Intracardiac beating heart tricuspid valve repair via robotics.

Summary About 2.5% of the US population has a valvular heart disease. While neglected for a long time, problems related to the tricuspid valve affect more than 70 million people worldwide. Among these, more than 1.6 million are in the US. The yearly incidence is about 200,000 with a 1-year mortality rate of 36.1%. The most common problem is tricuspid valve regurgitation. The majority of tricuspid regurgitation cases are treated surgically via prosthetic ring annuloplasty in open surgery. However, open surgery approaches introduce risks of perioperative complications and require long recovery times. A large percentage of the population with tricuspid regurgitation cannot receive surgical treatment because of the high-risk profile. Few patients undergo isolated tricuspid valve surgery because the challenging anatomy of the tricuspid valve and lack of clinical experience has hindered progress in this area. Therefore, there is a clinical need for novel approaches that would allow tricuspid valve repair in high-risk patients without complications associated with open-heart surgery. The intracardiac surgical applications for tricuspid valve repair present a unique set of challenges: small scale, large deformations (beating heart), pulsatile blood flow, and remote location from the entry access. Percutaneous approaches rely on catheters, however, current endovascular catheter-based platforms provide limited distal dexterity, lack sensor feedback, and cannot apply a significant amount of force. Robotic technologies can address these challenges, yet their application in beating heart surgery is underexplored. This proposal aims at developing a robotic platform for intracardiac tricuspid valve repair. In prior work, the PI and Co-Is have developed a robotic platform for transcatheter beating heart procedures. We successfully assessed the robot performance in-vitro and ex-vivo. Further, preliminary data show initial success in-vivo. Building upon these exciting results, this proposal aims to optimize the platform to perform percutaneous tricuspid valve annuloplasty. The proposal articulates in three aims. Aim 1 focuses on optimizing the design of the robot to enable navigation from subclavian vein access and implantation of an annuloplasty band to cinch the annulus. Within Aim 2, we will develop a magnetic localization system to allow real-time tracking of the robot’s position for closed-loop control of the robot. A distal soft sensor will monitor interaction forces with the surroundings, help confirm contact with anatomical structures, ensure continuous contact during deployment of annuloplasty coils, and enable haptic feedback to the user. Aim 3 will focus on validation in-vitro, ex-vivo, and in-vivo. These validations will be designed to ensure safety of the device as well as its ability to perform sequential placement of annuloplasty coils on a tricuspid valve annulus and enable controllable cinching on the annulus.