Evaluation of Explanted CorMatrix TYKE Extracardiac Patches in Infants with Congenital Heart Disease.

Abstract Background Animal data demonstrate that intracardiac patches of decellularized porcine small intestine sub-mucosa (CorMatrix; CorMatrix Cardiovascular, Inc, Atlanta, GA) become repopulated with native cells, suggesting the possibility of a substrate for regenerative tissue in humans. While human studies have not demonstrated this regenerative property with intra-cardiac patches, it is possible that other environments may better promote native cell repopulation. We report a prospective series of explanted CorMatrix extra-cardiac patches placed in infants with congenital heart disease. Methods CorMatrix TYKE patches were used in pulmonary artery patch closure during the Norwood procedure. The patch material was explanted as part of the hemi-Fontan procedure. Specimens were analyzed with the use of hematoxylin and eosin, Movat pentachrome, and trichrome stains. Results Of the 11 implantations, 9 specimens were explanted. One patient did not survive to hemi-Fontan procedure. One patient’s patch was removed, but not analyzed. Acellular material, chronic inflammation, fibrosis, and foreign body giant cell reaction was seen in all explanted patches. No explanted CorMatrix TYKE material demonstrated evidence of ingrowth of native endothelial tissue at a median of 4.9 months in vivo. Conclusions CorMatrix TYKE patch material, placed as a pulmonary artery patch in an extra-cardiac position, remained pliable and mostly free of calcification. However, these patches did not show evidence of native endothelial tissue at a median of 4.9 months in vivo.