Cardioscopically-guided Valve Repair in the Beating Heart

项目摘要 瓣膜性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 天然组织的手术修复仍然是金标准，降低了基于导管的干预的风险 提供了在疾病过程早期以及在病情最严重的患者中进行干预的能力， 避免心肺转流的风险。然而，经导管手术的结果并不是， 始终优于替代治疗的上级。例如，那些接受经导管边缘对- 二尖瓣返流的边缘修复受益于显著缩短的住院时间，但需要随访手术 复发性二尖瓣返流的发生率明显高于初次手术修复的患者。作为 第二个例子，当经导管三尖瓣修复装置成功展开时， 与药物治疗相比，大大降低了死亡风险，但器械植入成功率较低 超过3/4的时间。最佳的病人护理应该联合收割机心脏不停跳干预的好处， 手术修复的有效性和患者特异性定制。我们假设基本限制 基于导管的输送大大降低了介入医生的可视化能力， 控制器械输送。为了解决这些问题，在上一个资助期，我们创建了第一个心脏镜 用于在充满血液的跳动的心脏内执行瓣膜修复的成像系统。我们证明了 心脏镜检查可以改善局部可视化到这样的程度，即某些程序可以在 几分钟而不是几小时。我们还创造了一个自动控制的机器人导管， 控制界面和标准化平台，用于执行阀门维修。这些结果是使用 经心尖进入心脏的左心室。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输送。经皮递送呈现 由于心脏镜在血管导航期间必须紧凑， 放大瓣膜成像。此外，为了能够广泛采用经导管瓣膜修复， 为了使这些修复像手术修复一样有效，机器人导管不应该只进行单一修复， 该技术易于执行，而是应当允许临床医生容易地执行互补序列， 就像现在的外科手术一样。在目标1中，我们将克服经皮心脏镜的挑战 通过创建基于球囊的心脏镜设计，并为特定的 通过离体和体内试验修复二尖瓣腱索植入。在目标2中，我们将设计一个模块化的 机器人导管平台，以创建单个输送系统用于执行两个 重要的补充二尖瓣修复、腱索植入和瓣环成形术，通过标准化的 基于鼠标的界面。我们将使用体外和体内实验来评估该系统。

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.