Duraplasty: Our Current Experience - 3 go / dental&marketing

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.
After 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
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.
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
© 2004 Elsevier Inc. All rights reserved. 0090-3019/04/$–see front matter
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56 Surg Neurol Caroli et al
2004;61:55–9
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
50 th 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
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 7 th 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 Surg Neurol
2004;61:55–9
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-
57
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-

58 Surg Neurol Caroli et al
2004;61:55–9
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 cm 2 . This price is similar to that of the allograft
(i.e., Alloderm, $637 for 75 cm 2 ) and synthetic graft
(i.e., expanded polytetrafluorothylene, $1,080 for
144 cm 2 ).
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.
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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