Durability of tissue engineered bovine pericardium (cardiocel) when used for the repair of congenital heart defects at 24 months or longer follow up

Abstract

Background: To investigate the indications for usage and incidence of failure of CardioCel (Admedus, Fremantle, Australia) when used for the repair of congenital heart defects in the paediatric population. Material and Methods: Between October 2012 and November 2014, CardioCel was implanted in 130 patients (135 procedures, 194 implants) involving 16 (12%) neonates, 76 (56%) infants and 43 (32%) children >365 days with 99 (51%) simple septation procedures and 95 (49%) more complex three-dimensional reconstructions. All patients have been followed up for 24 months or longer. Implant failure was defined as embolism, infection, thrombosis, structural leak, radiologic evidence of calcification or re-intervention due to patch failure. Six explants underwent histological evaluation. Results: CardioCel failed in 9 patients (6.7%) (neo-intima/granulation tissue formation in 8; thrombosis in 1). Only 1 implant failed within 30 days (IVC reconstruction; thrombosis). 7 of the 9 failures occurred within 12 months. 8 patients have required 12 reinterventions (6 catheter, 6 surgical). Both implants failed when used for intra-atrial baffle reconstruction in total anomalous pulmonary venous drainage and 2 of 3 implants failed when used for reconstruction of systemic veins. Cumulative freedom from implant failure was 95% (95% CI: 91-98) after 12 months, and 93% (95% CI: 89-97) after 24 months and 36 months. The incidence of failure in neonates was 18.7% (3 of 22 implants), compared to infants (6.6%; 5 of 115 implants) and older children (2.3%; 1 of 57 implants) (p =0.14). Incidence of failure was higher when CardioCel was used for indications other than simple septation [9/ 95 (9.4%) versus 0/99, p= 0.001]. Histological evaluation of 6 explants demonstrated evidence of early remodeling. Conclusion: CardioCel demonstrates good durability when used for the repair of congenital heart defects. The incidence of failure is higher when used for the reconstruction of systemic veins or anomalous pulmonary venous drainage.L6200748212018-01-09 <br />