An evaluation of Admedus’ tissue engineering process-treated (ADAPT) bovine pericardium patch (CardioCel) for the repair of cardiac and vascular defects

Abstract

Tissue engineers have been seeking the ‘Holy Grail’ solution to calcification and cytotoxicity of implanted tissue for decades. Tissues with all of the desired qualities for surgical repair of congenital heart disease (CHD) are lacking. An anti-calcification tissue engineering process (ADAPT^® TEP) has been developed and applied to bovine pericardium (BP) tissue (CardioCel^®, AdmedusRegen Pty Ltd, Perth, WA, Australia) to eliminate cytotoxicity, improve resistance to acute and chronic inflammation, reduce calcification and facilitate controlled tissue remodeling. Clinical data in pediatric patients, and additional pre-market authorized prescriber data demonstrate that CardioCel performs extremely well in the short term and is safe and effective for a range of congenital heart deformations. These data are supported by animal studies which have shown no more than normal physiologic levels of calcification, with good durability, biocompatibility and controlled healing.

Keywords:

• ADAPT^®
• BP scaffold
• BP
• congenital heart disease
• tissue engineering process
• tissue-engineered xenograft

Financial & competing interests disclosure

G Strange is a consultant to AdmedusRegen Pty Ltd, and serves as Medical Director, Admedus Ltd. C Brizard has received honorarium for speaking for Admedus Ltd and serves on the scientific Medical advisory Board for Admedus Ltd. TR Karl has received travel grants and honorarium for speaking and serves on the Scientific Medical Advisory Board for Admedus Ltd. L Neethling serves as an advisory consultant to Admedus Ltd. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

The authors would like to thank J Statmoen for providing writing assistance on this manuscript.

Key issues

• Advances in cardiac surgery have led to longer life expectancy for congenital heart disease patients.

• While bovine pericardium has been successfully used in the repair of a range of congenital heart defects, calcification and degeneration remain limiting factors in the longevity of these xenogenic prostheses.

• When selecting materials to repair congenital cardiac defects in newborns and pediatric patients, consideration should be given to the implications of the changing demographics and longer life expectancy of patients.

• Degenerative processes involving rigidity, calcification and shrinkage leading to ultimate failure of the prosthesis are well-known limitations of GA-preserved bovine pericardium.

• Extensive research for more than a decade has resulted in the development of an anti-calcification tissue engineering process (ADAPT^®, AdmedusRegen, Perth, WA, Australia). This engineering process may represent a significant advance over current technology, providing a platform to produce a permanent solution for patients across a range of repair strategies.