Multicenter Experience With 500 CardioCel Implants Used for the Repair of Congenital Heart Defects

BACKGROUND: The purpose of this study was to assess the performance of more than 500 tissue-engineered bovine pericardial implants (CardioCel; Admedus, Toowong, Queensland, Australia) used for the repair of congenital heart defects.

METHODS: Clinical data were collected for all patients who received a CardioCel implant at three centers (Brisbane, Australia; and Leicester and Bristol, United Kingdom). During this period, 501 CardioCel patches were implanted in 377 patients. The primary endpoint was CardioCel-related surgical or catheter intervention. Secondary endpoints included implant-related thromboembolism, residual shunt, infection, calcification leading to loss of function, and hemodynamic compromise. Mortality or reintervention was considered early if the event occurred within 30 days of implantation.

RESULTS: The median follow-up was 31 months (range, 1 to 60). There were 11 deaths (2.9%), 1 related to CardioCel. There was no echocardiographic or radiologic evidence of patch calcification in any patient. Overall freedom from reintervention 3 and 5 years after implantation was 96% (95% confidence interval, 93% to 98%). Fourteen implants (2.8%) required 18 reinterventions (3.6%) at the site of implantation (9 catheter based and 9 operative). There was no difference in the incidence of reintervention in the pulmonary arterial or systemic circulations (P = .18). There was no difference in performance of CardioCel in neonates (aged 0 to 28 days), infants (aged 29 to 365 days), or children aged more than 1 year (P = .22).

CONCLUSIONS: CardioCel has good durability when used for the repair of congenital heart defects. It performs comparably in the systemic and pulmonary circulations in neonates, infants, and older children.