TY - JOUR
T1 - Evaluation of a biocompatible sealant for on-demand repair of vascular defects-a chronic study in a large animal model
AU - Wussler, Desiree
AU - Kiefer, Selina
AU - Naumann, Susanne
AU - Hackner, Danilo
AU - Nadjiri, Jonathan
AU - Meckel, Stephan
AU - Haberstroh, Jörg
AU - Kubicki, Rouven
AU - Seifert, Andreas
AU - Siepe, Matthias
AU - Ewert, Peter
AU - Stiller, Brigitte
AU - Lang, Nora
N1 - Publisher Copyright:
© The Author(s) 2020. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
PY - 2020/5/1
Y1 - 2020/5/1
N2 - OBJECTIVES: Existing surgical sealants fail to combine design requirements, such as sealing performance, on-demand activation and biocompatibility. The aim of this study was to compare the effectiveness and safety of the SETALIUMTM Vascular Sealant (SVS), a novel, on-demand activatable sealant, with the commercial sealant, BioGlueVR, for the repair of vascular defects. METHODS: In an in vivo porcine model, the use of SVS was compared with BioGlue, for sealing 2-mm defects of the carotid artery and jugular vein. Animals were followed for 7 days and 5 weeks (each time point and per experimental group, n = 4), respectively. The degree of stenosis and flow velocity was determined, and the local tissue response was evaluated. RESULTS: In vivo incision closure succeeded in all cases, and SVS was superior in clinical usability, enabled by its on-demand activation. Unlike BioGlue, SVS use did not induce stenosis and was associated with physiological blood flow in all cases. Moreover, closure with SVS was associated with a low inflammatory reaction and no thrombus formation or intima proliferation, in contrast to BioGlue. CONCLUSIONS: SVS demonstrated effective and rapid sealing of 2-mm vascular defects, with favourable biocompatibility compared to BioGlue. Thus, SVS seems to be an effective and safe vascular sealant.
AB - OBJECTIVES: Existing surgical sealants fail to combine design requirements, such as sealing performance, on-demand activation and biocompatibility. The aim of this study was to compare the effectiveness and safety of the SETALIUMTM Vascular Sealant (SVS), a novel, on-demand activatable sealant, with the commercial sealant, BioGlueVR, for the repair of vascular defects. METHODS: In an in vivo porcine model, the use of SVS was compared with BioGlue, for sealing 2-mm defects of the carotid artery and jugular vein. Animals were followed for 7 days and 5 weeks (each time point and per experimental group, n = 4), respectively. The degree of stenosis and flow velocity was determined, and the local tissue response was evaluated. RESULTS: In vivo incision closure succeeded in all cases, and SVS was superior in clinical usability, enabled by its on-demand activation. Unlike BioGlue, SVS use did not induce stenosis and was associated with physiological blood flow in all cases. Moreover, closure with SVS was associated with a low inflammatory reaction and no thrombus formation or intima proliferation, in contrast to BioGlue. CONCLUSIONS: SVS demonstrated effective and rapid sealing of 2-mm vascular defects, with favourable biocompatibility compared to BioGlue. Thus, SVS seems to be an effective and safe vascular sealant.
KW - Biocompatibility
KW - Large animal model
KW - Pre-clinical
KW - Synthetic polymer
KW - Tissue adhesive
KW - Vascular sealant
UR - http://www.scopus.com/inward/record.url?scp=85084105012&partnerID=8YFLogxK
U2 - 10.1093/icvts/ivaa012
DO - 10.1093/icvts/ivaa012
M3 - Article
C2 - 32159755
AN - SCOPUS:85084105012
SN - 1569-9293
VL - 30
SP - 715
EP - 723
JO - Interactive Cardiovascular and Thoracic Surgery
JF - Interactive Cardiovascular and Thoracic Surgery
IS - 5
ER -