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 » Introduction
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Table of Contents    
ORIGINAL ARTICLE
Year : 2014  |  Volume : 62  |  Issue : 1  |  Page : 26-31

Long-term outcome of decompressive hemicraniectomy in patients with malignant middle cerebral artery infarction: A prospective observational study


1 Department of Neurology, All India Institute of Medical Sciences, New Delhi, India
2 Department of Neurosurgery, All India Institute of Medical Sciences, New Delhi, India

Date of Submission21-Dec-2013
Date of Decision15-Jan-2014
Date of Acceptance26-Jan-2014
Date of Web Publication7-Mar-2014

Correspondence Address:
Rohit Bhatia
Department of Neurology, Room No. 3, 6th Floor, Neurosciences Centre, All India Institute of Medical Sciences, Ansari Nagar, New Delhi - 110 029
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0028-3886.128273

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 » Abstract 

Background: Malignant middle cerebral artery (MCA) infarction is associated with high mortality and morbidity. Decompressive hemicraniectomy (DH) reduces mortality significantly but evidence for long-term functional benefit is sparse and contradictory. Materials and Methods: A total of 60 patients with malignant MCA infarction were prospectively enrolled. 36 (60%) patients underwent DH and 24 (40%) patients received best medical therapy alone. Both groups were followed-up for 1 year for improvement in disability and aphasia using modified Rankin score (mRS) and Western Aphasia Battery respectively. Good outcome was defined as mRS ≤ 3. Secondary analysis using mRS ≤ 4 was also performed. Results: An absolute risk reduction of 45% was observed in mortality at 1 year; 38% (14/36) in the surgical group died versus 83% (20/24) in the medical group. Good outcome at 1 year was achieved in 20% (7/35) patients in the surgical group compared with none in the medical group (P = 0.025). Repeated measures regression suggested increased proportion of patients improving over time (discharge, 3, 6 and 12 months). Surgery reduced the odds of moderate to severe disability (mRS ≥ 4) by 93.5% (odds ratio: 0.064, 95% confidence interval: 0.01-0.045, P = 0.006). Conclusions: DH in malignant MCA infarction not only reduces mortality but also increases chances of a better functional outcome. The benefit of surgery in motor and aphasia recovery is progressive and sustained until 1 year.


Keywords: Decompressive hemicraniectomy, malignant middle cerebral artery infarction, ischemic stroke


How to cite this article:
Rai VK, Bhatia R, Prasad K, Padma Srivastava M V, Singh S, Rai N, Suri A. Long-term outcome of decompressive hemicraniectomy in patients with malignant middle cerebral artery infarction: A prospective observational study. Neurol India 2014;62:26-31

How to cite this URL:
Rai VK, Bhatia R, Prasad K, Padma Srivastava M V, Singh S, Rai N, Suri A. Long-term outcome of decompressive hemicraniectomy in patients with malignant middle cerebral artery infarction: A prospective observational study. Neurol India [serial online] 2014 [cited 2022 Oct 3];62:26-31. Available from: https://www.neurologyindia.com/text.asp?2014/62/1/26/128273



 » Introduction Top


About 10-15% patients with middle cerebral artery (MCA) territory cerebral infarction suffer from progressive clinical deterioration because of increased brain swelling, raised intracranial pressure, and subsequent herniation. [1],[2],[3] Such space occupying infarction is commonly referred to as malignant MCA infarction. Edema associated with these infarcts is usually observed between the 2 nd and 5 th day after the index event and is associated with a poor prognosis. [2],[4] Previously described series, have observed fatality rates of about 80%, and most survivors were left severely disabled. [1],[2] Unfortunately, medical management for malignant MCA infarction is generally ineffective, necessitating a surgical approach for its relief. [5]

A pooled analysis of individual patient data of the three randomized controlled trials showed that surgical decompression reduced the risk of death or disability, defined as modified Rankin Score (mRS) ≥3. [6] However, only those patients who were operated within 48 h from symptom onset and who were ≤60 years old were included in the analysis. Although decompressive hemicraniectomy (DH) has shown to reduce mortality significantly among patients compared to medical therapy alone, there has been concern that life is preserved at the potentially unacceptable cost of marked functional disability. [7]

Although various prognostic factors affecting the outcome after DH have been identified, the strength of association is not well-established. It is also important to realize that most of the published data comes from western populations where long-term stroke rehabilitation facilities exist and stroke units are well-established. We aimed to assess the long-term functional outcome (motor as well as language) of our patients undergoing DH for malignant MCA infarction, compared with those managed with best medical treatment alone, in real life situations where care and support following discharge is provided by family members at home.


