The Threat of Adhesive Embolization: BioGlue Leaks Through Needle Holes in Aortic Tissue and Prosthetic Grafts

doi:10.1016/j.athoracsur.2005.02.004

The Annals of Thoracic Surgery

Volume 80, Issue 1, July 2005, Pages 106-111

Presented at the Fortieth Annual Meeting of The Society of Thoracic Surgeons, San Antonio, TX, Jan 26–28, 2004.

https://doi.org/10.1016/j.athoracsur.2005.02.004 Get rights and content

Background

BioGlue Surgical Adhesive (CryoLife, Inc, Kennesaw, GA) is used to reinforce anastomoses during cardiovascular operations. Previous reports have raised concerns that adhesives may leak through suture-line needle holes and that resulting intraluminal glue may embolize. The purpose of this study was to determine if BioGlue leaks through anastomotic needle holes in aortic tissue and two common prosthetic graft materials.

Methods

Polypropylene suture was used to create end-to-end anastomoses in gelatin-sealed woven polyester grafts (n = 45), expanded polytetrafluoroethylene (ePTFE) grafts (n = 45), and fresh porcine aortas (n = 45). An additional 45 anastomoses were created in ePTFE grafts using ePTFE sutures. The outer surface of each anastomosis was covered with BioGlue. Anastomoses underwent inspection with direct magnification or histology.

Results

BioGlue leaked through needle holes and into the lumen in 10% of anastomoses (18 of 180). Leaks were significantly more common in fresh aorta (10 of 45, 22%) than in prosthetic grafts (8 of 135, 6%; p = 0.003). Suture size did not significantly affect the incidence of leak. The use of ePTFE sutures did not eliminate BioGlue leakage. Prosthetic graft leaks created discreet round adhesive particles. In contrast, aortic tissue leaks resulted in thin, friable flakes of glue extending along the intimal surface. Aortic histology confirmed that BioGlue reached the vessel lumen via the suture channels.

Conclusions

BioGlue leaked through the needle holes in fresh aortic tissue and prosthetic grafts. Intraluminal adhesive particles were easily dislodged, supporting concerns regarding embolization. The potential for adhesive embolization should be a factor when considering the relative risks and benefits of using BioGlue.

Section snippets

Anastomoses

Polypropylene suture (Prolene, Ethicon, Inc, San Angelo, TX) was used to construct end-to-end anastomoses in gelatin-sealed woven polyester grafts (Gelweave, Vascutek USA, Inc, Ann Arbor, MI; n = 45), expanded polytetrafluoroethylene (ePTFE) grafts (GORE-TEX Vascular Grafts, W.L. Gore & Associates, Inc, Flagstaff, AZ; n = 45), and fresh porcine aortas (n = 45). For each type of conduit, 15 anastomoses were sewn with 2-0 sutures (SH needle), 15 were sewn with 3-0 sutures (SH needle), and 15 were

Results

BioGlue leaked through the suture tracts and into the lumen at 18 of 180 anastomoses (10%, Table 1). Leaks were significantly more frequent in fresh porcine aorta (10 of 45, 22%) than in prosthetic grafts (8 of 135, 6%; p = 0.003). The difference in leak rates for polyester and ePTFE grafts sewn with polypropropylene (4% vs 9%, respectively) was not statistically significant (p = 0.7). The use of different suture sizes did not affect the incidence of leaks. The incidence of leak in ePTFE grafts

Comment

BioGlue Surgical Adhesive is commonly used as an adjunct for repairing tissue and achieving hemostasis during cardiovascular operations, especially repair of acute proximal aortic dissection [1, 2, 3, 4, 5, 6, 7]. This adhesive’s efficacy as a hemostatic agent has been reported in both animal and clinical studies [4, 5, 16]. BioGlue demonstrates excellent tensile strength (847 ± 127 g/cm²) when compared to other surgical adhesives and sealants, such as fibrin sealant or “French”

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BioGlue may embolize to peripheral organs when applied directly in the true lumen due to technical error or through a suture site. LeMaire et al. (7) demonstrated through in vitro experiments that BioGlue leaks through needle holes in the aortic tissue and prosthetic grafts. However, the coronary ostia are usually located below the sinotubular junction.
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Citation Excerpt :
Additionally, the size of embolized material demonstrated in previous cases ranged from 5–10 mm in size. This is sufficient to occluded the LMS, as noted in our case [15,21]. Despite its application on external surface of the aortic wall/prosthesis, few case reports have suggested that similar to GRF and Fibrin glue, BioGlue traverses the vessel wall/prosthesis and could result in embolization.
Ascending aortic dissection is a life threatening surgical emergency and carries high peri-operative mortality. Various biological adhesive materials are commonly used in such a surgery to enhance strengthening of separated layers of aortic wall. Despite of extensive use, embolization of the glue material remains a feared complication. Here we are describing a case where BioGlue embolized down the left main stem and resulted in refractory ventricular arrhythmia and hemodynamic instability.

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Original articleCardiovascularThe Threat of Adhesive Embolization: BioGlue Leaks Through Needle Holes in Aortic Tissue and Prosthetic Grafts

Background

Methods

Results

Conclusions

Section snippets

Anastomoses

Results

Comment

Op Tech Thorac Cardiovasc Surg

Ann Thorac Surg

Ann Thorac Surg

Ann Thorac Surg

Ann Thorac Surg

J Thorac Cardiovasc Surg

Ann Thorac Surg

Ann Thorac Surg

J Am Soc Echocardiogr

Ann Thorac Surg

Ann Thorac Surg

Prospective randomized study of a protein-based tissue adhesive used as a hemostatic and structural adjunct in cardiac and vascular anastomotic repair procedures

J Am Coll Surg

Original article
Cardiovascular
The Threat of Adhesive Embolization: BioGlue Leaks Through Needle Holes in Aortic Tissue and Prosthetic Grafts