Endovascular Therapy for Acute Stroke with a Large Ischemic Region.

BACKGROUND: Endovascular therapy for acute ischemic stroke is generally avoided when the infarction is large, but the effect of endovascular therapy with medical care as compared with medical care alone for large strokes has not been well studied. METHODS: We conducted a multicenter, open-label, randomized clinical trial in Japan involving patients with occlusion of large cerebral vessels and sizable strokes on imaging, as indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) value of 3 to 5 (on a scale from 0 to 10, with lower values indicating larger infarction). Patients were randomly assigned in a 1:1 ratio to receive endovascular therapy with medical care or medical care alone within 6 hours after they were last known to be well or within 24 hours if there was no early change on fluid-attenuated inversion recovery images. Alteplase (0.6 mg per kilogram of body weight) was used when appropriate in both groups. The primary outcome was a modified Rankin scale score of 0 to 3 (on a scale from 0 to 6, with higher scores indicating greater disability) at 90 days. Secondary outcomes included a shift across the range of modified Rankin scale scores toward a better outcome at 90 days and an improvement of at least 8 points in the National Institutes of Health Stroke Scale (NIHSS) score (range, 0 to 42, with higher scores indicating greater deficit) at 48 hours. RESULTS: A total of 203 patients underwent randomization; 101 patients were assigned to the endovascular-therapy group and 102 to the medical-care group. Approximately 27% of patients in each group received alteplase. The percentage of patients with a modified Rankin scale score of 0 to 3 at 90 days was 31.0% in the endovascular-therapy group and 12.7% in the medical-care group (relative risk, 2.43; 95% confidence interval [CI], 1.35 to 4.37; P = 0.002). The ordinal shift across the range of modified Rankin scale scores generally favored endovascular therapy. An improvement of at least 8 points on the NIHSS score at 48 hours was observed in 31.0% of the patients in the endovascular-therapy group and 8.8% of those in the medical-care group (relative risk, 3.51; 95% CI, 1.76 to 7.00), and any intracranial hemorrhage occurred in 58.0% and 31.4%, respectively (P<0.001). CONCLUSIONS: In a trial conducted in Japan, patients with large cerebral infarctions had better functional outcomes with endovascular therapy than with medical care alone but had more intracranial hemorrhages. (Funded by Mihara Cerebrovascular Disorder Research Promotion Fund and the Japanese Society for Neuroendovascular Therapy; RESCUE-Japan LIMIT ClinicalTrials.gov number, NCT03702413.).

Expanding the Treatable Imaging Profile in Patients With Large Ischemic Stroke: Subanalysis From a Randomized Clinical Trial.

BACKGROUND: We aimed to examine the boundary of the ischemic core volume in patients undergoing endovascular thrombectomy (EVT) versus those receiving medical management to determine the minimum optimal size for favorable treatment outcomes. METHODS: This is a prespecified substudy of the RESCUE-Japan LIMIT (Recovery by Endovascular Salvage for Cerebral Ultra-Acute Embolism-Japan Large Ischemic Core Trial). Patients with large vessel occlusion were enrolled between November 2018 and September 2021 with a National Institutes of Health Stroke Scale score of at least 6 on admission and an Alberta Stroke Program Early Computed Tomography Score value of 3 to 5. We investigated the correlation between optimal quantified ischemic core volume, assessed solely using magnetic resonance diffusion-weighted imaging, and functional outcomes (modified Rankin Scale score, 0-3) at 90 days by predictive marginal plots. Final infarct volume and safety outcomes (symptomatic intracerebral hemorrhage and mortality) were also assessed. RESULTS: Of the 203 cases, 168 patients (85 in the EVT group versus 83 in the medical management group) were included. The median (interquartile range) core volume was 94 (65-160) mL in patients with EVT and 115 (71-141) mL in the medical management group (P=0.72). The predictive marginal probabilities of the 2 groups intersected at 128 mL for estimating functional outcomes. Symptomatic intracerebral hemorrhage and mortality within 90 days had overlay margins through all core volumes in both groups. The median final infarct volume (interquartile range) was smaller in the EVT group (142 [80-223] mL versus 211 [123-289] mL in the medical management group; P<0.001). CONCLUSIONS: In this prespecified analysis of a randomized clinical trial involving patients with large ischemic strokes, patients with an estimated core volume of up to 128 mL on diffusion-weighted imaging benefit from EVT. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03702413.

Value of intravenous thrombolysis in endovascular treatment for large-vessel anterior circulation stroke: individual participant data meta-analysis of six randomised trials.

