Optimal management of sedation and airway during thrombectomy for acute ischemic stroke is controversial due to lack of evidence from randomized trials.
To assess whether conscious sedation is ...superior to general anesthesia for early neurological improvement among patients receiving stroke thrombectomy.
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.
Patients were randomly assigned to an intubated general anesthesia group (n = 73) or a nonintubated conscious sedation group (n = 77) during stroke thrombectomy.
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.
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).
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.
clinicaltrials.gov Identifier: NCT02126085.
Recent randomised controlled trials demonstrated the benefit of intracranial endovascular thrombectomy (EVT) in acute ischaemic stroke. There is no consensus, however, on how to treat concomitant ...extracranial carotid artery stenosis after EVT. The aim of this study was to evaluate the outcome in patients treated with carotid endarterectomy (CEA) after EVT, comparing complication rates among patients undergoing CEA for stroke without previous EVT.
This was a registry study of all patients (n = 3 780) treated with CEA after stroke in Sweden and the capital Helsinki region, Finland, from January 2011 to September 2020. Sixty three patients (1.7%; 0.5% 2011, 4.3% 2019) underwent EVT prior to CEA. The primary outcome was 30 day stroke and death rate.
The EVT+CEA group had major stroke as the qualifying neurological event (QNE) in 79%, but just 5.9% had this in the CEA only group (p < .001). Intravenous thrombolysis was administered before EVT in 54% of patients in the EVT+CEA group, but in just 12% in those receiving CEA only (p < .001). The combined stroke and death rate at 30 days for EVT+CEA was 0.0% (95% confidence interval CI 0.0 – 5.7). One patient had a post-operative TIA, none had post-operative intracerebral or surgical site haemorrhage. CEA was performed within a median of seven days (interquartile range 4, 15) after QNE, and 75% had CEA ≤14 days from QNE. The main reason to postpone CEA was an infarct larger than one third of the middle cerebral artery territory. The stroke and death rate in patients treated with CEA only was 3.7% (95% CI 3.2 – 4.4), CEA was performed a median of eight days after QNE, and in 79.7% in ≤14 days. The three year survival after EVT+CEA was 93% (95% CI 85 – 100), compared with 87% (95% CI 86 – 88) after CEA only. Cox regression analysis adjusting for age showed no increased all cause mortality after EVT+CEA (HR 1.3, 95% CI 0.6 – 2.7, p = .52).
These results indicate that CEA is safe to perform after previous successful EVT for acute ischaemic stroke. Results were comparable with those undergoing CEA only, despite the EVT+CEA patients having more severe stroke symptoms prior to surgery, and timing was similar.
Patients with acute pulmonary embolism (PE) and hypotension (high-risk PE) have high mortality. Cardiogenic shock can also occur in nonhypotensive or normotensive patients (intermediate-risk PE) but ...is less well characterized.
The authors sought to evaluate the prevalence and predictors of normotensive shock in intermediate-risk PE.
Intermediate-risk PE patients in the FLASH (FlowTriever All-Comer Registry for Patient Safety and Hemodynamics) registry undergoing mechanical thrombectomy with the FlowTriever System (Inari Medical) were included. The prevalence of normotensive shock (systolic blood pressure ≥90 mm Hg but cardiac index ≤2.2 L/min/m2) was assessed. A composite shock score consisting of markers of right ventricular function and ischemia (elevated troponin, elevated B-type natriuretic peptide, moderately/severely reduced right ventricular function), central thrombus burden (saddle PE), potential additional embolization (concomitant deep vein thrombosis), and cardiovascular compensation (tachycardia) was prespecified and assessed for its ability to identify normotensive shock patients.
Over one-third of intermediate-risk PE patients in FLASH (131/384, 34.1%) were in normotensive shock. The normotensive shock prevalence was 0% in patients with a composite shock score of 0 and 58.3% in those with a score of 6 (highest score). A score of 6 was a significant predictor of normotensive shock (odds ratio: 5.84; 95% CI: 2.00-17.04). Patients showed significant on-table improvements in hemodynamics post-thrombectomy, including normalization of the cardiac index in 30.5% of normotensive shock patients. Right ventricular size, function, dyspnea, and quality of life significantly improved at the 30-day follow-up.
