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

Abstract

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. 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. 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). 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.