About the registry
The International CardioCel Outcomes Registry (ICOR) is a part industry funded Queensland led health services initiative that records outcome and performance data relating to surgery involving the use of ADAPT treated bovine pericardium (CardioCel). The ADAPT process was patented by Anteristech based in Malaga near Perth in Western Australia. CardioCel is marketed by LeMaitre Vascular, Inc, a leading global innovator, manufacturer and marketer of devices for the treatment of vascular disease. Le Maitre is headquartered in Burlington, MA, USA.
Collation and analysis of data in ICOR provides a real-time picture of the clinical outcomes associated with the use of CardioCel across the world and monitors how these outcomes change with time.
ICOR is managed by the Queensland Paediatric Cardiac Research (QPCR) team based at the Centre for Children's Health Research Centre in Brisbane, Australia. QPCR is affiliated with the Child Health Research Centre at the University of Queensland. ICOR is co-funded by the Children's Hospital Foundation and LeMaitre.
Research Projects
2022-2025 ICOR Research Projects
Systematic Review
Accepted for publication in the World Journal of Pediatric and Congenital Heart Surgery in January 2023
A systematic review was performed for evaluation of the performance of CardioCel® in cardiac surgery. The review included all studies published from January 2013 to December 2020. We conclude that CardioCel is a strong, flexible tissue substitute with good handling characteristics and a low incidence of thrombosis, aneurysmal formation, infection, or structural degeneration. It can be used for a variety of intracardiac and extracardiac repairs of congenital heart defects in all age groups with good durability at mid-term follow-up. However, the use of CardioCel for repair of aortic valves requires caution. Information on the long-term performance of CardioCel is lacking.
Long-term performance of CardioCel in Australia
Presented at the 36th EACTS Annual Meeting | 5-8 October, 2022 | Milan, Italy
A retrospective study examining the long term outcomes following the repair of heart congenital heart defects from 3 centres across Australia between 2012 and 2019.
Report to Therapeutic Goods Administration (Australia)
2023
The ICOR project team will assist LeMaitre to prepare a report for the Therapeutic Goods Administration (TGA) in Australia describing the performance of CardioCel in Australia over 10 years from 2012 to 2022 as part of their application for TGA approval in Australia. CardioCel has FDA approval in the USA and CE marking in Europe.
Contact Us
Queensland Paediatric Cardiac Research
Level 4, Centre for Children's Health Research
Raymond Terrace, Brisbane
Australia
+61 7 3069 7256
