Abstract
A bio-corrodible nitrided iron stent was developed using a vacuum plasma nitriding technique. In the nitrided iron stents, the tensile strength, radial strength, stiffness and in vitro electrochemical corrosion rate were significantly increased compared with those of the control pure iron stent. To evaluate its performance in vivo, the deployment of the nitrided iron stents in juvenile pig iliac arteries was performed. At 3 or 6 months postoperatively, the stented vessels remained patent well; however, slight luminal loss resulting from intimal hyperplasia and relative stenosis of the stented vessel segment with piglets growth were observed by 12 months; no thrombosis or local tissue necrosis was found. At 1 month postoperatively, a nearly intact layer of endothelial cells formed on the stented vessel wall. Additionally, a decreased inflammation scoring, considerably corroded struts and corrosion products accumulation were seen. These findings indicate the potential of this nitrided iron stent as an attractive biodegradable stent.
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Ozawa A, Predescu D, Chaturvedi R, Lee KJ, Benson LN. Cutting balloon angioplasty for aortic coarctation. J Invasive Cardiol. 2009;21(6):295–9.
Mohan UR, Danon S, Levi D, Connolly D, Moore JW. Stent implantation for coarctation of the aorta in children <30 kg. JACC Cardiovasc Interv. 2009;2(9):877–83.
Baerlocher L, Kretschmar O, Harpes P, Arbenz U, Berger F, Knirsch W. Stent implantation and balloon angioplasty for treatment of branch pulmonary artery stenosis in children. Clin Res Cardiol. 2008;97(5):310–7.
Tomita H, Nakanishi T, Hamaoka K, Kobayashi T, Ono Y. Stenting in congenital heart disease: medium- and long-term outcomes from the JPIC stent survey. Circ J. 2010;74(8):1676–83.
Bruckheimer E, Dagan T, Amir G, Birk E. Covered cheatham-platinum stents for serial dilation of severe native aortic coarctation. Catheter Cardiovasc Interv. 2009;74(1):117–23.
Zanjani KS, Sabi T, Moysich A, Ovroutski S, Peters B, Miera O, Kühne T, Nagdyman N, Berger F, Ewert P. Feasibility and efficacy of stent redilatation aortic coarctation. Catheter Cardiovasc Interv. 2008;72(4):552–6.
Duke C, Rosenthal E, Qureshi SA. The efficacy and safety of stent redilatation in congenital heart disease. Heart. 2003;89(8):905–12.
Ewert P, Riesenkampff E, Neuss M, Kretschmar O, Nagdyman N, Lange PE. Novel growth stent for the permanent treatment of vessel stenosis in growing children: an experimental study. Catheter Cardiovasc Interv. 2004;62(4):506–10.
Mullins CE. Inappropriate stents: primary cause of failure of stent redilatation in coarctation of the aorta. Catheter Cardiovasc Interv. 2008;72(4):557–8.
Moravej M, Mantovani D. Biodegradable metals for cardiovascular stent application: interests and new opportunities. Int J Mol Sci. 2011;12(7):4250–70.
Waksman R, Pakala R. Biodegradable and bioabsorbable stents. Curr Pharm Des. 2010;16(36):4041–51.
O’Brien B, Carroll W. The evolution of cardiovascular stent materials and surfaces in response to clinical drivers: a review. Acta Biomater. 2009;5(4):945–58.
Ghimire G, Spiro J, Kharbanda R, Roughton M, Barlis P, Mason M, Ilsley C, Di Mario C, Erbel R, Waksman R, Dalby M. Initial evidence for the return of coronary vasoreactivity following the absorption of bio-absorbable magnesium alloy coronary stents. EuroIntervention. 2009;4(4):481–4.
Serruys PW, Ormiston JA, Onuma Y, Regar E, Gonzalo N, Garcia–Garcia HM, Nieman K, Bruining N, Dorange C, Miquel-Hébert K, Veldhof S, Webster M, Thuesen L, Dudek D. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet. 2009;373(9667):897–910.
