A novel design biodegradable stent for use in congenital heart disease: mid-term results in rabbit descending aorta

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Abstract

OBJECTIVES: This study evaluates the feasibility of delivery and deployment of low and medium molecular weight (LMW and MMW, respectively) double-opposing helical (DH) poly-l-lactic acid biodegradable stent (BDS) in rabbit descending aorta (DAO). Secondary objectives were to assess patency and inflammation of stented vessels at 9 months and to investigate safety following intentional embolization of stent fragments in DAO.

BACKGROUND: A BDS that will relieve aortic obstruction and disappears as the child grows older allowing for preservation of aortic wall elasticity and natural growth of aorta will be ideal to treat Coarctation (CoA). BDS have never been evaluated in the DAO.

METHODS: Seven New Zealand white rabbits underwent implantation of DH-LMW (n = 7), DH-MMW (n = 3), and metal stents (n = 7) in DAO. BDS fragments were intentionally embolized into DAO in two rabbits.

RESULTS: All stents were deployed via a 6-French sheath. Five BDS covered the origin of major DAO side branches. Angiography and intravascular ultrasound showed good stent apposition to the wall of DAO with minimal luminal loss at 9 months follow-up. All stents had minimal neointimal hyperplasia on histopathology. Adverse events included 1 death, 1 aortic aneurysm, and lower extremity ulceration due to self-mutilation in an embolization rabbit.

CONCLUSIONS: Pilot study confirms the feasibility of delivery and deployment of up to 6-millimeter diameter DH BDS in rabbit DAO. Stent integrity with DH design was maintained at 9 months with minimal vessel inflammation. Potential morbidity due to embolized BD fragments cannot be ruled out and needs further evaluation.

Original languageEnglish (US)
Pages (from-to)629-639
Number of pages11
JournalCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
Volume85
Issue number4
DOIs
StatePublished - Mar 1 2015

Fingerprint

Thoracic Aorta
Stents
Heart Diseases
Rabbits
Self Mutilation
Inflammation
Aortic Aneurysm
Elasticity
Feasibility Studies
Hyperplasia
Aorta
Lower Extremity
Angiography
Molecular Weight
Metals
Morbidity
Safety

Keywords

  • aortic stent
  • biodegradable stents
  • congenital heart disease
  • poly-l-lactic acid (PLLA)

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

@article{c274dc05427d47349ca533e629c36343,
title = "A novel design biodegradable stent for use in congenital heart disease: mid-term results in rabbit descending aorta",
abstract = "OBJECTIVES: This study evaluates the feasibility of delivery and deployment of low and medium molecular weight (LMW and MMW, respectively) double-opposing helical (DH) poly-l-lactic acid biodegradable stent (BDS) in rabbit descending aorta (DAO). Secondary objectives were to assess patency and inflammation of stented vessels at 9 months and to investigate safety following intentional embolization of stent fragments in DAO.BACKGROUND: A BDS that will relieve aortic obstruction and disappears as the child grows older allowing for preservation of aortic wall elasticity and natural growth of aorta will be ideal to treat Coarctation (CoA). BDS have never been evaluated in the DAO.METHODS: Seven New Zealand white rabbits underwent implantation of DH-LMW (n = 7), DH-MMW (n = 3), and metal stents (n = 7) in DAO. BDS fragments were intentionally embolized into DAO in two rabbits.RESULTS: All stents were deployed via a 6-French sheath. Five BDS covered the origin of major DAO side branches. Angiography and intravascular ultrasound showed good stent apposition to the wall of DAO with minimal luminal loss at 9 months follow-up. All stents had minimal neointimal hyperplasia on histopathology. Adverse events included 1 death, 1 aortic aneurysm, and lower extremity ulceration due to self-mutilation in an embolization rabbit.CONCLUSIONS: Pilot study confirms the feasibility of delivery and deployment of up to 6-millimeter diameter DH BDS in rabbit DAO. Stent integrity with DH design was maintained at 9 months with minimal vessel inflammation. Potential morbidity due to embolized BD fragments cannot be ruled out and needs further evaluation.",
keywords = "aortic stent, biodegradable stents, congenital heart disease, poly-l-lactic acid (PLLA)",
author = "{Veeram Reddy}, {Surendranath R.} and Welch, {Tr{\'e} R.} and Jian Wang and Richardson, {James A.} and Forbess, {Joseph M.} and Matthew Riegel and Nugent, {Alan W.}",
year = "2015",
month = "3",
day = "1",
doi = "10.1002/ccd.25648",
language = "English (US)",
volume = "85",
pages = "629--639",
journal = "Catheterization and Cardiovascular Interventions",
issn = "1522-1946",
publisher = "Wiley-Liss Inc.",
number = "4",

}

TY - JOUR

T1 - A novel design biodegradable stent for use in congenital heart disease

T2 - mid-term results in rabbit descending aorta

AU - Veeram Reddy, Surendranath R.

