ERASER.

Background and Purpose- Using a novel study design with virtual comparators based on predictive modeling, we investigated whether next-generation mechanical thrombectomy devices improve outcomes in patients with ischemic stroke. We hypothesized that this new study design shows that a next-generation mechanical thrombectomy system is superior to intravenous tPA (tissue-type plasminogen activator) therapy (IVT) alone. Methods- ERASER (Eric Acute Stroke Recanalization) was an investigator-initiated, prospective, multicenter, single-arm (virtual 2-arm) study that evaluated the effectiveness of a new recanalization device together with a specific intermediate catheter (Embolus Retriever with Interlinked Cages/SOFIA, Microvention) in stroke patients with internal carotid artery or middle cerebral artery occlusions. The primary end point was the volume of saved tissue. Volume of saved tissue was defined as the difference of actual infarct volume and brain volume predicted to develop infarction using a machine learning model based on data from intravenous tPA therapy patients. Results- Eighty-one patients were enrolled. The median patient age was 71 years (interquartile range, 61-77). National Institutes of Health Stroke Scale score was 14 (interquartile range, 12-18). The actual infarct volume was smaller than predicted by the intravenous tPA therapy model, with a median volume of saved tissue of 50 mL (interquartile range, 19-103; P<0.0001). Good clinical outcome (modified Rankin Scale, 0-2 at 90 days) was observed in 48 out of 69 (70%). The recanalization rate (Thrombolysis in Cerebral Infarction 2b/3) was 95%. Conclusions- ERASER is the first mechanical thrombectomy study with a primary end point based on predictive analytics enabling intraindividual virtual comparisons. The next-generation mechanical thrombectomy method resulted in smaller infarcts than predicted after intravenous tPA therapy alone and showed a high rate of good clinical outcome. The novel study design with virtual comparisons is promising for further application and testing in the neurovascular arena. Clinical Trial Registration- URL: https://www.clinicaltrials.gov . Unique identifier: NCT02534701.

A latent clinical-anatomical dimension relating metabolic syndrome to brain structure and cognition.

The link between metabolic syndrome (MetS) and neurodegenerative as well as cerebrovascular conditions holds substantial implications for brain health in at-risk populations. This study elucidates the complex relationship between MetS and brain health by conducting a comprehensive examination of cardiometabolic risk factors, brain morphology, and cognitive function in 40,087 individuals. Multivariate, data-driven statistics identified a latent dimension linking more severe MetS to widespread brain morphological abnormalities, accounting for up to 71% of shared variance in the data. This dimension was replicable across sub-samples. In a mediation analysis, we could demonstrate that MetS-related brain morphological abnormalities mediated the link between MetS severity and cognitive performance in multiple domains. Employing imaging transcriptomics and connectomics, our results also suggest that MetS-related morphological abnormalities are linked to the regional cellular composition and macroscopic brain network organization. By leveraging extensive, multi-domain data combined with a dimensional stratification approach, our analysis provides profound insights into the association of MetS and brain health. These findings can inform effective therapeutic and risk mitigation strategies aimed at maintaining brain integrity.

Early vs Late Anticoagulation in Minor, Moderate, and Major Ischemic Stroke With Atrial Fibrillation: Post Hoc Analysis of the ELAN Randomized Clinical Trial.

