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Duraplasty: our current experience
Technology
Duraplasty: Our Current Experience Emanuela Caroli,* Giovanni Rocchi,* Maurizio Salvati,† and Roberto Delfini* *Department of Neurological Sciences, †Department of Neurosurgery, INM Neuromed IRCCS, University of Rome “La Sapienza,” Rome, Italy
Caroli E, Rocchi G, Salvati M, Delfini R. Duraplasty: our current experience. Surg Neurol 2004;61:55–9. BACKGROUND
A large variety of biologic and artificial materials have been suggested as dural substitutes. However, no ideal material for dural repair in neurosurgical procedures has been identified. The authors report their experience with Tutoplast processed dura and pericardium. METHODS
This study is designed to evaluate Tutoplast dura and pericardium. The study population was composed of 250 consecutive patients who underwent cerebral duraplasty with these homologous materials between 1996 and 1998. The average follow-up was 5.4 years. RESULTS
We have observed only four complications with uncertain relationship with the dural implant. These resulted in complete recovery. CONCLUSIONS
We support the efficacy and safety of this natural dural substitute treated with Tutoplast method. © 2004 Elsevier Inc. All rights reserved. KEY WORDS
Dura mater, graft sterilization, dural substitute, dural implant, complications.
fter cerebral or spinal operative procedures, it is imperative to provide a complete and watertight dural closure to minimize the risks of cerebrospinal fluid fistulas, infections, brain herniation, cortical scarring, and adhesions [18,46,47]. Duraplasty is required in several instances [3,4,14,25,29,46,30]: 1) to substitute a loss of native dural tissue (i.e., in neoplastic or traumatic destruction); 2) to repair dural fistulas; 3) to enlarge the dural compartment (i.e., in Arnold-Chiari malformation or inoperable intramedullary tumors); 4) when the closure is difficult and not sufficiently watertight
A
This paper has been written without any financial arrangements with the dural substitute manufacturer. Address reprint requests to: Dr. Emanuela Caroli, Via Meropia 85, 00147 Rome, Italy. Received June 6, 2002; accepted June 9, 2003. © 2004 Elsevier Inc. All rights reserved. 360 Park Avenue South, New York, NY 10010 –1710
because dura mater edges have shrunken and they cannot be sutured directly; 5) in dura graft surgery (i.e., myelomeningocele). Despite 100 years of experimentation and investigation of a wide range of materials, the searches for the ideal substitute still continues. We report the clinical results in a consecutive series of 250 patients who underwent cerebral dural implant with Tutoplast processed dura and pericardium.
Materials and Methods This study is designed to evaluate the outcome of a consecutive series of 250 patients who underwent cerebral duraplasty between 1996 and 1998 at our institution with the following substitutive materials: Tutoplast Pericardium (149 patients—58.8% of the cases), and Tutoplast Dura (101 patients— 41.2% of the cases). Our study included 106 males and 144 females. Age ranged between ⬍0 and 83 years (mean age was 50 years). Grafting was performed on primary or secondary tumors (44.54% of the cases), mainly meningiomas (63%), cerebro-spinal fluid fistulas (25.61% of the cases: 42 posttraumatic, 12 spontaneous, and 8 iatrogenic), craniocerebral trauma (18.4%), Arnold-Chiari malformation (7.74 10.33%), and aneurysms (3.71%). Follow-up ranged from 4 to 6 years (mean 5.4). Seven patients underwent an early reoperation (less than 9 months after surgery), 2 for complications likely related to the dural graft, and the remaining 5 for other reasons. Nine patients underwent a reoperation after a long interval for recurrent tumor. Eleven patients were excluded from this study because 8 (3.2%) died from the progression of the primary disease in a period from 6 months to 2.8 years after surgical treatment, and 3 (1.2%) died of complications in the postoperative 0090-3019/04/$–see front matter doi:10.1016/S0090-3019(03)00524-X
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period. Four of the 239 remaining patients presented complications suspected to be related to the dural implant. CASE 1 A 28-year-old man was operated on for arachnoid cyst in posterior cranial fossa, and a Tutoplast pericardium implantation was performed. Immediately after operation, the patient presented fever and meningismus. A computed tomography (CT) scan showed a cerebral spinal fluid (CSF) collection in the operative field. Multiple CSF cultures failed to reveal bacterial growth. The symptoms were abated by corticosteroid administration. CASE 2 A 47-year-old woman was operated on for a melanoma of the cavernous sinus, and a Tutoplast pericardium patch implantation was performed. On the 50th postoperative day she presented rhinorrhea, headache, neck stiffness, and fever. Cultures of the CSF were positive for Enterococcus faecalis. The patient was treated with antibiotic therapy, and after 1 week the clinical picture regressed and 1 month later the cultures of the CSF were negative. In this case a second operation was not performed because rhinorrhea ceased spontaneously. CASE 3 A 42-year-old man operated on for cerebellar hemangioblastoma underwent a Tutoplast Dura patch implantation. Two weeks later, the patient presented fever and swelling of the surgical wound. Cultures of the purulent material taken from the swelling and CSF cultures revealed Staphilococcus aureus. The patient was reoperated; during the second operation we found subcutaneous and submuscular purulent material. Tutoplast Dura was reabsorbed and cerebellar surface was unaltered. The operative field was meticulously cleaned with hydrogen peroxide and local antibiotics. A second Tutoplast Dura patch was implanted. Daily wound medications were administered. The postoperative course was uneventful, and the patient was discharged on sixth postoperative day. CASE 4 A 70-year-old man treated for a ponto-cerebellar angle neurinoma underwent a Tutoplast pericardium patch implantation. One month later, he complained of headache, vomiting, SC pain, and swelling at surgical wound. Cultures of purulent material taken from swelling revealed Staphilococcus epidermidis. The patient was reoperated, and during the second operation we found a corpuscolar collection
Caroli et al
under the cutaneous and muscular planes. Dural implantation was reabsorbed, and the cerebellar surface presented a small cavity coated with necrotic tissue. The operative field was meticulously cleaned with hydrogen peroxide and local antibiotics. A new Tutoplast pericardium patch was implanted. Daily wound medications were administered. The postoperative course was uneventful, and the patient was discharged on 7th postoperative day. Tutoplast dura and Tutoplast pericardium are homologous materials treated with dehydration by solvent and sterilization by ␥ irradiation. These materials are immersed in a hydrogen peroxide and acetone solution to minimize the antigenic potential and the infection risk. The preservation temperature is 15–30°C. For use, it is recommended to rehydrate Tutoplast dura and Tutoplast pericardium in sterile physiologic saline or Ringer’s solution. The rehydration makes these materials even softer and improves their handling properties at surgery. These materials are a network of collagen fibers that act as a scaffold for the formation of vascularized, vital, connective tissue.
