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Outcomes of Anesthesia Selection in Endovascular Treatment of Acute Ischemic Stroke

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Background: The association between anesthesia type and outcomes in patients with acute ischemic stroke undergoing endovascular treatment (EVT) remains a subject of ongoing debate. Methods: This prospective nonrandomized controlled trial included 149 consecutive patients with acute anterior circulation stroke who underwent EVT. The primary outcome was functional independence assessed by the modified Rankin Scale (mRS) after 3 months. Results: A total of 105 (70.5%) and 44 (29.5%) patients undergoing EVT who received conscious sedation (CS) and general anesthesia (GA), respectively. The patients who received GA had similar demographics and basic National Institute of Health Stroke Scale scores (17 vs. 16, P>0.05) as the patients who received CS. The recanalization time (304 vs. 311 min, P=0.940) and the recanalization rate (86.4% vs. 84.1%, P=0.170) did not differ between the patients receiving the different types of anesthesia. The National Institute of Health Stroke Scale at 24 hours was lower in the patients who received CS than in those who received GA (β=-2.26, 95% confidence interval, -5.30 to 0.79). The independence (modified Rankin Scale score 0 to 2) at 3 months was equal between patients who received GA and those who received CS (odds ratio=0.73, 95% confidence interval, 0.32-1.68). The mortality and the morbidity rates did not differ. Conclusions: The data indicated that the selection of GA or CS during EVT had no impact on the independent outcomes of patients with anterior circulation occlusion.
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Outcomes of Anesthesia Selection in Endovascular
Treatment of Acute Ischemic Stroke
Yuming Peng, MD, PhD,* Youxuan Wu, MD,* Xiaochuan Huo, MD, PhD,Peng Wu, PhD,
Yang Zhou, MD,* Jiaxin Li, MD,* Fa Liang, MD,* Xiaoyuan Liu, MD, PhD,*
Yuesong Pan, PhD,Zhongrong Miao, MD, PhD,Ruquan Han, MD, PhD,*
and on behalf of Endovascular Therapy for Acute Ischemic Stroke Trial (EAST) group
Background: The association between anesthesia type and out-
comes in patients with acute ischemic stroke undergoing endo-
vascular treatment (EVT) remains a subject of ongoing debate.
Methods: This prospective nonrandomized controlled trial included
149 consecutive patients with acute anterior circulation stroke who
underwent EVT. The primary outcome was functional independence
assessed by the modied Rankin Scale (mRS) after 3 months.
Results: A total of 105 (70.5%) and 44 (29.5%) patients undergoing
EVT who received conscious sedation (CS) and general anesthesia
(GA), respectively. The patients who received GA had similar dem-
ographics and basic National Institute of Health Stroke Scale scores
(17 vs. 16, P>0.05) as the patients who received CS. The recanali-
zation time (304 vs. 311 min, P=0.940) and the recanalization rate
(86.4% vs. 84.1%, P=0.170) did not differ between the patients
receiving the different types of anesthesia. The National Institute of
Health Stroke Scale at 24 hours was lower in the patients who received
CS than in those who received GA (β=2.26, 95% condence
interval, 5.30 to 0.79). The independence (modied Rankin Scale
score 0 to 2) at 3 months was equal between patients who received GA
and those who received CS (odds ratio =0.73, 95% condence interval,
0.32-1.68). The mortality and the morbidity rates did not differ.
Conclusions: The data indicated that the selection of GA or CS
during EVT had no impact on the independent outcomes of
patients with anterior circulation occlusion.
Key Words: acute ischemic stroke, anesthesia, large artery
occlusion, outcome
(J Neurosurg Anesthesiol 2018;00:000000)
Acute stroke is one of the leading causes of death and
long-term disability,1particularly in China. Timely
reperfusion of the occluded large vessel through endo-
vascular treatment (EVT) is effective for decreasing neu-
ronal damage and improve outcomes.2,3 However, there is
no denite evidence on the selection of anesthesia for acute
ischemic stroke (AIS) patients undergoing EVT.
General anesthesia (GA) and local anesthesia, with or
without conscious sedation (CS), are commonly used dur-
ing EVT.4,5 However, the association between anesthesia
selection and independent outcomes is controversial. Ob-
servational studies have indicated that acute stroke patients
receiving GA for EVT had worse outcomes than those who
underwent local anesthesia, with or without CS,612 and
this nding was confounded by several factors.13 The con-
clusion has been debated in completed randomized con-
trolled trials (RCTs) in which anesthesia choice was
randomized.1416 In addition, there is still no evidence from
China on the association between anesthesia selection and
clinical outcomes, in which large artery atherosclerosis was
the primary etiological diagnosis.
The aim of the study was to prospectively investigate
the anesthesia strategy and the associated independent
outcomes, which were derived from the intervention arm
of the Endovascular Therapy for Acute Ischemic Stroke
Trial (EAST). The specic hypothesis was that local an-
esthesia, with or without CS, improved 90-day in-
dependence in AIS patients compared with GA.
METHODS
Design
The EAST trial was a multicentre, prospective, non-
randomized controlled study conducted in 17 stroke centers
across China, and consecutive patients with AIS were recruited
Received for publication November 28, 2017; accepted March 12, 2018.
From the Departments of *Anesthesiology; Interventional Neurology;
and Neurology, Tiantan Clinical Trial and Research Center for
Stroke, Beijing Tiantan Hospital, Capital Medical University, Beijing,
PR China.
Z.M. and R.H. contributed equally.
Y.P., Z.M., and R.H.: helped with the study design and manuscript
preparation. Y.W., J.L., and F.L.: helped with the data collection and
manuscript preparation. X.H. helped with the patient recruitment.
X.L. and Y.Z.: helped with the data collection. P.W. and Y.P.: helped
with the data analyses.
Clinical Trial Registration: www.clinicaltrials.gov (NCT02350283).
The trial was funded by the Youth Program(QML20150508) and
Hospitals Clinical Medicine Development of Special Funding Sup-
port (ZYLX201708) from the Beijing Municipal Administration of
Hospitals and programs from National Science and Technology
Major Project of China (2011BAI08B02, 2015BAI12B04, and
2015BAI12B02).
The authors have no conicts of interest to disclose.
Address correspondence to: Ruquan Han, MD, PhD, Department of
Anesthesiology, Beijing Tiantan Hospital, Capital Medical University,
No. 6, Tiantan Xili, Dongcheng District, Beijing 100050, PR China
(e-mail: ruquan.han@gmail.com).
Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.
DOI: 10.1097/ANA.0000000000000500
CLINICAL INVESTIGATION
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from January 2015 to August 2015. A central medical ethics
committee (Medical Ethics Committee, Beijing Tiantan
Hospital, Capital Medical University) approved the study
protocol. The EAST trial was registered on Clinicaltrials.gov
(number: NCT02350283). All written informed consent before
study enrolment was provided by legal representatives. The
protocol of the EAST trial has been previously published.17
Patients in the intervention group were treated with mech-
anical recanalization using Solitaire plus standard medical
therapy. Patients in the control group received standard
medical therapy alone.
Patients
Eligible patients were diagnosed with AIS due to large
vessel occlusion indicated for EVT within 12 hours after
symptom onset and met the inclusion criteria: (1) age 18 years
and older; (2) a clinical diagnosis of ischemic stroke, with
symptoms present for at least 30 minutes and without
signicant improvement before treatment; (3) a prestroke
modied Rankin Scale (mRS) score 1; (4) National In-
stitute of Health Stroke Scale (NIHSS) score 8and<30; (5)
occlusion at 1 of the following sites (as determined through
single-phase, multiphase or dynamic computed tomography
(CT) angiography or digital subtraction angiography):
carotid T/L, M1-middle cerebral artery (MCA), or M2-MCA
equivalent affecting at least 50% of the MCA territory;
and (6) provided written informed consent. Patients with an
Alberta Stroke Program Early CT Score (ASPECTS) from 0
to 6 in the area of symptomatic intracranial occlusion or a
DWI lesion volume >50 mL were excluded from the study.
