A novel biodegradable stent applicable for use in congenital heart disease

Bench testing and feasibility results in a rabbit model

Surendranath R. Veeram Reddy*, Tre R. Welch, Jian Wang, Frederic Bernstein, James A. Richardson, Joseph M. Forbess, Alan W. Nugent

*Corresponding author for this work

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

Objectives A novel double opposed helical (DH) biodegradable stent was designed and fabricated for CHD applications. The primary objective was to evaluate the feasibility of DH stent delivery and deployment in rabbit external iliac arteries (EIA). Secondary objectives were to assess stent patency, thrombosis and inflammation at 1-week and 1-month follow-up. Background Biodegradable stents have largely been designed for adult cardiovascular indications, to avoid long term complications of permanent implants. A growing child with congenital heart disease (CHD) would especially derive substantial benefit from this technology. Methods DH stents were manufactured to 3, 4, 5, and 6-mm diameter with poly-l-lactic acid (PLLA) fibers. Bench test analysis was performed. Six DH stents were implanted in rabbit EIA. Vessel patency was assessed at 1-week and 1-month follow-up with repeat angiography, intravascular ultrasound (IVUS). Histopathological evaluation was performed. Results The elastic recoil and collapse pressure of DH stents were comparable to conventional metal stents. All DH stents were successfully delivered and implanted with good apposition to the vessel wall and no collapse of the proximal, mid or distal ends. All stented vessels remained patent. No acute or early stent thrombosis was noted. Histopathology showed minimal inflammatory response and mild neointimal proliferation at 1 month follow-up. Conclusions In vitro results of DH PLLA biodegradable stents are comparable to conventional metal stents. The pilot animal study confirms the delivery and deployment of the DH stents to the desired location. The DH design can be used to fabricate larger diameter stents needed for CHD. © 2013 Wiley Periodicals, Inc.

Original languageEnglish (US)
Pages (from-to)448-456
Number of pages9
JournalCatheterization and Cardiovascular Interventions
Volume83
Issue number3
DOIs
StatePublished - Feb 15 2014

Fingerprint

Stents
Heart Diseases
Rabbits
Iliac Artery
Thrombosis
Metals
Angiography
Inflammation
Technology
Pressure

Keywords

  • 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

Veeram Reddy, Surendranath R. ; Welch, Tre R. ; Wang, Jian ; Bernstein, Frederic ; Richardson, James A. ; Forbess, Joseph M. ; Nugent, Alan W. / A novel biodegradable stent applicable for use in congenital heart disease : Bench testing and feasibility results in a rabbit model. In: Catheterization and Cardiovascular Interventions. 2014 ; Vol. 83, No. 3. pp. 448-456.
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abstract = "Objectives A novel double opposed helical (DH) biodegradable stent was designed and fabricated for CHD applications. The primary objective was to evaluate the feasibility of DH stent delivery and deployment in rabbit external iliac arteries (EIA). Secondary objectives were to assess stent patency, thrombosis and inflammation at 1-week and 1-month follow-up. Background Biodegradable stents have largely been designed for adult cardiovascular indications, to avoid long term complications of permanent implants. A growing child with congenital heart disease (CHD) would especially derive substantial benefit from this technology. Methods DH stents were manufactured to 3, 4, 5, and 6-mm diameter with poly-l-lactic acid (PLLA) fibers. Bench test analysis was performed. Six DH stents were implanted in rabbit EIA. Vessel patency was assessed at 1-week and 1-month follow-up with repeat angiography, intravascular ultrasound (IVUS). Histopathological evaluation was performed. Results The elastic recoil and collapse pressure of DH stents were comparable to conventional metal stents. All DH stents were successfully delivered and implanted with good apposition to the vessel wall and no collapse of the proximal, mid or distal ends. All stented vessels remained patent. No acute or early stent thrombosis was noted. Histopathology showed minimal inflammatory response and mild neointimal proliferation at 1 month follow-up. Conclusions In vitro results of DH PLLA biodegradable stents are comparable to conventional metal stents. The pilot animal study confirms the delivery and deployment of the DH stents to the desired location. The DH design can be used to fabricate larger diameter stents needed for CHD. {\circledC} 2013 Wiley Periodicals, Inc.",
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A novel biodegradable stent applicable for use in congenital heart disease : Bench testing and feasibility results in a rabbit model. / Veeram Reddy, Surendranath R.; Welch, Tre R.; Wang, Jian; Bernstein, Frederic; Richardson, James A.; Forbess, Joseph M.; Nugent, Alan W.

