Ann Thorac Surg 2007;84:1048-1052
© 2007 The Society of Thoracic Surgeons
How To Do It
Use of Bovine Albumin-Glutaraldehyde Glue in Cardiovascular Surgery
Kenton J. Zehr, MD*
Heart, Lung, and Esophageal Surgery Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
Accepted for publication January 10, 2007.
* Address correspondence to Dr Zehr, University of Pittsburgh Medical Center/UPMC, Presbyterian University Hospital, Suite C-700, 200 Lothrop St, Pittsburgh, PA 15213 (Email: zehrkj{at}upmc.edu).
| Dr Zehr discloses that he has a financial relationship with CryoLife, Inc.
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Abstract
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As with any new surgical device, effectiveness requires both an understanding of its characteristics and proper technique of application. This report details application techniques from the author’s experience for the use of bovine albumin-glutaraldehyde glue in a variety of cardiovascular surgical cases.
The current success of cardiac surgery in the modern era is in part a result of surgeons’ learning how to sew the myocardium and great vessels with relative confidence in elderly, fragile patients in a host of difficult settings. These settings include active infection, aortic dissection, aortic rupture, malignant calcification, and reoperation. There continue to be situations in which the patient is at high risk of morbidity and mortality related to bleeding caused by lack of tissue integrity, inability of tissue to hold sutures, and suture-line bleeding in positions that are difficult to place repair sutures.
Hemostatic agents and biological glues have been developed in an attempt to address these difficult situations. These range from topical solutions to structural adhesives. The former products address coagulation issues, whereas the latter address the issue of lack of tissue integrity. Bovine albumin-glutaraldehyde glue (BioGlue, Cryolife Inc, Kennesaw, GA) was developed to address both hemostatic issues and enhance tissue strength. The components (glutaraldehyde [10%] and albumin [45%]) are mixed during delivery through a specialized tip. No preparation is required beyond loading a mixing tip onto a dual chamber pre-packaged syringe. The bonding between the native tissues, albumin, and glutaraldehyde serves to plug needle holes as well as provide a better tissue substrate to hold sutures. As with any new surgical "device," effectiveness requires both an understanding of its characteristics and proper technique of application. There have been reports praising the effectiveness of bovine albumin-glutaraldehyde glue as well as cautionary reports of complications related to its use. This report details application techniques from the author’s experience for the use of bovine albumin-glutaraldehyde glue in a variety of cardiovascular surgical cases.
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Technique
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Repair of Type A Aortic Dissections
The initial Food and Drug Administration approval for bovine albumin-glutaraldehyde glue was for a humanitarian use device to aid in realigning the dissected aortic layers in aortic dissections. In these cases the dissected arch layers can be reapproximated as well as the layers proximally at the sinotubular junction at the top of the right and left coronary sinuses (Figs 1A,
1B). A dissected noncoronary sinus is usually removed, although the glue can be used to reapproximate the layers in this sinus as well. Caution must be taken to avoid using excessive glue as it will serve to permanently separate the tissue layers and be difficult for the body to absorb. Particular care must be taken to avoid infusing the glue distally past the arch down the false lumen, causing glue embolism. A sponge placed within the true lumen past the left subclavian artery will help prevent this. All thrombus and fibrinous debris should be removed from the false lumen within the arch, and the layers should be periodically tacked circumferentially with pledgeted sutures at the distal arch and periodically in the mid arch. The aorta should be buttressed from the inside with a sponge and a thin layer of glue deposited within the false lumen. I find it helpful to glue a strip of felt between the layers at the anastomotic site both proximally and distally. The glue will adhere very well to the felt strip and to the cleaned adventitia and media. This tissue-glue-felt-tissue sandwich makes an acceptable sewing edge of several millimeters thick.
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Fig 1. (A) Reapproximation of the dissected arch layers in type A aortic dissection repair using bovine albumin-glutaraldehyde glue. Note the use of individual pledgetted sutures to periodically reapproximate the dissected layers within the arch. A 4 x 4 sponge is used to apply pressure from the inside to help uniformly reapproximate the layers while gluing and avoid leakage of glue into the lumen through needle holes. (B) Reapproximation of the dissected layers at the sinotubular junction in type A aortic dissection repair using bovine albumin-glutaraldehyde glue. Note the use of individual pledgetted sutures to periodically reapproximate the dissected layers of the non-coronary sinus.
