Publications
References and Links to Papers
2017
Histologic Evaluation of Explanted Tissue-Engineered Bovine Pericardium (CardioCel)
Semin Thorac Cardiovasc Surg 2017 Autumn;29(3):356-363
Abstract
CardioCel is a bovine pericardium that is subjected to a novel anticalcification tissue-engineering process. We present the histopathologic findings of human explants of CardioCel that were used in operations for congenital heart disease in children. Six explants were identified from 140 patients undergoing CardioCel implants from October 2012 to March 2015. CardioCel explants were evaluated histologically using hematoxylin and eosin, Masson trichrome, and immunohistochemical staining. A variable inflammatory response was seen in the surrounding native tissue, but not within the CardioCel graft in any of the explants. A neointimal layer of varying thickness developed on the visceral surface of 5 CardioCel explants with endothelialization of the longest duration explant. A granulation tissue layer developed on the parietal surface of the graft (consistently thicker than the neointima). Maintained collagen fiber architecture (laminated) and variable fibroblastic invasion (which increased with the age of the implant) were identified in all 6 cases. Scattered capillary vessels were noted in the majority of the explants with new collagen fibers in one, suggesting early remodeling. Calcium was seen in 1 explant at the interface of the graft and inflammatory response on its parietal surface. Evidence of graft remodeling was noted in the majority of the explants without inflammatory cells or calcification within the explanted graft material. A noticeable feature was the differential thickness of the host reaction to the parietal compared with the visceral surface of the graft. We will continue to evaluate CardioCel as a cardiovascular substitute for extracardiac and intracardiac reconstructions.
​
2019
Multicenter Experience With 500 CardioCel Implants Used for the Repair of Congenital Heart Defects
Ann Thorac Surg 2019 Dec;108(6):1883-1888.
​
Abstract
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.
​
2019
Durability of tissue-engineered bovine pericardium (CardioCel) for a minimum of 24 months when used for the repair of congenital heart defects
Interact Cardiovasc Thorac Surg 2019 Feb 1;28(2):284-290.
Abstract
Objectives: This study aims to assess the performance of tissue-engineered bovine pericardium (CardioCel®) at 24 months and beyond when used for the repair of congenital heart defects.
Methods: Between October 2012 and November 2014, CardioCel was implanted in 135 patients (140 procedures and 195 implants). Applications included the closure of septal defects (98, 50.3%), repair of pulmonary arteries (63, 32.3%), intra-atrial/intraventricular baffles (10, 5.1%), repair of systemic arteries (15, 7.7%), valve repair (5, 2.6%), repair of systemic veins (3, 1.5%) and Fontan operation (1, 0.5%). There were 19 (13.6%) procedures performed in neonates, 77 (55%) in infants and 44 (31.4%) in children older than 365 days.
Results: Eight patients (n = 135, 5.9%) required reintervention in 12 instances (n = 195, 6.2%, 6 catheters and 6 surgical). There was no echocardiographic or radiological evidence of calcification in any patient. Ten of the reinterventions (83%) occurred within the first 12 months. All the reinterventions occurred within 36 months. Freedom from reintervention at both 12 and 24 months was 95% [confidence interval (CI) 91-97] and at 36 months was 94% (CI 89-97). There was no statistical difference in freedom from reintervention when stratified by age or patch position.
Conclusions: At 24 months and beyond the follow-up, the performance of CardioCel remains acceptable with good haemodynamic performance. There was no echocardiographic or radiological evidence of calcification in any patient. CardioCel performs comparably in systemic and pulmonary circulations.
​
https://doi-org.ezproxy.library.uq.edu.au/10.1093/icvts/ivy246
2021
Calcification Causing Failure of Tissue Engineered Bovine Pericardium After Aortic Valve Repair.
A case report.
Patukale AA, Davies J, Marathe S, Alphonso N, Venugopal P. Calcification Causing Failure of Tissue Engineered Bovine Pericardium After Aortic Valve Repair. World J Pediatr Congenit Heart Surg. 2021 Dec 3:21501351211036407. doi: 10.1177/21501351211036407. Epub ahead of print. PMID: 34861800.