Safety and efficacy of the SeparGateTM balloon-guiding catheter in neurointerventional surgery:A prospective,multicenter,single-arm clinical trial

Objective:To evaluate the safety and efficacy of the SeparGateballoon-guiding catheter(BGC)for blocking flow and delivering devices in neurointerventional surgery.Method:This prospective multicenter single-arm trial enrolled patients who received BGC adjuvant therapy to provide temporary blood flow arrest of the supra-aortic arch arteries and their branch vessels in interventional therapy.The primary endpoint was immediate procedural success rate in flow arrest,device delivery,and withdrawal.The efficacy endpoints were intraoperative product performance,including rigidity,smoothness,fracture resistance of the catheter wall,catheter push performance,compatibility and radiopaque display,integrity,adhesion thrombus after withdrawal and balloon rupture.The safety endpoints were adverse and serious adverse events associated with the test device and serious adverse events resulting in death or serious health deterioration.Result:A total of 129 patients were included;of them,128 were analyzed in the full analysis set(FAS)and per protocol set(PPS).Immediate procedural success was achieved in 97.7%of patients with FAS and PPS.The lower bound of the 95%confidence interval was 94.6%,higher than the preset efficacy margin of 94%.Device-related adverse events occurred in 2(1.6%)cases.One was mild adverse event of vasospasm,which resolved spontaneously.The other was serious adverse event of dissection aggravation,which was treated with stenting angioplasty.No device defects were observed.Conclusion:In neurointerventional surgery,the SeparGateBGC can be used to temporarily block the flow of the supra-aortic arch arteries and their branch vessels and guide the interventional device to the target vascular position.

Exploring the vital role of microglial membrane receptors in Alzheimer’s disease pathogenesis: a comprehensive review

Neurodegenerative diseases constitute a broad category of diseases caused by the degeneration of the neurons.They are mainly manifested by the gradual loss of neuron structure and function and eventually can cause death or loss of neurons.As the global population ages rapidly,increased people are being diagnosed with neurodegenerative diseases.It has been established that the onset of Alzheimer’s disease(AD)is closely linked with increasing age and its major pathological features include amyloid-beta plaques(Aβ),Tau hyperphosphorylation,Neurofibrillary tangles(NFTs),neuronal death as well as synaptic loss.The involvement of microglia is crucial in the pathogenesis and progression of AD and exhibits a dual role.For instance,in the early stage of AD,microglia surface membrane proteins or receptors can participate in immunophagocytosis,and anti-inflammatory functions and act as a physical barrier after recognizing various ligands such as Aβand NFTs.However,in the later stage of the disease,membrane receptors on the surface of microglia can cause its activation to release a substantial quantity of pro-inflammatory factors.Which can amplify the neuroinflammatory response.The rapid decline of normal immune phagocytosis can result in the continuous accumulation of abnormal proteins,leading to neuronal dysfunction and destruction of the formed physical barrier as well as the neurovascular microenvironment.It can also increase the transformation of microglia from anti-inflammatory phenotype M2 to pro-inflammatory phenotype M1,induce severe neuronal injury or apoptosis,and aggravate the progression of AD.Due to few articles have focused on the AD-related membrane protein receptors on microglia,thus in this paper,we have reviewed several representative microglial membrane proteins or receptors about their specific roles and functions implicated in AD,and expect that there will be more in-depth research and scientific research results in the treatment of AD by targeted regulation of microglia membrane protein receptors in the future.

