Title : Computational modelling for enhanced drug delivery in drug-coated balloon treatment
Abstract:
Drug-coated balloon (DCB) treatment has recently emerged as an effective non-stent-based strategy for the treatment of atherosclerotic arteries in peripheral artery disease (PAD). DCBs are designed to dilate into the stenotic lesions while delivering antiproliferative drugs to local arterial tissue via prolonged coated-balloon angioplasty inflation. However, insufficient delivery and non-homogeneous drug-coating transfer onto the arterial walls remain outstanding issues, hindering the DCB use as standard-of-care therapy for PAD treatment. Recent clinical evidence indicates that pre-treating the lesion with conventional angioplasty balloons plays a crucial role in adequately preparing the vessel footprint for subsequent drug- coating delivery to the target lesion. As drug-coating transfer is mediated by the mechanical interaction between the device and the artery and driven by local contact pressure (CP) gradients, computational models can be exploited to study the biophysical aspects underlying the device-artery interaction, aiming for a better understanding of the proper operating conditions and overall DCB treatment optimization. Therefore, this study aimed to develop a numerical pipeline to simulate lesion preparation using plain old balloon angioplasty (POBA) in atherosclerotic arteries followed by DCB inflation in the pre-dilated vessels. The finite element (FE) models employed different angioplasty balloon devices commonly adopted for lesion preparation, drug-coated balloons, and diseased arteries with heterogeneous tissue composition and different anatomical features. Vessel lumen gain and wall stiffness degradation due to tissue injury at the high strain levels induced by balloon angioplasty have been introduced to mechanically describe the arterial wall, obtaining a reliable vessel footprint with whom the DCB will interact in the next step. Quantitative data from experimental ring tensile tests on carotid swine arteries and balloon inflations using polyurethane resin have been exploited to feed and validate the numerical models. The numerical analyses demonstrated their applicability and potential capabilities in accurately simulating the DCB treatment, providing insights into how the device-artery interaction determines the efficacy of local coating delivery. Specifically, the findings revealed that the experimentally validated FE folded balloon models, in combination with a reliable pre- dilated artery model, is essential to properly describe the irregular spatial distribution of the CP, which reflects the non-homogeneous local coating transfer and, consequently, the drug-delivery. The proposed approach is versatile and could ultimately be adapted to patient-specific geometries to obtain a deeper understanding of the mechanism governing DCB efficacy and provide insights in both balloon angioplasty manufacturing and clinical contexts for improved therapeutic outcomes.
Audience Take Away Notes:
- The audience will learn how computational models can be exploited to predict and optimize the factors influencing drug delivery in drug-coated balloon treatment
- The developed models have the potential to indirectly support clinicians in the pre-operative planning phase and provide insights to medical device manufacturers into the influence of structural aspects of DCBs in their performances
- The audience will get a glimpse of how benchtop experiments and numerical simulations can feed and complement each other to develop reliable and robust computational models
