Ann Thorac Surg 2005;79:1529
© 2005 The Society of Thoracic Surgeons
Original articles: Cardiovascular: Invited commentary
INVITED COMMENTARY
Stephen Downing, MD
Catholic Health System of Western New York, Suite 310, Marion Bldg, 515 Abbott Rd, Buffalo, NY 14210
(E-mail: sdowning{at}wnychs.org).
Biologic glues have gained increasing acceptance in many areas of surgery. Two of the most popular early glues were cyanoacrylate and gelatin-resorcinol-formaldehyde. Early enthusiasm for these products was tempered by the later observation of significant complications including tissue necrosis, vascular thrombosis, anastomotic stenosis, and pseudoaneurysm formation [1, 2]. In addition, FDA approval was unlikely with formaldehyde classified as a carcinogen. To alleviate concerns about local tissue toxicity and malignancy risk, BioGlue (CryoLife, Kennesaw, GA) substitutes glutaraldehyde for formaldehyde as the active chemical agent. In addition, in the concentration provided, the glutaraldehyde is intended to interact primarily with the albumin in the mixing syringe and only minimally with the surrounding tissue.
Early tissue and clinical studies suggested that BioGlue was safe and effective. Unfortunately over time there have been a number of contradictory reports that associate BioGlue with nerve injury, myocardial necrosis, significant inflammatory response, superior vena caval obstruction, embolization, impairment of vascular growth, anastomotic strictures, and pseudoaneurysm formation [3–6].
In the data presented by Fürst and colleagues, BioGlue is demonstrated to have toxic effects of varying degrees on target tissues. After the glue set, there were local concentrations of glutaraldehyde significant enough to be toxic to other tissues. These mechanisms could explain some of the tissue death, inflammation, and other complications that have been noted clinically.
The work of Fürst and colleagues does not prove irrefutably that properly applied BioGlue is dangerous. However, the potential risk of tissue damage leading to late complications cannot be ignored. When a product is used by multiple practioners on a broad spectrum of patients it is highly likely that complications will be noted that could never be detected in the small numbers and controlled circumstances of a clinical trial. Physicians must be constantly open to the truth that the actual risks and benefits of a device or medication will not be properly known until thousands of patient-years have passed.
The glutaraldehyde in BioGlue molecularly links together protein molecules in the carrier albumin and the target tissues to provide adhesion. This linking also "toughens" the aorta to facilitate suturing in weak and friable vessels. However, it may be difficult to have these favorable changes in material properties and still maintain tissue viability. Ultimately the preservation of vital, self-repairing tissue may determine the durability of a glued repair.
Until the perfect glue is invented, it is prudent to be on the lookout for the potential downsides of these useful surgical adjuncts.
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References
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- Bingley JA, Gardner MA, Stafford EG, et al. Late complications of tissue glues in aortic surgery Ann Thorac Surg 2000;69:1764-1768.[Abstract/Free Full Text]
- Kazui T, Washiyama N, Bashar AH, et al. Role of biologic glue repair of proximal aortic dissection in the development of early and midterm redissection of the aortic root Ann Thorac Surg 2001;72:509-514.[Abstract/Free Full Text]
- Economopoulos GC, Dimitrakakis GK, Brountzos E, Kelekis DA. Superior vena cava stenosis: a delayed BioGlue complication J Thorac Cardiovasc Surg 2004;127(6):1819-1821.[Free Full Text]
- LeMaire SA, Schmittling ZC, Coselli JS, et al. BioGlue surgical adhesive impairs aortic growth and causes anastomotic strictures Ann Thorac Surg 2002;73:1500-1505.[Abstract/Free Full Text]
- Mahmood Z, Cook DS, Luckraz H, O'Keefe P. Fatal right ventricular infarction caused by Bioglue coronary embolism J Thorac Cardiovasc Surg 2004;128(5):770-771.[Free Full Text]
- Kazui T, Washiyama N, Bashar AH, et al. Role of biologic glue repair of proximal aortic dissection in the development of early and midterm redissection of the aortic root Ann Thorac Surg 2001;72:509-514.
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