Decompressive Hemicraniectomy in Malignant Middle Cerebral Artery Infarct: A Randomized Controlled Trial Enrolling Patients up to 80 Years Old

Zhao, Jingwei; Su, Yingying; Zhang, Yan; Zhang, Yun Zhou; Zhao, Rong; Lin, Wei; Gao, Ran; Chen, Weibi; Gao, Daiquan

doi:10.1007/s12028-012-9703-3

Cited by 152 publications

(140 citation statements)

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“…In the present study, three patients over 60 years of age were included. A Chinese study evaluated the effectiveness of DC in patients over 80 years of age, concluding that DC, even in patients in this age group, may increase the survival rate without severe compromise of functionality 18 . In a recent American study, involving more than 1,600 patients, the authors reported the results according to age as uni-and multivariate analysis, not taking into account this variable as a significant predictor of clinical outcome 20 .…”

Section: Discussionmentioning

confidence: 99%

Decompressive craniotomy for the treatment of malignant infarction of the middle cerebral artery: mortality and outcome

Bongiorni

Hockmuller

Klein

et al. 2017

Arq. Neuro-Psiquiatr.

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Objective: To assess, by Rankin scale, the functional disability of patients who had a malignant middle cerebral artery (MCA) ischemic stroke, who underwent decompressive craniotomy (DC) within the first 30 days. Methods: A cross-sectional study in a University hospital. Between June 2007 and December 2014, we retrospectively analyzed the records of all patients submitted to DC due to a malignant MCA infarction. The mortality rate was defined during the hospitalization period. The modified outcome Rankin score (mRS) was measured 30 days after the procedure, for stratification of the quality of life. Results: The DC mortality rate was 30% (95% CI 14.5 to 51.9) for the 20 patients reported. The mRS 30 days postoperatively was ≥ 4 [3.3 to 6] for all patients thereafter. Conclusion: DC is to be considered a real alternative for the treatment of patients with a malignant ischemic MCA infarction.Keywords: craniotomy; cerebral infarction; intracranial hypertension. RESUMOObjetivo: Avaliar a capacidade funcional de pacientes com acidente vascular cerebral isquêmico no território da artéria cerebral média (ACM) submetidos à craniotomia descompressiva (CD) no período de 30 dias pela escala de Rankin. Métodos: Estudo transversal em um hospital universitário. Entre junho de 2007 e dezembro de 2014, analisados retrospectivamente os registros de todos os pacientes submetidos a CD devido a enfarte maligno na ACM. A taxa de mortalidade foi definida durante o período de internação. O resultado da estratificação da qualidade de vida foi através da escala Rankin modificado (mRS) mensurado em 30 dias após o procedimento. Resultados: A taxa de mortalidade CD foi de 30% (IC 95% 14,5-51,9) para os 20 pacientes relatados. A mRS 30 dias de pós-operatório foi => 4 [3,3-6] para todos os pacientes. Conclusão: CD deve ser considerada uma alternativa real para o tratamento de pacientes com enfarte isquêmico no território da ACM.Palavras-chave: craniotomia; infarto cerebral; hipertensão intracraniana.A decompressive craniotomy (DC) has been a therapeutic option for an infarction of the middle cerebral artery (MCA) region. The goal of the surgical treatment is the reduction of the intracranial hypertension. The procedure is based on a fronto-parieto-temporal craniotomy, ipsilateral to the lesion, followed by plastic reconstruction of the dura mater, allowing immediate decompression of the brain 1,2,3,4,5 .Some complications, such as infection of the surgical area, temporal muscle hematoma with cerebral compression, intracerebral hemorrhage, or worsening of the neurological condition may follow DC 2,3,4 . In order to clearly define the indication for the surgical treatment and to decrease complications derived from DC in a university hospital in southern Brazil, a specific protocol for DC in the treatment of intracranial hypertension derived from ischemia of the MCA region has been implemented since 2007, in conjunction with the neurology department. Even though studies have demonstrated the efficacy of DC in patients presenting with ma...