In: Catheterization and Cardiovascular Interventions, Vol. 83, No. 3, 15.02.2014, p. 448-456.

Research output: Contribution to journalArticle

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AU - Veeram Reddy, Surendranath R.

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AU - Wang, Jian

AU - Bernstein, Frederic

AU - Richardson, James A.

AU - Forbess, Joseph M.

AU - Nugent, Alan W.

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N2 - Objectives A novel double opposed helical (DH) biodegradable stent was designed and fabricated for CHD applications. The primary objective was to evaluate the feasibility of DH stent delivery and deployment in rabbit external iliac arteries (EIA). Secondary objectives were to assess stent patency, thrombosis and inflammation at 1-week and 1-month follow-up. Background Biodegradable stents have largely been designed for adult cardiovascular indications, to avoid long term complications of permanent implants. A growing child with congenital heart disease (CHD) would especially derive substantial benefit from this technology. Methods DH stents were manufactured to 3, 4, 5, and 6-mm diameter with poly-l-lactic acid (PLLA) fibers. Bench test analysis was performed. Six DH stents were implanted in rabbit EIA. Vessel patency was assessed at 1-week and 1-month follow-up with repeat angiography, intravascular ultrasound (IVUS). Histopathological evaluation was performed. Results The elastic recoil and collapse pressure of DH stents were comparable to conventional metal stents. All DH stents were successfully delivered and implanted with good apposition to the vessel wall and no collapse of the proximal, mid or distal ends. All stented vessels remained patent. No acute or early stent thrombosis was noted. Histopathology showed minimal inflammatory response and mild neointimal proliferation at 1 month follow-up. Conclusions In vitro results of DH PLLA biodegradable stents are comparable to conventional metal stents. The pilot animal study confirms the delivery and deployment of the DH stents to the desired location. The DH design can be used to fabricate larger diameter stents needed for CHD. © 2013 Wiley Periodicals, Inc.

AB - Objectives A novel double opposed helical (DH) biodegradable stent was designed and fabricated for CHD applications. The primary objective was to evaluate the feasibility of DH stent delivery and deployment in rabbit external iliac arteries (EIA). Secondary objectives were to assess stent patency, thrombosis and inflammation at 1-week and 1-month follow-up. Background Biodegradable stents have largely been designed for adult cardiovascular indications, to avoid long term complications of permanent implants. A growing child with congenital heart disease (CHD) would especially derive substantial benefit from this technology. Methods DH stents were manufactured to 3, 4, 5, and 6-mm diameter with poly-l-lactic acid (PLLA) fibers. Bench test analysis was performed. Six DH stents were implanted in rabbit EIA. Vessel patency was assessed at 1-week and 1-month follow-up with repeat angiography, intravascular ultrasound (IVUS). Histopathological evaluation was performed. Results The elastic recoil and collapse pressure of DH stents were comparable to conventional metal stents. All DH stents were successfully delivered and implanted with good apposition to the vessel wall and no collapse of the proximal, mid or distal ends. All stented vessels remained patent. No acute or early stent thrombosis was noted. Histopathology showed minimal inflammatory response and mild neointimal proliferation at 1 month follow-up. Conclusions In vitro results of DH PLLA biodegradable stents are comparable to conventional metal stents. The pilot animal study confirms the delivery and deployment of the DH stents to the desired location. The DH design can be used to fabricate larger diameter stents needed for CHD. © 2013 Wiley Periodicals, Inc.

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