MagPAD: Magnetic Puncture, Access, and Delivery of Large Bore Devices to the Heart Via the Venous System

项目摘要 微创心胸手术，如经导管主动脉瓣置换术（TAVR）， 由于手术死亡率，发病率， 并缩短了恢复时间。经股动脉进入心脏是最常见的 用于递送大口径装置（例如心脏瓣膜和左心室辅助装置（LVAD））的方法。 尽管通过经股动脉经皮入路改善了健康结局，但大口径导管 在大约20%的患者中使用的鞘管由于血管直径小而不能安全插入， 动脉粥样硬化性疾病或广泛迂曲。经腔静脉进入心脏已经成为一种 将大口径器械引入腹主动脉的新方法，供体导管从 股静脉和接收导管从桡动脉进入，在下腔静脉中对齐，以及 穿过主动脉由于压力较低， 可控性，其由静脉系统的减少的弯曲度，减少的阻塞倾向， 和大尺寸的静脉。然而，经腔静脉入路在技术上具有挑战性，需要多次荧光镜检查 观察角度和操作员，这限制了其在专业医疗中心的使用。 MagPAD正在开发MagPAD（磁性穿刺，进入和输送）设备，一种心脏导管， 使用磁铁简化经腔静脉进入心脏的系统，用于通过 静脉系统该系统采用嵌入导管前端的磁铁， 在3维空间中，将导管对齐，并使下腔静脉和主动脉更接近， 交叉到主动脉这有可能大大降低该过程的难度，因为它消除了 通过消除对多个荧光透视视角的需求， 并且可能需要多个操作者来精确地使导丝穿过圈套器 三维空间在第一阶段提案之前，MagPAD已经开发了早期原型导管， 在猪尸体模型中证明了磁自动对准。该项目的目标是开发 功能原型，并证明磁性对准、组织缝合和导丝的可行性 交叉进入活猪模型中的主动脉。这些目标的成功将大大降低 采用经腔静脉手术，扩大不适合经股动脉TAVR的患者的入路， 并通过静脉系统进入心脏来改善健康结果， 所有患者的缺血和卒中并发症和风险

Project Summary Minimally invasive cardio-thoracic approaches, such as transcatheter aortic valve replacement (TAVR), have recently overtaken traditional surgical methods due to significant reductions in procedural mortality, morbidity, and improved time to recovery. Transfemoral access of the heart via the femoral artery is the most common approach for delivery of large bore devices such as heart valves and left ventricular assist devices (LVAD). Despite improvements in health outcomes through transfemoral percutaneous approaches, large bore catheter sheaths are used that cannot be inserted safely in approximately 20% of patients because of small vessel diam- eter, diffuse atherosclerotic disease, or extensive tortuosity. Transcaval access to the heart has emerged as a new approach to introducing large bore devices into the abdominal aorta, with the donor catheter entering from the femoral vein and the receiver catheter entering from the radial artery, aligning in the inferior vena cava, and crossing over to the aorta. It is vastly superior to transfemoral access due to lower pressure and increased controllability that results from the reduced tortuosity of the venous system, reduced propensity for obstruction, and large size of the veins. However, transcaval access is technically challenging, requiring multiple fluoroscopic viewing angles and operators, which limits its use to specialized medical centers. MagPAD is developing the MagPAD (Magnetic Puncture, Access, and Delivery) device, a cardiac catheter de- livery system that uses magnets to simplify transcaval access to the heart, for large bore access through the venous system. The system employs magnets that are embedded in the leading ends of catheters that automat- ically aligns the catheters and brings the inferior vena cava and aorta closer in 3-dimensional space to simplify crossover to the aorta. This has potential to substantially reduce the difficulty of the process, as it removes the variability in time and difficulty in each procedure by eliminating the need for multiple fluoroscopic viewing angles and potentially multiple operators that are necessary to accurately traverse the guidewire through the snare in three-dimensions. Prior to this Phase I proposal, MagPAD has developed an early prototype catheter and demonstrated magnetic auto-alignment in a porcine cadaveric model. The goal of this project will be to develop a functional prototype and demonstrate feasibility for magnetic alignment, tissue approximation, and guidewire crossover into the aorta in a live porcine model. Success with these goals will substantially lower the barrier to adoption for transcaval procedures, expand access to more patients that are unsuitable for transfemoral TAVR, and improve health outcomes by accessing the heart through the venous system which may reduce vascular complications and risks of ischemia and stroke across all patients