Discussion Since 1890 when Beach suggested use of gold foil to prevent meningocerebral adhesions [5], many substances have been tried experimentally and used clinically as dural substitutes. However, the ideal solution still remains to be found. Watertight dural closure is necessary to prevent postoperative cerebrospinal fluid fistula, infection, and cortical scarring. The large number of materials used as dural graft include both biologic tissues (autologous, homologous, and heterologous) [2,9,26,36,40,43] and synthetic materials [2,6,20,23,28,32,38,44 – 46,48]. Autografts, such as pericranium or temporal fascia, have several and certain advantages. They are easy to handle, nontoxic, inexpensive, and have a favorable biologic behavior [8,11,22,24,30,37]. Unfortunately, it is not always possible to perform autograft with these tissues. Pericranium can be damaged, especially in trauma, and can be insufficient when the dural defect is large or unavailable because it must be used in another way (e.g., for the frontal sinus closure). The use of autologous fascia lata has never been popular because it requires an additional operation, probable additional operating time, and it can be related with complications at the donor site [46]. We believe that autologous tissue such as pericranium or temporal fascia should be implanted when-
Duraplasty
ever possible, but when it is not possible, we prefer to use homologous implants. Despite the theoretical advantages of no risk of infection of the synthetic materials [2], most of these have been rejected because of local tissue reactions, excessive scar formation, meningitic symptoms, or hemorrhage risk [1,2,13,19,31,33,34,35,41,50]. For many years lyophilized homologous dura mater sterilized by ␥ rays (Lyodura) has been widely used because it is easy to handle and widely available [9,10,24,39,50]. Unfortunately, the current sterilization methods do not guarantee them free from risk of latent virus infections [16,42,49], and some cases of probable Creutzfeldt-Jacob disease (CJD) after homologous dura mater implant have been reported [42]. However, these cases remain circumstantial because there are not other cases in patients treated with the same lot of dura. Moreover, the use of cadaveric dural grafts has not been prohibited by World Health Organization [50]. In our institution we have used Tutoplast dura as dural substitution for many years because it is a material widely available, waterproof, with tensile strength, easily suturable, biocompatible, and relatively inexpensive. Despite achieving good results in our patients with Tutoplast Dura implant (no complication in more than 99% of the cases), we think that the risk of transmission of prionic disease, even if minimal and never proven, should proscribe its use. Until now, iatrogenic transmission of CJD occurred by corneal implantation, intracranial electrodes, human growth hormone extracts from cadaveric pituitary gland, and cadaveric dura mater graft [42]. In experimental transmission, the CJD agent has been found in brain, spinal cord, lung, liver, and kidney [7,27,42]. In the last several years in our institute we use Tutoplast pericardium that is a homologous material with the same advantages of the Tutoplast dura but likely safer than homologous dura mater. In our series, we found postoperative complications in 4 (1.7%) of the 250 patients subjected to implant of dural homologous substitutes. However, the relationship between dural patch and the complications in these four cases remains debatable. In patients No. 1 and No. 2 a postoperative meningeal syndrome was documented by clinical picture and laboratory test. In patient No. 1 meningeal reaction was aseptic, and the operation was performed in posterior cranial fossa. In this case we can hypothesize either an inflammatory reaction of the host against the implanted material or a spread of blood breakdown products into subarachnoidal spaces, causing an irritative meningeal syndrome. The latter hypothe-
