A Review of the Use of Decellularized, Porcine, Small-Intestinal, Submucosal, Extracellular-Matrix Patch Material in Congenital Heart Surgery

Patch material is frequently used by pediatric cardiac surgeons during repair of congenital heart disease. The ideal patch material would be pliable, durable, promote native tissue ingrowth, and allow for somatic growth. Intraoperatively, other desirable characteristics would include the material be hemostatic (i.e. lack of bleeding at needle holes) and isotropic (i.e. stretching in all directions, allowing for complex 3-dimensional patches). Decellularized, porcine, small-intestinal, submucosal, extracellular matrix material has shown promise as a potentially ideal patch material. Proxicor (4-ply) and Tyke (2-ply) (Aziyo Biologics, Silver Spring, MD) are commercially available, extracellular matrix material products that are approved by the United States Food and Drug Administration for use in pediatric cardiac surgery. While initial studies were encouraging regarding the extracellular matrix material potential for native tissue ingrowth, subsequent studies have not reproduced the early findings. In most histological analyses, explanted extracellular matrix material has demonstrated chronic inflammatory cell migration and scarring. Despite the lack of transformation, extracellular matrix material does have the advantages of remaining pliable and resisting calcification, which are desirable in the reconstruction of congenital heart defects.