|Year : 2018 | Volume
| Issue : 1 | Page : 15-20
Symptomatic hemorrhagic complications associated with dural substitutes
Po-Yuan Chen1, Szu-Ying Chen2, Te-Yuan Chen3, Han-Jung Chen4, Kang Lu4, Cheng-Loong Liang4, Po-Chou Liliang5, Kuo-Wei Wang5, San-Nan Yang6, Chih-Yuan Huang7, Hao-Kuang Wang4
1 Department of Neurosurgery, E-Da Cancer Hospital, I-Shou University, Kaohsiung, Taiwan
2 Department of Critical Care Medicine, E-Da Hospital, I-Shou University, Kaohsiung, Taiwan
3 Department of Neurosurgery, E-Da Hospital, I-Shou University, Kaohsiung, Taiwan
4 Department of Neurosurgery, E-Da Hospital, I-Shou University; School of Medicine for International Students, I-Shou University, Kaohsiung, Taiwan
5 Department of Neurosurgery, E-Da Cancer Hospital, I-Shou University; School of Medicine for International Students, Kaohsiung, Taiwan
6 School of Medicine for International Students, I-Shou University, Kaohsiung, Taiwan
7 Neurosurgical Service, Department of Surgery, National Cheng Kung University Hospital, Tainan, Taiwan
|Date of Submission||08-Jul-2017|
|Date of Decision||14-Aug-2017|
|Date of Acceptance||29-Sep-2017|
|Date of Web Publication||09-Feb-2018|
Dr. Hao-Kuang Wang
Department of Neurosurgery, E-Da Hospital, I-Shou University, No. 1, Yida Road, Jiaosu, Yanchao, Kaohsiung 82445
Source of Support: None, Conflict of Interest: None
Background: Duroplasty has been widely used in cranial surgery when primary closure is not possible. The goal is to protect the cerebrum and thereby ensure that complications were as few as possible. We reviewed a single-institution experience with a variety of dural substitutes in craniotomy and analyzed the risk factors for duroplasty-associated hemorrhagic complications.
Patients and Methods: Patients who received dural replacement after craniotomy or craniectomy between July 2004 and June 2009 were enrolled into this study. Medical records were reviewed for diagnosis, procedure, and type of dural replacement. Clinical courses were reviewed for hemorrhagic complications, including subdural hematoma, extradural hematoma, and subarachnoid hemorrhage. Logistic regression models were used to analyzed the risk factors of duroplasty-associated hemorrhagic complications.
Results: Two hundred and twelve patients were included in the study. Overall, the hemorrhagic complication rate was 4.7% (10 patients). Complications were seen for microporous polyester urethane, expanded polytetrafluoroethylene monolayer, polyester silicone, and Biomesh in 4.1%, 0%, and 38.5% of patients, respectively. Patients who received duroplasty with Biomesh had a higher hemorrhagic complication rate with the odds ratio of 24.75 (95% confidence interval, 4.33–141.41) in comparison of those with microporous polyester urethane group after adjusting for individual confounders.
Conclusion: The increased risk of hemorrhagic complications associated with craniotomy is modified by choice of dural replacement. Our results could assist clinicians in their decision-making with respect to the optimal timing for synthetic dural substitutes in patients with tumor infiltration of the patient's dura, severe brain swelling in traumatic brain injury, or a result of shrinkage from exposure and electrocautery.
Keywords: Complications, dural substitutes, duroplasty, neomembrane
|How to cite this article:|
Chen PY, Chen SY, Chen TY, Chen HJ, Lu K, Liang CL, Liliang PC, Wang KW, Yang SN, Huang CY, Wang HK. Symptomatic hemorrhagic complications associated with dural substitutes. Formos J Surg 2018;51:15-20
|How to cite this URL:|
Chen PY, Chen SY, Chen TY, Chen HJ, Lu K, Liang CL, Liliang PC, Wang KW, Yang SN, Huang CY, Wang HK. Symptomatic hemorrhagic complications associated with dural substitutes. Formos J Surg [serial online] 2018 [cited 2018 Apr 23];51:15-20. Available from: http://www.e-fjs.org/text.asp?2018/51/1/15/225127
| Introduction|| |
After many cranial and spinal neurosurgical procedure, reconstruction of the dura mater is needed to recreate the watertight barrier of the native dura to prevent leakage of cerebrospinal fluid (CSF) and minimize introduction of blood products into the CSF., However, a primary suture is not always possible. Numerous methods and materials have been evaluated for duroplasty, such as autografts, allografts, xenografts, and synthetic dural substitutes.,
However, several large clinical trials have demonstrated that none of these substitutes proved to be free of complications.,, Many of these products were associated with postoperative complications: CSF leakage, pseudomeningoceles, fistulae, infection, meningitis, hemorrhages, development of corticomeningeal adhesions, and inflammatory reactions.