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Aortic Root Reconstruction
Bovine albumin-glutaraldehyde glue can be used routinely to seal the proximal anastomoses of the left ventricular outflow tract to the replacement aortic root whether it be allograft, porcine aortic root, or mechanical valve-conduit composite graft (Fig 2). This suture line is very difficult to access to place repair sutures after the coronary anastomoses and distal reconstruction is performed, particularly posteriorly underneath the left coronary ostial button anastomosis. In the case of an allograft reconstruction, a dilator is inserted to maintain the aortic root shape and avoid stiffening of the aortic root in an improper position. It is helpful to let the glue slowly pass through the mixing tip so that it exits in a highly viscous consistency. This will keep the glue from soaking through the interstices of the Dacron graft (Boston Scientific, Natick, MA) and tracking through needle holes. Turning off the left ventricular vent while applying the glue will also keep it from tracking along the suture path. A thin layer of this viscous glue is circumferentially applied covering the tissues, sewing ring, sutures, and felt. A thin yellow coating will be evident. Extra globs of glue provide no added hemostasis or strength. They merely serve as foreign bodies.
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Fig 2. Sealing the proximal anastomoses of the left ventricular outflow tract to the replacement aortic root with bovine albumin-glutaraldehyde glue in aortic root reconstruction.
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Left Ventricular Apical Cannulation
Left ventricular cannulation sites are particularly prone to bleed. Bovine albumin-glutaraldehyde glue is routinely used when sewing a left ventricular assist device cannula cuff or an apical aortic conduit cannula to the left ventricular apex (Figs 3A,
3B). A large felt collar is used to support the radially placed interrupted mattress sutures. After sewing the cuff in place, glue is used to seal the apex circumferentially. In this setting it is helpful to inject more rapidly with the tip underneath the felt collar. The thinner bovine albumin-glutaraldehyde glue will soak up into the felt and ooze out against the left apical collar medially and fill in all the left ventricular muscle linear stretch holes made during suture tying. Sealing the apex is particularly valuable in the setting of an apical aortic-valved conduit as the left ventricular cannulation site is exposed to systolic left ventricular pressure and motion.
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Fig 3. (A) Sealing the suture line between the cuff of the left ventricular assist device and the left apical collar with bovine albumin-glutaraldehyde glue. (B) Sealing the suture line between the apical aortic conduit cannula to the left ventricular apex with bovine albumin-glutaraldehyde glue.
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Right or Left Ventricular Tear or Rupture Repair
Bovine albumin-glutaraldehyde glue can be used with woven cellulose patches (Surgicel or Nu-Knit [Ethicon Inc, Somerville, NJ]) to support fragile repairs of the right ventricle, particularly in the area of the infundibulum (Figs 4A–C). The usual setting is an elderly patient with pulmonary hypertension with oozing from a repaired injury caused by sternal re-entry in a redo situation. After complete right ventricular decompression on cardiopulmonary bypass, the area is completely dried. A layer of glue is first placed to adhere solidly to the macerated tissue and pledgets. A woven cellulose patch is then laid over the sticky glue in 10 seconds as it starts to set. Another thin layer is placed, followed by another thin layer of glue. This technique can be adapted for left ventricular rupture using layers of bovine pericardium (Periguard [Bio-Vascular, St. Paul, MN]) instead of woven cellulose. The edges of the bovine pericardium are tacked with polypropylene sutures far away from the friable areas. This technique has also been used as an adjunct for repair of perforation of the right ventricle from pericardiocentesis, pacemaker lead extraction, and injury caused by open heart massage.
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Fig 4. (A, B) Bovine albumin-glutaraldehyde glue applied over tissue and pledgets in left ventricular rupture-tear repair. (C) A woven cellulose patch applied over bovine albumin-glutaraldehyde glue followed by a thin layer of more glue and another woven cellulose patch, and so forth.
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Post-Infarction Ventricular Septal Defect Repair
In the setting of a nearly completely infarcted septum, the septum is very friable. After sewing a Dacron patch (Boston Scientific) to the edges of the defect using an interrupted technique, a second larger patch is started, anticipating near complete coverage of the left ventricular septum using a running stitch (Figs 5A,
5B). Bovine albumin-glutaraldehyde glue is then used to seal the two patches together. By injecting between the patches, no glue ends up in either the left or right ventricular cavity, or the friable septal tissue edges are buttressed with a glue layer over the entire septum.
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Fig 5. (A, B) Post-infarction septal defect repair using one small and one large Dacron patch (Boston Scientific, Natick, MA) and bovine albumin-glutaraldehyde glue. Glue is applied between the 2-layer patch repair.