BACKGROUND: Intravenous thrombolysis is recommended before endovascular treatment, but its value has been questioned in patients who are admitted directly to centres capable of endovascular treatment. Existing randomised controlled trials have indicated non-inferiority of endovascular treatment alone or have been statistically inconclusive. We formed the Improving Reperfusion Strategies in Acute Ischaemic Stroke collaboration to assess non-inferiority of endovascular treatment alone versus intravenous thrombolysis plus endovascular treatment. METHODS: We conducted a systematic review and individual participant data meta-analysis to establish non-inferiority of endovascular treatment alone versus intravenous thrombolysis plus endovascular treatment. We searched PubMed and MEDLINE with the terms "stroke", "endovascular treatment", "intravenous thrombolysis", and synonyms for articles published from database inception to March 9, 2023. We included randomised controlled trials on the topic of interest, without language restrictions. Authors of the identified trials agreed to take part, and individual participant data were provided by the principal investigators of the respective trials and collated centrally by the collaborators. Our primary outcome was the 90-day modified Rankin Scale (mRS) score. Non-inferiority of endovascular treatment alone was assessed using a lower boundary of 0·82 for the 95% CI around the adjusted common odds ratio (acOR) for shift towards improved outcome (analogous to 5% absolute difference in functional independence) with ordinal regression. We used mixed-effects models for all analyses. This study is registered with PROSPERO, CRD42023411986. FINDINGS: We identified 1081 studies, and six studies (n=2313; 1153 participants randomly assigned to receive endovascular treatment alone and 1160 randomly assigned to receive intravenous thrombolysis and endovascular treatment) were eligible for analysis. The risk of bias of the included studies was low to moderate. Variability between studies was small, and mainly related to the choice and dose of the thrombolytic drug and country of execution. The median mRS score at 90 days was 3 (IQR 1-5) for participants who received endovascular treatment alone and 2 (1-4) for participants who received intravenous thrombolysis plus endovascular treatment (acOR 0·89, 95% CI 0·76-1·04). Any intracranial haemorrhage (0·82, 0·68-0·99) occurred less frequently with endovascular treatment alone than with intravenous thrombolysis plus endovascular treatment. Symptomatic intracranial haemorrhage and mortality rates did not differ significantly. INTERPRETATION: We did not establish non-inferiority of endovascular treatment alone compared with intravenous thrombolysis plus endovascular treatment in patients presenting directly at endovascular treatment centres. Further research could focus on cost-effectiveness analysis and on individualised decisions when patient characteristics, medication shortages, or delays are expected to offset a potential benefit of administering intravenous thrombolysis before endovascular treatment. FUNDING: Stryker and Amsterdam University Medical Centers, University of Amsterdam.

Number of Passes of Endovascular Therapy for Stroke With a Large Ischemic Core: Secondary Analysis of RESCUE-Japan LIMIT.

BACKGROUND: The increased risk of intracranial hemorrhage with multiple passes in endovascular therapy (EVT) for large vessel occlusion with a large ischemic core is a concern. We explored the effect of the number of EVT passes on patients in a randomized clinical trial. METHODS: This post hoc study was the secondary analysis of RESCUE-Japan LIMIT, which was a randomized clinical trial comparing EVT and medical treatment alone for large vessel occlusion with large ischemic core. We grouped patients according to the number of passes with successful reperfusion (modified Thrombolysis in Cerebral Infarction score, ≥2b) in 1, 2, and 3 to 7 passes and failed reperfusion (modified Thrombolysis in Cerebral Infarction score, 0-2a) after any pass in the EVT group, and these groups were compared with medical treatment group. The primary outcome was modified Rankin Scale score of 0 to 3 at 90 days. Secondary outcomes were improvement in National Institutes of Health Stroke Scale score of ≥8 at 48 hours, mortality at 90 days, symptomatic intracranial hemorrhage, and any intracranial hemorrhage within 48 hours. RESULTS: The number of patients who received EVT with successful reperfusion after 1, 2, and 3 to 7 passes and failed reperfusion were 44, 23, 19, and 14, respectively, and 102 received medical treatment alone. The adjusted odds ratios (95% CIs) for the primary outcome relative to medical treatment were 5.52 (2.23-14.28) after 1 pass, 6.45 (2.22-19.30) after 2 passes, 1.03 (0.15-4.48) after 3 to 7 passes, and 1.17 (0.16-5.37) if reperfusion failed. The adjusted odds ratios (95% CIs) for any intracranial hemorrhage within 48 hours relative to medical treatment were 1.88 (0.90-3.93) after 1 pass, 5.14 (1.97-14.72) after 2 passes, 3.00 (1.09-8.58) after 3 to 7 passes, and 6.16 (1.87-24.27) if reperfusion failed. CONCLUSIONS: The successful reperfusion within 2 passes was associated with better clinical outcomes. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03702413.

Levetiracetam versus fosphenytoin as a second-line treatment after diazepam for adult convulsive status epilepticus: a multicentre non-inferiority randomised control trial.