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sis is sustained by the fact that aseptic meningitis syndrome has been described as a common complication of posterior cranial fossa surgery [12,15,17]. In the remaining patients there was an infection, and in those cases it can be hypothesized as both an infection arising from dural plasty and a contamination unrelated to the dural graft. The latter hypothesis is supported by the fact that the method of preparation of Tutoplast and ␥-irradiation ensures the sterility of the grafts [10] and because there were no other cases of infection in patients of our series treated with the same lot of dura. In patient No. 2 it could be reasonably assumed that the development of infection was because of a contamination from extracranial bacteria. This is supported by the presence of a connection between the endocranium and the airways. In patients No. 3 and No. 4 we found at the previous surgical wound an SC and submuscular purulent collection positive for St. Aureus and St. Epidemidis, respectively. At reintervention, Patient No. 3 presented SC and submuscular purulent collection, disappearance of the dural patch, and no signs of infection on the cerebellar surface. From these aspects we can presume that the infection started in the superficial tissues and destroyed the dural patch. In Patient No. 4 there was an extradural purulent collection, complete dural patch resorption, and signs of inflammatory reaction on cerebellar surface. Also, in this case we can suppose that infection is originated extradurally because the cultures of the purulent SC and submuscular collection were positive for an infective agent commonly present in the skin and easily destroyed by ␥-sterilization. Keener [21] stated that only fibroblast originating from soft tissues (muscle, fascia, SC space) regenerate the dura, and when dural defect is adjacent to bone, dural healing is inadequate. In our cases No. 3 and No. 4 dural patch was adjacent to soft tissue, but it is likely that the septic contamination and consequent inflammatory reaction destroyed the dural graft more rapidly than the time needed for fibrous infiltration and dural regeneration processes. Adherence to the cortex were not observed in the 4 patients who underwent an early reoperation or in the 9 patients reoperated on tardily. Macroscopically, dural patch was preserved and appeared as host dura. In 1 patient there was granulation tissue above the graft when this was exposed in a small area without bone. In 3 patients who had post-
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traumatic cortical damage, we found at reoperation cortical adherences with the dural patch. Pathologic examination showed in all these cases a vascularization and fibroblastic infiltration of the dural substitute with good incorporation into the surrounding host dura. This phenomenon is on the basis of dura mater regeneration [30] and is promoted from the connective tissue of the Tutoplast pericardium that acts as a scaffold for the fibroblasts proliferation inside the graft itself. The cost of the Tutoplast pericardium is $220 for 20 cm2. This price is similar to that of the allograft (i.e., Alloderm, $637 for 75 cm2) and synthetic graft (i.e., expanded polytetrafluorothylene, $1,080 for 144 cm2). In conclusion, it is questionable if the four complications of the presented series have to be ascribed to the dural plasty, but even if we assume that there is a relationship, our results remain satisfactory. Therefore, from our experience we can conclude that dehydrated human pericardium, sterilized by ␥ irradiation is a valuable alternative when autologous material is not available for dura mater repair. REFERENCES 1. Adegbite AB, Paine KWE, Rozdilsky B. The role of neomembranes in formation of hematoma around Silastic dura substitute: case report. J Neurosurg 1983; 58:295–7. 2. Anson JA, Marchand EP. Bovine pericardium foe dural grafts: clinical results in 35 patients. Neurosurgery 1996;39:764 –8. 3. Bartal A, Dchiffer J, Vodovotz D. Silicone coated dacron for enlargment of dural canal in cervical disc surgery. A preliminary report. Neurochirurgia 1970; 13:45–8. 4. Bartal AD, Heilbronn YD, Plashkes YY. Reconstruction of the dural canal in myelomeningocele. Case report. Plast Reconst Surg 1971;47:87–9. 5. Beach HHA. Compound comminute fractures of the skull: epilepsy for five years, operation, recovery. Boston Med Surg J 1890;122:313–5. 6. Brown MH, Grindlay JH, Craig WM. The use of polythee film as a dural substitute: an experimental and clinical study. Surg Gynecol Obstet 1948;86:663–9. 7. Brown P. An epidemiologi critique of CreutzfeldtJacob disease. Epidemiol Rev 1980;2:113–35. 8. Cairns H, Young JZ. Treatment of gunshot wounds of peripheral nerves. Lancet 1940;2:123–5. 9. Campbell JB, Basset CAL, Robertson JW. Clinical use of freeze-dried human dura mater. J Neurosurg 1958; 15:207–14. 10. Cantore G, Guidetti B, Delfini R. Neurosurgical use of human dura mater sterilized by gamma rays and stored in alcohol: long term results. J Neurosurg 1987; 66:93–5. 11. Caporale L, De Bernardis M. Sue les he`troplasties durales avec le catgut lamine`; contrinution experimentelle. Rev Chir 1936;74:10 –27.
