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Title: Comparison of Self-Expanding Polyethylene Terephthalate and Metallic Stents Implanted in Porcine Iliac Arteries

Abstract

Purpose: Comparison of the biocompatibility of self-expanding polyethylene terephthalate (PET) stents with self-expanding metallic stents (Wallstents). Methods: Diameter- and length-matched PET stents and Wallstents were symmetrically implanted in the paired iliac arteries of 13 crossbred domestic swine. Stent deployment was studied angiographically and with intravascular ultrasound immediately after stent implantation. The angiographic stented lumen diameter was measured using quantitative vessel analysis before, immediately after stenting, and at 6-week follow-up. Cross-section histopathology and area morphometry were performed. Results: Immediately poststenting, intravascular ultrasound revealed proximal dislocation of 5 of the 13 PET stents, whereas all metal stents were firmly embedded at the implantation site. At 6-week follow-up, three of the remaining PET stents were totally or subtotally occluded by organized thrombus, whereas all metal stents were patent. Compared with immediately poststenting, the angiographic lumen diameter within the five remaining PET stents was reduced by 30%, and that of the metallic stents was virtually unaltered (p < 0.02). This observation was confirmed by postmortem morphometry, wherein the PET-stented vessel segments a diameter stenosis of 40% was measured vs only 9% in the metallic stents (p < 0.0001). Conclusion: PET-stent deployment is difficult to control due to the lack of radiopacity of this stent.more » PET stents seem to be more thrombogenic and lead to significantly more neointimal proliferation than metallic stents.« less

Authors:
; ;  [1];  [2];  [1]
  1. Department of Cardiology, University Hospital Gasthuisberg, 49 Herestraat, 3000 Leuven (Belgium)
  2. Department of Histopathology, University Hospital Gasthuisberg, 49 Herestraat, 3000 Leuven (Belgium)
Publication Date:
OSTI Identifier:
21080538
Resource Type:
Journal Article
Resource Relation:
Journal Name: Cardiovascular and Interventional Radiology; Journal Volume: 19; Journal Issue: 3; Other Information: DOI: 10.1007/s002709900037; Copyright (c) 1996 Springer-Verlag New York Inc; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; ARTERIES; CROSS SECTIONS; PATENTS; POLYESTERS; SWINE

