Hemicraniectomy and Durotomy Upon Deterioration From Infarction-Related Swelling Trial

Abstract

Background and Purpose HeADDFIRST was a randomized pilot study to obtain information necessary to design a Phase III trial to evaluate the benefit of surgical decompression for brain swelling from large supratentorial cerebral hemispheric infarction (LSCHI). Methods All stroke patients were screened for eligibility [age 18–75, NIHSS ≥ 18 with Item 1a < 2 (responsive to minor stimulation), and CT demonstrating unilateral, complete MCA territory infarction by specific imaging criteria]. All enrolled patients were treated using a standardized medical treatment protocol. Those with both ≥ 4 mm of pineal shift and deterioration in level of arousal or ≥ 7.5 mm of anteroseptal shift within 96 hours of stroke onset were randomized to continued Medical Treatment Only (MTO) or Medical Treatment plus Surgery (MTS). Death at 21 days was the primary outcome measure. Results Among 4,909 screened patients, only 66 (1.3%) were eligible for HeADDFIRST. Forty patients were enrolled, and 26 developed the requisite brain swelling for randomization. All who failed to meet randomization criteria were alive at 21 days. Mortality at 21 and 180 days was 40% (4/10) in the MTO and 21% (3/14) and 36% (5/14) in the MTS arms, respectively. Conclusions HeADDFIRST randomization criteria effectively distinguished low from high risk of death from LSCHI. Lower mortality in the MTO group than in other published trials suggests a possible benefit to standardizing medical management. These results can inform the interpretation of recently completed European trials regarding patient selection and medical management.

Decompressive hemicraniectomy: predictors of functional outcome in patients with ischemic stroke

“…8,11,14,30,31 Its beneficial effects may vary among patients. In this study, we set out to identify risk factors that can be associated with increased mortality rate and poor outcome after surgery and aid the patient selection for DH.…”

“…8 Vahedi et al conducted a pooled analysis of the major trials and reported that 43% of patients in the decompressive surgery group had an mRS score of ≤ 3 (compared with 21% who received medical management), and the mortality rate was 22% (compared with 71%). 30 The ages of patients who underwent DH ranged from 22 to 82 in the present study.…”

Early decompressive craniectomy for malignant cerebral infarction

“…We could have expanded the number of eligible patients by including DC trials that enrolled patients past 48 hours; however, there is sufficient evidence to suggest that patients treated later experience a different clinical course. 5,26 We prespecified exclusion of patients undergoing late DC in order to maintain a pure sample population, which is reflected in the consistency of treatment effect across our studies as calculated by I 2 . For similar reasons, we excluded nonrandomized trials, whose results are potentially subject to substantial bias.…”

“…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). Baseline patient characteristics of the treatment groups were well-matched with exception of Jüttler et al 25 and Slezins et al, 23 which reported higher mean NIH Stroke Scale scores in the medically managed group.…”

Prospective studies on decompressive craniotomy for malignant MCA infarctions in Brazil: ready for prime time

“…However, a quick inquiry in the TABNET database system disclosed that, from January 2008 to December 2014, a total of 3,753 acute stroke patients were admitted at that institution 3 . If those numbers hold true, they suggest that Brazilian patients might be less than half as likely to receive DC than their counterparts in the HeADDFIRST trial, a significant difference (eligibility rate 0.53% vs 1.35%; OR 0.39, 95%CI 0.23-0.64; p = 0.0002) 4 . Key to understanding this conundrum -and definitely more important than statistics -is why patients are being declined surgery.…”