Although hemodynamically stable, over one-third of intermediate-risk FLASH patients were in normotensive shock with a depressed cardiac index. A composite shock score effectively further risk stratified these patients. Mechanical thrombectomy improved hemodynamics and functional outcomes at the 30-day follow-up.
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The aim of this study was to assess the safety and outcomes of mechanical thrombectomy (MT) performed at a stroke center by interventional cardiologists (ICs) compared with other interventionists. ...The primary endpoint was functional independence of stroke survivors (modified Rankin scale score 0-2) at 3 months. The secondary endpoints included recanalization rate, reduction in stroke severity, and 3-month mortality.
MT is a validated treatment for large vessel occlusion acute ischemic stroke. Incorporating ICs with their infrastructure into a comprehensive stroke team may increase the accessibility of this therapy.
In this single-center, prospective study, we included 248 ischemic stroke patients (mean age 68 ± 13 years, 48% women) with confirmed large vessel occlusion. The procedures were performed by ICs (n = 80), vascular surgeons (n = 116), and neuroradiologists (n = 52).
Functional independence after 3 months was similar between patients operated by cardiologists and other specialists (modified Rankin scale score 0-2 in 44% vs 55%; P = 0.275). Similarly, the mortality rate at 3 months did not differ (28% vs 31%; P = 0.585). Procedures performed by cardiologists took longer than those performed by other specialists (120 minutes vs 105 minutes; P = 0.020). A percentage of procedures with angiographic success (TICI Thrombolysis In Cerebral Infarction grade 2b or 3) was lower when performed by cardiologists (55.7% vs 71.7%; P = 0.013), but the change in stroke severity (National Institutes of Health Stroke Scale score after 24 hours) was similar.
Endovascular treatment in stroke provided by interventional cardiologists in cooperation with noninvasive stroke specialists is noninferior to procedures performed by the other endovascular specialists. Mortality and functional independence after 3 months are similar regardless of an interventionist performing the procedure.
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Performing mechanical thrombectomy (MT) in patients with basilar artery occlusion (BAO) is currently not evidence-based.
To compare patients' outcome, relative merits of achieving recanalization, and ...predictors of futile recanalization (FR) between BAO and anterior circulation large vessel occlusion (ACLVO) MT.
In the multicenter BEYOND-SWIFT registry (NCT03496064), univariate and multivariate (displayed as adjusted Odds Ratios, aOR and 95% confidence intervals, 95%-CI) outcome comparisons between BAO (N=165) and ACLVO (N=1574) were performed. The primary outcome was favorable outcome at 90 days (modified Rankin Scale, mRS 0-2). Secondary outcome included mortality, symptomatic intracranial hemorrhage (sICH) and FR. The relative merits of achieving successful recanalization between ACLVO and BAO were evaluated with interaction terms.
MT in BAO was more often technically effective and equally safe in regards to mortality and sICH when compared to ACLVO. When adjusting for baseline differences, there was no significant difference between BAO vs ACLVO regarding rates of favorable outcome (aOR 0.986, 95%-CI 0.553 - 1.758). However, BAO were associated with increased rates of FR (aOR 2.146, 95%-CI 1.267 - 3.633). Predictors for FR were age, stroke severity, maneuver count and intracranial stenting. No significant heterogeneity on the relative merits of achieving successful recanalization on several outcome parameters were observed when comparing BAO and ACLVO.
In selected patients, similar outcomes can be achieved in BAO and ACLVO patients treated with MT. Randomized controlled trials comparing patient selection and interventional strategies seem warranted to avoid FR.
NCT03496064.
Background
Endovascular treatment has become standard of care for the treatment of acute ischemic stroke with large vessel occlusion. However, patients treated in clinical practice differ from the ...selected populations randomized in clinical trials.
Aims
The German Stroke Registry Endovascular Treatment (GSR-ET) aims at a systematic evaluation of outcome, safety, and process parameters of endovascular stroke treatment in standard of care in Germany.
