Abstract
Background/ObjectivesDrug-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.MethodsAn 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.ResultsThe 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.ConclusionsThe 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.
Highlights
The number of individuals suffering from lower limb peripheral artery disease is increasing globally
The sequential application of two drug-coated balloons led to modest differences (~15%) in drug concentration immediately after inflation, which became negligible within 10
The overall findings suggest that paclitaxel kinetics may be affected by the geometrical and compositional features of the vessel treated with the drug-coated balloon, and by balloon design characteristics and procedural aspects that should be carefully considered
Summary
The number of individuals suffering from lower limb peripheral artery disease is increasing globally. The incidence of the disease in people aged 25 years and over was reported to be approximately 230 million in 2015, representing a notable increase compared with the estimated 202 million people affected by the disease in 2010 [1]. The pathology is characterized by the presence of atherosclerotic lesions that, by protruding into the arterial lumen, obstruct the blood flow and impair the perfusion of the lower limb [2]. The superficial femoral artery (SFA), the longest arterial vessel of the human body [3], is the location of around half of the peripheral atherosclerotic lesions, due to its morphology and biomechanics [4, 5]. In recent years, drug-coated balloons (DCBs) have emerged as an alternative to the conventional non-medicated angioplasty/ stenting treatment of atherosclerotic SFAs
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