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. 2001 Nov;86(5):563–569. doi: 10.1136/heart.86.5.563

A novel approach to temporary stenting: degradable cardiovascular stents produced from corrodible metal—results 6-18 months after implantation into New Zealand white rabbits

M Peuster 1, P Wohlsein 1, M Brugmann 1, M Ehlerding 1, K Seidler 1, C Fink 1, H Brauer 1, A Fischer 1, G Hausdorf 1
PMCID: PMC1729971  PMID: 11602554

Abstract

OBJECTIVE—To determine whether corrodible materials may be safely used as biodegradable cardiovascular implants.
DESIGN—Corrodible iron stents (> 99.8% iron) were produced from pure iron and laser cut with a stent design similar to a commercially available permanent stent (PUVA-AS16). A total of 16 NOR-I stents were implanted into the native descending aorta of 16 New Zealand white rabbits (mean luminal diameter at the implantation site 3.4 mm, balloon diameter to vessel diameter ratio 1.13).
RESULTS—No thromboembolic complications and no adverse events occurred during the follow up of 6-18 months. All stents were patent at repeat angiography after 6 (n = 9), 12 (n = 5), and 18 months (n = 2) with no significant neointimal proliferation, no pronounced inflammatory response, and no systemic toxicity.
CONCLUSIONS—This initial in vivo experience suggests that degradable iron stents can be safely implanted without significant obstruction of the stented vessel caused by inflammation, neointimal proliferation, or thrombotic events.


Keywords: congenital heart disease; corrosion; stents; biodegradation

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Figure 1  .

Figure 1  

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Accumulation of iron in the electrolyte in relation to time.

Figure 2  .

Figure 2  

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Lateral angiography of the stented descending aorta (A) six months, (B) 12 months, and (C) 18 months after implantation. There is complete patency of the vessel. (Arrows indicate stent implantation site.)

Figure 3  .

Figure 3  

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Rabbit aorta with degradable iron stent 12 months after implantation with numerous pinpoint, slightly raised plaques consisting of corroded stent material (arrows).

Figure 4  .

Figure 4  

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Rabbit aorta with degradable iron stent (S) six months after implantation; most of the stent struts are artificially lost and remnants of the iron are visible as plaques of brownish pigment. The stent strut is completely covered by neointima (N). Adjacent to the stent strut there is accumulation of iron laden macrophages within the media and adventitia (arrow). Azan stain, original magnification ×10.

Figure 5  .

Figure 5  

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Rabbit aorta with degradable iron stent 18 months after implantation. A stent strut is covered by neointima (N); along the adventitial side there is moderate infiltration of macrophages (arrows). Haematoxylin and eosin stain, original magnification ×40.

Figure 6  .

Figure 6  

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Rabbit aorta 18 months after iron stent implantation. Numerous siderophages are seen in the adventitia adjacent to a lymphatic capillary (*). Haematoxylin and eosin stain, original magnification ×40.

Figure 7  .

Figure 7  

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Rabbit aorta with iron stent 12 months after implantation. A stent strut is covered by neointima (N) and adjacent to the advanced degraded iron strut there is vascularisation with some capillaries (arrows). Azan stain, original magnification ×20.

Figure 8  .

Figure 8  

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Rabbit aorta with degradable iron stent 18 months after implantation showing a stent strut covered by neointima (N); media and internal elastic membrane destroyed adjacent to the stent strut. Elastic stain; original magnification ×20.

Figure 9  .

Figure 9  

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New Zealand white rabbit 12 months after implantation; scanning electron microscopic view of the aortic neointima continuously covered by confluent endothelial cells. Note that coagulation of plasma components and thrombocytes on the surface was caused by inadequate preparation of the specimen. Original magnification ×330.

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