ABSTRACT
OBJECTIVES: To assess the mid-term performance of CardioCel for the repair of congenital heart defects. METHODS: Data were retrospectively collected from databases and hospital records in 3 congenital cardiac surgery centres in Australia. Kaplan-Meier curves and log-rank tests were used to test for associations between patient age, gender, patch type and site of implantation. Multivariable Cox regression was used to test whether any specific implantation site was associated with reintervention risk, after adjusting for age group, gender and patch type. RESULTS: A total of 1184 CardioCel patches were implanted in 752 patients under the age of 18 years. Median age at implant was 12 months [interquartile range (IQR) 3.6-84]. Median follow-up was 2.1 years (IQR 0.6-4.6). Probability of freedom from CardioCel-related reintervention was 93% [95% confidence interval (CI) 91-95] at 1 year, 91% (95% CI 88-93) at 3 years and 88% (95% CI 85-91) at 5 years, respectively. On multivariable regression analysis, aortic valve repair had a higher incidence of reintervention [hazard ratio (HR) = 7.15, P = 0.008] compared to other sites. The probability of reintervention was higher in neonates (HR = 6.71, P = 0.0007), especially when used for augmentation of the pulmonary arteries (HR = 14.38, P = 0.029), as compared to other age groups. CONCLUSIONS: CardioCel can be used for the repair of a variety of congenital heart defects. In our study, in patients receiving a CardioCel implant, reinterventions were higher when CardioCel was used to augment the pulmonary arteries in neonates and for aortic valve repair as compared to other sites.
Subject(s)
Cardiac Surgical Procedures , Heart Defects, Congenital , Infant, Newborn , Humans , Infant , Adolescent , Tissue Engineering/methods , Retrospective Studies , Heart Defects, Congenital/epidemiology , Heart Defects, Congenital/surgery , Prostheses and Implants , Cardiac Surgical Procedures/methods , Treatment OutcomeABSTRACT
A systematic review was performed for evaluation of the performance of CardioCel® in cardiac surgery. The review included all studies published from January 2013 to December 2020. We conclude that CardioCel is a strong, flexible tissue substitute with good handling characteristics and a low incidence of thrombosis, aneurysm formation, infection, or structural degeneration. It can be used for a variety of intracardiac and extracardiac repairs of congenital heart defects in all age groups with good durability at mid-term follow-up. However, the use of CardioCel in certain positions requires caution. Information on the long-term performance of CardioCel is lacking.
Subject(s)
Cardiac Surgical Procedures , Heart Defects, Congenital , Humans , Tissue Engineering , Pericardium , Heart Defects, Congenital/surgery , IncidenceABSTRACT
CardioCel® is bovine pericardium which is subjected to a novel tissue engineering process (ADAPT®) to reduce cytotoxicity and retard calcification while maintaining strength and elasticity. We present a case where CardioCel® showed rapid degeneration and calcification after repair of an aortic valve.
