Arminio Mariachiara, Carbonaro Dario, Morbiducci Umberto, Gallo Diego, Chiastra Claudio
PoliToBIOMed Lab, Department of Mechanical and Aerospace Engineering, Politecnico di Torino, Turin, Italy.
Front Med Technol. 2024 Jul 1;6:1399729. doi: 10.3389/fmedt.2024.1399729. eCollection 2024.
Over the last years computer modelling and simulation has emerged as an effective tool to support the total product life cycle of cardiovascular devices, particularly in the device preclinical evaluation and post-market assessment. Computational modelling is particularly relevant for heart valve prostheses, which require an extensive assessment of their hydrodynamic performance and of risks of hemolysis and thromboembolic complications associated with mechanically-induced blood damage. These biomechanical aspects are typically evaluated through a fluid-structure interaction (FSI) approach, which enables valve fluid dynamics evaluation accounting for leaflets movement. In this context, the present narrative review focuses on the computational modelling of bileaflet mechanical aortic valves through FSI approach, aiming to foster and guide the use of simulations in device total product life cycle. The state of the art of FSI simulation of heart valve prostheses is reviewed to highlight the variety of modelling strategies adopted in the literature. Furthermore, the integration of FSI simulations in the total product life cycle of bileaflet aortic valves is discussed, with particular emphasis on the role of simulations in complementing and potentially replacing the experimental tests suggested by international standards. Simulations credibility assessment is also discussed in the light of recently published guidelines, thus paving the way for a broader inclusion of evidence in regulatory submissions. The present narrative review highlights that FSI simulations can be successfully framed within the total product life cycle of bileaflet mechanical aortic valves, emphasizing that credible models evaluating the performance of implantable devices can (at least) partially replace preclinical experimentation and support post-market biomechanical evaluation, leading to a reduction in both time and cost required for device development.
在过去几年中，计算机建模与仿真已成为支持心血管器械全产品生命周期的有效工具，尤其是在器械临床前评估和上市后评估方面。计算建模对于心脏瓣膜假体尤为重要，因为需要对其流体动力学性能以及与机械性血液损伤相关的溶血和血栓栓塞并发症风险进行广泛评估。这些生物力学方面通常通过流固耦合（FSI）方法进行评估，该方法能够在考虑瓣叶运动的情况下评估瓣膜流体动力学。在此背景下，本叙述性综述聚焦于通过FSI方法对双叶机械主动脉瓣进行计算建模，旨在促进和指导仿真在器械全产品生命周期中的应用。对心脏瓣膜假体的FSI仿真技术现状进行了综述，以突出文献中采用的各种建模策略。此外，还讨论了FSI仿真在双叶主动脉瓣全产品生命周期中的整合，特别强调了仿真在补充并可能替代国际标准建议的实验测试方面的作用。还根据最近发布的指南讨论了仿真可信度评估，从而为在监管申报中更广泛地纳入证据铺平道路。本叙述性综述强调，FSI仿真可以成功地纳入双叶机械主动脉瓣的全产品生命周期，强调可信的评估可植入器械性能的模型能够（至少）部分替代临床前实验，并支持上市后生物力学评估，从而减少器械开发所需的时间和成本。