Patients in the control arm receiving standard medical ther-
apy alone were excluded from the study.
Exposure
All patients in the intervention arm underwent com-
plete 4-vessel cerebral angiography performed by fully trained
interventional neuroradiologists. When the diagnostic an-
giography revealed arterial occlusion, thrombectomy with a
Solitaire stent was performed as the primary treatment. At
the end of treatment, recanalization was classied according
to the modied thrombolysis in cerebral infarction (mTICI)
perfusion grade.18
GA was dened as induction and maintenance with
sedation drugs, analgesic agents and muscle relaxants,
with controlled ventilation under tracheal intubation or
laryngeal mask, from the time of groin puncture to the end
of the procedure. If a patient underwent tracheal in-
tubation before entering the procedural room, the patient
was excluded from the analysis. CS was dened as local
anesthesia and spontaneous breathing, with or without
administration of sedatives throughout the procedure.
Conversion from CS to GA during the procedure was
another exclusion criterion. The selection of anesthesia
was not predened in the protocol.
Outcomes
The primary outcome was functional independence
as dened by a mRS of 0 to 2 and assessed by a neurol-
ogist who was blinded to the treatment details at 90 days
after the EVT during an outpatient visit. If a patient was
unable to come to the clinic, the mRS score was assessed
through a telephone interview. The mRS was a 7-point
scale ranging from 0 (no symptoms) to 6 (deceased).
The secondary outcomes were arterial reperfusion of the
occluded target vessel measured by mTICI (2b-3) at the end of
treatment by 2 experienced neurointerventionalists who were
blinded to the clinical data and outcomes. The periprocedural
hemodynamic parameters were recorded including systolic
blood pressure (SBP), diastolic blood pressure, and mean ar-
terial pressure (MAP). The neurological assessment was
measured by using the NIHSS score (range from 0 to 42, with
higher scores indicating more severe neurological decits) at
2 hours, 24 hours, and 7 days after the procedure. Quality of
life was evaluated by the European life quality (EQ-5D) score
and the Barthel Index (BI) score at 90 days. The rates of
device-related and procedure-related complications were
evaluated and recorded at discharge. Death due to any cause
at 90 days was measured. Symptomatic intracerebral
hemorrhage was detected by CT or magnetic resonance
imaging at 24 ± 3 hours postprocedure. An economic (cost-
effectiveness) analysis, including the total length of intensive
care unit and hospital stays and the inpatient cost in US
dollars, was performed at discharge.
Statistical Analysis
The EAST trial was an exploratory study that aimed
to observe the safety and the efcacy of Solitaire throm-
bectomy in patients with AIS. The sample size of the AIS
patients undergoing EVT was prospectively calculated as
150. Descriptive statistics were reported as the means with
SDs for normally distributed data, medians with inter-
quartile ranges for skewed continuous data, and counts
(percentages) for categorical data. Categorical variables
were analyzed with the χ
2
test, and continuous variables
were analyzed using the Student ttest or Wilcoxon test
between patients who received GA and CS.
Binary and continual outcomes were analyzed
through logistic and linear regression, and the results were
reported as adjusted and unadjusted odds ratios (ORs)
and βcoefcients, with 95% condence intervals (CIs),
respectively. The primary outcome was adjusted for po-
tential imbalances in known prognostic variables, as re-
ported by previous literature and our differential
comparison results, including age, sex, body mass index,
smoke history, NIHSS on admission, treatment with
r-tPA, onset-to-recanalization time and mTICI (2b-3).
Statistical signicance was declared with a type I error of
0.05. SPSS 17.0 (SPSS Inc., Chicago, IL) was used for the
statistical analyses.
RESULTS
Patient Characteristics
Among the 149 patients enrolled in the trial, 44 (29.5%)
underwent GA, and 105 (70.5%) received CS (Fig. 1).
The demographics, past medical history, baseline
NIHSS, results of laboratory studies, and occlusion site
did not differ between the patients receiving different types
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of anesthesia (P>0.05, see Table 1) with the exception of
sex and puncture-to-recanalization time. The male sex
proportion (54.3% vs. 79.6%, P=0.004), and puncture-to-
recanalization time (50, 35 to 85 vs. 73, 46 to 109;
P=0.028) differed, but the onset-to-recanalization time
and recanalization rate, evaluated as mTICI 2b-3, did not
differ between the patients who received CS and those who
received GA.
No patients were lost to follow-up. The primary
outcome, independence (mRS score 0 to 2) at 3 months,
did not differ between the patients who received CS and
those who received GA either before (OR, 0.72; 95% CI,
0.35-1.48) or after the adjustments (OR, 0.73; 95% CI,
0.32-1.68, Table 2). Moreover, we did not observe a shift
in the distribution of the mRS score in favor of the CS
group compared with the GA group (Fig. 2).
After EVT, the NIHSS at 24 hours for patients re-
ceiving CS was signicantly lower than that for the patients
who received GA (8.3-15 vs. 11.9-15.5, P=0.038); however,
the NIHSS at 2 hours and 7 days did not differ (Table 2). The
other outcomes, such as the BI score (75 to 100), EQ-5D, and
mortality and morbidity rates (symptomatic intracerebral
hemorrhage and complications with instruments and
operations), did not differ between the patients undergoing
CS and GA. The length of intensive care unit and hospital
stay, and the total inpatient cost in US dollars were similar
between the patients receiving GA and CS.
Among the patients who received local anesthesia at 14
centers, 7 (6.7%) patients did not receive any sedative, and 98
(93.3%) patients received sedatives. In contrast, only 23 pa-
tients who received CS at 2 centers were administered sedatives
by the anesthesiologists, and the other 75 were administered by
the interventionists. Dexmedetomidine was the most frequently
used sedative (48, 45.7%). Among the patients who received
GA at 12 centers, all were administered anesthesia by anes-
thesiologists. Sufentanil (37, 84.1%), with etomidate (22, 50%)
or propofol (19, 43.2%), was often used to induce GA, and
propofol, with (15, 34.1%) or without (28, 63.6%) volatile
agents, was used for maintenance (Table 3).
SBP and MAP were found to be signicantly lower
in patients who received GA 30 minutes after induction
compared with patients who received CS at the respective
time points (Fig. 3). However, the number of patients who
received vasoactive drugs was not signicantly different
between the 2 anesthesia types (Table 4). The uid input
for patients receiving GA included crystalloid (618 ± 248
mL) and colloid solution (685 ± 300 mL), whereas only
crystalloid (650 ± 124 mL) was administered to patients
who received CS, and the difference in the input amount
was signicant (P<0.05).
FIGURE 1. Flow diagram of the patients included in the study.