OBJECTIVE: Status epilepticus (SE) is an emergency condition for which rapid and secured cessation is crucial. Although fosphenytoin (FPHT) is recommended as a second-line treatment, levetiracetam (LEV) reportedly has similar efficacy, but higher safety. Therefore, we herein compared LEV with FPHT in adult SE. METHODS: We initiated a multicentre randomised control trial in emergency departments with adult patients with convulsive SE. Diazepam was initially administered, followed intravenously by FPHT at 22.5 mg/kg or LEV at 1000-3000 mg. The primary outcome was assigned as the seizure cessation rate within 30 min of the administration of the study drug. RESULTS: A total of 176 adult patients with SE were enrolled (82 FPHT and 94 LEV), and 3 were excluded from the full analysis set. Seizure cessation rates within 30 min were 83.8% (67/80) in the FPHT group and 89.2% (83/93) in the LEV group. The difference in these rates was 5.5% (95% CI -4.7 to 15.7, p=0.29). The non-inferiority of LEV to FPHT was confirmed with p<0.001 by the Farrington-Manning test. No significant differences were observed in the seizure recurrence rate or intubation rate within 24 hours. Serious adverse events developed in three patients in the FPHT group and none in the LEV group (p=0.061). CONCLUSION: The efficacy of LEV was similar to that of FPHT for adult SE following the administration of diazepam. LEV may be recommended as a second-line treatment for SE along with phenytoin/FPHT. TRIAL REGISTRATION NUMBER: jRCTs031190160.

Comparison of Prasugrel and Clopidogrel in Thrombotic Stroke Patients with Risk Factors for Ischemic Stroke Recurrence: An Integrated Analysis of PRASTRO-I, PRASTRO-II, and PRASTRO-III.

INTRODUCTION: Patients with stroke are at a high risk of recurrence, and although they receive antiplatelet therapies such as clopidogrel for secondary prevention of non-cardioembolic stroke, the recurrence rate remains high. Three phase 3 trials (PRASTRO-I/II/III) were conducted to determine the efficacy of prasugrel in preventing recurrent stroke. Here, we performed an integrated analysis of these studies to confirm the generalizability of the PRASTRO-III findings and to supplement the small sample size of the study. METHODS: Patients from PRASTRO-I, PRASTRO-II, and PRASTRO-III with ischemic stroke (large-artery atherosclerosis or small-artery occlusion) and at least one of the following were included: hypertension, dyslipidemia, diabetes mellitus, chronic kidney disease, or ischemic stroke history. The primary efficacy endpoint was the composite incidence of ischemic stroke, myocardial infarction (MI), and death from other vascular causes in the intention-to-treat population. Bleeding events (life-threatening bleeding, major bleeding, and clinically relevant bleeding) were evaluated as the primary safety endpoint. Cumulative incidences and 95% confidence intervals (CIs) were calculated for the study outcomes using the Kaplan-Meier method. Hazard ratios (HRs) and 95% CIs were calculated using the Cox regression model. RESULTS: The data of 2,184, 274, and 230 patients from PRASTRO-I, PRASTRO-II, and PRASTRO-III, respectively, were analyzed (N = 2,688; prasugrel, N = 1,337; clopidogrel, N = 1,351). Stroke at enrollment was classified as large-artery atherosclerosis in 49.3% of patients and small-artery occlusion in 50.7% of patients. The primary efficacy endpoint composite incidence (prasugrel vs. clopidogrel) was 3.4% versus 4.3% (HR: 0.771, 95% CI: 0.522-1.138). The incidence of each component of the primary efficacy endpoint for prasugrel versus clopidogrel was 3.1% (n = 41) versus 4.1% (n = 55) for ischemic stroke, 0.3% (n = 4) versus 0.2% (n = 3) for MI, and no events of death from other vascular causes. For the primary safety endpoint, bleeding events were reported in 6.0% of patients in the prasugrel group versus 5.5% of patients in the clopidogrel group (HR: 1.074, 95% CI: 0.783-1.473). CONCLUSIONS: This integrated analysis supports the findings of PRASTRO-III. Prasugrel is a promising treatment that results in a numerical reduction in the composite incidence of ischemic stroke, MI, and death from other vascular causes in patients with ischemic stroke who are at a high risk of stroke recurrence. No major safety issues were observed for prasugrel.

Comparison of the Clinical Outcome of Carotid Artery Stenting Between Institutions With a Treatment Strategy Based on Risk Factors and Those With First-Line Treatment.

