Abstract
The great success of stents in treating cardiovascular disease is actually undermined by their long-term fatigue failure. The high variability of stent failure incidence suggests that it is due to several correlated aspects, such as loading conditions, material properties, component design, surgical procedure, and patient functional anatomy. Numerical and experimental non-clinical assessments are included in the recommendations and requirements of several regulatory bodies and they are thus exploited in the analysis of stent fatigue performance. Optimization-based simulation methodologies have been developed as well, to improve the fatigue endurance of novel designs. This paper presents a review on the fatigue issue in metallic stents, starting from a description of clinical evidence about stent fracture up to the analysis of computational approaches available from the literature. The reported discussion on both the experimental and numerical framework aims at providing a general insight into stent lifetime prediction as well as at understanding the factors which affect stent fatigue performance for the design of novel components.
Similar content being viewed by others
References
Adlakha, S., M. Sheikh, J. Wu, M. W. Burket, U. Pandya, W. Colyer, E. Eltahawy, and C. J. Cooper. Stent fracture in the coronary and peripheral arteries. J. Interv. Cardiol. 23(4):411–419, 2010.
Aghel, A., E. J. Armstrong. Recent advances in self-expanding stents for use in the superficial femoral and popliteal arteries. Expert Rev. Cardiovasc. Ther. 12(7):833–842, 2014.
AL-Mangour, B., R. Mongrain, and S. Yue. Coronary stents fracture: an engineering approach (review). Mater. Sci. Appl. 4(10):606–621, 2013.
Amiable, S., S. Chapuliot, A. Constantinescu, and A. Fissolo. A comparison of lifetime prediction methods for a thermal fatigue experiment. Int. J. Fatigue 28(7):692–706, 2006.
Auricchio, F., A. Constantinescu, M. Conti, and G. Scalet. A computational approach for the lifetime prediction of cardiovascular balloon-expandable stents. Int. J. Fatigue 75:69–79, 2015.
Auricchio, F., A. Constantinescu, C. Menna, and G. Scalet. A shakedown analysis of high cycle fatigue of shape memory alloys. 2015 (submitted).
Auricchio, F., A. Constantinescu, and G. Scalet. Fatigue of 316L stainless steel notched μm-size components. Int. J. Fatigue, 68:231–247, 2014.
Auricchio, F., L. Petrini. A three-dimensional model describing stress-temperature induced solid phase transformations: solution algorithm and boundary value problems. Int. J. Numer. Methods Eng. 6:807–836, 2004.
Auricchio, F., R. L. Taylor, and J. Lubliner. Shape-memory alloys: macromodelling and numerical simulations of the superelastic behavior. Comput. Methods Appl. Mech. Eng. 146:281–312, 1997.
Azaouzi, M., A. Makradi, and S. Belouettar. Fatigue life prediction of cardiovascular stent using finite element method. Comput. Methods Biomech. Biomed. Eng. 15(S1):93–95, 2012.
Azaouzi, M., A. Makradi, and S. Belouettar. Deployment of a self-expanding stent inside an artery: a finite element analysis. Mater. Des. 41:410–420, 2012.
Azaouzi, M., A. Makradi, J. Petit, S. Belouettar, and O. Polit. On the numerical investigation of cardiovascular balloon-expandable stent using finite element method. Comput. Mater. Sci. 79:326–335, 2013.
Barrera, O., Makradi. A., M. Abbadi, M. Azaouzi, and S. Belouettar. On high-cycle fatigue of 316L stents. Comput. Methods Biomech. Biomed. Eng. 2014, 17(3):239-250
Bertolino, G., A. Constantinescu, M. Ferjani, and P. Treiber. A multiscale approach of fatigue and shakedown for notched structures. Theor. Appl. Fract. Mech. 48(2):140–151, 2007.
Bessias, N., G. Sfyroeras, and K. G. Moulakakis. Renal artery thrombosis caused by stent fracture in a single kidney patient. J. Endovasc. Ther. 12:516–520, 2005.
Chang, C. K., C. P. Huded, B. W. Nolan, and R. J. Powell. Prevalence and clinical significance of stent fracture and deformation following carotid artery stenting. J. Vasc. Surg. 54(3):685–90, 2011.
Charkaluk, E., A. Constantinescu, F. Szmytka, and S. Tabibian. Probability density functions: from porosities to fatigue lifetime. Int. J. Fatigue 63:127–136, 2014.
