Long-term safety and absorption assessment of a novel bioresorbable nitrided iron scaffold in porcine coronary artery

Zheng, Jianfeng; Xi, Ziwei; Li, Yang; Li, Jianan; Qiu, Hong; Hu, Xiaoying; Luo, Tong; Wu, Chao; Wang, Xin; Song, Li; Li, Li; Qi, Haiping; Gui, Zhilun; Q, Li; Zhang, Wan-Qian; Shi, Xiaoli; Wang, Shuhan; Zhang, Deyuan; Xu, Bo; Gao, Runlin

doi:10.1016/j.bioactmat.2022.01.005

Cited by 25 publications

(21 citation statements)

References 29 publications

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“…However, semi-quantitative Prussian blue staining for iron demonstrated considerable iron accumulation in the spleen of the experimental groups at 6 and 12 months ( Figure 9 ). All the aforementioned findings corroborate those of previous studies: clearance of iron-scaffold corrosion products might occur via the lymphatic system, and these products may enter the spleen via the circulatory system [ 34 , 35 , 36 ].…”

Section: Discussionsupporting

confidence: 90%

“…According to the results of our histopathological analysis, all the retrieved visceral organs were normal, without detectable tissue toxicity. In the in vitro immersion test, iron_IS and TCP_IS demonstrated an average mass loss of 6.28 ± 4.95 and 6.06 ± 2.71 mg/month, respectively ( Figure 1 E and Table 1 )—considerably lower than the physiological daily iron intake from diet [ 12 , 34 ]. This result, along with the result noted for blood iron concentrations, indicated that only few soluble iron ions were absorbed into the serum ( Figure 6 ).…”

Section: Discussionmentioning

confidence: 99%

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Biocompatibility and Biological Performance of Additive-Manufactured Bioabsorbable Iron-Based Porous Interference Screws in a Rabbit Model: A 1-Year Observational Study

Tai

Huang

Liaw

et al. 2022

IJMS

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This study evaluated the mid-term (12-month) biomechanical, biocompatibility, and biological performance of additive-manufactured bioabsorbable iron-based interference screws (ISs). Two bioabsorbable iron IS types—manufactured using pure iron powder (iron_IS) and using pure iron powder with 0.2 wt% tricalcium phosphate (TCP_IS)—were compared with conventional metallic IS (control) using in vitro biocompatibility and degradation analyses and an in vivo animal study. The in vitro ultimate failure strength was significantly higher for iron_IS and TCP_IS than for control ISs at 3 months post-operatively; however, the difference between groups were nonsignificant thereafter. Moreover, at 3 months after implantation, iron_IS and TCP_IS increased bone volume fraction, bone surface area fraction, and percent intersection surface; the changes thereafter were nonsignificant. Iron_IS and TCP_IS demonstrated degradation over time with increased implant surface, decreased implant volume, and structure thickness; nevertheless, the analyses of visceral organs and biochemistry demonstrated normal results, except for time-dependent iron deposition in the spleen. Therefore, compared with conventional ISs, bioabsorbable iron-based ISs exhibit higher initial mechanical strength. Although iron-based ISs demonstrate high biocompatibility 12 months after implantation, their corrosive iron products may accumulate in the spleen. Because they demonstrate mechanical superiority along with considerable absorption capability after implantation, iron-based ISs may have potential applications in implantable medical-device development in the future.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 99%

Biocompatibility and Biological Performance of Additive-Manufactured Bioabsorbable Iron-Based Porous Interference Screws in a Rabbit Model: A 1-Year Observational Study

Tai

Huang

Liaw

et al. 2022

IJMS

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“… Fe-based alloys Fe-based alloys Fe can generate hydroxyl radicals (HO) during the corrosion process, specifically when it is in direct contact with the aortic tissue as coronary stents [ 145 ]. Iron clearance take place in lymphatic circulation [ 146 ] where adaptive immune cells reside. Giant cells are the most dominant cells that contributed to the Fe implant inflammatory responses and the highest inflammation was reported in Cr-coated Fe implants [ 147 ].…”

