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Ann Thorac Surg 2008;86:1055-1056. doi:10.1016/j.athoracsur.2007.10.022
© 2008 The Society of Thoracic Surgeons
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Correspondence

Bioglue: A Word of Caution

Suvitesh Luthra, MS, MRCS-Ed, Sanjay Theodore, MS, MCh(CTVS), James Tatoulis, MS, FRACS

Department of Cardiothoracic Surgery, Royal Melbourne Hospital, University of Melbourne, 2 North Grattan St, Parkville, Melbourne, Victoria 3050, Australia

(Email: suviteshluthra{at}yahoo.com).

To the Editor:

We read with interest the article by Zehr and colleagues [1] that describes the use of albumin-glutaraldehyde glue in cardiac surgery.

Our experience with Bioglue (bovine serum albumin [BSA] 25% and glutaraldehyde 10%, Cryolife Inc, Kennesaw, GA) extends to uses in aortic suture lines, lung surgery, and occasionally securing hemostasis in very thin-walled atria. Earlier we had described its use in pericardial patch reinforcement of a drug-eluting stent induced coronary aneurysm [2].

The two components of Bioglue (Cryolife, Inc) can have a number of additional potential adverse consequences that have not been listed by the authors:

1 Primary hypersensitivity and allergy to the components.
2 Immune response on repeat application in persons in whom it has been previously used.
3 Transmission of infectious agents via bovine albumin.
4 Mineralization and deformation of tissues.
5 Foreign body reaction.
6 Concerns of use over infected, contaminated, and inflamed areas.
7 Circumferential application in pediatric cardiac surgery in relation to structures with future growth prospects.
8 Absorption of unpolymerized and depolymerized glutaraldehyde from the surface of application.
9 Unreacted glutaraldehyde has been proven to have mutagenic effects in laboratory animals.
10 Handling safety hazards for personnel during surgery.

We have a few more interesting facts to add about the components of Bioglue. Glutaraldehyde is a pungent, colorless, extremely toxic liquid that causes severe mucosal and lung irritation on contact, and central nervous system manifestations of intense headaches, drowsiness, and dizziness on systemic absorption, even in small amounts. Even at concentrations of 0.1% to 1%, it can kill cells very quickly. It has been known to cause phrenic nerve injury and myocardial necrosis that can extend into the conduction tissues of the heart. It is chiefly used for sterilization of medical equipment, as a tissue fixative for electron microscopy, for study of oligomeric proteins by fixing them, for use in embalming fluids, and for leather tanning. All of these uses stem from its ability to cause cross linkages, fixation of proteins, and coagulative necrosis.

Monomeric glutaraldehyde can itself polymerize by aldol condensation to form polyglutaraldehyde. It can then cross link other proteins that it comes in contact with, independent of the clotting cascade.

Bovine serum albumin was isolated by the Harvard biochemist Edwin Cohn in need for a blood substitute for World War II trauma patients [3]. Albumin (bovine) was the "fifth element" in the final step of the extraction technique described by him that exploited the differential solubility of plasma proteins at various temperatures, pH ranges, and salt and organic solvent concentrations. The protein is still referred to as "Fraction V" in manufacturing lexicon. Although, the structure of albumin is highly conserved among mammals, there is a 76% sequence homology between bovine and human forms, which is a difference that was enough to make the molecule dangerously allergenic to preclude its use in humans for the purpose of its original extraction.

For a long time, the molecule yearned to find an application. Its use in more recent times was largely restricted to medical diagnostics in laboratory immunoassays and cell culture techniques rather than human therapeutics.

Existing techniques use a continuous heat-shock process of extraction and subsequent purification that supposedly destroys everything else in bovine plasma.

There are concerns of bovine spongiform encephalopathy and Creutzfeldt-Jakob disease transmission to humans. These are prion and slow virus diseases in which the mechanisms of infection and propagation remain mysterious. Prions are considered quite resistant to proteases, heat, radiation, and formalin. The BSA for Bioglue is claimed to be sourced from cattle, exclusively from bovine spongiform encephalopathy free countries and it undergoes processing that reduces or inactivates viruses.

Incidentally, therapeutic-grade recombinant human albumin that could have been used in Bioglue costs 10 times as much compared with bovine albumin in the diagnostic market.


   References
Top
 References
 

  1. Zehr KJ. Use of bovine albumin-glutaraldehyde glue in cardiovascular surgery Ann Thorac Surg 2007;84:1048-1052.[Abstract/Free Full Text]
  2. Luthra S, Tatoulis J, Warren RJ. Drug eluting stent induced left anterior descending coronary artery aneurysm: repair by pericardial patch Where are we headed? Ann Thorac Surg 2007;83:1530-1532.
  3. Cohn EJ, Hughes Jr WL, Weare JH. Preparation and properties of serum and plasma proteins XIII. Crystallization of serum albumins from ethanol-water mixtures. J Am Chem Soc 1947;69:1753-1755.

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Reply
Kenton J. Zehr
Ann. Thorac. Surg. 2008 86: 1056-1057. [Extract] [Full Text] [PDF]



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Ann. Thorac. Surg., September 1, 2008; 86(3): 1056 - 1057.
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