Computational Modelling of Multi-folded Balloon Delivery Systems for Coronary Artery Stenting: Insights into Patient-Specific Stent Malapposition
- 477 Downloads
Despite the clinical effectiveness of coronary artery stenting, percutaneous coronary intervention or “stenting” is not free of complications. Stent malapposition (SM) is a common feature of “stenting” particularly in challenging anatomy, such as that characterized by long, tortuous and bifurcated segments. SM is an important risk factor for stent thrombosis and recently it has been associated with longitudinal stent deformation. SM is the result of many factors including reference diameter, vessel tapering, the deployment pressure and the eccentric anatomy of the vessel. For the purpose of the present paper, virtual multi-folded balloon models have been developed for simulated deployment in both constant and varying diameter vessels under uniform pressure. The virtual balloons have been compared to available compliance charts to ensure realistic inflation response at nominal pressures. Thereafter, patient-specific simulations of stenting have been conducted aiming to reduce SM. Different scalar indicators, which allow a more global quantitative judgement of the mechanical performance of each delivery system, have been implemented. The results indicate that at constant pressure, the proposed balloon models can increase the minimum stent lumen area and thereby significantly decrease SM.
KeywordsCoronary stents Balloon delivery systems Patient-specific model Stent malapposition Finite element analysis
Percutaneous coronary intervention
Drug eluting stent
Finite element analysis
Right coronary artery
Left anterior descenting
Total average curvature
Total average torsion
Volume average stress
Area average stent malapposition
Minimum lumen area
This work was funded by Medtronic Inc. (Minnesota, USA), the Faculty of Engineering and the Environment and the Faculty of Medicine of Southampton University. The authors would like to acknowledge the unrestricted support offered which ultimately allowed the project to be completed.
- 1.AbbotVascular. The Xience Everolimus Eluting Coronary Stent System Instructions for Use, 2008. URL http://www.accessdata.fda.gov/cdrh_docs/pdf7/P070015c.pdf. p. 59. Accessed 11 July 2014.
- 3.Chua, S. D., B. M. Donald, and M. Hashmi. Finite element simulation of stent and balloon interaction. J. Mater. Process. Technol., 143–144(0):591–597, 2003. Proceedings of the International Conference on the Advanced Materials Processing Technology, 2001.Google Scholar
- 5.De Beule, M. Finite element stent design. PhD Thesis, Ghent University, 2008. URL http://lib.ugent.be/fulltxt/RUG01/001/257/673/RUG01-001257673_2010_0001_AC.pdf.
- 7.Doulaverakis, C., I. Tsampoulatidis, A. P. Antoniadis, Y. S. Chatzizisis, A. Giannopoulos, I. Kompatsiaris, and G. D. Giannoglou. Ivusangio tool: a publicly available software for fast and accurate 3d reconstruction of coronary arteries. Comput. Biol. Med. 43(11):1793–1803, 2013.PubMedCrossRefGoogle Scholar
- 11.Gastaldi, D., S. Morlacchi, R. Nichetti, C. Capelli, G. Dubini, L. Petrini, and F. Migliavacca. Modelling of the provisional side-branch stenting approach for the treatment of atherosclerotic coronary bifurcations: effects of stent positioning. Biomech. Model. Mechanobiol. 9(5):551–561, 2010.PubMedCrossRefGoogle Scholar
- 18.Holzapfel, G. A. Non Linear Solid Mechanics: A Continuum Approach for Engineering. Chichester: Wiley, 2000. pp. 239–249.Google Scholar