Citation Formats

Wilczek, Krzysztof, Scheerder, Ivan de, Wang Kai, Verbeken, Eric, and Piessens, Jan. Comparison of Self-Expanding Polyethylene Terephthalate and Metallic Stents Implanted in Porcine Iliac Arteries. United States: N. p., 1996. Web. doi:10.1007/S002709900037.
Wilczek, Krzysztof, Scheerder, Ivan de, Wang Kai, Verbeken, Eric, & Piessens, Jan. Comparison of Self-Expanding Polyethylene Terephthalate and Metallic Stents Implanted in Porcine Iliac Arteries. United States. doi:10.1007/S002709900037.
Wilczek, Krzysztof, Scheerder, Ivan de, Wang Kai, Verbeken, Eric, and Piessens, Jan. 1996. "Comparison of Self-Expanding Polyethylene Terephthalate and Metallic Stents Implanted in Porcine Iliac Arteries". United States. doi:10.1007/S002709900037.
@article{osti_21080538,
title = {Comparison of Self-Expanding Polyethylene Terephthalate and Metallic Stents Implanted in Porcine Iliac Arteries},
author = {Wilczek, Krzysztof and Scheerder, Ivan de and Wang Kai and Verbeken, Eric and Piessens, Jan},
abstractNote = {Purpose: Comparison of the biocompatibility of self-expanding polyethylene terephthalate (PET) stents with self-expanding metallic stents (Wallstents). Methods: Diameter- and length-matched PET stents and Wallstents were symmetrically implanted in the paired iliac arteries of 13 crossbred domestic swine. Stent deployment was studied angiographically and with intravascular ultrasound immediately after stent implantation. The angiographic stented lumen diameter was measured using quantitative vessel analysis before, immediately after stenting, and at 6-week follow-up. Cross-section histopathology and area morphometry were performed. Results: Immediately poststenting, intravascular ultrasound revealed proximal dislocation of 5 of the 13 PET stents, whereas all metal stents were firmly embedded at the implantation site. At 6-week follow-up, three of the remaining PET stents were totally or subtotally occluded by organized thrombus, whereas all metal stents were patent. Compared with immediately poststenting, the angiographic lumen diameter within the five remaining PET stents was reduced by 30%, and that of the metallic stents was virtually unaltered (p < 0.02). This observation was confirmed by postmortem morphometry, wherein the PET-stented vessel segments a diameter stenosis of 40% was measured vs only 9% in the metallic stents (p < 0.0001). Conclusion: PET-stent deployment is difficult to control due to the lack of radiopacity of this stent. PET stents seem to be more thrombogenic and lead to significantly more neointimal proliferation than metallic stents.},
doi = {10.1007/S002709900037},
journal = {Cardiovascular and Interventional Radiology},
number = 3,
volume = 19,
place = {United States},
year = 1996,
month = 5
}
  • Objective: To investigate the safety and efficacy of a Polyzene-F nanocoat on new low-profile self-expandable nitinol stents in minipig renal arteries. Materials and Methods: Ten bare nitinol stents (BNS) and 10 stents coated with a 50 nm-thin Polyzene-F coating were randomly implanted into renal arteries of 10 minipigs (4- and 12-week follow-up, 5 animals/group). Thrombogenicity, on-stent surface endothelialization, vessel wall injury, late in-stent stenosis, and peristrut vessel wall inflammation were determined by quantitative angiography and postmortem histomorphometry. Results: In 6 of 10 BNS, >50% stenosis was found, but no stenosis was found in stents with a nanothin Polyzene-F coating. Histomorphometrymore » showed a statistically significant (p < 0.05) different average maximum luminal loss of 55.16% {+-} 8.43% at 12 weeks in BNS versus 39.77% {+-} 7.41% in stents with a nanothin Polyzene-F coating. Stents with a nanothin Polyzene-F coating had a significantly (p < 0.05) lower inflammation score after 12 weeks, 1.31 {+-} 1.17 versus 2.17 {+-} 0.85 in BNS. The results for vessel wall injury (0.6 {+-} 0.58 for Polyzene-F-coated stents; 0.72 {+-} 0.98 for BNS) and re-endothelialization, (1.16 {+-} 0.43 and 1.23 {+-} 0.54, respectively) were not statistically significant at 12-week follow-up. No thrombus deposition was observed on the stents at either follow-up time point. Conclusion: Nitinol stents with a nanothin Polyzene-F coating successfully decreased in-stent stenosis and vessel wall inflammation compared with BNS. Endothelialization and vessel wall injury were found to be equal. These studies warrant long-term pig studies ({>=}120 days) because 12 weeks may not be sufficient time for complete healing; thereafter, human studies may be warranted.« less
