BioGlue Surgical Adhesive Research Articles

Intravascular Ultrasound Findings of BioGlue Surgical Adhesive Coronary Embolism After Ascending Aorta Replacement.

Intravascular Ultrasound Findings of BioGlue Surgical Adhesive Coronary Embolism After Ascending Aorta Replacement.

Percutaneous Ventricular Assist Device Exclusion: Institutional Case Series and Review of Literature

Surgical left ventricular assist device (LVAD) explantation is associated with increased risk of perioperative mortality (9.2%), myocardial infarction (10.8%), stroke (4.9%), and postexplant infections (4.3%).1 Minimally invasive surgical strategies have been explored, but still expose patients to risks associated with blood transfusion and myocardial trauma during dissection of adhesions.2 Percutaneous LVAD exclusion can potentially avoid perioperative complications associated with surgical exclusion. In this case series, we examined our institutional experience and reviewed published data for risks and benefits associated with percutaneous LVAD exclusion. A total of four patients underwent percutaneous LVAD exclusion between 2011 and 2018 at our institution. Subsequently, we performed a systematic review of all reported cases of percutaneous LVAD exclusion published in Pubmed/Medline between the years 2011 and 2018 and identified seven additional cases. The cumulative results (n = 11) are presented in Supplemental Table 1 https://links.lww.com/ASAIO/A436. The average age of all patients was 44 ± 17 years, 7 (64%) were men, and 9 (82%) had non-ischemic cardiomyopathy. The average time between LVAD implantation and percutaneous LVAD exclusion was 16 ± 9 months. Majority of the patients underwent percutaneous LVAD exclusion for myocardial recovery (n = 7, 64%); four patients had LVAD-related complications (mainly, pump thrombosis) and were deemed poor surgical candidates for exchange or explant and were not suitable for transplant listing. Either an Amplatzer Vascular Plug II (St. Jude Medical, St. Paul, Minnesota) (n = 8, 73%) or an Amplatzer Septal Occluder (St. Jude Medical, St. Paul, Minnesota) (n = 3, 27%) were used to occlude the VAD outflow or inflow grafts. The type of Amplatzer device used to occlude the grafts was mainly based on operator’s preference. The average disc diameter of Amplatzer device used to occlude the outflow graft of HeartMate II device was 19 ± 2 mm and HeartWare LVAD was 13 ± 1 mm. The majority of implantations occluded the outflow graft (n = 9, 82%), while two cases reported occluding only the inflow graft (n = 2, 18%). The occlusion device was deployed at both proximal and distal portions of the outflow graft in the majority of the cases (n = 7, 64%). All cases reported successful LVAD exclusion. Following implantation, the driveline was excised followed by closing the open end with either Gore-Tex or BioGlue Surgical Adhesive (CryoLife Inc, Kennesaw, Georgia) in most cases. None of the cases reported any procedure related direct complications or death. The average reported postprocedure follow-up was 18 ± 11 months. For postexclusion stroke prophylaxis; majority of patients received warfarin with an INR goal range between 1.5 and 3. Nonetheless, one patient was discharged on daily Aspirin 100 mg only,3 while another did not receive any anticoagulation.4 The reason for using only Aspirin was not clarified by the authors while the patient without anticoagulation had percutaneous LVAD exclusion as a palliative option. However, both patients were reported to be alive without any cerebrovascular complications on long-term follow-up. These two cases suggest that warfarin might not be needed postexclusion for stroke prophylaxis, and further studies are required to validate this observation. Two of the four patients who underwent exclusion due to LVAD-related complications died within 2 weeks of the procedure, whereas the remaining seven patients who underwent exclusion for myocardial recovery were still alive at last reported follow-up. In summary, percutaneous LVAD exclusion appears to be associated with high procedural success and minimal procedural complications, and is potentially, an attractive alternative to conventional surgical exclusion. However, it is worth mentioning a few limitations of our study. First, percutaneous LVAD exclusion can theoretically be associated with higher risk of thromboembolic complications and therefore, necessitates lifelong anticoagulation. Second, the presence of retained LVAD hardware with direct endovascular access also carries the risk of endocarditis. However, neither of the abovementioned complications were reported in our review of these patients. A larger sample size or a longer follow-up period of these cases will be necessary to establish the incidence of the abovementioned potential long-term complications. Lastly, the publication bias also needs to be kept in mind which may have resulted in overestimation of the success rate of percutaneous LVAD exclusion. Prospective studies with larger sample size and longer duration of follow-up are necessary to accurately understand the risk and benefit associated with percutaneous LVAD exclusion. Acknowledgement The authors thank Balsara K., Brinkley M., Wigger M., Menachem J., Punnoose L., and Brown Sacks S. for their valuable clinical contribution.

