Ann Thorac Surg 2004;77:506-511
© 2004 The Society of Thoracic Surgeons
Original article: cardiovascular
Application of biological glue in repair of intracardiac structural defects
Daniel Fink, MDa,
James J. Klein, MDa,
Hyun Kang, MDb,
M. Arisan Ergin, MD, PhDa*
a Department of Cardiothoracic Surgery, Heart and Vascular Institute of New Jersey, Englewood, NJ, USA
b Department of Critical Care Medicine, Englewood Hospital and Medical Center, Englewood, New Jersey, USA
Accepted for publication August 6, 2003.
* Address reprint requests to Dr Ergin, Department of Cardiothoracic Surgery, Heart and Vascular Institute of New Jersey, Englewood Hospital and Medical Center, 350 Engle St, Englewood, NJ 07631, USA
e-mail: m.arisan.ergin{at}ehmc.com
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Abstract
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BACKGROUND: BioGlue (Cryolife Inc, Kennesaw GA) was introduced as an alternative tissue sealant. Its most common application has been in repairs of acute dissections of the aorta. There is no reported experience with its use in the repair of intracardiac structural defects.
METHODS: In 5 patients BioGlue was used as an adjunct in repairs of complex intracardiac structural defects. It was used during patch repair of posterior mitral annular defects in 2 patients and aortic annular defect in 1 patient in the presence of active endocarditis. It was also used in 1 patient with a chronic atrioventricular groove pseudoaneurysm following mitral valve replacement, and in 1 patient during repair of a postinfarction posterior ventricular septal rupture.
RESULTS: There were no hospital or late deaths. Immediate intraoperative transesophageal echocardiography and late follow-up echocardiography documented complete and durable repair of all defects without recurrence. At follow-up all patients are in New York Heart Association class I–II, 6 to 29 months postoperatively. No patient has suffered late complications or exhibited signs of glue embolization.
CONCLUSIONS: BioGlue was found to be an effective adjuvant to the standard techniques used for the repair of intracardiac structural defects of various etiologies. Long-term follow-up is recommended to determine its long-term safety in this application.
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Introduction
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Tissue glues are emerging as standard adjuncts in cardiac surgery [1–4]. They are used to seal suture lines for hemostasis and or to strengthen and reinforce fragile tissues by tissue adherence. The gelatin resorcinol formaldehyde (GRF) glue has been, until recently, the glue most commonly used in Europe and elsewhere. The Food and Drug Administration never approved it for use in the United States because of concerns about carcinogenicity and tissue toxicity from its formaldehyde component. With recent reports of high reoperation rates following its use, many surgeons have abandoned this glue [5–7]. Recently, a new biological glue, BioGlue (Cryolife Inc, Kennesaw GA), was introduced as an alternative. Although there is some skepticism about its long-term effects, BioGlue's most common application has been in repairs of acute dissections of the aorta where it was found to contribute to improved outcome and reduced mortality as part of an integrated operative approach [8–9]. It primarily works by providing structural strength to friable dissected tissues and by sealing off suture lines and preventing leaks through needle holes. There is no reported experience with its use in the repair of intracardiac structural defects. We report the application and outcome following the use of BioGlue tissue sealant, as an adjunct in the repair of intracardiac structural defects.
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Material and methods
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BioGlue was used as an adjunct to surgical techniques for repairs of defects of the annular structures due to infectious destruction in bacterial endocarditis or due to sterile mechanical disruption and also during repair of post infarction ventricular septal rupture.
General principles and precautions
Aside from the well known principles of dealing with these challenging problems, such as thorough debridement and complete elimination of necrotic tissue in the presence of infection, exclusion of weakened structures from exposure to high pressure chambers, and use of autologous or prosthetic patches for tension-free repairs to preserve the functional integrity and geometry of the repaired area, some additional precautions and steps specific to the adjunct use of BioGlue need to be observed:
- The suture line has to be absolutely dry before the application of the glue. After thoroughly obtaining a completely bloodless field additional insufflation of CO2 for a brief period through a fine nozzle dries the area rapidly in preparation for the application of the glue.
