Cardioscopically-guided Bimanual Valve Repair in the Beating Heart

描述（由申请人提供）：瓣膜性心脏病是困扰超过2.5%美国人口的重要健康问题，虽然自体组织的手术修复仍然是金标准，但基于导管的干预风险降低，提供了在疾病过程早期进行干预的能力，同时避免了体外循环的风险，也使术中修复的评估成为可能。然而，经导管手术的效果仍然不如手术。例如，在经导管主动脉瓣置换术（TAVR）中，中度至重度瓣旁泄漏是一个重大问题，并已被证明会降低短期生存率。第二个例子是，接受经导管二尖瓣边缘修复术的患者复发性二尖瓣返流需要随访手术的频率明显高于接受首次手术修复的患者。最佳的病人护理将结合心脏搏动干预的益处和手术修复的有效性。我们假设，实现这一目标的基本限制是临床医生在设备植入时操纵组织以优化设备功能的能力。与光学引导的开放手术相比，基于导管的手术极大地降低了介入医生观察和精确操作组织的能力。为了解决这些局限性，我们建议开发一种具有综合心镜成像的经根尖双臂机器人导管平台，用于心脏瓣膜修复。两只协调臂的使用将使组织操作与手术相媲美，其中一只手放置组织，另一只手与之相互作用。导管尖端的心镜成像将提供导管与组织接触的高保真光学成像，以实现安全和精确的组织相互作用。经根尖入路使器械更短、更可控，而机器人控制为双手组织在跳动的心脏内的操作提供了精确的操纵性，以及基于计算机的力控制的潜力。我们将通过离体和体内动物实验，在经导管主动脉PVL闭合和二尖瓣边缘到边缘修复这两个重要问题的背景下，评估所提出的技术在当前临床实践中的有效性。该项目的总体影响延伸到所有心脏瓣膜的操作。

DESCRIPTION (provided by applicant): 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 risk of cardiopulmonary bypass and also enabling intra-operative assessment of the repair. The outcomes of transcatheter procedures, however, remain inferior to surgery. For example, in transcatheter aortic valve replacement (TAVR), moderate to severe paravalvular leaks are a significant problem and have been shown to decrease short-term survival. As a second example, those patients receiving transcatheter edge-to-edge repair of mitral regurgitation required follow-up surgery for recurrent mitral regurgitation substantially more often than those undergoing initial surgical repair. Optimal patient care would combine the benefits of beating-heart interventions with the effectiveness of surgical repair. We hypothesize that the fundamental limitation toward meeting this goal is the ability of the clinician to manipulate tissu at the time of device implantation to optimize device function. In contrast to optically-guided open surgery, catheter-based delivery greatly reduces the interventionalist's capability to visualize and precisely manipulate tissue. To address these limitations, we propose to develop a transapical two-arm robotic catheter platform with integrated cardioscopic imaging for beating-heart valve repair. The use of two coordinated arms will enable tissue manipulation comparable to surgery in which one hand positions tissue and the other hand interacts with it. Cardioscopic imaging in the catheter tip(s) will provide high-fidelity optical imaging of catheter-tissue contac for safe and precise tissue interaction. The transapical approach enables substantially shorter and more controllable instruments while robotic control provides precise steerability for two-handed tissue manipulation inside the beating heart as well as the potential for computer-based force control. We will evaluate the effectiveness of the proposed technology against current clinical practice in the context of two important problems, transcatheter aortic PVL closure and mitral edge-to-edge repair, using ex vivo and in vivo animal experiments. The overall impact of the project extends to all beating-heart valve procedures.