ABSTRACT
Introduction Replacement heart valve device design and physician use have advanced over the past 50 years from the first implant of the Hufnagel valve in the descending thoracic aorta without cardiopulmonary bypass in 1952 (1) to recent clinical use of transcatheter implantation or replacement heart valves (2-6). Along with the evolution of heart valve designs and materials, the preclinical testing of devices has also improved over the past quarter-century, providing data critical to the initiation of clinical investigations. During this time, test method development for replacement heart valves has progressed because of advances in measurement techniques and systems, lessons learned from previous clinical device failures (7), unanticipated clinical complications not discovered during preclinical testing (8), and the introduction of new types of replacement heart valves, such as stentless bioprostheses (9). Preclinical evaluation of transcatheter heart valves will again necessitate the development of testing methods based on specific design and intended use.