PURPOSE: Carotid endarterectomy (CEA) and carotid artery stenting (CAS) are recommended based on certain risk factors. The volume of an institution's treatment experience may be associated with good clinical outcomes. There is a dilemma between the treatment strategy based on risk factors and the experience volume. Therefore, we investigated the clinical outcomes of CAS performed at institutions that selected the treatment strategy based on risk factors and those that performed CAS at the first-line treatment. MATERIALS AND METHODS: Patients who underwent CAS at 5 institutions were included in this retrospective case-control study. We defined CEA/CAS institutions as those that selected the treatment option based on risk factors, and CAS-first institutions as those that performed CAS as the first-line treatment. We investigated cases of ischemic stroke, hemorrhagic stroke, myocardial infarction, and deaths within 30 days of the intervention between the CEA/CAS- and CAS-first institution groups. One-to-one propensity score matching was performed to compare rates of ischemic and hemorrhagic strokes within 30 days of the intervention. RESULTS: A total of 239 and 302 patients underwent CAS at the CEA/CAS institutions and CAS-first institutions, respectively; ischemic stroke occurred in 12 (5.0%) and 7 patients (2.3%), respectively (p=0.09). No differences in major ischemic strokes (0.8% vs 1.3%; p=0.59), hemorrhagic strokes (0.4% vs 0.3%; p=0.87), or deaths (0.0% vs 0.7%; p=0.21) were observed. Myocardial infarction did not occur in either group. Propensity score analysis showed that ischemic stroke (odds ratio: 1.845, 95% confidence interval: 0.601-5.668, p=0.28) and hemorrhagic stroke (odds ratio: 1.000, 95% confidence interval: 0.0061-16.418, p=1.00) were not significantly associated with either institution group. CONCLUSIONS: The CAS-specific treatment strategies for CAS can achieve the same level of outcomes as the treatment strategy based on risk factors. The CAS performed based on risk factors in CEA/CAS institutions and the treatment of more than 30 patients/year/institution in CAS-first institutions were associated with good clinical outcomes.

Remodeling of venous drainage after the treatment of dural sinus malformation with arteriovenous shunts in a neonate: a case report and literature review.

Dural sinus malformations (DSMs) are rare congenital vascular diseases characterized by a giant venous pouch with or without arteriovenous shunts. We present a neonatal case of DSM that was diagnosed prenatally and treated via endovascular intervention in the early postnatal period. The patient presented with a large DSM involving the torcular Herophilion prenatal magnetic resonance imaging (MRI). Enlargement of the head circumference and respiratory failure rapidly progressed after birth. On the 5th day after birth, the neonate underwent endovascular occlusion via the umbilical artery. The arteriovenous shunt was occluded, and the reflux from the enlarged venous pouch to the dural sinus was decreased. No additional procedure other than ventriculoperitoneal shunting was required. The neonate's development slowly caught up to normal parameters. Follow-up MRI demonstrated the successful development of the venous drainage system. DSMs are characterized by an abnormally dilated dural sinus, which can block the venous return and ultimately increase intracranial pressure and cerebral ischemia. Long-term follow-up indicates that an abnormally developed dural sinus can be reconstructed by appropriate and timely treatment.

Development of cortical microvascularization in Moyamoya disease using the maximum intensity projection method from three-dimensional rotational angiography.

BACKGROUND: Neurosurgeons often experience increased cortical microvascularization in Moyamoya disease (MMD). However, there are no previous reports that radiologically evaluated preoperative cortical microvascularization. We investigated the development of cortical microvascularization and clinical characteristics of MMD using the maximum intensity projection (MIP) method. METHODS: We enrolled 64 patients at our institution, including patients with MMD (n = 26), intracranial atherosclerotic disease (ICAD; n = 18), and unruptured cerebral aneurysms (n = 20) as the control group. All patients underwent three-dimensional rotational angiography (3D-RA). The 3D-RA images were reconstructed using partial MIP images. Cortical microvascularization was defined as the vessels that branched off from the cerebral arteries and were classified as grade 0-2 depending on their development. RESULTS: Cortical microvascularization observed in patients with MMD was classified into grade 0 (n = 4, 8.9%), grade 1 (n = 17, 37.8%), and grade 2 (n = 24, 53.3%). The development of cortical microvascularization was more common in the MMD group than in the other groups. The inter-rater reliability measured using weighted kappa was 0.68 (95% confidence interval = 0.56-0.80). There were no significant differences in cortical microvascularization according to the onset type and hemispheres. Cortical microvascularization correlated with periventricular anastomosis. Most patients with Suzuki classifications 2-5 developed cortical microvascularization. CONCLUSION: Cortical microvascularization was characteristic of patients with MMD. These findings developed in the early stages of MMD and may act as a bridge to the development of periventricular anastomosis.

Relationship between platelet aggregation and stroke risk after percutaneous coronary intervention: a PENDULUM analysis.