Methods
The GSR-ET is an academic, independent, prospective, multicenter, observational registry study. Participating stroke centers from all over of Germany consecutively enroll patients transferred to the angiography suite with an intention to be treated with endovascular stroke treatment. Patients receive regular care. Data are collected as part of clinical routine. Baseline clinical and procedural information and clinical follow-up information after 90 days are recorded. Here, we present an analysis of baseline data of the first 1662 patients included in the GSR-ET.
Results
The registry was established in June 2015. By 31 December 2017, 1662 patients were enrolled in 23 active sites. Mean age was 72 ± 13 years, 50% were female, and median National Institutes of Health Stroke Scale on admission was 15 (IQR 10–19), 88% had anterior circulation occlusion. Median ASPECT score was 8 (IQR 7–10) prior to intervention. Fifty-nine percent of patients received intravenous thrombolysis prior to thrombectomy. Mean “onset-to-groin” time was 224 ± 176 min.
Conclusions
Baseline characteristics of stroke patients undergoing thrombectomy in clinical practice differ from those in the randomized trials. The GSR-ET will provide valuable insights into practices of endovascular treatment in routine care of acute ischemic stroke. (GSR-ET ClinicalTrials.gov Identifier: NCT03356392.)
Mechanical thrombectomy techniques for intracranial medium vessel occlusions (MeVOs) have evolved in recent years, although the optimal approach is still unclear. The aim of this study was to ...investigate the effectiveness and safety of mechanical thrombectomy in MeVOs using mini (0.017 inches microcatheter compatible) stent retrievers combined with low-profile (0.035 inches distal inner diameter) distal aspiration catheters through the blind exchange/mini-pinning (BEMP) technique compared with mini stent retrievers alone.
Retrospective review of a prospectively maintained database of patients treated with the BEMP technique or mini stent retriever alone for intracranial MeVOs from 2017 to 2020 in a comprehensive stroke center. Both groups were compared about baseline characteristics, occlusion site, clinical presentation, clot cause, procedural outcomes (MeVO first-pass and final expanded Thrombolysis in Cerebral Ischemia score, the mini stent retriever used, number of passes with the front-line approach, and need of rescue therapy), safety outcomes (emboli to unwanted territories and hemorrhagic complications), and clinical outcomes at 90 days. Multivariable logistic regression analysis was performed with potential predictors of vessel recanalization to find independent variables associated with MeVO first-pass expanded Thrombolysis in Cerebral Ischemia 2c/3 recanalization.
We reviewed 102 patients/106 MeVOs treated with the BEMP technique (n=56) or mini stent retriever (n=50). There was a higher rate of MeVO first-pass expanded Thrombolysis in Cerebral Ischemia 2c/3 recanalization (57% versus 34%,
=0.017), lower need of rescue therapy (7.1% versus 22%,
=0.028), and lower rate of emboli to new territory (1.8% versus 12%,
=0.035) and symptomatic intracranial hemorrhage (1.9% versus 12.8%,
=0.038) with the BEMP technique. After multivariable analysis, the sole independent factor associated to MeVO first-pass expanded Thrombolysis in Cerebral Ischemia 2c/3 recanalization was the BEMP technique (odds ratio, 2.72 95% CI, 1.19-6.22;
=0.018).
In the setting of MeVOs, the BEMP technique may lead to higher rates of the first-pass recanalization and a lower incidence of symptomatic intracranial hemorrhage than mini stent retrievers alone.
Despite several retrospective studies analyzing the safety and efficacy of transradial access (TRA) versus transfemoral access (TFA) for cerebral angiography, this transition for neurointerventional ...procedures has been gradual. Nonetheless, based on our positive initial institutional experience with TRA for mechanical thrombectomy in acute ischemic stroke patients, we have started transitioning more of our cerebral angiography cases to TRA. Here we present our single institution experience.
We performed a retrospective review of patients receiving TRA cerebral angiography at our institution between January 2016 and February 2017. We present our experience transitioning from TFA to TRA, including our criteria for patient selection, technical nuances, patient experience, complications, and operator learning curve.