We reviewed our single-institution experiences with a variety of dural substitutes in craniotomy or craniectomy and reported the complication rates for these materials. The risk factors of duroplasty-associated hemorrhagic complications were also analyzed.
| Patients And Methods|| |
We performed a retrospective review of consecutive patients after obtaining the approval of an institutional review board. Patients admitted to the neurosurgical department in our hospital from July 2004 to June 2009 were screened for dural replacement. Patients who underwent craniotomies or craniectomies for tumors, traumatic brain injuries, and vascular lesions were included in the study. Medical records were reviewed for patient demographics, including age, primary diagnosis, surgeon, and operative procedure. The type and the size number of the dural replacements were also identified. Postoperative clinical courses were reviewed for hemorrhagic complications, including subdural hematoma, extradural hematoma, and subarachnoid hemorrhage. Since postoperative imaging was not performed routinely, most cases were considered only when clinically significant and included consciousness disturbance, limb weakness, or severe headache.
Descriptive statistics of individual characteristics and hemorrhage complications was reported as mean and standard deviation for continuous variables and n (%) for categorical variables. The ANOVA tests and independent t-tests were used to compare continuous variables between groups, and Chi-square tests were used to compare categorical variables between groups. Logistic regression models were applied to estimate the risks of duroplasty-associated hemorrhage complications. We obtained the unadjusted odds ratio (OR) and adjusted OR after adjusting for potential confounding factors. The estimates of the OR were expressed as the mean values and their 95% confidence. All of the analyses were performed using (SPSS for Windows, Version 16.0. Statistical Product and Service Solutions Inc, Chicago, IL, USA.). A significance level of 0.05, with a two-tailed distribution, was used to determine statistical significance.
The study was conducted in accordance with the Declaration of Helsinki and was approved by the local ethics committee of the institute. Informed written consent was obtained from all patients prior to their enrollment in this study.
| Results|| |
Two hundred and twelve patients were identified. Demographic characteristics and comorbidities of the patients who received different dural substitutes are shown in [Table 1]. The microporous polyester urethane (Neuro-Patch; B. Braun Melsungen AG, Melsungen, Germany) was used in 121 patients; the expanded polytetrafluoroethylene monolayer (Gore-Tex; W. L. Gore and Associates, Newark, DE, USA) in 78 patients; and polyester silicone (Patch Biomesh N3; Cousin Biotech, Wervicq-Sud, France) in 13 patients. Demographic characteristics and comorbidities of the patients who received different dural substitutes are shown in [Table 1]. The mean age of the patients was 52.7 ± 17.06 years (range, 1–92 years). Primary diagnoses indicated tumors in 155 patients, forty-four patients developed traumatic brain injury, and thirteen patients experienced a vascular lesion. Symptomatic hemorrhagic complications were seen in ten patients.
|Table 1: Characteristics of patients receiving Neuro-Patch, Gore-Tex, or Biomesh for dural closure|
Click here to view
[Table 2] presents the differences in complications between the dural substitute groups. Complications associated with Neuro-Patch were seen in 5 of 121 patients (4.1%) and those associated with Biomesh were seen in 5 of 13 (38.5%) patients. Among the 10 patients who developed complications, 8 patients had subdural hematoma; one had epidural hematoma; and one developed subarachnoid hemorrhage and pneumocranium. Reoperation was recommended for these patients. However, only seven patients underwent repeated craniotomy.
|Table 2: Type of complications in patients receiving Neuro-Patch, Gore-Tex, or Biomesh for dural closure|
Click here to view
[Table 3]a and [Table 3]b shows the demographic characteristics and comorbidities of the patients with complications and those without complications. The patients with complications had a higher prevalence rate of hepatitis, craniotomy for brain tumor, and received duroplasty with Biomesh.