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Left Ventricular Endoaneurysmorrhaphy
When performing left ventricular remodeling procedures, bovine albumin-glutaraldehyde glue can be used to seal the edges of the ovoid Dacron patch (Figs 6A–C) (Boston Scientific). Again it is important to allow the bovine albumin-glutaraldehyde glue to be viscous and to turn off the aortic or left ventricular vent to avoid sucking glue into the left ventricle with resultant glue embolism after cross-clamp removal. Prior to finishing the linear closure of the left ventricle cut edges over the patch, the dead space can be eliminated with a layer of several millimeters of glue. The linear closure is also sealed with a thin layer of glue.
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Fig 6. (A) The edges of an ovoid Dacron patch (Boston Scientific, Natick, MA) are sealed with bovine albumin-glutaraldehyde glue in a left ventricular remodeling procedure. (B, C) The dead space is eliminated and linear closure of the left ventricle cut edges over the Dacron patch are sealed with bovine albumin-glutaraldehyde glue.
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General Use Tips
Perhaps the most important use of the glue is to provide absolute hemostasis of suture lines related to aortic aneurysm repair, coronary ostia anastomoses, and aortotomies in elderly patients with fragile tissues. The absence of needle hole bleeding reduces post-pump drying-up anxiety significantly. Intravascular glue can be avoided by injecting it slowly to allow the glue to set a bit prior to expelling it from the mixing tip. By using this method and turning off the vents during application of glue this problem will be eliminated. The tissues must be completely dry prior to applying the glue. Otherwise it will not bond to the tissue surfaces. In the absence of the cross clamp, this can be accomplished by turning off the cardiopulmonary bypass machine for 30 seconds to 1 minute to dry the field for proper glue application. Extra glue is detrimental and does not add to hemostasis, because it creates a foreign body that the body deals with much like a sequestrum.
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Comment
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Advances in cardiac surgery have been aided by systematic introduction of new devices. The proper use of any new product or device requires a bit of time and experience with a healthy dose of intuition and common sense. This is certainly true regarding the use of surgical adhesives such as bovine albumin-glutaraldehyde glue. Proponents have argued that the use of this glue has dramatically altered the risk-benefit ratio in a positive way and has reduced bleeding in several higher risk cardiovascular surgical procedures. In a large, multicenter randomized study of 151 patients, Coselli and colleagues [1] reported a reduction in intraoperative anastomotic site bleeding, use of pledgets, and occurrence of neurologic events in patients undergoing cardiac and vascular anastomotic repair procedures using glue to reinforce the suture lines. Chao and Torchiana [2] reported reduced bleeding and operative times in a group of patients with a type A dissection using the glue as an adjunct compared with a conventionally repaired group. Other more unique uses have been reported, including repair of an atrioventricular groove rupture during mitral valve replacement [3]. Fink and colleagues [4] reported 5 patients who were undergoing repair of intracardiac structural defects. Reports detailing benefits have been reported by other surgical subspecialties. Kumar and colleagues [5] reported on its use as a dura mater sealant in 210 patients undergoing neurosurgical procedures. There were no complications of the glue. The cerebrospinal fluid leak rate was an exceedingly low 0.93% compared with the usual 2.7% to 6% historically. Potaris and colleagues [6] reported safety and efficacy to seal lung lacerations and suture or staple lines in patients with emphysematous lungs.
