Preliminary Experience in the Use of an Extracellular Matrix (CorMatrix) as a Tube Graft: Word of Caution

Abstract

A number of materials have been used for the repair of congenital heart disease. However, an ideal material is yet to be discovered. Decellularized extracellular matrix from porcine small intestinal submucosa (CorMatrix) has been developed and commercialized as a biological tissue substitute. This has been used for valvuloplasty, sepal defect repair, or angioplasty as a patch. In this study, we demonstrate our preliminary experience using CorMatrix as a tube graft. A retrospective review of 13 patients who underwent cardiac surgery using CorMatrix as an interposition graft was performed (10 patients for central pulmonary artery reconstruction in comprehensive stage II surgery for hypoplastic left-sided heart syndrome and 3 patients for aortic arch reconstruction in interrupted aortic arch). At a mean follow-up of 9.7 months, 8 of 10 patients who underwent central pulmonary artery reconstruction using CorMatrix tube showed progressive significant stenosis. One patient underwent replacement of the CorMatrix tube with a homograft because of severe stenosis after the placement of a stent. All 3 patients who had aortic arch reconstruction with the CorMatrix tube demonstrated no stenosis, no dilatation, and no aneurysm formation. Although angioplasty using CorMatrix as an interposition tube vascular graft demonstrated no adverse event in the aortic position in short term, a high rate of intimal hyperplasia formation with significant stenosis was found in the low-pressure small-diameter system. Longer follow-up is required to assess the growth potential of the arterial conduit. CorMatrix may not be the ideal material as conduit in the low-pressure small-diameter system to provide long-term durable outcomes.

Keywords: angioplasty; biomaterials; extracellular matrix; stenosis.