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12. Carmel P, Greif LK. The aseptic meningitis syndrome: a complication of posterior fossa surgery. Pediatr Neurosurg 1993;19:276 –80. 13. Cohen AR, Aleksic S, Ransohoff J. Inflammatory reaction to synthetic dural substitute. J Neurosurg 1989; 70:633–5. 14. Crandall PH, Batzdorf U. Cervical spondylotic myelopathy. J Neurosurg 1966;25:57–66. 15. Cushing H. Experiences with the cerebellar atrocytoma. Surg Gynecol Obstet 1931;52:129 –204. 16. Fasullo C, PocChiari M, Macchi G, et al. Transmission of Creutzfeldt-Jacob disease by dural cadaveric graft. J Neurosurg 1989;71:954 –5 (letter). 17. Finlayson AI, Penfield W. Acute postoperative aseptic leptomeningitis: review of cases and discussion of pathogenesis. Arch Neurol Psychiatry 1941;46:250 – 76. 18. Fontana R, Talamonti G, D’ Angelo V, Arena O, Monte V, Collice M. Spontaneous haematoma as unusual complication of silastic dural substitute. Report of 2 cases. Acta Neurochir (Wien) 1992;115:64 –6. 19. Gomez H, Little JR. Spinal cord compression: a complication of silicone-coated Dacron dural graft-Report of two cases. Neurosurgery 1989;24:115–8. 20. Gortler M, Brown M, Becker I, Roggendorf W, Heiss E, Grote E. Animal experiments with a new dura graft (polytetrafluorethlene): results. Neurochirurgia (Stuttg) 1991;34:103–6. 21. Keener EB. Regeneration of dural defects. A review. J Neurosurg 1959;16:424 –47. 22. Kirschner M. Zur Frage des plastischen Ersatzes der Dura mater. Arch Klin Chir 1090;91:541–2. 23. Laquerriere A, Yun J, Tiollier J, Hemet J, Tadie M. Experimental evaluation of bilayered human collagen as a dural substituted. J Neurosurg 1993;78:487–91. 24. Laun A, Tonn JC, Jerusalem C. Comparative study of lyophilized human dura mater and lyophilized bovine pericardium as dural substitutes in neurosurgery. Acta Neurochir (Wien) 1990;107:16 –21. 25. Lee JF, Odom GL, Tindall GT. Experimental evaluation of silicone-coated Dacron and collagen fabric-film laminate as dural substitutes. J Neurosurg 1967;27: 558 –64. 26. MacFarlane MR, Symon L. Lyophilized dura mater: experimental implantation and extended clinical neurosurgical use. J Neurol Neurosurg Psychiatry 1979; 42:854 –8. 27. Manuelidis EE, Gorgacz EJ, Manuelidis L. Viremia in experimental Creutzfeldt-Jacob disease. Science 1978;200:1069 –71. 28. Maurer PK, McDonald JV. Vicryl (plyglactin 910) mesh as a dural substitute. J Neurosurg 1985;63:448 – 52. 29. Meddings N, Scott R, Bullock R, French DA, Hide TA., Gorham SD. Collagen Vicryl: a new dural prosthesis. Acta Neurochir 1992;117:53–8. 30. Mello LR, Feltrin LT, Fontes Neto PT, Ferraz FAP. Duraplasty with biosynthetic cellulose: an experimental study. J Neurosurg 1997;86:143–50. 31. Misra BK, Shaw JF. Extacerebral hematoma in association with dural substitute. Neurosurgery 1987;21: 399 –400. 32. 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.
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33. Ng TH, Chan KH, Leung S, et al. An unusual complication of silastic dural substitute: case report. Neurosurgery 1990;27:491–3. 34. Ohbayashi N, Inagawa T, Katoh Y, et al. Complications of silastic dural substitute 20 years after dural plasty. Surg Neurol 1994;41:338 –41. 35. Ongkiko CM, Keller JT, Mayfield FH, et al. An unusual complication of Dura Film as a dural substitute. Report of two cases. J Neurosurg 1984;60:1076 –9. 36. Parizek J, Mericka P, Spacek J, Nemecek S, Elias P, Sercl M. Xenogenic pericardium as a dural substitute in reconstruction of suboccipital dura mater in children. J Neurosurg 1989;70:905–9. 37. Penfield W£G. Meningocerebral adhesions. A histological study of the results of cerebral incision and cranioplasty. Surg Gynecol Obstet 1924;39:803–10. 38. Robertson RCL, Peacher WG. The use of tantalum foil in the subdural space. J Neurosurg 1948;2:281–4. 39. Rosomoff HL. Ethilene oxide sterilized freeze-dried dura mater for the repair of pachymeningeal defects. J Neurosurg 1959;16:197–208. 40. Sharkey PC, Usher FC, Robertson RCL, Pollard C. Lyophilized human dura mater as a dural substitute. J Neurosurg 1958;15:192–8. 41. Simpson D, Robson A. Recurrent subarachnoid bleeding in association with dural substitute. J Neurosurg 1984;60:408 –9. 42. Thadani V, Penar PL, Partington J, et al. CreutzfeldtJacob disease probably acquired from a cadaveric dura mater graft: case report. J Neurosurg 1988;69: 766 –9. 43. Thammavaran KV, Benzel EC, Kesterson L. Fascia lata graft as a dural substitute in neurosurgery. South Med J 1990;83:634 –6. 44. Thompson DN, Taylor WF, Hayward RD. Silastic dural substitute: experience of its use in spinal and foramen magnum surgery. Br J Neurosurg 1994;8:157–67. 45. Thompson D, Taylor W, Hayward R. Haemorrhage associated with silastic dural substitute. J Neurol Neurosurg Psychiatry 1994;57:646 –8. 46. Van Calenberg F, Quintens E, Sciot R, Van Loon J, Goffin J, Plets C. The use of Vicryl as a dura substitute: a clinical review of 78 surgical cases. Acta Neurochir (Wien) 1997;139:120 –3. 47. Verheggen R, Schulte-Baumann WJ, Hahm G, Lang J, Freudenthaler S, Schaake Th, Markakis E. A new technique of dural closure: experience with a Vicryl mesh. Acta Neurochir (Wien) 1997;139:1074 –9. 48. Yamada S, Goto K, Oda Y, Kikuchi H. Clinical experience with expanded polytetrafluoroethyene sheet used as an artificial dura mater. Neurol Med Chir (Tokyo) 1993;33:582–5. 49. Yamada K, Miyamoto S, Nagata I, Kikuchi H, Ikada Y, Iwata H, Yamamoto K. Development of a dural substitute from synthetic bioabsorbable polymers. J Neurosurg 1997;86:1012–7.