 » Materials and Methods Top


This was a non-randomized, prospective, observational cohort study conducted between January 2010 and June 2011 in the department of Neurology at the All India Institute of Medical Sciences, New Delhi, a tertiary referral center in India. The study protocol was approved by the Institutional Ethics Committee and written informed consent was obtained from all participants. All admitted patients with life threatening malignant MCA infarction indicated to undergo DH [Supplemental Appendix e-1] [Additional file 4] on the basis of clinical assessment (National Institute of Health Stroke Scale [NIHSS], Glasgow coma scale [GCS]) and neuroimaging (computed tomography head) were prospectively enrolled. Patients who died within 24 h of presentation, those with dilated and fixed pupils at presentation, GCS < 6, mRS ≥ 2 prior to the current stroke and known metabolic cause for altered sensorium were excluded to reduce the risk of bias. All patients meeting the inclusion criteria but not undergoing surgery due to any of the reasons cited below were included in the control group (best medical management); (1) no consent; (2) non-availability of neurosurgeon; (3) high surgical risk due to severe co-morbidities; and (4) deranged coagulation profile.

The diagnosis of stroke was established clinically and confirmed by neuroimaging (non-contrast CT [NCCT] head). Details of demographics including age, sex, address, contact number, detailed history of event, presenting symptoms and signs, risk factors for stroke, blood pressure, GCS and NIHSS score, laboratory parameters and imaging findings (type of stroke, arterial territory involved, mid line shift) were noted. Western Aphasia Battery was used to record the severity of aphasia. Aphasia quotient (AQ) was calculated by kerrtesz formula; a score ≤93.8 was taken as cut off for defining aphasia. [8] Decompressive surgery in our patients consisted of creation of a large fronto-parieto-temporal free bone flap (at least 12 cm) and duroplasty. Bone flap was placed in the subcutaneous fat pocket in the right iliac region for cranioplasty later. No intervention on brain tissue was performed. Details of surgery including time of onset of symptoms to hemicraniectomy, duration of surgery, blood loss, post-operative complications and intensive care unit (ICU) stay were recorded. Course of hospital stay including stroke recurrence, death and status at discharge was noted. Clinical status at the time of discharge was measured using GCS, NIHSS and mRS score. Outcome on follow-up was assessed using mRS during out-patient department (OPD) visits in the stroke clinic and or telephonically at 3, 6 and 12 months. Aphasia testing using Western Aphasia Battery was done on follow-up visits in the stroke clinic. mRS of ≤ 3 was taken as a good outcome. We also analyzed the results using mRS of ≤4 as a good outcome.

Statistical methods

The data was entered in Microsoft Excel format and analyzed using StataCorp USA. Version 11.1 and SPSS IBM version 16. Continuous variables were compared using Student's t-test and categorical variables were compared using Pearson's Chi-square test, in the bivariate analysis. All tests were two tailed. Relative risk along with 95% confidence interval (CI) was calculated. Multivariate analysis was performed using logistic regression. Survival analysis was performed using Kaplan-Meier survival curve. Repeated measures regression for dichotomized mRS was applied to see the change in the proportion of patients improving over time (discharge, 3, 6 and 12 months).


