scholarly journals GASS Trial study protocol: a multicentre, single-blind, randomised clinical trial comparing general anaesthesia and sedation during intra-arterial treatment for stroke

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e024249 ◽  
Author(s):  
Axelle Maurice ◽  
Jean-Christophe Ferré ◽  
Thomas Ronzière ◽  
Jean-Michel Devys ◽  
Aurelie Subileau ◽  
...  
Keyword(s):  
Multicentre Study ◽  
General Anaesthesia ◽  
Endovascular Therapy ◽  
Conscious Sedation ◽  
Randomised Clinical Trial ◽  
Primary Outcome Measure ◽  
Anterior Circulation ◽  
Vessel Occlusion ◽  
The Impact ◽  
Single Blind

IntroductionTreatment of acute stroke has drastically changed in the last 10 years. Endovascular therapy is now the standard of care for patients with a stroke caused by a large vessel occlusion in the anterior circulation. The impact of the type of anaesthesia (general anaesthesia or conscious sedation) during endovascular therapy on the outcome of the patients is still a matter of debate. Previous studies are mostly retrospective and/or focused on the early postprocedure outcome and/or without blood pressure goals and/or single-centre small size studies. We therefore designed a multicentre study hypothesising that conscious sedation is associated with a better functional outcome 3 months after endovascular therapy for the treatment of stroke compared with general anaesthesia.Methods/analysisThe General Anesthesia vs Sedation for Stroke (GASS) Trial is a randomised, parallel, single-blind, multicentre study of 350 patients undergoing endovascular therapy for the treatment of stroke. Patients will be randomly allocated to receive either a general anaesthesia or a conscious sedation. The primary outcome measure is the modified Rankin score assessed 3 months after the treatment. Data will be analysed on the intention-to-treat principle.Ethics/disseminationThe GASS Trial has been approved by an independent ethics committee for all study centres. Participant recruitment begins in September 2016. Results will be published in international peer-reviewed medical journals.Trial registration numberNCT02822144.

Abstract WP330: Protocol Approaches Negate the “Weekend Effect” for Endovascular Stroke Treatment

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Scott B Raymond ◽  
Feras Akbik ◽  
Joshua A Hirsch ◽  
Christopher J Stapleton ◽  
Ramon G Gonzalez ◽  
...  
Keyword(s):  
Endovascular Therapy ◽  
Care Delivery ◽  
Working Hours ◽  
Weekend Effect ◽  
Complication Rates ◽  
Anterior Circulation ◽  
Vessel Occlusion ◽  
Stroke Treatment ◽  
Therapeutic Procedures ◽  
The Impact

Background: Endovascular management of stroke from acute large vessel occlusion (LVO) requires complex, emergent diagnostic and therapeutic procedures. The “weekend effect” (worsened outcomes from stroke presenting on weekends or evenings) is a recognized phenomenon, attributed to non-uniform availability of services throughout the week. We assessed the impact of institutional protocols for stroke patients undergoing endovascular therapy during off hours. Methods: We analyzed a prospective observational stroke database for consecutive patients with anterior circulation stroke undergoing endovascular therapy between 6/2012 and 10/2015. Patients were grouped and analyzed based on day of the week and time of presentation to the emergency department. Off-hours were considered between 1900hrs and 0700hrs on weekdays and 1900hrs on Friday to 0700hrs on Mondays for weekends. Functional outcome was assessed prospectively by 3 month modified Rankin scale (mRS), dichotomized into good (mRS 0-2) versus poor (mRS 3-6). Results: In a cohort of 129 patients, 75 (58%) patients were treated off-hours. Patients treated off-hours demonstrated equivalent imaging to groin puncture times (78 vs 72 min, p = 0.4) and procedure durations (75 vs 68 min, p = 0.3). Reperfusion rates (TICI 2b or 3) were 68% off hours and 76% during working hours (p = 0.4). Complication rates were similar between the two groups. Outcome at 90 days was no different in the patients treated off hours, with 35 of 75 treated off-hours achieving a good outcome (mRS 0-2) compared to 22 of 54 treated during working hours (p = 0.6). With protocol adherence, temporal improvement was noted in imaging to groin times. Discussion/Conclusions: Following recent evidence of benefit from endovascular therapy for LVOs there is increased attention to care delivery. Our findings demonstrate that under the guidance of protocols, the “weekend effect” was negated. Evaluation and treatment times, and 90 day outcomes were equivalent in patients treated off- vs business hours, with improving treatment times as familiarity with protocols increased. Our findings highlight the importance of establishing institutional and regional protocols in the optimized management of these patients.