BioGlue Surgical Adhesive

Biomedical Safety & Standards 44(15):p 118, September 01, 2014. | DOI: 10.1097/01.BMSAS.0000453085.99100.79

Use of BioGlue Surgical Adhesive in Hypospadias Repair

Purpose: To prospectively evaluate the efficacy of albumin glutaraldehyde tissue adhesive (BioGlue) in the surgical treatment of patients with hypospadias. Materials and Methods: Two groups of 20 patients each who underwent hypospadias repair were included in the study. In the first group we utilized BioGlue as an additional protective layer to the suture line of the neo-urethra, while patients in the second group were operated on utilizing a routine surgical technique. Results: There were no statistical differences between patients from the 2 groups in terms of surgical complications. Urethrocutaneous fistula was revealed in 4 (20%) patients after repair with BioGlue and in 3 (15%) patients from the control group (p = 0.686), suture line breakdown in 4 (20%) and in 1 (5%) patients (p = 0.478), meatal stenosis in 1 (5%) and in 1 (5%) patient (p = 1). Furthermore more patients in the BioGlue group (n = 12, 60%) demonstrated poor cosmetic results compared to the control group where most patients - 19 (95%) had acceptable cosmetic outcomes (p = 0.007). Conclusions: Our data showed no benefits of BioGlue use in hypospadias repair.

BioGlue Surgical Adhesive as a Thermal Reflector During Laparoscopic Cryoablation: Effect on Iceball Size and Ablation Zone Diameter

Cryoablation represents an alternative for treating small renal cortical neoplasms (RCN). Previously, we demonstrated that applying BioGlue during cryoablation diminished bleeding and incidentally noted that the iceballs seemed larger than those in controls. We examined the effects of BioGlue as a thermal insulator of cryoablated tissue to determine its effect on iceball size. Laparoscopic cryoablation (LCA) was performed in 6 female pigs (24 ablations) by using a single 1.47-mm cryoablation probe. One pole of each kidney was randomly treated with BioGlue prior to ablation, while the contralateral pole was the untreated control. The size of the iceball was measured using laparoscopic ultrasound. The tissue ablation zone was measured grossly after the specimens were harvested. We also documented the amount of bleeding on a subjective scale. There were no differences in the diameters of the iceballs between the BioGlue and control groups when measured with laparoscopic ultrasound (P=.85). Similarly, the ablation zones on gross measurement were not significantly different (P=.47). No difference occurred in the amount of subjective bleeding. In a porcine model, the application of BioGlue prior to LCA does not appear to increase the size of the iceball generated. No change was observed in the amount of subjective bleeding as a result of using BioGlue.