In patients undergoing percutaneous coronary intervention (PCI) with a stent, high on-treatment platelet reactivity may be associated with an increased risk of stroke. This post hoc analysis of the PENDULUM registry compared the risk of post-PCI stroke according to on-treatment P2Y12 reaction unit (PRU) values. Patients aged ≥ 20 years who underwent PCI were stratified by baseline PRU (at 12 and 48 h post-PCI) as either high (HPR, > 208), optimal (OPR, > 85 to ≤ 208), or low on-treatment platelet reactivity (LPR, ≤ 85). The incidences of non-fatal ischemic and non-ischemic stroke through to 12 months post-PCI were recorded. Almost all enrolled patients (6102/6267 [97.4%]) had a risk factor for ischemic stroke, and most were receiving dual antiplatelet therapy. Of the 5906 patients with PRU data (HPR, n = 2227; OPR, n = 3002; LPR, n = 677), 47 had a non-fatal stroke post-PCI (cumulative incidence: 0.68%, ischemic; 0.18%, non-ischemic stroke). Patients with a non-fatal ischemic stroke event had statistically significantly higher post-PCI PRU values versus those without an event (P = 0.037). The incidence of non-fatal non-ischemic stroke was not related to PRU value. When the patients were stratified by PRU ≤ 153 versus > 153 at 12-48 h post-PCI, a significant difference was observed in the cumulative incidence of non-fatal stroke at 12 months (P = 0.044). We found that patients with ischemic stroke tended to have higher PRU values at 12-48 h after PCI versus those without ischemic stroke.Clinical trial registration: UMIN000020332.

Middle meningeal artery embolization for pediatric chronic subdural hematoma under anticoagulant therapy with ventricular assist device: a case report.

INTRODUCTION: Recently, the efficacy of middle meningeal artery (MMA) embolization for chronic subdural hematoma (cSDH) in the elderly has been reported. However, no previous reports of MMA embolization for cSDH in children with ventricular assist devices (VAD) have been published. Here, we report a case of MMA embolization for cSDH in a child with VAD. CASE: A 15-month-old female was diagnosed with dilated cardiomyopathy at 7 months old. Soon, a VAD was inserted, and anticoagulant and antiplatelet therapy was started. Bilateral cSDH was observed at 15 months, and, 2 months later, an acute exacerbation of the right cSDH necessitated intracerebral hemorrhage removal. Afterwards, increased intracranial pressure occurred due to a contralateral subdural hematoma but, 4 months after intracerebral hemorrhage removal, CT showed new hemorrhaging in the left cSDH. MMA embolization was then conducted to prevent rebleeding in the hematoma. Selective angiography of the left MMA demonstrated stains of hematoma capsules from the frontal and parietal branches, which were embolized using liquid embolic material. During the procedure, the material migrated into the intracranial vessels via an undetected transdural anastomosis. Postoperatively, no new neurological abnormalities, including hemiparesis, were observed. Two months later, CT showed a decrease in hematoma size. CONCLUSION: MMA embolization for cSDH in pediatric patients with VAD may be effective, if vigilance is maintained against transdural anastomoses.

Supervised Myoelectrical Hand Gesture Recognition in Post-Acute Stroke Patients with Upper Limb Paresis on Affected and Non-Affected Sides.

In clinical practice, acute post-stroke paresis of the extremities fundamentally complicates timely rehabilitation of motor functions; however, recently, residual and distorted musculoskeletal signals have been used to initiate feedback-driven solutions for establishing motor rehabilitation. Here, we investigate the possibilities of basic hand gesture recognition in acute stroke patients with hand paresis using a novel, acute stroke, four-component multidomain feature set (ASF-4) with feature vector weight additions (ASF-14NP, ASF-24P) and supervised learning algorithms trained only by surface electromyography (sEMG). A total of 19 (65.9 ± 12.4 years old; 12 men, seven women) acute stroke survivors (12.4 ± 6.3 days since onset) with hand paresis (Brunnstrom stage 4 ± 1/4 ± 1, SIAS 3 ± 1/3 ± 2, FMA-UE 40 ± 20) performed 10 repetitive hand movements reflecting basic activities of daily living (ADLs): rest, fist, pinch, wrist flexion, wrist extension, finger spread, and thumb up. Signals were recorded using an eight-channel, portable sEMG device with electrode placement on the forearms and thenar areas of both limbs (four sensors on each extremity). Using data preprocessing, semi-automatic segmentation, and a set of extracted feature vectors, support vector machine (SVM), linear discriminant analysis (LDA), and k-nearest neighbors (k-NN) classifiers for statistical comparison and validity (paired t-tests, p-value < 0.05), we were able to discriminate myoelectrical patterns for each gesture on both paretic and non-paretic sides. Despite any post-stroke conditions, the evaluated total accuracy rate by the 10-fold cross-validation using SVM among four-, five-, six-, and seven-gesture models were 96.62%, 94.20%, 94.45%, and 95.57% for non-paretic and 90.37%, 88.48%, 88.60%, and 89.75% for paretic limbs, respectively. LDA had competitive results using PCA whereas k-NN was a less efficient classifier in gesture prediction. Thus, we demonstrate partial efficacy of the combination of sEMG and supervised learning for upper-limb rehabilitation procedures for early acute stroke motor recovery and various treatment applications.