scholarly journals Safety and quality of endovascular therapy under general anesthesia and conscious sedation are comparable: results from the GOLIATH trial

2019 ◽  
Vol 11 (11) ◽  
pp. 1070-1072 ◽  
Author(s):  
Leif H Sørensen ◽  
Lasse Speiser ◽  
Sanja Karabegovic ◽  
Albert J Yoo ◽  
Mads Rasmussen ◽  
...  
Keyword(s):  
General Anesthesia ◽  
Endovascular Therapy ◽  
Conscious Sedation ◽  
Stent Retriever ◽  
Procedure Time ◽  
Anterior Circulation ◽  
Unique Identifier ◽  
Vessel Occlusion ◽  
Aspiration Technique

BackgroundThe “General or Local Anesthesia in Intra-Arterial Therapy” (GOLIATH) trial compared infarct growth and outcome in patients undergoing endovascular therapy (EVT) under either general anesthesia (GA) or conscious sedation (CS). The results were the same for the primary outcome (infarct growth) but successful reperfusion was higher in the GA arm.ObjectiveTo further examine differences in the quality and safety of EVT with the two anesthetic regimens in a post hoc analysis of GOLIATH.MethodsIn GOLIATH, 128 subjects with anterior circulation large vessel occlusion stroke within 6 hours of onset were randomized to either GA or CS (1:1 allocation). We compared the quality of reperfusion, treatment delay, use of catheters, and contrast and radiation dosage between the trial arms.ResultsSixty-five subjects were randomized to GA. Baseline demographic and clinical variables were similar between the treatment arms. We found no difference in procedure time, contrast dose, or radiation dose between the two arms. Tandem occlusions were associated with a longer procedure time, but there was no difference between the two arms. There was no difference in reperfusion rates between the direct aspiration technique and a stent retriever (86% vs 79%, respectively, p=0.54), but aspiration was associated with a shorter procedure time (28 min vs 42 min for a stent retriever), p=0.03.ConclusionSafety and quality of EVT under either GA and CS are comparable.Trial registrationUnique identifier: NCT02317237;Post-results.

Abstract 202: Endovascular Therapy for Acute Ischemic Stroke With Distal Large Vessel Occlusion in the Anterior Circulation

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Amrou Sarraj ◽  
Navdeep Sangha ◽  
Muhammad Shazam Hussain ◽  
Dolora Wisco ◽  
Nirav Vora ◽  
...  
Keyword(s):  
Endovascular Therapy ◽  
Primary Outcome ◽  
Large Vessel ◽  
Secondary Outcome ◽  
Large Vessel Occlusion ◽  
Anterior Circulation ◽  
Vessel Occlusion ◽  
Good Outcome ◽  
Baseline Characteristics ◽  
Iv Tpa

Introduction: Five RCTs demonstrated the superiority of endovascular therapy (EVT) over best medical management (MM) for acute ischemic strokes (AIS) with large vessel occlusion (LVO) in the anterior circulation. Patients with M2 occlusions, however, were underrepresented (95 randomized; 51 EVT treated). Evidence from RCTs of the benefit of EVT for M2 occlusions is lacking, as reflected in the recent AHA guidelines. Methods: A retrospective cohort was pooled from 10 academic centers from 1/12 to 4/15 of AIS patients with LVO isolated to M2 presenting within 8 hours from last known normal (LKN). Patients were divided into EVT and MM groups. Primary outcome was 90 day mRS (good outcome 0-2); secondary outcome was sICH. Logistic regression compared the 2 groups. Univariate and multivariate analyses evaluated predictors of good outcome in the EVT group. Results: Figure 1 shows participating centers, 522 patients (288 EVT and 234 MM) were identified. Table (1) shows baseline characteristics. MM treated patients were older and had higher IV tPA treatment rates, otherwise the 2 groups were balanced. 62.7 % EVT patients had mRS 0-2 at 90 days compared to 35.4 % MM (figure 2). EVT patients had 3 times the odds of good outcome as compared to MM patients (OR: 3.1, 95% CI:2.1-4.4, P <0.001) even after adjustment for age, NIHSS, ASPECTS, IV tPA and LKN to door time (OR: 3.2, 95%CI: 2-5.2, P<0.001). sICH rate was 5.6 %, which was not statistically different than the MM group (table 1, P=0.1). Age, NIHSS, good ASPECTS, LKN to reperfusion time and successful reperfusion mTICI ≥ 2b were independent predictors of good outcome in EVT patients. There was a linear relationship between good outcome and time LKN to reperfusion (Figure 3). Conclusion: Despite inherent limitations of its retrospective design, our study suggests that EVT may be effective and safe for distal LVO (M2) relative to best MM. A trial randomizing M2 occlusions to EVT vs. MM is warranted to confirm these findings.

