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    Eur J Cardiothorac Surg. 2014 Apr;45(4):e110-7. doi: 10.1093/ejcts/ezt623. Epub 2014 Jan 14.
    Biostability, durability and calcification of cryopreserved human pericardium after rapid glutaraldehyde-stabilization versus multistep ADAPT(R) treatment in a subcutaneous rat model.

    Neethling W1, Brizard C, Firth L, Glancy R.
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    • 1Department of Cardiothoracic Surgery, Fremantle Heart Institute, Fremantle Hospital and School of Surgery, University of Western Australia, Fremantle, WA, Australia.
    Abstract

    OBJECTIVES:

    Autologous pericardium rapidly fixed with glutaraldehyde (GA) in theatre is considered in many cardiac surgery centres the best material currently available for intracardiac, valvular or vascular repair. Implanted non-fixed autologous tissues suffer rapid degeneration, shrinkage and absorption whereas standard xenotypic fixed tissues cause local cytotoxicity and calcification. In the present study, using a subcutaneous rat model, we tested the biostability, durability and calcification potential of four different pericardium patches treated with GA and relevant to current clinical practice.
    METHODS:

    Pericardium samples were divided into four groups according to the method of treatment. Group I consisted of bovine pericardium (BP) fixed with 0.6% GA (control), Group II cryopreserved human pericardium (CHP) rapidly fixed with 0.6% GA for 4 min and detoxified with MgCl2, Group III CHP treated with the multistep ADAPT(®) process (delipidized, decellularized with Tx-100, deoxycholate, IgePal CA-630 and denucleased, fixed in 0.05% monomeric GA and detoxified) and Group IV BP treated with the multistep ADAPT(®) process (CardioCel(®)). Biostability was determined by shrinkage temperature which measures the degree of cross-linking, and durability assessed by resistance to a mixture of proteinases (pronase digestion). Treated pericardium samples (n = 10 in each of Groups I-IV) were implanted in the subcutaneous rat model for 8 and 16 weeks, followed by histology and calcium analysis (atomic absorption spectrophotometry).
    RESULTS:

    The biostability and the durability of both CHP and BP after the multistep ADAPT(®) treatment remained stable without any microscopic calcification. Extractable calcium levels of CHP were significantly (P < 0.01) reduced in Group II (1.89 ± 0.77 μg Ca/mg tissue) compared with Group I (64.37 ± 6.25 μg/mg) after 8 weeks. Calcification of CHP (Group III) and BP (Group IV) after the multistep ADAPT(®) treatment was significantly reduced (1.43 ± 0.48 µg/mg and 0.75 ± 0.10 μg/mg, respectively) compared with Group I (282.52 ± 18.26 μg/mg) and the rapidly treated CHP in Group II (11.32 ± 3.21 μg/mg) after 16 weeks.
    CONCLUSIONS:

    Improved biostability and durability with reduced calcification of tissues after the multistep ADAPT(®) tissue treatment suggest improved alternative substitutes to autologous pericardium.
    KEYWORDS:

    Calcification; Glutaraldehyde; Pericardium (bovine); Pericardium (human)
 
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