Section: Immune Response Differences Between Degradable and Non-degra...mentioning

confidence: 99%

“…These findings not only show the deleterious effect of Fe on endothelial cells and smooth muscle cells but also developed new concerns about the biocompatibility of degradable Fe alloys since HO is a potent ROS that play a key role in activation of pro-inflammatory cytokines [ 41 ]. Recently Zheng et al studied the long-term behavior of the absorbable Nitrated-Fe (Fe- 0.05%N) implants in porcine coronary for 7 years where Co–Cr alloy was used as a control [ 146 ]. The first important finding was that nearly all the samples were resorbed within 7 years contrary to the Mg alloys that left calcium phosphate deposits in the tissues [ 171 ].…”

Section: Immune Response Differences Between Degradable and Non-degra...mentioning

confidence: 99%

Immune response differences in degradable and non-degradable alloy implants

Khodaei

Schmitzer

Suresh

et al. 2023

Bioactive Materials

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“…The Absorb™ BVS consisted of a 7-μm-thick coating layer of drug (everolimus, EVL) on a 150-μm-thick PLLA scaffold core. Unfortunately, randomized clinical trials and long-term follow-up of observational registration studies identified clinical events, including local inflammation and thrombosis that were caused by scaffold degradation, leading to withdrawal from the clinical trials and the market [ 8 , 9 ]. We hypothesized that one of the pivotal reasons for this failure was an acidic byproduct of PLLA, lactic acid, which induced an acidic microenvironment at the implanting site.…”

Section: Introductionmentioning

confidence: 99%

Reduced restenosis and enhanced re-endothelialization of functional biodegradable vascular scaffolds by everolimus and magnesium hydroxide

et al. 2022

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Background Coronary artery disease is a cardiovascular disease with a high mortality and mortality rate in modern society. Vascular stent insertion to restore blood flow is essential to treat this disease. A fully biodegradable vascular scaffold (BVS) is a vascular poly (L-lactic acid) (PLLA) stent that is receiving growing interest as this is biodegradable in the body and does not require secondary removal surgery. However, acidic byproducts composed of PLLA produced during the biodegradation of the BVS can induce an inflammatory response. Magnesium hydroxide, a basic inorganic particle, neutralizes the acidic byproducts of PLLA. Methods In this study, we investigated using a BVS coated with everolimus and surface-modified magnesium hydroxide that suppresses smooth muscle cell proliferation and protects endothelial cells, respectively. The various characteristics of the functional stent were evaluated using in vitro and in vivo analyses. Results The BVS was successfully prepared with evenly coated everolimus and surface-modified magnesium hydroxide. A neutral pH value was maintained by magnesium hydroxide during degradation, and everolimus was released for one month. The coated BVS effectively inhibited protein adsorption and platelet adhesion, demonstrating excellent blood compatibility. In vitro analysis showed that BVS protects endothelial cells with magnesium hydroxide and selectively inhibits smooth muscle cell proliferation via everolimus treatment. The functional BVS was inserted into porcine coronary arteries for 28 days, and the results demonstrated that the restenosis and inflammation greatly decreased and re-endothelialization was enhanced as compared to others. Conclusions This study provides new insights into the design of drug-incorporated BVS stent for coronary artery disease. Graphical Abstract

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Long-term safety and absorption assessment of a novel bioresorbable nitrided iron scaffold in porcine coronary artery

Cited by 25 publications

References 29 publications

Biocompatibility and Biological Performance of Additive-Manufactured Bioabsorbable Iron-Based Porous Interference Screws in a Rabbit Model: A 1-Year Observational Study

Biocompatibility and Biological Performance of Additive-Manufactured Bioabsorbable Iron-Based Porous Interference Screws in a Rabbit Model: A 1-Year Observational Study

Immune response differences in degradable and non-degradable alloy implants

Reduced restenosis and enhanced re-endothelialization of functional biodegradable vascular scaffolds by everolimus and magnesium hydroxide

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