Effect of Sinotubular Junction Size on TAVR Leaflet Thrombosis: A Fluid-structure Interaction Analysis

Purpose: TAVR has emerged as a standard approach for treating severe aortic stenosis patients. However, it is associated with several clinical complications, including subclinical leaflet thrombosis characterized by Hypoattenuated Leaflet Thickening (HALT). A rigorous analysis of TAVR device thrombogenicity considering anatomical variations is essential for estimating this risk. Clinicians use the Sinotubular Junction (STJ) diameter for TAVR sizing, but there is a paucity of research on its influence on TAVR devices thrombogenicity. Methods: A Medtronic Evolut(R) TAVR device was deployed in three patient models with varying STJ diameters (26, 30, and 34mm) to evaluate its impact on post-deployment hemodynamics and thrombogenicity, employing a novel computational framework combining prosthesis deployment and fluidstructure interaction analysis. Results: The 30 mm STJ patient case exhibited the best hemodynamic performance: 5.94 mmHg mean transvalvular pressure gradient (TPG), 2.64 cm2 mean geometric orifice area (GOA), and the lowest mean residence time (TR) - indicating a reduced thrombogenic risk; 26 mm STJ exhibited a 10 % reduction in GOA and a 35% increase in mean TPG compared to the 30 mm STJ; 34 mm STJ depicted hemodynamics comparable to the 30 mm STJ, but with a 6% increase in TR and elevated platelet stress accumulation. Conclusion: A smaller STJ size impairs adequate expansion of the TAVR stent, which may lead to suboptimal hemodynamic performance. Conversely, a larger STJ size marginally enhances the hemodynamic performance but increases the risk of TAVR leaflet thrombosis. Such analysis can aid preprocedural planning and minimize the risk of TAVR leaflet thrombosis.

[1]  Brandon J Kovarovic,et al.  Mild Paravalvular Leak May Pose an Increased Thrombogenic Risk in Transcatheter Aortic Valve Replacement (TAVR) Patients-Insights from Patient Specific In Vitro and In Silico Studies , 2023, Bioengineering.

[2]  Xiaoqing Li,et al.  Anatomic predictor of severe prosthesis malposition following transcatheter aortic valve replacement with self- expandable Venus-A Valve among pure aortic regurgitation: A multicenter retrospective study , 2022, Frontiers in Cardiovascular Medicine.

[3]  Anas M. Saad,et al.  Left Main Protection During Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve , 2022, Journal of the Society for Cardiovascular Angiography & Interventions.

[4]  Ram P. Ghosh,et al.  Validating In Silico and In Vitro Patient-Specific Structural and Flow Models with Transcatheter Bicuspid Aortic Valve Replacement Procedure. , 2022, Cardiovascular engineering and technology.

[5]  Brandon J Kovarovic,et al.  A computational framework for post-TAVR cardiac conduction abnormality (CCA) risk assessment in patient-specific anatomy. , 2022, Artificial organs.

[6]  C. Butakoff,et al.  Fluid-structure interaction analysis of eccentricity and leaflet rigidity on thrombosis biomarkers in bioprosthetic aortic valve replacements , 2022, bioRxiv.

[7]  Ram P. Ghosh,et al.  Assessment of Paravalvular Leak Severity and Thrombogenic Potential in Transcatheter Bicuspid Aortic Valve Replacements Using Patient-Specific Computational Modeling , 2021, Journal of Cardiovascular Translational Research.

[8]  A. Yoganathan,et al.  Predictive Model for Thrombus Formation After Transcatheter Valve Replacement , 2021, Cardiovascular Engineering and Technology.

[9]  C. Butakoff,et al.  Design and execution of a verification, validation, and uncertainty quantification plan for a numerical model of left ventricular flow after LVAD implantation , 2021, bioRxiv.

[10]  P. Lamata,et al.  Clinically-Driven Virtual Patient Cohorts Generation: An Application to Aorta , 2021, Frontiers in Physiology.

[11]  Guillaume Houzeaux,et al.  Performance assessment of CUDA and OpenACC in large scale combustion simulations , 2021, ArXiv.

[12]  Jeroen J. Bax,et al.  Subclinical Leaflet Thrombosis in Transcatheter and Surgical Bioprosthetic Valves: PARTNER 3 Cardiac Computed Tomography Substudy. , 2020, Journal of the American College of Cardiology.

