Hemodynamic alternations following stent deployment and post-dilation in a heavily calcified coronary artery: In silico and ex-vivo approaches

In this work, hemodynamic alterations in a patient-specific, heavily calcified coronary artery following stent deployment and post-dilations are quantified using in silico and ex-vivo approaches. Three-dimensional artery models were reconstructed from OCT images. Stent deployment and post-dilation with various inflation pressures were performed through both the finite element method (FEM) and ex vivo experiments. Results from FEM agreed very well with the ex-vivo measurements, interms of lumen areas, stent underexpansion, and strut malapposition. In addition, computational fluid dynamics (CFD) simulations were performed to delineate the hemodynamic alterations after stent deployment and post-dilations. A pressure time history at the inlet and a lumped parameter model (LPM) at the outlet were adopted to mimic the aortic pressure and the distal arterial tree, respectively. The pressure drop across the lesion, pertaining to the clinical measure of instantaneous wave-free flow ratio (iFR), was investigated. Results have shown that post-dilations are necessary for the lumen gain as well as the hemodynamic restoration towards hemostasis. Malapposed struts induced much higher shear rate, flow disturbances and lower time-averaged wall shear stress (TAWSS) around struts. Post-dilations mitigated the strut malapposition, and thus the shear rate. Moreover, stenting induced larger area of low TAWSS (<0.4 Pa) and lager volume of high shear rate (>2000 s-1), indicating higher risks of in-stent restenosis (ISR) and stent thrombosis (ST), respectively. Oscillatory shear index (OSI) and relative residence time (RRT) indicated the wall regions more prone to ISR are located near the malapposed stent struts.

[1]  X. Xu,et al.  Patient-specific simulation of stent-graft deployment in type B aortic dissection: model development and validation , 2021, Biomechanics and Modeling in Mechanobiology.

[2]  Michael Joner,et al.  Stent thrombosis and restenosis: what have we learned and where are we going? The Andreas Grüntzig Lecture ESC 2014 , 2015, European heart journal.

[3]  P. Serruys,et al.  Usefulness of shear stress pattern in predicting neointima distribution in sirolimus-eluting stents in coronary arteries. , 2003, The American journal of cardiology.

[4]  C. Indolfi,et al.  Diagnostic Performance of the Instantaneous Wave-Free Ratio: Comparison With Fractional Flow Reserve , 2018, Circulation. Cardiovascular interventions.

[5]  R D Safian,et al.  The Importance of Acute Luminal Diameter in Determining Restenosis After Coronary Atherectomy or Stenting , 1992, Circulation.

[6]  John Cater,et al.  Hemodynamics in Idealized Stented Coronary Arteries: Important Stent Design Considerations , 2015, Annals of Biomedical Engineering.

[7]  Hui Zhu,et al.  Cataloguing the geometry of the human coronary arteries: a potential tool for predicting risk of coronary artery disease. , 2009, International journal of cardiology.

[8]  M. F. Mahmod,et al.  Evaluation System on Haemodynamic Parameters for Stented Carotid Artery: Stent Pictorial Selection Method , 2019, International Journal of Integrated Engineering.

[9]  Jeffrey W Moses,et al.  Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. , 2003, The New England journal of medicine.

[10]  R. Pettigrew,et al.  Impact of Malapposed and Overlapping Stents on Hemodynamics: A 2D Parametric Computational Fluid Dynamics Study , 2021, Mathematics.

[11]  T. Sanborn,et al.  The history of interventional cardiology: cardiac catheterization, angioplasty, and related interventions. , 1995, American heart journal.

[12]  F. Jaffer,et al.  Stent thrombosis: a clinical perspective. , 2014, JACC. Cardiovascular interventions.

[13]  Claudio Chiastra,et al.  On the necessity of modelling fluid-structure interaction for stented coronary arteries. , 2014, Journal of the mechanical behavior of biomedical materials.

[14]  Ryo Torii,et al.  Local Hemodynamic Forces After Stenting: Implications on Restenosis and Thrombosis , 2017, Arteriosclerosis, thrombosis, and vascular biology.

[15]  S. Jana Endothelialization of cardiovascular devices. , 2019, Acta biomaterialia.

[16]  J. Tobis,et al.  Subacute stent thrombosis in the era of intravascular ultrasound-guided coronary stenting without anticoagulation: frequency, predictors and clinical outcome. , 1997, Journal of the American College of Cardiology.

[17]  Martin J. Leahy,et al.  Measurement of the blood flow rate and velocity in coronary artery stenosis using intracoronary frequency domain optical coherence tomography: Validation against fractional flow reserve , 2014, International journal of cardiology. Heart & vasculature.