TABLE 1. Basic Characteristics and Interventional Parameters
Conscious
Sedation
(N =105)
General
Anesthesia
(N =44) P
Age (median [IQR]) (y) 65.0 (56-73) 61.5 (52-69) 0.131
Sex, male (n [%]) 57 (54.3) 35 (79.6) 0.004*
Body mass index
(median [IQR])
23.6 (22.0-25.5) 24.0 (22.5-26.0) 0.188
mRS 0-2 (n [%]) 99 (94.29) 42 (95.45) 1.000
TOAST type (n [%]) 0.239
Large artery
atherosclerosis
43 (41.0) 26 (59.1)
Cardioembolism 50 (47.6) 15 (34.1)
Stroke of other
determined etiology
3 (2.8) 1 (2.3)
Stroke of
undetermined
etiology
9 (8.6) 2 (4.5)
Atrial brillation (n [%]) 45 (42.9) 15 (34.1) 0.320
Hypertension (n [%]) 62 (59.1) 22 (50.0) 0.310
Diabetes mellitus (n [%]) 8 (7.6) 6 (13.6) 0.251
Hypercholesterolemia
(n [%])
4 (3.8) 3 (6.8) 0.422
Ischemic heart disease
(n [%])
2 (1.9) 3 (6.8) 0.153
History of ischemic
stroke (n [%])
12 (11.4) 4 (9.1) 0.896
Smoking history (n [%]) 27 (25.7) 16 (36.4) 0.191
NIHSS on admission
(median [IQR])
16 (12-19) 17 (12-21.5) 0.585
Site of occlusion (n [%]) 0.630
Internal carotid artery 27 (25.7) 13 (29.6)
Middle cerebral artery 78 (74.3) 31 (70.4)
Laboratory test (mean [SD]) (mmol/L)
Blood glucose 7.4 (2.8) 6.8 (1.8) 0.216
Blood creatinine 75.1 (29.5) 74.3 (21.3) 0.567
Blood urea nitrogen 6.1 (2.1) 6.9 (6.3) 0.626
ASPECTS on CT
(median [IQR])
9 (8-10) 9 (8-10) 0.238
Treatment with r-tPA
(n [%])
21 (20.0) 4 (9.1) 0.104
Workow time in minutes (median [IQR])
Door-to-puncture 115 (60-165) 104 (71-147) 0.896
Puncture-to-
recanalization
50 (35-85) 73 (46-109) 0.028*
Onset-to-
recanalization
304 (243-440) 311 (240-470) 0.940
mTICI score 0.170
2b-3 (n [%]) 89 (86.4) 37 (84.1)
Missing data (n) 2 0
ASPECT indicates Alberta Stroke Program Early CT Score; CT, computed
tomography; DBP, diastolic blood pressure; IQR, interquartile range; mRs,
modied Rankin Scale; mTICI, modied thrombolysis in cerebral infarction;
NIHSS, National Institute of Health Stroke Scale; r-tPA, recombinant tissue-type
plasminogen activator; SBP, systolic blood pressure; TOAST, Trial of Org 10172 in
Acute Stroke Treatment.
*Indicates signicance at a P-value of <0.05.
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DISCUSSION
This anesthesia-related analysis of a multicentre,
prospective study assessed the association between anes-
thesia selection and outcomes from the EVT for AIS. The
primary outcome of independence (mRS 0-2) at 3 months,
as well as the mortality and morbidity rates, did not differ
between the patients who received GA and those who
received CS; however, the hemodynamic parameters and
the uid input were signicantly different between the
patients receiving the 2 types of anesthesia.
Previous observational studies have found better
90-day independent outcomes in patients who received CS6;
however, the imbalance in age,19 ischemic severity,7,8,10,11,20
and ischemic site21 led to concern with regard to the
TABLE 2. Primary and Secondary Outcomes
Conscious
Sedation
(N =105)
General
Anesthesia
(N =44) P
Effect
Parameter
Unadjusted Effect of
Conscious Sedation vs. GA
(95% CI)
Adjusted Effect of Conscious
Sedation vs. GA (95% CI)
mRS 0-2 (n [%])
At 7 d or discharge 42 (40.4) 16 (36.4) 0.647 OR 1.19 (0.57-2.46) 1.33 (0.58-3.04)
At 90 d 56 (53.3) 27 (61.4) 0.368 OR 0.72 (0.35-1.48) 0.73 (0.32-1.68)
NIHSS (median [IQR])
At 2 h 11 (7-16) 13.5 (10-19) 0.067 β2.19 (4.68 to 0.31) 1.95 (4.18 to 0.28)
At 24 h 8 (3-15) 11 (9-15.5) 0.038* β2.07 (5.10 to 0.95) 2.26 (5.30 to 0.79)
At 7 d 6 (2-13) 8 (2-11) 0.407 β0.62 (3.51 to 2.27) 1.24 (4.03 to 1.55)
BI score of 75-100 (n [%])
At 7 d or discharge 46 (46.0) 18 (41.7) 0.648 OR 1.18 (0.58-2.44) 1.47 (0.65-3.30)
At 90 d 63 (60.0) 29 (65.9) 0.498 OR 0.78 (0.37-1.62) 0.88 (0.38-2.04)
EQ-5D at 90 d (median
[IQR])
6 (5-10) 7 (5-9) 0.802 β0.13 (0.99 to 1.27) 0.26 (1.40 to 0.88)
Symptomatic ICH at
24 h (n [%])
5 (4.76) 1 (2.27) 0.671 OR 2.15 (0.24-18.95) 2.25 (0.23-22.06)
Complication with
instrument (n [%])
10 (9.52) 5 (11.36) 0.769 OR 0.82 (0.26-2.56) 0.57 (0.16-2.10)
Complication with
operation (n [%])
11 (10.48) 6 (13.64) 0.580 OR 0.74 (0.26-2.15) 0.71 (0.23-2.24)
Mortality at 90 d
(n [%])
13 (12.4) 5 (11.4) 0.862 OR 1.10 (0.37-3.30) 1.12 (0.33-3.87)
ICU stay (median
[IQR]) (d)
4 (1-7) 5 (2-8) 0.582 β0.19 (2.71-2.32) 0.19 (2.90-2.51)
Total hospital stay
(median [IQR]) (d)
14 (8-22) 14 (9-22) 0.781 β1.54 (5.15-8.23) 0.43 (7.08-6.23)
Total cost in
thousands of
dollars (mean [SD])
12.7 (7.8) 14.6 (5.3) 0.122 β12.52 (30.36-5.32) 12.45 (30.77-5.86)
Adjusted by age, sex, body mass index, smoke history, NIHSS on admission, treatment with r-tPA, onset-to-recanalization time and mTICI (2b-3). OR calculated as the
odds in the conscious sedation group versus that in the general anesthesia group.
*Indicates signicance at a P-value of <0.05.
The number of missing values was 24.
The number of missing values was 13.
BI indicates Barthel Index; EQ-5D, 5-dimension European quality of life; ICU, intensive care unit; IQR, interquartile range; mRs, modied Rankin Scale; NIHSS1,
National Institute of Health Stroke Scale; OR, odds ratio.
FIGURE 2. mRS at 90 days divided by general anesthesia and conscious sedation. The numbers and percentages of patients are
shown in each cell according to the distribution of mRS scores (range 0 to 6, with 0 to 2 indicating no symptoms to slight disability
and 3 to 6 indicating moderate disability to death). The shift in the distribution on the mRS between groups is shown (P=0.5523).
mRS indicates modified Rankin Scale.
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selection bias and a cautious interpretation of the con-
clusion. Moreover, the association was also confounded by
the intraprocedural parameters, such as the decrease in
MAP >40%,22 the minimal diastolic blood pressure and
the maximal SBP variability.21 Therefore, the preprocedure
ischemia (site and severity) and the intraprocedure hemo-
dynamic uctuation were often regarded as confounding
factors between anesthesia selection and independence
after EVT. The sensitivity analysis from the recent
metaanalysis23 indicated that the pooled incidence of
independence (mRS score 0 to 2) from the RCTs favored
GA; however, patients receiving GA had signicantly
higher morbidity and mortality rates compared with patients
who received CS. Therefore, the evidence for selection of
anesthesia for AIS patients undergoing EVT still requires
results from a diverse population. Our results were from a
nonrandomized study. However, the baseline NIHSS, the
ischemic site, and the other preprocedure parameters were
all comparable between the patients receiving the 2 types of
anesthesia, and the primary outcome was also in accordance
with the AnStroke trial,15 which studied the same subjects
with anterior circulation ischemia. However, the other 2
recently completed trials, both SIESTA14 and GOLIATH,16
favored GA from the point of better 90-day independent
outcome (mRS score 0 to 2).
The time from onset-to-recanalization is critical for
the independent outcome in AIS patients after EVT,
which may be affected by the etiological cause of ischemia.
Good clinical outcomes at 90 days (mRS 0-2) was greatest
TABLE 3. Anesthetic Drugs Administered
N (%)
Conscious sedative
Diazepam 7 (6.7)
Midazolam 18 (17.1)
Propofol 22 (20.9)
Dexmedetomidine 48 (45.7)
Phenobarbital 3 (2.8)
General anesthesia induction
Fentanyl 6 (13.6)
Sufentanil 37 (84.1)
Remifentanil 1 (2.3)
Propofol 19 (43.2)
Dexmedetomidine 2 (4.5)
Etomidate 22 (50)
Midazolam 1 (2.3)
General anesthesia maintenance
Continual infusion of propofol 28 (63.6)
Inhalation 1 (2.3)
Combined infusion of propofol with inhalation 15 (34.1)
FIGURE 3. Hemodynamic changes during endovascular treatment. Preprocedural blood pressure was defined as the pressure
obtained immediately on arrival in the angiography suite. & represents anesthesia induction in patients receiving GA, while &
represents arterial puncture in patients receiving local anesthesia, with or without CS. *Compared with patients who received CS,
P<0.05. CS indicates conscious sedation; DBP, diastolic blood pressure; GA, general anesthesia; MAP, mean arterial pressure;
SBP, systolic blood pressure.
