatheter aortic valves. Specific Aim 2: Demonstrate the clinical feasibility of IVUS-guided valve implantation by delivering the valves in a sheep model (within a previously-implanted calcified polymeric aortic valve) and testing its functionality. Then compare the procedure's outcome variables to commonly-practiced TEE-guided implantation procedures.