Cheng, C., G. Choi, R. Herfkens, and C. Taylor. The effect of aging on deformations of the superficial femoral artery resulting from hip and knee flexion: Potential clinical implications. J. Vasc. Interv. Radiol. 21(2):195–202, 2010.
Chen, Q., G. A. Thouas. Metallic implant biomaterials. Mater. Sci. Eng. R Rep. 87:1–57, 2015.
Chung, W. S., C. S. Park, K. B. Seung, P. J. Kim, J. M. Lee, B. K. Koo, Y. S. Jang, J. Y. Yang, J. H. Yoon, D. I. Kim, Y. W. Yoon, J. S. Park, Y. H. Cho, and S. J. Park. The incidence and clinical impact of stent strut fractures developed after drugeluting stent implantation. Int. J. Cardiol. 125(3):325–331, 2008.
Constantinescu, A., K. Van Dang, and M. H. Maitournam. A unified approach for high and low cycle fatigue based on shakedown concepts. Fatigue Fract. Eng. Mater. Struct. 26:561–568, 2003.
Coppi, G., R. Moratto, J. Veronesi, E. Nicolosi, and R. Silingardi. Carotid artery stent fracture identification and clinical relevance. J. Vasc. Surg. 51(6):1397–405, 2010.
Donnelly, E. Geometry effect in the fatigue behaviour of microscale 316L stainless steel specimens. PhD thesis, National University of Ireland, Galway, 2012.
Dordoni, E., A. Meoli, W. Wu, G. Dubini, F. Migliavacca, G. Pennati, and L. Petrini. Fatigue behaviour of nitinol peripheral stents: the role of plaque shape studied with computational structural analyses. Med. Eng. Phys. 36(7):842–849, 2014.
Dordoni, E., L. Petrini, W. Wu, F. Migliavacca, G. Dubini, and G. Pennati. Computational modeling to predict fatigue behavior of NiTi stents: what do we need? J. Funct. Biomater. 6(2):299, 2015.
dos Santos, H. A. F., F. Auricchio, and M. Conti. Fatigue life assessment of cardiovascular balloon-expandable stents: a two-scale plasticity-damage model approach. J. Mech. Behav. Biomed. 15:78–92, 2012.
Foerst, J., T. Ball, and A. V. Kaplan. Postmortem in situ micro-CT evaluation of coronary stent fracture. Catheter Cardiovasc. Interv. 76(4):527–31, 2010.
Gall, K., H. Sehitoglu. The role of texture in tension–compression asymmetry in polycrystalline NiTi. Int. J. Plast. 15:69–92, 1999.
Garcia, L., M. R. Jaff, C. Metzger, G. Sedillo, A. Pershad, F. Zidar, R. Patlola, R. G. Wilkins, A. Espinoza, A. Iskander, et al. Wire-interwoven nitinol stent outcome in the superficial femoral and proximal popliteal arteries twelve-month results of the superb trial. Circ. Cardiovasc. Interv. 8(5):e000937, 2015.
Garcia-Toca, M., H. E. Rodriguez, P. A. Naughton, A. Keeling, S. V. Phade, M. D. Morasch, M. R. Kibbe, and M. K. Eskandari. Are carotid stent fractures clinically significant? Cardiovasc. Intervent Radiol. 35:263–267, 2012.
Garg, S., P. W. Serruys. Coronary stents: current status. J. Am. Coll. Cardiol. 56(10):S1–S42, 2010.
Gastaldi, D., V. Sassi, L. Petrini, M. Vedani, S. Trasatti, and F. Migliavacca. Continuum damage model for bioresorbable magnesium alloy devices—application to coronary stents. J. Mech. Behav. Biomed. Mater. 4:352–365, 2011.
Glenn, R., J. Lee. Accelerated pulsite fatigue testing of Ni-Ti coronary stents. In A. Pelton, D. Hodgson, S. Russell, and T. Duerig, editors, Proceedings of the Second International Conference on Shape Memory and Superelastic Technologies (SMST 1997). SMST Society, Pacific Grove, California, CA, USA, 1997.
Gong, X., A. Pelton, T. Duerig, N. Rebelo, and K. Perry. Finite element analysis and experimental evaluation of superelastic nitinol stent. In Proceedings of the International Conference on Shape Memory and Superelastic Technologies (SMST2003), pp. 453–462, 2003.