|Table 3a: Comparison of comorbidities between hemorrhagic complication and no complication patients|
Click here to view
|Table 3b: Risk factors between hemorrhagic complications and no complications patients|
Click here to view
[Table 4] presents the risk analysis of hemorrhagic complications in the different dural substitute groups. Since there was no complications happened among Gore-Tex group, we directly evaluated the risk factors of hemorrhagic complications between Neuro-Patch and Biomesh groups. The crude model showed that patients who had hepatitis history or received Biomesh duroplasty had significant hemorrhagic complications in comparison of those who denied hepatitis history or received Neuro-Patch duroplasty, with OR 8.17 (1.42–46.97) and 14.50 (3.46–60.70), respectively. Using logistic regression analysis, the adjusted OR for hemorrhagic complications was significantly increased in patients with the Biomesh in comparison of those with Neuro-Patch, with estimates of 24.75 (95% confidence interval, 4.33–141.41), respectively.
|Table 4: Logistic regression analysis of comorbidities for hemorrhagic complications|
Click here to view
| Discussion|| |
The dura mater is the toughest and outermost layer that surrounds the brain and spinal cord. However, the dura mater can be damaged by trauma or excising during intracranial or spinal surgery. Primary suture of the dural edges and a watertight dural closure have been well emphasized to prevent leakage of CSF and minimize introduction of blood products into the CSF., However, primary closure is not always possible. Duroplasty may be needed under certain circumstances, such as tumor infiltration of the dura, severe brain swelling in traumatic brain injury, or shrinkage resulting from exposure and electrocautery. Numerous methods and materials have been evaluated for this purpose, such as rubber; gold, platinum, silver, and tantalum foil;, autografts of pericranium, peritoneum, and fascia lata; allografts of cadaveric fascia lata and dura; xenografts of porcine small intestinal submucosa, dura, or pericardium; and synthetic dural substitutes.,,,,,
An ideal dural substitute should be safe and efficacious, easy to handle, and able to provide watertight dural closure. The following criteria are of importance for an optimal substitute dura mater: (a) ability to protect the cerebrum against inflammation; (b) ability to avoid fusion and adhesions between the skull and the dura or between the meninges and the brain surface, which can cause epileptogenic cortical focus; (c) ability to prevent leakage of the CSF; (d) noninflammatory integration without rejection or reaction of the body to the dural substitute; and (e) pliable material, without tearing, degradation, or small changes in the substitute.,,,
However, no substitute has proven to be free of complications in a large clinical trial. Many of these products were associated with postoperative complications: CSF leakage,, pseudomeningoceles, fistulae, infection,,, meningitis,, hemorrhages,,,,,,,,, development of corticomeningeal adhesions, and inflammatory reactions.,,
Development of complications associated with the use of an artificial dural substitute has rarely been reported before this study and has been considered infrequent. The exact incidence of various complications after using artificial dural substitutes remains unknown. In a study by Moskowitz et al., hydrodynamic complications occurred in 28 patients (21.9%) among a total of 106 patients who had undergone suboccipital craniotomies. In the present study, the incidence of hemorrhagic complications was 4.7%.
Several possible mechanisms could be responsible for the development of hemorrhagic complications. First, hemorrhage could result from the disruption of the local vessels by movement of the synthetic dural substitutes. This hypothesis can explain complications located at the suboccipital area  and the occipital-cervical junction. A study by Nixon et al. showed that hemorrhage occurred 3–12 years after suboccipital craniectomy for tumor (ependymoma, medulloblastoma, astrocytoma, and ganglioglioma in 3, 2, 1, and 1 patients, respectively). Furthermore, four patients had multiple hemorrhagic episodes. However, these authors did not explain that bleeding associated with synthetic dural substitutes is often reported in the surface of the cerebral hemisphere. In our series, only 1 case of bleeding occurred in the suboccipital area. Disruption of the local vessels by movement of the synthetic dural substitutes is strongly suspected.
Second, hemorrhage is the result of inflammation.,,,, The presence of synthetic dural substitutes in surgical wounds can induce a local tissue reaction from the edge of the dura and lead to the formation of a thick connective tissue. Under such conditions, rupture of these fragile vessels in response to minor trauma leads to bleeding. Multiple hemorrhagic episodes were resolved in four cases in our report until dural graft removal. The role of inflammation could explain the resolved hemorrhagic episodes in these cases. Several case reports also support this hypothesis.,,,,,,,,,,,,,,, Our results also revealed that the incidence of hemorrhagic complications was different between several materials. Gore-Tex is made up of fibrillated polymer of polytetrafluoroethylene with pore sizes in the range of 22um which allows limited tissue in growth. It is a soft implant and allows the tissue to fixate the implant for a more stable feel. Neuro-Patch is a type of fine fibred microporous fleece manufactured from a highly purified polyesterurethane. In this aspect, Neuro-Patch is similar to Gore-Tex. However, Biomesh is different and coated by silicone. Silicone is made from linked chains of siloxane molecules and has been used as a casing for implants in the body, including mammary, pacemaker, and cochlear implants and joint prostheses. However, implants made of these materials may be responsible for a number of complications.,,,,,,, In a meta-analysis, they reported that the removal rate of silicone implants was reportedly higher than that of Gore-Tex or high-density polyethylene implants. The material in our study that had a clearly increased rate of complication rate was polyester silicone (Patch Biomesh N3). Although immunologic reactions have been considered to account for some of these effects of silicones, the mechanisms underlying silicone-mediated inflammatory responses have not been well defined.
