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Handling and performance characteristics of a new small caliber radiopaque embolic microsphere

The in vitro and in vivo handling and performance characteristics of a small caliber radiopaque embolic microsphere, 40–90 μm DC Bead LUMI™ (LUMI40‐90), were studied. Microsphere drug loading and elution and effects on size, suspension, and microcatheter delivery were evaluated using established in...

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Autores principales: Lewis, Andrew L., Caine, Marcus, Garcia, Pedro, Ashrafi, Koorosh, Tang, Yiqing, Hinchcliffe, Lorcan, Guo, Wei, Bascal, Zainab, Kilpatrick, Hugh, Willis, Sean L.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7496950/
https://www.ncbi.nlm.nih.gov/pubmed/32578348
http://dx.doi.org/10.1002/jbm.b.34619
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author Lewis, Andrew L.
Caine, Marcus
Garcia, Pedro
Ashrafi, Koorosh
Tang, Yiqing
Hinchcliffe, Lorcan
Guo, Wei
Bascal, Zainab
Kilpatrick, Hugh
Willis, Sean L.
author_facet Lewis, Andrew L.
Caine, Marcus
Garcia, Pedro
Ashrafi, Koorosh
Tang, Yiqing
Hinchcliffe, Lorcan
Guo, Wei
Bascal, Zainab
Kilpatrick, Hugh
Willis, Sean L.
author_sort Lewis, Andrew L.
collection PubMed
description The in vitro and in vivo handling and performance characteristics of a small caliber radiopaque embolic microsphere, 40–90 μm DC Bead LUMI™ (LUMI40‐90), were studied. Microsphere drug loading and elution and effects on size, suspension, and microcatheter delivery were evaluated using established in vitro methodologies. In vivo evaluations of vascular penetration (rabbit renal artery embolization), long‐term biocompatibility and X‐ray imaging properties, pharmacokinetics and local tissue effects of both doxorubicin (Dox) and irinotecan (Iri) loaded microspheres (swine hepatic artery embolization) were conducted. Compared to 70–150 μm DC Bead LUMI (LUMI70‐150), LUMI40‐90 averaged 70 μm versus 100 μm, which was unchanged upon drug loading. Handling, suspension, and microsphere delivery studies were successfully performed. Dox loading was faster (20 min) and Iri equivalent (<10 min) while drug elution rates were similar. Contrast suspension times were longer with no delivery complications. Vascular penetration was statistically greater (rabbit) with no unexpected adverse safety findings (swine). Microspheres ± drug were visible under X‐ray imaging (CT) at 90 days. Peak plasma drug levels and area under the curve were greater for LUMI40‐90 compared to LUMI70‐150 but comparable to 70–150 μm DC BeadM1™ (DC70‐150). Local tissue effects showed extensive hepatic necrosis for Dox, whereas Iri displayed lower toxicity with more pronounced lobar fibrosis. LUMI40‐90 remains suspended for longer and have greater vessel penetration compared to the other DC Bead LUMI sizes and are similarly highly biocompatible with long‐term visibility under X‐ray imaging. Drug loading is equivalent or faster with pharmacokinetics similar to DC70‐150 for both Dox and Iri.
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spelling pubmed-74969502020-09-25 Handling and performance characteristics of a new small caliber radiopaque embolic microsphere Lewis, Andrew L. Caine, Marcus Garcia, Pedro Ashrafi, Koorosh Tang, Yiqing Hinchcliffe, Lorcan Guo, Wei Bascal, Zainab Kilpatrick, Hugh Willis, Sean L. J Biomed Mater Res B Appl Biomater Original Research Reports The in vitro and in vivo handling and performance characteristics of a small caliber radiopaque embolic microsphere, 40–90 μm DC Bead LUMI™ (LUMI40‐90), were studied. Microsphere drug loading and elution and effects on size, suspension, and microcatheter delivery were evaluated using established in vitro methodologies. In vivo evaluations of vascular penetration (rabbit renal artery embolization), long‐term biocompatibility and X‐ray imaging properties, pharmacokinetics and local tissue effects of both doxorubicin (Dox) and irinotecan (Iri) loaded microspheres (swine hepatic artery embolization) were conducted. Compared to 70–150 μm DC Bead LUMI (LUMI70‐150), LUMI40‐90 averaged 70 μm versus 100 μm, which was unchanged upon drug loading. Handling, suspension, and microsphere delivery studies were successfully performed. Dox loading was faster (20 min) and Iri equivalent (<10 min) while drug elution rates were similar. Contrast suspension times were longer with no delivery complications. Vascular penetration was statistically greater (rabbit) with no unexpected adverse safety findings (swine). Microspheres ± drug were visible under X‐ray imaging (CT) at 90 days. Peak plasma drug levels and area under the curve were greater for LUMI40‐90 compared to LUMI70‐150 but comparable to 70–150 μm DC BeadM1™ (DC70‐150). Local tissue effects showed extensive hepatic necrosis for Dox, whereas Iri displayed lower toxicity with more pronounced lobar fibrosis. LUMI40‐90 remains suspended for longer and have greater vessel penetration compared to the other DC Bead LUMI sizes and are similarly highly biocompatible with long‐term visibility under X‐ray imaging. Drug loading is equivalent or faster with pharmacokinetics similar to DC70‐150 for both Dox and Iri. John Wiley & Sons, Inc. 2020-06-23 2020-10 /pmc/articles/PMC7496950/ /pubmed/32578348 http://dx.doi.org/10.1002/jbm.b.34619 Text en © 2020 The Authors. Journal of Biomedical Materials Research Part B: Applied Biomaterials published by Wiley Periodicals LLC. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Original Research Reports
Lewis, Andrew L.
Caine, Marcus
Garcia, Pedro
Ashrafi, Koorosh
Tang, Yiqing
Hinchcliffe, Lorcan
Guo, Wei
Bascal, Zainab
Kilpatrick, Hugh
Willis, Sean L.
Handling and performance characteristics of a new small caliber radiopaque embolic microsphere
title Handling and performance characteristics of a new small caliber radiopaque embolic microsphere
title_full Handling and performance characteristics of a new small caliber radiopaque embolic microsphere
title_fullStr Handling and performance characteristics of a new small caliber radiopaque embolic microsphere
title_full_unstemmed Handling and performance characteristics of a new small caliber radiopaque embolic microsphere
title_short Handling and performance characteristics of a new small caliber radiopaque embolic microsphere
title_sort handling and performance characteristics of a new small caliber radiopaque embolic microsphere
topic Original Research Reports
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7496950/
https://www.ncbi.nlm.nih.gov/pubmed/32578348
http://dx.doi.org/10.1002/jbm.b.34619
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