Comparison of small intestinal submucosa-covered and noncovered nitinol stents in sheep iliac arteries: A pilot study

Naoyuki Toyota, Dusan Pavcnik, William VanAlstine, Barry Uchida, Hans A. Timmermans, Qiang (Michael) Yin, John Kaufman, Frederick Keller, Katsuhide Ito, Josef Rosch

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

PURPOSE: To compare the biocompatibility and performance of nitinol endografts covered externally or internally with small intestinal submucosa (SIS) with bare nitinol stents in medium-sized arteries. MATERIALS AND METHODS: Eighteen nitinol Zilver stents were used: six externally SIS-covered endografts (ECEs), six internally SIS-covered endografts (ICEs), and six bare stents (BSs). Devices were implanted in the balloon-injured external iliac arteries (EIAs) of nine female sheep via carotid approach. Arteriograms were obtained before and after implantation and before animal sacrifice at 1, 3, and 6 months. Histologic studies of explanted specimens were performed. RESULTS: Implantation of all BSs, ECEs, and ICEs was successful, but slight luminal narrowing of 19% ± 5.3% (range, 12%-28%) was seen in ICEs on postimplantation angiograms. At sacrifice, all six BSs and ECEs were patent, with BSs showing a mean angiographic luminal narrowing of 8.4% ± 7.2% (range, 0%-18%) and ECEs showing a mean angiographic luminal narrowing of 16% ± 7.5% (range, 6.5%-26%) as a result of neointimal hyperplasia. Four ICEs showed luminal narrowing of 21% ± 17% (range, 0%-35%) as a result of marked neointimal hyperplasia and two were occluded, one at 3 months and the other at 6 months. ECEs and BSs showed approximately 80% lumen endothelialization at 1 month, which increased to 100% at 3 and 6 months. ICEs did not show complete endothelialization. CONCLUSION: The BS had the least vessel wall reaction. ECEs exhibited early endothelialization with early mild to moderate wall reaction decreasing at the late study stages. ICEs showed extensive wall reaction, possibly as a result of technical problems with SIS attachment.

Original languageEnglish (US)
Pages (from-to)489-498
Number of pages10
JournalJournal of Vascular and Interventional Radiology
Volume13
Issue number5
StatePublished - 2002

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Iliac Artery
Stents
Sheep
Hyperplasia
nitinol
Angiography
Arteries
Equipment and Supplies

Keywords

  • Arteries, grafts and prostheses
  • Endovascular stent-grafts
  • Stents and prostheses

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Radiological and Ultrasound Technology

Cite this

Comparison of small intestinal submucosa-covered and noncovered nitinol stents in sheep iliac arteries : A pilot study. / Toyota, Naoyuki; Pavcnik, Dusan; VanAlstine, William; Uchida, Barry; Timmermans, Hans A.; Yin, Qiang (Michael); Kaufman, John; Keller, Frederick; Ito, Katsuhide; Rosch, Josef.

In: Journal of Vascular and Interventional Radiology, Vol. 13, No. 5, 2002, p. 489-498.

Research output: Contribution to journalArticle

Toyota, Naoyuki ; Pavcnik, Dusan ; VanAlstine, William ; Uchida, Barry ; Timmermans, Hans A. ; Yin, Qiang (Michael) ; Kaufman, John ; Keller, Frederick ; Ito, Katsuhide ; Rosch, Josef. / Comparison of small intestinal submucosa-covered and noncovered nitinol stents in sheep iliac arteries : A pilot study. In: Journal of Vascular and Interventional Radiology. 2002 ; Vol. 13, No. 5. pp. 489-498.
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author = "Naoyuki Toyota and Dusan Pavcnik and William VanAlstine and Barry Uchida and Timmermans, {Hans A.} and Yin, {Qiang (Michael)} and John Kaufman and Frederick Keller and Katsuhide Ito and Josef Rosch",
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T1 - Comparison of small intestinal submucosa-covered and noncovered nitinol stents in sheep iliac arteries

T2 - A pilot study

AU - Toyota, Naoyuki

AU - Pavcnik, Dusan

AU - VanAlstine, William

AU - Uchida, Barry

AU - Timmermans, Hans A.

