Computational modelling of magnesium stent mechanical performance in a remodelling artery: Effects of multiple remodelling stimuli

Significant research has been conducted in the area of coronary stents/scaffolds made from resorbable metallic and polymeric biomaterials. These next generation bioabsorbable stents have the potential to completely revolutionise the treatment of coronary artery disease. The primary advantage of resorbable devices over permanent stents is their temporary presence which, from a theoretical point of view, means only a healed coronary artery will be left behind following degradation of the stent potentially eliminating long term clinical problems associated with permanent stents. The healing of the artery following coronary stent/scaffold implantation is crucial for the long-term safety of these devices. Computational modelling can be used to evaluate the performance of complex stent devices in-silico and assist in the design and development and understanding of the next generation resorbable stents. What is lacking in computational modelling literature is the representation of the active response of the arterial tissue in the weeks and months following stent implantation, i.e., neointimal remodelling, in particular for the case of biodegradable stents. In this paper, a computational modelling framework is developed, that accounts for two major physiological stimuli responsible for neointimal remodelling and combined with a magnesium corrosion model that is capable of simulating localised pitting (realistic) stent corrosion. The framework is used to simulate different neointimal growth patterns and to explore the effects the neointimal remodelling has on the mechanical performance (scaffolding support) of the bioabsorbable magnesium stent.

[1]  Fergal Boyle,et al.  Predicting neointimal hyperplasia in stented arteries using time-dependant computational fluid dynamics: A review , 2010, Comput. Biol. Medicine.

[2]  Claudio Chiastra,et al.  Computational fluid dynamics of stented coronary bifurcations studied with a hybrid discretization method , 2012 .

[3]  Enda L. Boland,et al.  Computational Modeling of the Mechanical Performance of a Magnesium Stent Undergoing Uniform and Pitting Corrosion in a Remodeling Artery , 2017 .

[4]  R. Whitbourn,et al.  Head-to-head comparison of the neointimal response between metallic and bioresorbable everolimus-eluting scaffolds using optical coherence tomography. , 2011, JACC. Cardiovascular interventions.

[5]  H. Van Oosterwyck,et al.  A multi-scale mechanobiological model of in-stent restenosis: deciphering the role of matrix metalloproteinase and extracellular matrix changes , 2014, Computer methods in biomechanics and biomedical engineering.

[6]  Pascal Verdonck,et al.  A Novel Simulation Strategy for Stent Insertion and Deployment in Curved Coronary Bifurcations: Comparison of Three Drug-Eluting Stents , 2009, Annals of Biomedical Engineering.

[7]  Fergal Boyle,et al.  A Numerical Methodology to Fully Elucidate the Altered Wall Shear Stress in a Stented Coronary Artery , 2010 .

[8]  Pavel S. Zun,et al.  A Comparison of Fully-Coupled 3D In-Stent Restenosis Simulations to In-vivo Data , 2017, Front. Physiol..

[9]  P. E. McHugh,et al.  Comparing coronary stent material performance on a common geometric platform through simulated bench testing. , 2012, Journal of the mechanical behavior of biomedical materials.

[10]  J. Drelich,et al.  Tensile testing as a novel method for quantitatively evaluating bioabsorbable material degradation. , 2012, Journal of biomedical materials research. Part B, Applied biomaterials.

[11]  Patrick W Serruys,et al.  Late angiographic stent thrombosis (LAST) events with drug-eluting stents. , 2005, Journal of the American College of Cardiology.

[12]  R. Virmani,et al.  Pathological Correlates of Late Drug-Eluting Stent Thrombosis: Strut Coverage as a Marker of Endothelialization , 2007, Circulation.

[13]  P. McHugh,et al.  Modelling of Atherosclerotic Plaque for Use in a Computational Test-Bed for Stent Angioplasty , 2014, Annals of Biomedical Engineering.

[14]  Caitríona Lally,et al.  A multiscale mechanobiological modelling framework using agent-based models and finite element analysis: application to vascular tissue engineering , 2012, Biomechanics and modeling in mechanobiology.

[15]  P E McHugh,et al.  A corrosion model for bioabsorbable metallic stents. , 2011, Acta biomaterialia.