 » Results Top


A total of 60 patients were enrolled during the study period. Mean age was 49.6 (range: 20-91) years and 15 patients (25%) were above 60 years of age. There were 72% males [Table 1]. There were 25 (42%) patients with left MCA territory stroke and 35 (58%) patients were right MCA territory stroke. Among these, 36 (60%) patients underwent DH and 24 (40%) received best medical management. Median interquartile range NIHSS and GCS at admission were 18 (12-28) and 10 (3-15) respectively. Mean delay to surgery from time of onset of symptoms was 56 h (9-148). Distribution of most baseline variables including gender, cause of stroke, aphasia, NIHSS and GCS Score were similar in both groups except age and midline shift. Surgical group patients were significantly younger (mean age: 44.6 ± 12 years) than patients in the medical group (mean age 57.12 ± 19) however midline shift > 5 mm was more common in the surgical group (17 [47%] vs. 4 [17%]) [Table 1].
Table 1: Characteristics of patients in decompressive hemicraniectomy (surgical) and medical management alone (medical) groups

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Significantly high mortality was noted in the medical management group within the hospital, at 3 months, 6 months and 12 months follow up. 62% (15/24) patients died during the hospital stay in medical management group as compared to 13% (5/36) deaths in the hemicraniectomy group. Cumulative risk of death reached up to 83% (20/24) in medical group as compared with 38% (14/36) in the surgical group by 1 year suggesting an absolute risk reduction of 45% in mortality [Table 2]. Log rank test for equality of the survivor function showed significantly higher deaths (20) than expected. Since surgical group patients were younger in age with greater midline shift, cox regression was used to compute adjusted hazard rate [Table 3]. Risk of death in the surgical group was 63% less when compared to the medical group (Hazard Ratio of 0.37 [95% CI: 0.20, 0.69; P = 0.002]) [Figure 1].
Figure 1: Survival estimates adjusted for age and midline shift

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Table 2: Cumulative risk of death in medical versus surgical group

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Table 3: Adjusted analysis for death and disability at 1 year

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Functional outcome measured by dichotomized mRS at 3 and 4 was significantly better in the surgical group at 3 months, 6 months and 1 year follow-up. Good outcome was achieved by 20% patients in the surgical group at 1 year as compared to none in medical group. 53% patients achieved mRS ≤ 4 in the surgery group as compared to 8% in medical group at 1 year follow-up [Table 4] and Supplemental [Figure e-1] [Additional file 1].
Table 4: Comparison of functional outcome (dichotomized mRS) in medical and surgical group

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Proportion of patients for dichotomized mRS at every time point was calculated in the surgically treated group. Repeated measures regression for dichotomized mRS ≤ 3 and mRS ≤ 4 were applied to see the change in the proportion of patients improving over time (discharge, 3, 6 and 12 months). On average, between any two consecutive time points, 1.98% (95% CI: 1.1%-2.8%, P < 0.0001) more patients achieved a mRS ≤ 3 and 3.7% (95% CI: 2.2%-5.1%, P < 0.0001) achieved mRS of ≤ 4, suggesting significant improvement with time.

All 25 patients of left MCA stroke were aphasic at the time of the first assessment (discharge or 1 month after stroke). Out of the 25 patients, 16 were in the surgery group and 9 were in medical group. 11 patients died before 3 months follow-up (8 in medical group, 3 in the surgical group). 1 year follow-up data of language assessment (on OPD basis) was available for only 6 patients, all from surgical group. Progressive improvement in aphasia was observed over time on the mean AQ score (Western Aphasia Battery). Maximum improvement was seen in first 3 months of follow-up [Supplemental Table e-1] [Additional file 2]. Among 36 patients who underwent DH, 21 (58.33%) achieved good outcome (mRS ≤ 4) and 15 (41.66%) had a poor outcome at 1 year. No significant differences were observed between the two groups among baseline variables [Supplemental Table e-2] [Additional file 3].

In the post-operative period, ten patients developed fever of which six patients were diagnosed to have aspiration or ventilator associated pneumonia, three urinary tract infection and in one patient source of infection could not be identified. Surgical site examination and NCCT head were done to rule out any infection, subdural or epidural hematoma or collection; none of which were seen in our patients. Five patients died before discharge, out of which three died because of malignant cerebral edema and two due to sepsis and refractory septic shock.