AU - Yin, Qiang (Michael)

AU - Kaufman, John

AU - Keller, Frederick

AU - Ito, Katsuhide

AU - Rosch, Josef

PY - 2002

Y1 - 2002

N2 - PURPOSE: To compare the biocompatibility and performance of nitinol endografts covered externally or internally with small intestinal submucosa (SIS) with bare nitinol stents in medium-sized arteries. MATERIALS AND METHODS: Eighteen nitinol Zilver stents were used: six externally SIS-covered endografts (ECEs), six internally SIS-covered endografts (ICEs), and six bare stents (BSs). Devices were implanted in the balloon-injured external iliac arteries (EIAs) of nine female sheep via carotid approach. Arteriograms were obtained before and after implantation and before animal sacrifice at 1, 3, and 6 months. Histologic studies of explanted specimens were performed. RESULTS: Implantation of all BSs, ECEs, and ICEs was successful, but slight luminal narrowing of 19% ± 5.3% (range, 12%-28%) was seen in ICEs on postimplantation angiograms. At sacrifice, all six BSs and ECEs were patent, with BSs showing a mean angiographic luminal narrowing of 8.4% ± 7.2% (range, 0%-18%) and ECEs showing a mean angiographic luminal narrowing of 16% ± 7.5% (range, 6.5%-26%) as a result of neointimal hyperplasia. Four ICEs showed luminal narrowing of 21% ± 17% (range, 0%-35%) as a result of marked neointimal hyperplasia and two were occluded, one at 3 months and the other at 6 months. ECEs and BSs showed approximately 80% lumen endothelialization at 1 month, which increased to 100% at 3 and 6 months. ICEs did not show complete endothelialization. CONCLUSION: The BS had the least vessel wall reaction. ECEs exhibited early endothelialization with early mild to moderate wall reaction decreasing at the late study stages. ICEs showed extensive wall reaction, possibly as a result of technical problems with SIS attachment.

AB - PURPOSE: To compare the biocompatibility and performance of nitinol endografts covered externally or internally with small intestinal submucosa (SIS) with bare nitinol stents in medium-sized arteries. MATERIALS AND METHODS: Eighteen nitinol Zilver stents were used: six externally SIS-covered endografts (ECEs), six internally SIS-covered endografts (ICEs), and six bare stents (BSs). Devices were implanted in the balloon-injured external iliac arteries (EIAs) of nine female sheep via carotid approach. Arteriograms were obtained before and after implantation and before animal sacrifice at 1, 3, and 6 months. Histologic studies of explanted specimens were performed. RESULTS: Implantation of all BSs, ECEs, and ICEs was successful, but slight luminal narrowing of 19% ± 5.3% (range, 12%-28%) was seen in ICEs on postimplantation angiograms. At sacrifice, all six BSs and ECEs were patent, with BSs showing a mean angiographic luminal narrowing of 8.4% ± 7.2% (range, 0%-18%) and ECEs showing a mean angiographic luminal narrowing of 16% ± 7.5% (range, 6.5%-26%) as a result of neointimal hyperplasia. Four ICEs showed luminal narrowing of 21% ± 17% (range, 0%-35%) as a result of marked neointimal hyperplasia and two were occluded, one at 3 months and the other at 6 months. ECEs and BSs showed approximately 80% lumen endothelialization at 1 month, which increased to 100% at 3 and 6 months. ICEs did not show complete endothelialization. CONCLUSION: The BS had the least vessel wall reaction. ECEs exhibited early endothelialization with early mild to moderate wall reaction decreasing at the late study stages. ICEs showed extensive wall reaction, possibly as a result of technical problems with SIS attachment.

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