Investigator-initiated clinical trial of stabilizer device: A novel intracranial exchange guidewire for neuroendovascular treatments.

BACKGROUND: Neuroendovascular procedures, especially those involving significant vessel tortuosity, giant intracranial aneurysms, or distally located lesions, frequently necessitate exchange methods. However, exchange maneuvers pose a risk of inadvertent vessel injury. To address these challenges, a Stabilizer device was developed and evaluated for its efficacy and safety. This clinical trial aimed to assess the efficacy and safety of the Stabilizer device in facilitating the navigation of neuroendovascular devices to target lesions in cases where the exchange technique was necessary. METHODS: This was a single-arm, prospective, open-label, multicenter clinical trial performed at nine different sites. It focused on investigating the use of the Stabilizer device for treating intracranial aneurysms and atherosclerosis. RESULTS: A total of 31 patients were enrolled across nine centers in Japan from July 21, 2022, to March 10, 2023. The study enrolled 24 (77.4%) patients with intracranial aneurysms and seven (22.6%) patients with intracranial artery stenosis. Majority of the target lesions were in the middle cerebral artery territory (83.9%). The Stabilizer device was used to exchange for 0.027-inch catheters, intermediate catheters, PTA balloons, and Wingspan stent system. The Stabilizer device demonstrated 100% technical success rate. While three complications related to the treatment were noted, there were no complications related to the device, including any vascular damage. CONCLUSIONS: This is the first multicenter clinical trial that investigated and demonstrated technical efficacy as well as overall safety profile of the Stabilizer device in neuroendovascular procedures where the use of an exchange method was necessary.

Impact of the COVID-19 Pandemic on Acute Stroke Rehabilitation in Japanese Primary Stroke Centers: A Nationwide Cross-Sectional Study Using a Web-based Questionnaire Survey.

INTRODUCTION: Acute stroke rehabilitation is crucial for achieving good functional recovery, even during the coronavirus disease 2019 (COVID-19) pandemic. This study aimed to clarify the impact of the COVID-19 pandemic on acute stroke rehabilitation and identify which components in the acute stroke rehabilitation provision system were susceptible to the pandemic. METHODS: A web-based questionnaire survey was conducted in all primary stroke centers (PSCs) in Japan between February 7 and April 21, 2022. The survey included questions about the current status of acute stroke rehabilitation and the influence of the pandemic. We classified the influences and investigated the relationship between the influence of the pandemic and the provision of rehabilitation. Additionally, we investigated a group of prefectures divided according to the grade of the pandemic. RESULTS: The survey response rate was 67% (639 of 959 PSCs). Among them, 387 PSCs (61%) reported that the COVID-19 pandemic affected acute stroke rehabilitation. In PSCs affected by the pandemic, more rehabilitation-related staff were working, and the proportion of weekend/holiday rehabilitation implementation was higher compared to those unaffected. In PSCs from highly infected prefectures, no significant relationship was observed between the influence of the pandemic and the rehabilitation provision system. CONCLUSIONS: PSCs that provide denser acute stroke rehabilitation may be affected to a greater extent by the pandemic. We conclude that stroke hospitals should formulate infection control procedures for acute stroke rehabilitation in advance, depending on the conditions of the region and facility.

Bacterial Meningitis Following Aneurysmal Subarachnoid Hemorrhage and Its Association with Cerebral Vasospasm.

Aneurysmal subarachnoid hemorrhage (aSAH) is a critical condition with high in-hospital mortality rates. Delayed cerebral ischemia (DCI), a secondary complication associated with aSAH, can also contribute to morbidity and mortality. Although draining the hematoma from the subarachnoid space has been considered effective in preventing DCI, the placement of a drainage system could increase the risk of bacterial meningitis and ventriculitis. This study aimed to examine the association between meningitis following aSAH and the occurrence of DCI, focusing on the role of cerebral vasospasm. Patients who underwent endovascular coiling or surgical clipping for aSAH from April 2001 to March 2022 were included in this study, while those who did not undergo postoperative drainage were excluded. The patient's clinical characteristics, treatment modalities, and outcomes were then analyzed, after which logistic regression was used to assess the odds ratios (OR) for DCI. A total of 810 patients with aSAH were included in this study. Meningitis following aSAH was identified as an independent factor associated with DCI (odds ratio 5.0 [95% confidence intervals (CI) 2.3-11]). Other significant factors were female sex (odds ratio 1.5 [95% CI 0.89-2.5]) and surgical clipping (odds ratio 2.1 [95% CI 1.3-3.4]). This study demonstrated a significant association between meningitis following aSAH and the development of DCI, suggesting that the inflammatory environment associated with meningitis may contribute to cerebral vasospasm. Early recognition and treatment of meningitis in patients with aSAH could reduce the risk of DCI and improve patient outcomes.