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Section: Discussionmentioning

confidence: 99%

Decompressive craniotomy for the treatment of malignant infarction of the middle cerebral artery: mortality and outcome

Bongiorni

Hockmuller

Klein

et al. 2017

Arq. Neuro-Psiquiatr.

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“…Six RCTs comprising 289 patients met our inclusion criteria: 4 completed trials of early DC, the published preliminary results from a trial of early DC, and a subgroup analysis comprised of patients randomized within 48 hours from Hemicraniectomy After Middle Cerebral Artery Infarction With Life-threatening Edema Trial (HAMLET), a DC trial which enrolled patients up to 96 hours from onset (table). 5,10,11,[23][24][25] One study was excluded, Hemicraniectomy and Durotomy Upon Deterioration From Infarction-Related Swelling Trial (HeADDFIRST), which enrolled patients up to 96 hours from onset and, notably, intentionally delayed DC until patients had severe clinical or radiographic deterioration. 26 Inclusion criteria for the individual trials were similar, with exception of the prespecified age ranges (table).…”

Section: Study Selection and Study Characteristicsmentioning

confidence: 99%

“…The 4 completed RCTs of early DC, Jüttler et al, 25 Vahedi et al, 24 Zhao et al, 11 and Jüttler et al, 10 received a low risk of bias rating. Slezins et al 23 is a brief preliminary report that does not comprehensively detail study methodology.…”

Section: Risk Of Bias For Independent Studiesmentioning

confidence: 99%

“…2,7 In 2007, a landmark interim pooled analysis of 3 RCTs demonstrated improved functional outcomes, defined as modified Rankin Scale (mRS) scores 0-3, for MCI patients treated with early DC. 6 However, this morbidity benefit was not present upon completion of the trials 5,8,9 ; nor has it been demonstrated in subsequent RCTs, 10,11 which employed a less stringent definition of acceptable functional outcome (mRS 0-4) with poor generalizability. [12][13][14][15][16][17] Consequently, there is enduring concern that early DC increases survival only at the cost of poor quality of life.…”

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Early decompressive craniectomy for malignant cerebral infarction

2016

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Background: Decompressive craniectomy (DC) is an aggressive life-saving surgical intervention for patients with malignant cerebral infarction (MCI). However, DC remains inconsistently and infrequently utilized, primarily due to enduring concern that increased survival occurs only at the cost of poor functional outcome. Our aim was to clarify the role of DC performed within 48 hours (early DC) for patients with MCI, including patients aged .60 years. Methods: We performed a meta-analysis of all available randomized controlled trials comparing early DC to best medical care for MCI. Studies were identified through literature searches of electronic databases including PubMed, EMBASE, and Scopus. We employed a Mantel-Haenszel fixed effects model to assess treatment effect on dichotomized modified Rankin Scale (mRS) outcomes at 12 months. Results: A total of 289 patients from 6 randomized controlled trials comparing early DC to best medical care were included. Early DC resulted in an increased rate of excellent outcomes, defined as mRS #2 (relative risk [RR] 2.81, 95% confidence interval [CI] 1.01-7.82, p 5 0.047), and favorable outcomes, defined as mRS #3 (RR 2.06, 95% CI 1.25-3.40, p 5 0.005). Early DC also increased the rate of survival with unfavorable outcomes, defined as mRS 4-5 (RR 3.03, 95% CI 1.98-4.65, p , 0.001). Conclusions: Early DC increases the rate of excellent outcomes, i.e., functional independence, in addition to favorable and unfavorable outcomes; however, these findings must be interpreted within the context of patients' goals of care. We have developed a clinical decision algorithm that incorporates goals of care, which may guide consideration of early DC for MCI in clinical practice. Neurol Clin Pract 2016;6:433-443 M alignant cerebral infarction (MCI) refers to large-volume ischemic strokes involving the middle cerebral artery territory, which are complicated by lifethreatening cerebral edema. 1 Managed medically, MCI carries a mortality rate of 80%. 1,2 Decompressive craniectomy (DC), the surgical removal of a portion Editorial, page 381

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“…In the current issue of Neurocritical Care, Zhao and colleagues report the results of a Chinese randomised controlled study [9] which investigated the effect of early decompressive hemicraniectomy after large mMCAI in patients aged 18-80 years. Forty-seven patients were included in the trial and 24 of them were randomized to early DHC.…”

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Should Age be Considered When Proposing Decompressive Hemicraniectomy in Malignant Stroke, and If so Where is the Limit?

