Transcatheter heart valves: Development and evaluation

This chapter focuses on the engineering behind transcatheter heart valves (THV), both in scientific terms and in way of thought. It begins with a brief history of the development of artificial heart valves, encompasses the major advances along its path, and escalates to its current evolution. Each aspect of the THV implantation procedure, from crimping to valve implantation and function, is assessed for possible and proven risks and hazards. They are analyzed using the international standards for heart valve development and testing, in order to show the approach by which an engineer tackles the design and improvement of transcatheter heart valves. The chapter progresses on to materials currently used in THV applications, specifically conversing the advantages and obstacles of each material. Similarly, the material science behind balloon and self-expanding valve technology is summarized. Corrosion and biocompatibility are discussed to demonstrate the utmost need for proper material processing and stent design, followed by description of the tissue component, how it is modified, designed, and optimized. Lastly, the engineering evaluation of the THV is explained through the use of the international standards in order to shed light on additional clinical and engineering challenges required to develop a successful THV design.