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50. Yamada K, Miyamoto S, Takayama M, Nagata I, Hashimoto N, Ikada Y, Kikuchi H. Clinical application of a new bioasorbable artificial dura mater. J Neurosurg 2002;96:731–5.
COMMENTARY
Caroli et al have presented their massive experience with Tutoplast pericardial and dural implants in circumstances where autologous dural substitute is unavailable, insufficient, or inconvenient. Their overall results are excellent, and their rare complications are well reported. Their rationale for switching from dura to pericardium is reasonable, despite their previous excellent results. My only quibble with the authors is the undocumented assertion in the first sentence of their introduction that “it is imperative to provide a complete and watertight dural closure. . .” This statement places them at one far end of what is clearly a spectrum of practice, which, at its other end, includes the plication open of suboccipital decompressions for Chiari malformations. With the exception of large defects with underlying denuded cortex, my routine practice for small defects has been the placement of gelfoam, and the specifically nonwatertight Durogen has also proved satisfactory in our institution. I have long doubted the possibility of watertight closure without formal obeisance to the coagulation cascade, which I believe to be the final arbiter of fistula formation. It is of interest that in their two cases involving subacute reoperation, there had been complete reabsorbtion of the Tutoplast dura and pericardium, respectively. Perhaps, as suggested, this is only a reflection of the underlying secondary infections, but perhaps the closures are not able to maintain their watertight character as well as might be thought. All this said, I applaud the efforts of the authors to prevent scar bridging and CSF fistulae, am impressed by their results, and appreciate the sharing of their experience. C. David Hunt, M.D. Department of Neurological Surgery New Jersey Medical School Newark, New Jersey
Duraplasty: Our Current Experience Emanuela Caroli,* Giovanni Rocchi,* Maurizio Salvati,† and Roberto Delfini* *Department of Neurological Sciences, †Department of Neurosurgery, INM Neuromed IRCCS, University of Rome “La Sapienza,” Rome, Italy
Caroli E, Rocchi G, Salvati M, Delfini R. Duraplasty: our current experience. Surg Neurol 2004;61:55–9. BACKGROUND
A large variety of biologic and artificial materials have been suggested as dural substitutes. However, no ideal material for dural repair in neurosurgical procedures has been identified. The authors report their experience with Tutoplast processed dura and pericardium. METHODS
This study is designed to evaluate Tutoplast dura and pericardium. The study population was composed of 250 consecutive patients who underwent cerebral duraplasty with these homologous materials between 1996 and 1998. The average follow-up was 5.4 years. RESULTS
We have observed only four complications with uncertain relationship with the dural implant. These resulted in complete recovery. CONCLUSIONS
We support the efficacy and safety of this natural dural substitute treated with Tutoplast method. © 2004 Elsevier Inc. All rights reserved. KEY WORDS
Dura mater, graft sterilization, dural substitute, dural implant, complications.
fter cerebral or spinal operative procedures, it is imperative to provide a complete and watertight dural closure to minimize the risks of cerebrospinal fluid fistulas, infections, brain herniation, cortical scarring, and adhesions [18,46,47]. Duraplasty is required in several instances [3,4,14,25,29,46,30]: 1) to substitute a loss of native dural tissue (i.e., in neoplastic or traumatic destruction); 2) to repair dural fistulas; 3) to enlarge the dural compartment (i.e., in Arnold-Chiari malformation or inoperable intramedullary tumors); 4) when the closure is difficult and not sufficiently watertight
A
This paper has been written without any financial arrangements with the dural substitute manufacturer. Address reprint requests to: Dr. Emanuela Caroli, Via Meropia 85, 00147 Rome, Italy. Received June 6, 2002; accepted June 9, 2003. © 2004 Elsevier Inc. All rights reserved. 360 Park Avenue South, New York, NY 10010 –1710
because dura mater edges have shrunken and they cannot be sutured directly; 5) in dura graft surgery (i.e., myelomeningocele). Despite 100 years of experimentation and investigation of a wide range of materials, the searches for the ideal substitute still continues. We report the clinical results in a consecutive series of 250 patients who underwent cerebral dural implant with Tutoplast processed dura and pericardium.