Waksman R, Erbel R, Di Mario C, Bartunek J, de Bruyne B, Eberli FR, Erne P, Haude M, Horrigan M, Ilsley C, Böse D, Bonnier H, Koolen J, Lüscher TF, Weissman NJ. Early- and long-term intravascular ultrasound and angiographic findings after bioabsorbable magnesium stent implantation in human coronary arteries. JACC Cardiovasc Interv. 2009;2(4):312–20.
Hermawan H, Purnama A, Dube D, Couet J, Mantovani D. Fe-Mn alloys for metallic biodegradable stents: degradation and cell viability studies. Acta Biomater. 2010;6(5):1852–60.
Zartner P, Cesnjevar R, Singer H, Weyand M. First successful implantation of a biodegradable metal stent into the left pulmonary artery of a preterm baby. Catheter Cardiovasc Interv. 2005;66(4):590–4.
Rao PS. Stents in the management of aortic coarctation in young children. JACC Cardiovasc Interv. 2009;2(9):884–6.
Anderews NC. Disorders of iron metabolism. N Engl J Med. 1999;341(26):1986–95.
Waksman R, Pakala R, Baffour R, Seabron R, Hellinga D, Tio FO. Short-term effects of biocorrodible iron stents in porcine coronary arteries. J Interv Cardiol. 2008;21(1):15–20.
Peuster M, Hesse C, Schloo T, Fink C, Beerbaum P, von Schnakenburg C. Long-term biocompatibility of a corrodible peripheral iron stent in the porcine descending aorta. Biomaterials. 2006;27(28):4955–62.
Peuster M, Beerbaum P, Bach FW, Hauser H. Are resorbable implants about to become a reality? Cardiol Young. 2006;16(2):107–16.
Schinhammer M, Hänzi AC, Löffler JF, Uggowitzer PJ. Design strategy for biodegradable Fe-based alloys for medical applications. Acta Biomater. 2010;6(5):1705–13.
Kornowski R, Hong MK, Tio FO, Bramwell O, Wu H, Leon MB. In-stent restenosis: contributions of inflammatory responses and arterial injury to neointimal hyperplasia. J Am Coll Cardiol. 1998;31(1):224–30.
Liu B, Zheng YF. Effects of alloying elements (Mn, Co., Al, W, Sn, B, C and S) on biodegradability and in vitro biocompatibility of pure iron. Acta Biomater. 2011;7(3):1407–20.
Bayer U. Implant and method for manufacturing same. US Patent No. 20110112628A1, 2011.
Moravej M, Prima F, Fiset M, Mantovani D. Electroformed iron as new biomaterial for degradable stents: development process and structure-properties relationship. Acta Biomater. 2010;6(5):1726–35.
Moravej M, Purnama A, Fiset M, Couet J, Mantovani D. Electroformed pure iron as a new biomaterial for degradable stents: in vitro degradation and preliminary cell viability studies. Acta Biomater. 2010;6(5):1843–51.
Zhu SF, Huang N, Shu H, Wu YP, Xu L. Corrosion resistance and blood compatibility of lanthanum ion implanted pure iron by MEVVA. Appl Surf Sci. 2009;256(1):99–104.
Zhu SF, Huang N, Xu L, Zhang Y, Liu HQ, Lei YF, Sun H, Yao Y. Biocompatibility of Fe–O films synthesized by plasma immersion ion implantation and deposition. Surf Coat Tech. 2009;203(10):1523–9.
Chen CZ, Li Q, Leng YX, Chen JY, Zhang PC, Bai B, Huang N. Improved hardness and corrosion resistance of iron by Ti/TiN multilayer coating and plasma nitriding duplex treatment. Surf Coat Tech. 2010;204(18):3082–6.
Chen CZ, Shi XH, Zhang PC, Bai B, Leng YX, Huang N. The microstructure and properties of commercial pure iron modified by plasma nitriding. Solid State Ionics. 2008;179(21):971–4.
Schmidt W, Andresen R, Behrens P, Schmitz KP. Characteristic mechanical properties of balloon-expandable peripheral stent systems. Rofo. 2002;174(11):1430–7.
