Evaluation of the use of BioGlue® in neurosurgical procedures

Kumar, Arun; Maartens, Nicholas F.; Kaye, Andrew H.

doi:10.1016/s0967-5868(03)00163-2

Cited by 111 publications

(65 citation statements)

References 28 publications

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“…2,4,12 Several studies have described the use of sealants as useful in avoiding CSF leakage in supratentorial, 4,20,28,33 Object. Cerebrospinal fluid leakage is an immanent risk of cranial surgery with dural opening.…”

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confidence: 99%

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Risk factors for postoperative CSF leakage after elective craniotomy and the efficacy of fleece-bound tissue sealing against dural suturing alone: a randomized controlled trial

Hütter

Felten²,

Sailer³

et al. 2014

JNS

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W hile performing cranial surgery, it is of utmost importance to achieve a tight and reliable closure of the dura mater. Cerebrospinal fluid leakage leads to increased morbidity, prolongation of hospital stay, surgical revision, and enhanced costs as well as possible surgical revisions. 15,19 The incidence of CSF leakage is reported to depend on the location of surgery (for example, more likely in the posterior fossa)15 but may also depend on the size of the craniotomy and dural opening or on patient-related factors such as immune status, age, or the underlying pathological process. Dural closure is usually achieved with an intended watertight suture and the addition of hemostyptic or hemostatic agents such as fibrin glue or cellulose collections.2,4,12 Several studies have described the use of sealants as useful in avoiding CSF leakage in supratentorial, 4,20,28,33 Object. Cerebrospinal fluid leakage is an immanent risk of cranial surgery with dural opening. Recognizing the risk factors for this complication and improving the technique of dural closure may reduce the associated morbidity and its surgical burden. The aim of this paper was to investigate whether the addition of TachoSil on top of the dural suture reduces postoperative CSF leakage compared with dural suturing alone and to assess the frequency and risk factors for dural leakage and potentially related complications after elective craniotomy.Methods. The authors conducted a prospective, randomized, double-blinded single-center trial in patients undergoing elective craniotomy with dural opening. They compared their standard dural closure by running suture alone (with the use of a dural patch if needed) to the same closure with the addition of TachoSil on top of the suture. The primary end point was the incidence of CSF leakage, defined as CSF collection or any open CSF fistula within 30 days. Secondary end points were the incidence of infection, surgical revision, and length of stay in the intensive care unit (ICU) or intermediate care (IMC) unit. The site of craniotomy, a history of diabetes mellitus, a diagnosis of meningioma, the intraoperative need of a suturable dural substitute, and blood parameters were assessed as potential risk factors for CSF leakage.Results. The authors enrolled 241 patients, of whom 229 were included in the analysis. Cerebrospinal fluid leakage, mostly self-limiting subgaleal collections, occurred in 13.5% of patients. Invasive treatment was performed in 8 patients (3.5%) (subgaleal puncture in 6, lumbar drainage in 1, and surgical revision in 1 patient). Diabetes mellitus, a higher preoperative level of C-reactive protein (CRP), and the intraoperative need for a dural patch were positively associated with the occurrence of the primary end point (p = 0.014, 0.01, and 0.049, respectively). Cerebrospinal fluid leakage (9.7% vs 17.2%, OR 0.53 [95% CI 0.23-1.15], p = 0.108) and infection (OR 0.18 [95% CI 0.01-1.18], p = 0.077) occurred less frequently in the study group than in the control group. TachoSil significantly reduc...

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confidence: 99%

“…20 After sealant application, the percentages of CSF leaks vary from 0.9% 20 to 10.7%. 15 Dural sealants have been described to be safe when used in combination with autologous dural substitute material.…”

mentioning

confidence: 99%

Risk factors for postoperative CSF leakage after elective craniotomy and the efficacy of fleece-bound tissue sealing against dural suturing alone: a randomized controlled trial

Hütter

Felten²,

Sailer³

et al. 2014

JNS

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“…It has been used in neurosurgical procedures to minimize the risk of cerebrospinal leak after dural closure and in sellar reconstruction following transsphenoidal surgery. [5][6][7] BSAG is composed of a highly cross-linked protein polymer and takes several months to degrade, much longer than the other 2 water-based compounds. 8 Both fibrin glue and PEGH have a high water content and thus have characteristics similar to CSF or reactive inflammation on MR imaging.…”

