Chapter 5 - Advancing the Design and Testing of Novel Cardiac Device Technologies Using the Visible Heart

Abstract

Pre- and postimplant evaluations of implantable cardiac devices require innovative and critical testing during all phases of the design process. The Visible Heart Project was successfully launched in 1997, and 3 years later, the Atlas of Human Cardiac Anatomy website was published online. The Visible Heart methodologies and Atlas website provide users with a unique experimental toolset and a comprehensive anatomical archive to improve understanding of human cardiac anatomy and preclinical device testing results. To date, Visible Heart methodologies have been used to reanimate over 80 human hearts, all considered nonviable for transplantation. These studies provide imaging datasets that are then uploaded to the Atlas, a free-access website featuring novel images of functional and fixed human cardiac anatomies from >500 human heart specimens. Furthermore, this website includes educational tutorials on anatomy, physiology, congenital heart disease, and various imaging modalities. Examples of clinically approved devices that were present at the time of in vitro reanimation, or were subsequently delivered into perfusion-fixed specimens (i.e., pacing and defibrillator leads, catheters, valves, annuloplasty rings, leadless pacemakers, and stents), can be found online within the Device Tutorial. Another section of the website displays 3D models of vasculature, blood volumes, and/or tissue volumes reconstructed from computed tomography and magnetic resonance images of various heart specimens. Importantly, the methodologies developed and employed within the Visible Heart laboratory have led to a more comprehensive understanding of human cardiac anatomy, physiology, and device–tissue interactions, building the foundation of knowledge needed for modern cardiovascular device design and development.