3D modelling of drug-coated balloons for the treatment of calcified superficial femoral arteries

Colombo, M., Corti, A., Berceli, S., Migliavacca, F., Mcginty, S. and Chiastra, C. (2021) 3D modelling of drug-coated balloons for the treatment of calcified superficial femoral arteries. PLoS ONE, 16(10), e0256783. (doi: 10.1371/journal.pone.0256783) (PMID:34634057) (PMCID:PMC8504744)

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Abstract

Background/Objectives: 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. Methods: 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. Results: 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. Conclusions: 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.

Item Type:Articles
Additional Information:Funding: MC, AC and CC have been supported by Fondazione Cariplo (https://www. fondazionecariplo.it/en/index.html), Italy (Grant no. 2017-0792, TIME). SM and FM have been partially supported from EPSRC (https://epsrc.ukri.org/), United Kingdom (Grant no. EP/S030875/1).
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Mcginty, Dr Sean
Authors: Colombo, M., Corti, A., Berceli, S., Migliavacca, F., Mcginty, S., and Chiastra, C.
College/School:College of Science and Engineering > School of Engineering > Biomedical Engineering
Journal Name:PLoS ONE
Publisher:Public Library of Science
ISSN:1932-6203
Copyright Holders:Copyright © 2021 Colombo et al.
First Published:First published in PLoS ONE 16(10): e0256783
Publisher Policy:Reproduced under a Creative Commons licence

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
303232EPSRC Centre for Multiscale soft tissue mechanics with MIT and POLIMI (SofTMech-MP)Xiaoyu LuoEngineering and Physical Sciences Research Council (EPSRC)EP/S030875/1M&S - Mathematics