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Objective: To assess the utility of IV thrombolysis (IVT) treatment in patients with acute ischemic stroke (AIS) with unclear symptom onset time or outside the 4.5-hour time window selected by advanced neuroimaging., Methods: We performed random-effects meta-analyses on the unadjusted and adjusted for potential confounders associations of IVT (alteplase 0.9 mg/kg) with the following outcomes: 3-month favorable functional outcome (FFO; modified Rankin Scale [mRS] scores 0-1), 3-month functional independence (FI; mRS scores 0-2), 3-month mortality, 3-month functional improvement (assessed with ordinal analysis on the mRS scores), symptomatic intracranial hemorrhage (sICH), and complete recanalization (CR)., Results: We identified 4 eligible randomized clinical trials (859 total patients). In unadjusted analyses, IVT was associated with a higher likelihood of 3-month FFO (odds ratio [OR] 1.48, 95% confidence interval [CI] 1.12-1.96), FI (OR 1.42, 95% CI 1.07-1.90), sICH (OR 5.28, 95% CI 1.35-20.68), and CR (OR 3.29, 95% CI 1.90-5.69), with no significant difference in the odds of all-cause mortality risk at 3 months (OR 1.75, 95% CI 0.93-3.29). In the adjusted analyses, IVT was also associated with higher odds of 3-month FFO (adjusted OR [OR adj ] 1.62, 95% CI 1.20-2.20), functional improvement (OR adj 1.42, 95% CI 1.11-1.81), and sICH (OR adj 6.22, 95% CI 1.37-28.26). There was no association between IVT and FI (OR adj 1.61, 95% CI 0.94-2.75) or all-cause mortality (OR adj 1.75, 95% CI 0.93-3.29) at 3 months. No evidence of heterogeneity was evident in any of the analyses ( I 2 = 0)., Conclusion: IVT in patients with AIS with unknown symptom onset time or elapsed time from symptom onset >4.5 hours selected with advanced neuroimaging results in a higher likelihood of CR and functional improvement at 3 months despite the increased risk of sICH., (© 2019 American Academy of Neurology.)

Importance: The benefit of mechanical thrombectomy (MT) in patients with stroke presenting with mild deficits (National Institutes of Health Stroke Scale [NIHSS] score <6) owing to emergency large-vessel occlusion (ELVO) remains uncertain., Objective: To assess the outcomes of patients with mild-deficits ELVO (mELVO) treated with MT vs best medical management (bMM)., Data Sources: We retrospectively pooled patients with mELVO during a 5-year period from 16 centers. A meta-analysis of studies reporting efficacy and safety outcomes with MT or bMM among patients with mELVO was also conducted. Data were analyzed between 2013 and 2017., Study Selection: We identified studies that enrolled patients with stroke (within 24 hours of symptom onset) with mELVO treated with MT or bMM., Main Outcomes and Measures: Efficacy outcomes included 3-month favorable functional outcome and 3-month functional independence that were defined as modified Rankin Scale scores of 0 to 1 and 0 to 2, respectively. Safety outcomes included 3-month mortality and symptomatic and asymptomatic intracranial hemorrhage (ICH)., Results: We evaluated a total of 251 patients with mELVO who were treated with MT (n = 138; 65 women; mean age, 65.2 years; median NIHSS score, 4; interquartile range [IQR], 3-5) or bMM (n = 113; 51 women; mean age, 64.8; median NIHSS score, 3; interquartile range [IQR], 2-4). The rate of asymptomatic ICH was lower in bMM (4.6% vs 17.5%; P = .002), while the rate of 3-month FI (after imputation of missing follow-up evaluations) was lower in MT (77.4% vs 88.5%; P = .02). The 2 groups did not differ in any other efficacy or safety outcomes. In multivariable analyses, MT was associated with higher odds of asymptomatic ICH (odds ratio [OR], 11.07; 95% CI, 1.31-93.53; P = .03). In the meta-analysis of 4 studies (843 patients), MT was associated with higher odds of symptomatic ICH in unadjusted analyses (OR, 5.52; 95% CI, 1.91-15.49; P = .002; I2 = 0%). This association did not retain its significance in adjusted analyses including 2 studies (OR, 2.06; 95% CI, 0.49-8.63; P = .32; I2 = 0%). The meta-analysis did not document any other independent associations between treatment groups and safety or efficacy outcomes., Conclusions and Relevance: Our multicenter study coupled with the meta-analysis suggests similar outcomes of MT and bMM in patients with stroke with mELVO, but no conclusions about treatment effect can be made. The clinical equipoise can further be resolved by a randomized clinical trial.

