3D modelling of drug-coated balloons for the treatment of calcified superficial femoral arteries.
3D modelling of drug-coated balloons for the treatment of calcified superficial femoral arteries.
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DOI：
10.1371/journal.pone.0256783
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发表时间：
2021
期刊：
影响因子：
3.7
通讯作者：
Chiastra C
中科院分区：
文献类型：
--
作者：
Colombo M;Corti A;Berceli S;Migliavacca F;McGinty S;Chiastra C
药物涂层球囊治疗患病股浅动脉仍存在争议。尽管其具有临床相关性，但迄今为止仅提出了一些基于简单二维模型的计算研究来研究这种血管内治疗。这项工作通过分析药物涂层球囊在三维几何结构中展开过程中发生的药物转运和动力学来解决上述限制。创建了具有钙化斑块并用药物涂层球囊处理的股浅动脉的理想三维模型，以执行瞬态质量传递模拟。为了解释装置释放的药物（即紫杉醇）的转运，通过描述通过非线性、可逆反应与特定细胞内受体结合的药物来实现扩散反应方程。研究了以下有关程序方面、病理学和建模假设的特征：(i) 球囊应用时间（60-180 秒）； (ii) 血管壁成分（健康壁与钙化壁）； (iii) 连续应用球囊； (iv) 血流药物洗出与涂层保留，建模为指数衰减。球囊充气时间影响血管壁中游离药物和特异性结合药物的浓度。血管壁成分对药物浓度影响很大。特别是，与健康血管壁部分相比，钙化处的特异性结合药物浓度低四个数量级，这主要是由于药物扩散减少的结果。连续应用两个药物涂层球囊在膨胀后立即导致药物浓度略有差异（~15%），这种差异在 10 分钟内变得可以忽略不计。球囊涂层的保留使血管壁中的药物浓度增加了四倍。总体研究结果表明，紫杉醇动力学不仅可能受到药物涂层球囊治疗血管的几何和成分特征的影响，而且还受到球囊设计特征和应仔细考虑的程序方面的影响。
Drug-coated balloon therapy for diseased superficial femoral arteries remains controversial. Despite its clinical relevance, only a few computational studies based on simplistic two-dimensional models have been proposed to investigate this endovascular therapy to date. This work addresses the aforementioned limitation by analyzing the drug transport and kinetics occurring during drug-coated balloon deployment in a three-dimensional geometry. An idealized three-dimensional model of a superficial femoral artery presenting with a calcific plaque and treated with a drug-coated balloon was created to perform transient mass transport simulations. To account for the transport of drug (i.e. paclitaxel) released by the device, a diffusion-reaction equation was implemented by describing the drug bound to specific intracellular receptors through a non-linear, reversible reaction. The following features concerning procedural aspects, pathologies and modelling assumptions were investigated: (i) balloon application time (60–180 seconds); (ii) vessel wall composition (healthy vs. calcified wall); (iii) sequential balloon application; and (iv) drug wash-out by the blood stream vs. coating retention, modeled as exponential decay. The balloon inflation time impacted both the free and specifically-bound drug concentrations in the vessel wall. The vessel wall composition highly affected the drug concentrations. In particular, the specifically-bound drug concentration was four orders of magnitude lower in the calcific compared with healthy vessel wall portions, primarily as a result of reduced drug diffusion. The sequential application of two drug-coated balloons led to modest differences (~15%) in drug concentration immediately after inflation, which became negligible within 10 minutes. The retention of the balloon coating increased the drug concentration in the vessel wall fourfold. The overall findings suggest that paclitaxel kinetics may be affected not only by the geometrical and compositional features of the vessel treated with the drug-coated balloon, but also by balloon design characteristics and procedural aspects that should be carefully considered.