Evaluation of Explanted CorMatrix Intracardiac Patches in Children With Congenital Heart Disease

Background. Animal data demonstrate that intracardiac patches of decellularized porcine small intestine submucosa (CorMatrix; CorMatrix Cardiovascular, Inc, Atlanta, GA) become repopulated with native cells, suggesting the possibility of a substrate for regenerative tissue in humans. We report the only prospective series to date of explanted CorMatrix patches placed in infants with congenital heart disease. Methods. CorMatrix patches were implanted as the hemi-Fontan baffle in patients during their second stage of palliation. The patch material was explanted as part of the standard Fontan operation. Specimens were analyzed with the use of hematoxylin and eosin, Movat pentachrome, and trichrome stains. Results. Of the 12 implantations, 10 specimens were explanted. Two patients did not undergo Fontan because of unfavorable hemodynamics. Acellular material, chronic inflammation, fibrosis, and foreign body giant cell reaction was seen in all explanted patches. Also noted in explanted specimens was calcification (n=2), elastic fibers (n=2), and eosinophils (n=2). No explanted CorMatrix material showed evidence of ingrowth of native cells or transformation into cardiac tissue at a median of 21 months after implantation. Conclusions. Although the CorMatrix remained pliable and most did not exhibit calcification, these intracardiac patches did not show evidence of native heart tissue ingrowth at a median of 21 months in vivo. (C) 2016 by The Society of Thoracic Surgeons