This article was downloaded by: [OARE Consortium] On: 08 July 2015, At: 02:49 Publisher: Taylor & Francis Informa Ltd Registered in England and Wales Registered Number: 1072954 Registered office: 5 Howick Place, London, SW1P 1WG
British Journal of Neurosurgery Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/ibjn20
Complications of cranioplasty after decompressive craniectomy for traumatic brain injury a
b
a
a
Jitender Chaturvedi , Ragasudha Botta , A. R. Prabhuraj , Dhaval Shukla , Dahnanjay I. a
Bhat & B. Indira Devi a
a
Department of Neurosurgery, NIMHANS, Bengaluru, India
b
Department of Clinical Neurosciences, NIMHANS, Bengaluru, India Published online: 26 Jun 2015.
To cite this article: Jitender Chaturvedi, Ragasudha Botta, A. R. Prabhuraj, Dhaval Shukla, Dahnanjay I. Bhat & B. Indira Devi (2015): Complications of cranioplasty after decompressive craniectomy for traumatic brain injury, British Journal of Neurosurgery To link to this article: http://dx.doi.org/10.3109/02688697.2015.1054356
PLEASE SCROLL DOWN FOR ARTICLE Taylor & Francis makes every effort to ensure the accuracy of all the information (the “Content”) contained in the publications on our platform. However, Taylor & Francis, our agents, and our licensors make no representations or warranties whatsoever as to the accuracy, completeness, or suitability for any purpose of the Content. Any opinions and views expressed in this publication are the opinions and views of the authors, and are not the views of or endorsed by Taylor & Francis. The accuracy of the Content should not be relied upon and should be independently verified with primary sources of information. Taylor and Francis shall not be liable for any losses, actions, claims, proceedings, demands, costs, expenses, damages, and other liabilities whatsoever or howsoever caused arising directly or indirectly in connection with, in relation to or arising out of the use of the Content. This article may be used for research, teaching, and private study purposes. Any substantial or systematic reproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in any form to anyone is expressly forbidden. Terms & Conditions of access and use can be found at http:// www.tandfonline.com/page/terms-and-conditions
British Journal of Neurosurgery, 2015; Early Online: 1–5 © 2015 The Neurosurgical Foundation ISSN: 0268-8697 print / ISSN 1360-046X online DOI: 10.3109/02688697.2015.1054356
ORIGINAL ARTICLE
Complications of cranioplasty after decompressive craniectomy for traumatic brain injury Jitender Chaturvedi1, Ragasudha Botta2, A. R. Prabhuraj1, Dhaval Shukla1, Dahnanjay I. Bhat1 & B. Indira Devi1
Downloaded by [OARE Consortium] at 02:49 08 July 2015
1Department of Neurosurgery, NIMHANS, Bengaluru, India, and 2Department of Clinical Neurosciences, NIMHANS, Bengaluru, India
life-saving intervention for medically refractory-raised ICP due to severe traumatic brain injury (TBI). In survivors of DC, cranioplasty (CP) is widely performed for the restoration of skull continuity following craniectomy procedures. The benefits of CP are often mentioned, but complications after CP are not well recognized. The overall benefits of DC must include procedural risks from CP as well. Though CP sounds as simple as placing a lid on the cooker, it is not free from complications. Factors highlighted in the literature considered relevant to influencing complications and thus outcome in CP include time delay following craniectomy,1–3 implant material,3,4 and bilateral or unilateral procedure.5 We aimed to determine and analyze predictors of complications after CP in patients in whom DC was done to treat raised ICP after TBI.
Abstract Introduction. Decompressive craniectomy (DC)—a potentially life-saving intervention following traumatic brain injury (TBI) with medically refractory brain swelling—once performed, surviving patients, more often than not, undergo a second procedure with cranioplasty (CP) in the future. This study analyzes complications following CP after DC, as the beneficial effects of the DC can’t be extrapolated in long run over a population unless one adds into it the complications associated with the CP in the survivors of TBI. Materials and methods. An observational study was performed retrospectively, with the review of case records. Demographic, clinical, and outcome data were collected, and complications were studied for any predictive parameters. A multivariate analysis was performed to identify factors that influenced these complications. Results. Data were collected for a total of 74 patients who underwent CP with a median age of 32, and a mean follow-up time of 2 years and 8 months. The mortality rate was 1.35% and overall complication rate 31%. The most significant factor determining complications were operating time more than 90 min Odds ratio (OR) 4.77 (1.61–14.20); timing of CP less than 3 months after craniectomy, OR 2.86 (1.48–8.11); age more than 20 years, OR 2.59 (1.20–6.53); and female gender, OR 1.91 (1.13–4.17). Conclusions. Although considered as a straight-forward procedure, the risks associated with this elective procedure should be kept in mind by the surgeon so that the patients and families can be apprised judiciously. It should be ascertained that patient and/or family consents for the procedure after being appropriately informed about the benefits and risks associated with the procedure.