Importance: Whether infarct size modifies the treatment effect of early vs late direct oral anticoagulant (DOAC) initiation in people with ischemic stroke and atrial fibrillation is unknown. Objective: To assess whether infarct size modifies the safety and efficacy of early vs late DOAC initiation. Design, Setting, and Participants: Post hoc analysis of participants from the multinational (>100 sites in 15 countries) randomized clinical Early Versus Later Anticoagulation for Stroke With Atrial Fibrillation (ELAN) trial who had (1) acute ischemic stroke, (2) atrial fibrillation, and (3) brain imaging available before randomization. The ELAN trial was conducted between October 2017 and December 2022. Data were analyzed from October to December 2023 for this post hoc analysis. Intervention: Early vs late DOAC initiation after ischemic stroke. Early DOAC initiation was within 48 hours for minor or moderate stroke or on days 6 to 7 for major stroke; late DOAC initiation was on days 3 to 4 for minor stroke, days 6 to 7 for moderate stroke, and days 12 to 14 for major stroke. Main Outcomes and Measures: The primary outcome was a composite of recurrent ischemic stroke, symptomatic intracranial hemorrhage, extracranial bleeding, systemic embolism, or vascular death within 30 days. The outcome was assessed according to infarct size (minor, moderate, or major) using odds ratios and risk differences between treatment arms. Interrater reliability for infarct size between the core laboratory and local raters was assessed, and whether this modified the estimated treatment effects was also examined. Results: A total of 1962 of the original 2013 participants (909 [46.3%] female; median [IQR] age, 77 [70-84] years) were included. The primary outcome occurred in 10 of 371 participants (2.7%) with early DOAC initiation vs 11 of 364 (3.0%) with late DOAC initiation among those with minor stroke (odds ratio [OR], 0.89; 95% CI, 0.38-2.10); in 11 of 388 (2.8%) with early DOAC initiation vs 14 of 392 (3.6%) with late DOAC initiation among those with moderate stroke (OR, 0.80; 95% CI, 0.35-1.74); and in 8 of 219 (3.7%) with early DOAC initiation vs 16 of 228 (7.0%) with late DOAC initiation among those with major stroke (OR, 0.52; 95% CI, 0.21-1.18). The 95% CI for the estimated risk difference of the primary outcome in early anticoagulation was -2.78% to 2.12% for minor stroke, -3.23% to 1.76% for moderate stroke, and -7.49% to 0.81% for major stroke. There was no significant treatment interaction for the primary outcome. For infarct size, interrater reliability was moderate (κ = 0.675; 95% CI, 0.647-0.702) for local vs core laboratory raters and strong (κ = 0.875; 95% CI, 0.855-0.894) between core laboratory raters. Conclusions and Relevance: The treatment effect of early DOAC initiation did not differ in people with minor, moderate, or major stroke assessed by brain imaging. Early treatment was not associated with a higher rate of adverse events, especially symptomatic intracranial hemorrhage, for any infarct size, including major stroke. Trial Registration: ClinicalTrials.gov Identifier: NCT03148457.

Mechanical thrombectomy in ischemic stroke after cardiovascular procedures: a propensity-matched cohort analysis.

BACKGROUND: Stroke after a cardiovascular procedure (CVP) is a devastating complication adversely affecting outcome. Mechanical thrombectomy (MT) has not been investigated systematically in this population. OBJECTIVE: To carry out a retrospective study in patients undergoing MT for early stroke after CVP, aiming to further characterize this cohort of patients, and to evaluate the efficacy, safety, procedural characteristics, and outcome of MT. METHODS: A single-center stroke registry of patients who received MT was analyzed. Baseline and procedural parameters, mortality, functional outcome, recanalization rates, and complications were evaluated. Propensity score matching was carried out, identifying a control cohort with non-periprocedural large vessel occlusion (LVO). RESULTS: Overall 913 patients were included (mean age 73.0 (±13.0) years, 52.5% female, median National Institutes of Health Stroke Scale score 15 (10-19)). Eleven patients with a LVO after a recent (<30 days postoperatively) CVP were identified (n=3 transcatheter aortic valve and n=1 surgical aortic valve replacements (SAVR), n=3 coronary bypass grafting (CABG) surgeries, n=2 SAVR+CABG, and n=2 aortic surgeries). After matching, 8 patients in the CVP group were compared with 16 patients in the matched cohort. Comparable rates of reperfusion were achieved. Time from symptom onset to groin puncture (171.5 min (136.3, 178.3) vs 284.0 min (215.0, 490.5); p=0.039), as well as recanalization (195.0 min (146.0, 201.0) vs 419.0 min (274.0, 613.0); p=0.028) was faster in the CVP group. However, this was not reflected by an improved outcome (modified Rankin Scale score after 90 days: 5.5 (3.3, 6.0) vs 5.0 (4.0, 6.0), mortality after 90 days 50.0% vs 37.5%). Complications did not differ between the groups. CONCLUSIONS: Use of MT for LVO stroke in patients after a recent CVP is a safe and efficient treatment in comparison with patients with a non-periprocedural LVO undergoing MT.

How much of the outcome improvement after successful recanalization is explained by follow-up infarct volume reduction?