Grogan, J. A., S. B. Leen, and P. E. McHugh. Comparing coronary stent material performance on a common geometric platform through simulated bench testing. J. Mech. Behav. Biomed. Mater. 12:129–138, 2012.
Grogan, J. A., S. B. Leen, and P. E. McHugh. Computational micromechanics of bioabsorbable magnesium stents. J. Mech. Behav. Biomed. Mater. 34:93–105, 2014.
Guerchais, R., F. Morel, N. Saintier, and C. Robert. Influence of the microstructure and voids on the high-cycle fatigue strength of 316l stainless steel under multiaxial loading. Fatigue Fract. Eng. Mater. Struct. 38(9):1087–1104, 2015.
Halwani, D. O., P. P. G. Anderson, B. C. Brott, A. S. Anayiotos, and J. E. Lemons. The role of vascular calcificationin inducing fatigue and fracture of coronary stents. J. Biomed. Mater. Res. B Appl. Biomater. 100(1):292–304, 2012.
Harvey, S. M. Nitinol stent fatigue in a peripheral human artery subjected to pulsatile and articulation loading. J. Mater. Eng. Perform. 20:697–705, 2011.
W. Higashiura, Y. Kubota, S. Sakaguchi, N. Kurumatani, M. Nakamae, K. Nishimine, and K. Kichikawa. Prevalence, factors, and clinical impact of self-expanding stent fractures following iliac artery stenting. J. Vasc. Surg., 49(3):645–652, 2009.
Hsiao, H. M., A. Nikanorov, S. Prabhu, and M. K. Razavi. Respiration-induced kidney motion on cobalt-chromium stent fatigue resistance. J. Biomed. Mater. Res. B Appl. Biomater. 91B(2):508–516, 2009.
Hsiao, H. M., S. Prabhu, A. Nikanorov, and M. Razavi. Renal artery stent bending fatigue analysis. J. Med. Devices 1(2):113–118, 2006.
Hsiao, H. M., M. T. Yin. An intriguing design concept to enhance the pulsatile fatigue life of self-expanding stents. Biomed. Microdevices 16(1):133–41, 2014.
International Standard ISO 25539-2. Cardiovascular implants—endovascular devices—Part 2: Vascular stents, 2012.
Jabbado, M., H. Maitournam. A high-cycle fatigue life model for variable amplitude multiaxial loading. Fatigue Fract. Eng. Mater. Struct. 31(1):67–75, 2008.
James, B. A., R. A. Sire. Fatigue-life assessment and validation techniques for metallic vascular implants. Biomaterials 31(2):181–186, 2010.
Kapnisis, K., G. Constantinides, H. Georgiou, D. Cristea, C. Gabor, D. Munteanu, B. Brott, P. Anderson, J. Lemons, and A. Anayiotos. Multi-scale mechanical investigation of stainless steel and cobalt-chromium stents. J. Mech. Behav. Biomed. Mater. 40:240–251, 2014.
Kapnisis, K. K., D. O. Halwani, B. C. Brott, P. G. Anderson, J. E. Lemons, and A. S. Anayiotos. Stent overlapping and geometric curvature influence the structural integrity and surface characteristics of coronary nitinol stents. J. Mech. Behav. Biomed. Mater. 20:227–236, 2013.
Kinkel, S., N. Wollmerstedt, J. A. Kleinhans, C. Hendrich, and C. Heisel. Patient activity after total hip arthroplasty declines with advancing age. Clin. Orthop. Relat. Res. 467(8):2053–2058, 2009.
Lagoudas, D. C., D. J. Hartl, Y. Chemisky, L. Machado, and P. Popov. Constitutive model for the numerical analysis of phase transformation in polycrystalline shape memory alloys. Int. J. Plast. 32–33:155–183, 2012.
Lewitton, S., A. Babaev. Superficial femoral artery stent fracture that led to perforation, hematoma and deep venous thrombosis. J. Invasive Cardiol. 20(9):479–81, 2008.
Li, J., Q. Luo, Z. Xie, Y. Li, and Y. Zeng. Fatigue life analysis and experimental verification of coronary stent. Heart Vessels 25(4):333–337, 2010.
Lin, Y., X. Tang, W. Fu, R. Kovach, J. C. George, and D. Guo. Stent fractures after superficial femoral artery stenting: risk factors and impact on patency. J. Endovasc. Ther. 22(3):319–326, 2015.