[13]  R. W. dos Santos,et al.  Creation and application of virtual patient cohorts of heart models , 2020, Philosophical Transactions of the Royal Society A.

[14]  A. Yoganathan,et al.  Influence of Patient-Specific Characteristics on Transcatheter Heart Valve Neo-Sinus Flow: An In Silico Study , 2020, Annals of Biomedical Engineering.

[15]  F. Gentile,et al.  Are the dynamic changes of the aortic root determinant for thrombosis or leaflet degeneration after transcatheter aortic valve replacement? , 2020, Journal of thoracic disease.

[16]  M. Steigner,et al.  Imaging of the aortic root on high-pitch non-gated and ECG-gated CT: awareness is the key! , 2020, Insights into Imaging.

[17]  Ram P. Ghosh,et al.  Numerical evaluation of transcatheter aortic valve performance during heart beating and its post-deployment fluid–structure interaction analysis , 2020, Biomechanics and Modeling in Mechanobiology.

[18]  Guillaume Houzeaux,et al.  A low-dissipation finite element scheme for scale resolving simulations of turbulent flows , 2019, J. Comput. Phys..

[19]  Yaiza Beatriz Molero-Díez,et al.  Fourth universal definition of myocardial infarction , 2019, Colombian Journal of Anesthesiology.

[20]  M. Cortés Barcelona Supercomputing Center , 2019 .

[21]  Amirhossein Arzani,et al.  A critical comparison of different residence time measures in aneurysms. , 2019, Journal of biomechanics.

[22]  O. Lehmkuhl,et al.  Fluid dynamics and heat transfer in the wake of a sphere , 2019, International Journal of Heat and Fluid Flow.

[23]  Ram P. Ghosh,et al.  Patient-specific simulation of transcatheter aortic valve replacement: impact of deployment options on paravalvular leakage , 2018, Biomechanics and Modeling in Mechanobiology.

[24]  John F LaDisa,et al.  Impact of annular and supra-annular CoreValve deployment locations on aortic and coronary artery hemodynamics. , 2018, Journal of the mechanical behavior of biomedical materials.

[25]  Guillaume Houzeaux,et al.  Flow features and micro-particle deposition in a human respiratory system during sniffing , 2018, Journal of Aerosol Science.

[26]  Prem A. Midha,et al.  The Fluid Mechanics of Transcatheter Heart Valve Leaflet Thrombosis in the Neosinus , 2017, Circulation.

[27]  Brandon L. Moore,et al.  Aortic sinus flow stasis likely in valve‐in‐valve transcatheter aortic valve implantation , 2017, The Journal of thoracic and cardiovascular surgery.

[28]  D. Ku,et al.  Thrombus Formation at High Shear Rates. , 2017, Annual review of biomedical engineering.

[29]  Wen Cheng,et al.  Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study , 2017, The Lancet.

[30]  Ali N Azadani,et al.  Supra-annular Valve-in-Valve implantation reduces blood stasis on the transcatheter aortic valve leaflets. , 2017, Journal of biomechanics.

[31]  A. Azadani,et al.  Valve thrombosis following transcatheter aortic valve replacement: significance of blood stasis on the leaflets , 2017, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[32]  G. Richardt,et al.  Clinical Bioprosthetic Heart Valve Thrombosis After Transcatheter Aortic Valve Replacement: Incidence, Characteristics, and Treatment Outcomes. , 2017, JACC. Cardiovascular interventions.

[33]  M. Vázquez,et al.  Heat loss prediction of a confined premixed jet flame using a conjugate heat transfer approach , 2017 .

[34]  E. Schwammenthal,et al.  Sex differences in aortic root and vascular anatomy in patients undergoing transcatheter aortic valve implantation: A computed-tomographic study. , 2017, Journal of cardiovascular computed tomography.

[35]  Deepak L. Bhatt,et al.  Leaflet Thrombosis in Surgically Explanted or Post-Mortem TAVR Valves. , 2017, JACC. Cardiovascular imaging.

[36]  A. Ducci,et al.  Transcatheter aortic valves produce unphysiological flows which may contribute to thromboembolic events: An in-vitro study , 2016, Journal of biomechanics.