[18]  F. Migliavacca,et al.  Computational fluid dynamic simulations of image-based stented coronary bifurcation models , 2013, Journal of The Royal Society Interface.

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

[20]  Jennifer K. W. Chesnutt,et al.  Computational simulation of platelet interactions in the initiation of stent thrombosis due to stent malapposition , 2016, Physical biology.

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

[22]  K S Sakariassen,et al.  Shear-induced platelet activation and platelet microparticle formation at blood flow conditions as in arteries with a severe stenosis. , 1997, Arteriosclerosis, thrombosis, and vascular biology.

[23]  P. Barlis,et al.  Numerical study of incomplete stent apposition caused by deploying undersized stent in arteries with elliptical cross-sections. , 2019, Journal of biomechanical engineering.

[24]  George D Giannoglou,et al.  Wall shear stress on LDL accumulation in human RCAs. , 2010, Medical engineering & physics.

[25]  David A. Steinman,et al.  Correlation Between Local Hemodynamics and Lesion Distribution in a Novel Aortic Regurgitation Murine Model of Atherosclerosis , 2011, Annals of Biomedical Engineering.

[26]  Malapposition: is it a major cause of stent thrombosis? , 2016, European heart journal.

[27]  Patrick Segers,et al.  Impact of competitive flow on wall shear stress in coronary surgery: computational fluid dynamics of a LIMA-LAD model. , 2010, Cardiovascular research.

[28]  S. Izumo,et al.  Physiological fluid shear stress causes downregulation of endothelin-1 mRNA in bovine aortic endothelium. , 1992, The American journal of physiology.

[29]  Joel L. Berry,et al.  Experimental and Computational Flow Evaluation of Coronary Stents , 2000, Annals of Biomedical Engineering.

[30]  B. Reddy,et al.  Computational analysis of the radial mechanical performance of PLLA coronary artery stents. , 2015, Medical engineering & physics.

[31]  L. Gu,et al.  Hemodynamic Interference of Serial Stenoses and Its Impact on FFR and iFR Measurements , 2019, Applied Sciences.

[32]  R. Stone,et al.  Differential effects of post-dilation after stent deployment in patients presenting with and without acute myocardial infarction. , 2010, American heart journal.

[33]  S. Chien,et al.  Effects of disturbed flow on vascular endothelium: pathophysiological basis and clinical perspectives. , 2011, Physiological reviews.

[34]  J. Y. Goulermas,et al.  The Windkessel model revisited: a qualitative analysis of the circulatory system. , 2009, Medical engineering & physics.

[35]  Claudio Chiastra,et al.  Computational replication of the patient-specific stenting procedure for coronary artery bifurcations: From OCT and CT imaging to structural and hemodynamics analyses. , 2016, Journal of biomechanics.

[36]  A. Beaudoin,et al.  Analysis of shear stress and hemodynamic factors in a model of coronary artery stenosis and thrombosis. , 1993, The American journal of physiology.

[37]  John F LaDisa,et al.  Alterations in wall shear stress predict sites of neointimal hyperplasia after stent implantation in rabbit iliac arteries. , 2005, American journal of physiology. Heart and circulatory physiology.

[38]  J. LaDisa,et al.  Three-Dimensional Computational Fluid Dynamics Modeling of Alterations in Coronary Wall Shear Stress Produced by Stent Implantation , 2003, Annals of Biomedical Engineering.

[39]  P. Pagel,et al.  Stent Implantation Alters Coronary Artery Hemodynamics and Wall Shear Stress During Maximal Vasodilation. , 2002, Journal of applied physiology.

[40]  Ryo Torii,et al.  Incomplete Stent Apposition Causes High Shear Flow Disturbances and Delay in Neointimal Coverage as a Function of Strut to Wall Detachment Distance: Implications for the Management of Incomplete Stent Apposition , 2014, Circulation. Cardiovascular interventions.

[41]  Michael R. Moreno,et al.  Stented Artery Flow Patterns and Their Effects on the Artery Wall , 2007 .

[42]  A. Jeremias,et al.  Use of the Instantaneous Wave‐free Ratio or Fractional Flow Reserve in PCI , 2017, The New England journal of medicine.

[43]  Hwa Liang Leo,et al.  Structural and Hemodynamic Analyses of Different Stent Structures in Curved and Stenotic Coronary Artery , 2019, Front. Bioeng. Biotechnol..

[44]  C. Fryar,et al.  Prevalence of uncontrolled risk factors for cardiovascular disease: United States, 1999-2010. , 2012, NCHS data brief.

[45]  Luca Mainardi,et al.  Reconstruction of stented coronary arteries from optical coherence tomography images: Feasibility, validation, and repeatability of a segmentation method , 2017, PloS one.