BACKGROUND: Follow-up infarct volume (FIV) is used as surrogate for treatment efficiency in mechanical thrombectomy (MT). However, previous works suggest that MT-related FIV reduction has only limited association with outcome comparing MT independently of recanalization success versus medical care. It remains unclear to what extent the relationship between successful recanalization versus persistent occlusion and functional outcome is explained by FIV reduction. OBJECTIVE: To determine whether FIV mediates the relationship between successful recanalization and functional outcome. METHODS: All patients from our institution enrolled in the German Stroke Registry (May 2015-December 2019) with anterior circulation stroke; availability of the relevant clinical data, and follow-up-CT were analyzed. The effect of FIV reduction on functional outcome (90-day modified Rankin Scale (mRS) score ≤2) after successful recanalization (Thrombolysis in Cerebral Infarction ≥2b) was quantified using mediation analysis. RESULTS: 429 patients were included, of whom, 309 (72 %) had successful recanalization and 127 (39%) had good functional outcome. Good outcome was associated with age (OR=0.89, P<0.001), pre-stroke mRS score (OR=0.38, P<0.001), FIV (OR=0.98, P<0.001), hypertension (OR=2.08, P<0.05), and successful recanalization (OR=3.57, P<0.01). Using linear regression in the mediator pathway, FIV was associated with Alberta Stroke program Early CT Score (coefficient (Co)=-26.13, P<0.001), admission National Institutes of Health Stroke Scale score (Co=3.69, P<0.001), age (Co=-1.18, P<0.05), and successful recanalization (Co=-85.22, P<0.001). Successful recanalization increased the probability of good outcome by 23 percentage points (pp) (95% CI 16pp to 29pp). 56% (95% CI 38% to 78%) of the improvement in good outcome was explained by FIV reduction. CONCLUSION: 56% (95% CI 38% to 78%) of outcome improvement after successful recanalization was explained by FIV reduction. Results corroborate pathophysiological assumptions and confirm the value of FIV as an imaging endpoint in clinical trials. 44% (95% CI 22% to 62%) of the improvement in outcome was not explained by FIV reduction and reflects the remaining mismatch between radiological and clinical outcome measures.

Thrombectomy in M2 occlusion compared to M1 occlusion: treatment effects of Thrombolysis In Cerebral Infarction (TICI) 2b and TICI 3 recanalization on functional outcome.

BACKGROUND: Emerging data suggest that mechanical thrombectomy (MT) might also be safe and efficient for medium and distal occlusions. This study aims to compare average treatment effects on functional outcome of different degrees of recanalization after MT in patients with M2 occlusion and M1 occlusion. METHODS: All patients enrolled in the German Stroke Registry (GSR) between June 2015 and December 2021 were analyzed. Inclusion criteria were stroke with primary M1 occlusion or M2 occlusion, and availability of relevant clinical data. 4259 patients were included, thereof 1353 with M2 occlusion and 2906 with M1 occlusion. Treatment effects were analyzed using double-robust inverse-probability-weighted regression-adjustment (IPWRA) estimators to control for confounding covariates. Binarized endpoint metrics were defined as good outcome with modified Rankin Scale (mRS) ≤2 at 90 days, and linearized endpoint metrics were defined as mRS shift pre-stroke to 90 days. Effects were evaluated for near complete recanalization (Thrombolysis In Cerebral Infarction scale (TICI) 2b) and complete recanalization (TICI 3). RESULTS: Treatment effect estimation for TICI ≥2b versus TICI <2b in M2 occlusions showed an increase in the probability of a good outcome from 27% to 47% with a number-needed-to-treat (NNT) of 5. For M1 occlusions the probability of a good outcome increased from 16% to 38% with NNT 4.5. TICI 3 versus TICI 2b increased the probability of a good outcome by 7 percentage points in M1 occlusions; for M2 occlusions the beneficial effect was not significant. CONCLUSIONS: Results suggest that successful recanalization with TICI ≥2b versus TICI <2b after MT in M2 occlusions provides significant patient benefit with treatment effects comparable to M1 occlusions. The probability of functional independence increased by 20 percentage points (NNT 5) and stroke-related mRS increase was reduced by 0.9 mRS points. In contrast to M1 occlusions, complete recanalization TICI 3 versus TICI 2b had lower additional beneficial effect.