Methods and materials Case ascertainment was achieved by manually searching operation-theater list from January 2004 to December 2014 of our institute, for procedures including the term “cranioplasty” following DC for TBI. Patients in whom DC was done for etiologies other than TBI, for example, brain tumors, cortical venous thrombosis, arterial infarcts, were excluded from this study. The patients who underwent DC at other hospitals and referred to our institute for CP were also excluded. Patients for whom at least 6 months follow-up after CP was not available were also excluded from the study. Patients in whom permanent cerebrospinal fluid (CSF) diversion like ventriculoperitoneal or thecoperitoneal shunt was done either before or during CP procedure were also excluded. The clinical, imaging, surgical findings, postoperative course, and follow-up data of the patients included in the study were reviewed. Abstracted data and specific factors considered were age at the time of CP, gender (male or female), site of DC (hemicranial or bifrontal), time interval between DC and CP (months), type of material used (autologous bone flap preserved in anterior abdominal wall, titanium, or acrylic), operative time (in minutes from cranial skin incision to skin closure completion), intraoperative CSF leak (yes or
Keywords: complications; cranioplasty; decompressive craniectomy
Introduction Raised intracranial pressure (ICP) occurs in several brain disorders and is increasingly being treated with surgical decompressive craniectomy (DC). DC is a potentially
Correspondence: Jitender Chaturvedi, Department of Neurosurgery, NIMHANS, Bengaluru 560029, India. Tel. +919900788501 and +919900788501. E-mail: [email protected] Received for publication 5 January 2015; accepted 10 May 2015
1
2 J. Chaturvedi et al. no), post-operative seizures, worsening of the preexisting neurological deficits or appearance of new deficits, infection requiring removal of implant, intracranial hematoma requiring re-exploration and evacuation, and mortality.
Statistical analysis
Downloaded by [OARE Consortium] at 02:49 08 July 2015
Comparison of association between Categorical variables was done using Chi-square test or Fisher’s exact test (when expected numbers were less than 5); while that of continuous variables was done using unpaired 2-tailed Student t-test. Associations between patient data and outcome were examined. After applying and analyzing the Pearson chi-square test and Fischer’s exact test for complications with each single dependent variable of interest, a multivariate binary logistic regression analysis with backward elimination method was carried out for all the dependent variables of interest. Significance was established at the 95% level.
Results A total of 112 patients underwent CP during the study period out of which 74 CP procedures were performed for TBI. Relevant data were available for all of these 74 patients. The median age at CP was 32 years (8–64 years). Males constituted 71% (n 52) of the patient population. The most common indication for DC was an acute subdural hematoma (n 42, 56.8%), followed by diffuse brain swelling (n 22, 29.7%). Ten (13.5%) patients had combined acute subdural hematoma with extradural hematoma. Sixty-two (83.8%) procedures were hemicraniectomy, and 12 (16.2%) were bifrontal DC. The mean size of the DC defect was 11.5 cm. The mean time interval to CP after DC was 10.17 months, and 80% of CPs was done within 12 months of DC. Only 1 patient underwent CP within 1 month of DC. The autologous bone flap was the most commonly implanted CP material used in 64 patients (86.5%). Titanium mesh and acrylic CP were used in 8 (10.8%) and 2 (2.7%) cases, respectively. Follow-up ranged from 6 months to 8 years with median of 2 years and 8 months.
Complications Complications occurred in 23 (31%) patients including one death resulting in mortality rate of 1.4%. The patient who underwent CP within 1 month of DC died at 16th postoperative day due to meningitis. Table I summarizes complications seen in the present study. The commonest complication was postoperative surgical-site infection seen in 10 (13.5%). Two of the infections could be managed with antibiotics, and 8 (10.8%) required removal of the implanted material
to control infection. Post-operative intracranial hematoma necessitating re-exploration and evacuation was seen in 3 (4.0%) patients: one case each of intracerebral hematoma, intracerebral hematoma with intraventricular extension, and extradural hematoma (Fig. 1). Eight (10.8%) patients had an intra-operative dural tear, but none of these patients had CSF leak or meningitis in the post-operative period. New onset post-operative seizures and worsening of the preexisting neurological deficits were seen in 5 (6.7%) patients each. The new onset neurological deficits were due to intracranial hematoma requiring re-exploration in 3 patients. Complications were seen in patients irrespective of the material used for CP. Both acrylic CP procedures had complications; 1 patient had postoperative new-onset seizures, and another one had an infection requiring removal of the implant. Among 8 patients who underwent titanium mesh placement, 25% (n 2) had complications; one had post-operative hematoma requiring re-exploration and another one had an infection requiring removal of the mesh. Complications were seen more frequently with older age, female gender, less time interval between DC and CP, and increase in the duration of surgery (Table II). Using the multivariate binary logistic regression analysis, operative time more than 90 min was found as the most significant independent factor (OR 4.77, 95% CI 1.66–14.20, p 0.005) in predicting complications after CP. Other variables that were significant were timing of surgery less than 3 months after DC (OR 2.86, 95% CI 1.48–8.11, p 0.004), age more than 20 years (OR 2.59, 95% CI 1.20–6.53, p 0.05), and female gender (OR 1.91, 95% CI 1.13–4.17, p 0.05). The size of DC, site of DC, or the material used for DC was not found to be significant in determining complications after CP (Table III).
Discussion The present study reports a relatively large cohort of patients who underwent CP after DC for TBI. The data were available for patients who were followed up to 6 months after CP, hence we could determine both early and late complications. We also determined the factors responsible for complications. The complication rate in our series was 31%, which is similar to that reported in the literature. We found that operative time more than 90 min, timing of surgery less than 3 months after DC, age more than 20 years, and the female gender as significant factors determining complications after CP. The size of DC, type of DC, or the material used for DC was not found to be significant in determining complications after CP. We discuss each of them in following sections.
Incidence of complications Table I. Complications with frequencies. Complications Overall (n 23) Infection requiring removal of implant (n 8) Dural tear (n 8) Neurological worsening (n 5) New onset seizure (n 5) Hematoma requiring re-exploration and evacuation (n 3) CSF leak (n 0)
Percentages (%) 31.0 10.8 10.8 6.7 6.7 4.0 0
Though the procedure of CP sounds simple, it is not free from complications. The incidence of complications after CP is variable, mainly due to the definition of complications, indications of DC that required CP, and the timing of reporting of complications (early or late). The overall rate of complications related to CP after DC is greater than with other standard elective cranial procedures.3 The reported incidence of complication ranges from 10–43%.6–10 Though TBI was the commonest indication for DC requiring CP in most of the
Cranioplasty complications prediction after TBI 3
Downloaded by [OARE Consortium] at 02:49 08 July 2015
Fig. 1. Postoperative computerized tomography (CT) scan images of patients in whom intracranial hematoma was seen after CP. (A) Intracerebral hematoma, (B) Intracerebral hematoma with intraventricular extension, and (C) Extradural hematoma.
studies, only one of the studies reported separately the incidence of complication specifically for CP after DC for TBI.7 The incidence of complication requiring a reoperation in this particular study was 40.8%. The incidence of complications of CP after DC for TBI was 31% in our series, which is similar to other studies of CP after DC for various etiologies.3 As the number of cases of DC for other indications was fewer in our series we excluded them from our analysis, hence we cannot extrapolate the incidence of complications for other etiologies such as stroke. We discuss the specific factors responsible for complication in the following paragraphs.