Delineability and anatomical variations of perforating arteries from normal vertebral artery on 3D DSA: implications for endovascular treatment of dissecting aneurysms.

BACKGROUND AND PURPOSE: Endovascular trapping of the vertebral artery dissecting aneurysms (VADAs) carries a risk of medullary infarction due to the occlusion of the perforating arteries. We evaluated the detectability and anatomical variations of perforating arteries arising from the vertebral artery (VA) using three-dimensional DSA. METHODS: In 120 patients without VA lesions who underwent rotational vertebral arteriography, the anatomical configurations of perforating arteries from the VA were retrospectively evaluated on the bi-plane DSA and reconstructed images to reach the consensus between two experienced reviewers. The images were interpreted by focusing on the numbers and types of perforating arteries, the relationships between the number of perforators and the anatomy of the VA and its branches. RESULTS: Zero, 1, 2, 3, 4, and 6 perforators were detected in 2, 51, 56, 9, 1, and 1 patient, respectively (median of 2 perforators per VA). The 200 perforators were classified into 146 terminal and 54 longitudinal course types and into 32 ventral, 151 lateral, and 17 dorsolateral distribution types. All ventral type perforators were also terminal type. In contrast, the longitudinal type was seen in 28.5% of lateral types and in 65% of dorsolateral types. Regarding the difference in the origin of the posterior inferior cerebellar artery (PICA), non-PICA type VAs gave off larger number of perforators than the other types of VAs. CONCLUSIONS: Non-PICA type VAs give off a significantly larger number of perforators than other types, indicating that the trapping of non-PICA type VAs is associated with a risk of ischemic complications.

Risk factors for medullary infarction after endovascular trapping of vertebral artery dissecting aneurysms.

Internal trapping (IT) is a treatment option for intracranial vertebral artery dissecting aneurysms (VADAs). Medullary infarction (MI) is a complication linked to this treatment. This study aims to clarify the outcomes of IT for VADAs and the risk factors for MIs. We retrospectively reviewed the databases from 2010 to 2017 to identify patients with VADAs treated by IT at seven collaborating institutions. Radiological findings, clinical courses, and outcomes were analyzed. Perforating arteries were classified into terminal or longitudinal types using preoperative angiography. IT was completed in 90 patients (74 ruptured and 16 unruptured VADA). Postoperative rebleeding did not occur in any ruptured VADA patients. Postoperative MRI detected MIs in 26 patients (28.9%). The incidence of MIs in the ruptured VADA (32%) was higher compared with that in the unruptured VADA (13%), though it was not significant. In the MI group, the occlusion or blind alley of the terminal-type and longitudinal-type perforator was confirmed in 23 patients (88%) and 11 patients (42%), respectively. The occlusion or blind alley of the terminal-type perforator was an independent risk factor for MIs in the logistic regression analysis (OR 5.81; 95% CI 1.34-25.11; p = 0.018). In ruptured VADA, postoperative MI (OR 12.2; 95% CI 3.19-64.55; p = 0.0001) and high-grade SAH (OR 8.02; 95% CI 2.32-37.70; p = 0.0006) were independent risk factors of an unfavorable clinical outcome. In conclusion, MIs were an independent risk factor for unfavorable outcomes after IT, especially for a ruptured VADA. The occlusion or blind alley of the terminal-type perforator caused by the IT was associated with postoperative MIs.

Effect of Mechanical Thrombectomy Without vs With Intravenous Thrombolysis on Functional Outcome Among Patients With Acute Ischemic Stroke: The SKIP Randomized Clinical Trial.

