Decompressive craniectomy using gelatin film and future ...neurosurgery.med.wayne.edu/pdfs/dh_-_gelatin_film_at_craniectomy_for_cranioplasty_jns...decompressive craniectomy (left panels)

J Neurosurg 118:776–782, 2013

776 J Neurosurg / Volume 118 / April 2013

©AANS, 2013

Decompressive craniectomy is a common and im-portant neurosurgical technique used in the man-agement of patients with medically refractory

ele vated ICP and midline shift from TBI, stroke, IPH, and SAH. Randomized clinical trials have demonstrated the benefits of this operation for patients with malignant MCA infarction,13,19,37 and its use in patients with medical-ly refractory elevated ICP has been advocated.1,5,10,11,30,34 The most common use of decompressive craniectomy is

in the management of severe TBI;1,5,34 although early bi-frontal craniectomy in patients with diffuse brain injury is controversial,7 a randomized clinical trial is currently underway to compare decompressive craniectomy with medical management in severe TBI.18 With the contin-ued widespread use of decompressive craniectomy in the management of a variety of acute neurological insults, the technical aspects of this surgery warrant further con-sideration.

Most technical reports on decompressive craniectomy have focused on maximizing the ICP lowering effects of the operation,26,32,34,39 with limited emphasis placed on surgical techniques that may reduce morbidity. Importantly, decom-pressive craniectomy is the first stage of a 2-step procedure;

Decompressive craniectomy using gelatin film and future bone flap replacement

Technical noteAzeem O. OlAdunjOye, m.d., RudOlph j. SchROt, m.d., mARike zwienenbeRg-lee, m.d., j. pAul muizelAAR, m.d., ph.d., And kiARASh ShAhlAie, m.d., ph.d.Department of Neurological Surgery, University of California Davis School of Medicine, Sacramento, California

Object. Decompressive craniectomy plays an important role in the management of patients with traumatic brain injury (TBI) and stroke. Risks of decompressive craniectomy include those associated with cranioplasty, and may be related to adhesions that develop between the brain surface and overlying scalp and temporalis muscle. The authors report their institutional experience using a multilayered technique (collagen and gelatin film barriers) to facilitate safe and rapid cranioplasty following decompressive craniectomy.

Methods. The authors conducted a retrospective chart review of 62 consecutive adult and pediatric patients who underwent decompressive craniectomy and subsequent cranioplasty between December 2007 and January 2011. Diagnoses included TBI, ischemic stroke, intraparenchymal hemorrhage, or subarachnoid hemorrhage. A detailed review of clinical charts was performed, including anesthesia records and radiographic study results.

Results. The majority of patients underwent unilateral hemicraniectomy (n = 56), with indications for surgery including midline shift (n = 37) or elevated intracranial pressure (n = 25). Multilayered decompressive craniectomy was safe and easy to perform, and was associated with a low complication rate, minimal operative time, and limited blood loss.

Conclusions. Decompressive craniectomy repair using an absorbable gelatin film barrier facilitates subsequent cranioplasty by preventing adhesions between intracranial contents and the overlying galea aponeurotica and tem-poralis muscle fascia. This technique makes cranioplasty dissection faster and potentially safer, which may improve clinical outcomes. The indications for gelatin film should be expanded to include placement in the epidural space after craniectomy.(http://thejns.org/doi/abs/10.3171/2013.1.JNS121475)

key wORdS • decompressive craniectomy • cranioplasty • stroke • peridural scarring • traumatic brain injury • surgical technique

Abbreviations used in this paper: ICP = intracranial pressure; IPH = intraparenchymal hemorrhage; MCA = middle cerebral artery; SAH = subarachnoid hemorrhage; TBI = traumatic brain injury; VP = ventriculoperitoneal.

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Multilayered repair for decompressive craniectomy

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those patients who survive usually undergo repair of the defect with the original bone or with a prosthetic implant. The risks of decompressive craniectomy are therefore not only limited to the initial operation, but also include com-plications that may occur during subsequent cranioplasty with bone flap replacement.4,12,14,36 Risks of cranioplasty include injury to the underlying cortex, infection, CSF fistula, epidural or subdural hematoma, and IPH.3,20,24,25,38 Many of these complications result from difficulties with soft-tissue plane dissection required to expose and prepare the cranial defect for repair, and are significantly worse in patients with scarring between the brain surface and over-lying galea aponeurotica and temporalis muscle.3,20,24,25,38

