Bruun Villads Juul, Jensen Line Lyngbak, Hasenkam J Michael, Jedrzejczyk Johannes H
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Aarhus, Denmark.
Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Front Cardiovasc Med. 2025 Jun 25;12:1532157. doi: 10.3389/fcvm.2025.1532157. eCollection 2025.
Porcine small intestinal submucosal extracellular matrix (PSIS-ECM) is a biomaterial that has gained increasing popularity in cardiovascular surgery over the past three decades. This popularity is due to PSIS-ECM demonstrating properties of an ideal biological scaffold; it is easy to use, lacks immunogenicity, is absorbable, possesses the potential to promote native tissue growth, and exhibits remodelling properties. We systematically reviewed the literature on the preclinical and clinical use of this approach in cardiovascular surgery over the past decade.
Utilizing a box-search methodology, an extensive survey of the literature on PSIS-ECM's application in cardiovascular surgery from 2013 until September 2023 was conducted within the PubMed and Embase databases. Initially, 245 publications were identified. Following title, abstract, and full-text screening, 66 articles were included in the survey.
Among nine preclinical studies conducting histological assessments of explants, eight did not report signs of inflammation. Tissue remodelling was documented in six preclinical studies. Histological examination of explants was incorporated into thirteen clinical cohort studies, all of which demonstrated varying intensities of inflammation and no or minimal signs of regeneration and remodeling. The reintervention rates among clinical cohort studies range from 4.5% to 87.5%. Eleven studies reported a reintervention rate exceeding 15%, while six reported a reintervention rate below 15%.
Preclinical studies corroborate the notion that PSIS-ECM exhibits properties of an ideal biological scaffold. However, these findings lack reproducibility in clinical settings. Combined with reports from clinical studies showing reintervention rates exceeding 15%, this has raised concerns about whether clinical application of PSIS-ECM should be confined to selected cases.
猪小肠黏膜下层细胞外基质（PSIS - ECM）是一种生物材料，在过去三十年中，它在心血管外科手术中的应用越来越广泛。这种广泛应用是因为PSIS - ECM具有理想生物支架的特性；它易于使用，缺乏免疫原性，可吸收，具有促进天然组织生长的潜力，并表现出重塑特性。我们系统回顾了过去十年中该方法在心血管外科手术中的临床前和临床应用的文献。
采用箱式搜索方法，在PubMed和Embase数据库中对2013年至2023年9月期间关于PSIS - ECM在心血管外科手术中应用的文献进行了广泛检索。最初，识别出245篇出版物。经过标题、摘要和全文筛选，66篇文章被纳入调查。
在九项对外植体进行组织学评估的临床前研究中，八项未报告炎症迹象。六项临床前研究记录了组织重塑。十三项临床队列研究纳入了外植体的组织学检查，所有这些研究均显示出不同程度的炎症，且无再生和重塑迹象或迹象极小。临床队列研究中的再次干预率在4.5%至87.5%之间。十一项研究报告的再次干预率超过15%，而六项研究报告的再次干预率低于15%。
临床前研究证实了PSIS - ECM具有理想生物支架特性的观点。然而，这些发现在临床环境中缺乏可重复性。结合临床研究报告显示再次干预率超过15%，这引发了关于PSIS - ECM的临床应用是否应局限于特定病例的担忧。