Materials and Methods This study is designed to evaluate the outcome of a consecutive series of 250 patients who underwent cerebral duraplasty between 1996 and 1998 at our institution with the following substitutive materials: Tutoplast Pericardium (149 patients—58.8% of the cases), and Tutoplast Dura (101 patients— 41.2% of the cases). Our study included 106 males and 144 females. Age ranged between ⬍0 and 83 years (mean age was 50 years). Grafting was performed on primary or secondary tumors (44.54% of the cases), mainly meningiomas (63%), cerebro-spinal fluid fistulas (25.61% of the cases: 42 posttraumatic, 12 spontaneous, and 8 iatrogenic), craniocerebral trauma (18.4%), Arnold-Chiari malformation (7.74 10.33%), and aneurysms (3.71%). Follow-up ranged from 4 to 6 years (mean 5.4). Seven patients underwent an early reoperation (less than 9 months after surgery), 2 for complications likely related to the dural graft, and the remaining 5 for other reasons. Nine patients underwent a reoperation after a long interval for recurrent tumor. Eleven patients were excluded from this study because 8 (3.2%) died from the progression of the primary disease in a period from 6 months to 2.8 years after surgical treatment, and 3 (1.2%) died of complications in the postoperative 0090-3019/04/$–see front matter doi:10.1016/S0090-3019(03)00524-X
56
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period. Four of the 239 remaining patients presented complications suspected to be related to the dural implant. CASE 1 A 28-year-old man was operated on for arachnoid cyst in posterior cranial fossa, and a Tutoplast pericardium implantation was performed. Immediately after operation, the patient presented fever and meningismus. A computed tomography (CT) scan showed a cerebral spinal fluid (CSF) collection in the operative field. Multiple CSF cultures failed to reveal bacterial growth. The symptoms were abated by corticosteroid administration. CASE 2 A 47-year-old woman was operated on for a melanoma of the cavernous sinus, and a Tutoplast pericardium patch implantation was performed. On the 50th postoperative day she presented rhinorrhea, headache, neck stiffness, and fever. Cultures of the CSF were positive for Enterococcus faecalis. The patient was treated with antibiotic therapy, and after 1 week the clinical picture regressed and 1 month later the cultures of the CSF were negative. In this case a second operation was not performed because rhinorrhea ceased spontaneously. CASE 3 A 42-year-old man operated on for cerebellar hemangioblastoma underwent a Tutoplast Dura patch implantation. Two weeks later, the patient presented fever and swelling of the surgical wound. Cultures of the purulent material taken from the swelling and CSF cultures revealed Staphilococcus aureus. The patient was reoperated; during the second operation we found subcutaneous and submuscular purulent material. Tutoplast Dura was reabsorbed and cerebellar surface was unaltered. The operative field was meticulously cleaned with hydrogen peroxide and local antibiotics. A second Tutoplast Dura patch was implanted. Daily wound medications were administered. The postoperative course was uneventful, and the patient was discharged on sixth postoperative day. CASE 4 A 70-year-old man treated for a ponto-cerebellar angle neurinoma underwent a Tutoplast pericardium patch implantation. One month later, he complained of headache, vomiting, SC pain, and swelling at surgical wound. Cultures of purulent material taken from swelling revealed Staphilococcus epidermidis. The patient was reoperated, and during the second operation we found a corpuscolar collection
Caroli et al
under the cutaneous and muscular planes. Dural implantation was reabsorbed, and the cerebellar surface presented a small cavity coated with necrotic tissue. The operative field was meticulously cleaned with hydrogen peroxide and local antibiotics. A new Tutoplast pericardium patch was implanted. Daily wound medications were administered. The postoperative course was uneventful, and the patient was discharged on 7th postoperative day. Tutoplast dura and Tutoplast pericardium are homologous materials treated with dehydration by solvent and sterilization by ␥ irradiation. These materials are immersed in a hydrogen peroxide and acetone solution to minimize the antigenic potential and the infection risk. The preservation temperature is 15–30°C. For use, it is recommended to rehydrate Tutoplast dura and Tutoplast pericardium in sterile physiologic saline or Ringer’s solution. The rehydration makes these materials even softer and improves their handling properties at surgery. These materials are a network of collagen fibers that act as a scaffold for the formation of vascularized, vital, connective tissue.
Discussion Since 1890 when Beach suggested use of gold foil to prevent meningocerebral adhesions [5], many substances have been tried experimentally and used clinically as dural substitutes. However, the ideal solution still remains to be found. Watertight dural closure is necessary to prevent postoperative cerebrospinal fluid fistula, infection, and cortical scarring. The large number of materials used as dural graft include both biologic tissues (autologous, homologous, and heterologous) [2,9,26,36,40,43] and synthetic materials [2,6,20,23,28,32,38,44 – 46,48]. Autografts, such as pericranium or temporal fascia, have several and certain advantages. They are easy to handle, nontoxic, inexpensive, and have a favorable biologic behavior [8,11,22,24,30,37]. Unfortunately, it is not always possible to perform autograft with these tissues. Pericranium can be damaged, especially in trauma, and can be insufficient when the dural defect is large or unavailable because it must be used in another way (e.g., for the frontal sinus closure). The use of autologous fascia lata has never been popular because it requires an additional operation, probable additional operating time, and it can be related with complications at the donor site [46]. We believe that autologous tissue such as pericranium or temporal fascia should be implanted when-