- The glue is applied to the suture line and the patch always on the side of the cavity that is being excluded so that once the suturing of the patch is completed, the glued area is also excluded from the left heart chambers and the bloodstream.
- The glue is applied sparingly and spread evenly with a cotton tipped applicator while still liquid.
- The left heart chambers are carefully protected from contamination with the glue.
- The excluding pericardial patch is glued to the base of the cavity with a thin layer of glue after the base of the cavity is again prepared and dried to ensure effective adherence of the pericardial patch to the base.
- After the glue solidifies, placing sutures in the already glued portion of the pericardial patch completes the remainder of the repair.
Repair of defects of the posterior mitral annulus
In 3 patients complex repairs of defects at the posterior mitral annulus was carried out with BioGlue as an adjunct sealant. In 2 patients the defect was a result of active infection that had destroyed a portion of the posterior annulus. In 1 patient the repair was necessary for a large pseudoaneurysm due to mechanical disruption of the atrioventricular (AV) groove during previous mitral valve replacement (Table 1)
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Operative technique
In endocarditis, large defects following liberal debridement and removal of all infected and necrotic tissues along the posterior annulus are repaired with a patch of autologous pericardium. Use of the patch allows removal of all infected tissues and also exclusion of weakened areas from the high-pressure chamber [10].
Following adequate debridement of the infected tissues the pericardial patch is sutured with deep bites along the inferior margin of the defect to healthy ventricular endocardium with a running monofilament suture. The base of the defect and the resultant cavity is dried by insufflation of CO2. The pericardial patch is then reflected toward the ventricular chamber and the glue initially applied to the suture line from the atrial side of the cavity and spread evenly with a cotton-tipped applicator (Fig 1A–1C).
The ventricular chamber is carefully isolated and protected from contamination with the glue. A thin layer of glue is then applied and spread to the dried base of the cavity. The pericardial patch is apposed to the base of the cavity with pressure applied by sponges and the glue is allowed to set. The suture line is then completed along the atrial margin of the defect with bites taken in the glued portion of the pericardial patch and healthy atrial tissue (patients 1 and 3; Fig 1D and 1E).
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Fig 1. Repair of the defect in the posterior mitral annulus with an autologous pericardial patch and subsequent mitral valve replacement with a bioprosthesis. (A) Defect in the annulus following debridement. (B) Suturing the pericardial patch to the ventricular endocardium. (C) Application of BioGlue along the suture line. (D) Completion of the suturing of the pericardial patch. (E) Implantation of the prosthetic mitral valve.
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In the patient with a pseudoaneurysm of the AV groove due to disruption related to previous mitral valve replacement, the same techniques were used substituting a properly tailored patch of Hemashield graft for the autologous pericardium (patient 2).
Repair of defects of the aortic annulus
In 1 patient the defect of the aortic annulus was a result of active infection that had destroyed a portion of the annulus along the noncoronary sinus extending through the left fibrous trigone with an abscess cavity. The anterior leaflet of the mitral valve was detached along the inferior rim of the abscess (patient 5; Table 1).
Operative technique
Following adequate debridement of the infected tissues and removal of all necrotic material the autologous pericardial patch is sutured with deep bites along the inferior margin of the defect to healthy ventricular endocardium and the detached anterior leaflet of the mitral valve with a running monofilament suture (Fig 2A and 2B).
The base of the defect and the resultant cavity is dried by insufflation of CO2. The pericardial patch is reflected into the left ventricle and the glue is initially applied to the suture line from the aortic side of the cavity and spread evenly with a cotton tipped applicator (Fig 2C). The ventricular chamber and the coronary orifices are carefully isolated and protected from contamination with the glue. A thin layer of glue is then applied and spread to the dried base of the cavity. The pericardial patch is apposed to the base of the cavity with pressure applied by sponges and the glue is allowed to set. The suture line is then completed along the aortic margin of the defect with bites taken in the glued portion of the pericardial patch and healthy aortic sinus tissue. Along the repaired defect the valve fixation sutures are passed through the glued pericardial patch at the plane of the original annulus from outside, leaving the pledgets on the perimeter of the aorta (patient 5; Figs 2D and 2E).