 » Discussion Top


The results of this prospective cohort study reconfirms mortality benefit of decompressive surgery, with 45% risk reduction in death at 1 year compared to medical management alone. This benefit is sustained beyond the postoperative period and up to 1 year (follow-up period in the present study) in our study. Functional outcome (mRS ≤ 3) at 1 year was significantly improved by surgery; almost 20% patients achieved good outcome as compared to none in the other group. The difference was statistically not significant at 3 months but became significant at 1 year suggesting that the benefit of surgery on functional outcome improves with time. Better functional outcome at 1 year (when dichotomized at 4) was significantly more in the surgical group (53%) as compared to the medical group (8%). Significant recovery in aphasia was observed in the surgery group over a period of 1 year. Progressive improvement in AQ was seen throughout the year, maximum recovery was seen in the initial 3 months. Although age, sex, side of stroke, cause of stroke, NIHSS, GCS, midline shift, time to surgery, ICU stay were studied, none of these could be identified as an outcome predictor.

Three randomized controlled trials; HAMLET, [9] DECIMAL [10] and DESTINY [11] have compared decompressive surgery plus medical treatment versus medical treatment alone in patients with malignant MCA infarction. Present study showed similar mortality benefit and better functional outcome (mRS ≤ 3) at the end of 1 year in comparison to studies mentioned earlier. Inclusion of less severe stroke than previous studies may have resulted in better functional outcome. A recent Cochrane review concluded that surgical decompression lowers the risk of death or severe disability (defined as mRS > 4) in selected patients 60 years of age or younger with a massive hemispheric infarction and edema. [12] This meta-analysis involving 134 patients who were 60 years of age or younger suggested that surgical decompression reduced the risk of death at the end of follow-up (OR: 0.19, 95% CI: 0.09-0.37) and the risk of death or disability defined as mRS > 4 at 12 months (OR: 0.26, 95% CI: 0.13-0.51). Death or disability defined as mRS > 3 at the end of follow-up was no different between the treatment arms (OR: 0.56, 95% CI: 0.27-1.15). Since all the trials were stopped early, possibility of an overestimation of the effect size was expressed.

In a review of 13 uncontrolled studies of 138 patients, being older than 50 years was a strong predictor of poor functional outcome after surgical decompression. However timing of the operation, side of the infarct and the involvement of other vascular territories did not affect the outcome. [13] In a recent review of uncontrolled studies, just 6 (8%) of 72 patients older than age 60 years had a favorable outcome after surgery, as compared with 77 (54%) of 143 younger patients. [14] In our study, age was not identified as a predictor of outcome of surgery as only a small number of patients (n = 3) aged > 60 years were operated. A large prospective study enrolling 330 patients with post stroke aphasia showed that Stationary language function in 95% was reached within 2 weeks in those with initial mild aphasia, within 6 weeks in those with moderate, and within 10 weeks in those with severe aphasia. [15] In our study, we found progressive improvement in AQ up to 1 year follow-up. This suggests surgical intervention may have a beneficial effect on recovery of aphasia beyond 3 months. Similar results have been observed in a previously published study. [16]

Limitations of our study include younger patients in the surgical group at baseline (however adjusted analysis done showed similar results), slightly less severe stroke as compared to previous trials and unavailability of quantitative measure of infarct volume. However, our results reflect a real world scenario out of context of randomized clinical trials as our patients continued to receive best medical management during the hospital stay, irrespective of not being operated. The follow-up period was long to ascertain true outcome after such large strokes. Furthermore, our patients were cared for at home by family members. This is a more realistic situation of understanding the outcome in resource limited setting like ours where patients don't spend time in dedicated rehabilitation centers. In the future, we also wish to ascertain caregiver burden and patients perception of the illness with a larger multicenter study.


 » Conclusion Top


DH in large MCA stroke patients leads to markedly improved survival and better functional outcome (motor and language) at 1 year. The benefit of surgery in motor and aphasia recovery is progressive and sustained until 1 year. Results of the present study suggests that 3 months or 6 months outcome assessment may be insufficient to understand the true benefit of this life saving surgery and at least 1 year follow-up should be recommended for measuring its functional benefit. The results are valid in real life situations, out of context of randomized controlled trials.