A limited number of studies have described decom-pressive craniectomy techniques that may reduce the mor-bidity associated with subsequent cranioplasty.3,17,20,24,25,38 Some groups have focused on the lack of a dural layer over the decompressed cortical surface, and have de-scribed recreating this barrier by performing a watertight expansile duraplasty or using an onlay dural substitute technique.24,25,38 Others groups attempt to correct for the lack of a structural barrier between the intracranial con-tents and the temporalis muscle and scalp by using a syn-thetic barrier at the time of decompressive craniectomy.3,20 A modified technique that accounts for both the lack of a dural layer and the lack of bone to physically separate the galea and temporalis muscle from intracranial structures has not been previously described. We present our institu-tional experience with decompressive craniectomy using a multilayered onlay repair with both a collagen-based dural substitute (DuraGen; Integra LifeSciences), as well as a gelatin film barrier that prevents scarring and tissue adhe-sion (Gelfilm; Pfizer).

Methods

Study Population

After Institutional Board Review approval, we con-ducted a retrospective chart review on 62 consecutive patients who underwent decompressive craniectomy sur-gery for a variety of clinical indications, including TBI with significant mass effect and midline shift, malignant MCA infarction, and elevated ICP refractory to maximal medical management. The decision to perform a unilat-eral hemicraniectomy or bifrontal craniectomy was made by the treating physician based on the pattern of intracra-nial hemorrhage, compression of basal cisterns, and the presence of midline shift, applying an institutional proto-col based on currently available guidelines2 and clinical trial data.13,19,37

Decompressive Craniectomy TechniqueA frontotemporoparietal hemicraniectomy was per-

formed using a standard, large, question mark–shaped musculocutaneous flap based on the root of the zygoma; a bifrontal craniectomy was performed using a linear bi-coronal musculocutaneous flap.31,32 The lateral sphenoid wing and the squamous portion of the temporal bone were resected to maximize temporal lobe and middle fossa decompression. The goal of decompressive craniec-

tomy was to achieve a final craniectomy size of at least 12 cm (craniocaudal) × 15 cm (anteroposterior). If the frontal sinus or mastoid air cells were transgressed during sur-gery, they were obliterated and/or cranialized. The dura was opened using a “trap door” or stellate technique32 to facilitate hematoma evacuation and allow for brain swell-ing, while avoiding transcalvarial herniation across cut dural edges.

Prior to closure, DuraGen was placed underneath or over the native dural leaflets to provide complete cover-age of exposed brain surfaces. If a ventricular drain was present, a small opening was made in the DuraGen to allow passage of the drain while still providing complete coverage of the exposed craniectomy defect. As an an-tiscar device, Gelfilm was then placed over the craniec-tomy defect and onto the surrounding 1–2 cm of the outer table of the skull beyond the craniectomy defect (Fig. 1). Care was taken to be sure that the Gelfilm abutted the undersurface of the temporalis muscle to prevent scarring and subsequent adhesion of the muscle and its fascia to underlying dural leaflets and exposed cortical surfaces. If necessary, corners of the Gelfilm were sutured to the native dura to prevent movement of the implant during reflection of the musculocutaneous flap for closure. The autologous bone flaps were packaged in a sterile manner and stored at -70°C in a specialized freezer on site for future reimplantation.

Cranioplasty TechniqueCranioplasty was performed when brain swelling

had resolved on physical examination and CT. The scar was reincised and sharp dissection was performed to ex-pose the native bone surfaces, and continued toward the epidural space to fully expose the cut bone edges of the craniectomy defect. The Gelfilm barrier was encountered at the bone edge and was used to identify the epidural space circumferentially. The musculocutaneous flap was separated from the Gelfilm layer and reflected anteriorly, as was also done for the initial decompressive craniec-tomy surgery. The entire temporalis muscle was elevated with the musculocutaneous flap from the Gelfilm layer, thus separating it from the underlying cortical surface (Fig. 1). The Gelfilm was then removed, taking care to not leave any fragments behind. Bone edges were defined cir-cumferentially to facilitate replacement of the bone flap into its native position. The defect was closely inspected for signs of CSF leakage; if present, a new sheet of Dura-Gen was placed over these areas as an onlay repair. The bone flap was then replaced and secured in position using titanium plates and screws. The temporalis muscle fascia, galea, and skin were then closed in layers.

