Evaluation of a Bioabsorbable Self-Expandable Vein Stent-Base Made of Poly(L-lactide) In Vitro and In Vivo

Alexandra Liv Vest Løvdal, Sarah Calve, Shuo Yang, William Van Alstine, Christoph A Binkert, Kasper Klausen

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    Abstract

    Purpose  This study was designed to evaluate performance and tissue response to a self-expandable bioabsorbable vein stent-base cut from a tube with enhanced stiffness and strength in vitro and in vivo.
    Methods  A diamond-shaped stent-base was cut from a sequential biaxially strained poly(L-lactide) (PLLA) tube for optimized performance. The performance of the stent-base was evaluated in a finite element analysis model, and validation was attempted in vitro through a cyclic flat-plate compression and radial force measurement. The performance of the stent-base was tested in vivo using 3 sheep with 2 implants each for 2 and 3½ weeks, respectively.
    Results  In vitro the stent-base showed an elliptical deformation but no fractures. In vivo the stent-base showed adequate radial force and no migration. All implanted stent-bases showed multiple fractures not only at the predicted stress zones but at all connecting points. Fragments of the caudal stent-base stayed in the vein wall indicating sufficient tissue coverage to avoid embolization of the fractured stent pieces, whereas fragments from the cranial device remaining were few. Neointima formation was confirmed histologically at 2 and 3½ weeks.
    Conclusion  A bioabsorbable self-expandable stent-base made from PLLA for large veins seems feasible, but over time, the PLLA used in this study appears too stiff and lacks the sufficient flexibility to move with the vena cava, causing multiple fractures.
    Original languageEnglish
    JournalCardiovascular and Interventional Radiology
    Volume40
    Issue number1
    Pages (from-to)112–119
    Number of pages8
    ISSN0174-1551
    DOIs
    Publication statusPublished - 2017

    Keywords

    • Self-expandable
    • Vein stent
    • Bioabsorbable
    • PLLA
    • Poly-(L-lactide)

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