Background and Purpose- To date, there is still uncertainty about age and sex differences in access to stroke unit treatment and use of intravenous thrombolysis (IVT), while age and sex differences have not been investigated for the new treatment option of mechanical thrombectomy (MT). We, therefore, undertook a complete nationwide analysis of all hospitalized ischemic stroke patients in Germany from 2013 to 2017. Methods- We used the nationwide administrative database of the German Federal Statistical Office and investigated access to stroke unit treatment, IVT, MT, and in-hospital mortality. Patients were subdivided into 6 predefined age groups (20-44, 45-59, 60-69, 70-79, 80-89, and >90 years). Pooled overall and age group estimates were calculated using the random-effects model. To evaluate potential sex disparities, we estimated odds ratios (ORs) with 95% CIs. Results- A total of 1 112 570 patients were hospitalized for first or recurrent ischemic stroke from 2013 to 2017. Overall, stroke unit treatment increased significantly from 66.8% in 2013 to 73.5% in 2017, as did IVT (from 12.4% to 15.9%) and MT (from 2.4% to 5.8%; all P <0.001). Although the difference became smaller over time, patients ≥80 years of age still received significantly less often treatments. Men of all age groups had a significantly higher probability receiving stroke unit treatment (OR, 1.11; 95% CI, 1.09-1.12) and lower in-hospital mortality (OR, 0.91; 95% CI, 0.89-0.93). No disparity was observed in the use of IVT (OR, 1.00; 95% CI, 0.98-1.01), while women of all ages were treated more often with MT (OR, 1.26; 95% CI, 1.22-1.30). Conclusions- Access to stroke unit treatment has to be increased in both older patients and women of all ages. While there was no sex difference in IVT use, it is important to further investigate the significantly higher frequency of MT in women with ischemic stroke irrespective of age.

Objective: The substantial clinical improvement in acute ischemic stroke (AIS) patients treated with mechanical thrombectomy (MT), combined with the poor response of proximal intracranial occlusions to intravenous thrombolysis (IVT), led to questions regarding the utility of bridging therapy (BT; IVT followed by MT) compared to direct mechanical thrombectomy (dMT) for AIS patients with large vessel occlusion (LVO)., Methods: We aimed to investigate the comparative safety and efficacy of BT and dMT in AIS patients. We included all observational studies and post hoc analyses from randomized controlled clinical trials that provided data on the outcomes of AIS patients with LVO stratified by IVT treatment status prior to MT., Results: We identified 38 eligible observational studies (11,798 LVO patients, mean age = 68 years, 56% treated with BT). In unadjusted analyses, BT was associated with a higher likelihood of 3-month functional independence (odds ratio [OR] = 1.52, 95% confidence interval [CI] = 1.32-1.76), 3-month functional improvement (common OR [cOR] for 1-point decrease in modified Rankin Scale score = 1.52, 95% CI = 1.18-1.97), early neurological improvement (OR = 1.21, 95% CI = 1.83-1.76), successful recanalization (OR = 1.22, 95% CI = 1.02-1.46), and successful recanalization with ≤2 device passes (OR = 2.28, 95% CI = 1.43-3.64) compared to dMT. BT was also related to a lower likelihood of 3-month mortality (OR = 0.64, 95% CI = 0.57-0.73). In the adjusted analyses, BT was independently associated with a higher likelihood of 3-month functional independence (adjusted OR = 1.55, 95% CI = 1.26-1.91) and lower odds of 3-month mortality (adjusted OR = 0.80, 95% CI = 0.66-0.97) compared to dMT. The two groups did not differ in functional improvement (adjusted cOR = 1.24, 95% CI = 0.89-1.74) or symptomatic intracranial hemorrhage (adjusted OR = 0.87, 95% CI = 0.61-1.25)., Interpretation: BT appears to be associated with improved functional independence without evidence for safety concerns, compared to dMT, for AIS patients with LVO. ANN NEUROL 2019;86:395-406., (© 2019 American Neurological Association.)

Background: Mechanical thrombectomy (MT) has become an evidence-based therapy for stroke patients with proximal vessel occlusion of the anterior cerebral circulation. Nationwide availability of MT for all eligible patients within the shortest possible time window is a major challenge., Aim of the Study: Nationwide analysis of the rates of systemic thrombolysis (STL) and MT in Germany according to region and hospital-based evaluation., Methods: The evaluation involved data analysis of the diagnosis-related groups (DRG) statistics and structured quality reports of hospitals for 2010 and 2014. The rates and changes of STL and MT were evaluated in the 413 German districts with reference to the corresponding case number of patients with acute ischemic stroke., Results: Nationwide recanalization treatment rates increased from 2010 to 2014 both for STL (from 8.0% to 11.6%) and MT (from 0.7% to 2.3%). High variations were observed depending on the patient's place of residence (STL = 3.4-36.7%, MT = 0-7.4%). In 2014 a total of 5526 MT were coded in a total of 244,757 ischemic strokes. A total of 134 hospitals with more than 2 MT per year were identified; however, 21% of the nationwide MTs were performed in only 7 hospitals with more than 100 MT/year. In 308 (75%) of the 413 districts, not a single MT was performed., Conclusion: Due to a narrow net of certified stroke units with nationwide availability of STL, excellent structural conditions for treatment of acute stroke patients are already established in Germany. With regard to the nationwide availability of MT, there is still a need for optimization. Despite the increasing number of hospitals providing MT as an emergency procedure, a trend toward large intervention centers with supraregional catchment areas can be observed.