IMPORTANCE: Whether intravenous thrombolysis is needed in combination with mechanical thrombectomy in patients with acute large vessel occlusion stroke is unclear. OBJECTIVE: To examine whether mechanical thrombectomy alone is noninferior to combined intravenous thrombolysis plus mechanical thrombectomy for favorable poststroke outcome. DESIGN, SETTING, AND PARTICIPANTS: Investigator-initiated, multicenter, randomized, open-label, noninferiority clinical trial in 204 patients with acute ischemic stroke due to large vessel occlusion enrolled at 23 hospital networks in Japan from January 1, 2017, to July 31, 2019, with final follow-up on October 31, 2019. INTERVENTIONS: Patients were randomly assigned to mechanical thrombectomy alone (n = 101) or combined intravenous thrombolysis (alteplase at a 0.6-mg/kg dose) plus mechanical thrombectomy (n = 103). MAIN OUTCOMES AND MEASURES: The primary efficacy end point was a favorable outcome defined as a modified Rankin Scale score (range, 0 [no symptoms] to 6 [death]) of 0 to 2 at 90 days, with a noninferiority margin odds ratio of 0.74, assessed using a 1-sided significance threshold of .025 (97.5% CI). There were 7 prespecified secondary efficacy end points, including mortality by day 90. There were 4 prespecified safety end points, including any intracerebral hemorrhage and symptomatic intracerebral hemorrhage within 36 hours. RESULTS: Among 204 patients (median age, 74 years; 62.7% men; median National Institutes of Health Stroke Scale score, 18), all patients completed the trial. Favorable outcome occurred in 60 patients (59.4%) in the mechanical thrombectomy alone group and 59 patients (57.3%) in the combined intravenous thrombolysis plus mechanical thrombectomy group, with no significant between-group difference (difference, 2.1% [1-sided 97.5% CI, -11.4% to ∞]; odds ratio, 1.09 [1-sided 97.5% CI, 0.63 to ∞]; P = .18 for noninferiority). Among the 7 secondary efficacy end points and 4 safety end points, 10 were not significantly different, including mortality at 90 days (8 [7.9%] vs 9 [8.7%]; difference, -0.8% [95% CI, -9.5% to 7.8%]; odds ratio, 0.90 [95% CI, 0.33 to 2.43]; P > .99). Any intracerebral hemorrhage was observed less frequently in the mechanical thrombectomy alone group than in the combined group (34 [33.7%] vs 52 [50.5%]; difference, -16.8% [95% CI, -32.1% to -1.6%]; odds ratio, 0.50 [95% CI, 0.28 to 0.88]; P = .02). Symptomatic intracerebral hemorrhage was not significantly different between groups (6 [5.9%] vs 8 [7.7%]; difference, -1.8% [95% CI, -9.7% to 6.1%]; odds ratio, 0.75 [95% CI, 0.25 to 2.24]; P = .78). CONCLUSIONS AND RELEVANCE: Among patients with acute large vessel occlusion stroke, mechanical thrombectomy alone, compared with combined intravenous thrombolysis plus mechanical thrombectomy, failed to demonstrate noninferiority regarding favorable functional outcome. However, the wide confidence intervals around the effect estimate also did not allow a conclusion of inferiority. TRIAL REGISTRATION: umin.ac.jp/ctr Identifier: UMIN000021488.

Clinical Trial of the New Stent Retriever Tron FX for both Proximal and Distal Intracranial Large Vessel Occlusions.

BACKGROUND: In all of randomized controlled trials of mechanical thrombectomy, the target vessels were proximal. Herein we report a clinical trial of the Tron FX stent retriever, including the smallest size of 2/15 mm for distal intracranial large vessel occlusion (LVO). OBJECTIVE: Eligible patients presented within 8 h of onset with proximal or distal LVOs, and the Tron FX 4/20 mm or 2/15 mm were used as the first-line device. METHODS: The primary endpoints were rate of modified Thrombolysis in Cerebral Infarction (mTICI) grade 2a-3 immediately after using Tron FX only, and mortality rate 90 d. We compared the outcomes between sizes 4/20 and 2/15 mm. RESULTS: The clinical trial was conducted in 50 cases, of which 44% presented with distal LVO and 15 cases were treated using only Tron FX 2/15 mm. The overall rate of mTICI grade 2a-3 was 80.0% (75.8% with Tron FX 4/20 mm, and 86.7% with 2/15 mm), and a 90-day modified Rankin Scale ≤ 2 or improvement of National Institute of Health Stroke Scale after thrombectomy ≥ 10 was achieved in 66.7% of cases (61.3% with Tron FX 4/20 mm, and 80.0% with 2/15 mm). The overall 90-day mortality rate was 8.0%, and symptomatic intracranial hemorrhage within 24 h occurred in 2.0% of cases. CONCLUSION: In this clinical trial using the Tron FX, which included the size of 2/15 mm for distal LVO, its efficacy was similar and its safety was superior compared with previous studies.

[Coil Selection, Handling and Troubleshooting in Detachment Failure].