Intraorbital Dural Arteriovenous Fistula Treated by Transarterial Embolization Using Onyx: A Case Report.

Objective: Intraorbital dural arteriovenous fistula (IO-dAVF) is a rare condition, and treatment options vary from case to case. We report a case of transarterial embolization (TAE) for IO-dAVF. Case Presentation: A 62-year-old male complained of gradually worsening pain, hyperemia, and visual impairment in the right eye. He did not exhibit diplopia or exophthalmos. Cerebral angiography revealed an arteriovenous fistula in the right orbit. The feeding arteries were the ophthalmic artery (OphA) and the artery of the superior orbital fissure (ASOF), with the superior ophthalmic vein (SOV) as the main draining vein. The venous pathway from the SOV was not clearly visible, and considering the risk of blindness with TAE from the OphA, TAE from the ASOF was performed. Onyx 18 was selected as the liquid embolic material and injected through a microcatheter placed in the internal maxillary artery. Occlusion up to the SOV was achieved, and the shunt flow completely disappeared. Normal blood flow in the OphA was maintained, hyperemia improved, and no complications were observed. Conclusion: In cases of IO-dAVF, when transvenous embolization is difficult to perform, TAE using Onyx from the vessel of the external carotid artery system may be preferred over OphA.

One-Stage Combined Open and Endovascular Treatment Using a Hybrid Operating Room is Safe and Effective for Distal Middle Cerebral Artery Aneurysms.

BACKGROUND: Aneurysms located in the distal middle cerebral artery (DMCA) are relatively rare and lack an established treatment strategy. For DMCA aneurysms, we performed a one-stage combined procedure of endovascular parent artery occlusion (PAO) with coils and superficial temporal artery to middle cerebral artery (STA-MCA) bypass in a hybrid operating room (HOR). The aim of this study was to evaluate the safety and efficacy of this procedure. METHODS: Cases of unruptured DMCA aneurysms treated with the one-stage combined PAO and STA-MCA bypass in HOR were retrospectively examined, and patients' and aneurysmal backgrounds, surgical procedures, and treatment outcomes were analyzed. RESULTS: Six patients were included in the study. The average maximum diameter of the aneurysms was 14.4 mm. One aneurysm was located at M2 and five at M3. All aneurysms had a fusiform shape. No cases were associated with infection, trauma, or malignant tumors. In all 6 cases, the combined PAO and STA-MCA bypass was successfully completed. No postoperative hemorrhagic complications occurred. A symptomatic ischemic complication occurred in 1 case whose symptom disappeared in a week. Three months after surgery, complete obliteration of the aneurysm and patency of the bypass was confirmed in all cases. CONCLUSIONS: The one-stage combined PAO and STA-MCA bypass in the HOR is safe and effective for DMCA aneurysms, potentially serving as a treatment option for this complex aneurysm.

Comorbidity burden and outcomes after mechanical thrombectomy for large vessel occlusion: A retrospective analysis.

OBJECTIVES: Patients with acute ischemic stroke (AIS) often have an accumulation of pre-existing comorbidities, but its clinical impact on outcomes after mechanical thrombectomy (MT) remains unknown. Therefore, we examined whether comorbidity burden before AIS onset could predict clinical outcomes after MT. METHODS: In this retrospective cohort, we enrolled consecutive patients with community-onset AIS who underwent MT between April 2016 and December 2021. To evaluate each patient's comorbidity burden, we calculated Charlson comorbidity index (CCI), then classified the patients into the High CCI (≥ 3) and the Low CCI (< 3) groups. The primary outcome was a good neurological outcome at 90 days, defined as a modified Rankin scale 0-2 or no worse than the previous daily conditions. All-cause mortality at 90 days and hemorrhagic complications after MT were also compared between the two groups. We estimated the odds ratios and their confidence intervals using a multivariable logistic regression model. RESULTS: A total of 388 patients were enrolled, of whom 86 (22.2%) were classified into the High CCI group. Patients in the High CCI group were less likely to achieve a good neurological outcome (adjusted odds ratio of 0.26 [95% confidence interval, 0.12-0.58]). Moreover, symptomatic intracranial hemorrhage was more common in the High CCI (14.0% vs. 4.6%; adjusted odds ratio, 4.10 [95% confidence interval, 1.62-10.3]). CONCLUSIONS: Comorbidity burden assessed by CCI was associated with clinical outcomes after MT. CCI has the potential to become a simple and valuable tool for predicting neurological prognosis among patients with AIS and MT.

Electrical impedance measurements can identify red blood cell-rich content in acute ischemic stroke clots ex vivo associated with first-pass successful recanalization.