We included 148 angiograms performed in 141 people by one of four operators. No major complications were observed, and the technical success of the procedures was consistent with those of TFA. Marked improvement in operator efficiency was achieved in a short number of cases during this transition when looking at operator proficiency as a function of angiograms performed and days of exposure to TRA (4.3 vs 3.6 min/vessel, P<0.05).
Safety and efficiency can be preserved while transitioning to TRA. While further investigation is necessary to support transition to TRA, these findings should call for a re-evaluation of the role of TRA in catheter cerebral angiography.
When the coronavirus disease 2019 (COVID-19) outbreak became paramount, medical care for other devastating diseases was negatively impacted. In this study, we investigated the impact of the COVID-19 ...outbreak on stroke care across China.
Data from the Big Data Observatory Platform for Stroke of China consisting of 280 hospitals across China demonstrated a significant drop in the number of cases of thrombolysis and thrombectomy. We designed a survey to investigate the major changes during the COVID-19 outbreak and potential causes of these changes. The survey was distributed to the leaders of stroke centers in these 280 hospitals.
From the data of Big Data Observatory Platform for Stroke of China, the total number of thrombolysis and thrombectomy cases dropped 26.7% (
<0.0001) and 25.3% (
<0.0001), respectively, in February 2020 as compared with February 2019. We retrieved 227 valid complete datasets from the 280 stroke centers. Nearly 50% of these hospitals were designated hospitals for COVID-19. The capacity for stroke care was reduced in the majority of the hospitals. Most of the stroke centers stopped or reduced their efforts in stroke education for the public. Hospital admissions related to stroke dropped ≈40%; thrombolysis and thrombectomy cases dropped ≈25%, which is similar to the results from the Big Data Observatory Platform for Stroke of China as compared with the same period in 2019. Many factors contributed to the reduced admissions and prehospital delays; lack of stroke knowledge and proper transportation were significant limiting factors. Patients not coming to the hospital for fear of virus infection was also a likely key factor.
The COVID-19 outbreak impacted stroke care significantly in China, including prehospital and in-hospital care, resulting in a significant drop in admissions, thrombolysis, and thrombectomy. Although many factors contributed, patients not coming to the hospital was probably the major limiting factor. Recommendations based on the data are provided.
Despite the Joint Commission’s certification requirement of ≥15 stroke thrombectomy (ST) cases per center and proceduralist annually, the relationship between ST case volumes and outcomes is ...uncertain. We sought to determine whether a proceduralist or hospital volume threshold exists that is associated with better outcomes among Medicare beneficiaries.
Retrospective cohort study using validated International Classification of Diseases, Tenth Revision, Clinical Modification codes to identify admissions with acute ischemic stroke and treatment with ST. We used de-identified, national 100% inpatient Medicare data sets from January 1, 2016, to December 31, 2017 for US individuals aged ≥65 years. We calculated total procedures by proceduralist and hospital. We performed adjusted logistic regression of total cases as a predictor of inpatient mortality, good outcome (defined by dichotomized discharge disposition of inpatient rehabilitation or better), and 30-day readmission. We adjusted for sex, age, Charlson Comorbidity Index, availability of neurocritical care, teaching hospital status, socioeconomic status, 2-year stroke volume, and urban versus rural hospital location. We dichotomized case numbers incrementally to determine a volume threshold for better outcomes.
Thirteen thousand three hundred thirty-five patients were treated with ST by 2754 proceduralists at 641 hospitals. For every 10 more proceduralist cases, patients had 4% lower adjusted odds of inpatient mortality (adjusted odds ratio, 0.96 95% CI, 0.95–0.98, P<0.0001) and 3% greater adjusted odds of good outcome (adjusted odds ratio, 1.03 95% CI, 1.02–1.04, P<0.0001). For every 10 more hospital cases, patients had 2% lower odds of inpatient mortality (adjusted odds ratio, 0.98 95% CI, 0.98–0.99, P=0.0003) and 2% greater odds of good outcome (adjusted odds ratio, 1.02 95% CI, 1.01–1.02, P<0.0001). With increasing volumes, there were higher odds of better outcomes.
Nationally, higher proceduralist and hospital ST case volumes were associated with reduced inpatient mortality and better outcome. These data support volume requirements in guidelines for ST training and certification.
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