The first coil should be as thick, long, and large as possible. A retrospective study at the Toranomon Hospital revealed that if the volume of the first coil is 1/3rd or more of the total coil volume, there are less chances of retreatment. Thus, a thick and long first coil contributes to stable long-term anatomical results. The length of the first coil should be approximately 8% of the volume of the aneurysm. After the placement of the first coil, a smaller and shorter coil should be placed sufficiently close to it to complete the procedure. The goal is to achieve prevention of acute re-rupture in ruptured acute aneurysms and life-long prevention of rupture in unruptured asymptomatic aneurysms. If the coil does not detach, check the position of the detachment point, and replace the power supply. In addition, refer to the direction for use of the device for prevention of coil disconnection failure and countermeasures. Although it is not a recommended method, a method of rotating the delivery wire at the detached position to thread the coil and a method of reconstructing the electric circuit with a crocodile clip has been reported.

Tokyo Metropolitan Stroke Emergency Medical Services for Interventional Stroke Treatment: The Tama-REgistry of Acute Thrombectomy (TREAT) Study.

OBJECTIVE: It is not clear how patients with large vessel occlusion (LVO) who have undergone mechanical thrombectomy (MT) were transported to hospitals by emergency medical services. Here, we describe the current status of the stroke delivery system in a large city. METHODS: We investigated data from 328 patients (male, n = 199; average age, 74.8 ± 12.9 years) who underwent MT at 12 facilities in the Tama area of Tokyo, between January 2015 and December 2017. The patients were classified according to the destination institution as Stroke A eligible (group A, n = 266 [8.2%]), Tertiary critical care center (group T; n = 35 [10.7%]), and other destinations such as emergency rooms (group O; n = 27 [8.2%]), and then reasons for using Emergency Medical Service (EMS) services and outcomes were compared among the groups. RESULTS: Rates of milder stroke, and middle cerebral artery occlusion were significantly higher in group A than T, whereas that of vertebral-basilar artery occlusion was significantly lower in group A than in groups T and O. The amount of elapsed time from door to picture (DTP) was significantly lower in group A. The time from onset to recanalization, as well as rates of successful recanalization and favorable outcomes (90-day modified Rankin scale 0-2) did not significantly differ regardless of destination. CONCLUSIONS: Most patients with LVO in the Tama area were categorized into group A. DTP was significantly lower in group A.

Development of Quality Indicators of Stroke Centers and Feasibility of Their Measurement Using a Nationwide Insurance Claims Database in Japan　­ J-ASPECT Study ­

BACKGROUND: We aimed to develop quality indicators (QIs) related to primary and comprehensive stroke care and examine the feasibility of their measurement using the existing Diagnosis Procedure Combination (DPC) database. METHODS AND RESULTS: We conducted a systematic review of domestic and international studies using the modified Delphi method. Feasibility of measuring the QI adherence rates was examined using a DPC-based nationwide stroke database (396,350 patients admitted during 2013-2015 to 558 hospitals participating in the J-ASPECT study). Associations between adherence rates of these QIs and hospital characteristics were analyzed using hierarchical logistic regression analysis. We developed 17 and 12 measures as QIs for primary and comprehensive stroke care, respectively. We found that measurement of the adherence rates of the developed QIs using the existing DPC database was feasible for the 6 QIs (primary stroke care: early and discharge antithrombotic drugs, mean 54.6% and 58.7%; discharge anticoagulation for atrial fibrillation, 64.4%; discharge antihypertensive agents, 51.7%; comprehensive stroke care: fasudil hydrochloride or ozagrel sodium for vasospasm prevention, 86.9%; death complications of diagnostic neuroangiography, 0.4%). We found wide inter-hospital variation in QI adherence rates based on hospital characteristics. CONCLUSIONS: We developed QIs for primary and comprehensive stroke care. The DPC database may allow efficient data collection at low cost and decreased burden to evaluate the developed QIs.

Standards of Practice in Acute Ischemic Stroke Intervention International Recommendations.

After five positive randomized controlled trials showed benefit of mechanical thrombectomy in the management of acute ischemic stroke with emergent large-vessel occlusion, a multi-society meeting was organized during the 17th Congress of the World Federation of Interventional and Therapeutic Neuroradiology in October 2017 in Budapest, Hungary. This multi-society meeting was dedicated to establish standards of practice in acute ischemic stroke intervention aiming for a consensus on the minimum requirements for centers providing such treatment. In an ideal situation, all patients would be treated at a center offering a full spectrum of neuroendovascular care (a level 1 center). However, for geographical reasons, some patients are unable to reach such a center in a reasonable period of time. With this in mind, the group paid special attention to define recommendations on the prerequisites of organizing stroke centers providing medical thrombectomy for acute ischemic stroke, but not for other neurovascular diseases (level 2 centers). Finally, some centers will have a stroke unit and offer intravenous thrombolysis, but not any endovascular stroke therapy (level 3 centers). Together, these level 1, 2, and 3 centers form a complete stroke system of care. The multi-society group provides recommendations and a framework for the development of medical thrombectomy services worldwide.