[16]  Lorenza Petrini,et al.  Finite element analyses for design evaluation of biodegradable magnesium alloy stents in arterial vessels , 2011 .

[17]  Caitríona Lally,et al.  An investigation of damage mechanisms in mechanobiological models of in-stent restenosis , 2017, J. Comput. Sci..

[18]  P. Prendergast,et al.  Simulation of In-stent Restenosis for the Design of Cardiovascular Stents , 2006 .

[19]  Claire Conway,et al.  Computer Simulation of the Mechanical Behaviour of Implanted Biodegradable Stents in a Remodelling Artery , 2016 .

[20]  E. Edelman,et al.  Numerical Simulation of Stent Angioplasty with Predilation: An Investigation into Lesion Constitutive Representation and Calcification Influence , 2017, Annals of Biomedical Engineering.

[21]  Caoimhe A. Sweeney,et al.  A Review of Material Degradation Modelling for the Analysis and Design of Bioabsorbable Stents , 2015, Annals of Biomedical Engineering.

[22]  Patrick J. Prendergast,et al.  Application of a mechanobiological simulation technique to stents used clinically. , 2013, Journal of biomechanics.

[23]  Michael Weyand,et al.  First successful implantation of a biodegradable metal stent into the left pulmonary artery of a preterm baby , 2005, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[24]  G. Boylan,et al.  Commentary: Computerised interpretation of fetal heart rate during labour (INFANT): a randomised controlled trial , 2017, Front. Physiol..

[25]  D. Lacroix,et al.  Biomechanical model to simulate tissue differentiation and bone regeneration: Application to fracture healing , 2006, Medical and Biological Engineering and Computing.

[26]  Caitríona Lally,et al.  Determination of the influence of stent strut thickness using the finite element method: implications for vascular injury and in-stent restenosis , 2009, Medical & Biological Engineering & Computing.

[27]  Michail I. Papafaklis,et al.  Effect of the endothelial shear stress patterns on neointimal proliferation following drug-eluting bioresorbable vascular scaffold implantation: an optical coherence tomography study. , 2014, JACC: Cardiovascular Interventions.

[28]  H. Tahir,et al.  Modelling the Effect of a Functional Endothelium on the Development of In-Stent Restenosis , 2013, PloS one.

[29]  Gerhard Sommer,et al.  Determination of layer-specific mechanical properties of human coronary arteries with nonatherosclerotic intimal thickening and related constitutive modeling. , 2005, American journal of physiology. Heart and circulatory physiology.

[30]  Patrick J Prendergast,et al.  In silico prediction of the mechanobiological response of arterial tissue: application to angioplasty and stenting. , 2011, Journal of biomechanical engineering.

[31]  P. Serruys,et al.  Stent thrombosis. , 2010, Journal of the American College of Cardiology.

[32]  Giuseppe Biondi-Zoccai,et al.  Optical coherence tomography assessment of in vivo vascular response after implantation of overlapping bare-metal and drug-eluting stents. , 2010, JACC. Cardiovascular interventions.

[33]  Seid Koric,et al.  Explicit coupled thermo‐mechanical finite element model of steel solidification , 2009 .

[34]  Francesco Migliavacca,et al.  Hemodynamics and In-stent Restenosis: Micro-CT Images, Histology, and Computer Simulations , 2011, Annals of Biomedical Engineering.

[35]  Michael R Moreno,et al.  Effects of stent design parameters on normal artery wall mechanics. , 2006, Journal of biomechanical engineering.

[36]  W. Nammas,et al.  Neointimal Healing Evaluated by Optical Coherence Tomography after Drug-Eluting Absorbable Metal Scaffold Implantation in de novo Native Coronary Lesions: Rationale and Design of the Magmaris-OCT Study , 2017, Cardiology.

[37]  Dawn Walker,et al.  A Complex Automata approach for in-stent restenosis: Two-dimensional multiscale modelling and simulations , 2011, J. Comput. Sci..

[38]  M J Gómez-Benito,et al.  Influence of fracture gap size on the pattern of long bone healing: a computational study. , 2005, Journal of theoretical biology.

