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.

Public Health Relevance

Valvular heart disease affects over 2.5% of the US population. While catheter-based valve interventions substantially decrease patient risk in comparison to open surgery, they are less effective since existing catheters and imaging technologies cannot replicate the dexterity and visualization afforded by open surgery. To enable more effective and complex beating-heart procedures, we propose to develop a two-handed robotic catheter system with integrated endoscopic imaging.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Research Project (R01)
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Special Emphasis Panel (ZRG1)
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Lee, Albert
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Children's Hospital Boston
United States
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