Abstract W MP60: Atrial Fibrillation is Associated with Worse Collaterals in Acute Stroke: Angiography in the ENDOSTROKE Registry

Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
David S Liebeskind ◽  
Christian H Nolte ◽  
Georg Bohner ◽  
Tobias Neumann-Haefelin ◽  
Erich Hofmann ◽  
...  
Keyword(s):  
Risk Factors ◽  
Atrial Fibrillation ◽  
Acute Stroke ◽  
Endovascular Therapy ◽  
Cardioembolic Stroke ◽  
Baseline Risk ◽  
Anterior Circulation ◽  
Stroke Treatment ◽  
Stroke Etiology ◽  
The Impact

Background: Risk factors for stroke may alter hemodynamics or invoke ischemic preconditioning, yet the impact of such factors on response to acute stroke treatment and the potential relationship with collateral circulation remains unknown. Methods: Consecutive cases enrolled in the International Multicenter Registry for Mechanical Recanalization Procedures in Acute Stroke (ENDOSTROKE) were analyzed with respect to collateral status on baseline angiography before endovascular therapy. ASITN/SIR collateral grade (0-1/2/3-4) was scored by the core lab, blind to all other data. Collateral grade was analyzed with respect to numerous baseline risk factors, demographics and outcomes after endovascular intervention. Results: 109 patients (median age 69 years (25 th , 75 th percentiles: 56, 77); 51% women; median baseline NIHSS 15 (13, 18)) with complete (TICI 0) anterior circulation occlusions (M1, n=71; ICA, n=28; M2, n=10) at baseline were evaluated based on collateral grade (0-1, n=12; 2, n=41; 3-4, n=56). Worse collaterals were noted in patients with atrial fibrillation (ASITN grades 0-1/2/3-4: 21%/30%/49%) as compared to patients without atrial fibrillation (5%/42%/53%, p=0.024), yet cardioembolic stroke etiology was unrelated. Other baseline features such as age, gender, time to presentation, other co-morbidities and labs were unrelated to collateral grade. Post-procedure reperfusion (TICI 2b-3) was significantly associated with better collaterals (OR 2.58 (1.343-4.957, p=0.004). Similarly, final infarct size was significantly smaller in those with better collaterals. Good clinical outcomes (mRS 0-2 at day 90) were less frequent in those with poorer collaterals (OR 0.403 (0.199-0.813, p=0.011). Conclusions: Atrial fibrillation, but not cardioembolic stroke etiology, is associated with worse collaterals. Hemodynamic implications, such as diminished cardiac output due to atrial fibrillation, may result in less favorable outcomes after endovascular therapy for acute stroke.

Abstract TP74: Aspects Scoring Applied to CTA Source Images is Predictive of Final Infarct Volume and Good Functional Outcome

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Joseph F Carrera ◽  
Joseph H Donahue ◽  
Prem P Batchala ◽  
Andrew M Southerland ◽  
Bradford B Worrall
Keyword(s):  
Linear Regression ◽  
Functional Outcome ◽  
Infarct Volume ◽  
Univariate Analysis ◽  
Large Vessel ◽  
Large Vessel Occlusion ◽  
Anterior Circulation ◽  
Vessel Occlusion ◽  
Good Outcome ◽  
The Impact