Background: Electrochemical impedance spectroscopy can determine characteristics such as cell density, size, and shape. The development of an electrical impedance-based medical device to estimate acute ischemic stroke (AIS) clot characteristics could improve stroke patient outcomes by informing clinical decision making. Objectives: To assess how well electrical impedance combined with machine learning identified red blood cell (RBC)-rich composition of AIS clots ex vivo, which is associated with a successfully modified first-pass effect. Methods: A total of 253 clots from 231 patients who underwent thrombectomy in 5 hospitals in France, Japan, Serbia, and Spain between February 2021 and October 2023 were analyzed in the Clotbase International Registry. Electrical impedance measurements were taken following clot retrieval by thrombectomy, followed by Martius Scarlet Blue staining. The clot components were quantified via Orbit Image Analysis, and RBC percentages were correlated with the RBC estimations made by the electrical impedance machine learning model. Results: Quantification by Martius Scarlet Blue staining identified RBCs as the major component in clots (RBCs, 37.6%; white blood cells, 5.7%; fibrin, 25.5%; platelets/other, 30.3%; and collagen, 1%). The impedance-based RBC estimation correlated well with the RBC content determined by histology, with a slope of 0.9 and Spearman's correlation of r = 0.7. Clots removed in 1 pass were significantly richer in RBCs and clots with successful recanalization in 1 pass (modified first-pass effect) were richer in RBCs as assessed using histology and impedance signature. Conclusion: Electrical impedance estimations of RBC content in AIS clots are consistent with histologic findings and may have potential for clinically relevant parameters.

Novel use of a closed-tip stent retriever to prevent distal embolism in the posterior circulation: illustrative case.

BACKGROUND: In mechanical thrombectomy for tandem occlusions in vertebrobasilar stroke, distal emboli from the vertebral artery lesion should be prevented. However, no suitable embolic protection devices are currently available in the posterior circulation. Here, the authors describe the case of a vertebral artery lesion effectively treated with a closed-tip stent retriever as an embolic protection device in the posterior circulation. OBSERVATIONS: A 65-year-old male underwent mechanical thrombectomy for basilar artery occlusion, with tandem occlusion of the proximal vertebral artery. After basilar artery recanalization via the nonoccluded vertebral artery, a subsequent mechanical thrombectomy was performed for the occluded proximal vertebral artery. To prevent distal embolization of the basilar artery, an EmboTrap III stent retriever was deployed as an embolic protection device within the basilar artery to successfully capture the thrombus. LESSONS: A stent retriever with a closed-tip structure can effectively capture thrombi, making it a suitable distal embolic protection device in the posterior circulation.

Evidence and Recommendations for Acute Stroke Rehabilitation from the Japan Stroke Society: Abridged Secondary Publication of the Japanese-language Version.

Objectives: In Japan, acute stroke rehabilitation has been expanding more steadily than previously with the nationwide establishment of primary stroke centers. However, Japan previously had no established guidelines for the rehabilitation. Consequently, rehabilitation programs and the provision systems for acute stroke varied among the facilities. To equalize and standardize acute stroke rehabilitation in Japan, it is necessary to develop clinical recommendations for rehabilitation. Therefore, the rehabilitation project team of the Japan Stroke Society aimed to develop the first recommendations for acute stroke rehabilitation in Japan. Methods: The recommendations are based on the results of a survey on the current status of acute stroke rehabilitation at primary stroke centers in Japan, which was completed in 2022, and on a literature review conducted by the rehabilitation project team. Results: The recommendations consist of 19 clinical questions regarding the following topics of acute stroke rehabilitation: (1) head elevation and mobilization training, (2) acute complications, (3) training time and frequency for acute stroke rehabilitation, (4) dysphagia in the acute phase, and (5) acute rehabilitation during pandemics of novel and re-emerging infections, particularly novel coronavirus disease 2019 (COVID-19). The team members agreed on all answers for these 19 clinical questions. Conclusions: These recommendations suggest broad principles of rehabilitative intervention in the acute phase of stroke. In the near future, it is expected that the dissemination of these recommendations will result in an increase in the quality of acute stroke rehabilitation in Japan.

Treatment Results of Carotid Artery Stenting with an Open-Cell Stent: Analysis of 734 Consecutive Cases at a Single Center.