Interval between DC and CP The timing of CP is controversial. The timing between DC and CP makes a lot of difference in the outcome of patients. Some studies report that the complication rate is minimized by early CP.6 Proponents of early replacement debates that early CP procedure provides a good surgical plane between galea and the underlying dura, thus chances of dural tear and pial breach leading to various complications can be minimized. However, this comes at a price of operating early on a person who is still in recovering phase of his/her brain injury with poor nutritional status. The nosocomial flora that inhabitated Table II. Variables associated with complications. Variables (n) Complications (%) Age 20 years (23) 20 years (51) Gender Male (52) Female (22) Interval of CP 3 months (54) 3 months (20) Site of DC Hemicraniectomy (62) Bifrontal (12) Materials used for CP Autologous bone flap (64) Titanium mesh (8) Acrylic (2) Duration of surgery 90 min (37) 90 min (37) Size of craniectomy 8 cms (18) 8 cms (56)
p-value
16.6 34.4
0.04
23.0 36.0
0.05
22.6 45.0
0.03
31.8% 25.3%
0.93
28.7% 25% 100%
0.88
10.8% 48.6%
0.035
44.4% 28.6%
0.665
the local incision sites is still not replaced by commensals. These factors can increase the risk of infection, hence others recommend a minimum delay of 6 months to avoid risk of infection.2 On the other hand replacing bone at a later date exposes a patient recovering from TBI vulnerable to injury during rehabilitation. In our study, complications were noted to be highest in group of patients who underwent CP within 3 months of DC (45%), which dropped to less than 20% when CP was done within 3–12 months after DC. The CP done after 3 months of DC had almost three times lesser chances of being affected by complications in our study. The incidence of complications rose again when CP was done after 12 months. However, as only 20% of CPs was done after 12 months, the significance of this cannot be ascertained. We believe that the CP should be deferred till the patient has recovered, and out of hospital. We hypothesize that CP as a continuation of care during recovery phases poses an increased risk of infection due to nosocomial organisms. This is evident by our single case who underwent CP within 1 month of DC, and died due to meningitis. Many authors would not agree with present study in showing association between time delay and Table III. Results of multivariate binary logistic regression analysis with backward elimination method for predictors of complications among variables. Variables p-value Odds ratio 95% confidence interval Operative time 90 min* 90 min Interval 3 months* 3 months Age 20 years* 20 years Gender Male* Female Type of CP Autologous bone flap* Titanium mesh Acrylic Location of CP Hemi-DC* Bi-frontal-DC DC size 8 cm* 8 cm
*Reference group.
– 0.005
– 4.77
– 1.61–14.20
– 0.04
– 2.86
– 1.48–8.11
– 0.05
– 2.59
– 1.20–6.53
– 0.05
– 1.91
– 1.13–4.17
– 0.68 0.31
– 0.30 0.78
– 0.06–8.56 0.35–2.11
– 0.79
– 1.06
– 0.77–2.43
– 0.83
– 1.44
– 0.81–3.69
4 J. Chaturvedi et al. complication rate.5,11–13 An approach with holistic view might be the best as far as interval of CP is concerned and should be governed by general medical condition.
Downloaded by [OARE Consortium] at 02:49 08 July 2015
Age and gender Better outcomes among patients with younger age may reflect the overall better outcome in general among the younger population undergoing any surgical procedure because of the lack of co-morbid conditions, with CP being no exception. We found that younger patients (age 20 years) had nearly 2.5 times less risk of complications after CP. The contribution of gender in determining the outcome of head injury is a controversial area. According to one meta-analysis, which reported outcome separately for men and women, outcome was found worse in women than in men for 85% of the measured variables, with an average effect size of 0.15.15 Although clinical opinion is often that women tend to experience better outcomes than do men after TBI, the opposite pattern was suggested in the results of this meta-analysis.14 Relevant to DC or CP, the greater dimension of the frontal sinus in males may make them more vulnerable to infection due to inadvertent opening of frontal sinus.15 In the present study, the risk of complication in females was nearly twice as compare with males. Males performing better in comparison with females in the present study; could only be explained by the overall better outcome of male gender among patients with TBI and this finding is just an extrapolation of better performance of males in general. We are not aware of any study that has found the impact of age and gender on the outcome of CP.
Type of implant material and location of DC There is no specific surgical technique or material that has consistently proven to be superior, and postoperative complication rates vary widely among different methods.13,16 Any difference in complication rates between different types of implant material used, in the present study, could not be commented upon as the number of mesh CP and acrylic CP were eight and two, respectively, which was significantly low to give any statistically powerful correlation. Even after applying the multivariate logistic regression, there was no statistical significance found when comparing different types of implant material used and prediction of complications.