Inflammatory burden, lifestyle and atherosclerotic cardiovascular disease: insights from a population based cohort study.

The inflammatory burden as measured by high-sensitivity C-reactive Protein (hsCRP) is recognized as a cardiovascular risk factor, which can however be affected by lifestyle-related risk factors (LRF). Up-to-date the interplay between hsCRP, LRF and presence and extent of atherosclerotic disease is still largely unknown, which we therefore sought to investigate in a contemporary population-based cohort. We included participants from the cross-sectional population-based Hamburg City Health Study. Affected vascular beds were defined as coronary, peripheral, and cerebrovascular arteries. LRF considered were lack of physical activity, overweight, active smoking and poor adherence to a Mediterranean diet. We computed multivariable analyses with hsCRP as the dependent variable and LRF as covariates according to the number of vascular beds affected. In the 6765 individuals available for analysis, we found a stepwise increase of hsCRP concentration both according to the number of LRF present as well as the number of vascular beds affected. Adjusted regression analyses showed an independent association between increasing numbers of LRF with hsCRP levels across the extent of atherosclerosis. We demonstrate increasing hsCRP concentrations according to both the number of LRF as well as the extent of atherosclerosis, emphasizing the necessity of lifestyle-related risk factor optimization.

Comparison of Thrombolysis In Cerebral Infarction (TICI) 2b and TICI 3 reperfusion in endovascular therapy for large ischemic anterior circulation strokes.

BACKGROUND: Landmark thrombectomy trials have provided evidence that selected patients with large ischemic stroke benefit from successful endovascular therapy, commonly defined as incomplete (modified Thrombolysis In Cerebral Infarction (mTICI) 2b) or complete reperfusion (mTICI 3). We aimed to investigate whether mTICI 3 improves functional outcomes compared with mTICI 2b in large ischemic strokes. METHODS: This retrospective multicenter cohort study was conducted to compare mTICI 2b versus mTICI 3 in large ischemic strokes in the anterior circulation. Patients enrolled in the German Stroke Registry between 2015-2021 were analyzed. Large ischemic stroke was defined as an Alberta Stroke Program Early CT Score (ASPECTS) of 3-5. Patients were matched by final mTICI grade using propensity score matching. Primary outcome was the 90-day modified Rankin Scale (mRS) score. RESULTS: After matching, 226 patients were included. Baseline and imaging characteristics were balanced between mTICI 2b and mTICI 3 patients. There was no shift on the mRS favoring mTICI 3 compared with mTICI 2b in large ischemic strokes (adjusted common odds ratio (acOR) 1.12, 95% confidence interval (95% CI) 0.64 to 1.94, P=0.70). The rate of symptomatic intracranial hemorrhage was higher in mTICI 2b than in mTICI 3 patients (12.6% vs 4.5%, P=0.03). Mortality at 90 days did not differ between mTICI 3 and mTICI 2b (33.6% vs 37.2%; adjusted OR 0.69, 95% CI 0.33 to 1.45, P=0.33). CONCLUSIONS: In endovascular therapy for large ischemic strokes, mTICI 3 was not associated with better 90-day functional outcomes compared with mTICI 2b. This study suggests that mTICI 2b might be warranted as the final angiographic result, questioning the benefit/risk ratio of additional maneuvers to seek for mTICI 3 in large ischemic strokes. TRIAL REGISTRATION NUMBER: NCT03356392.

Endovascular treatment of acute tandem lesions in patients with mild anterior circulation stroke.