Presealing of the chorioamniotic membranes prior to fetoscopic surgery: Preliminary study with unfertilised chicken egg models

Background Fetoscopic surgical techniques continue to develop. However, progress has been hindered by premature rupture of membranes (PROM), which complicates 5–30% of fetoscopic procedures. Several membrane closure techniques have been devised but none proven reliable. Objective We propose a new approach that of presealing the chorioamniotic membrane prior to membrane disruption–a so called Amnioseal. A set of pilot experiments were designed using unfertilised chicken egg models to test our proposal. Study design Two novel unfertilised chicken egg models were developed. Model 1 simulated the chorioamniotic membrane and amniotic cavity. Model 2 simulated the uterine muscle/chorioamniotic membrane interface and amniotic cavity. Four sealants (100% petroleum jelly, FloSeal Hemostatic Matrix, CoSeal Hemostatic Matrix and BioGlue Surgical Adhesive) were tested against untreated controls. The sealants were applied directly to the egg membranes followed by biopsy needle puncture and needle membrane manipulation. Results BioGlue adhered strongly to the membrane correlating with the smallest defect size, greatest resistance to rupture, lowest degree of leakage and formed a water tight seal around the needle during membrane manipulation. In comparison, the weak adherence of FloSeal correlated with a larger defect size and higher degree of leakage. 100% petroleum jelly was non-adhesive, provided no membrane support and resulted in membrane rupture. Conclusion Adhesive sealants confer mechanical support to the membrane and form a water tight seal. Experiments show that Sealant properties greatly affect outcomes. As such the Amnioseal's success will be determined by the properties of the sealant used. Specifically designed sealants are being developed along side a delivery device and will be tested using an in vitro human chorioamniotic membrane model.

Determination of Shear Strength of Periosteum Attached to Bone With BioGlue Surgical Adhesive

To determine the shear strength of BioGlue Surgical Adhesive (Cryolife Inc, Kennesaw, Georgia) for use in periosteal fixation in endoscopic browplasty. In a controlled design, the shear strength of periosteal attachment to native bone and that of dissected periosteum affixed to bone with BioGlue surgical adhesive was physiologically determined. Twenty-one periosteum and bone samples were harvested from 3 human cadavers. These samples were tested for maximum shear strength using an Instron Model 5500 universal materials testing machine. Native samples consisted of periosteum still attached to the bone surface, while BioGlue samples consisted of dissected periosteum reattached to the bone surface using BioGlue surgical adhesive. The maximum shear strength attained for each sample was recorded and used to determine if native samples differed from those using BioGlue surgical adhesive. The mean (SD) maximum shear strength values obtained during testing were 57.8 (31.7) kPa and 45.9 (27.4) kPa (589.4 [323.3] gram force [gf]/cm(2) and 468.0 [279.4] gf/cm(2)) for native (n=8) and BioGlue (n=9) samples, respectively. There was no statistical difference between the native and BioGlue samples (P> .05) using analysis of variance. This study demonstrates that the adhesive properties of BioGlue are similar to the strength of attachment of native periosteum to bone and supports the use of BioGlue as an alternative method of fixation for use in endoscopic brow-lifting.

Use of a protein-based tissue adhesive as an aid for the surgical reconstruction of advanced and recurrent skin cancer tumors to the head and neck region: a technical report

Background Patients with advanced skin cancer present a unique challenge to neurosurgeons. Treatment involves aggressive surgical intervention and lengthy reconstructive procedures with considerable morbidity to obtain adequate and safe oncological margins. We reviewed our experience with BioGlue Surgical Adhesive, a protein-based adhesive, as an adjunct in free tissue transfer procedures to prevent CSF leakage and seroma formation. Methods Between January 2000 and June 2004, 11 patients ranging in age from 32 to 87 years presented with advanced skin cancer tumors in the head and neck. Pathology included squamous (7) and basal (3) cell carcinoma and malignant schwannoma (1). Of the 11 patients, 8 had undergone previous surgery and/or radiation therapy. All were treated with a combination of craniotomy, skull base, and craniofacial approaches with reconstruction of the large defects using muscular or myocutaneous free flaps in a single operation. Fat, muscle, and a 1-mm epidural layer of BioGlue were used to seal the dural sutures and to obliterate any potential seroma-forming dead space. Results A total of 6 patients underwent craniofacial resection with orbital exenteration and partial rhinectomy, whereas the remaining 5 underwent frontal, parietal, and/or occipital craniotomies. All patients required dural repair. Three patients required additional brain resection because of tumor infiltration. No patient developed a CSF leak or seroma. There were no adverse events related to the use of BioGlue. Three patients died of medical complications (pulmonary embolism, myocardial infarction, late-onset myelodysplasia). The remaining patients are alive, and our follow-up (range, 9-58 months) has revealed no recurrence or distal metastasis. Conclusions Advanced skin cancer tumors in the head and neck region are associated with complex and disfiguring surgical procedures with increased morbidity. We demonstrate that an adjunctive use of a sufficiently strong tissue adhesive can yield acceptable outcomes and minimize comorbidity in this challenging patient population.