Site and size of the DC We did not find any association of complications with the location of DC (hemicraniectomy or bifrontal). However, it is very difficult to get any statistically significant meaning from the present study because of disparity between the number of hemicraniectomies (n 62) and bifrontal craniectomies (n 12). In other study, bifrontal procedures had a higher risk of complication, particularly infection.5 This is due to the increased likelihood of involving the frontal sinus at the time of bifrontal craniectomy, as compared with a unilateral procedure. There was no significant correlation between the size of the DC and complication in our study. Though minimizing the DC size theoretically minimizes the operative time of the procedure (which is an independent parameter for outcome assessment, as mentioned below) it does not affect the complication of CP.
Operating time It is well-known fact that the duration of any surgery increases the risk of complications. In our study, we found that the duration of surgery was the most significant factor determining complications. Complication rates were almost five times higher in patients with operating time more than 90 min. It is a routine practice at our institute to do augmented duraplasty using pericranium harvested during scalp flap reflection at the time of DC. The closure is attempted watertight, so as to reduce the incidence of CSF leak. We do not know whether use of pericranium increases adhesion, hence operation time during CP. We also do not know whether use of artificial dural substitute will result in less adhesion. Considering the simplicity, particularly replacement of the autologous bone flap, CP procedure in our institute is often delegated to junior residents. As these residents are less experienced they take a longer time to complete the operation. The prolongation of surgery time increases the risk of postoperative infection.
Limitations Being a retrospective study, the present study carries with it all the drawbacks associated with this form of the analysis. It is not powered to analyze patient-specific factors in greater details like steroid use or smoking habits, body–mass index, co-morbid illnesses like diabetes or hypertension. We did not analyze the preoperative functional status of the patients. Comparison of the materials and location of CP could not be ascertained with significance in the study. Our study does not extrapolate the results among stroke patients undergoing CP. Knowledge of the indication-specific risk factors will allow the development of preventive measures designed to reduce infection rates, as well as overall complication rates in future. However, our standardized definitions of variables, a relatively large number of patients, and sufficient follow-up period may outweigh these shortcomings.
Conclusion In this study, we determined the risk factors for complications after CP done specifically for TBI, which has been addressed sparsely in published literature. We had a mortality rate of 1.35% and overall complication rate of 31%. The operative time of procedure and timing of surgery were the most significant determinants of complication. The key conclusion from this study is to recognize that although considered as a straightforward procedure, the risks associated with this elective procedure should be kept in mind by the surgeon, so that the patients and families can be apprised judiciously. It should be ascertained that patient and/or family consents for the procedure after being appropriately informed about the benefits and risks associated with the procedure.
Acknowledgment Dr. P Marimuthu, Additional Professor of Biostatistics, NIMHANS, Bangalore for helping with statistics.
Cranioplasty complications prediction after TBI 5 Declaration of interest: The authors report no declarations of interest. The authors alone are responsible for the content and writing of the paper.
Downloaded by [OARE Consortium] at 02:49 08 July 2015
References 1. Chibbaro S, Di Rocco F, Mirone G, et al. Decompressive craniectomy and early cranioplasty for the management of severe head injury: A prospective multicenter study on 147 patients. World Neurosurg 2011;75:558–62. 2. Thavarajah D, De Lacy P, Hussien A, Sugar A. The minimum time for cranioplasty insertion from craniectomy is six months to reduce risk of infection - a case series of 82 patients. Br J Neurosurg 2012;26:78–80. 3. Chang V, Hartzfeld P, Langlois M, Mahmood A, Seyfried D. Outcomes of cranial repair after craniectomy. J Neurosurg 2010;112:1120–4. 4. Joffe J, Harris M, Kahugu F, et al. A prospective study of computer aided design and manufacture of titanium plate for cranioplasty and its clinical outcome. Br J Neurosurg 1999;13:576–80. 5. De Bonis P, Frassanito P, Mangiola A, et al. Cranial repair: How complicated is filling a “hole”? J Neurotrauma 2012;29:1071–6. 6. Broughton E, Pobereskin L, Whitfield PC. Seven years of cranioplasty in a regional neurosurgical centre. Br J Neurosurg 2014;28:34–9. 7. Bobinski L, Koskinen LO, Lindvall P. Complications following cranioplasty using autologous bone or polymethylmethacrylateretrospective experience from a single center. Clin Neurol Neurosurg 2013;115:1788–91.
8. Coulter IC, Pesic-Smith JD, Cato-Addison WB, et al. Routine but risky: A multicenter analysis of the outcomes of cranioplasty in the Northeast of England. Acta Neurochir (Wien) 2014;156: 1361–8. 9. Klinger DR, Madden C, Beshay J, et al. Autologous and acrylic cranioplasty: A review of 10 years and 258 cases. World Neurosurg 2014;82:e525–30. 10. Heo J, Park SQ, Cho SJ, Chang JC, Park HK. Evaluation of simultaneous cranioplasty and ventriculoperitoneal shunt procedures. J Neurosurg 2014;121:313–8. 11. Gooch MR, Gin GE, Kenning TJ, German JW. Complications of cranioplasty following decompressive craniectomy: Analysis of 62 cases. Neurosurg Focus 2009;26:E9. 12. Sobani ZA, Shamim MS, Zafar SN, et al. Cranioplasty after decompressive craniectomy: An institutional audit and analysis of factors related to complications. Surg Neurol Int 2011;2:123. 13. Yadla S, Campbell PG, Chitale R, et al. Effect of early surgery, material, and method of flap preservation on cranioplasty infections: A systematic review. Neurosurgery 2011;68:1124–9. 14. Farace E, Alves WM. Do women fare worse: A meta-analysis of gender differences in traumatic brain injury outcome? J Neurosurg 2000;93:539–45. 15. Lee MK, Sakai O, Spiegel JH. CT measurement of the frontal sinus - gender differences and implications for frontal cranioplasty. J Craniomaxillofac Surg 2010;38:494–500. 16. Shaffrey ME, Persing JA, Shaffrey CI, Delashaw JB, Jane JA. Craniofacial reconstruction. In: Apuzzo MLJ ed. Brain Surgery: Complication and Avoidance Management. New York: Churchill Livingstone, 1993;1373–98.