BACKGROUND: In patients with mild strokes the risk-benefit ratio of endovascular treatment (EVT) for tandem lesions has yet to be evaluated outside of current guideline recommendations. This study investigates the frequency as well as procedural and safety outcomes in daily clinical practice. METHODS: Using data from the German Stroke Registry-Endovascular Treatment (GSR-ET) we analyzed patients with anterior circulation stroke due to tandem-lesions and mild deficits. These patients were defined as ≤5 on the National Institutes of Health Stroke Scale (NIHSS). Recanalization was assessed with the modified Thrombolysis in Cerebral Infarction Scale (mTICI). Early neurological and long-term functional outcomes were assessed with the NIHSS change and modified Rankin scale (mRS), respectively. Safety assessment included periprocedural complications and the rate of symptomatic intracerebral hemorrhage (sICH). RESULTS: A total of 61 patients met the inclusion criteria and were treated endovascularly for tandem lesions. The median age was 68 (IQR:59-76) and 32.9% (20) were female. Patients were admitted to the hospital with a median NIHSS score of 4 (IQR:2-5) and a median Alberta Stroke Programme Early CT Score (ASPECTS) of 9 (IQR:8-10). Successful recanalization (mTICI 2b-3) was observed in 86.9% (53). NIHSS decreased non-significantly (p=0.382) from baseline to two points (IQR:1-9) at discharge. Excellent (mRS≤1) and favorable (mRS≤2) long-term functional outcome at 90-days was 55.8% (29) and 69.2% (36), respectively. Mortality rates at 90-days were 9.6% (5) and sICH occurred in 8.2% (5). CONCLUSIONS: EVT for tandem lesions in patients with mild anterior circulation stroke appears to be feasible but may lead to increased rates of sICH. Further studies comparing endovascular with best medical treatment (BMT) especially investigating the risk of periprocedural hemorrhagic complications, are needed.

Health-related quality of life after thrombectomy in young-onset versus older stroke patients: a multicenter analysis.

BACKGROUND: Information is lacking on self-reported health-related quality of life (HRQoL) as a complementary outcome measure in addition to the modified Rankin scale (mRS) in young patients with ischemic stroke after endovascular thrombectomy (EVT) compared with older patients. METHODS: Data on consecutive patients with stroke who underwent thrombectomy (June 2015-2019) from a multicenter prospective registry (German Stroke Registry) were analyzed. HRQoL was measured by the European QoL-5 dimension questionnaire utility index (EQ-5D-I; higher values indicate better HRQoL) 3 months after stroke in patients aged ≤55 and >55 years. Multivariate regression analyses identified predictors of better HRQoL. RESULTS: Of 4561 included patients, 526 (11.5%) were ≤55 years old. Young-onset patients had a better outcome assessed by mRS (mRS 0-2: 64.3% vs 31.8%, p<0.001) and EQ-5D-I (mean 0.639 vs 0.342, p<0.001). Young survivors after EVT had fewer complaints in the EQ-5D domains mobility (p<0.001), self-care (p<0.001), usual activities (p<0.001) and pain/discomfort (p=0.008), whereas no difference was observed in anxiety/depression (p=0.819). Adjusted regression analysis for 90-day mRS showed no difference in HRQoL between the two subgroups of patients. Lower age, National Institutes of Health Stroke Scale score and pre-stroke mRS, a higher Alberta Stroke Program Early CT Score, concomitant intravenous thrombolysis therapy and successful recanalization were associated with better HRQoL in both patient subgroups. CONCLUSIONS: Young-onset stroke patients have a better HRQoL after EVT than older patients. Their higher HRQoL is mainly explained by less physical disability assessed by mRS. Depressive symptoms should be actively assessed and targeted in rehabilitation therapies of young-onset stroke patients to improve quality of life after stroke.

Predictors of poor clinical outcome despite complete reperfusion in acute ischemic stroke patients.

BACKGROUND: In patients suffering from acute ischemic stroke from large vessel occlusion (LVO), mechanical thrombectomy (MT) often leads to successful reperfusion. Only approximately half of these patients have a favorable clinical outcome. Our aim was to determine the prognostic factors associated with poor clinical outcome following complete reperfusion. METHODS: Patients treated with MT for LVO from a prospective single-center stroke registry between July 2015 and April 2019 were screened. Complete reperfusion was defined as Thrombolysis in Cerebral Infarction (TICI) grade 3. A modified Rankin scale at 90 days (mRS90) of 3-6 was defined as 'poor outcome'. A logistic regression analysis was performed with poor outcome as a dependent variable, and baseline clinical data, comorbidities, stroke severity, collateral status, and treatment information as independent variables. RESULTS: 123 patients with complete reperfusion (TICI 3) were included in this study. Poor clinical outcome was observed in 67 (54.5%) of these patients. Multivariable logistic regression analysis identified greater age (adjusted OR 1.10, 95% CI 1.04 to 1.17; p=0.001), higher admission National Institutes of Health Stroke Scale (NIHSS) (OR 1.14, 95% CI 1.02 to 1.28; p=0.024), and lower Alberta Stroke Program Early CT Score (ASPECTS) (OR 0.6, 95% CI 0.4 to 0.84; p=0.007) as independent predictors of poor outcome. Poor outcome was independent of collateral score. CONCLUSION: Poor clinical outcome is observed in a large proportion of acute ischemic stroke patients treated with MT, despite complete reperfusion. In this study, futile recanalization was shown to occur independently of collateral status, but was associated with increasing age and stroke severity.