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Fig 2. Repair of the defect in the aortic annulus with an autologous pericardial patch and aortic valve replacement with a prosthetic valve. (A) Defect in the annulus following debridement. (B) Suturing the pericardial patch along the inferior margin. (C) Application of BioGlue along the suture line. (D) Completion of the suturing of the pericardial patch. (E) Implantation of the prosthetic aortic valve.
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Repair of postinfarction posterior ventricular septal defect
In 1 patient BioGlue was used to seal the suture line between the septum and the septal patch and provide tissue adhesion between the remnant of the septum and the patch (patient 4; Table 1).
Operative technique
The ventricular septal defect (VSD) is approached through a left ventriculotomy through the infarcted inferior wall close to the base of the heart on the left side of the posterior descending coronary artery. An infarctectomy is carried out and the septal rupture delineated to reveal its margins clearly. A tailored Teflon patch (DuPont Pharmaceuticals, Wilmington, DE) is then sutured with pledgetted transseptal mattress sutures on the left side of the septum. These sutures pass through healthy septal tissue beyond the margins of the infarction with pledgets on the right side of the septum and the Teflon patch abutting the left side of the septum (Figs 3A, 3B, and 3D
[1]). BioGlue is applied to the dry suture line between the septal endocardium on the left side and the patch to prevent suture line leaks and provide adherence of the remnant of the infarcted septum to the patch. The opening of the right ventricular (RV) free wall is closed by mattress sutures passing through the Teflon patch on the septum and RV wall with a strip of Teflon felt bolster on the RV epicardium (Fig 3D [2]). The opening in the left ventricular (LV) free wall is closed with a patch of Hemashield graft to maintain size and geometry of the remaining LV cavity. This patch is laid in the LV cavity, minimizing the disruptive force that each left ventricular contraction exerts on the suture line. (Fig 3D [3]). The oversized epicardial Teflon strip bolster on the left side is then sutured to its counterpart on the right side completing the repair (Fig 3D [4]. This repair accomplishes an absolutely hemostatic reconstruction that preserves the left ventricular chamber size and geometry for optimal function (patient 4; Fig 3).
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Fig 3. Repair of posterior postinfarction ventricular septal defect by infarctectomy and reconstruction of the septum and ventricular free wall using Dacron and Teflon patches. (A) View of the septal defect from the inferior aspect of the heart following infarct excision. L = left ventricle; R = right ventricle. (B) Same view with the Teflon patch in place indicating the site of the BioGlue application. (C) Relationship of the patch to the septal defect in a longitudinal cross-sectional view at the plane of the interventricular septum. (D) Sequence of the placement of the patches in a transverse cross-sectional view of the heart. 1 = Teflon patch on the septum; 2 = closure of the right ventricle; 3 = inside patch closing the left ventricle; 4 = outside Teflon bolster for closure of the left ventricle.
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Results
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The clinical details, the operative procedure, BioGlue application, outcome, and follow-up are summarized in Table 1 for the 5 patients. There were no operative deaths. Two patients required prolonged mechanical ventilation secondary to respiratory failure. One of these patients, with borderline preoperative renal function, also required temporary hemodialysis postoperatively. There was no evidence of systemic embolization or neurologic complications in any of the patients. Postoperative transesophageal echocardiography confirmed successful operative correction of the defects in all patients. Follow-up was achieved in all patients who are all alive and well ranging 6 to 29 months following surgery. Late echocardiography in all patients confirmed intact repairs without recurrences.
