Ding Xili, Sha Dongyu, Sun Kaixin, Fan Yubo
Medical Engineering & Engineering Medicine Innovation Center, Hangzhou International Innovation Institute, Beihang University, Hangzhou, 311115, China; Key Laboratory of Biomechanics and Mechanobiology of Ministry of Education, Beijing Advanced Innovation Center for Biomedical Engineering, School of Biological and Medical Engineering, and with the School of Engineering Medicine, Beihang University, Beijing, 100191, China; National Medical Innovation Platform for Industry-Education Integration in Advanced Medical Devices (Interdiscipline of Medicine and Engineering), Key Laboratory of Innovation and Transformation of Advanced Medical Devices of Ministry of Industry and Information Technology, Beihang University, Beijing, 100083, China.
Key Laboratory of Biomechanics and Mechanobiology of Ministry of Education, Beijing Advanced Innovation Center for Biomedical Engineering, School of Biological and Medical Engineering, and with the School of Engineering Medicine, Beihang University, Beijing, 100191, China.
Acta Biomater. 2025 Apr 15. doi: 10.1016/j.actbio.2025.04.028.
Small-diameter vascular grafts (SDVGs; inner diameter ≤6 mm) offer transformative potential for treating cardiovascular diseases, yet their clinical application remains limited due to high rates of complications such as acute thrombosis and intimal hyperplasia (IH), which compromise long-term patency. While advancements in biological and material science have driven progress, the critical role of biomechanical factors-such as hemodynamic forces and mechanical mismatch-in graft failure is often overlooked. This review presents insights from recent clinical trials of SDVG products and summarizes biomechanical contributors to failure, including disturbed flow patterns, mechanical mismatch, and insufficient mechanical strength. We outline essential mechanical performance criteria (e.g., compliance, burst pressure) and evaluation methodologies to assess SDVG performance. Furthermore, we present optimization strategies based on biomechanical principles: (1) graft morphological design optimization to improve hemodynamic stability, (2) structural, material, and fabrication innovations to achieve compliance matching with native arteries, and (3) biomimetic approaches to mimic vascular tissue and promote endothelialization. By systematically addressing these biomechanical challenges, next-generation SDVGs may achieve superior patency, accelerating their clinical translation. This review highlights the necessity of considering biomechanical compatibility in SDVG development, thereby providing initial insights for the clinical translation of SDVG. STATEMENT OF SIGNIFICANCE: Small-diameter vascular grafts (SDVGs) offer transformative potential for cardiovascular disease treatment but face clinical limitations. While significant progress has been made in biological and material innovations, the critical role of biomechanical factors in graft failure has often been underestimated. This review highlights the importance of biomechanical compatibility in SDVG design and performance, emphasizing the need to address disturbed flow patterns, mechanical mismatch, and inadequate mechanical strength. By proposing optimization strategies based on biomechanical principles, such as graft morphological design, compliance matching, and biomimetic approaches, this work provides a roadmap for developing next-generation SDVGs with improved patency. These advancements have the potential to overcome current limitations, accelerate clinical translation, ultimately benefiting patients worldwide.
小口径血管移植物(SDVGs;内径≤6毫米)为治疗心血管疾病提供了变革性潜力,然而由于急性血栓形成和内膜增生(IH)等高并发症发生率,其临床应用仍然有限,这些并发症会影响长期通畅性。虽然生物和材料科学的进步推动了进展,但生物力学因素(如血流动力学力和机械不匹配)在移植物失败中的关键作用常常被忽视。本综述介绍了SDVG产品近期临床试验的见解,并总结了导致失败的生物力学因素,包括紊乱的血流模式、机械不匹配和机械强度不足。我们概述了评估SDVG性能的基本机械性能标准(如顺应性、爆破压力)和评估方法。此外,我们提出了基于生物力学原理的优化策略:(1)移植物形态设计优化以提高血流动力学稳定性,(2)结构、材料和制造创新以实现与天然动脉的顺应性匹配,以及(3)仿生方法以模拟血管组织并促进内皮化。通过系统地应对这些生物力学挑战,下一代SDVGs可能实现卓越的通畅性,加速其临床转化。本综述强调了在SDVG开发中考虑生物力学兼容性的必要性,从而为SDVG的临床转化提供初步见解。重要性声明:小口径血管移植物(SDVGs)为心血管疾病治疗提供了变革性潜力,但面临临床局限性。虽然在生物和材料创新方面取得了重大进展,但生物力学因素在移植物失败中的关键作用常常被低估。本综述强调了生物力学兼容性在SDVG设计和性能中的重要性,强调需要解决紊乱的血流模式、机械不匹配和机械强度不足的问题。通过提出基于生物力学原理的优化策略,如移植物形态设计、顺应性匹配和仿生方法,这项工作为开发具有更好通畅性的下一代SDVGs提供了路线图。这些进展有可能克服当前的局限性,加速临床转化,最终使全球患者受益。