 
 » References Top

1.Berrouschot J, Sterker M, Bettin S, Köster J, Schneider D. Mortality of space-occupying (′malignant′) middle cerebral artery infarction under conservative intensive care. Intensive Care Med 1998;24:620-3.  Back to cited text no. 1
    
2.Hacke W, Schwab S, Horn M, Spranger M, De Georgia M, von Kummer R. ′Malignant′ middle cerebral artery territory infarction: Clinical course and prognostic signs. Arch Neurol 1996;53:309-15.  Back to cited text no. 2
    
3.Rieke K, Schwab S, Krieger D, von Kummer R, Aschoff A, Schuchardt V, et al. Decompressive surgery in space-occupying hemispheric infarction: Results of an open, prospective trial. Crit Care Med 1995;23:1576-87.  Back to cited text no. 3
    
4.Ropper AH, Shafran B. Brain edema after stroke. Clinical syndrome and intracranial pressure. Arch Neurol 1984;41:26-9.  Back to cited text no. 4
    
5.Hofmeijer J, van der Worp HB, Kappelle LJ. Treatment of space-occupying cerebral infarction. Crit Care Med 2003;31:617-25.  Back to cited text no. 5
    
6.Vahedi K, Hofmeijer J, Juettler E, Vicaut E, George B, Algra A, et al. Early decompressive surgery in malignant infarction of the middle cerebral artery: A pooled analysis of three randomised controlled trials. Lancet Neurol 2007;6:215-22.  Back to cited text no. 6
    
7.Puetz V, Campos CR, Eliasziw M, Hill MD, Demchuk AM, Calgary Stroke Program. Assessing the benefits of hemicraniectomy: What is a favourable outcome? Lancet Neurol 2007;6:580.  Back to cited text no. 7
    
8.Kerrtesz A. Western Aphasia Battery. New York: Grune and Stratton; 1982.  Back to cited text no. 8
    
9.Hofmeijer J, Kappelle LJ, Algra A, Amelink GJ, van Gijn J, van der Worp HB, et al. Surgical decompression for space-occupying cerebral infarction (the Hemicraniectomy After Middle Cerebral Artery infarction with Life-threatening Edema Trial [HAMLET]): A multicentre, open, randomised trial. Lancet Neurol 2009;8:326-33.  Back to cited text no. 9
    
10.Vahedi K, Vicaut E, Mateo J, Kurtz A, Orabi M, Guichard JP, et al. Sequential-design, multicenter, randomized, controlled trial of early decompressive craniectomy in malignant middle cerebral artery infarction (DECIMAL Trial). Stroke 2007;38:2506-17.  Back to cited text no. 10
    
11.Jüttler E, Schwab S, Schmiedek P, Unterberg A, Hennerici M, Woitzik J, et al. Decompressive Surgery for the Treatment of Malignant Infarction of the Middle Cerebral Artery (DESTINY): A randomized, controlled trial. Stroke 2007;38:2518-25.  Back to cited text no. 11
    
12.Cruz-Flores S, Berge E, Whittle IR. Surgical decompression for cerebral oedema in acute ischaemic stroke. Cochrane Database Syst Rev 2012;1:CD003435.  Back to cited text no. 12
    
13.Gupta R, Connolly ES, Mayer S, Elkind MS. Hemicraniectomy for massive middle cerebral artery territory infarction: A systematic review. Stroke 2004;35:539-43.  Back to cited text no. 13
    
14.Arac A, Blanchard V, Lee M, Steinberg GK. Assessment of outcome following decompressive craniectomy for malignant middle cerebral artery infarction in patients older than 60 years of age. Neurosurg Focus 2009;26:E3.  Back to cited text no. 14
    
15.Pedersen PM, Jørgensen HS, Nakayama H, Raaschou HO, Olsen TS. Aphasia in acute stroke: Incidence, determinants, and recovery. Ann Neurol 1995;38:659-66.  Back to cited text no. 15
    
16.Kastrau F, Wolter M, Huber W, Block F. Recovery from aphasia after hemicraniectomy for infarction of the speech-dominant hemisphere. Stroke 2005;36:825-9.  Back to cited text no. 16
    


    Figures

  [Figure 1]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4]

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