OBJECTIVE: In carotid artery stenting (CAS) for internal carotid artery stenosis, the stent is often selected according to the plaque properties and arterial tortuosity. In our institute, an open-cell stent is used as the first-line stent regardless of the characteristics of the lesion. This study was performed to examine the outcome of CAS with an open-cell stent as the real-world results. METHODS: In total, 811 CAS procedures using open-cell stents were performed for internal carotid artery stenosis from April 2002 to December 2019. Of these patients, we excluded those with hyperacute conditions for which CAS was performed within 3 days of onset, those in whom acute mechanical thrombectomy was performed simultaneously with CAS, and those with stenosis due to arterial dissection. Thus, 734 patients were retrospectively analyzed. Perioperative and long-term outcomes and risk factors for perioperative infarction were investigated. RESULTS: The periprocedural stroke rate and mortality rate were 3.7% (27/734) and 0.4% (3/734), respectively. Low-echoic plaque was a significant risk factor for periprocedural stroke in both univariate (P < 0.03) and multivariate (odds ratio, 2.69; 95% confidence interval, 1.14-6.66; P = 0.02) analyses. Cerebral infarction and high grade restenosis were observed in 15 (2.0%) and 17 (2.3%) patients during a median 50-month follow-up. CONCLUSIONS: CAS with open-cell stents showed good results in terms of both the postoperative stroke incidence and long-term severe restenosis rate. However, low-echoic plaque was a risk factor for perioperative stroke incidence, which should be considered when deciding on the indication for CAS with an open-cell stent.

Clinical evaluation of mechanical thrombectomy for patients with posterior circulation occlusion: A retrospective study.

OBJECTIVE: Although consensus has been reached regarding the use of mechanical thrombectomy for acute large anterior circulation occlusion, its effectiveness in patients with posterior circulation occlusion remains unclear. This study aimed to establish the determining factors for good clinical outcomes of mechanical thrombectomy for posterior circulation occlusion. METHODS: We extracted cases of acute large vessel occlusion (LVO) in the posterior circulation from a database comprising 536 patients who underwent mechanical thrombectomy at our hospital between April 2015 and March 2021. RESULTS: Fifty-two patients who underwent mechanical thrombectomy for LVO in the posterior circulation were identified. Five patients with simultaneous occlusion of the anterior and posterior circulation were excluded; finally, 47 patients were included in this study. The median patient age was 78 years, and 36% of the patients were women. The median National Institutes of Health Stroke Scale (NIHSS) score on admission was 31, the median posterior circulation-Alberta Stroke Program Early Computed Tomography Score (pc-ASPECTS) was 8, and the median Basilar Artery on Computed Tomography Angiography (BATMAN) score was 6. The rate of good recanalization (Thrombolysis in Cerebral Infarction scale grades 2b and 3) was 96%, and a good prognosis (modified Rankin Scale score of 0-2 at 90 days) was achieved in 19 patients (40%). The median pc-ASPECTS was significantly higher in the good prognosis group than in the poor prognosis group (10 vs. 7; p = 0.007). The median NIHSS score at presentation was significantly lower in the good prognosis group than in the poor prognosis group (17 vs. 34; p = 0.02). The median BATMAN score was significantly higher in the good prognosis group than in the poor prognosis group (8 vs. 3.5; p = 0.0002). Multivariate analysis showed that an NIHSS score ≦ 20 at presentation was the only independent factor for good prognoses. CONCLUSION: The prognosis of mechanical thrombectomy for posterior circulation LVO was better in patients with lower NIHSS scores at presentation.

A nationwide survey for the provision of acute stroke rehabilitation in Japan: initial dose and weekend/holiday rehabilitation.

OBJECTIVES: The early initiation of acute stroke rehabilitation with a sufficient dose, including at weekends/holidays, is important to improve functional outcome. We investigated the status of acute stroke rehabilitation in Japan by using a nationwide survey. MATERIALS AND METHODS: Facility features, rehabilitation dose provided in the first week in each stroke subtype, and weekend/holiday rehabilitation were investigated by using the results of a web-based survey among primary stroke centers. The relationships between facility features and weekend/holiday rehabilitation were also analyzed. RESULTS: A total of 639 stroke centers (66.6%) completed the questionnaire. The overall median dose was 2.0 (interquartile range, 1.7-3.0) U/day (1U = 20 min). After 7 days, the overall median dose increased to 4.0 (2.0-5.4) U/day. Almost 50% of facilities replied that they could not provide a sufficient dose of rehabilitation; the main reason was a lack of therapists (31%). For rehabilitation on long weekends, no rehabilitation was provided on 3-day weekends in 19% of facilities, and in 5% of facilities on ≥4-day weekends. The mean number of therapists was almost 50% less in the facilities that provided no rehabilitation on 3-day weekends compared to those that provided daily rehabilitation (19.4 vs. 36.2 therapists, respectively, p < 0.001). CONCLUSIONS: In this survey, the provision of acute stroke rehabilitation, including non-working days, was clarified. According to the results, prospective interventional or observational studies are needed to design more effective rehabilitation programs to improve outcome. In particular, it is important to determine the optimal dose and intensity of acute stroke rehabilitation.