Calcification or Not. This Is the Question. A 1-Year Study of Bovine Pericardial Vascular Patches (CardioCel) in Minipigs.

A main problem with bioprosthesis used for surgical correction of congenital cardiac malformation is its tendency to shrink and to calcify. Recently, a new material, that is, decellularized bovine pericardium (CardioCel), was introduced in clinics. It was proposed that this new patch material should not calcify and should be particularly suitable for the correction of vascular defects in inborn cardiac diseases. The aim of our chronic minipig study was to evaluate the performance of CardioCel patches implanted in aortic and pulmonary artery position, respectively. Ten minipigs aged 3 months were operated on. A CardioCel patch was implanted in the aorta ascendens and arteria pulmonalis, respectively. Seven minipigs completed the 12 months' follow-up. Angiography of both vessels, measurement of pressure gradients, and histologic evaluation of the implanted patches were carried out. Angiography of both great vessels revealed a good clinical outcome without stenosis. However, histologic examination of the patches showed calcification and neo-formation of hyaline cartilage in both vessel types. Staining of collagen and elastic fibers as well as α-smooth muscle actin demonstrated that the patches did not remodel into an anatomic vascular structure during the 1 year of implantation. In our chronic piglet model, CardioCel patches, when implanted in the ascending aorta and the pulmonary artery, led to calcification and neo-formation of hyaline cartilage in both vessel types 1 year after implantation. The present study indicates that the ideal patch biomaterial for repair of inborn cardiac diseases is still a goal not achieved yet.