The Development and Testing of a Fixation Apparatus for Inducing the Coaptation of the Cardiac Atrioventricular Valves

Abstract

As the prevalence of mitral and tricuspid valvular disease continues to grow with the aging population [1,2], there is a growing critical need to treat high mortality risk patients using minimally invasive and/or non-surgical percutaneous procedures. However, these transcatheter procedures, especially those aimed at repairing or replacing the mitral and tricuspid valves, are mostly still in development and/or early clinical testing. Catheter delivery, prosthesis fixation, and/or demonstrating device efficacy are major challenges currently being addressed [3,4]. Although in situ animal models can assess catheter systems with clinical imaging, direct visualization of tissue-device interactions in real human heart anatomies are desired. In vitro delivery and implantations of valvular prototypes in human heart specimens can be instrumental for accurate device testing and gaining important design insights. Such investigations can be performed on a pulsatile flow apparatus, utilizing perfusion fixed human hearts with mitral and/or tricuspid valves eliciting coaptation and relative function. The employment of endoscopic cameras provides direct visualization and can be coupled with echocardiography, providing novel insights relative to these transcatheter devices in a dynamic environment. However, these investigative approaches require appropriately fixed human heart specimens that will allow for dynamic valve movement. This study discusses the design, construction, and implementation of a novel fixation apparatus to promote the coaptation of the mitral and tricuspid valves in swine and fresh human heart specimen.