There are a few cautionary reports questioning the effectiveness of the glue and the ability of the body to handle the foreign body aspect long term. In a frequently referenced article, Kazui and colleagues [7] reported 4 of 57 patients undergoing type A dissection repair who had early and midterm re-dissection of the aortic root after biological glue assisted repair develop. Of note, gelatin-formaldehyde-resorcinol glue was used in 3 patients and bovine albumin-glutaraldehyde glue was used in only 1. Most cardiovascular surgeons have operated on patients with residual flaps and pseudoaneurysms after previous type A dissection repair. It must be mentioned that a patient must survive the initial repair to represent a re-dissection or pseudoaneurysm. It is unknown if use of the glue contributed to the initial patient survival. In contrast to Kazui and colleagues’ [7] report, Bavaria and colleagues’ [8] have reported on a series of 58 patients undergoing type A dissection repair using bovine albumin-glutaraldehyde glue as an adjunct. There were no reoperations on the aortic root and only 2 patients required reoperation for complications at the distal suture line. Passage and colleagues [9] reported on 115 consecutive patients undergoing complex cardiac surgery including aortic surgery, ventricular aneurysm repair, postinfarction ventricular septal defect repair, and congenital repairs using bovine albumin-glutaraldehyde glue as an adjunct. Only 1 patient required reoperation for pseudoaneurysm formation at the distal aortic suture line. All surgeons believed that the glue facilitated the operation. Carelessness or indiscriminant use of the glue must be cautioned against. It can produce a solid obstructive mass. It has been reported as the cause of a superior vena cava stenosis when a large amount was used to encase bleeding from the dome of the left atrium [10]. A fatal right ventricular infarction was caused by a coronary artery glue embolism introduced during the gluing of dissected aortic root layers [11]. The coronary ostia must be protected during this maneuver. There are two reports that the glue incited an inflammatory granulomatous response. One case was in the absence of an adverse event [12] and the other occurred in the presence of a pseudoaneurysm [13]. Glue has also been reported to be present, but it was inert up to 2 years postoperatively after use in spinal dural repair [14]. There has been one experimental report voicing concern that bovine albumin-glutaraldehyde glue can leak through needle holes into a vascular lumen with potential for particulate embolization [15]. In a porcine model, 10% of anastomoses had evidence of some leakage of the glue along a suture path through a needle hole both in a fresh aorta and prosthetic materials. This underscores the need to apply the glue slowly, allowing polymerization to begin as it travels down the mixing tip, thus increasing the viscosity a bit prior to direct application on the anastomosis.
The introduction of any new device or treatment in cardiac surgery must find its way. Bovine albumin-glutaraldehyde glue is no exception. When used excessively, the mass of excess glue may result in an inflammatory, foreign body response. This may retard healing and decrease tissue integrity. When used judiciously, this author has found that the glue is a useful operative adjunct to aid in hemostasis and to provide structural integrity for fragile tissues.
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References
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- Coselli JS, Bavaria JE, Fehrenbacher J, Stowe CI, Macheers SK, Gundry SR. 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 2003;197:243-252.[Medline]
- Chao HH, Torchiana DF. BioGlue: albumin/glutaraldehyde sealant in cardiac surgery J Card Surg 2003;18:500-503.[Medline]
- Masroor S, Schor J, Carrillo R, Williams DB. Endoventricular pocket repair of type I myocardial rupture after mitral valve replacement: a new technique using pericardial patch, Teflon felt, and BioGlue Ann Thorac Surg 2004;77:1439-1441.[Abstract/Free Full Text]
- Fink D, Klein JJ, Kang H, Ergin MA. Application of biological glue in repair of intracardiac structural defects Ann Thorac Surg 2004;77:506-511.[Abstract/Free Full Text]
- Kumar AM, Maartens NF, Kaye AH. Evaluation of the use of BioGlue in neurosurgical procedures J Clin Neuro 2003;10:661-694.
- Potaris K, Mihos P, Gakidis I. Preliminary results with the use of an albumin-glutaraldehyde tissue adhesive in lung surgery Med Sci Monit 2003;9:P179-P183.
- Kazui T, Washiyama N, Bashar AHM, 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]
- Bavaria JE, Brinster DR, Gorman RC, Woo YJ, Gleason T, Pochettino A. Advances in the treatment of acute type A dissection: an integrated approach Ann Thorac Surg 2002;74:S1848-S1852.[Abstract/Free Full Text]
- Passage J, Jalali H, Tam RKW, Harrocks S, O’Brien MF. BioGlue surgical adhesive—an appraisal of its indications in cardiac surgery Ann Thorac Surg 2002;74:432-437.[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;127:1819-1821.[Free Full Text]
- Mahmood Z, Cook DS, Luckraz H, O’Keefe P. Fatal right ventricular infarction by Bioglue coronary embolism J Thorac Cardiovasc Surg 2004;128:770-771.[Free Full Text]
- Erasmi AW, Sievers HH. Inflammatory response after Bioglue application Ann Thorac Surg 2002;73:1020-1028.[Medline]
- Ngaage DL, Edwards WD, Bell MR, Sundt TM. A cautionary note regarding long-term sequelae of biologic glue J Thorac Cardiovasc Surg 2005;129:937-938.[Free Full Text]
- Yuen T, Kaye AH. Persistence of BioGlue in spinal dural repair J Clin Neuro 2005;12:100-101.
- LeMaire SA, Carter SA, Won T, Wang X, Conklin LD, Coselli JS. The threat of adhesive embolization: Bioglue leaks through needle holes in aortic tissue and prosthetic grafts Ann Thorac Surg 2005;80:106-111.[Abstract/Free Full Text]
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Top
Abstract
Introduction