Predictors of independent outcome of thrombectomy in stroke patients with large baseline infarcts in clinical practice: a multicenter analysis.

OBJECTIVE: To analyze outcome and its predictors after endovascular treatment (ET) in stroke patients suffering from large vessel occlusion with large pre-treatment infarct cores defined by an Alberta Stroke Program Early CT Score (ASPECTS) <6. METHODS: We analyzed data from an industry-independent, multicenter, prospective registry (German Stroke Registry - Endovascular Treatment) which enrolled consecutive patients treated by ET (June 2015-April 2018) with different devices. Multivariate logistic regression analyses identified predictors of independent outcome (IO) defined as a modified Rankin Scale (mRS) 0-2, and mortality at 90 days in patients with ASPECTS <6. RESULTS: Of 1700 patients included in the analysis, 152 (8.9%) had a baseline ASPECTS <6. Of these, 33 patients (21.6%) achieved IO, and 68 (44.7%) were dead at 90 days. A lower age, lower baseline National Institutes of Health Stroke Scale (NIHSS) score, and successful recanalization (defined as modified Thrombolysis in Cerebral Infarction Score, mTICI 2b/3) were predictors of IO. Successful recanalization had the strongest association with IO (OR 7.0, 95% CI 1.8 to 26.8). Pre-treatment parameters predicting IO were age <70 years (sensitivity 0.79, specificity 0.69) and NIHSS <12 (0.57 and 0.94). A higher age, a pre-stroke mRS score >1, and failed recanalization were predictors of death. CONCLUSIONS: A substantial proportion of stroke patients with an ASPECTS <6 can achieve independence after thrombectomy, in particular, if they are younger, have only moderate baseline stroke symptoms, and no relevant pre-stroke disability. These results may encourage considering thrombectomy in low ASPECTS patients in clinical practice until randomized trials are available.

Stenting with Acclino (flex) for symptomatic intracranial stenosis as secondary stroke prevention.

BACKGROUND AND PURPOSE: Stroke recurrence is high in patients with symptomatic intracranial stenosis despite best medical treatment. Based on evidence from past studies using previous stent generations, elective intracranial stenting (eICS) is considered in a minority of patients. This study aims to report on experience performing eICS with a novel device combination. METHODS: We retrospectively reviewed data from three high volume stroke centers and analyzed patients that were treated with eICS for symptomatic intracranial stenosis using the Acclino (flex) stent and the NeuroSpeed balloon catheter (Acandis GmbH, Pforzheim, Germany). Study endpoints were periprocedural rates of stroke regardless of territory or death at discharge and at the time of follow-up after eICS. Safety evaluation included asymptomatic and symptomatic intracranial hemorrhage, serious adverse events related to the intervention, and evaluation of stent patency at the time of follow-up. RESULTS: The median age of patients that met the inclusion criteria (n=76) was 69 years. Target vessels were located in the anterior circulation in 55.3% (42/76) of patients. The periprocedural stroke rate was 6.5% (fatal stroke 2.6%; non-fatal stroke 3.9%) at discharge after eICS. Asymptomatic intracranial hemorrhage was observed in 5.2% (4/76) of patients. Follow-up DSA revealed in-stent restenosis of 25% (15/60), and percutaneous transluminal angioplasty was performed again in 11.6% (7/60) of patients. CONCLUSION: Stenting for symptomatic intracranial stenosis with the Acclino (flex)/NeuroSpeed balloon catheter seemed to be safe and reinforces eICS as an endovascular therapy option for secondary stroke prevention. Future studies are warranted to confirm these findings and investigate antithrombotic strategies and in-stent restenosis to minimize periprocedural complications and guarantee long term stent patency.