British Journal of Neurosurgery Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/ibjn20
Complications of cranioplasty after decompressive craniectomy for traumatic brain injury a
b
a
a
Jitender Chaturvedi , Ragasudha Botta , A. R. Prabhuraj , Dhaval Shukla , Dahnanjay I. a
Bhat & B. Indira Devi a
a
Department of Neurosurgery, NIMHANS, Bengaluru, India
b
Department of Clinical Neurosciences, NIMHANS, Bengaluru, India Published online: 26 Jun 2015.
To cite this article: Jitender Chaturvedi, Ragasudha Botta, A. R. Prabhuraj, Dhaval Shukla, Dahnanjay I. Bhat & B. Indira Devi (2015): Complications of cranioplasty after decompressive craniectomy for traumatic brain injury, British Journal of Neurosurgery To link to this article: http://dx.doi.org/10.3109/02688697.2015.1054356
PLEASE SCROLL DOWN FOR ARTICLE Taylor & Francis makes every effort to ensure the accuracy of all the information (the “Content”) contained in the publications on our platform. However, Taylor & Francis, our agents, and our licensors make no representations or warranties whatsoever as to the accuracy, completeness, or suitability for any purpose of the Content. Any opinions and views expressed in this publication are the opinions and views of the authors, and are not the views of or endorsed by Taylor & Francis. The accuracy of the Content should not be relied upon and should be independently verified with primary sources of information. Taylor and Francis shall not be liable for any losses, actions, claims, proceedings, demands, costs, expenses, damages, and other liabilities whatsoever or howsoever caused arising directly or indirectly in connection with, in relation to or arising out of the use of the Content. This article may be used for research, teaching, and private study purposes. Any substantial or systematic reproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in any form to anyone is expressly forbidden. Terms & Conditions of access and use can be found at http:// www.tandfonline.com/page/terms-and-conditions
British Journal of Neurosurgery, 2015; Early Online: 1–5 © 2015 The Neurosurgical Foundation ISSN: 0268-8697 print / ISSN 1360-046X online DOI: 10.3109/02688697.2015.1054356
ORIGINAL ARTICLE
Complications of cranioplasty after decompressive craniectomy for traumatic brain injury Jitender Chaturvedi1, Ragasudha Botta2, A. R. Prabhuraj1, Dhaval Shukla1, Dahnanjay I. Bhat1 & B. Indira Devi1
Downloaded by [OARE Consortium] at 02:49 08 July 2015
1Department of Neurosurgery, NIMHANS, Bengaluru, India, and 2Department of Clinical Neurosciences, NIMHANS, Bengaluru, India
life-saving intervention for medically refractory-raised ICP due to severe traumatic brain injury (TBI). In survivors of DC, cranioplasty (CP) is widely performed for the restoration of skull continuity following craniectomy procedures. The benefits of CP are often mentioned, but complications after CP are not well recognized. The overall benefits of DC must include procedural risks from CP as well. Though CP sounds as simple as placing a lid on the cooker, it is not free from complications. Factors highlighted in the literature considered relevant to influencing complications and thus outcome in CP include time delay following craniectomy,1–3 implant material,3,4 and bilateral or unilateral procedure.5 We aimed to determine and analyze predictors of complications after CP in patients in whom DC was done to treat raised ICP after TBI.
Abstract Introduction. Decompressive craniectomy (DC)—a potentially life-saving intervention following traumatic brain injury (TBI) with medically refractory brain swelling—once performed, surviving patients, more often than not, undergo a second procedure with cranioplasty (CP) in the future. This study analyzes complications following CP after DC, as the beneficial effects of the DC can’t be extrapolated in long run over a population unless one adds into it the complications associated with the CP in the survivors of TBI. Materials and methods. An observational study was performed retrospectively, with the review of case records. Demographic, clinical, and outcome data were collected, and complications were studied for any predictive parameters. A multivariate analysis was performed to identify factors that influenced these complications. Results. Data were collected for a total of 74 patients who underwent CP with a median age of 32, and a mean follow-up time of 2 years and 8 months. The mortality rate was 1.35% and overall complication rate 31%. The most significant factor determining complications were operating time more than 90 min Odds ratio (OR) 4.77 (1.61–14.20); timing of CP less than 3 months after craniectomy, OR 2.86 (1.48–8.11); age more than 20 years, OR 2.59 (1.20–6.53); and female gender, OR 1.91 (1.13–4.17). Conclusions. Although considered as a straight-forward procedure, the risks associated with this elective procedure should be kept in mind by the surgeon so that the patients and families can be apprised judiciously. It should be ascertained that patient and/or family consents for the procedure after being appropriately informed about the benefits and risks associated with the procedure.
Methods and materials Case ascertainment was achieved by manually searching operation-theater list from January 2004 to December 2014 of our institute, for procedures including the term “cranioplasty” following DC for TBI. Patients in whom DC was done for etiologies other than TBI, for example, brain tumors, cortical venous thrombosis, arterial infarcts, were excluded from this study. The patients who underwent DC at other hospitals and referred to our institute for CP were also excluded. Patients for whom at least 6 months follow-up after CP was not available were also excluded from the study. Patients in whom permanent cerebrospinal fluid (CSF) diversion like ventriculoperitoneal or thecoperitoneal shunt was done either before or during CP procedure were also excluded. The clinical, imaging, surgical findings, postoperative course, and follow-up data of the patients included in the study were reviewed. Abstracted data and specific factors considered were age at the time of CP, gender (male or female), site of DC (hemicranial or bifrontal), time interval between DC and CP (months), type of material used (autologous bone flap preserved in anterior abdominal wall, titanium, or acrylic), operative time (in minutes from cranial skin incision to skin closure completion), intraoperative CSF leak (yes or
Keywords: complications; cranioplasty; decompressive craniectomy
Introduction Raised intracranial pressure (ICP) occurs in several brain disorders and is increasingly being treated with surgical decompressive craniectomy (DC). DC is a potentially
Correspondence: Jitender Chaturvedi, Department of Neurosurgery, NIMHANS, Bengaluru 560029, India. Tel. +919900788501 and +919900788501. E-mail: [email protected] Received for publication 5 January 2015; accepted 10 May 2015
1
2 J. Chaturvedi et al. no), post-operative seizures, worsening of the preexisting neurological deficits or appearance of new deficits, infection requiring removal of implant, intracranial hematoma requiring re-exploration and evacuation, and mortality.