- 20.Holzapfel, G. A., G. Sommer, C. T. Gasser, and P. Regitnig. Determination of layer-specific mechanical properties of human coronary arteries with nonatherosclerotic intimal thickening and related constitutive modeling. Am. J. Physiol. Heart Circ. Physiol. 289(5):H2048–H2058, 2005b.PubMedCrossRefGoogle Scholar
- 22.Laroche, D., S. Delorme, T. Anderson, and R. DiRaddo. Computer prediction of friction in balloon angioplasty and stent implantation. In: Biomedical Simulation. Lecture Notes in Computer Science, vol. 4072. Berlin: Springer, 2006, pp. 1–8.Google Scholar
- 25.Lim, D., S.-K. Cho, W.-P. Park, A. Kristensson, J.-Y. Ko, S. Al-Hassani, and H.-S. Kim. Suggestion of potential stent design parameters to reduce restenosis risk driven by foreshortening or dogboning due to non-uniform balloon-stent expansion. Ann. Biomed. Eng. 36(7):1118–1129, 2008.PubMedCrossRefGoogle Scholar
- 28.Millman, R. S., and G. D. Parker. Elements of Differential Geometry. Berkeley: Prentice Hall Inc, 1977. pp. 46.Google Scholar
- 30.Morlacchi, S., C. Chiastra, D. Gastaldi, G. Pennati, G. Dubini, and F. Migliavacca. Sequential structural and fluid dynamic nurical simulations of a stented bifurcated coronary artery. J. Biomech. Eng. 133(2):121010(1–11), 2011.Google Scholar
- 31.Morlacchi, S., C. Chiastra, E. Cutri, P. Zunino, F. Burzotta, L. Formaggia, G. Dubini, and F. Migliavacca. Stent deformation, physical stress, and drug elution obtained with provisional stenting, conventional culotte and tryton-based culotte to treat bifurcations: a virtual simulation study. EuroIntervention 9:1441–1453, 2014.PubMedCrossRefGoogle Scholar
- 32.Mortier, P., S. Carlier, R. Van Impe, B. Verhegghe, and P. Verdonck. Numerical study of the uniformity of balloon-expandable stent deployment. J. Biomech. Eng. 130(2):021018(1–7), 2008.Google Scholar
- 33.Mortier, P., G. Holzapfel, M. De Beule, D. Loo, Y. Taeymans, P. Segers, P. Verdonck, and B. Verhegghe. A novel simulation strategy for stent insertion and deployment in curved coronary bifurcations: comparison of three drug-eluting stents. Ann. Biomed. Eng. 38(1):88–99, 2010.PubMedCrossRefGoogle Scholar
- 35.Mortier, P., Y. Hikichi, N. Foin, G. De Santis, P. Segers, B. Verhegghe, and M. De Beule. Provisional stenting of coronary bifurcations: insights into final kissing balloon post-dilation and stent design by computational modeling. JACC Cardiovasc. Interv. 7(3):325–333, 2014.PubMedCrossRefGoogle Scholar
- 40.Pleva, L., T. Jonszta, P. Kukla, J. Zapletalova, P. Berger, J. Mrozek, M. Porzer, and B. Obzut. Dedicated tryton side branch stents used in the treatment of coronary bifurcation lesions. Cor et Vasa, 2014. In press.Google Scholar
- 42.Saab, M. A. Applications of high-pressure balloons in the medical device industry. http://www.mddionline.com, September 2000. Assessed May 2014.
- 43.Vasa-Nicotera, M., and T. Gershlick. Stent thrombosis. In: Oxford Textbook of Interventional Cardiology. Oxford: Oxford University Press, chapter 29, pp. 504–523, 2010.Google Scholar
- 45.Wang, D. L., B.-S. Wung, Y.-J. Shyy, C.-F. Lin, Y.-J. Chao, S. Usami, and S. Chien. Mechanical strain induces monocyte chemotactic protein-1 gene expression in endothelial cells: effects of mechanical strain on monocyte adhesion to endothelial cells. Circ. Res. 77(2):294–302, 1995.PubMedCrossRefGoogle Scholar
- 46.Williams, D. P., M. Mamas, K. Morgan, M. El-Omar, B. Clarke, A. Brainbridge, Fath-Ordoubadi, and D. D. Fraser (2012) Longitudinal stent deformation: a retrospective analysis of frequency and mechanisms. EuroIntervention 8(2):267–74.Google Scholar