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

Abstract

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.

Calcific Degeneration of CorMatrix 4 Years After Bicuspidization of Unicuspid Aortic Valve

“…Recent reports, however, have detailed the histologic features of explants from failed repair procedures, revealing a high frequency of chronic inflammation, little to no patch resorption, and minimal remodeling [3]. The mode of valve failure (severe regurgitation) and histologic findings of variable chronic inflammation in these reports [4][5][6] were similar to the current case. However, this is the longest reported follow-up of a patient to date, showing complete calcification of the patch in the AV position.…”

“…However, this is the longest reported follow-up of a patient to date, showing complete calcification of the patch in the AV position. Previous reports detailed intact patches without remodeling [4][5][6], but we observed a different pattern of failure: no residual scaffold but a failure of constructive remodeling into functional cusp tissue with fibrotic and calcific degeneration throughout the entire patch. The mixed inflammation status and the presence of infiltrates within calcific tissue and surrounding native tissues indicated an ongoing degenerative process and impaired remodeling.…”

“…Contrary to other published observations [4] that cellular invasion and tissue remodeling of the substitute only occur at the native tissue boundary and not at the free edge, we observed the opposite, adding to information about the in vivo reaction of CorMatrix in the valvular position midterm. Although the material has potential as a pericardial substitute, this case and other emerging reports [4][5][6] have prompted us to await further details about its tissue-and site-specific behavior and data on time intervals for remodeling in clinical practice.…”

Early complications of biologic extracellular matrix patch after use for femoral artery repair

“…In this image, the lower edge is partially "rolled over" on itself due to the formalin fixation process. 13 report that explanted hemi-Fontan SIS patches "did not show evidence of native heart tissue ingrowth at a median of 21 months in vivo." Histologic findings of our explanted specimens are consistent with previous reports and suggested no infection and poor patch strength.…”

Regenerative Therapy for Patients with Congenital Heart Disease

“…In animal experiments, it has been reported that the application of SIS-ECM resulted in remodeling of the heart and regeneration into myocardial tissue 39 ; however, disappointing results have also been observed in retrospective human studies in recent years. 40,41 SIS-ECM was explanted from CHD patients who underwent surgical repair using SIS-ECM to repair cardiac defects. Histological studies showed no regeneration of native tissue in the patch.…”