Suggestion of Potential Stent Design Parameters to Reduce Restenosis Risk driven by Foreshortening or Dogboning due to Non-uniform Balloon-Stent Expansion

The foreshortening or dogboning of a stent that occurs due to transient non-uniform balloon-stent expansion can induce a vascular injury, resulting in restenosis of the coronary artery. However, previous studies rarely considered the effects of transient non-uniform balloon expansion on analysis of the mechanical properties and behaviors of stents during stent deployment, nor did they determine design parameters to minimize the restenosis risk driven by foreshortening or dogboning. The aim of the current study was, therefore, to suggest potential design parameters capable of reducing the possibility of restenosis risk driven by foreshortening or dogboning through a comparative study of seven commercial stents using finite element (FE) analyses of a realistic transient non-uniform balloon-stent expansion process. The results indicate that using stents composed of opened unit cells connected by bend-shaped link structures, in particular the MAC Plus stent, and controlling the geometrical and morphological features of the unit cell strut or the link structure at the distal ends of stent may prevent restenosis risk caused by foreshortening or dogboning. This study provides a first look at the realistic transient non-uniform balloon-stent expansion by investigating the mechanical properties, behaviors, and design parameters capable of reducing the possibility of restenosis risk induced by the foreshortening or the dogboning.

[1]  J. Isner,et al.  Restenosis of endovascular stents from stent compression. , 1997, Journal of the American College of Cardiology.

[2]  F. Auricchio,et al.  Mechanical behavior of coronary stents investigated through the finite element method. , 2002, Journal of biomechanics.

[3]  A J Stewart,et al.  Coronary artery stents. , 1996, Postgraduate medical journal.

[4]  C Dumoulin,et al.  Mechanical behaviour modelling of balloon-expandable stents. , 2000, Journal of biomechanics.

[5]  K Ulm,et al.  Restenosis after coronary placement of various stent types. , 2001, The American journal of cardiology.

[6]  M. Montagnani,et al.  Dynamic uniaxial and biaxial stress-strain relationships for austenitic stainless steels , 1980 .

[7]  F. Etave,et al.  Mechanical properties of coronary stents determined by using finite element analysis. , 2001, Journal of biomechanics.

[8]  A Dodek,et al.  Mechanisms, management, and outcome of failure of delivery of coronary stents. , 1999, The American journal of cardiology.

[9]  V. Fuster,et al.  Management of restenosis after coronary intervention. , 1996, American heart journal.

[10]  Renu Virmani,et al.  Experimental evaluation of a short transitional edge protection balloon for intracoronary stent deployment , 2000, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[11]  L. Freitag,et al.  Theoretical and experimental basis for the development of a dynamic airway stent. , 1994, The European respiratory journal.

[12]  James E. Moore,et al.  Stented artery biomechanics and device design optimization , 2007, Medical & Biological Engineering & Computing.

[13]  Raimund Erbel,et al.  Coronary-Artery Stenting Compared with Balloon Angioplasty for Restenosis After Initial Balloon Angioplasty , 1999 .

[14]  Weiqiang Wang,et al.  Analysis of the transient expansion behavior and design optimization of coronary stents by finite element method. , 2006, Journal of biomechanics.

[15]  S. Chua,et al.  Finite element simulation of slotted tube (stent) with the presence of plaque and artery by balloon expansion , 2004 .

[16]  C. Wong,et al.  Migration of the AVE Micro coronary stent. , 1996, Catheterization and cardiovascular diagnosis.

[17]  Joel L Berry,et al.  Hemodynamics and wall mechanics of a compliance matching stent: in vitro and in vivo analysis. , 2002, Journal of vascular and interventional radiology : JVIR.

[18]  E. Edelman,et al.  Balloon-artery interactions during stent placement: a finite element analysis approach to pressure, compliance, and stent design as contributors to vascular injury. , 1999, Circulation research.

[19]  P Serruys,et al.  Coronary-artery stenting compared with balloon angioplasty for restenosis after initial balloon angioplasty. Restenosis Stent Study Group. , 1998, The New England journal of medicine.

[20]  D W Hunter,et al.  Collapse of a Palmaz stent in the subclavian vein. , 1993, AJR. American journal of roentgenology.

[21]  James E Tcheng,et al.  Coronary artery stents: Evaluating new designs for contemporary percutaneous intervention , 2002, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[22]  S. Chua,et al.  Finite element simulation of stent and balloon interaction , 2003 .

[23]  C. Dotter,et al.  Transluminally-placed coilspring endarterial tube grafts. Long-term patency in canine popliteal artery. , 1969, Investigative radiology.

[24]  R. Schwartz,et al.  Pathophysiology of restenosis: interaction of thrombosis, hyperplasia, and/or remodeling. , 1998, The American journal of cardiology.

[25]  Lambros K. Michalis,et al.  Development in Intracoronary Stents , 2002 .

[26]  Gerhard A. Holzapfel,et al.  A Layer-Specific Three-Dimensional Model for the Simulation of Balloon Angioplasty using Magnetic Resonance Imaging and Mechanical Testing , 2002, Annals of Biomedical Engineering.

[27]  P. Teirstein,et al.  A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. , 1994, The New England journal of medicine.

[28]  W Rutsch,et al.  A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. , 1994, The New England journal of medicine.

[29]  P J Prendergast,et al.  Analysis of prolapse in cardiovascular stents: a constitutive equation for vascular tissue and finite-element modelling. , 2003, Journal of biomechanical engineering.

[30]  F. Auricchio,et al.  Stainless and shape memory alloy coronary stents: a computational study on the interaction with the vascular wall , 2004, Biomechanics and modeling in mechanobiology.

[31]  S. Chua,et al.  Finite-element simulation of stent expansion , 2002 .

[32]  S. Chua,et al.  Effects of varying slotted tube (stent) geometry on its expansion behaviour using finite element method , 2004 .

[33]  Lorenza Petrini,et al.  A predictive study of the mechanical behaviour of coronary stents by computer modelling. , 2005, Medical engineering & physics.