Prosthetic Heart Values: A Study of In Vitro Performance - Phase I

摘要

In order to identify and define the fluid dynamic characteristics of primary importance in quantifying heart valve performance, GTRI has carried out a paper study of this subject under contract with the FDA. Where possible these fluid dynamic characteristics have been related to valve hemodynamics and clinical complications such as hemolysis, thromembolism, thrombus formation, tissue overgrowth and other valve dysfunctions. This Phase I study is intended to provide a better understanding for the need to establish in vitro flow testing guidelines which encompass state-of-the-art instrumentation and methodology. The study indicates very clearly that there is more to the in vitro and in vivo fluid dynamic performance of a heart valve prosthesis other than pressure drop and regurgitation. The study also indicates the need for good clinical followup date on heart valve recipients, analysis of sublethal and/or lethal damage to blood components and endothelial tissue, and detailed pathologic studies on recovered (at surgery and/or autopsy) valve prostheses.