title: Long-term biocompatibility, imaging appearance and tissue effects associated with delivery of a novel radiopaque embolization bead for image-guided therapy.
abstract: The objective of this study was to undertake a comprehensive long-term biocompatibility and imaging assessment of a new intrinsically radiopaque bead (LC Bead LUMI™) for use in transarterial embolization. The sterilized device and its extracts were subjected to the raft of ISO10993 biocompatibility tests that demonstrated safety with respect to cytotoxicity, mutagenicity, blood contact, irritation, sensitization, systemic toxicity and tissue reaction. Intra-arterial administration was performed in a swine model of hepatic arterial embolization in which 0.22-1 mL of sedimented bead volume was administered to the targeted lobe(s) of the liver. The beads could be visualized during the embolization procedure with fluoroscopy, DSA and single X-ray snapshot imaging modalities. CT imaging was performed before and 1 h after embolization and then again at 7, 14, 30 and 90 days. LC Bead LUMI™ could be clearly visualized in the hepatic arteries with or without administration of IV contrast and appeared more dense than soluble contrast agent. The CT density of the beads did not deteriorate during the 90 day evaluation period. The beads embolized predictably and effectively, resulting in areas devoid of contrast enhancement on CT imaging suggesting ischaemia-induced necrosis nearby the sites of occlusion. Instances of off target embolization were easily detected on imaging and confirmed pathologically. Histopathology revealed a classic foreign body response at 14 days, which resolved over time leading to fibrosis and eventual integration of the beads into the tissue, demonstrating excellent long-term tissue compatibility.
authors.affiliation: Children's Hospital, Children's National Medical Center, 1630 Euclid Street NW#1, Washington, DC, USA.
authors.forename: Karun V
authors.initials: KV
authors.lastname: Sharma
authors.affiliation: Biocompatibles UK Ltd, A BTG International group company, Lakeview, Riverside Way, Watchmoor Park, Camberley, Surrey GU15 3YL, UK.
authors.forename: Zainab
authors.initials: Z
authors.lastname: Bascal
authors.affiliation: Biocompatibles UK Ltd, A BTG International group company, Lakeview, Riverside Way, Watchmoor Park, Camberley, Surrey GU15 3YL, UK.
authors.forename: Hugh
authors.initials: H
authors.lastname: Kilpatrick
authors.affiliation: Biocompatibles UK Ltd, A BTG International group company, Lakeview, Riverside Way, Watchmoor Park, Camberley, Surrey GU15 3YL, UK.
authors.forename: Koorosh
authors.initials: K
authors.lastname: Ashrafi
authors.affiliation: Biocompatibles UK Ltd, A BTG International group company, Lakeview, Riverside Way, Watchmoor Park, Camberley, Surrey GU15 3YL, UK.
authors.forename: Sean L
authors.initials: SL
authors.lastname: Willis
authors.affiliation: Biocompatibles Inc., A BTG International group company, Five Tower Bridge, Suite 810, 300 Barr Harbor Drive, West Conshohocken, PA 19428, USA.
authors.forename: Matthew R
authors.initials: MR
authors.lastname: Dreher
authors.affiliation: Biocompatibles UK Ltd, A BTG International group company, Lakeview, Riverside Way, Watchmoor Park, Camberley, Surrey GU15 3YL, UK. Electronic address: andrew.lewis@btgplc.com.
authors.forename: Andrew L
authors.initials: AL
authors.lastname: Lewis
mesh_terms: D000818:Animals; D001672:Biocompatible Materials / Q000009:adverse effects / Q000138:chemical synthesis; D003287:Contrast Media / Q000009:adverse effects / Q000138:chemical synthesis; D004621:Embolization, Therapeutic / Q000009:adverse effects / Q000379:methods*; D006490:Hemostatics / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use*; D053758:Nanoparticles / Q000009:adverse effects / Q000627:therapeutic use* / Q000648:ultrastructure; D015641:Radiography, Interventional / Q000379:methods*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013552:Swine; D000068936:Theranostic Nanomedicine / Q000379:methods
chemical_list: D001672:Biocompatible Materials; D003287:Contrast Media; D006490:Hemostatics
keywords: Biocompatibility; CT imaging; Embolization; LC Bead LUMI™; Radiopaque beads; X-ray imaging