Intracranial bailout stenting with the Acclino (Flex) Stent/NeuroSpeed Balloon Catheter after failed thrombectomy in acute ischemic stroke: a multicenter experience.

BACKGROUND AND PURPOSE: To report on the feasibility, safety, and outcome of acute intracranial stenting (ICS) with the Acclino (Flex) Stent and NeuroSpeed Balloon Catheter in cases of failed mechanical thrombectomy (MT) for acute ischemic stroke (AIS). METHODS: We retrospectively reviewed the data of patients treated with acute bailout stenting after failed MT in three large neurointerventional centers using exclusively the Acclino (Flex) Stent and the NeuroSpeed Balloon Catheter. Functional outcome was assessed by the rate of major early neurological recovery (mENR) at 24 hours and at 90 days with the modified Rankin Scale (mRS). Safety evaluation included symptomatic intracranial hemorrhage (sICH), mortality, and intervention-related serious adverse events (SAEs). RESULTS: 50 patients with a median age of 71 years met the inclusion criteria and 52% (26/50) of the occluded vessels were located within the anterior circulation. mENR was observed in 38.8% and 90-day favorable outcome (mRS ≤2) was 40.6% (13/32). Higher NIH Stroke Scale scores on admission were significantly associated with poor functional outcome (mRS ≥3) at 90 days (adjusted OR 1.28; 95% CI 1.07 to 1.53; p=0.007). sICH occurred in two cases of the study population. There were no intervention-related SAEs. CONCLUSION: Intracranial bailout stenting with the Acclino (Flex) Stent and the NeuroSpeed Balloon Catheter after failed MT is a feasible and effective recanalization method for atherosclerotic stenosis-based stroke that is associated especially with low rates of sICH.

Risk assessment of symptomatic intracerebral hemorrhage after thrombolysis using DWI-ASPECTS.

BACKGROUND AND PURPOSE: Pretreatment lesion size on diffusion-weighted imaging (DWI) is a risk factor for symptomatic intracerebral hemorrhage (sICH) associated with thrombolytic treatment. Here, we investigated whether the Alberta Stroke Programme Early CT Score (ASPECTS) applied to DWI images (DWI-ASPECTS) predicts sICH risk accurately. METHODS: In this retrospective multicenter study, prospectively collected data of 217 patients with anterior circulation stroke treated with intravenous or intraarterial thrombolysis within 6 hours after symptom onset were analyzed. Pretreatment DWI-ASPECTS scores were assessed by 2 independent investigators. For bleeding risk analysis, DWI-ASPECTS scores were either categorized into 0 to 7 (n=105) or 8 to 10 (n=112) or in 3 groups of similar sample size (DWI-ASPECTS 0 to 5 [n=69], 6 to 7 [n=70], and 8 to 10 [n=78]). RESULTS: DWI-ASPECTS scores correlated well with the DWI lesion volume (r=0.77, P<0.001, Spearman Rank test). Interobserver reliability for the assessment of DWI-ASPECTS was moderate (weighted kappa 0.441 [95% CI 0.373 to 0.509]). Twenty-three (10.6%) patients developed sICH. The sICH rate was significantly higher in patients with DWI-ASPECTS scores 0 to 7 (n=21, 15.1%) as compared to patients with DWI-ASPECTS scores 8 to 10 (n=2, 2.6%, P=0.004). sICH risk was 20.3%, 10%, and 2.6% in the 0 to 5, 6 to 7, and 8 to 10 DWI-ASPECTS groups, respectively. DWI-ASPECTS remained an independent prognostic factor for sICH after adjustment for clinical baseline variables (age, NIHSS, time to thrombolysis). CONCLUSIONS: DWI-ASPECTS predicts sICH risk after thrombolysis and may be helpful to contributing to quick sICH risk assessment before thrombolytic therapy.

Mechanical thrombectomy in nonagenarians with acute ischemic stroke.

