CardioCel® for the Repair of Congenital Heart Defects: An Australian Single-Centre Experience

Abstract

Introduction: CardioCel® (Lemaitre, Kensington, VIC) is decellularised tissue-engineered bovine pericardium subjected to anticalcification treatment using the ADAPT® process. Its use for the repair of congenital heart defects has been increasing over the past decade. However, the mid-long-term performance of this material remains to be described. Methods: We retrospectively reviewed the outcomes of CardioCel patches in paediatric cardiac surgery at the Queensland Children’s Hospital (QCH) from 2012 to 2020. All patients were consented for the use of CardioCel. Data were obtained from hospital records. Results: A total of 536 patches were implanted in 374 patients across the study period. Median age at implantation was 8.3 months (IQR: 3.4–55.4 months). Anatomic locations are given in Table 1. Eight patients (2.1%) died during a median follow-up of 3.4 years (IQR: 1.1 – 5.2 years). Only one death was related to CardioCel (rupture of infundibular patch most likely related to infection). Survival was 100% (95%CI 98%-100%) at 1, 3 and 5 years. Nineteen (5.1%) patients underwent reintervention (13 surgical, 6 interventional) related to CardioCel (Table 1). The highest incidence of reintervention occurred in the right ventricular outflow tract (n=11, 11/19 = 58%). Freedom from CardioCel-related intervention was 97% (95%CI: 94%-98%), 95% (95%CI: 92%-97%), and 92% (95%CI: 88%-95%) at 1 year, 3 years, and 5 years, respectively. Conclusion: CardioCel can be used for the repair of a wide variety of congenital heart defects in the paediatric population with acceptable mid-term durability. [Formula presented]L20138248062022-03-11 <br />