  • Purpose: Uncoated self-expanding nitinol stents (NS) are commonly oversized in peripheral arteries. In current practice, 1-mm oversizing is recommended. Yet, oversizing of NS may be associated with increased restenosis. To provide further evidence, NS were implanted in porcine iliofemoral arteries with a stent-to-artery-ratio between 1.0 and 2.3. Besides conventional uncoated NS, a novel self-expanding NS with an antiproliferative titanium-nitride-oxide (TiNOX) coating was tested for safety and efficacy. Methods: Ten uncoated NS and six TiNOX-coated NS (5-6 mm) were implanted randomly in the iliofemoral artery of six mini-pigs. After implantation, quantitative angiography (QA) was performed for calculation of artery and minimalmore » luminal diameter. Follow-up was performed by QA and histomorphometry after 5 months. Results: Stent migration, stent fracture, or thrombus formation were not observed. All stents were patent at follow-up. Based on the location of the stent (iliac/femoral) and the stent-to-artery-ratio, stent segments were divided into 'normal-sized' (stent-to-artery-ratio < 1.4, n = 12) and 'oversized' (stent-to-artery-ratio {>=} 1.4, n = 9). All stent segments expanded to their near nominal diameter during follow-up. Normal-sized stent segments increased their diameter by 6% and oversized segments by 29%. A significant correlation between oversizing and restenosis by both angiography and histomorphometry was observed. Restenosis rates were similar for uncoated NS and TiNOX-coated NS. Conclusions: TiNOX-coated NS are as safe and effective as uncoated NS in the porcine iliofemoral artery. All stents further expand to near their nominal diameter during follow-up. Oversizing is linearly and positively correlated with neointimal proliferation and restenosis, which may not be reduced by TiNOX-coating.« less
  • The objective of this study was to evaluate the efficacy of heparin-polymer-coated intravascular stents in the reduction of vessel stenosis. Three types of coatings for Palmaz stents were tested: 1) heparin covalently bound to a polyethylene oxide(Hp-PEO) tether; 2) heparin copolymerized with ethylene vinyl acetate(Hp-Elvax) and 3) Elvax alone. Polymer-coated stents and uncoated controls were deployed in the external iliac arteries following endothelial injury in 18 swine. The animals were maintained on anatherogenic diet and examined by angiography at 6 and 12 weeks. The stented segments were then harvested for histopathologic analysis. Both types of heparin-coated stents resulted in increasedmore » luminal narrowing as compared to the contralateral uncoated stents. At 6 weeks, average luminal stenosis was 48% for Hp-PEO stents vs 35% for uncoated stents (p < 0.05). At 12 weeks, average luminal stenosis was 36% for Hp-PEO stents vs 26% for uncoated stents(p = NS). For Hp-Elvax stents, the average stenosis was 58% vs 33% for uncoated controls (p <0.05) at 6 weeks and 47% vs 19% for uncoated controls(p < 0.05) at 12 weeks. There was no significant difference between Hp-Elvax stents and Elvax stents(p = NS). Increased luminal narrowing in coated stents was primarily secondary to a marked inflammatory response.Heparin-polyethylene oxide and heparin-ethylene vinyl acetate-coated stents resulted in increased luminal narrowing as compared with uncoated stents, due to a marked inflammatory response.« less
  • The role of metallic stents in the palliation of esophageal cancer is well established. Self-expanding metal stents (SEMSs) are frequently used, as they provide an effective and safe method of relieving malignant dysphagia. A number of complications are associated with the use of SEMSs, including esophageal perforation. We report a case of thoracic discitis occurring in a patient with advanced esophageal malignancy, treated with SEMSs. We propose that the likely etiology in this patient was esophageal perforation by a metallic stent.
  • Purpose: To compare patency and neointima formation of single and tandem arterial stents. Methods: In each of six sheep, two Memotherm nitinol stents (tandem stents) were inserted into the external iliac artery on one side and a single stent into the artery on the opposite side. The size of the iliac lumen was assessed in the proximal, middle, and distal segments of the stents by intravascular ultrasound (IVUS) before, immediately after, and 1 month after implantation when the sheep were killed. Neointimal thickness was determined in the proximal, middle, and distal segments of each stent by light microscopy. Results: Allmore » stents remained patent. There was no significant difference in lumen and neointimal thickness between single and tandem stents. Cranial tandem stents showed a significantly wider lumen and smaller neointimal thickness than caudal tandem stents. In the proximal and distal segments, the lumen of the stents was significantly smaller and the neointimal thickness greater than in the middle segment; differences in neointimal thickness were significant only between the proximal and the middle segment. Conclusion: In an experimental setting, tandem stents did not interfere with one another with regard to patency and neointima formation when compared with a single contralateral stent. Neointimal thickening after stent insertion seems to be inversely related to the original arterial diameter.« less