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

https://doi.org/10.1053/j.semtcvs.2015.08.008Get rights and content

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.

Section snippets

Clinical Data

The study was approved by the Institutional Review Board at Nationwide Children׳s Hospital. The data were retrospectively collected from patients who underwent cardiac surgery using CorMatrix as an interposition graft from May 2012 to May 2013. Demographic and clinical data such as cardiac diagnosis, echocardiography, and cardiac catheterization results were reviewed.

Surgery

The CorMatrix patch was wrapped around a Hegar dilator of the required size while the edge was sutured with 7-0 PROLENE (PROLENE,

Results

A total of 13 patients underwent cardiac surgery using CorMatrix conduit as an interposition graft.

Of these patients, the grafts were used for central PA reconstruction in comprehensive stage II surgery for hypoplastic left-sided heart syndrome in 10 patients (Supplementary Table 1). Sudden death occurred in 2 patients at home due to unknown causes after stage II surgery. Of the 8 surviving patients, 4 underwent the Fontan procedure, and the other 4 patients are waiting for it. The average

Discussion

Core matrix is made from subintestinal mucosa (SIS) and has been used extensively as an ECM, especially for reconstruction of various tissues such as the abdominal wall, urinary bladder wall, tendons, intestine wall tissue, urethra, and ureter.11 CorMatrix has recently been used in cardiac surgery for intraventricular septal repair,12 myocardial regeneration,13 valvuloplasty,9 or angioplasty as a patch.7, 14 The use of CorMatrix in congenital heart disease has also been reported recently.8, 10,

Conclusion

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 venous circulation. Longer-term follow-up is required to assess the potential for growth of an arterial conduit. CorMatrix may not be the ideal conduit material in the low-pressure small-diameter system in children to provide long-term durable outcomes.

Conflict of Interest

Patrick McConnell

Grant/Research Support—CorMatrix cardiovascular, Inc; Thoratec Corporation

Consultant—Q test Laboratories; Clear Catheter Systems, Inc

Toshiharu Shinoka

Grant or Research Support—Gunze, Inc

References (23)

  • F.G. Scholl et al.

    Preliminary experience with cardiac reconstruction using decellularized porcine extracellular matrix scaffold: Human applications in congenital heart disease

    World J Pediatr Congenit Heart Surg

    (2010)
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