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ever possible, but when it is not possible, we prefer to use homologous implants. Despite the theoretical advantages of no risk of infection of the synthetic materials [2], most of these have been rejected because of local tissue reactions, excessive scar formation, meningitic symptoms, or hemorrhage risk [1,2,13,19,31,33,34,35,41,50]. For many years lyophilized homologous dura mater sterilized by ␥ rays (Lyodura) has been widely used because it is easy to handle and widely available [9,10,24,39,50]. Unfortunately, the current sterilization methods do not guarantee them free from risk of latent virus infections [16,42,49], and some cases of probable Creutzfeldt-Jacob disease (CJD) after homologous dura mater implant have been reported [42]. However, these cases remain circumstantial because there are not other cases in patients treated with the same lot of dura. Moreover, the use of cadaveric dural grafts has not been prohibited by World Health Organization [50]. In our institution we have used Tutoplast dura as dural substitution for many years because it is a material widely available, waterproof, with tensile strength, easily suturable, biocompatible, and relatively inexpensive. Despite achieving good results in our patients with Tutoplast Dura implant (no complication in more than 99% of the cases), we think that the risk of transmission of prionic disease, even if minimal and never proven, should proscribe its use. Until now, iatrogenic transmission of CJD occurred by corneal implantation, intracranial electrodes, human growth hormone extracts from cadaveric pituitary gland, and cadaveric dura mater graft [42]. In experimental transmission, the CJD agent has been found in brain, spinal cord, lung, liver, and kidney [7,27,42]. In the last several years in our institute we use Tutoplast pericardium that is a homologous material with the same advantages of the Tutoplast dura but likely safer than homologous dura mater. In our series, we found postoperative complications in 4 (1.7%) of the 250 patients subjected to implant of dural homologous substitutes. However, the relationship between dural patch and the complications in these four cases remains debatable. In patients No. 1 and No. 2 a postoperative meningeal syndrome was documented by clinical picture and laboratory test. In patient No. 1 meningeal reaction was aseptic, and the operation was performed in posterior cranial fossa. In this case we can hypothesize either an inflammatory reaction of the host against the implanted material or a spread of blood breakdown products into subarachnoidal spaces, causing an irritative meningeal syndrome. The latter hypothe-
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sis is sustained by the fact that aseptic meningitis syndrome has been described as a common complication of posterior cranial fossa surgery [12,15,17]. In the remaining patients there was an infection, and in those cases it can be hypothesized as both an infection arising from dural plasty and a contamination unrelated to the dural graft. The latter hypothesis is supported by the fact that the method of preparation of Tutoplast and ␥-irradiation ensures the sterility of the grafts [10] and because there were no other cases of infection in patients of our series treated with the same lot of dura. In patient No. 2 it could be reasonably assumed that the development of infection was because of a contamination from extracranial bacteria. This is supported by the presence of a connection between the endocranium and the airways. In patients No. 3 and No. 4 we found at the previous surgical wound an SC and submuscular purulent collection positive for St. Aureus and St. Epidemidis, respectively. At reintervention, Patient No. 3 presented SC and submuscular purulent collection, disappearance of the dural patch, and no signs of infection on the cerebellar surface. From these aspects we can presume that the infection started in the superficial tissues and destroyed the dural patch. In Patient No. 4 there was an extradural purulent collection, complete dural patch resorption, and signs of inflammatory reaction on cerebellar surface. Also, in this case we can suppose that infection is originated extradurally because the cultures of the purulent SC and submuscular collection were positive for an infective agent commonly present in the skin and easily destroyed by ␥-sterilization. Keener [21] stated that only fibroblast originating from soft tissues (muscle, fascia, SC space) regenerate the dura, and when dural defect is adjacent to bone, dural healing is inadequate. In our cases No. 3 and No. 4 dural patch was adjacent to soft tissue, but it is likely that the septic contamination and consequent inflammatory reaction destroyed the dural graft more rapidly than the time needed for fibrous infiltration and dural regeneration processes. Adherence to the cortex were not observed in the 4 patients who underwent an early reoperation or in the 9 patients reoperated on tardily. Macroscopically, dural patch was preserved and appeared as host dura. In 1 patient there was granulation tissue above the graft when this was exposed in a small area without bone. In 3 patients who had post-
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traumatic cortical damage, we found at reoperation cortical adherences with the dural patch. Pathologic examination showed in all these cases a vascularization and fibroblastic infiltration of the dural substitute with good incorporation into the surrounding host dura. This phenomenon is on the basis of dura mater regeneration [30] and is promoted from the connective tissue of the Tutoplast pericardium that acts as a scaffold for the fibroblasts proliferation inside the graft itself. The cost of the Tutoplast pericardium is $220 for 20 cm2. This price is similar to that of the allograft (i.e., Alloderm, $637 for 75 cm2) and synthetic graft (i.e., expanded polytetrafluorothylene, $1,080 for 144 cm2). In conclusion, it is questionable if the four complications of the presented series have to be ascribed to the dural plasty, but even if we assume that there is a relationship, our results remain satisfactory. Therefore, from our experience we can conclude that dehydrated human pericardium, sterilized by ␥ irradiation is a valuable alternative when autologous material is not available for dura mater repair. REFERENCES 1. Adegbite AB, Paine KWE, Rozdilsky B. The role of neomembranes in formation of hematoma around Silastic dura substitute: case report. J Neurosurg 1983; 58:295–7. 2. Anson JA, Marchand EP. Bovine pericardium foe dural grafts: clinical results in 35 patients. Neurosurgery 1996;39:764 –8. 3. Bartal A, Dchiffer J, Vodovotz D. Silicone coated dacron for enlargment of dural canal in cervical disc surgery. A preliminary report. Neurochirurgia 1970; 13:45–8. 4. Bartal AD, Heilbronn YD, Plashkes YY. Reconstruction of the dural canal in myelomeningocele. Case report. Plast Reconst Surg 1971;47:87–9. 5. Beach HHA. Compound comminute fractures of the skull: epilepsy for five years, operation, recovery. Boston Med Surg J 1890;122:313–5. 6. Brown MH, Grindlay JH, Craig WM. The use of polythee film as a dural substitute: an experimental and clinical study. Surg Gynecol Obstet 1948;86:663–9. 7. Brown P. An epidemiologi critique of CreutzfeldtJacob disease. Epidemiol Rev 1980;2:113–35. 8. Cairns H, Young JZ. Treatment of gunshot wounds of peripheral nerves. Lancet 1940;2:123–5. 9. Campbell JB, Basset CAL, Robertson JW. Clinical use of freeze-dried human dura mater. J Neurosurg 1958; 15:207–14. 10. Cantore G, Guidetti B, Delfini R. Neurosurgical use of human dura mater sterilized by gamma rays and stored in alcohol: long term results. J Neurosurg 1987; 66:93–5. 11. Caporale L, De Bernardis M. Sue les he`troplasties durales avec le catgut lamine`; contrinution experimentelle. Rev Chir 1936;74:10 –27.
