Agrafiotis Emmanouil, Zimpfer Daniel, Mächler Heinrich, Holzapfel Gerhard A
Institute of Biomechanics, Graz University of Technology, Graz, Austria.
Division of Cardiac Surgery, Medical University of Graz, Graz, Austria.
J Endovasc Ther. 2025 Oct;32(5):1278-1300. doi: 10.1177/15266028241235876. Epub 2024 Mar 25.
Implantable cardiovascular devices must undergo evaluation prior to animal testing and clinical trials to ensure their performance and efficiency. Mock circulation loops (MCLs) are on-demand tools capable of reproducing physiological conditions in vivo and are also devices for preventative testing. Recognition of their success as useful tools comes from the fact that over 100 MCLs have been submitted for device assessment in recent years. Mock circulation loops could detect malfunctions that patients might otherwise experience. Thus, MCLs can complement preclinical and prototype evaluation rather than being mutually exclusive. In this review, we emphasize the experimental value of MCLs while providing a brief overview of the history of the field. In addition, the necessary hemodynamic parameters are analyzed to reproduce physiological scenarios in vitro. We also discuss the relevant setups when evaluating devices to assist heart failure and aortic pathologies, namely artificial hearts, left ventricular assist devices, stent-grafts, and artificial heart valves. Finally, we report novel setups developed to evaluate soft biological tissues for translational research.Clinical ImpactOn needs-based ex vivo monitoring of implantable devices or tissues/organs in cardiovascular simulators provides new insights and paves new paths for device prototypes. The insights gained could not only support the needs of patients, but also inform engineers, scientists and clinicians about undiscovered aspects of diseases (during routine monitoring). We analyze seminal and current work and highlight a variety of opportunities for developing preclinical tools that would improve strategies for future implantable devices. Holistically, mock circulation loop studies can bridge the gap between in vivo and in vitro approaches, as well as clinical and laboratory settings, in a mutually beneficial manner.
可植入式心血管设备在进行动物试验和临床试验之前必须经过评估，以确保其性能和效率。模拟循环回路（MCLs）是能够在体内再现生理条件的按需工具，也是用于预防性测试的设备。近年来有超过100个MCLs被提交用于设备评估，这一事实表明它们作为有用工具获得了认可。模拟循环回路可以检测出患者可能会出现的故障。因此，MCLs可以补充临床前和原型评估，而不是相互排斥。在本综述中，我们在简要概述该领域历史的同时，强调了MCLs的实验价值。此外，还分析了在体外再现生理场景所需的血流动力学参数。我们还讨论了评估用于辅助心力衰竭和主动脉病变的设备时的相关设置，即人工心脏、左心室辅助装置、支架移植物和人工心脏瓣膜。最后，我们报告了为转化研究而开发的用于评估软生物组织的新设置。临床影响基于需求的心血管模拟器中可植入设备或组织/器官的离体监测提供了新的见解，并为设备原型开辟了新的道路。获得的见解不仅可以满足患者的需求，还可以在常规监测期间让工程师、科学家和临床医生了解疾病未被发现的方面。我们分析了开创性和当前的工作，并强调了开发临床前工具的各种机会，这些工具将改进未来可植入设备的策略。总体而言，模拟循环回路研究可以以互利的方式弥合体内和体外方法以及临床和实验室环境之间的差距。