TABLE 4. Fluid Input and Vasoactive Drug Used
Conscious
Sedation
(N =105)
General
Anesthesia
(N =44) P
Centers 17 12 NA
Fluid input (mean [SD])
(mL)
650 (124) 968 (414) 0.034
Crystalloid 650 (124) 618 (248) 0.058
Colloid NA 685 (300) NA
Vasodilator (n [%]) 30 (28.6) 11 (25.0) 0.656
Urapidil 18 (17.1) 9 (20.5) 0.632
Nicardipine 12 (11.4) 2 (4.5) 0.315
Vasoconstrictor (n [%]) NA 3 (6.8) NA
Ephedrine NA 1 (2.3) NA
Dopamine NA 1 (2.3) NA
Phenylephrine NA 1 (2.3) NA
NA indicates not applicable.
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with time from symptom onset to arterial puncture of
under 2 hours and became nonsignicant after 7.3 hours,24
and was also closely related with the time to reperfusion.25
The TOAST classication of large artery atherosclerosis
was found in 69 patients (46.3%) in our trial, and the
onset-to-puncture time in our study was ~238 and
254 minutes in patients who received GA and CS, re-
spectively, both of which were in the suggested effective
time window. In addition, the onset-to-recanalization time
in our trial (304 min in CS vs. 311 min in GA) was slightly
longer than that in the AnStroke trial (250 min in CS vs.
254 min in GA),15 comparable with that reported in the
MR CLEAN trial (349 min in CS vs. 334 min in GA)12
and shorter than those in some previous observational
studies.9,26 In the current trial, the recanalization time
would not inuence the association between anesthesia
selection and outcomes in AIS patients undergoing EVT.
The proportion of GA administered to patients un-
dergoing EVT was higher in some observational studies10,20
than that in our study; however, in some recent trials,12,19,27
this proportion was lower than those found in the above-
mentioned observational studies. It often takes more time to
prepare GA induction and tracheal intubation than to pre-
pare CS for patients, and needs more cooperation from
anesthesiologists. Therefore, CS was the rst choice of the
interventional neurologists for EVT. In the EAST trial,
the mean difference between GA and CS in door-to-puncture
time (11 min) and onset-to-recanalization time (7 min) were
acceptable. This small time difference might be explained by
the fact that a special team of anesthesiologists was on duty at
the intervention-treatment room to conduct all GA, but the
agents for CS were administered by the anesthesiologists in
only 23 cases (23.5%) in 2 centers (13.3%) and by the inter-
ventionists for the other cases. This time difference was not the
confounding factor between anesthesia selection and in-
dependence for the patients who received EVT.
In the EAST trial, dexmedetomidine was the most
frequently used agent (45.7%) during sedation; however,
all administrations were performed by interventionists. In
addition, no patients received analgesic or colloid during
CS. Hence, a series of problems for AIS patients under
sedation could occur, including substantial movement,
respiratory depression and high conversion rate from se-
dation to GA. Even in the SIESTA14 trial, in which the
anesthesia selection was randomized, a high rate of sub-
stantial movement, diverse drug choices and a high rate of
conversion from CS to GA were detected. However, the
number of movement and respiratory parameters were not
recorded in the EAST trial. In addition, the proportions of
induction with sufentanil and etomidate and maintenance
with total intravenous anesthesia increased in this study
compared with the study conducted by Jagani et al,21 in
which fentanyl and propofol were primarily used. SBP and
MAP were signicantly decreased within 30 minutes after
induction; however, the number of patients who received
vasoactive drugs, particularly a vasoconstrictor, did not
differ between the patients under the 2 anesthesia types,
and a >40% decrease in MAP from the preprocedure
value was not found in patients receiving GA.
This study has several limitations. First, the data
were from a nonrandomized trial, and the anesthesia
choice was decided by the interventional neurologists.
However, the baseline characteristics of ischemia and
demographics were well balanced. Second, the sample size
was not calculated but predened in the EAST trial and
might be not sufcient to test the difference in 90-day mRS
between the different anesthesia types. However, we cal-
culated the power for testing the primary outcome divided
by the anesthesia type as >85%. Third, some anesthesia-
specic information was not collected in detail, including
the ventilator parameters, end-expiratory carbon dioxide
and real-time hemodynamic parameters, which might be
potential risk factors for the independent outcome. How-
ever, the EAST study was an exploratory trial and had
provided a foundation for further research in such pop-
ulations, such as the ongoing CANVAS trial,5a multi-
centre, parallel-group RCT observing the effect of
anesthesia selection on independent outcome in patients
with acute anterior circulation stroke undergoing EVT.
CONCLUSIONS
Among patients with AIS in the anterior circulation
undergoing EVT, CS compared with GA did not result in
more improvements in the independent status at 3 months
after the procedure. RCTs are still needed to provide more
perioperative evidence of the hemodynamics and respira-
tion effects of anesthesia choice on outcomes of patients
with AIS during EVT.
ACKNOWLEDGMENTS
We gratefully acknowledge the enrolled centers and
investigators for their outstanding work. The following
centers and investigators were involved: Ya Peng, MD,
Department of Neurosurgery, Changzhou No. 1 Peoples
Hospital, Changzhou, China; Yibin Cao, MD, Department
of Neurology, Tangshan Gongren Hospital, Tangshan,
China; Shengli Chen, MD, Department of Neurology,
Chongqing Sanxia Central Hospital, Chongqing, China;
Meng Zhang, MD, Department of Neurology, Daping
Hospital, Chongqing, China; Changchun Jiang, MD, De-
partment of Neurology, Baotou Central Hospital, Baotou,
China; Xiaoxiang Peng, MD, Department of Neurology,
Hubei Zhongshan Hospital, Wuhan, China; Cunfeng Song,
MD, Department of Neurology, Liaocheng 3rd Peoples
Hospital, Liaocheng, China; Liping Wei, MD, Department
of Neurology, Luoyang Central Hospital Afliated to
Zhengzhou University, Luoyang, China; Qiyi Zhu, MD,
Department of Neurology, Peoples Hospital of Linyi City,
China; Zaiyu Guo, MD, Department of Neurology, Tianjin
Teda Hospital, Tianjin, China; Li Liu, MD, Department of
Neurology, Chifeng Municipal Hospital, Chifeng, China;
Hang Lin, MD, Department of Neurology, Fuzhou PLA
General Hospital, Fuzhou, China; Hua Yang, MD, De-
partment of Neurology, Afliated Hospital of Guiyang
Medical College, Guiyang, China; Wei Wu, MD, Department
of Neurology, QiLu Hospital of ShanDong University, Jinan,
China; Hui Liang, MD, Department of Neurology, Yantai
Peng et al J Neurosurg Anesthesiol Volume 00, Number 00, ’’ 2018
6
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www.jnsa.com Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.
Copyright r2018 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
This paper can be cited using the date of access and the unique DOI number which can be found in the footnotes.
Hill Hospital, Yantai, China; Anding Xu, MD, Department of
Neurology, The First Afliated Hospital of Jinan University,
China; and Kangning Chen, MD, Department of Neurology,
Xinan Hospital, China.
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J Neurosurg Anesthesiol Volume 00, Number 00, ’’ 2018 Outcomes After Acute Ischemic Stroke With Anesthesia
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This paper can be cited using the date of access and the unique DOI number which can be found in the footnotes.