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Comment
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Successful repair of intracardiac structural defects challenges the ingenuity of the most resourceful cardiac surgeon. These defects in general result from life-threatening events that destroy cardiac skeleton and tissue with infection or infarction and are associated with weakened friable tissues exposed to arterial pressure. Such weakening of the intracardiac tissues not infrequently leads to early or late failure of the repair due to immediate failure of sutures or late pseudoaneurysm formation due to initial leaks at the suture lines. A method of strengthening these friable tissues and assuring watertight suture lines is highly desirable. BioGlue has demonstrated its facility in accomplishing both of these objectives in acute dissections of the aorta [11]. It is composed of purified bovine albumin (45%), and glutaraldehyde (10%) [12]. It polymerizes rapidly, does not crumble, and effectively glues apposing tissues allowing for weakened tissues to hold sutures securely. The potential toxicity and mutagenicity of the once popular GRF glue has been attributed to its formaldehyde component. BioGlue does not contain formaldehyde. It is applied through a reliable delivery system that ensures mixing and the start of the polymerization in the nozzle, thus minimizing the risk of tissue contamination by free glutaraldehyde. Therefore, there is substantially reduced risk of local tissue toxicity, compared with the GRF glue. We have used these advantageous characteristics of the new glue as an adjunct during complex repairs of intracardiac structural defects. The use of BioGlue in addition to principles and techniques of repair described earlier adds the extra security ensuring absolutely watertight suture lines. The principles of repair, especially in endocarditis, dictate thorough debridement and removal of all infected or necrotic tissues and repair of the resultant defect with a structurally sound autologous or prosthetic patch that preserves the anatomic and the functional integrity of the hert. We prefer autologous pericardium as the patch material in the presence of active infection and prosthetic patches in other situations, ie, postinfarction VSD or noninfected pseudoaneurysm. Because these patches cover cavities and exclude them from high-pressure chambers it is quite important to have watertight suture lines securing these patches. Otherwise even a small initial leak into the excluded cavity can eventually lead to the disruption of the suture line exposing the cavity to increased pressures and formation or recurrence of another pseudoaneurysm. This may lead to paravalvular leaks in the case of annular reconstructions and to recurrent VSD in the case of septal rupture repairs. Cautious application of BioGlue to these suture lines effectively eliminates these leaks and provides for a more secure repair. However, there are several precautions that need to be observed during its use as outlined above. Because the areas where glue is applied are completely excluded from the systemic circulation by the described techniques, the risk of systemic embolization of glue particles is eliminated. There is some concern about the use of the glue in the presence of local infection. In 3 patients we have used the glue in this situation without any observable adverse effect. One cannot overemphasize the importance of thorough debridement and removal of all necrotic material in these patients. The availability of the glue provides the added confidence for a sound repair following liberal excision of all infected tissues. Whether the glue might act as a bactericidal agent on the remaining organisms in the tissue is open to speculation. In spite of the substantially advanced infection and destruction that we observed before repair, none of our patients had recurrent infection or paravalvular leaks. Postoperative early and late echocardiographic examinations confirmed the integrity and durability of the repairs. Tissue necrosis due to glue is another concern. It has been suggested that such damage may lead to late pseudoaneurysm formation [8]. By properly preparing the area for the application of the glue and limiting the amount of glue used, inadvertent glue related tissue damage can be avoided. In the limited follow-up we have with these patients we have not observed any adverse events that could be attributed to glue related tissue necrosis. On the contrary, in the patient with the postinfarction VSD the immediate observation in the operating room suggests that the necrotic friable portion of the septum becomes quite firm and well adhered to the Teflon patch after application of the glue. This patient had no demonstrable early or late leaks across the septum by echocardiography, although such leaks are not uncommon following conventional repairs of these defects.
This limited early experience with the application of BioGlue as an adjunct in repair of challenging intracardiac structural defects indicates that it can be used safely in the heart. With increasing experience and longer follow-up this might prove to be an important addition to the current techniques in use with the promise of reliable repairs and improved early and late results.
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References
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- Guilmet D., Bachet J., Goudot B., et al. Use of biological glue in acute aortic dissections. J Thorac Cardiovasc Surg 1979;77:515-521.
- Seguin J.R., Frapier J.M., Colson P., Chaptal P.A. Fibrin sealant for early repair of acquired ventricular septal defect. J Thorac Cardiovasc Surg 1992;104:749-751.
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Top
Abstract
Introduction
