Application of the CardioCel bovine pericardial patch – a preliminary report

Abstract

IntroductionAnimal pericardial patches are widely used in adult and pediatric cardiac surgery. A search is ongoing for a new material with optimal surgical properties that will reduce intraoperative bleeding and the occurrence of restenosis, calcification, and pseudoaneurysms in long-term observation. One product of interest is the CardioCel bovine pericardial patch.AimEvaluation of the short-term results of CardioCel bovine pericardial patch implantation during pediatric cardiac surgery.Material and methodsThe study included 8 patients who underwent surgical correction of congenital cardiac defects between January 2015 and February 2016. Pericardial patches were used to repair supravalvular aortic stenosis and reconstruct the aortic arch and pulmonary arteries. The age of the patients ranged from 10 days to 14 years.ResultsThere were no hospital deaths. The new material exhibited satisfactory durability and elasticity during surgery, facilitating optimal adaptation of the patch to the patient's tissues. No significant bleeding was reported from the suture site. The median duration of follow-up was 58 days. During the follow-up, there were no symptoms of pseudoaneurysm formation, patch thickening, or calcification in the areas where the pericardial patches were implanted. No clinical or laboratory symptoms of infection were observed in locations where the new material was applied.ConclusionsSatisfactory surgical properties of the patch were observed intraoperatively. Positive results using the new pericardial patch were obtained in short-term follow-up.

Congenital heart defect repair with ADAPT tissue engineered pericardium scaffold: An early-stage health economic model

“…The ADAPT tissue-engineered bovine pericardium bio-scaffold (CardioCel) is distinct from comparable patches by the removal of calcium-binding phospholipids and antigens during manufacture, both of which are known to promote the calcification observed with other patches [ 13 , 16 ]. Recent data from the extension study of the Phase II trial of CardioCel in CHD repair reported no calcification or repeat surgery across 14 patients followed-up for between five and eight years [unpublished data, [ 17 ]].…”

Performance of CardioCel in Cardiac Surgery: A Systematic Review

“…Stenosis at the anastomotic site was observed in 2 patients soon after surgery, however, at a follow-up of a median of 58 (range 14-219) days, no patient demonstrated failure of repair or required reintervention. 14…”

Decellularized xenografts in regenerative medicine: From processing to clinical application

“…These complications were often related to high pressure conditions, which could be indicative of the low performance due to insufficient mechanical properties of the source of tissue, as observed in vitro 205 . Therefore, crosslinked materials with enhanced mechanical properties, like bovine pericardium, that include processing steps preventing crosslinker‐related complications (eg calcification 211 ) have been developed, which have shown positive short‐term results in paediatric cardiovascular applications, 211‐213 but long‐term assessment is required.…”