Wussler Desiree, Kiefer Selina, Naumann Susanne, Hackner Danilo, Nadjiri Jonathan, Meckel Stephan, Haberstroh Jörg, Kubicki Rouven, Seifert Andreas, Siepe Matthias, Ewert Peter, Stiller Brigitte, Lang Nora
Department of Congenital Heart Defects and Pediatric Cardiology, University Heart Center Freiburg-Bad Krozingen, University of Freiburg, Freiburg, Germany.
Institute for Surgical Pathology, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Interact Cardiovasc Thorac Surg. 2020 May 1;30(5):715-723. doi: 10.1093/icvts/ivaa012.
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 SETALIUM™ Vascular Sealant (SVS), a novel, on-demand activatable sealant, with the commercial sealant, BioGlue®, for the repair of vascular defects.
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.
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.
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.
现有的手术密封剂未能兼顾密封性能、按需激活和生物相容性等设计要求。本研究旨在比较新型按需激活密封剂SETALIUM™血管密封剂（SVS）与商用密封剂BioGlue®修复血管缺损的有效性和安全性。
在猪体内模型中，比较SVS与BioGlue用于封闭颈动脉和颈静脉2毫米缺损的情况。分别对动物进行7天和5周的随访（每个时间点和每个实验组，n = 4）。测定狭窄程度和流速，并评估局部组织反应。
所有病例的体内切口均成功闭合，SVS因其按需激活在临床可用性方面更具优势。与BioGlue不同，使用SVS不会导致狭窄，且所有病例均与生理性血流相关。此外，与BioGlue相比，使用SVS闭合与低炎症反应相关，无血栓形成或内膜增生。
SVS对2毫米血管缺损具有有效且快速的密封效果，与BioGlue相比具有良好的生物相容性。因此，SVS似乎是一种有效且安全的血管密封剂。