... [6][7][8][9][10] Recent RCTs comparing GA and non-GA techniques (monitored anesthesia care [MAC]) and pooled analysis of these RCTs have reported variable outcomes when GA is compared with MAC. [10][11][12][13][14][15][16][17] However, local patient populations may differ significantly from those enrolled into RCTs, 18,19 and those differences may have considerable impact on outcomes. For example, racial disparities are significant; African Americans experience a higher prevalence and age adjusted death rate for stroke compared with non-Hispanic whites. ...
... Like recent trials, the NIHSS score in the GA and MAC groups was similar in our study. 12,[14][15][16][17]28 However, our 90-day outcomes are different to those in the SIESTA 15 and GOLIATH 16 trials and to the aggregated data from the SIESTA, 15 GOLIATH, 16 AnStroke, 14 and CANVAS pilot trials which indicated that GA is superior to MAC for improved 90-day outcomes (mRS 0 to 2). 11,[14][15][16]28 Consistent with previous studies, the multivariate analysis of our patient cohort identified age, baseline NIHSS, ASPECTS, and recanalization as predictive of functional outcomes after AIS. ...
... The BP target during MT at our institution is SBP 140 to 180 mm Hg, and we also observed greater hemodynamic instability with GA as previously reported. 12,14,17,28,33,35 Based on recent studies implicating low BP (MAP <60 and <70 mm Hg) with worse 90-day outcomes, we also evaluated our cohort with regard to those low MAP thresholds in addition to SBP. 30,33 We observed a 15.2% incidence (GA, n = 12; MAC, n = 7) of MAP <60 mm Hg compared with the 56% incidence reported by Fandler-Höfler et al. 30 We also observed a 29.6% incidence of any MAP <70 mm Hg which is lower than that reported in previous retrospective studies but similar to GOLIATH (25.7%) 35 and AnStroke (26.7%). 14 While we found differences in low MAP between GA and MAC groups, the MAP perturbations were not associated with worse 90-day outcomes (mRS 3 to 6) in the binary multivariate analysis. ...
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... 27 Pada tindakan trombektomi mekanik, pilihan pembiusan adalah teknik sedasi ringan (conscious sedation) atau pada kondisi tertentu dengan anestesi umum. [28][29][30][31] Disposition Setelah pasien mendapat terapi yang sesuai, pasien dapat dipindahkan ke ruang perawatan biasa atau unit stroke. Unit stroke adalah ruang rawat terintegrasi yang dikelola secara multidisiplin dari berbagai tenaga kesehatan guna memberikan pelayanan terbaik bagi pasien stroke. ...
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... proposed to streamline EVT procedures, with Jadhav et al 16 73 Simonsen et al, 74 and Henden et al 75 , which conclude a statistically insignificant effect of conscious sedation on clinical outcomes in comparison to GA. The single-centre nature of these trials limits generalizability of results, and treatment impacts may be overlooked due to small sample space and poor statistical power. ...
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Background: The use of mechanical thrombectomy to restore intracranial blood flow after proximal large artery occlusion by a thrombus has increased over time and led to better outcomes than intravenous thrombolytic therapy alone. Currently, the type of anaesthetic technique during mechanical thrombectomy is under debate as having a relevant impact on neurological outcomes. Objectives: To assess the effects of different types of anaesthesia for endovascular interventions in people with acute ischaemic stroke. Search methods: We searched the Cochrane Stroke Group Specialised Register of Trials on 5 July 2022, and CENTRAL, MEDLINE, and seven other databases on 21 March 2022. We performed searches of reference lists of included trials, grey literature sources, and other systematic reviews. SELECTION CRITERIA: We included all randomised controlled trials with a parallel design that compared general anaesthesia versus local anaesthesia, conscious sedation anaesthesia, or monitored care anaesthesia for mechanical thrombectomy in acute ischaemic stroke. We also included studies reported as full-text, those published as abstract only, and unpublished data. We excluded quasi-randomised trials, studies without a comparator group, and studies with a retrospective design. Data collection and analysis: Two review authors independently applied the inclusion criteria, extracted data, and assessed the risk of bias and the certainty of the evidence using the GRADE approach. The outcomes were assessed at different time periods, ranging from the onset of the stroke symptoms to 90 days after the start of the intervention. The main outcomes were functional outcome, neurological impairment, stroke-related mortality, all intracranial haemorrhage, target artery revascularisation status, time to revascularisation, adverse events, and quality of life. All included studies reported data for early (up to 30 days) and long-term (above 30 days) time points. Main results: We included seven trials with 982 participants, which investigated the type of anaesthesia for endovascular treatment in large vessel occlusion in the intracranial circulation. The outcomes were assessed at different time periods, ranging from the onset of stroke symptoms to 90 days after the procedure. Therefore, all included studies reported data for early (up to 30 days) and long-term (above 30 up to 90 days) time points. General anaesthesia versus non-general anaesthesia(early) We are uncertain about the effect of general anaesthesia on functional outcomes compared to non-general anaesthesia (mean difference (MD) 0, 95% confidence interval (CI) -0.31 to 0.31; P = 1.0; 1 study, 90 participants; very low-certainty evidence) and in time to revascularisation from groin puncture until the arterial reperfusion (MD 2.91 minutes, 95% CI -5.11 to 10.92; P = 0.48; I² = 48%; 5 studies, 498 participants; very low-certainty evidence). General anaesthesia may lead to no difference in neurological impairment up to 48 hours after the procedure (MD -0.29, 95% CI -1.18 to 0.59; P = 0.52; I² = 0%; 7 studies, 982 participants; low-certainty evidence), and in stroke-related mortality (risk ratio (RR) 0.98, 95% CI 0.52 to 1.84; P = 0.94; I² = 0%; 3 studies, 330 participants; low-certainty evidence), all intracranial haemorrhages (RR 0.92, 95% CI 0.65 to 1.29; P = 0.63; I² = 0%; 5 studies, 693 participants; low-certainty evidence) compared to non-general anaesthesia. General anaesthesia may improve adverse events (haemodynamic instability) compared to non-general anaesthesia (RR 0.21, 95% CI 0.05 to 0.79; P = 0.02; I² = 71%; 2 studies, 229 participants; low-certainty evidence). General anaesthesia improves target artery revascularisation compared to non-general anaesthesia (RR 1.10, 95% CI 1.02 to 1.18; P = 0.02; I² = 29%; 7 studies, 982 participants; moderate-certainty evidence). There were no available data for quality of life. General anaesthesia versus non-general anaesthesia (long-term) There is no difference in general anaesthesia compared to non-general anaesthesia for dichotomous and continuous functional outcomes (dichotomous: RR 1.21, 95% CI 0.93 to 1.58; P = 0.16; I² = 29%; 4 studies, 625 participants; low-certainty evidence; continuous: MD -0.14, 95% CI -0.34 to 0.06; P = 0.17; I² = 0%; 7 studies, 978 participants; low-certainty evidence). General anaesthesia showed no changes in stroke-related mortality compared to non-general anaesthesia (RR 0.88, 95% CI 0.64 to 1.22; P = 0.44; I² = 12%; 6 studies, 843 participants; low-certainty evidence). There were no available data for neurological impairment, all intracranial haemorrhages, target artery revascularisation status, time to revascularisation from groin puncture until the arterial reperfusion, adverse events (haemodynamic instability), or quality of life. Ongoing studies We identified eight ongoing studies. Five studies compared general anaesthesia versus conscious sedation anaesthesia, one study compared general anaesthesia versus conscious sedation anaesthesia plus local anaesthesia, and two studies compared general anaesthesia versus local anaesthesia. Of these studies, seven plan to report data on functional outcomes using the modified Rankin Scale, five studies on neurological impairment, six studies on stroke-related mortality, two studies on all intracranial haemorrhage, five studies on target artery revascularisation status, four studies on time to revascularisation, and four studies on adverse events. One ongoing study plans to report data on quality of life. One study did not plan to report any outcome of interest for this review. Authors' conclusions: In early outcomes, general anaesthesia improves target artery revascularisation compared to non-general anaesthesia with moderate-certainty evidence. General anaesthesia may improve adverse events (haemodynamic instability) compared to non-general anaesthesia with low-certainty evidence. We found no evidence of a difference in neurological impairment, stroke-related mortality, all intracranial haemorrhage and haemodynamic instability adverse events between groups with low-certainty evidence. We are uncertain whether general anaesthesia improves functional outcomes and time to revascularisation because the certainty of the evidence is very low. However, regarding long-term outcomes, general anaesthesia makes no difference to functional outcomes compared to non-general anaesthesia with low-certainty evidence. General anaesthesia did not change stroke-related mortality when compared to non-general anaesthesia with low-certainty evidence. There were no reported data for other outcomes. In view of the limited evidence of effect, more randomised controlled trials with a large number of participants and good protocol design with a low risk of bias should be performed to reduce our uncertainty and to aid decision-making in the choice of anaesthesia.