Staykov

Schwab

2012

Neurocrit Care

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Malignant middle cerebral infarction is defined as a clinical deterioration from hemispheric swelling and is named ''malignant'' because it is rapidly injurious to the patient. Recommendations for early decompressive hemicraniectomy (DHC) in malignant middle cerebral artery infarction (mMCAI) [3,4]. The results clearly demonstrated that DHC is more than just an optional intervention in mMCAI as mortality was consistently significantly lower in patients who underwent surgery across all three trials, as compared with controls. None of the trials or meta-analyses were able to show significant improvement in functional outcome with DHC when the predefined dichotomization between a modified Rankin scale score (mRS) of 0-3 and 4-6 was used [3,5]. However, a post hoc meta-analysis of the pooled data including totally 109 patients indicates that early surgery (<48 h after symptom onset) may also result in a higher proportion of patients with a mRS of 4 or lower, as compared to best medical treatment [3]. One of the unresolved and important questions after DECIMAL, DESTINY, and HAMLET is, if there is an age limit from which on the benefits of DHC are nullified.The difficulty to derive any conclusions on this age issue is because the clinical trials included only patients younger than 60 years; however, a major proportion of the patients suffering mMCAI belong to an older age cohort [6]. Observational studies reporting on older patients treated with DHC are rather skeptical showing improved survival achieved at the cost of poor functional outcome and dependency [6][7][8].In the current issue of Neurocritical Care, Zhao and colleagues report the results of a Chinese randomised controlled study [9] which investigated the effect of early decompressive hemicraniectomy after large mMCAI in patients aged 18-80 years. Forty-seven patients were included in the trial and 24 of them were randomized to early DHC. In line with the findings of the 3 European RCTs, surgical treatment resulted in significantly lower mortality at six months (12.5 vs. 60.9 %) and one year after symptom onset (16.7 vs. 69.6 %). In addition, Zhao et al. could demonstrate a significant benefit from surgery as emphasized by the higher rate of patients with a mRS of 5 or 6 six months (33.3 vs. 82.6 %) and one year after symptom onset (25 vs. 87 %). The most interesting aspect of this study is the age distribution of the included participants. Of totally 47 patients enrolled, 29 were older than 60 years and 16 of them were randomized to surgical treatment. Subgroup analyses including only patients older than 60 years yielded similar results. A significant benefit of surgery was found in this older cohort considering mortality (6 months: 12.5 vs. 61.5 %; 1 year: 18.8 vs. 69.2 %), as well as poor outcome, defined as mRS > 4 (6 months: 31.2 vs. 92.3 %; 1 year: 37.5 vs. 100 %). Based on those findings, the authors come to the optimistic conclusion that DHC is beneficial for patients aged 61-80 years although there seems to be an increased likelihood for those pa...

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Decompressive Hemicraniectomy in Malignant Middle Cerebral Artery Infarct: A Randomized Controlled Trial Enrolling Patients up to 80 Years Old

Abstract: For patients up to 80 years who suffered mMCAI, DHC within 48 h of stroke onset not only is a life-saving treatment, but also increases the possibility of surviving without severe disability (mRS = 5).

Cited by 152 publications

References 25 publications

Decompressive craniotomy for the treatment of malignant infarction of the middle cerebral artery: mortality and outcome

Decompressive craniotomy for the treatment of malignant infarction of the middle cerebral artery: mortality and outcome

Early decompressive craniectomy for malignant cerebral infarction

Should Age be Considered When Proposing Decompressive Hemicraniectomy in Malignant Stroke, and If so Where is the Limit?

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