Introduction: CTP and MRI are increasingly used to assess endovascular thrombectomy (EVT) candidacy in large vessel occlusion stroke. Unfortunately, availability of these advanced neuroimaging techniques is not widespread and this can lead to over-triage to EVT-capable centers. Hypothesis: ASPECTS scoring applied to computed tomography angiography source images (CTA-SI) will be predictive of final infarct volume (FIV) and functional outcome. Methods: We reviewed data from consecutive patients undergoing EVT at our institution for anterior circulation occlusion between 01/14 - 01/19. We recorded demographics, comorbidities, NIHSS, treatment time parameters, and outcomes as defined by mRS (0-2 = good outcome). Cerebrovascular images were assessed by outcome-blinded raters and collateral score, TICI score, FIV, and both CT and CTA-SI ASPECTS scores were noted. Patients were grouped by ASPECTS score into low (0-4), intermediate (5-7), and high (8-10) for some analyses. FIV was predicted using a linear regression with NIHSS, good reperfusion (TICI 2b/3), collateral score, CT to groin puncture, CT and CTA-SI ASPECTS as independent variables. After excluding those with baseline mRS≥2, a binary logistic regression was performed including covariates of age, NIHSS, good reperfusion, and diabetes (factors significant at p<0.05 on univariate analysis) to assess the impact of CTA-SI ASPECTS group on outcome. Results: Analysis included 137 patients for FIV and 102 for outcome analysis (35 excluded for baseline mRS≥ 2). Linear regression found CTA-SI ASPECTS (Beta -10.8, p=0.002), collateral score (Beta -42.9, p=0.001) and good reperfusion (Beta 72.605, p=0.000) were independent predictors of FIV. Relative to the low CTA-SI ASPECTS group, the high CTA-SI ASPECTS group was more likely to have good outcome (OR 3.75 [95% CI 1.05-13.3]; p=0.41). CT ASPECTS was not predictive of FIV or good outcome. Outcomes: In those undergoing EVT for anterior circulation occlusion, CTA-SI ASPECTS is predictive of both FIV and functional outcome, while CT ASPECTS predicts neither. CTA-SI ASPECTS holds promise as a lower-cost, more widely available option for triage of patients with large vessel occlusion. Further study is needed comparing CTA-SI ASPECTS to CTP parameters.

Abstract TP72: Localization of Large Vessel Occlusion (LVO) Stroke in the Posterior Circulation Based on Perfusion Imaging

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Carlo W Cereda ◽  
Jeremy Heit ◽  
Abid Qureshi ◽  
Archana Hinduja ◽  
Mikayel Grigoryan ◽  
...  
Keyword(s):  
Perfusion Imaging ◽  
Primary Outcome Measure ◽  
Posterior Circulation ◽  
Large Vessel ◽  
Large Vessel Occlusion ◽  
Rater Agreement ◽  
Anterior Circulation ◽  
Vessel Occlusion ◽  
Intracranial Vessel ◽  
Imaging Results

Introduction: The vascular territory of an occluded large intracranial vessel can be reliably identified by CT or MR perfusion imaging. Furthermore, prior studies have shown that perfusion imaging can reliably predict the specific vessel that is occluded in anterior circulation large vessel strokes. We evaluated whether perfusion imaging can predict the specific vessel occlusion (vertebral, basilar, or posterior cerebral) in posterior circulation strokes. Hypothesis: We hypothesized that the occluded vessel could be inferred from the perfusion imaging results in >80% of patients with an acute stroke due to large vessel occlusion in the posterior circulation using the simultaneous CTA or MRA as the gold standard. Furthermore, the inter-rater agreement between a vascular neurologist and a neuroradiologist would be > 90%. Agreement Coefficients (AC1) were determined. Methods: From a multicenter cohort of consecutive patients with posterior circulation stroke, we included patients with documented occlusion of the Basilar Artery (BA) posterior cerebral Artery (PCA) or vertebral artery (VA) who had perfusion imaging (MRI or CT) processed by RAPID software. Perfusion images were evaluated blinded to the angiography or any other brain imaging results. The primary outcome measure was agreement on LVO location based on the CTA/MRA results. Results: 74 patients were eligible: age 63±2, female 32%, median NIHSS 15 (IQR 5-24). The distribution of large vessel occlusions on CTA/MRA was BA (74%), PCA (14%) and VA (12%). Perfusion imaging was able to correctly predict the occluded vessel in 63 (85%), AC1 = 0.82 (95% CI 0.72-0.92), p<0.001. Interrater agreement (n=41) was high [AC1 = 0.94 (95% CI 0.87-1.0), p < 0.001]. Conclusion: Perfusion imaging can predict the site of vessel occlusion (vertebral, basilar, or posterior cerebral) in posterior circulation strokes with good accuracy and high inter-rater agreement.

