Wei Zhenglun Alan, Sonntag Simon Johannes, Toma Milan, Singh-Gryzbon Shelly, Sun Wei
Wallace H. Coulter School of Biomedical Engineering, Georgia Institute of Technology, Technology Enterprise Park, Room 206, 387 Technology Circle, Atlanta, GA, 30313-2412, USA.
enmodes GmbH, Aachen, Germany.
Cardiovasc Eng Technol. 2018 Sep;9(3):289-299. doi: 10.1007/s13239-018-0349-y. Epub 2018 Apr 19.
The governing international standard for the development of prosthetic heart valves is International Organization for Standardization (ISO) 5840. This standard requires the assessment of the thrombus potential of transcatheter heart valve substitutes using an integrated thrombus evaluation. Besides experimental flow field assessment and ex vivo flow testing, computational fluid dynamics is a critical component of this integrated approach. This position paper is intended to provide and discuss best practices for the setup of a computational model, numerical solving, post-processing, data evaluation and reporting, as it relates to transcatheter heart valve substitutes. This paper is not intended to be a review of current computational technology; instead, it represents the position of the ISO working group consisting of experts from academia and industry with regards to considerations for computational fluid dynamic assessment of transcatheter heart valve substitutes.
人工心脏瓣膜研发的主导国际标准是国际标准化组织(ISO)5840。该标准要求使用综合血栓评估来评估经导管心脏瓣膜替代品的血栓形成潜力。除了实验流场评估和体外流动测试外,计算流体动力学是这种综合方法的关键组成部分。本立场文件旨在提供并讨论与经导管心脏瓣膜替代品相关的计算模型设置、数值求解、后处理、数据评估和报告的最佳实践。本文并非对当前计算技术的综述;相反,它代表了由学术界和行业专家组成的ISO工作组对于经导管心脏瓣膜替代品计算流体动力学评估考量的立场。