Statistical analysis
Downloaded by [OARE Consortium] at 02:49 08 July 2015
Comparison of association between Categorical variables was done using Chi-square test or Fisher’s exact test (when expected numbers were less than 5); while that of continuous variables was done using unpaired 2-tailed Student t-test. Associations between patient data and outcome were examined. After applying and analyzing the Pearson chi-square test and Fischer’s exact test for complications with each single dependent variable of interest, a multivariate binary logistic regression analysis with backward elimination method was carried out for all the dependent variables of interest. Significance was established at the 95% level.
Results A total of 112 patients underwent CP during the study period out of which 74 CP procedures were performed for TBI. Relevant data were available for all of these 74 patients. The median age at CP was 32 years (8–64 years). Males constituted 71% (n 52) of the patient population. The most common indication for DC was an acute subdural hematoma (n 42, 56.8%), followed by diffuse brain swelling (n 22, 29.7%). Ten (13.5%) patients had combined acute subdural hematoma with extradural hematoma. Sixty-two (83.8%) procedures were hemicraniectomy, and 12 (16.2%) were bifrontal DC. The mean size of the DC defect was 11.5 cm. The mean time interval to CP after DC was 10.17 months, and 80% of CPs was done within 12 months of DC. Only 1 patient underwent CP within 1 month of DC. The autologous bone flap was the most commonly implanted CP material used in 64 patients (86.5%). Titanium mesh and acrylic CP were used in 8 (10.8%) and 2 (2.7%) cases, respectively. Follow-up ranged from 6 months to 8 years with median of 2 years and 8 months.
Complications Complications occurred in 23 (31%) patients including one death resulting in mortality rate of 1.4%. The patient who underwent CP within 1 month of DC died at 16th postoperative day due to meningitis. Table I summarizes complications seen in the present study. The commonest complication was postoperative surgical-site infection seen in 10 (13.5%). Two of the infections could be managed with antibiotics, and 8 (10.8%) required removal of the implanted material
to control infection. Post-operative intracranial hematoma necessitating re-exploration and evacuation was seen in 3 (4.0%) patients: one case each of intracerebral hematoma, intracerebral hematoma with intraventricular extension, and extradural hematoma (Fig. 1). Eight (10.8%) patients had an intra-operative dural tear, but none of these patients had CSF leak or meningitis in the post-operative period. New onset post-operative seizures and worsening of the preexisting neurological deficits were seen in 5 (6.7%) patients each. The new onset neurological deficits were due to intracranial hematoma requiring re-exploration in 3 patients. Complications were seen in patients irrespective of the material used for CP. Both acrylic CP procedures had complications; 1 patient had postoperative new-onset seizures, and another one had an infection requiring removal of the implant. Among 8 patients who underwent titanium mesh placement, 25% (n 2) had complications; one had post-operative hematoma requiring re-exploration and another one had an infection requiring removal of the mesh. Complications were seen more frequently with older age, female gender, less time interval between DC and CP, and increase in the duration of surgery (Table II). Using the multivariate binary logistic regression analysis, operative time more than 90 min was found as the most significant independent factor (OR 4.77, 95% CI 1.66–14.20, p 0.005) in predicting complications after CP. Other variables that were significant were timing of surgery less than 3 months after DC (OR 2.86, 95% CI 1.48–8.11, p 0.004), age more than 20 years (OR 2.59, 95% CI 1.20–6.53, p 0.05), and female gender (OR 1.91, 95% CI 1.13–4.17, p 0.05). The size of DC, site of DC, or the material used for DC was not found to be significant in determining complications after CP (Table III).
Discussion The present study reports a relatively large cohort of patients who underwent CP after DC for TBI. The data were available for patients who were followed up to 6 months after CP, hence we could determine both early and late complications. We also determined the factors responsible for complications. The complication rate in our series was 31%, which is similar to that reported in the literature. We found that operative time more than 90 min, timing of surgery less than 3 months after DC, age more than 20 years, and the female gender as significant factors determining complications after CP. The size of DC, type of DC, or the material used for DC was not found to be significant in determining complications after CP. We discuss each of them in following sections.
Incidence of complications Table I. Complications with frequencies. Complications Overall (n 23) Infection requiring removal of implant (n 8) Dural tear (n 8) Neurological worsening (n 5) New onset seizure (n 5) Hematoma requiring re-exploration and evacuation (n 3) CSF leak (n 0)
Percentages (%) 31.0 10.8 10.8 6.7 6.7 4.0 0
Though the procedure of CP sounds simple, it is not free from complications. The incidence of complications after CP is variable, mainly due to the definition of complications, indications of DC that required CP, and the timing of reporting of complications (early or late). The overall rate of complications related to CP after DC is greater than with other standard elective cranial procedures.3 The reported incidence of complication ranges from 10–43%.6–10 Though TBI was the commonest indication for DC requiring CP in most of the
Cranioplasty complications prediction after TBI 3
Downloaded by [OARE Consortium] at 02:49 08 July 2015
Fig. 1. Postoperative computerized tomography (CT) scan images of patients in whom intracranial hematoma was seen after CP. (A) Intracerebral hematoma, (B) Intracerebral hematoma with intraventricular extension, and (C) Extradural hematoma.
studies, only one of the studies reported separately the incidence of complication specifically for CP after DC for TBI.7 The incidence of complication requiring a reoperation in this particular study was 40.8%. The incidence of complications of CP after DC for TBI was 31% in our series, which is similar to other studies of CP after DC for various etiologies.3 As the number of cases of DC for other indications was fewer in our series we excluded them from our analysis, hence we cannot extrapolate the incidence of complications for other etiologies such as stroke. We discuss the specific factors responsible for complication in the following paragraphs.