Mueller PP, May T, Perz A, Hauser H, Peuster M. Control of smooth muscle cell proliferation by ferrous iron. Biomaterials. 2006;27(10):2193–200.
Nakazawa G, Finn AV, Vorpahl M, Ladich ER, Kolodgie FD, Virmani R. Coronary responses and differential mechanisms of late stent thrombosis attributed to first-generation sirolimus- and paclitaxel-eluting stents. J Am Coll Cardiol. 2011;57(4):390–8.
Niccoli G, Montone RA, Ferrante G, Crea F. The evolving role of inflammatory biomarkers in risk assessment after stent implantation. J Am Coll Cardiol. 2010;56(22):1783–93.
Ielasi A, Al-Lamee R, Colombo A. Stent thrombosis and duration of dual antiplatelet therapy. Curr Pharm Des. 2010;16(36):4052–63.
El-Omar MM, Dangas G, Iakovou I, Mehran R. Update on in-stent restenosis. Curr Interv Cardiol Rep. 2001;3(4):296–305.
Schömig A, Kastrati A, Mudra H, Blasini R, Schühlen H, Klauss V, Richardt G, Neumann FJ. Four-year experience with Palmaz-Schatz stenting in coronary angioplasty complicated by dissection with threatened or present vessel closure. Circulation. 1994;90(6):2716–24.
Serruys PW, Kutryk MJ, Ong AT. Coronary-artery stents. N Engl J Med. 2006;354(5):483–95.
Hermawan H, Dubé D, Mantovani D. Developments in metallic biodegradable stents. Acta Biomater. 2010;6(5):1693–7.
Pendyala LK, Yin X, Li J, Chen JP, Chronos N, Hou D. The first generation drug-eluting stents and coronary endothelial dysfunction. JACC Cardiovasc Interv. 2009;2(12):1169–77.
Yao ZH, Matsubara T, Inada T, Suzuki Y, Suzuki T. Neointimal coverage of sirolimus-eluting stents 6 months and 12 months after implantation: evaluation by optical coherence tomography. Chin Med J (Engl). 2008;121(6):503–7.
Uurto I, Mikkonen J, Parkkinen J, Keski-Nisula L, Nevalainen T, Kellomaki M, Törmälä P, Salenius JP. Drug-eluting biodegradable poly-d/l-lactic acid vascular stents: an experimental pilot study. J Endovasc Ther. 2005;12(3):371–9.
Pierson D, Edick J, Tauscher A, Pokorney E, Bowen P, Gelbaugh J, Stinson J, Getty H. A simplified in vivo approach for evaluating the bioabsorbable behavior of candidate stent materials. J Biomed Mater Res B Appl Biomater. 2012;100(1):58–67.
[46] Bornapour M, Muja N, Shum-Tim D, Cerruti M, Pekguleryuz M. Biocompatibility and biodegradability of Mg-Sr alloys: the formation of Sr-substituted hydroxyapatite. Acta Biomater 2012.
Acknowledgments
This program was financially supported by the National 863 Program (Grant No. 2011AA030103), the Provincial Science and Technology Plan Program of Guangdong (Grant No. 2008A030102006), the Municipal Key Technologies R&D Program of Shenzhen (Grant No. ZD200904300071A), the Municipal Special Funds for Industry-University-Research Institute Collaboration (Grant No. SY200806270124A), the Municipal Science and Technology Plan of Shenzhen General Program (Grant No. JSA201006010138A), and the Municipal Education committee of Shanghai-Project in Budget (Grant No. 2011JW54). The authors thank Ke Dai, Ning Ma, Ruidong Zhang, Zuming Jiang, Xiaoqing Yu, and Yiwei Chen from the Heart Center, Shanghai Children’s Medical Center, Shanghai JiaoTong University School of Medicine, China, for their assistance with the animal experiments.
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Feng, Q., Zhang, D., Xin, C. et al. Characterization and in vivo evaluation of a bio-corrodible nitrided iron stent. J Mater Sci: Mater Med 24, 713–724 (2013). https://doi.org/10.1007/s10856-012-4823-z
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DOI: https://doi.org/10.1007/s10856-012-4823-z