[37]  F Auricchio,et al.  Prediction of patient-specific post-operative outcomes of TAVI procedure: The impact of the positioning strategy on valve performance. , 2016, Journal of biomechanics.

[38]  David Pastor-Escuredo,et al.  A clinical method for mapping and quantifying blood stasis in the left ventricle. , 2016, Journal of biomechanics.

[39]  Jan Vierendeels,et al.  Fluid-Structure Interaction Simulation of Prosthetic Aortic Valves: Comparison between Immersed Boundary and Arbitrary Lagrangian-Eulerian Techniques for the Mesh Representation , 2016, PloS one.

[40]  M. Mack,et al.  Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. , 2016, The New England journal of medicine.

[41]  D. Doorly,et al.  Large-scale CFD simulations of the transitional and turbulent regime for the large human airways during rapid inhalation , 2016, Comput. Biol. Medicine.

[42]  M. Vázquez,et al.  Heat Transfer Effects on a Fully Premixed Methane Impinging Flame , 2016 .

[43]  Deepak L. Bhatt,et al.  Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves. , 2015, The New England journal of medicine.

[44]  D. Ku,et al.  Role of high shear rate in thrombosis. , 2015, Journal of vascular surgery.

[45]  M. Horner,et al.  Numerical Model of Full-Cardiac Cycle Hemodynamics in a Total Artificial Heart and the Effect of Its Size on Platelet Activation , 2014, Journal of Cardiovascular Translational Research.

[46]  A. Qiao,et al.  Fluid–Structure Interaction Simulation of Aortic Valve Closure with Various Sinotubular Junction and Sinus Diameters , 2014, Annals of Biomedical Engineering.

[47]  J. Coselli,et al.  Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. , 2014, Journal of the American College of Cardiology.

[48]  Maurice Buchbinder,et al.  Transcatheter aortic-valve replacement with a self-expanding prosthesis. , 2014, The New England journal of medicine.

[49]  Gil Marom,et al.  Numerical model of the aortic root and valve: optimization of graft size and sinotubular junction to annulus ratio. , 2013, The Journal of thoracic and cardiovascular surgery.

[50]  T. Sochi Non-Newtonian Rheology in Blood Circulation , 2013, 1306.2067.

[51]  Shmuel Einav,et al.  Device thrombogenicity emulation: a novel methodology for optimizing the thromboresistance of cardiovascular devices. , 2013, Journal of biomechanics.

[52]  Wei Sun,et al.  Biomechanical characterization of aortic valve tissue in humans and common animal models. , 2012, Journal of biomedical materials research. Part A.

[53]  Shmuel Einav,et al.  Device Thrombogenicity Emulation: A Novel Method for Optimizing Mechanical Circulatory Support Device Thromboresistance , 2012, PloS one.

[54]  Wei Sun,et al.  Significant differences in the material properties between aged human and porcine aortic tissues. , 2011, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[55]  S. Einav,et al.  Device Thrombogenicity Emulator (DTE)--design optimization methodology for cardiovascular devices: a study in two bileaflet MHV designs. , 2010, Journal of biomechanics.

[56]  V. L. Rayz,et al.  Flow Residence Time and Regions of Intraluminal Thrombus Deposition in Intracranial Aneurysms , 2010, Annals of Biomedical Engineering.

[57]  Danny Bluestein,et al.  Flow-induced platelet activation and damage accumulation in a mechanical heart valve: numerical studies. , 2007, Artificial organs.

[58]  Michael V Sefton,et al.  Biomaterial-associated thrombosis: roles of coagulation factors, complement, platelets and leukocytes. , 2004, Biomaterials.

[59]  Danny Bluestein,et al.  Flow-Induced Platelet Activation in Bileaflet and Monoleaflet Mechanical Heart Valves , 2004, Annals of Biomedical Engineering.

[60]  C Bludszuweit,et al.  Model for a general mechanical blood damage prediction. , 1995, Artificial organs.

[61]  J. D. Hellums,et al.  1993 Whitaker lecture: Biorheology in thrombosis research , 1994, Annals of Biomedical Engineering.

[62]  Guillaume Houzeaux,et al.  Subject-variability effects on micron particle deposition in human nasal cavities , 2018 .

[63]  Michael Smith,et al.  ABAQUS/Standard User's Manual, Version 6.9 , 2009 .