Australia-Wide Experience With Tissue-Engineered Bovine Pericardium (CardioCel) for the Repair of Congenital Heart Defects

Abstract

Aim: To report the Australia-wide clinical experience with tissue-engineered bovine pericardium (CardioCel; Admedus, Perth, Australia) used for the repair of congenital heart defects. Method: Between October 2012 and March 2018, CardioCel was implanted in 496 patients totalling 707 implants across the two paediatric cardiac centres in Brisbane and Melbourne. Applications included closure of septal defects (n = 183; 25.9%), repair of pulmonary arteries (n = 170; 24.0%), aortic root and arch repair (n = 114; 16.1%), valve repair (n = 99; 14.0%), right ventricular outflow tract reconstruction or placement of a trans-annular patch (n = 80; 11.3%), and other indications (n = 61; 8.6%). There were 82 (11.6%) procedures performed in neonates, 288 (40.7%) in infants, and 337 (47.7%) in children older than 365 days. Results: Median follow-up was 24 months (range 1–64 mo). Nineteen reinterventions (73%) occurred within the first 12 months and all occurred within 36 months. Overall freedom from reintervention was 97.8% (95% confidence interval [CI] 93–99) at 12 and 24 months, and 96.3% (95% CI 91–98) at 60 months. There was an increased risk of reintervention in neonates versus children older than 1 year of age (hazard ratio [HR] 4.7, 95% CI 1.52–14.8); p = 0.007) and in infants versus children older than 1 year of age (HR 2.98, 95% CI 1.34–7.81; p = 0.026]. There was no increased risk related to use in the ascending aorta and aortic arch (HR 0.50, 95% CI 0.12–2.13; p = 0.35). An increased risk of reintervention was observed for pulmonary artery patches (HR 2.14, 95% CI 0.99–4.62; p = 0.054). Conclusions: CardioCel has good durability when used for the repair of congenital heart defects, including the aortic arch in neonates and infants. The risk of reintervention is higher when it is used to reconstruct pulmonary arteries, especially in neonates and infants versus older children.L20020515472019-06-12 <br />