AU - Welch, Tré R.

AU - Wang, Jian

AU - Richardson, James A.

AU - Forbess, Joseph M.

AU - Riegel, Matthew

AU - Nugent, Alan W.

PY - 2015/3/1

Y1 - 2015/3/1

N2 - OBJECTIVES: This study evaluates the feasibility of delivery and deployment of low and medium molecular weight (LMW and MMW, respectively) double-opposing helical (DH) poly-l-lactic acid biodegradable stent (BDS) in rabbit descending aorta (DAO). Secondary objectives were to assess patency and inflammation of stented vessels at 9 months and to investigate safety following intentional embolization of stent fragments in DAO.BACKGROUND: A BDS that will relieve aortic obstruction and disappears as the child grows older allowing for preservation of aortic wall elasticity and natural growth of aorta will be ideal to treat Coarctation (CoA). BDS have never been evaluated in the DAO.METHODS: Seven New Zealand white rabbits underwent implantation of DH-LMW (n = 7), DH-MMW (n = 3), and metal stents (n = 7) in DAO. BDS fragments were intentionally embolized into DAO in two rabbits.RESULTS: All stents were deployed via a 6-French sheath. Five BDS covered the origin of major DAO side branches. Angiography and intravascular ultrasound showed good stent apposition to the wall of DAO with minimal luminal loss at 9 months follow-up. All stents had minimal neointimal hyperplasia on histopathology. Adverse events included 1 death, 1 aortic aneurysm, and lower extremity ulceration due to self-mutilation in an embolization rabbit.CONCLUSIONS: Pilot study confirms the feasibility of delivery and deployment of up to 6-millimeter diameter DH BDS in rabbit DAO. Stent integrity with DH design was maintained at 9 months with minimal vessel inflammation. Potential morbidity due to embolized BD fragments cannot be ruled out and needs further evaluation.

AB - OBJECTIVES: This study evaluates the feasibility of delivery and deployment of low and medium molecular weight (LMW and MMW, respectively) double-opposing helical (DH) poly-l-lactic acid biodegradable stent (BDS) in rabbit descending aorta (DAO). Secondary objectives were to assess patency and inflammation of stented vessels at 9 months and to investigate safety following intentional embolization of stent fragments in DAO.BACKGROUND: A BDS that will relieve aortic obstruction and disappears as the child grows older allowing for preservation of aortic wall elasticity and natural growth of aorta will be ideal to treat Coarctation (CoA). BDS have never been evaluated in the DAO.METHODS: Seven New Zealand white rabbits underwent implantation of DH-LMW (n = 7), DH-MMW (n = 3), and metal stents (n = 7) in DAO. BDS fragments were intentionally embolized into DAO in two rabbits.RESULTS: All stents were deployed via a 6-French sheath. Five BDS covered the origin of major DAO side branches. Angiography and intravascular ultrasound showed good stent apposition to the wall of DAO with minimal luminal loss at 9 months follow-up. All stents had minimal neointimal hyperplasia on histopathology. Adverse events included 1 death, 1 aortic aneurysm, and lower extremity ulceration due to self-mutilation in an embolization rabbit.CONCLUSIONS: Pilot study confirms the feasibility of delivery and deployment of up to 6-millimeter diameter DH BDS in rabbit DAO. Stent integrity with DH design was maintained at 9 months with minimal vessel inflammation. Potential morbidity due to embolized BD fragments cannot be ruled out and needs further evaluation.

KW - aortic stent

KW - biodegradable stents

KW - congenital heart disease

KW - poly-l-lactic acid (PLLA)

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U2 - 10.1002/ccd.25648

DO - 10.1002/ccd.25648

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C2 - 25157439

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JO - Catheterization and Cardiovascular Interventions

JF - Catheterization and Cardiovascular Interventions

SN - 1522-1946

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