Cardioscopically-guided Valve Repair in the Beating Heart

项目摘要 瓣膜心脏病是一个重要的健康问题，困扰着超过2.5%的美国人口，而 手术修复天然组织仍然是金标准，降低了基于导管的介入治疗的风险 提供了在疾病过程中早期干预以及在病情最严重的患者中进行干预的能力 避免体外循环的风险。然而，经导管手术的结果并不是， 一贯优于其他治疗方法。例如，那些接受经导管边缘到边缘治疗的患者 二尖瓣反流边缘修补术住院时间明显缩短，但需要后续手术 复发性二尖瓣返流的发生率明显高于初次手术修复的二尖瓣返流。作为一名 第二个例子，当经导管三尖瓣修复器成功部署时，他们 与药物治疗相比，大大降低了死亡风险，但装置植入的成功率较低 超过四分之三的时间。最佳的患者护理应将心脏跳动干预的好处与 手术修复的有效性和针对患者的量身定制。我们假设根本的限制是 以导管为基础的输液极大地降低了干预者的视觉和直觉能力 控制设备交付。为了解决这些问题，在前一个资金阶段，我们创造了第一台心内窥镜检查系统 用于在充满血液的跳动心脏内进行瓣膜修复的成像系统。我们证明了这一点 心脏内窥镜检查可以改善局部的可视化，以至于某些程序可以在 几分钟而不是几小时。我们还创造了一种操纵杆控制的机器人导管，它提供了一种直观的 控制界面和用于执行阀门维修的标准化平台。这些结果是通过使用 经心尖入路进入心脏左室。为了广泛采用，我们需要进一步发展这一点 技术，使其能够通过股静脉经皮给药。经皮递送礼物 重大的新挑战，因为心脏内窥镜在血管导航过程中必须紧凑，然后 放大以进行瓣膜成像。此外，为了使经导管瓣膜修补术得到广泛采用，并 使这些修复与外科修复一样有效，机器人导管不应该只进行一次修复 该技术易于执行，但应允许临床医生容易地执行一系列补充 现在外科手术中所做的修复。在目标1中，我们将克服经皮心内窥镜的挑战 通过创建基于球囊的心内窥镜设计并为特定患者演示这项技术进行交付 二尖瓣索植入修复的体内外试验。在目标2中，我们将设计一个模块 机器人导管平台，为单个输送系统创造能力，用于执行两个 重要的补充二尖瓣修补术，脊索植入和瓣环成形术，通过标准化 基于操纵杆的界面。我们将通过体外和体内实验对该系统进行评估。

Project Summary Valvular heart disease is an important health problem afflicting over 2.5% of the US population and, while surgical repair of native tissue remains the gold standard, the reduced risk of catheter-based interventions has provided the capability to intervene earlier in the disease process as well as in the sickest patients while avoiding the risks of cardiopulmonary bypass. The outcomes of transcatheter procedures are not, however, consistently superior to alternative treatments. For example, those patients receiving transcatheter edge-to- edge repair of mitral regurgitation benefit from a significantly shorter hospital stay but require follow-up surgery for recurrent mitral regurgitation substantially more often than those undergoing initial surgical repair. As a second example, when transcatheter tricuspid valve repair devices are successfully deployed, they substantially reduce the risk of death compared to medical therapy, but device implantation is successful less than 3/4 of the time. Optimal patient care should combine the benefits of beating-heart interventions with the effectiveness and patient-specific tailoring of surgical repair. We hypothesize that the fundamental limitation is that catheter-based delivery greatly reduces the interventionalist's capability to visualize and to intuitively control device delivery. To address these issues, in the prior funding period, we created the first cardioscopic imaging systems for performing valve repair inside the blood-filled beating heart. We demonstrated that cardioscopy can improve local visualization to such a degree that certain procedures can be accomplished in minutes rather than hours. We also created a joystick-controlled robotic catheter that provided an intuitive control interface and a standardized platform for performing valve repairs. These results were achieved using transapical access to the left ventricle of the heart. For broad adoption, we need to further develop this technology to enable its percutaneous delivery via the femoral vein. Percutaneous delivery presents significant new challenges since the cardioscopes must be compact during vascular navigation and then enlarge for valvular imaging. Furthermore, to enable broad adoption of transcatheter valve repairs and to make those repairs as effective as surgical repairs, the robotic catheter should not just make a single repair technique easy to perform, but instead should allow a clinician to easily perform a sequence of complementary repairs as is now done in surgery. In Aim 1, we will overcome the challenges of percutaneous cardioscope delivery by creating balloon-based cardioscope designs and demonstrating this technology for the specific repair of mitral chordae implantation through ex vivo and in vivo testing. In Aim 2, we will design a modular robotic catheter platform to create the capability for a single delivery system to be used to perform two important complementary mitral valve repairs, chordae implantation and annuloplasty, through a standardized joystick-based interface. We will evaluate this system using ex vivo and in vivo experiments.