Clinical Outcomes DataSurgeon and anesthesia operative records were re-

viewed to document intraoperative findings, estimated blood loss, and operative time. Computed tomography scans of the head obtained before and after cranioplasty were evaluated for the presence of temporalis muscle injury, cortical hemorrhage/IPH, or extraaxial fluid col-lections. Postcranioplasty fluid collections were consid-

A. O. Oladunjoye et al.


ered significant if the greatest thickness was at least 10 mm and/or there was resultant midline shift of at least 5 mm. Follow-up CT scans were reviewed for evidence of hydrocephalus or delayed extraaxial fluid collections. Hydrocephalus was diagnosed if serial CT scans demon-strated progressive ventricular enlargement that was not attributable to loss of brain parenchyma and/or resolution of cortical swelling. Infection was classified as before or after cranioplasty, and defined as scalp erythema, puru-lent drainage, or skin breakdown at the craniectomy site. All infections were identified with a contrast-enhanced head CT scan or brain MR image.

ResultsPatient Series

Between December 2007 and January 2011, 62 pa-tients underwent decompressive craniectomy and subse-quent cranioplasty using the modified multilayer tech-nique with absorbable gelatin film. Adult patients (≥ 18 years old) accounted for 77.4% of patients, including 37 men and 25 women. Indications for decompressive crani-ectomy included midline shift in 37 patients and elevated ICP refractory to maximal medical therapy in 25 patients. Neurological insults included TBI (n = 44), ischemic stroke (n = 9), spontaneous IPH (n = 7), and SAH (n = 2). Fifty-three patients underwent unilateral hemicrani-ectomy (90.3%), with 36 right-sided and 20 left-sided op-erations (Table 1). All patients underwent replacement of their native bone flap at the time of cranioplasty.

Cranioplasty ProcedureCranioplasty was performed a median of 54 days

(range 19–262 days) after the initial decompressive cra-niectomy procedure. In all cases, the surgeon’s operative note described an intact gelatin film barrier, resulting in a preserved plane between the dura/brain and the overly-ing tissues of the musculocutaneous flap (galea aponeu-rotica and temporalis muscle). Sharp dissection of the

temporalis muscle from the underlying brain surface was necessary in 2 of 62 cases, both of which described the absence of Gelfilm in the caudal temporal space, deep to the temporalis muscle. The median operative time for cranioplasty was 120.06 minutes (mean 147 ± 42 min-utes). The mean estimated blood loss was 213 ± 24 ml (Table 2). There were no documented intraoperative com-plications in this series. A representative CT scan after decompressive craniectomy (left panels) and cranioplasty (right panels) is presented in Fig. 2.

Clinical OutcomesPostoperative CT scans obtained within 48 hours of

cranioplasty did not reveal any cases of cortical injury or

Fig. 1. Multilayered repair technique using gelatin film barrier (left) facilitates subsequent cranioplasty by preventing adhesions between the musculocutaneous scalp flap and underlying tissue layers (right).

TABLE 1: Patient characteristics

Variable No. of Patients (%)

age (yrs) pediatric (<18) 14 (22.6) adult (≥18) 48 (77.4)sex male 37 (59.7) female 25 (40.3)neurological insult TBI 44 (71) ischemic stroke 9 (14.5) spontaneous IPH 7 (11.3) SAH 2 (3.2)indication for surgery midline shift ≥5 mm 37 (59.7) elevated ICP 25 (40.3)decompressive craniectomy rt hemicraniectomy 36 (58.1) lt hemicraniectomy 20 (32.3) bifrontal craniectomy 6 (9.7)



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temporalis muscle hemorrhage. Eight patients developed extraaxial collections after cranioplasty, all of which were managed conservatively and demonstrated eventual resolution on follow-up CT. One patient required reop-eration for evacuation of a subdural hematoma. Eleven patients developed hydrocephalus, 9 of whom underwent VP shunt placement and the remaining 2 resolved with close observation (Table 2).

Infections after decompressive craniectomy occurred in 4 patients (6.5%), and infections after cranioplasty oc-curred in 4 separate patients (6.5%). All infections after decompressive craniectomy were treated with irrigation and debridement of the wound, and treatment with at least 6 weeks of intravenous antibiotics. Cranioplasty was performed 2–8 months after irrigation and debridement, with replacement of native bone flaps. None of these ear-

ly-infected patients developed subsequent infections after cranioplasty. Of the 4 patients who developed infection after cranioplasty, 3 were patients with TBI and 1 had malignant MCA infarction. All 4 underwent cranioplasty more than 60 days after decompressive surgery.

Two patients with infections after cranioplasty were treated with removal of the bone flap, irrigation and de-bridement of the wound, and treatment with at least 6 weeks of intravenous antibiotics. Subsequent cranioplasty was performed 4–5 months after removal of the bone flap using a custom-made implant (n = 2) with satisfactory outcome. One patient with infection after cranioplasty was treated with 6 weeks of intravenous antibiotics with-out removal of the bone flap, with no complications. One patient with infection after cranioplasty died prior to re-peat cranioplasty due to an unrelated medical condition.