Interval between DC and CP The timing of CP is controversial. The timing between DC and CP makes a lot of difference in the outcome of patients. Some studies report that the complication rate is minimized by early CP.6 Proponents of early replacement debates that early CP procedure provides a good surgical plane between galea and the underlying dura, thus chances of dural tear and pial breach leading to various complications can be minimized. However, this comes at a price of operating early on a person who is still in recovering phase of his/her brain injury with poor nutritional status. The nosocomial flora that inhabitated Table II. Variables associated with complications. Variables (n) Complications (%) Age 20 years (23) 20 years (51) Gender Male (52) Female (22) Interval of CP 3 months (54) 3 months (20) Site of DC Hemicraniectomy (62) Bifrontal (12) Materials used for CP Autologous bone flap (64) Titanium mesh (8) Acrylic (2) Duration of surgery 90 min (37) 90 min (37) Size of craniectomy 8 cms (18) 8 cms (56)
p-value
16.6 34.4
0.04
23.0 36.0
0.05
22.6 45.0
0.03
31.8% 25.3%
0.93
28.7% 25% 100%
0.88
10.8% 48.6%
0.035
44.4% 28.6%
0.665
the local incision sites is still not replaced by commensals. These factors can increase the risk of infection, hence others recommend a minimum delay of 6 months to avoid risk of infection.2 On the other hand replacing bone at a later date exposes a patient recovering from TBI vulnerable to injury during rehabilitation. In our study, complications were noted to be highest in group of patients who underwent CP within 3 months of DC (45%), which dropped to less than 20% when CP was done within 3–12 months after DC. The CP done after 3 months of DC had almost three times lesser chances of being affected by complications in our study. The incidence of complications rose again when CP was done after 12 months. However, as only 20% of CPs was done after 12 months, the significance of this cannot be ascertained. We believe that the CP should be deferred till the patient has recovered, and out of hospital. We hypothesize that CP as a continuation of care during recovery phases poses an increased risk of infection due to nosocomial organisms. This is evident by our single case who underwent CP within 1 month of DC, and died due to meningitis. Many authors would not agree with present study in showing association between time delay and Table III. Results of multivariate binary logistic regression analysis with backward elimination method for predictors of complications among variables. Variables p-value Odds ratio 95% confidence interval Operative time 90 min* 90 min Interval 3 months* 3 months Age 20 years* 20 years Gender Male* Female Type of CP Autologous bone flap* Titanium mesh Acrylic Location of CP Hemi-DC* Bi-frontal-DC DC size 8 cm* 8 cm
*Reference group.
– 0.005
– 4.77
– 1.61–14.20
– 0.04
– 2.86
– 1.48–8.11
– 0.05
– 2.59
– 1.20–6.53
– 0.05
– 1.91
– 1.13–4.17
– 0.68 0.31
– 0.30 0.78
– 0.06–8.56 0.35–2.11
– 0.79
– 1.06
– 0.77–2.43
– 0.83
– 1.44
– 0.81–3.69
4 J. Chaturvedi et al. complication rate.5,11–13 An approach with holistic view might be the best as far as interval of CP is concerned and should be governed by general medical condition.
Downloaded by [OARE Consortium] at 02:49 08 July 2015
Age and gender Better outcomes among patients with younger age may reflect the overall better outcome in general among the younger population undergoing any surgical procedure because of the lack of co-morbid conditions, with CP being no exception. We found that younger patients (age 20 years) had nearly 2.5 times less risk of complications after CP. The contribution of gender in determining the outcome of head injury is a controversial area. According to one meta-analysis, which reported outcome separately for men and women, outcome was found worse in women than in men for 85% of the measured variables, with an average effect size of 0.15.15 Although clinical opinion is often that women tend to experience better outcomes than do men after TBI, the opposite pattern was suggested in the results of this meta-analysis.14 Relevant to DC or CP, the greater dimension of the frontal sinus in males may make them more vulnerable to infection due to inadvertent opening of frontal sinus.15 In the present study, the risk of complication in females was nearly twice as compare with males. Males performing better in comparison with females in the present study; could only be explained by the overall better outcome of male gender among patients with TBI and this finding is just an extrapolation of better performance of males in general. We are not aware of any study that has found the impact of age and gender on the outcome of CP.
Type of implant material and location of DC There is no specific surgical technique or material that has consistently proven to be superior, and postoperative complication rates vary widely among different methods.13,16 Any difference in complication rates between different types of implant material used, in the present study, could not be commented upon as the number of mesh CP and acrylic CP were eight and two, respectively, which was significantly low to give any statistically powerful correlation. Even after applying the multivariate logistic regression, there was no statistical significance found when comparing different types of implant material used and prediction of complications.
Site and size of the DC We did not find any association of complications with the location of DC (hemicraniectomy or bifrontal). However, it is very difficult to get any statistically significant meaning from the present study because of disparity between the number of hemicraniectomies (n 62) and bifrontal craniectomies (n 12). In other study, bifrontal procedures had a higher risk of complication, particularly infection.5 This is due to the increased likelihood of involving the frontal sinus at the time of bifrontal craniectomy, as compared with a unilateral procedure. There was no significant correlation between the size of the DC and complication in our study. Though minimizing the DC size theoretically minimizes the operative time of the procedure (which is an independent parameter for outcome assessment, as mentioned below) it does not affect the complication of CP.
