title: New engineering treatment of bovine pericardium confers outstanding resistance to calcification in mitral and pulmonary implantations in a juvenile sheep model.
abstract: OBJECTIVE
  To conduct a test of noninferiority for CardioCel (Admedus, Brisbane, Australia), a chemically engineered bovine pericardium over autologous pericardium treated intraoperatively with glutaraldehyde in a chronic juvenile sheep model of pulmonary valve (PV) and mitral valve (MV) reconstruction.
  
  
  METHODS
  We replaced the posterior leaflet of the MV and of 1 PV cusp with patches in ewes aged 10 months. There were 2 groups: CardioCel (n = 6) and control (n = 4). All valves were competent. Echocardiography was performed before euthanasia. The collected data were function, macroscopy, histology, and calcium contents. The primary end points were thickening and calcium content.
  
  
  RESULTS
  All animals survived until sacrifice after 7 months. The valves had normal echo. The macroscopic aspect of the valves was excellent. Examination of the slides for both groups revealed a continuous endothelium on both sides of the patch and a layer of new collagen developed on both sides between patch and endothelium and interstitial cells and smooth muscle cell in these layers. The patch had not thickened but the 2 layers of new collagen for the PV showed a median thickening of 37% in the CardioCel group and 111% in the control group (P = .01), and for the MV a thickening of 108% and 251%, respectively, was seen (P = .01). The median calcium content in the PV was 0.24 μg/mg (range, 0.19-0.30) in the CardioCel group versus 0.34 μg/mg (range, 0.24-0.62) in controls (P = .20). In the MV it was 0.46 μg/mg (range, 0.30-1.0) in the CardioCel group and 0.47 μg/mg (range, 0.29-1.9) in controls (P = 1.0).
  
  
  CONCLUSIONS
  In this growing lamb model the CardioCel patch allowed accurate valve repair at both systemic and pulmonary pressure. The mechanical properties of CardioCel after 7 months were preserved with a more controlled healing than the treated autologous pericardium and without calcification.
authors.affiliation: Cardiac Surgery Department, Royal Childrens Hospital, Melbourne, Victoria, Australia; Murdoch Children's Research Institute, Parkville, Victoria, Australia; Department of Pediatrics, University of Melbourne, Parkville, Victoria, Australia. Electronic address: christian.brizard@rch.org.au.
authors.forename: Christian P
authors.initials: CP
authors.lastname: Brizard
authors.affiliation: Cardiac Surgery Department, Royal Childrens Hospital, Melbourne, Victoria, Australia.
authors.forename: Johann
authors.initials: J
authors.lastname: Brink
authors.affiliation: Cardiac Surgery Department, Royal Childrens Hospital, Melbourne, Victoria, Australia; Murdoch Children's Research Institute, Parkville, Victoria, Australia; Department of Pediatrics, University of Melbourne, Parkville, Victoria, Australia.
authors.forename: Steven B
authors.initials: SB
authors.lastname: Horton
authors.affiliation: School of Veterinary Science, University of Melbourne, Parkville, Victoria, Australia.
authors.forename: Glenn Anthony
authors.initials: GA
authors.lastname: Edwards
authors.affiliation: Murdoch Children's Research Institute, Parkville, Victoria, Australia; Department of Mathematics and Statistics, La Trobe University, Melbourne, Victoria, Australia.
authors.forename: John C
authors.initials: JC
authors.lastname: Galati
authors.affiliation: Fremantle Heart Institute, Fremantle Hospital, School of Surgery, University of Western Australia, Perth, Western Australia, Australia; Department of Cardiothoracic Surgery, Fremantle Hospital, School of Surgery, University of Western Australia, Perth, Western Australia, Australia.
authors.forename: William M L
authors.initials: WM
authors.lastname: Neethling
mesh_terms: D000367:Age Factors; D000818:Animals; D064592:Autografts; D057005:Bioengineering / Q000379:methods*; D002114:Calcinosis / Q000175:diagnosis / Q000209:etiology / Q000378:metabolism / Q000517:prevention & control*; D002118:Calcium / Q000378:metabolism; D006348:Cardiac Surgical Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D002417:Cattle; D003094:Collagen / Q000378:metabolism; D003432:Cross-Linking Reagents / Q000494:pharmacology; D005260:Female; D005976:Glutaral / Q000494:pharmacology; D006439:Hemodynamics; D064593:Heterografts; D008943:Mitral Valve / Q000000981:diagnostic imaging / Q000378:metabolism / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D023421:Models, Animal; D010496:Pericardium / Q000000981:diagnostic imaging / Q000187:drug effects / Q000378:metabolism / Q000637:transplantation*; D011664:Pulmonary Valve / Q000000981:diagnostic imaging / Q000378:metabolism / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D012756:Sheep; D013997:Time Factors; D014463:Ultrasonography; D014945:Wound Healing
chemical_list: D003432:Cross-Linking Reagents; D003094:Collagen; D002118:Calcium; D005976:Glutaral