A Novel Transcatheter Edge-to-Edge Suturing Technique and Prototype for Repairing Tricuspid Valve Regurgitation

Abstract Tricuspid valve regurgitation is a major clinical issue that continues to attract interest from interventional cardiologists and medical device designers due to its rising prevalence and progressive nature. This disease impact is exacerbated among the aging population, considered as high risk of mortality for open-heart surgical procedures. Furthermore, early intervention for tricuspid regurgitation following left-sided heart procedures continues to increase. Thus, percutaneous or transcatheter interventions have emerged as the new frontier for tricuspid valve therapy. Specifically, tricuspid leaflet plication, or edge-to-edge repair, is a valvular procedure to enhance the coaptation of the leaflets and reduce regurgitation. The current landscape of approved transcatheter devices for leaflet coaptation are exclusive to the mitral valve or being investigated for tricuspid treatment. However, most of these transcatheter systems are designed with high procedure specificities, are expensive, and require extensive procedural training. Hence, there is an opportunity to percutaneously plicate the tricuspid leaflets using commonly available right-heart catheter equipment. This study details a novel transcatheter repair procedure that can plicate the tricuspid valve leaflets solely using current market released catheters and/or surgical equipment. Testing and evaluation of this prototype procedure was performed using Visible Heart® methodologies.