BACKGROUND: Mechanical thrombectomy (MT) is a safe and effective therapy for ischemic stroke. Nevertheless, very elderly patients aged ≥90 years were either excluded or under-represented in previous trials. It remains uncertain whether MT is warranted for this population or whether there should be an upper age limit. METHODS: We retrospectively reviewed 79 patients with stroke aged ≥90 years from three neurointerventional centers who underwent MT between 2013 and 2017. Good functional outcome was defined as modified Rankin scale (mRS) ≤2 and assessed at 90-day follow-up. Successful recanalization was graded by Thrombolysis in Cerebral Infarction Scale (TICI) ≥2 b. Feasibility and safety assessments included unsuccessful recanalization attempts (TICI 0), time from groin puncture to recanalization, symptomatic intracranial hemorrhage (sICH), mortality, and intervention-related serious adverse events. RESULTS: Only occlusions within the anterior circulation were included. Median time from groin puncture to recanalization was 39 min (IQR 25-57 min). The rate of successful recanalization (TICI ≥2 b) was 69.6% (55/79). Good functional outcome (mRS ≤2) at 90 days was observed in 16% (12/75) of patients. In-hospital mortality was 29.1% (23/79) and increased significantly at 90 days (46.7%, 35/75; p<0.001). sICH occurred in 5.1% (4/79) of patients. No independent predictor for good functional outcome (mRS ≤2) at 90 days was identified through logistic regression analysis. CONCLUSION: MT in nonagenarians leads to high mortality rates and less frequently good functional outcome compared with younger patient cohorts in previous large randomized trials. However, MT appears to be safe and beneficial for a certain number of very elderly patients and therefore should generally not be withheld from nonagenarians.

Intracranial Rescue Stent Angioplasty After Stent-Retriever Thrombectomy : Multicenter Experience.

PURPOSE: Stent-retriever thrombectomy (SRT) for acute intracranial large artery occlusion (LAO) may not result in permanent recanalization in rare cases, e.g. due to an underlying stenosis or dissection. In this specific patient group, rescue stent angioplasty (RSA) may be the only treatment option to achieve permanent vessel patency and potentially a good clinical outcome. To date, the experience with RSA is limited. METHODS: In this retrospective analysis, interventional and clinical data of patients with acute intracranial LAO of the anterior and posterior circulation who underwent RSA after SRT due to an underlying lesion between 2012-2017 in four neurovascular centers were studied. RESULTS: In this study 34 patients (mean age 67 years) were included whereby 18 patients had anterior circulation LAO and 16 patients posterior circulation LAO. The SRT maneuver count ranged between 1 and 15 (median 2). Indications for RSA were an immediate re-occlusion in 25 (74%), and a persistent high-grade stenosis in 9 patients (26%). The RSA was technically feasible in 33 patients (97%). A mTICI 2b/3 result was obtained in 26 patients (76%). Median onset-to-recanalization time was 248 min (range 80-650 min). After 3 months 10/34 patients (29%) had a good clinical outcome (modified Rankin Scale, mRS 0-2). In detail, 4/18 patients (22%) with anterior circulation LAO and 6/16 patients (38%) with posterior circulation LAO were functionally independent. CONCLUSION: The use of RSA can be considered for acute intracranial LAO in cases with immediate re-occlusion or high-grade stenosis after SRT alone.

Multivariate dynamic prediction of ischemic infarction and tissue salvage as a function of time and degree of recanalization.

Benefit of endovascular recanalization beyond established treatment time windows likely exists in select stroke patients. However, there is currently no imaging model that predicts infarction adjusting for elapsed time between the pathologic snapshot of admission imaging until endovascular recanalization. We trained and cross validated a multivariate generalized linear model (GLM) that uses computer tomography perfusion and clinical data to quantify patient-specific dynamic change of tissue infarction depending on degree and time of recanalization. Multicenter data of 161 patients with proximal anterior circulation occlusion undergoing endovascular therapy were included. Multivariate voxelwise infarct probability was calculated within the GLM. The effect of increasing time to treatment and degree of recanalization on voxelwise infarction was calculated in each patient. Tissue benefit of successful relative to unsuccessful recanalization was shown up to 15 hours after onset in individual patients and decreased nonlinearly with time. On average, the relative reduction of infarct volume at the treatment interval of 5 hours was 53% and this salvage effect decreased by 5% units per hour to <5% after 10 additional hours to treatment. Treatment time-adjusted multivariate prediction of infarction by perfusion and clinical status may identify patients who benefit from extended time to recanalization therapy.