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confidence: 99%

The Appearance of Dural Sealants under MR Imaging

Tarapore

Mukherjee

Mummaneni

et al. 2012

AJNR Am J Neuroradiol

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SUMMARY:Dural sealants are an adjunct to obtain watertight closure after intradural procedures. This study aims to characterize the appearance on MR imaging of 3 commonly employed dural sealants: fibrin glue, PEGH, and BSAG. To this end, patients who underwent spinal intradural procedures that included the use of dural sealant during closure were identified retrospectively. Post-operative data on 15 patients, including complications such as pseudomeningocele formation and infection, were gathered. The appearance of dural sealants on follow-up MR imaging scans within 3 days of surgery was analyzed. Fifteen patients were identified (5 with fibrin glue, 5 with PEGH, and 5 with BSAG applied during closure) with appropriately timed post-operative MR imaging scans. All 3 substances were identifiable based on anatomic location and imaging characteristics on post-operative MR imaging in standard T1, T1 PGFS, and T2 FSE. Definite differentiation between CSF and fibrin glue or PEGH was not possible with the T1 or T1 PGFS, or with the T2 FSE. Differences in intensity between CSF and BSAG were also not significant on either T1 sequence, but they were statistically significant on the T2 FSE. All patients had an uneventful post-operative course, and no patients developed post-operative pseudomeningocele at 30 days. This study concludes that water-based dural sealants such as fibrin glue and PEGH are difficult to differentiate from CSF on standard T1, T1 PGFS and T2 FSE, while BSAG is easily recognized on the T2 FSE. Recognition of water-based sealants therefore requires communication between the neurosurgeon and the neuroradiologist to avoid post-operative misidentification.ABBREVIATIONS: BSAG ϭ bovine serum albumin and gluteraldehyde polymer; FSE ϭ fast spinecho; PEGH ϭ polyethylene glycol hydrogel; PGFS ϭ postgadolinium fat saturation W atertight closure of the dura is a primary concern in the management of intradural spine tumors. Although Harvey Cushing asserted that "an accurate approximation of the dura in its two layers is desirable," 1 in the modern era, a single-layered dural closure with suture is the standard of care. To further reduce the chance of leakage, numerous adjunctive dural sealants have emerged in the last several years. By being applied to the suture line following primary repair, these substances are designed to bond with the tissue and fill small gaps in the closure, thus preventing leakage of CSF through the repair site. 2,3Three such substances are commonly used in our practice. Fibrin glue (TISSEEL; Baxter BioSurgery, Deerfield, Illinois) has been used as a dural sealant in both cranial and spinal cases. It relies on a solution of fibrinogen, aprotinin, and clotting factors. When mixed with a thrombin counterpart, the fibrin cross-links, causing coagulation and binding to surrounding tissues. The glue is subsequently degraded by natural fibrinolysis during several weeks. Hydrogel (DuraSeal; Covidien, Dublin, Ireland) is a compound based on polyethylene glycol and trilysine, a small amino acid. When...

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“…However, in our study, the use of a simple rounded and polished impactor similar to other marketed impactors did not induce dural tears. Moreover, to prevent CSF leakage around the catheters, we applied biological glue designed to serve as a sealant agent for dural tear repair [37]. Note that in the present study, no CSF leakage was observed between catheter insertion and application of glue.…”

Section: Discussionmentioning

confidence: 66%

Rat model of spinal cord injury preserving dura mater integrity and allowing measurements of cerebrospinal fluid pressure and spinal cord blood flow

et al. 2013

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Purposes Cerebrospinal fluid (CSF) pressure elevation may worsen spinal cord ischaemia after spinal cord injury (SCI). We developed a rat model to investigate relationships between CSF pressure and spinal cord blood flow (SCBF). Methods Male Wistar rats had SCI induced at Th10 (n = 7) or a sham operation (n = 10). SCBF was measured using laser-Doppler and CSF pressure via a sacral catheter. Dural integrity was assessed using subdural methyleneblue injection (n = 5) and myelography (n = 5). Results The SCI group had significantly lower SCBF (p \ 0.0001) and higher CSF pressure (p \ 0.0001) values compared to the sham-operated group. Sixty minutes after SCI or sham operation, CSF pressure was 8.6 ± 0.4 mmHg in the SCI group versus 5.5 ± 0.5 mmHg in the shamoperated group. No dural tears were found after SCI. Conclusion Our rat model allows SCBF and CSF pressure measurements after induced SCI. After SCI, CSF pressure significantly increases.

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Evaluation of the use of BioGlue® in neurosurgical procedures

Cited by 111 publications

References 28 publications

Risk factors for postoperative CSF leakage after elective craniotomy and the efficacy of fleece-bound tissue sealing against dural suturing alone: a randomized controlled trial

Risk factors for postoperative CSF leakage after elective craniotomy and the efficacy of fleece-bound tissue sealing against dural suturing alone: a randomized controlled trial

The Appearance of Dural Sealants under MR Imaging

Rat model of spinal cord injury preserving dura mater integrity and allowing measurements of cerebrospinal fluid pressure and spinal cord blood flow

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