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

用于精确定位/重新定位经导管主动脉瓣的超声引导输送系统

• 批准号: 9182314
• 负责人: Arash Kheradvar
• 金额: $ 23.18万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9182314
• 关键词: Anatomy; Animals; Aorta; Aortic Valve Stenosis; Area; Award; Calcified; Catheters; Clinical; Clinical Trials; Conscious Sedation; Coronary; Coronary artery; Data; Devices; Dislocations; Effectiveness; Ensure; Extravasation; Failure; Fluoroscopy; General Anesthesia; Heart Valves; Image; Implant; Implantation procedure; Inferior; Ischemia; Left ventricular structure; Length; Marketing; Medical; Modality; Modeling; Obstruction; Operative Surgical Procedures; Outcome; Patients; Plant Roots; Positioning Attribute; Procedures; Prosthesis; Reporting; Resolution; Severities; Sheep; Stents; Stroke; Surgical Valves; System; Testing; Time; Transesophageal Echocardiography; Ultrasonography; Valsalva sinus; aortic valve; aortic valve replacement; ascending aorta; design and construction; failure Implantation; imaging modality; implantation; improved; in vivo; migration; new technology; novel; success; valve replacement

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.

项目概要 拟议项目旨在开发和测试一种新型超声引导植入输送系统 经导管主动脉瓣。这项新技术将能够实现精确定位和重新定位 植入过程中的装置，以确保瓣膜功能，并避免瓣周漏和冠状动脉口 梗阻。 目前，实时透视成像不足以准确识别最佳部署区域 主动脉解剖。植入不当可能会导致植入的瓣膜阻塞冠状动脉口，或 高度钙化瓣膜中的碎片错位。经食管超声心动图（TEE）已被研究 作为 TAVR 手术的补充成像方式；然而，TEE 以较低的分辨率运行，可以 导致严重的并发症，并且让大多数患者感到不舒服。此外，TEE 需要通用的 手术期间进行麻醉，并且正在推动仅在清醒镇静下进行 TAVR， 这将不允许长期使用 TEE。该项目旨在结合血管内 超声 (IVUS)，已成功用于最佳定位冠状动脉支架，我们的 用于 TAVR 手术的重新定位/可回收输送导管。我们假设 IVUS 将有助于 主动脉环和根部的精确成像，可改进 TAVR 植入程序 与传统的 TEE 引导手术相比。在此期间我们将完成以下具体目标 奖项有效期为两年： 具体目标 1：设计并构建集成超声引导输送系统，以实现准确的 经导管主动脉瓣的定位/重新定位。 具体目标 2：通过输送瓣膜来展示 IVUS 引导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用的 TEE 引导植入进行比较 程序。