Image-guided Intravascular Robotic System for Mitral Valve Repair and Implants

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Mitral regurgitation (MR) is one of the most common valve lesions, which affects 9 million Americans, and is known to increase morbidity and mortality. MR occurs due to leakage of blood through the mitral valve and induces volume overload on the left ventricle, elevates diastolic wall stress and causes rapid left ventricular dilatation, ultimately leading to congestive heart failure within 5 years and death. Timely and effective repair of MR is of utmost importance to halt the progression of heart failure, but current options are limited. Open- heart surgery is the current standard of care and has a relatively high risk of post-operative mortality. Transcatheter mitral valve repair, is a new class of technologies in which MR repair is performed on a beating heart using a catheter that is guided to the mitral valve to deploy reparative devices. However, the route to the mitral valve is a challenging path for existing catheters to follow. The complexity associated with their implantation in a beating heart, often leads to failed procedures and conversion to open heart surgery. We propose to develop a novel intravascular steerable robot that is guided to the mitral valve by multimodality imaging and deploys a novel, low profile device that can effectively repair MR of all forms. In four years, we propose to complete four specific aims: Specific Aim 1 (GT-Desai): Design and develop an articulated hollow robotic catheter probe with multiple degrees-of-freedom to steer the implant towards and beyond the mitral valve opening as well as orient the implant for accurate deployment on the valve leaflet. The robot will have the capability of both proximal and distal roll joint along with a bending link capability sandwiched between the two roll joints; Specific Aim 2 (Emory-Fei): Design a multimodality image-guided navigation and visualization platform that registers and visualizes three-dimensional (3D) echocardiography and X-ray fluoroscopy and provides a real-time image-guided navigation and visualization system for the clinician to manipulate the robot to the destination through an optimal path with a localization accuracy of ≤ 3 mm; Specific Aim 3 (Emory-Padala): Determine the efficacy of three mitral valve implants of increasing complexity for use with the intravascular robotic system to enable mitral valve repair; Specific Aim 4 (GT+Emory): Validate the safety and efficacy of the steerable robotic catheter system such that its translation to human use is seamless. The integrated system (robot + imaging + implant) will be systematically tested and optimized in pulsatile flow phantoms, ex vivo swine, beating heart human cadavers, and in chronic in vivo studies in swine induced with mitral valve disease. This highly innovative and interdisciplinary project combines expertise in surgical robotics (Desai-BME, GT), imaging (Fei-Radiology, Emory) and mitral repair devices (Padala, Guyton-Surgery, Emory). We envision that the intravascular steerable robot and implant, guided by multimodality imaging will significantly simplify Transcatheter mitral valve repair, increasing the procedural accuracy and control, and reducing failure rates.