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.

描述(申请人提供)：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，虽然手术修复本地组织仍然是黄金标准，但基于导管的干预风险的降低提供了在疾病过程中早期干预以及对病情最重的患者进行干预的能力，同时避免了体外循环的风险，并使术中评估修复成为可能。然而，经导管手术的结果仍然不如手术。例如，在经导管主动脉瓣置换术(TAVR)中，中到重度的瓣膜旁渗漏是一个严重的问题，已被证明会降低短期存活率。作为第二个例子，那些接受经导管边缘到边缘修复的二尖瓣反流的患者需要复发性二尖瓣反流的后续手术比那些接受初次手术修复的患者要频繁得多。最佳的患者护理将结合心脏跳动干预的好处和手术修复的有效性。我们假设，实现这一目标的根本限制是临床医生在装置植入时操纵组织以优化装置功能的能力。与光学引导的开放手术相比，基于导管的递送大大降低了干预者可视化和精确操纵组织的能力。为了解决这些局限性，我们建议开发一种经心尖双臂机器人导管平台，集成心内窥镜成像用于心脏不停跳瓣膜修复。使用两个协调的手臂将使组织操作可以与外科手术相媲美，在手术中，一只手放置组织，另一只手与组织互动。导管尖端的心脏内窥镜成像(S)将提供高保真的导管-组织接触光学成像，以实现安全和精确的组织交互。经心尖的方法使器械更短、更易控制，而机器人控制为心脏跳动中的双手组织操作提供了精确的操纵性，以及基于计算机的力量控制的可能性。我们将在两个重要问题的背景下，通过体外和体内动物实验，评估所提出的技术针对当前临床实践的有效性，即经导管主动脉PVL关闭和二尖瓣边缘到边缘修复。该项目的总体影响延伸到所有心脏不停跳瓣膜手术。