[39]  Georgia S Karanasiou,et al.  Stents: Biomechanics, Biomaterials, and Insights from Computational Modeling , 2017, Annals of Biomedical Engineering.

[40]  P. Serruys,et al.  Coronary stents: current status. , 2010, Journal of the American College of Cardiology.

[41]  Claire Conway,et al.  A Computational Test-Bed to Assess Coronary Stent Implantation Mechanics Using a Population-Specific Approach , 2012 .

[42]  Michael Joner,et al.  Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. , 2006, Journal of the American College of Cardiology.

[43]  Fergal J Boyle,et al.  Computational fluid dynamics analysis of balloon-expandable coronary stents: influence of stent and vessel deformation. , 2014, Medical engineering & physics.

[44]  S. Alper,et al.  Hemodynamic shear stress and its role in atherosclerosis. , 1999, JAMA.

[45]  Soo Teik Lim,et al.  Safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de-novo coronary artery lesions (BIOSOLVE-II): 6 month results of a prospective, multicentre, non-randomised, first-in-man trial , 2016, The Lancet.

[46]  P. Prendergast,et al.  Cardiovascular stent design and vessel stresses: a finite element analysis. , 2005, Journal of biomechanics.

[47]  Marc Garbey,et al.  Rule-Based Simulation of Multi-Cellular Biological Systems—A Review of Modeling Techniques , 2009, Cellular and molecular bioengineering.

[48]  Pascal Verdonck,et al.  Realistic finite element-based stent design: the impact of balloon folding. , 2008, Journal of biomechanics.

[49]  Erhan Tenekecioglu,et al.  Bioresorbable Scaffold: The Emerging Reality and Future Directions , 2017, Circulation research.

[50]  Patrick J Prendergast,et al.  Cortical and interfacial bone changes around a non-cemented hip implant: simulations using a combined strain/damage remodelling algorithm. , 2009, Medical engineering & physics.

[51]  Darren Paul Burke,et al.  Substrate Stiffness and Oxygen as Regulators of Stem Cell Differentiation during Skeletal Tissue Regeneration: A Mechanobiological Model , 2012, PloS one.

[52]  G. Song,et al.  Corrosion mechanisms of magnesium alloys , 1999 .

[53]  D R Hose,et al.  A Thermal Analogy for Modelling Drug Elution from Cardiovascular Stents , 2004, Computer methods in biomechanics and biomedical engineering.

[54]  Reyhaneh Neghabat Shirazi,et al.  Mechanical and Corrosion Testing of Magnesium WE43 Specimens for Pitting Corrosion Model Calibration , 2018, Advanced Engineering Materials.

[55]  J J Wentzel,et al.  Relationship Between Neointimal Thickness and Shear Stress After Wallstent Implantation in Human Coronary Arteries , 2001, Circulation.

[56]  R. Krams,et al.  Intimal hyperplasia following implantation of helical-centreline and straight-centreline stents in common carotid arteries in healthy pigs: influence of intraluminal flow† , 2013, Journal of The Royal Society Interface.

[57]  M. Joner,et al.  Second-generation magnesium scaffold Magmaris: device design and preclinical evaluation in a porcine coronary artery model. , 2017, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[58]  D. Agrawal,et al.  In stent restenosis: bane of the stent era , 2006, Journal of Clinical Pathology.

[59]  D. Mantovani,et al.  Developments in metallic biodegradable stents. , 2010, Acta biomaterialia.

[60]  John C. Criscione,et al.  Stented artery biomechanics and device design optimization , 2007, Medical & Biological Engineering & Computing.

[61]  David M Martin,et al.  Sequential Structural and Fluid Dynamics Analysis of Balloon-Expandable Coronary Stents: A Multivariable Statistical Analysis , 2015, Cardiovascular Engineering and Technology.

[62]  C. Lally,et al.  A strain-mediated corrosion model for bioabsorbable metallic stents. , 2017, Acta biomaterialia.

[63]  John A Ormiston,et al.  Bioabsorbable coronary stents. , 2009, Circulation. Cardiovascular interventions.