Bench and initial preclinical results of a novel 8 mm diameter double opposed helical biodegradable stent

Carrie E. Herbert, Surendranath Veeram Reddy, Tré R. Welch, Jian Wang, James A. Richardson, Joseph M. Forbess, Alan W. Nugent*

*Corresponding author for this work

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background: Metallic endovascular stents are utilized off-label in congenital heart disease. Biodegradable stents (BDS) offer potential advantages in a growing child. We have previously reported double opposed helical (DH) BDS up to 6 mm diameter (DH-6). The objectives are to investigate the bench characteristics of larger 8 mm diameter BDS (DH-8) manufactured with increasing strut thicknesses and the inflammatory profile in a porcine model. Methods: DH-8 were manufactured with strut thicknesses 0.10, 0.12, and 0.18 mm and mechanical testing performed. Stents were deployed into the infrarenal descending aorta (DAO) of nine minipigs. At insertion (nonsurvival = 2), 1 week (n = 2), 1 month (n = 2), and 9 months (n = 3) follow-up angiography, intravascular ultrasound and histopathology were performed. Results: There was superior recoil and collapse pressure with increasing strut thickness, with 0.18 mm having 1.0% elastic recoil and collapse pressure 0.75 Atmospheres. There was good wall apposition at insertion with 5 BDS (4 DH-8 and 1 DH-6) but suboptimal in 4 as the minipigs infrarenal DAO were >8 mm (deployed at iliac bifurcation). Structural integrity was maintained in 8 BDS with 1 DH-8 collapsed at 9 months, secondary to strut damage at insertion. No thrombosis was seen. There was mild inflammation and neointimal proliferation at 1 week and 1 month, but a moderate inflammatory response at 9 months. Conclusions: DH-8 with increased strut thickness had acceptable mechanical properties at the cost of an increased inflammatory response. Miniaturization to improve delivery and further investigation on the long-term inflammatory profile of thicker struts, including through degradation, is needed.

Original languageEnglish (US)
Pages (from-to)902-911
Number of pages10
JournalCatheterization and Cardiovascular Interventions
Volume88
Issue number6
DOIs
StatePublished - Nov 15 2016

Fingerprint

Stents
Miniature Swine
Thoracic Aorta
Miniaturization
Pressure
Atmosphere
Heart Diseases
Angiography
Thrombosis
Swine
Inflammation

Keywords

  • bioabsorbable
  • bioabsorbable devices/polymers
  • BIOD
  • SBIO
  • SDES
  • stent
  • stent design/structure/coatings

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

Herbert, Carrie E. ; Veeram Reddy, Surendranath ; Welch, Tré R. ; Wang, Jian ; Richardson, James A. ; Forbess, Joseph M. ; Nugent, Alan W. / Bench and initial preclinical results of a novel 8 mm diameter double opposed helical biodegradable stent. In: Catheterization and Cardiovascular Interventions. 2016 ; Vol. 88, No. 6. pp. 902-911.
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abstract = "Background: Metallic endovascular stents are utilized off-label in congenital heart disease. Biodegradable stents (BDS) offer potential advantages in a growing child. We have previously reported double opposed helical (DH) BDS up to 6 mm diameter (DH-6). The objectives are to investigate the bench characteristics of larger 8 mm diameter BDS (DH-8) manufactured with increasing strut thicknesses and the inflammatory profile in a porcine model. Methods: DH-8 were manufactured with strut thicknesses 0.10, 0.12, and 0.18 mm and mechanical testing performed. Stents were deployed into the infrarenal descending aorta (DAO) of nine minipigs. At insertion (nonsurvival = 2), 1 week (n = 2), 1 month (n = 2), and 9 months (n = 3) follow-up angiography, intravascular ultrasound and histopathology were performed. Results: There was superior recoil and collapse pressure with increasing strut thickness, with 0.18 mm having 1.0{\%} elastic recoil and collapse pressure 0.75 Atmospheres. There was good wall apposition at insertion with 5 BDS (4 DH-8 and 1 DH-6) but suboptimal in 4 as the minipigs infrarenal DAO were >8 mm (deployed at iliac bifurcation). Structural integrity was maintained in 8 BDS with 1 DH-8 collapsed at 9 months, secondary to strut damage at insertion. No thrombosis was seen. There was mild inflammation and neointimal proliferation at 1 week and 1 month, but a moderate inflammatory response at 9 months. Conclusions: DH-8 with increased strut thickness had acceptable mechanical properties at the cost of an increased inflammatory response. Miniaturization to improve delivery and further investigation on the long-term inflammatory profile of thicker struts, including through degradation, is needed.",
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Bench and initial preclinical results of a novel 8 mm diameter double opposed helical biodegradable stent. / Herbert, Carrie E.; Veeram Reddy, Surendranath; Welch, Tré R.; Wang, Jian; Richardson, James A.; Forbess, Joseph M.; Nugent, Alan W.

In: Catheterization and Cardiovascular Interventions, Vol. 88, No. 6, 15.11.2016, p. 902-911.

Research output: Contribution to journalArticle

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T1 - Bench and initial preclinical results of a novel 8 mm diameter double opposed helical biodegradable stent

AU - Herbert, Carrie E.

AU - Veeram Reddy, Surendranath

AU - Welch, Tré R.

AU - Wang, Jian

AU - Richardson, James A.

AU - Forbess, Joseph M.

AU - Nugent, Alan W.

PY - 2016/11/15

Y1 - 2016/11/15

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AB - Background: Metallic endovascular stents are utilized off-label in congenital heart disease. Biodegradable stents (BDS) offer potential advantages in a growing child. We have previously reported double opposed helical (DH) BDS up to 6 mm diameter (DH-6). The objectives are to investigate the bench characteristics of larger 8 mm diameter BDS (DH-8) manufactured with increasing strut thicknesses and the inflammatory profile in a porcine model. Methods: DH-8 were manufactured with strut thicknesses 0.10, 0.12, and 0.18 mm and mechanical testing performed. Stents were deployed into the infrarenal descending aorta (DAO) of nine minipigs. At insertion (nonsurvival = 2), 1 week (n = 2), 1 month (n = 2), and 9 months (n = 3) follow-up angiography, intravascular ultrasound and histopathology were performed. Results: There was superior recoil and collapse pressure with increasing strut thickness, with 0.18 mm having 1.0% elastic recoil and collapse pressure 0.75 Atmospheres. There was good wall apposition at insertion with 5 BDS (4 DH-8 and 1 DH-6) but suboptimal in 4 as the minipigs infrarenal DAO were >8 mm (deployed at iliac bifurcation). Structural integrity was maintained in 8 BDS with 1 DH-8 collapsed at 9 months, secondary to strut damage at insertion. No thrombosis was seen. There was mild inflammation and neointimal proliferation at 1 week and 1 month, but a moderate inflammatory response at 9 months. Conclusions: DH-8 with increased strut thickness had acceptable mechanical properties at the cost of an increased inflammatory response. Miniaturization to improve delivery and further investigation on the long-term inflammatory profile of thicker struts, including through degradation, is needed.

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