The safety and efficacy of intravenous thrombolysis (IVT) in dissection-related ischemic stroke (DRIS) has not been established. We sought to determine safety and recovery rates of IVT in DRIS using prospective, international, multicenter data and by conducting a comprehensive meta-analysis of reported case series. We analyzed consecutive DRIS patients treated with IVT according to national guidelines during a 5-year period at six tertiary-care stroke centers, and also conducted a comprehensive review and meta-analysis of all available case series reporting safety outcomes in DRIS treated with IVT according to PRISMA guidelines. A total of 39 DRIS patients (mean age 60 ± 18 years; 59% men; median NIHSS 13 points, IQR 9-17) received IVT in our multicenter study. Symptomatic intracranial hemorrhage (sICH), in-hospital mortality, complete recanalization, favorable functional outcome (FFO; mRS-score of 0-1) and functional independence (FI; mRS-score of 0-2) were 0% (adjusted Wald 95% CI 0-8%), 10% (3-24%), 55% (40-70%), 61% (45-74%) and 68% (52-81%). The pooled sICH and mortality rates in meta-analysis including 10 case series (234 IVT-DRIS patients) were 2% (0-5%) and 4% (0-8%). The pooled recanalization, FFO and FI rates were 45% (26-67%), 41% (29-54%) and 61% (48-72%), respectively. Substantial heterogeneity was only found for FFO (I(2) = 61%; p = 0.006). Subsequent meta-regression analysis identified baseline NIHSS and dissection in the posterior circulation as independent predictors of FFO (p < 0.05), accounting for FFO variance across different studies. Our prospective, international data coupled with comprehensive meta-analysis results underscore IVT safety in DRIS, while further independent validation is required in larger observational registries or RCTs.

Promising advances in stroke medicine have been reported recently regarding specialized stroke unit (SU) care, expansion of the time window of iv thrombolysis (IVT), mechanical thrombectomy (MT), and decompressive hemicraniectomy (DHC) for malignant brain infarction. It remains unclear to what extent new evidence of therapeutic procedures is transferred to the "real-world" of everyday hospital care. We analyzed epidemiologic and procedural therapeutic trends of hospitalized acute stroke patients in Germany by the comparison of administrative hospital data of the years 2008 (n=219,359) and 2012 (n=239,394). Proportion of specialized SU care rose from 43.4% to 56.9%. Even in age-matched analysis women were less likely to obtain this procedure. Rate of IVT increased from 5.6% to 10.2%. 32% of IVT therapies in 2012 were performed in patients over 80 years. Number of MT increased exponentially from 298 to 3906 procedures. Number of DHC did not increase significantly (2008=636; 2011=796). A strong momentum in transferring scientific insights to the "real-world" stroke care in Germany was documented. Increase of IVT therapy is largely due to the increase of off-label treatment. Almost every 46 th patient <80 years was treated by MT in 2012. Despite proven benefits in selected patients, utilization of DHC remained almost stable., (Copyright © 2014 Elsevier B.V. All rights reserved.)

Background: Networking structures are constructed to improve daily care of acute stroke patients, in the Ruhr area by the association of 26 neurological departments. Quality of care can be measured by the rate of stroke unit treatment and of thrombolysis. Epidemiological data are mainly derived from registers resulting in sparse insight into incidence and rate of specialized care in daily practice., Methods: The study involved data analysis of diagnosis-related groups (DRG) statistics and structured quality reports for 2008 and 2010 for depiction of the quality of routine treatment. Aggregation of the number of cases for incidence, rate of stroke unit treatment and thrombolysis district, province, and nation wide were analyzed., Results: In 5.2 million inhabitants, the incidence of ischemic stroke (ICD I63) was 296/100,000 in 2010 (district-wise range 244-364) and 56% of patients were treated on a stroke unit (range 18-80%; 2008: 43%, range 10-72%). The rate of thrombolysis (ICD I63) was 6.4% and 9.1% in 2008 and 2010 (2008 range 0-11.2%, 2010 range 3.9-18.0%), respectively, which was significantly above the provincial average in 10 out of 15 districts., Discussion: Ischemic stroke is a common disease in the area and the quality of care (e.g. stroke unit treatment and thrombolysis rate) is above average. The heterogeneous character of the region allows an exemplary networking aiming for the improvement of routine patient care, e.g. by the implementation of homogeneous standards and structural measures for the implementation of novel therapies. The current analysis allows the identification of the potential for optimization and monitoring of any changes.