DiscussionThis study demonstrates that a multilayered repair

technique can be safely used in adult and pediatric patients undergoing unilateral or bilateral decompressive crani-ectomy for treatment of elevated ICP and midline shift. The decompressive craniectomy technique described in this paper did not significantly affect operative time or blood loss when compared with data from other series, which report 60.4–172.5 minutes and 58–452 ml, respec-tively.6,20,38 The wound infection rate was 6.5%, which is also within the expected range of 1%–14.3%.1,5,10,16,27,30,36,41

Cranioplasty with replacement of the native bone flap was performed a median of 54 days after decompres-sive craniectomy, and in all cases the gelatin film bar-rier was still intact and there were no significant adhe-sions between the components of the musculocutaneous

TABLE 2: Operative and clinical data*

Variable

Total Population TBI CVA IPH SAH

time to cranioplasty (days)† <30 8 7 0 1 0 30–60 27 19 5 2 1 60–90 6 4 2 0 0 90–120 10 6 1 3 0 >120 11 8 1 1 1 average (days) 80 81 66 95 78EBL (ml) minimum 5 5 50 20 275 maximum 1000 1000 400 100 1000 mean 213 220 189 74 638operative time (hrs:min) minimum 1:05 1:05 1:21 1:22 3:40 maximum 4:46 4:46 3:21 2:24 4:13 mean 2:27 2:30 2:21 1:50 3:56complications† cortical injury 0 0 0 0 0 muscle transgression 0 0 0 0 0 hydrocephalus 11 8 0 2 1 VP shunt 10 8 0 1 1 before cranioplasty 1 0 0 1 0 during cranioplasty 3 2 0 0 1 after cranioplasty 5 5 0 0 0 no VP shunt 2 1 0 1 0 extraaxial fluid 8 4 1 3 0 subdural 8 4 1 3 0 reoperation 1 0 0 1 0 epidural 0 0 0 0 0 infections 8 7 1 0 0 before cranioplasty 4 3 1 0 0 after cranioplasty 4 4 0 0 0

* CVA = cerebrovascular accident; EBL = estimated blood loss.† Values in this section represent the number of patients.

Fig. 2. Representative axial (upper) and 3D reconstructed (lower) CT scans after decompressive craniectomy (left) and following subsequent cranioplasty with native bone flap replacement (right).



flap and the underlying brain/dura. Sharp dissection was only necessary in 2 cases (3.2%) where the Gelfilm im-plant did not completely cover the cranial defect under the temporalis muscle. The incidence of wound infec-tions (6.5%) and shunt-dependent hydrocephalus (14.5%) following cranioplasty in this series was consistent with other recent reports.1,14,16 A multilayered repair technique for decompressive craniectomy results in technically sim-pler and fast cranioplasty surgery, which may result in improved clinical outcomes.

Multilayered RepairThe formation of scar tissue or adhesions between

the musculocutaneous flap and intracranial contents (brain and dura) is a consequence of craniectomy and makes subsequent cranioplasty more tedious and may increase operative morbidity.3,20,24,25,36,38 As a result, vari-ous authors have described the importance of creating a barrier between the flap and underlying brain, but all have focused on a single-layer technique to repair the du-ral defect.3,20,25,38 Dural repair options include temporalis muscle fascia,10,17 the waterproof fabric Gore-Tex,25,38,40 and various silicone-based materials.3,20 Many neuro-surgeons use DuraGen or Durepair, allogeneic collagen matrices that can be sutured into position or used as an onlay in the subdural or epidural space. DuraGen typi-cally becomes incorporated into the dura by allowing in-growth of connective tissue with dura-like properties,15 and is often used to treat and prevent CSF leaks in both cranial8,22,33 and spinal28 procedures. An important limita-tion of DuraGen as single-layer repair in decompressive craniectomy surgery, however, is that it does not prevent adhesion formation between the musculocutaneous flap and the underlying dural repair.

To effectively prevent epidural adhesion formation following decompressive craniectomy surgery, Gelfilm can be used as an antiscar device. Gelfilm is a nonad-hesive gelatin film with a thickness of approximately 0.075 mm. In its dry packaged form, Gelfilm has the ap-pearance and texture of cellophane of equivalent thick-ness; when hydrated, it has the consistency of rubber and maintains its structural integrity for 2–5 months when implanted for neurosurgical applications. Gelfilm slowly resorbs over time and has been successfully used in car-diac surgery, otolaryngology, and other staged operations to prevent the development of adhesions.21,23,29 Gelfilm is labeled for use in neurosurgery as a dural substitute and to prevent meningocerebral adhesions. Therefore, our use of Gelfilm as an antiscar device in the epidural space is technically off-label. Nevertheless, as demonstrated in the surgical series presented here, we believe it is indi-cated for use in the epidural space as an antiscar device following decompressive craniectomy.

