Magnetic resonance (MR) safety and compatibility of a novel iron bioresorbable scaffold
Magnetic resonance (MR) safety and compatibility of a novel iron bioresorbable scaffold
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DOI：
10.1016/j.bioactmat.2020.02.011
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发表时间：
2020-06-01
影响因子：
18.9
通讯作者：
Zheng, Yufeng
中科院分区：
文献类型：
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作者：
Bian, Dong;Qin, Li;Zheng, Yufeng
完全生物可吸收支架的设计是为了克服传统药物洗脱支架(DESS)的局限性，这些支架永久地固定在天然的血管壁上，并可能造成并发症。超薄支架设计的西罗莫司洗脱铁生物可吸收冠状动脉支架系统(IBS)具有与传统DESS相似的力学性能，并在靶血管愈合过程中表现出自适应的降解特征，这使其成为所有患者群体中的一种有前途的候选材料。对于植入式医疗设备，在临床使用之前，特别是对于具有本征铁磁性的设备，应该评估磁共振(MR)成像特性，包括MR的安全性和兼容性。在这项研究中，基于一系列精心设计的体外、体外和体内实验，考虑了典型MR条件下可能存在的风险，包括支架移动、过热、图像伪影和可能的血管损伤，对IBS支架的安全性和兼容性进行了评估。参考了血管内装置MR安全性和兼容性评价的传统ASTM标准，但不仅限于此。还讨论了生物可吸收支架独特的时间相关磁共振特性。在MR扫描过程中施加在支架上的可能的力和MR图像伪影随着支架的降解/吸收而逐渐减小。基于科学基础设计的严格实验表明，IBS支架是有条件的MR，尽管在完全吸收之前不是MR相容的。本研究中使用的方法可以深入了解磁性支架(可生物吸收的)或支架(永久性的)的MR评估。
Fully bioresorbable scaffolds have been designed to overcome the limitations of traditional drug-eluting stents (DESs), which permanently cage the native vessel wall and pose possible complications. The ultrathin-strut designed sirolimus-eluting iron bioresorbable coronary scaffold system (IBS) shows comparable mechanical properties to traditional DESs and exhibits an adaptive degradation profile during target vessel healing, which makes it a promising candidate in all-comers patient population. For implanted medical devices, magnetic resonance (MR) imaging properties, including MR safety and compatibility, should be evaluated before its clinical use, especially for devices with intrinsic ferromagnetism. In this study, MR safety and compatibility of the IBS scaffold were evaluated based on a series of well-designed in-vitro, ex-vivo and in-vivo experiments, considering possible risks, including scaffold movement, over-heating, image artifact, and possible vessel injury, under typical MR condition. Traditional ASTM standards for MR safety and compatibility evaluation of intravascular devices were referred, but not only limited to that. The unique time-relevant MR properties of bioresorbable scaffolds were also discussed. Possible forces imposed on the scaffold during MR scanning and MR image artifacts gradually decreased along with scaffold degradation/absorption. Rigorous experiments designed based on a scientifically based rationale revealed that the IBS scaffold is MR conditional, though not MR compatible before complete absorption. The methodology used in the present study can give insight into the MR evaluation of magnetic scaffolds (bioresorbable) or stents (permanent).