Cardioscopically-guided Bimanual Valve Repair in the Beating Heart

心镜引导下跳动心脏的双手瓣膜修复术

• 批准号: 9110350
• 负责人: Pierre E Dupont
• 金额: $ 69.18万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-22 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9110350
• 关键词: Address; Affect; Animal Experiments; Animal Testing; Cardiac Surgery procedures; Cardiopulmonary Bypass; Catheters; Clinic; Clinical; Complex; Computers; Development; Devices; Disease; Effectiveness; Goals; Gold; Hand; Health; Heart; Heart Valve Diseases; Heart Valves; Image; Imagery; Imaging technology; Inferior; Intervention; Left ventricular structure; Length of Stay; Mitral Valve Insufficiency; Operative Surgical Procedures; Outcome; Patient Care; Patient risk; Patients; Population; Positioning Attribute; Procedures; Process; Recurrence; Repeat Surgery; Residual state; Right ventricular structure; Risk; Robotics; System; Systems Development; Technology; Time; Tissues; Ultrasonography; aortic valve replacement; arm; base; clinical practice; design; dexterity; experience; follow-up; imaging system; implantation; in vivo; instrument; meetings; optical imaging; randomized trial; repaired; robot control; trial comparing; valve replacement

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.

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.但是，经导管程序的结果仍然不如手术。例如，在经导管主动脉瓣置换（TAVR）中，中度至重度侧侧泄漏是一个重大问题，已证明可以降低短期生存率。第二个例子，那些接受经导管的二尖瓣反流的边缘到边缘修复的患者需要进行随访手术，以比进行初始手术修复的那些经常发生的二尖瓣反流。最佳的患者护理将结合殴打心脏干预措施的好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Tissu以优化设备功能的能力。与光学引导的开放手术相反，基于导管的递送大大降低了干预主义者可视化和精确操纵组织的能力。为了解决这些局限性，我们建议开发一个具有整合心脏镜面成像的跨副臂机器人导管平台，用于打击心脏瓣膜修复。使用两个协调的手臂将使组织操作与手术相当，其中一手位置组织，另一只手与之相互作用。导管尖端中的心镜成像（S）将提供导管组织CONTAC的高保真光学成像，以实现安全，精确的组织相互作用。跨速方法可实现实质性更短，更可控制的仪器，而机器人控制为双手组织在跳动心脏内部提供精确的可识别性，并为基于计算机的力控制提供了潜力。在两个重要问题的背景下，我们将使用离体和体内动物实验评估提出的技术针对当前临床实践的有效性。该项目的总体影响扩展到所有跳动的心脏瓣膜程序。