Risks Associated With Decompressive Craniectomy and Cranioplasty

The multilayered decompressive craniectomy tech-nique used in this series simplified the technical complex-ity associated with safely elevating the musculocutaneous flap during cranioplasty surgery. This is a significant ad-vantage of the multilayered technique, because extensive

adhesions between the musculocutaneous scalp flap and the underlying brain and dura significantly increase op-erative risks and extend operative time.3,20,24,25,36,38

The implantation of additional foreign material (Gel-film) did not correlate with an increased infection rate in this clinical series. Wound infections occurred in 4 pa-tients (6.5%) after cranioplasty, a rate that is comparable to previous reports that range from 1% to 14.3%.1,5,10,16,27,30,36,41 These data suggest that the multilayered technique does not expose patients to an increased risk of infection.

Another complication of decompressive craniecto-my is the development of hydrocephalus, which occurs in 2%–29% of patients.1,5,10,16,30,36,41 Hydrocephalus was pres-ent in 11 patients in our series, 9 of whom (14.5% of the population) required placement of a VP shunt. This rate is consistent with a recent publication by Honeybul and Ho,14 who reported a 14% incidence of VP shunt placement af-ter craniectomy/cranioplasty.

Extraaxial fluid collections after cranioplasty oc-curred in 9 patients: 1 (1.6%) required reoperation for evacuation of a subdural hematoma, and the rest were successfully managed conservatively. Our experience is similar to a report by Gooch and colleagues,9 who found that 2 (3.2%) of 62 patients developed extraaxial fluid col-lections after cranioplasty that required reoperation. In a recent report by Stephens et al.,35 7.4% of patients devel-oped extraaxial hematomas after cranioplasty.

In our 2 cases requiring sharp dissection in the epi-dural plane, both involved adhesions in the region of the temporalis muscle. It is the experience of the authors that in traditional cranial repair surgeries following craniec-tomy, the densest adhesions are encountered in the region deep to the temporalis muscle. Defects in the dural repair may result in direct musculoleptomeningeal cicatrization, which poses a risk of cortical injury during muscle eleva-tion. One option is to leave part of the temporalis attached to the brain and deep to the replaced bone flap, although the potential exists for seizures and/or headache from brain and dural irritation, respectively. Additionally, and theo-retically, an encephaloduromyosynangiosis could form in the time interval between craniectomy and cranioplasty, in which the pia recruits and becomes dependent on a tempo-ralis muscular blood supply. In this situation, cranioplasty with muscle elevation could compromise this supply. Plac-ing Gelfilm deep to the temporalis muscle in the epidural space at the time of craniectomy ensures that both of these potential situations are avoided.

ConclusionsA modified multilayered technique, using a collagen-

based dural substitute onlay and a gelatin film barrier to prevent scar formation, has the following potential ad-vantages: 1) addresses both the dural defect as well as the absence of bone; 2) prevents adhesions between the musculocutaneous flap and intracranial contents; and 3) makes the cranioplasty surgery technically simpler and safer to perform. This technique does not increase the risks normally associated with decompressive craniec-tomy and subsequent cranioplasty, and may improve pa-tient outcomes. Therefore, the neurosurgical indications



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for Gelfilm should include its use in the epidural space following decompressive craniectomy.

Disclosure

The authors report no conflict of interest concerning the mate-rials or methods used in this study or the findings specified in this paper.

Author contributions to the study and manuscript preparation include the following. Conception and design: Shahlaie, Schrot, Zwienenberg-Lee, Muizelaar. Acquisition of data: Oladunjoye. Analysis and interpretation of data: all authors. Drafting the article: Oladunjoye. Critically revising the article: all authors. Reviewed submitted version of manuscript: Shahlaie, Schrot. Approved the final version of the manuscript on behalf of all authors: Shahlaie. Statistical analysis: Shahlaie. Study supervision: Shahlaie.

Acknowledgment

The authors would like to thank Steve Dana for his graphical art contributions.

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Manuscript submitted July 29, 2012.Accepted January 8, 2013.Please include this information when citing this paper: pub-

lished online February 8, 2013; DOI: 10.3171/2013.1.JNS121475.Address correspondence to: Kiarash Shahlaie, M.D., Ph.D., De -

part ment of Neurological Surgery, University of California Davis School of Medicine, 4860 Y Street, Suite 3740, Sacramento, Cali-fornia 95817. email: [email protected].

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