Marrey, R. V., R. Burgermeister, R. B. Grishaber, and R. O. Ritchie. Fatigue and life prediction for cobalt-chromium stents: a fracture mechanics analysis. Biomaterials 27:1988–2000, 2006.
McGarry, J. P., B. P. O’Donnell, P. E. McHugh, and J. G. McGarry. Analysis of the mechanical performance of a cardiovascular stent design based on micromechanical modelling. Comput. Mater. Sci. 31:421–438, 2004.
Meoli, A., E. Dordoni, L. Petrini, F. Migliavacca, G. Dubini, and G. Pennati. Computational study of axial fatigue for peripheral nitinol stents. J. Mater. Eng. Perform. 23(7):2606–2613, 2014.
Morlacchi, S., G. Pennati, L. Petrini, G. Dubini, and F. Migliavacca. Influence of plaque calcifications on coronary stent fracture: a numerical fatigue life analysis including cardiac wall movement. J. Biomech. 47(4):899–907, 2014.
Z. Moumni, W. Zaki, and H. Maitournam. Cyclic behaviour and energy approach of the fatigue of Shape Memory Alloys. J. Mech. Mater. Struct., 4(2):395–411, 2009.
Müller-Hülsbeck, S., P. J. Schäfer, N. Charalambous, H. Yagi, M. Heller, and T. Jahnke. Comparison of second-generation stents for application in the superficial femoral artery: an in vitro evaluation focusing on stent design. J. Endovasc. Ther. 17(6):767–776, 2010.
Neil, N. Stent fracture in the superficial femoral and proximal popliteal arteries: literature summary and economic impacts. Perspect. Vasc. Surg. Endovasc. Ther. 25(1–2):20–27, 2013.
Nichols, M., N. Townsend, P. Scarborough, and M. Rayner. Cardiovascular disease in europe 2014: epidemiological update. Eur. Heart J. 35(42):2950–9, 2014.
Nikanorov, A., H. B. Smouse, K. Osman, M. Bialas, S. Shrivastava, and L. B. Schwartz. Fracture of self-expanding nitinol stents stressed in vitro under simulated intravascular conditions. J. Vasc. Surg. 48(2):435–440, 2008.
Paulsen, F., J. Waschke. Sobotta Atlas of Human Anatomy, 15th Edition 2013 ©Elsevier GmbH, Urban & Fischer, Munich.
Peigney, M. Shakedown theorems and asymptotic behaviour of solids in non-smooth mechanics. Eur. J. Mech. A 29(5):784–793, 2010.
Pelton, A. R., V. Schroeder, M. R. Mitchell, X.-Y. Gong, M. Barney, and S. W. Robertson. Fatigue and durability of Nitinol stents. J. Mech. Behav. Biomed. 1:153–164, 2008.
Petrini, L., W. Wu, E. Dordoni, A. Meoli, F. Migliavacca, and G. Pennati. Fatigue behavior characterization of nitinol for peripheral stents. Funct. Mater. Lett. 05(01):1250012, 2012.
Petrini, L., E. Dordoni, W. Wu, C. Guala, C. Silvestro, F. Migliavacca, and G. Pennati. Fatigue resistance of Nitinol peripheral stents. In Proceedings of 6th ECCOMAS Conference on Smart Structures and Materials (SMART 2013), 2013.
Rebelo, N., A. Zipse, M. Schlun, and G. Dreher. A material model for the cyclic behavior of nitinol. J. Mater. Eng. Perform. 20:605–612, 2011.
Robertson, S. W., C. P. Cheng, and M. K. Razavi. Biomechanical response of stented carotid arteries to swallowing and neck motion. J. Endovasc Ther. 15(6):663–71, 2008.
Robertson, S. W., D. B. Jessup, I. J. Boero, and C. P. Cheng. Right renal artery in vivo stent fracture. J. Vasc. Interv. Radiol. 19(3):439–442, 2008.
Robertson, S. W., A. R. Pelton, and R. O. Ritchie. Mechanical fatigue and fracture of Nitinol. Int. Mater. Rev. 57(1):1–37, 2012.
Robertson, S. W., R. O. Ritchie. A fracture-mechanics-based approach to fracture control in biomedical devices manufactured from superelastic Nitinol tube. J. Biomed. Mater. Res. B 84B(1):26–33, 2008.
Runciman, A., D. Xu, A. R. Pelton, and R. O. Ritchie. An equivalent strain/Coffin-Manson approach to multiaxial fatigue and life prediction in superelastic Nitinol medical devices. Biomaterials 32:4987–4993, 2011.