Other important factors have been suggested, including a slight female prevalence  and craniotomy for meningioma. Robertson and Menezesretrospectively reviewed 36 patients with hemorrhagic complications with silastic dural substitute. These investigators found a higher female prevalence in reported hemorrhagic disease. Estrogen deficiency results in a decreased amount of collagen in tissue, including arterial walls, which could weaken the connective tissue layers and predispose the vessel to rupture. However, these studies were unable to provide sufficient evidence to support the hypothesis that a hormonal component was responsible for the vascular abnormality. In our study, we did not observe a gender bias in the incidence of hemorrhagic complications.
The surgical removal of tumors presents an additional problem in supratentorial cases. In a study by Bartosz and Vasterling, cerebral tissue collapse into the cavity left by a tumor resection was found to be capable of inducing tension on the bridging veins, causing bleeding, and in some cases, intracerebral hematoma formation. Most retrospective studies tend to support this observation. Our results also confirm these findings that craniotomy for brain tumor has a higher incidence of hemorrhagic complications.
Another important factor that can induce a higher incidence of hemorrhagic complications but that was not examined before this study is hepatitis. In patients with chronic liver disease, hemostatic abnormalities, such as impaired synthesis of coagulation factors, production of abnormally functioning clotting factor, Vitamin K deficiency, thrombocytopenia, qualitative platelet dysfunction, consumptive coagulopathy, and impaired clearance of circulating activation complex, were noted. Therefore, care should be taken in using synthetic dural substitutes in patients with hepatitis history.
Our study had several limitations. First, the data extraction and analysis were performed retrospectively in this observational cohort study. Since the database was not designed specifically to examine hemorrhagic complications, certain issues were not documented, e.g., alcohol consumption and the physician's judgment and preference. Second, postoperative imaging was not performed routinely in our study. Care must be taken in extrapolating from these results because cases were considered only when clinically significant. Third, the study was conducted in a single hospital. A large, multicenter, randomized, controlled trial would be the ideal way to test the safety of dural substitutes.
| Conclusion|| |
An optimal selection of substitute dura mater should be emphasized. However, no substitute has proven to be free of complications. We think that our results could assist clinicians in their decision-making with respect to the optimal synthetic dural substitutes in patients with tumor infiltration of the dura, severe brain swelling in traumatic brain injury, or shrinkage resulting from exposure and electrocautery.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Malliti M, Page P, Gury C, Chomette E, Nataf F, Roux FX, et al.
Comparison of deep wound infection rates using a synthetic dural substitute (neuro-patch) or pericranium graft for dural closure: A clinical review of 1 year. Neurosurgery 2004;54:599-603.
Moskowitz SI, Liu J, Krishnaney AA. Postoperative complications associated with dural substitutes in suboccipital craniotomies. Neurosurgery 2009;64:ons28-33.
Bartosz DK, Vasterling MK. Dura mater substitutes in the surgical treatment of meningiomas. J Neurosci Nurs 1994;26:140-5.
Arieli A, Grinvald A, Slovin H. Dural substitute for long-term imaging of cortical activity in behaving monkeys and its clinical implications. J Neurosci Methods 2002;114:119-33.
Ongkiko CM Jr., Keller JT, Mayfield FH, Dunsker SB. An unusual complication of Dura film as a dural substitute. Report of two cases. J Neurosurg 1984;60:1076-9.
Warren WL, Medary MB, Dureza CD, Bellotte JB, Flannagan PP, Oh MY, et al.
Dural repair using acellular human dermis: Experience with 200 cases: Technique assessment. Neurosurgery 2000;46:1391-6.
Yamada K, Miyamoto S, Nagata I, Kikuchi H, Ikada Y, Iwata H, et al.
Development of a dural substitute from synthetic bioabsorbable polymers. J Neurosurg 1997;86:1012-7.
Ferroli P, Acerbi F, Broggi M, Schiariti M, Albanese E, Tringali G, et al.