Endovascular treatment for acute basilar artery occlusion: descriptive analysis of the experience in a comprehensive stroke centre

2021 ◽  
Keyword(s):  
General Anaesthesia ◽  
Basilar Artery ◽  
Endovascular Therapy ◽  
Mechanical Thrombectomy ◽  
Functional Independence ◽  
Artery Occlusion ◽  
Basilar Artery Occlusion ◽  
Anterior Circulation ◽  
Significant Difference ◽  
Epidemiological Characteristics

Objectives: To describe the clinical and epidemiological characteristics of patients with basilar artery occlusion (BAO) treated with mechanical thrombectomy (MT) in Aragón, and to compare its anaesthetic management, technical effectivity, security, and prognosis with those of anterior circulation. Methods: 322 patients from the prospective registry of mechanical thrombectomies from Aragon were assessed: 29 with BAO and 293 with an anterior circulation large vessel occlusion. Baseline characteristics, procedural, clinical and safety outcomes variables were compared. Results: Out of 29 patients with BAO that underwent endovascular therapy (62.1% men; average age 69.8 ± 14.05 years) 18 (62.1%) received endovascular therapy (EVT) alone and 11 (37.9%) EVT plus intravenous thrombolysis. Atherothrombotic stroke was the most common etiology (41%). The BAO group had longer Door-to-groin (160 vs 141 min; P = 0.043) and Onset-to-reperfusion times (340 vs 297 min; P = 0.005), and higher use of general anaesthesia (60.7% vs 14.7%; P < 0.01). No statistically significant difference was found for Procedure time (60 vs 50 min; P = 0.231) nor the rate of successful recanalization (72.4% vs 82.7%; P = 0.171). Functional independence at 90 days was significantly worse in the BAO group (17.9% vs 38.2%; P < 0.01). Conclusions: Patients with basilar artery occlusion had higher morbimortality despite similar angiographic results. Mechanical thrombectomy for BAOs is a safe and effective procedure in selected patients. A consensus about the effect of anaesthesia has yet to be reached, for BAO general anaesthesia remains the most frequently used technique.

Abstract WP26: Validation of Predictive Scales of Functional Outcome After Endovascular Therapy Using the REVASCAT Data

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Natalia Perez de la Ossa ◽  
Srikant Rangaraju ◽  
Tudor Jovin ◽  
Anoni Dávalos ◽  
Keyword(s):  
Functional Outcome ◽  
Endovascular Therapy ◽  
Predictive Accuracy ◽  
Functional Independence ◽  
Large Vessel ◽  
Large Vessel Occlusion ◽  
Anterior Circulation ◽  
Vessel Occlusion ◽  
Good Outcome ◽  
Best Medical Treatment

Introduction: Various scales have been developed to predict long-term clinical outcome after endovascular therapy (EVT) in stroke patients. The objective of this study was to validate and compare five well-validated scales in terms of predictive accuracy for functional independence in a recent endovascular stroke trial (REVASCAT). Hypothesis: We hypothesize that predictive scales (PRE, THRIVE, HIAT2, SPAN-100, FAR) have good-excellent (AUC>0.7) predictive accuracy for good functional outcome and can predict the beneficial effect of EVT demonstrated in randomized clinical trials. Methods: REVASCAT (Randomized Trial of Revascularization with Solitaire-FR Device versus Best Medical Therapy in the Treatment of Acute Stroke Due to Anterior Circulation Large Vessel Occlusion Presenting within Eight Hours of Symptom Onset) enrolled 206 patients who were randomized to receive EVT or best medical treatment. Five scores (PRE-score, THRIVE, HIAT2, SPAN-100 and FAR-score) were retrospectively calculated on patients who received EVT. Receiver-operator characteristics (ROC) for good outcome (mRS 0-2 at 90 days) for each scale were compared. Using the highest predictive scales, the proportion of patients with good outcome by the score categorized in quartiles was analyzed. Results: 103 patients received EVT in the REVASCAT trial (mean age 65.7, median NIHSS 17). Baseline NIHSS, baseline CT-ASPECTS, age and atrial fibrillation, but not previous iv tPA or DM, were associated with good outcome in multivariable analysis. AUC for good outcome was ≥0.70 for FAR (0.74) and PRE (0.70) scores while SPAN-100 (0.67), HIAT2 (0.65) and THRIVE (0.64) had lower AUCs although differences were not statistically significant. The higher the score on the PRE and FAR scores, the lower the proportion of patients with good outcome (PRE-score: 1QT 44.4%, 2QT 24.4%, 3QT 22.2%, 4 QT 8.9%; FAR-score: 1QT 57.8%, 2QT 22.2%, 3QT 6.7%, 4QT 3.3%). Benefit of EVT accordingly to the score on the different scales will be also presented. Conclusions: Of the 5 stroke scales, FAR and PRE had better predictive accuracy for functional independence after EVT. These tools may facilitate decision making for EVT in anterior circulation large vessel occlusion stroke.

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