Scheinert, D., S. Scheinert, J. Sax, C. Piorkowski, S. Braunlich, and M. Ulrich. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J. Am. Coll. Cardiol. 45:312–315, 2005.
Shechter, G., J. R. Resar, and E. R. McVeigh. Displacement and velocity of the coronary arteries: cardiac and respiratory motion. IEEE Trans. Med. Imaging 25(3):369–375, 2006.
Sources: Cdc.gov—heart disease facts american heart association—2015 heart disease and stroke update, compiled by aha, cdc, nih and other governmental sources, 2014.
Souza, A. C., E. N. Mamiya, and N. Zouain. Three-dimensional model for solids undergoing stress-induced phase transformations. Eur. J. Mech. A-Solid 17:789–806, 1998.
Sweeney, C. A., P. E. McHugh, J. P. McGarry, and S. B. Leen. Micromechanical methodology for fatigue in cardiovascular stents. Int. J. Fatigue 44:202–216, 2012.
Sweeney, C. A., B. O’Brien, F. P. E. Dunne, P. E. McHugh, and S. B. Leen. Strain-gradient modelling of grain size effects on fatigue of cocr alloy. Acta Mater. 78:341–353, 2014.
Sweeney, C. A., B. O’Brien, F. P. E. Dunne, P. E. McHugh, and S. B. Leen. Micro-scale testing and micromechanical modelling for high cycle fatigue of cocr stent material. J. Mech. Behav. Biomed. Mater. 46:244–260, 2015.
Sweeney, C. A., B. O’Brien, P. E. McHugh, and S. B. Leen. Experimental characterisation for micromechanical modelling of CoCr stent fatigue. Biomaterials 35:36–48, 2014.
Tabanli, R. M., N. K. Simha, and B. T. Berg. Mean strain effects on the fatigue properties of superelastic NiTi. Metall. Mater. Trans. A 32:1866–1869, 2001.
US Food and Drug Administration. Non-clinical engineering tests and recommended labeling for intravascular stents and associated delivery systems: guidance for industry and FDA staff. US Department of Health and Human Services; Food and Drug Administration, Centre for Devices and Radiological, Health, April 18th 2010.
Van Dang, K. High-cycle metal fatigue in the context of mechanical design. In: CISM Courses and Lectures no 392 edited by K. Dang Van and I. V. Papadopoulos. Springer, 57–88, 1999.
Weafer, F. M., M. S. Bruzzi. Influence of microstructure on the performance of nitinol: a computational analysis. J. Mater. Eng. Perform. 23(7):2539–2544, 2014.
Weiss, S., H. Szymczak, and A. Meissner. Fatigue and endurance of coronary stents. Materialwissenschaft und Werkstofftechnik 40(1–2):61–64, 2009.
Wiersma, S., F. Dolan, and D. Taylor. Fatigue and fracture in materials used for micro-scale biomedical components. Biomed. Mater. Eng. 16(2):137–146, 2006.
Wiersma, S., D. Taylor. Fatigue of materials used in microscopic components. Fatigue Fract. Eng. Mater. Struct. 28(12):1153–1160, 2005.
World Health Organization (WHO). World Health Statistics 2014. Technical Report, 2014.
Zaki, W., Z. Moumni. A 3D model of the cyclic thermomechanical behavior of shape memory alloys. J. Mech. Phys. Solids 55(11):2427–2454, 2007.
Acknowledgments
This work is partially funded by: the Cariplo Foundation through the Project No. 2009.2822; ERC Starting Grant through the Project ISOBIO: Isogeometric Methods for Biomechanics (No. 259229); Ministero dell’Istruzione, dell’Università e della Ricerca through the Project No. 2010BFXRHS; the French National Research Agency (Project Fast3D-ANR-11-BS09-012-01).
Author information
Authors and Affiliations
Corresponding author
Additional information
Associate Editor Peter E. McHugh oversaw the review of this article.
Electronic supplementary material
Below is the link to the electronic supplementary material.
Rights and permissions
About this article
Cite this article
Auricchio, F., Constantinescu, A., Conti, M. et al. Fatigue of Metallic Stents: From Clinical Evidence to Computational Analysis. Ann Biomed Eng 44, 287–301 (2016). https://doi.org/10.1007/s10439-015-1447-8
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10439-015-1447-8