Committee:

Ajit P. Yoganathan, PhD (BME, Georgia Tech) (Advisor)

Wei Sun, PhD (BME, Georgia Tech)

Robert E. Guldberg, PhD (BME, Georgia Tech)

Joseph H. Gorman, MD (Penn School of Medicine)

Changfu Wu, PhD (Food and Drug Administration, Center for Devices & Radiological Health)

Title: Design Parameters and Physiologic Factors Governing Mitral Valve Annular Loading Following Device Implantation

Abstract: To address the growing global population suffering from mitral regurgitation, an increasing variety of corrective devices is becoming available to the cardiac care team. This predominantly consists of annuloplasty rings, which restore native valve competency, and prosthetic valve replacements. Both of these devices are conventionally implanted surgically, using suture anchors. Additionally, numerous percutaneously delivered valve replacements, which do not use sutures, are under rapid development. Nearly all corrective devices (suture-based and percutaneous) anchor and/or seal by mechanically loading the complex, poorly understood mitral annulus. Yet, adverse annular loading can cause disastrous post-operative failures, notably device detachment and/or perivalvular leak. This project proposes that improved understanding of the mechanical loading between the mitral valve corrective device and the native annulus can reduce the risk of failure at their interface. Suture-based and percutaneous devices will be explored independently. A series of custom imaging, force sensing, and other quantification techniques will be applied across in vivo and in vitro settings. Suture detachment risk, perivalvular leakage, and the tissue’s mechanical response to loading will be quantified as functions of device shape, size, stiffness, and deployment technique. Findings will promote development of next-generation devices, implantation techniques, and regulatory standards, ultimately supporting improved clinical outcomes.