Operating time It is well-known fact that the duration of any surgery increases the risk of complications. In our study, we found that the duration of surgery was the most significant factor determining complications. Complication rates were almost five times higher in patients with operating time more than 90 min. It is a routine practice at our institute to do augmented duraplasty using pericranium harvested during scalp flap reflection at the time of DC. The closure is attempted watertight, so as to reduce the incidence of CSF leak. We do not know whether use of pericranium increases adhesion, hence operation time during CP. We also do not know whether use of artificial dural substitute will result in less adhesion. Considering the simplicity, particularly replacement of the autologous bone flap, CP procedure in our institute is often delegated to junior residents. As these residents are less experienced they take a longer time to complete the operation. The prolongation of surgery time increases the risk of postoperative infection.
Limitations Being a retrospective study, the present study carries with it all the drawbacks associated with this form of the analysis. It is not powered to analyze patient-specific factors in greater details like steroid use or smoking habits, body–mass index, co-morbid illnesses like diabetes or hypertension. We did not analyze the preoperative functional status of the patients. Comparison of the materials and location of CP could not be ascertained with significance in the study. Our study does not extrapolate the results among stroke patients undergoing CP. Knowledge of the indication-specific risk factors will allow the development of preventive measures designed to reduce infection rates, as well as overall complication rates in future. However, our standardized definitions of variables, a relatively large number of patients, and sufficient follow-up period may outweigh these shortcomings.
Conclusion In this study, we determined the risk factors for complications after CP done specifically for TBI, which has been addressed sparsely in published literature. We had a mortality rate of 1.35% and overall complication rate of 31%. The operative time of procedure and timing of surgery were the most significant determinants of complication. The key conclusion from this study is to recognize that although considered as a straightforward procedure, the risks associated with this elective procedure should be kept in mind by the surgeon, so that the patients and families can be apprised judiciously. It should be ascertained that patient and/or family consents for the procedure after being appropriately informed about the benefits and risks associated with the procedure.
Acknowledgment Dr. P Marimuthu, Additional Professor of Biostatistics, NIMHANS, Bangalore for helping with statistics.
Cranioplasty complications prediction after TBI 5 Declaration of interest: The authors report no declarations of interest. The authors alone are responsible for the content and writing of the paper.
Downloaded by [OARE Consortium] at 02:49 08 July 2015
References 1. Chibbaro S, Di Rocco F, Mirone G, et al. Decompressive craniectomy and early cranioplasty for the management of severe head injury: A prospective multicenter study on 147 patients. World Neurosurg 2011;75:558–62. 2. Thavarajah D, De Lacy P, Hussien A, Sugar A. The minimum time for cranioplasty insertion from craniectomy is six months to reduce risk of infection - a case series of 82 patients. Br J Neurosurg 2012;26:78–80. 3. Chang V, Hartzfeld P, Langlois M, Mahmood A, Seyfried D. Outcomes of cranial repair after craniectomy. J Neurosurg 2010;112:1120–4. 4. Joffe J, Harris M, Kahugu F, et al. A prospective study of computer aided design and manufacture of titanium plate for cranioplasty and its clinical outcome. Br J Neurosurg 1999;13:576–80. 5. De Bonis P, Frassanito P, Mangiola A, et al. Cranial repair: How complicated is filling a “hole”? J Neurotrauma 2012;29:1071–6. 6. Broughton E, Pobereskin L, Whitfield PC. Seven years of cranioplasty in a regional neurosurgical centre. Br J Neurosurg 2014;28:34–9. 7. Bobinski L, Koskinen LO, Lindvall P. Complications following cranioplasty using autologous bone or polymethylmethacrylateretrospective experience from a single center. Clin Neurol Neurosurg 2013;115:1788–91.
8. Coulter IC, Pesic-Smith JD, Cato-Addison WB, et al. Routine but risky: A multicenter analysis of the outcomes of cranioplasty in the Northeast of England. Acta Neurochir (Wien) 2014;156: 1361–8. 9. Klinger DR, Madden C, Beshay J, et al. Autologous and acrylic cranioplasty: A review of 10 years and 258 cases. World Neurosurg 2014;82:e525–30. 10. Heo J, Park SQ, Cho SJ, Chang JC, Park HK. Evaluation of simultaneous cranioplasty and ventriculoperitoneal shunt procedures. J Neurosurg 2014;121:313–8. 11. Gooch MR, Gin GE, Kenning TJ, German JW. Complications of cranioplasty following decompressive craniectomy: Analysis of 62 cases. Neurosurg Focus 2009;26:E9. 12. Sobani ZA, Shamim MS, Zafar SN, et al. Cranioplasty after decompressive craniectomy: An institutional audit and analysis of factors related to complications. Surg Neurol Int 2011;2:123. 13. Yadla S, Campbell PG, Chitale R, et al. Effect of early surgery, material, and method of flap preservation on cranioplasty infections: A systematic review. Neurosurgery 2011;68:1124–9. 14. Farace E, Alves WM. Do women fare worse: A meta-analysis of gender differences in traumatic brain injury outcome? J Neurosurg 2000;93:539–45. 15. Lee MK, Sakai O, Spiegel JH. CT measurement of the frontal sinus - gender differences and implications for frontal cranioplasty. J Craniomaxillofac Surg 2010;38:494–500. 16. Shaffrey ME, Persing JA, Shaffrey CI, Delashaw JB, Jane JA. Craniofacial reconstruction. In: Apuzzo MLJ ed. Brain Surgery: Complication and Avoidance Management. New York: Churchill Livingstone, 1993;1373–98.
