Bioresorbable vascular scaffolds were considered the fourth generation of endovascular implants deemed to revolutionize cardiovascular interventions. Yet, unexpected high risk of scaffold thrombosis and post-procedural myocardial infractions quenched the early enthusiasm and highlighted the gap between benchtop predictions and clinical observations. To better understand scaffold behavior in the mechanical environment of vessels, animal, and benchtop tests with multimodal loading environment were conducted using industrial standard scaffolds. Finite element analysis was also performed to study the relationship among structural failure, scaffold design, and load types. We identified that applying the combination of bending, axial compression, and torsion better reflects incidence observed in-vivo, far more than tranditional single mode loads. Predication of fracture locations is also more accurate when at least bending and axial compression are applied during benchtop tests (>60% fractures at connected peak). These structural failures may be initiated by implantation-induced microstructural damages and worsened by cyclic loads from the beating heart. Ignoring the multi-modal loading environment in benchtop fatigue tests and computational platforms can lead to undetected potential design defects, calling for redefining consensus evaluation strategies for scaffold performance. With the robust evaluation strategy presented herein, which exploits the results of in-vivo, in-vitro and in-silico investigations, we may be able to compare alternative designs of prototypes at the early stages of device development and optimize the performance of endovascular implants according to patients-specific vessel dynamics and lesion configurations in the future.

生物可吸收血管支架被认为是第四代血管内植入物，被认为彻底改变了心血管干预措施。然而，支架血栓形成和术后心肌梗死的意外高风险熄灭了早期的热情，并突出了台式预测与临床观察之间的差距。为了更好地了解支架在容器机械环境中的行为，使用工业标准支架进行了多模式加载环境下的动物和台式测试。还进行了有限元分析以研究结构失效、脚手架设计和载荷类型之间的关系。我们发现应用弯曲、轴向压缩和扭转的组合更好地反映了体内观察到的发生率，远远超过传统的单模负载。如果在台式测试期间至少应用弯曲和轴向压缩（在连接峰值处 >60% 的断裂），则断裂位置的预测也更准确。这些结构故障可能由植入引起的微观结构损伤引发，并因跳动心脏的循环载荷而恶化。在台式疲劳测试和计算平台中忽略多模态加载环境可能导致未被发现的潜在设计缺陷，需要重新定义脚手架性能的共识评估策略。借助本文提出的稳健评估策略，该策略利用了体内、体外和计算机模拟的结果 通过调查，我们可能能够在设备开发的早期阶段比较原型的替代设计，并在未来根据患者特定的血管动力学和病变配置优化血管内植入物的性能。