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12. Carmel P, Greif LK. The aseptic meningitis syndrome: a complication of posterior fossa surgery. Pediatr Neurosurg 1993;19:276 –80. 13. Cohen AR, Aleksic S, Ransohoff J. Inflammatory reaction to synthetic dural substitute. J Neurosurg 1989; 70:633–5. 14. Crandall PH, Batzdorf U. Cervical spondylotic myelopathy. J Neurosurg 1966;25:57–66. 15. Cushing H. Experiences with the cerebellar atrocytoma. Surg Gynecol Obstet 1931;52:129 –204. 16. Fasullo C, PocChiari M, Macchi G, et al. Transmission of Creutzfeldt-Jacob disease by dural cadaveric graft. J Neurosurg 1989;71:954 –5 (letter). 17. Finlayson AI, Penfield W. Acute postoperative aseptic leptomeningitis: review of cases and discussion of pathogenesis. Arch Neurol Psychiatry 1941;46:250 – 76. 18. Fontana R, Talamonti G, D’ Angelo V, Arena O, Monte V, Collice M. Spontaneous haematoma as unusual complication of silastic dural substitute. Report of 2 cases. Acta Neurochir (Wien) 1992;115:64 –6. 19. Gomez H, Little JR. Spinal cord compression: a complication of silicone-coated Dacron dural graft-Report of two cases. Neurosurgery 1989;24:115–8. 20. Gortler M, Brown M, Becker I, Roggendorf W, Heiss E, Grote E. Animal experiments with a new dura graft (polytetrafluorethlene): results. Neurochirurgia (Stuttg) 1991;34:103–6. 21. Keener EB. Regeneration of dural defects. A review. J Neurosurg 1959;16:424 –47. 22. Kirschner M. Zur Frage des plastischen Ersatzes der Dura mater. Arch Klin Chir 1090;91:541–2. 23. Laquerriere A, Yun J, Tiollier J, Hemet J, Tadie M. Experimental evaluation of bilayered human collagen as a dural substituted. J Neurosurg 1993;78:487–91. 24. Laun A, Tonn JC, Jerusalem C. Comparative study of lyophilized human dura mater and lyophilized bovine pericardium as dural substitutes in neurosurgery. Acta Neurochir (Wien) 1990;107:16 –21. 25. Lee JF, Odom GL, Tindall GT. Experimental evaluation of silicone-coated Dacron and collagen fabric-film laminate as dural substitutes. J Neurosurg 1967;27: 558 –64. 26. MacFarlane MR, Symon L. Lyophilized dura mater: experimental implantation and extended clinical neurosurgical use. J Neurol Neurosurg Psychiatry 1979; 42:854 –8. 27. Manuelidis EE, Gorgacz EJ, Manuelidis L. Viremia in experimental Creutzfeldt-Jacob disease. Science 1978;200:1069 –71. 28. Maurer PK, McDonald JV. Vicryl (plyglactin 910) mesh as a dural substitute. J Neurosurg 1985;63:448 – 52. 29. Meddings N, Scott R, Bullock R, French DA, Hide TA., Gorham SD. Collagen Vicryl: a new dural prosthesis. Acta Neurochir 1992;117:53–8. 30. Mello LR, Feltrin LT, Fontes Neto PT, Ferraz FAP. Duraplasty with biosynthetic cellulose: an experimental study. J Neurosurg 1997;86:143–50. 31. Misra BK, Shaw JF. Extacerebral hematoma in association with dural substitute. Neurosurgery 1987;21: 399 –400. 32. 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.
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COMMENTARY
Caroli et al have presented their massive experience with Tutoplast pericardial and dural implants in circumstances where autologous dural substitute is unavailable, insufficient, or inconvenient. Their overall results are excellent, and their rare complications are well reported. Their rationale for switching from dura to pericardium is reasonable, despite their previous excellent results. My only quibble with the authors is the undocumented assertion in the first sentence of their introduction that “it is imperative to provide a complete and watertight dural closure. . .” This statement places them at one far end of what is clearly a spectrum of practice, which, at its other end, includes the plication open of suboccipital decompressions for Chiari malformations. With the exception of large defects with underlying denuded cortex, my routine practice for small defects has been the placement of gelfoam, and the specifically nonwatertight Durogen has also proved satisfactory in our institution. I have long doubted the possibility of watertight closure without formal obeisance to the coagulation cascade, which I believe to be the final arbiter of fistula formation. It is of interest that in their two cases involving subacute reoperation, there had been complete reabsorbtion of the Tutoplast dura and pericardium, respectively. Perhaps, as suggested, this is only a reflection of the underlying secondary infections, but perhaps the closures are not able to maintain their watertight character as well as might be thought. All this said, I applaud the efforts of the authors to prevent scar bridging and CSF fistulae, am impressed by their results, and appreciate the sharing of their experience. C. David Hunt, M.D. Department of Neurological Surgery New Jersey Medical School Newark, New Jersey