Influência da cola Bioglue® na deiscência de anastomose colônica: estudo experimental

A grande parte da morbimortalidade associada com a cirurgia colorretal, é associada com a deiscência anastomótica. Trabalhos experimentais sobre a utilidade de adesivos tissulares nas anastomoses colônicas são controversos, assim como estudos clínicos prospectivos randomizados são ausentes. O adesivo cirúrgico BioGlue®, formado por dois componentes - albumina sérica bovina purificada e glutaraldeído, forma uma ligação co-valente entre esses dois componentes e as proteínas teciduais no local de aplicação. O objetivo do estudo é avaliar a eficácia da BioGlue® na prevenção da deiscência anastomótica colônica em ratos. Foram utilizados 30 ratos machos da raça Wistar albino. A anastomose colocolônica foi confeccionada com sutura em pontos separados com polipropileno 5-0 (grupo 1) e aplicação da cola BioGlue® envolvendo a anastomose (grupo 2). Avaliaram-se a formação e extensão das aderências, a pressão de ruptura nas anastomoses e as alterações histológicas. Apenas um animal do grupo 1 (7%) faleceu, sendo constatada na necropsia, obstrução intestinal com grande distensão de alças. A mortalidade no grupo 2, por outro lado, foi de 10 animais (67%), sendo observado: distensão de alças intestinais, vazamento anastomótico e, em algumas situações, franca peritonite fecal por deiscência quase que total da anastomose. O presente trabalho nos permitiu concluir que, o uso da Bioglue® nas anastomoses colônicas realizadas em ratos, promoveu um aumento na morbimortalidade que foi estatisticamente significante comparado à sutura convencional.

Use of BioGlue Surgical Adhesive for Brow Fixation in Endoscopic Brow-plasty

Use of BioGlue Surgical Adhesive for Brow Fixation in Endoscopic Brow-plasty

Evaluation of the Use of BioGlue® in the Treatment of High Anal Fistulas: Preliminary Results of a Pilot Study

Treatment of anal fistulas by use of adhesives is an attractive method because of its simplicity and it can be performed on an ambulatory basis. Furthermore, if the treatment is unsuccessful, adhesive use does not subsequently prevent the surgeon from utilizing alternative surgical techniques and/or products. BioGlue Surgical Adhesive is a two-component surgical adhesive composed of bovine serum albumin and glutaraldehyde. We evaluated the usefulness of BioGlue for the treatment of high transsphincter anal fistulas. Patients diagnosed with high transsphincter anal fistulas of cryptoglandular origin, whether relapsed or not, were included in this study. A seton was placed before the injection of BioGlue into the fistula track of high transsphincter anal fistulas in patients with secondary tracts and/or purulent collections. Clinical charts, operative reports, and endoanal echography results obtained for each patient were reviewed. Fourteen patients (13 males; mean age, 39.9 (range, 24-66) years) with high transsphincter anal fistulas of cryptoglandular origin were recruited into the study. The average time of symptom evolution was 35.6 (range, 2-96) months. Ten of 14 cases were for relapsed fistulas. Six patients required the placement of a seton 37 (range, 32-42) days before the BioGlue injection. Patients were followed for a mean length of 13.92 (range, 3-21) months, and the fistula healed completely in only seven patients (50 percent). These preliminary results demonstrate that BioGlue may be useful for treating patients with high transsphincter anal fistulas. Further prospective long-term studies are needed.