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Purpose of review: The introduction of clot removement by endovascular treatment (EVT) in 2015 has improved the clinical outcome of patients with acute ischemic stroke (AIS) due to a large vessel occlusion (LVO). Anesthetic strategies during EVT vary widely between hospitals, with some departments employing local anesthesia (LA), others performing conscious sedation (CS) or general anesthesia (GA). The optimal anesthetic strategy remains debated. This review will describe the effects of anesthetic strategy on clinical and radiological outcomes and hemodynamic parameters in patients with AIS undergoing EVT. Recent findings: Small single-center randomized controlled trails (RCTs) found either no difference or favored GA, while large observational cohort studies favored CS or LA. RCTs using LA as separate comparator arm are still lacking and a meta-analysis of observational studies failed to show differences in functional outcome between LA vs. other anesthetic strategies. Advantages of LA were shorter door-to-groin time in patients and less intraprocedural hypotension, which are both variables that are known to impact functional outcome. Summary: The optimal anesthetic approach in patients undergoing EVT for stroke therapy is still unclear, but based on logistics and peri-procedural hemodynamics, LA may be the optimal choice. Multicenter RCTs are warranted comparing LA, CS and GS with strict blood pressure targets and use of the same anesthetic agents to minimize confounding variables.
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Endovascular thrombectomy (EVT) has significantly improved outcomes for patients with acute ischemic stroke due to large vessel occlusion. However, despite advances, more than half of patients remain functionally dependent 3 months after their initial stroke. Anesthetic strategy may influence both the technical success of the procedure and overall outcomes. Conventionally, general anesthesia (GA) has been widely used for neuroendovascular procedures, particularly for the distal intracranial circulation, because the complete absence of movement has been considered imperative for procedural success and to minimize complications. In contrast, in patients with acute stroke undergoing EVT, the optimal anesthetic strategy is controversial. Nonrandomized studies suggest GA negatively affects outcomes while the more recent anesthesia-specific RCTs report improved or unchanged outcomes in patients managed with versus without GA, although these findings cannot be generalized to other EVT capable centers due to a number of limitations. Potential explanations for these contrasting results will be addressed in this review including the effect of different anesthetic strategies on cerebral and systemic hemodynamics, revascularization times, and periprocedural complications.
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Objectives: The value of in-hospital systems-based interventions in streamlining treatment delays associated with reperfusion therapy delivery in acute ischemic stroke (AIS), in the emergency department (ED), is poorly understood. This systematic review and meta-analysis aim to assess and quantify the value of in-hospital interventions in streamlining reperfusion therapy delivery following AIS. Material & Methods: Articles from the following databases were retrieved: Medline, Embase and Cochrane Central Register of Controlled Trials. The primary endpoint was in-hospital time metrics between the intervention and control group. The secondary endpoint included the rate of good functional outcome at 90-days. Results: 393 Systems intervention studies published after 2015 were screened, and 231 full articles were then read. In total, 35 studies with 35,815 patients were included in the final systematic review and 26 studies with 7,089 patients were used in the meta-analysis. The greatest time reductions from in-hospital system interventions were achieved in door to needle (DTN) time (SMD: -2.696, 95% CI: -2.976, -2.416, z = 3.03, p = 0.002). Systems interventions were also associated with a statistically significant improvement in mortality (RR: 0.25, 95% CI: 0.18, 0.38), rate of symptomatic intracerebral haemorrhage (RR: 0.07, 95% CI: 0.04, 0.1) and ≤60-minute reperfusion rates (RR: 0.63, 95% CI: 0.51, 0.79). Conclusions: The use of in-hospital workflow optimization is imperative to expedite reperfusion therapy delivery and improving patient outcomes. To reduce the morbidity and mortality of stroke globally, in-hospital workflow guidelines should be adhered to and incorporated including the optimal elements identified in this study.
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This review summarizes the literature published in 2020 that is relevant to the perioperative care of neurosurgical patients and patients with neurological diseases as well as critically ill patients with neurological diseases. Broad topics include general perioperative neuroscientific considerations, stroke, traumatic brain injury, monitoring, anesthetic neurotoxicity, and perioperative disorders of cognitive function.
Chapter
Stroke is a clinical diagnosis. Once recognized an emergent brain imaging usually a non-contrast CT is warranted without any delay to initiate time sensitive treatments. Revascularization therapies like intravenous thrombolysis (IVT) and endovascular treatment (EVT) have revolutionized the treatment of acute ischemic stroke. Even in centers where these treatment facilities are available most patients are referred late and thus they are ineligible for these time sensitive treatments or the outcomes are poor when there is delay in initiation of these treatments. “Time is Brain,” a protocol based approach to management of stroke once identified starting from prehospital care reduce the time delay in initiation of treatment. Creating hospital stroke team and CODE stroke will improve the outcome of the patients with acute ischemic stroke.
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Importance Endovascular therapy (EVT) is the standard of care for select patients who had a stroke caused by a large vessel occlusion in the anterior circulation, but there is uncertainty regarding the optimal anesthetic approach during EVT. Observational studies suggest that general anesthesia (GA) is associated with worse outcomes compared with conscious sedation (CS). Objective To examine the effect of type of anesthesia during EVT on infarct growth and clinical outcome. Design, Setting, and Participants The General or Local Anesthesia in Intra Arterial Therapy (GOLIATH) trial was a single-center prospective, randomized, open-label, blinded end-point evaluation that enrolled patients from March 12, 2015, to February 2, 2017. Although the trial screened 1501 patients, it included 128 consecutive patients with acute ischemic stroke caused by large vessel occlusions in the anterior circulation within 6 hours of onset; 1372 patients who did not fulfill inclusion criteria and 1 who did not provide consent were excluded. Primary analysis was unadjusted and according to the intention-to-treat principle. Interventions Patients were randomized to either the GA group or the CS group (1:1 allocation) before EVT. Main Outcomes and Measures The primary end point was infarct growth between magnetic resonance imaging scans performed before EVT and 48 to 72 hours after EVT. The hypothesis formulated before data collection was that patients who were under CS would have less infarct growth. Results Of 128 patients included in the trial, 65 were randomized to GA, and 63 were randomized to CS. For the entire cohort, the mean (SD) age was 71.4 (11.4) years, and 62 (48.4%) were women. Baseline demographic and clinical variables were balanced between the GA and CS treatment arms. The median National Institutes of Health Stroke Scale score was 18 (interquartile range [IQR], 14-21). Four patients (6.3%) in the CS group were converted to the GA group. Successful reperfusion was significantly higher in the GA arm than in the CS arm (76.9% vs 60.3%; P = .04). The difference in the volume of infarct growth among patients treated under GA or CS did not reach statistical significance (median [IQR] growth, 8.2 [2.2-38.6] mL vs 19.4 [2.4-79.0] mL; P = .10). There were better clinical outcomes in the GA group, with an odds ratio for a shift to a lower modified Rankin Scale score of 1.91 (95% CI, 1.03-3.56). Conclusions and Relevance For patients who underwent thrombectomy for acute ischemic stroke caused by large vessel occlusions in the anterior circulation, GA did not result in worse tissue or clinical outcomes compared with CS. Trial Registration clinicaltrials.gov Identifier: NCT02317237
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Background and purpose: Retrospective studies have found that patients receiving general anesthesia for endovascular treatment in acute ischemic stroke have worse neurological outcome compared with patients receiving conscious sedation. In this prospective randomized single-center study, we investigated the impact of anesthesia technique on neurological outcome in acute ischemic stroke patients. Methods: Ninety patients receiving endovascular treatment for acute ischemic stroke in 2013 to 2016 were included and randomized to general anesthesia or conscious sedation. Difference in neurological outcome at 3 months, measured as modified Rankin Scale score, was analyzed (primary outcome) and early neurological improvement of National Institutes of Health Stroke Scale and cerebral infarction volume. Age, sex, comorbidities, admission National Institutes of Health Stroke Scale score, intraprocedural blood pressure, blood glucose, Paco2 and Pco2 modified Thrombolysis in Cerebral Ischemia score, and relevant time intervals were recorded. Results: In the general anesthesia group 19 of 45 patients (42.2%) and in the conscious sedation group 18 of 45 patients (40.0%) achieved a modified Rankin Scale score ≤2 (P=1.00) at 3 months, with no differences in intraoperative blood pressure decline from baseline (P=0.57); blood glucose (P=0.94); PaCO2 (P=0.68); time intervals (P=0.78); degree of successful recanalization, 91.1% versus 88.9% (P=1.00); National Institutes of Health Stroke Scale score at 24 hours 8 (3-5) versus 9 (2-15; P=0.60); infarction volume, 20 (10-100) versus 20(10-54) mL (P=0.53); and hospital mortality (13.3% in both groups; P=1.00). Conclusions: In endovascular treatment for acute ischemic stroke, no difference was found between general anesthesia and conscious sedation in neurological outcome 3 months after stroke. Clinical trial registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01872884.