A novel impermeable adhesive membrane to reinforce dural closure: A preliminary retrospective study on 119 consecutive high-risk patients. World Neurosurg 2013;79:551-7.
Sabatino G, Della Pepa GM, Bianchi F, Capone G, Rigante L, Albanese A, et al.
Autologous dural substitutes: A prospective study. Clin Neurol Neurosurg 2014;116:20-3.
Agarwal N, Agarwal P, Querry A, Mazurkiewicz A, Whiteside B, Marroquin OC, et al.
Reducing surgical infections and implant costs via a novel paradigm of enhanced physician awareness. Neurosurgery 2017. doi: 10.1093/neuros/nyx273. [Epub ahead of print].
Gazzeri R, Neroni M, Alfieri A, Galarza M, Faiola A, Esposito S, et al.
Transparent equine collagen biomatrix as dural repair. A prospective clinical study. Acta Neurochir (Wien) 2009;151:537-43.
Goldblum RM, Pelley RP, O'Donell AA, Pyron D, Heggers JP. Antibodies to silicone elastomers and reactions to ventriculoperitoneal shunts. Lancet 1992;340:510-3.
Cohen AR, Aleksic S, Ransohoff J. Inflammatory reaction to synthetic dural substitute. Case report. J Neurosurg 1989;70:633-5.
Adegbite AB, Paine KW, Rozdilsky B. The role of neomembranes in formation of hematoma around silastic Dura substitute. Case report. J Neurosurg 1983;58:295-7.
Berrington NR. Acute extradural hematoma associated with silastic dural substitute: Case report. Surg Neurol 1992;38:469-70.
Gouda JJ, Brown JA, Brinker RA. Delayed cervical epidural hemorrhage associated with silastic dural implant: Case report. Neurosurgery 1997;41:943-5.
Misra BK, Shaw JF. Extracerebral hematoma in association with dural substitute. Neurosurgery 1987;21:399-400.
Ohbayashi N, Inagawa T, Katoh Y, Kumano K, Nagasako R, Hada H, et al.
Complication of silastic dural substitute 20 years after dural plasty. Surg Neurol 1994;41:338-41.
Pak MW, Chan ES, van Hasselt CA. Late complications of nasal augmentation using silicone implants. J Laryngol Otol 1998;112:1074-7.
Robertson SC, Menezes AH. Hemorrhagic complications in association with silastic dural substitute: Pediatric and adult case reports with a review of the literature. Neurosurgery 1997;40:201-5.
Siccardi D, Ventimiglia A. Fibrotic-haemorrhagic reaction to synthetic dural substitute. Acta Neurochir (Wien) 1995;132:148-9.
Simpson D, Robson A. Recurrent subarachnoid bleeding in association with dural substitute. Report of three cases. J Neurosurg 1984;60:408-9.
Ng TH, Chan KH, Leung SY, Mann KS. An unusual complication of silastic dural substitute: Case report. Neurosurgery 1990;27:491-3.
Nixon KT, Hudgins PA, Davis PC, O'Brien MS, Hudgins RJ, Hoffman JC Jr., et al.
Delayed intracranial hemorrhage in children after suboccipital craniectomy. AJR Am J Roentgenol 1994;163:897-900.
Tang L, Eaton JW. Inflammatory responses to biomaterials. Am J Clin Pathol 1995;103:466-71.
Narotam PK, van Dellen JR, Bhoola KD. A clinicopathological study of collagen sponge as a dural graft in neurosurgery. J Neurosurg 1995;82:406-12.
Fontana R, Talamonti G, D'Angelo V, Arena O, Monte V, Collice M, et al.
Spontaneous haematoma as unusual complication of silastic dural substitute. Report of 2 cases. Acta Neurochir (Wien) 1992;115:64-6.
Thompson D, Taylor W, Hayward R. Haemorrhage associated with silastic dural substitute. J Neurol Neurosurg Psychiatry 1994;57:646-8.
Gudmundsson G, Søgaard I. Complications to the use of vicryl-collagen dural substitute. Acta Neurochir (Wien) 1995;132:145-7.
Tang L, Eaton JW. Fibrin (ogen) mediates acute inflammatory responses to biomaterials. J Exp Med 1993;178:2147-56.
Warrier S, Prabhakaran VC, Davis G, Selva D. Delayed complications of silicone implants used in orbital fracture repairs. Orbit 2008;27:147-51.
Peled ZM, Warren AG, Johnston P, Yaremchuk MJ. The use of alloplastic materials in rhinoplasty surgery: A meta-analysis. Plast Reconstr Surg 2008;121:85e-92e.
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]