Use of BioGlue in Aortic Surgery: Proper Application Techniques and Results in 92 Patients

Surgery for pathology of the proximal aorta requires aortic wall reconstruction, re-approximation of the graft to native vessels, and potentially root replacement and valve resuspension or replacement. The purpose of this study is to describe proper application techniques and the results obtained with the adjunctive use of BioGlue Surgical Adhesive in this challenging patient population. Between August 1998 and June 2002, 92 consecutive patients underwent ascending/arch repairs, ascending/root repairs, Ross procedures, or ascending/arch repairs with a concomitant Ross procedure using BioGlue as an adjunct for anastomotic hemostasis. Twenty-six patients (28.3%) in this series required no postoperative blood products. The mortality rate for this single-surgeon series was 3.3%. No device-related complications were observed. The incidence rate for postoperative pseudoaneurysm formation was 3.3%. This series demonstrates the safety and effectiveness of BioGlue as a hemostatic adjunct in proximal aortic surgery. Use of the product helped to facilitate a minimal reliance on blood products and a low mortality rate.

Use of BioGlue Surgical Adhesive for Brow Fixation in Endoscopic Browplasty

To determine the efficacy, longevity, and safety of BioGlue Surgical Adhesive for periosteal fixation in endoscopic browlifts. Retrospective review of 80 patients who underwent endoscopic browlift using BioGlue as the primary means of periosteal fixation. Visits were categorized as preoperative, 1 to 2 months, 3 to 6 months, and 7 to 12 months, and photographs of the first 15 patients were evaluated for change in brow position at each of these visits. Brow position was measured at the lowest brow hairs at the midpupillary and lateral canthus positions. Follow-up was 3 months to 3 years. All of the first 15 patients were included in the 1- to 2-month postoperative grouping, 13 in the 3- to 6-month grouping, and 10 in the 7- to 12-month grouping. At all postoperative visits, brow elevation was significantly maintained during 12-month follow-up. Revision has been required in only 1 of 80 patients to date. BioGlue is an effective and safe method of maintaining brow position in endoscopic browplasty. Brow elevation achieved using BioGlue was significantly maintained during the 7- to 12-month postoperative period. Tissue adhesives such as BioGlue have the potential to become significant adjuncts in facial plastic surgery and warrant more critical evaluation.

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

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. 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. 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. 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.

BioGlue surgical adhesive—an appraisal of its indications in cardiac surgery

Background. The recent emergence of BioGlue Surgical Adhesive has widened the field of surgical adhesives for the cardiac surgeon. We believe the present series, in a wider spectrum of cardiac conditions, is the first larger scale evaluation of the use of this new adhesive. Methods. BioGlue was used in 115 consecutive patients (90 male and 25 female, age range 5 days to 87 years) from September 9, 1998 to March 12, 2001. Preoperative, intraoperative, and postoperative data were examined to establish its use, indications, and outcomes in patients undergoing cardiac surgical procedures. Results. The most common underlying pathologic conditions were aortic dissections (30 patients) and aortic aneurysms (39 patients). The procedures carried out were aortic root replacement (36 patients), aortic wall replacement (39), ascending aorta repair (2), coronary artery bypass grafting (28), valve procedures (11), ventricular aneurysm repair (6), repair of postinfarct ventricular septal defect (2), and correction of congenital conditions (13 patients). The indications for BioGlue use were hemostasis in 79 patients, tissue adherence in 21, and tissue strengthening in 30. The hospital mortality was 10.1% (11 patients). Only 1 patient required a late reoperation for dehiscence of a suture line with formation of a false aneurysm. The mean postoperative blood loss at 12 hours was 702 mL. Ten patients developed a cerebrovascular accident postoperatively, which was considered to be unrelated to the use of BioGlue. Conclusions. All surgeons in this study believed that BioGlue facilitated the operation. Future follow-up of patients is required to validate our early promising results and to assess the long-term outcome of patients treated with BioGlue.