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Background and purpose 5 recent trials have shown the benefit of endovascular treatment for acute ischaemic stroke (AIS) due to large vessel occlusion of the anterior circulation. This study aims to evaluate the safety and efficacy of Solitaire thrombectomy in patients with moderate-to-severe stroke in the Chinese population, which has a high prevalence of intracranial atherosclerosis. Methods and analysis This multicentre prospective control study will involve 17 stroke centres in China, and plans to recruit 150 patients in the intervention group, and 150 patients in the medical group, in which patients meet enrolment criteria but refuse intervention. Patients with AIS due to large vessel occlusion indicated for treatment with Solitaire stent retriever within 12 hours of symptom onset, and who meet the inclusion and exclusion criteria, will be enrolled in this study. The primary efficacy endpoint is functional independence as defined by a modified Rankin Scale (mRS) score ≤2 at 90 days or by functional improvement as defined by mRS, using shift analysis. The procedural efficacy endpoint is arterial recanalisation of the occluded target vessel measured by a modified Thrombolysis in Cerebral Infarction (mTICI) score equal or superior to 2b right following the use of the study device. The primary safety endpoint is symptomatic intracranial haemorrhage (sICH) within 24±3 hours postprocedure. Ethics and dissemination The protocol was approved by the Ethics Committee at the coordinating centre and by the local Institutional Review Board of each participating centre. Trial registration number NCT02350283.
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Background and purpose: There is currently controversy on the ideal anesthesia strategy during mechanical thrombectomy for acute ischemic stroke. We performed a systematic review and meta-analysis of studies comparing clinical and angiographic outcomes of patients undergoing general anesthesia (GA group) and those receiving either local anesthesia or conscious sedation (non-GA group). Methods: A literature search on anesthesia and endovascular treatment of acute ischemic stroke was performed. Using random-effects meta-analysis, we evaluated the following outcomes: recanalization rate, good functional outcome at 90 days (modified Rankin Score≤2), symptomatic intracranial hemorrhage, death, vascular complications, respiratory complications, procedure time, and time to groin puncture. Results: Twenty-two studies (3 randomized controlled trials and 19 observational studies), including 4716 patients (1819 GA and 2897 non-GA) were included. In the nonadjusted analysis, patients in the GA group had higher odds of death (odds ratio [OR], 2.02; 95% confidence interval [CI], 1.66-2.45) and respiratory complications (OR, 1.70; 95% CI, 1.22-2.37) and lower odds of good functional outcome (OR, 0.58; 95% CI, 0.48-0.64) compared with the non-GA group. There was no difference in procedure time between the 2 primary comparison groups. When adjusting for baseline National Institutes of Health Stroke Scale, GA was still associated with lower odds of good functional outcome (OR, 0.59; 95% CI, 0.29-0.94). When considering studies performed in the stent-retriever/aspiration era, there was no significant difference in good neurological outcome rates (OR, 0.84; 95% CI, 0.67-1.06). Conclusions: Acute ischemic stroke patients undergoing intra-arterial therapy may have worse outcomes when treated with GA as compared with conscious sedation/local anesthesia. However, major limitations of current evidence (ie, retrospective studies and selection bias) indicate a need for adequately powered, multicenter randomized controlled trials to answer this question.
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Background and purpose: General anesthesia during endovascular treatment of acute ischemic stroke may have an adverse effect on outcome compared with conscious sedation. The aim of this study was to examine the impact of the type of anesthesia on the outcome of patients with acute ischemic stroke treated with the Solitaire stent retriever, accounting for confounding factors. Materials and methods: Four-hundred one patients with consecutive acute anterior circulation stroke treated with a Solitaire stent retriever were included in this prospective analysis. Outcome was assessed after 3 months by the modified Rankin Scale. Results: One-hundred thirty-five patients (31%) underwent endovascular treatment with conscious sedation, and 266 patients (69%), with general anesthesia. Patients under general anesthesia had higher NIHSS scores on admission (17 versus 13,P< .001) and more internal carotid artery occlusions (44.6% versus 14.8%,P< .001) than patients under conscious sedation. Other baseline characteristics such as time from symptom onset to the start of endovascular treatment did not differ. Favorable outcome (mRS 0-2) was more frequent with conscious sedation (47.4% versus 32%; OR, 0.773; 95% CI, 0.646-0.925;P= .002) in univariable but not multivariable logistic regression analysis (P= .629). Mortality did not differ (P= .077). Independent predictors of outcome were age (OR, 0.95; 95% CI, 0.933-0.969;P< .001), NIHSS score (OR, 0.894; 95% CI, 0.855-0.933;P< .001), time from symptom onset to the start of endovascular treatment (OR, 0.998; 95% CI, 0.996-0.999;P= .011), diabetes mellitus (OR, 0.544; 95% CI, 0.305-0.927;P= .04), and symptomatic intracerebral hemorrhage (OR, 0.109; 95% CI, 0.028-0.428;P= .002). Conclusions: In this single-center study, the anesthetic management during stent retriever thrombectomy with general anesthesia or conscious sedation had no impact on the outcome of patients with large-vessel occlusion in the anterior circulation.
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Background Observational studies indicate that the type of anesthesia, local or general, may be associated with the post-procedural neurological function in patients with acute ischemic stroke undergoing endovascular treatment. However, these results need further confirmation, and the causal relationship has not yet been established. Methods This is a randomized controlled equivalence trial. Permuted block randomization stratified by culprit vessels will be used. Six hundred and forty patients with acute ischemic stroke undergoing endovascular recanalization will be randomized one to one to receive either general anesthesia or local anesthesia. The primary endpoint is the modified Rankin scale at 90 days after endovascular treatment. The secondary endpoints are the peri-procedural mortality and morbidity. Discussion The study aims to determine the effects of anesthetic choice on neurological outcomes in patients with acute ischemic stroke undergoing intra-arterial recanalization. If the results are positive, the study will indicate that the type of anesthesia does not affect neurological outcome after endovascular treatment. Trial registration: ClinicalTrial.gov identifier: NCT02677415.