[46]  Daniel Polsky,et al.  Coronary revascularization trends in the United States, 2001-2008. , 2011, JAMA.

[47]  E. Edelman,et al.  Stent Thrombogenicity Early in High-Risk Interventional Settings Is Driven by Stent Design and Deployment and Protected by Polymer-Drug Coatings , 2011, Circulation.

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

[49]  E. Benjamin,et al.  Windkessel Measures Derived From Pressure Waveforms Only: The Framingham Heart Study , 2019, Journal of the American Heart Association.

[50]  B. MacVicar,et al.  Astrocyte control of the cerebrovasculature , 2007, Glia.

[51]  H. Gerlach,et al.  Modulation of endothelial hemostatic properties: an active role in the host response. , 1990, Annual review of medicine.

[52]  A. Wahle,et al.  Effect of Endothelial Shear Stress on the Progression of Coronary Artery Disease, Vascular Remodeling, and In-Stent Restenosis in Humans: In Vivo 6-Month Follow-Up Study , 2003, Circulation.

[53]  Patrick W Serruys,et al.  The influence of shear stress on in-stent restenosis and thrombosis. , 2008, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[54]  S. Anwaruddin,et al.  How Do We Treat Complex Calcified Coronary Artery Disease? , 2016, Current Treatment Options in Cardiovascular Medicine.

[55]  A. Hazel,et al.  Spatial comparison between wall shear stress measures and porcine arterial endothelial permeability. , 2004, American journal of physiology. Heart and circulatory physiology.

[56]  Akiko Maehara,et al.  Consensus standards for acquisition, measurement, and reporting of intravascular optical coherence tomography studies: a report from the International Working Group for Intravascular Optical Coherence Tomography Standardization and Validation. , 2012, Journal of the American College of Cardiology.

[57]  N. Hutchins,et al.  Haemodynamic effects of incomplete stent apposition in curved coronary arteries. , 2017, Journal of biomechanics.

[58]  V. Fuster,et al.  Platelet thrombus formation on collagen type I. A model of deep vessel injury. Influence of blood rheology, von Willebrand factor, and blood coagulation. , 1988, Circulation.

[59]  C. Di Mario,et al.  Coronary Calcified Lesions , 2019 .

[60]  Timothy J. Gundert,et al.  Local hemodynamic changes caused by main branch stent implantation and subsequent virtual side branch balloon angioplasty in a representative coronary bifurcation. , 2010, Journal of applied physiology.

[61]  Mark D. Huffman,et al.  Heart disease and stroke statistics--2013 update: a report from the American Heart Association. , 2013, Circulation.

[62]  M. Zakkar,et al.  Instantaneous wave- free ratio for decision making in cardiac surgery, an important step in the right direction. , 2020, International journal of cardiology.

[63]  Vartan Kurtcuoglu,et al.  Computed high concentrations of low-density lipoprotein correlate with plaque locations in human coronary arteries. , 2011, Journal of biomechanics.

[64]  Abdul I. Barakat,et al.  Computational Study of Fluid Mechanical Disturbance Induced by Endovascular Stents , 2005, Annals of Biomedical Engineering.

[65]  David L. Wilson,et al.  Mechanical performances of balloon post-dilation for improving stent expansion in calcified coronary artery: Computational and experimental investigations. , 2021, Journal of the mechanical behavior of biomedical materials.

[66]  L. Gu,et al.  Hemodynamics and pathology of an enlarging abdominal aortic aneurysm model in rabbits , 2018, PLoS ONE.

[67]  David L. Wilson,et al.  Oct-based Modeling of Stent Deployment in Heavily Calcified Coronary Lesion. , 2020, Journal of biomechanical engineering.

[68]  Wei Yang,et al.  Automatic stent reconstruction in optical coherence tomography based on a deep convolutional model. , 2020, Biomedical optics express.

[69]  S Chien,et al.  Effects of hematocrit and plasma proteins on human blood rheology at low shear rates. , 1966, Journal of applied physiology.

[70]  Shu Chien,et al.  Effects of Flow Patterns on the Localization and Expression of VE-Cadherin at Vascular Endothelial Cell Junctions: In vivo and in vitro Investigations , 2005, Journal of Vascular Research.

[71]  Hao Gao,et al.  A One-Dimensional Hemodynamic Model of the Coronary Arterial Tree , 2019, Front. Physiol..

[72]  E. Edelman,et al.  Role of endothelial shear stress in the natural history of coronary atherosclerosis and vascular remodeling: molecular, cellular, and vascular behavior. , 2007, Journal of the American College of Cardiology.