Article
Importance: Endovascular thrombectomy with second-generation devices is beneficial for patients with ischemic stroke due to intracranial large-vessel occlusions. Delineation of the association of treatment time with outcomes would help to guide implementation. Objective: To characterize the period in which endovascular thrombectomy is associated with benefit, and the extent to which treatment delay is related to functional outcomes, mortality, and symptomatic intracranial hemorrhage. Design, setting, and patients: Demographic, clinical, and brain imaging data as well as functional and radiologic outcomes were pooled from randomized phase 3 trials involving stent retrievers or other second-generation devices in a peer-reviewed publication (by July 1, 2016). The identified 5 trials enrolled patients at 89 international sites. Exposures: Endovascular thrombectomy plus medical therapy vs medical therapy alone; time to treatment. Main outcomes and measures: The primary outcome was degree of disability (mRS range, 0-6; lower scores indicating less disability) at 3 months, analyzed with the common odds ratio (cOR) to detect ordinal shift in the distribution of disability over the range of the mRS; secondary outcomes included functional independence at 3 months, mortality by 3 months, and symptomatic hemorrhagic transformation. Results: Among all 1287 patients (endovascular thrombectomy + medical therapy [n = 634]; medical therapy alone [n = 653]) enrolled in the 5 trials (mean age, 66.5 years [SD, 13.1]; women, 47.0%), time from symptom onset to randomization was 196 minutes (IQR, 142 to 267). Among the endovascular group, symptom onset to arterial puncture was 238 minutes (IQR, 180 to 302) and symptom onset to reperfusion was 286 minutes (IQR, 215 to 363). At 90 days, the mean mRS score was 2.9 (95% CI, 2.7 to 3.1) in the endovascular group and 3.6 (95% CI, 3.5 to 3.8) in the medical therapy group. The odds of better disability outcomes at 90 days (mRS scale distribution) with the endovascular group declined with longer time from symptom onset to arterial puncture: cOR at 3 hours, 2.79 (95% CI, 1.96 to 3.98), absolute risk difference (ARD) for lower disability scores, 39.2%; cOR at 6 hours, 1.98 (95% CI, 1.30 to 3.00), ARD, 30.2%; cOR at 8 hours,1.57 (95% CI, 0.86 to 2.88), ARD, 15.7%; retaining statistical significance through 7 hours and 18 minutes. Among 390 patients who achieved substantial reperfusion with endovascular thrombectomy, each 1-hour delay to reperfusion was associated with a less favorable degree of disability (cOR, 0.84 [95% CI, 0.76 to 0.93]; ARD, -6.7%) and less functional independence (OR, 0.81 [95% CI, 0.71 to 0.92], ARD, -5.2% [95% CI, -8.3% to -2.1%]), but no change in mortality (OR, 1.12 [95% CI, 0.93 to 1.34]; ARD, 1.5% [95% CI, -0.9% to 4.2%]). Conclusions and relevance: In this individual patient data meta-analysis of patients with large-vessel ischemic stroke, earlier treatment with endovascular thrombectomy + medical therapy compared with medical therapy alone was associated with lower degrees of disability at 3 months. Benefit became nonsignificant after 7.3 hours.
Article
Importance: Optimal management of sedation and airway during thrombectomy for acute ischemic stroke is controversial due to lack of evidence from randomized trials. Objective: To assess whether conscious sedation is superior to general anesthesia for early neurological improvement among patients receiving stroke thrombectomy. Design, setting, and participants: SIESTA (Sedation vs Intubation for Endovascular Stroke Treatment), a single-center, randomized, parallel-group, open-label treatment trial with blinded outcome evaluation conducted at Heidelberg University Hospital in Germany (April 2014-February 2016) included 150 patients with acute ischemic stroke in the anterior circulation, higher National Institutes of Health Stroke Scale (NIHSS) score (>10), and isolated/combined occlusion at any level of the internal carotid or middle cerebral artery. Intervention: Patients were randomly assigned to an intubated general anesthesia group (n = 73) or a nonintubated conscious sedation group (n = 77) during stroke thrombectomy. Main outcomes and measures: Primary outcome was early neurological improvement on the NIHSS after 24 hours (0-42 [none to most severe neurological deficits; a 4-point difference considered clinically relevant]). Secondary outcomes were functional outcome by modified Rankin Scale (mRS) after 3 months (0-6 [symptom free to dead]), mortality, and peri-interventional parameters of feasibility and safety. Results: Among 150 patients (60 women [40%]; mean age, 71.5 years; median NIHSS score, 17), primary outcome was not significantly different between the general anesthesia group (mean NIHSS score, 16.8 at admission vs 13.6 after 24 hours; difference, -3.2 points [95% CI, -5.6 to -0.8]) vs the conscious sedation group (mean NIHSS score, 17.2 at admission vs 13.6 after 24 hour; difference, -3.6 points [95% CI, -5.5 to -1.7]); mean difference between groups, -0.4 (95% CI, -3.4 to 2.7; P = .82). Of 47 prespecified secondary outcomes analyzed, 41 showed no significant differences. In the general anesthesia vs the conscious sedation group, substantial patient movement was less frequent (0% vs 9.1%; difference, 9.1%; P = .008), but postinterventional complications were more frequent for hypothermia (32.9% vs 9.1%; P < .001), delayed extubation (49.3% vs 6.5%; P < .001), and pneumonia (13.7% vs 3.9%; P = .03). More patients were functionally independent (unadjusted mRS score, 0 to 2 after 3 months [37.0% in the general anesthesia group vs 18.2% in the conscious sedation group P = .01]). There were no differences in mortality at 3 months (24.7% in both groups). Conclusions and relevance: Among patients with acute ischemic stroke in the anterior circulation undergoing thrombectomy, conscious sedation vs general anesthesia did not result in greater improvement in neurological status at 24 hours. The study findings do not support an advantage for the use of conscious sedation. Trial registration: clinicaltrials.gov Identifier: NCT02126085.
Article
Background: The aim of the current study was to assess the influence of anesthetic management on the effect of treatment in the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN). Methods: MR CLEAN was a multicenter, randomized, open-label trial of intra-arterial therapy (IAT) vs no IAT. The intended anesthetic management at the start of the procedure was used for this post hoc analysis. The primary effect parameter was the adjusted common odds ratio (acOR) for a shift in direction of a better outcome on the modified Rankin Scale (mRS) at 90 days, estimated with multivariable ordinal logistic regression analysis, which included a term for general anesthesia (GA). Results: GA was associated with significant (p = 0.011) effect modification, resulting in estimated decrease of 51% (95% confidence interval [CI] 31%-86%) in treatment effect compared to non-GA. We found a shift in the distribution on the mRS in favor of non-GA compared to control group (acOR 2.18 [95% CI 1.49-3.20]). The shift in distribution between GA and control group was in a similar direction (acOR 1.12 [95% CI 0.71-1.78]) with loss of statistical significance. Conclusions: In this post hoc analysis, we found that the type of anesthetic management influences outcome following IAT. Only treatment without general anesthesia was associated with a significant treatment benefit in MR CLEAN. Classification of evidence: This study provides Class II evidence that for patients with acute ischemic stroke undergoing IAT, mRS scores at 90 days improve only in patients treated without GA.
Article
Background Recent studies have strongly indicated the benefits of endovascular therapy for acute ischemic stroke, but what remains a continued debate is the role for general anaesthesia versus conscious sedation (CS) for such procedures. Retrospective studies have found poorer neurological outcomes in patients who underwent general anesthesia (GA); however, some have revealed worse baseline stroke severity in these patients. Methods This study is a retrospective cohort study aimed at comparing mortality and morbidity of GA versus CS in patients treated with endovascular intervention in acute ischemic stroke. Chi-square and t-test analyses were used. Results Patients in the GA (n=42) group were more likely to be deceased than those in the CS (n=67) group at hospital discharge, 3 months, and 6 months poststroke onset. Morbidity, as defined by modified Rankin Score, was significantly greater in the GA group at hospital discharge, and a similar trend was seen in morbidity at 3 months postdischarge. Conclusion General anesthesia for endovascular intervention in acute ischemic stroke was associated with increased mortality and poorer neurological incomes compared with conscious sedation. In our study, age, gender, history of hypertension, history of diabetes, and baseline National Institute of Health Stroke Scale were not significantly different between the groups. Although the need for a randomized, prospective study on this topic is clear, our study represents further corroboration of the safety and efficacy of conscious sedation in these procedures.