Management of lumbar zygapophysial (facet) joint pain

AIM: To investigate the diagnostic validity and therapeutic value of lumbar facet joint interventions in managing chronic low back pain.METHODS: The review process applied systematic evidence-based assessment methodology of controlled trials of diagnostic validity and randomized controlled trials of therapeutic efficacy. Inclusion criteria encompassed all facet joint interventions performed in a controlled fashion. The pain relief of greater than 50% was the outcome measure for diagnostic accuracy assessment of the controlled studies with ability to perform previously painful movements, whereas, for randomized controlled therapeutic efficacy studies, the primary outcome was significant pain relief and the secondary outcome was a positive change in functional status. For the inclusion of the diagnostic controlled studies, all studies must have utilized either placebo controlled facet joint blocks or comparative local anesthetic blocks. In assessing therapeutic interventions, short-term and long-term reliefs were defined as either up to 6 mo or greater than 6 mo of relief. The literature search was extensive utilizing various types of electronic search media including Pub Med from 1966 onwards, Cochrane library, National Guideline Clearinghouse, clinicaltrials.gov, along with other sources includingprevious systematic reviews, non-indexed journals, and abstracts until March 2015. Each manuscript included in the assessment was assessed for methodologic quality or risk of bias assessment utilizing the Quality Appraisal of Reliability Studies checklist for diagnostic interventions, and Cochrane review criteria and the Interventional Pain Management Techniques- Quality Appraisal of Reliability and Risk of Bias Assessment tool for therapeutic interventions. Evidence based on the review of the systematic assessment of controlled studies was graded utilizing a modified schema of qualitative evidence with best evidence synthesis, variable from level Ⅰ to level Ⅴ.RESULTS: Across all databases, 16 high quality diagnostic accuracy studies were identified. In addition, multiple studies assessed the influence of multiple factors on diagnostic validity. In contrast to diagnostic validity studies, therapeutic efficacy trials were limited to a total of 14 randomized controlled trials, assessing the efficacy of intraarticular injections, facet or zygapophysial joint nerve blocks, and radiofrequency neurotomy of the innervation of the facet joints. The evidence for the diagnostic validity of lumbar facet joint nerve blocks with at least 75% pain relief with ability to perform previously painful movements was level Ⅰ, based on a range of level Ⅰ to Ⅴ derived from a best evidence synthesis. For therapeutic interventions, the evidence was variable from level Ⅱ to Ⅲ, with level Ⅱ evidence for lumbar facet joint nerve blocks and radiofrequency neurotomy for long-term improvement(greater than 6 mo), and level Ⅲ evidence for lumbosacral zygapophysial joint injections for short-term improvement only.CONCLUSION: This review provides significant evidence for the diagnostic validity of facet joint nerve blocks, and moderate evidence for therapeutic radiofrequency neurotomy and therapeutic facet joint nerve blocks in managing chronic low back pain.

Nursing care of 22 patients with complex intracranial aneurysms treated with flow-diverting stents:A retrospective study

Objective:To summarize the nursing treatment of patients who underwent implantation of a blood flow diverter to treat complex intracranial aneurysms.Methods:Data from 22 patients with complex aneurysms,diagnosed at an interventional center for blood flow diverter implantation between February 2015 and February 2016,treated in the Henan Provincial People’s Hospital(Zhengzhou,China),were retrospectively analyzed.Nursing methods,including preoperative,intraoperative,and postoperative care,were analyzed.Results:All 22 patients underwent successful surgery,with no related complications or hospital mortality,and were cured in hospital.Conclusion:Interventional flow diverter therapy for patients with complex intracranial aneurysms is a new technology,and involves intensive care by nursing staff and appears to be a promising new treatment method.

Willis covered stent in the treatment of a recurrent blood blister-like aneurysm after pipeline implementation:A case report

Blood blister-like aneurysms(BBAs)are fragile and difficult to treat.However,the optimal treatment has yet to be determined.Pipeline embolization devices and Willis covered stent implementation are still controversial strategies for treating BBA.Herein,we report a case of recurrent BBA successfully treated with a Willis covered stent.A long-term follow-up angiography after the procedure indicated complete occlusion of the aneurysm.This case demonstrates the safety and efficacy of applying the Wills cover stent in the treatment of recurrent BBA after Pipeline implantation.

Evaluation of using a double helical, closed-cell stent-retriever(Skyflow) for thrombectomy procedures in acute arterial occlusion: A preclinical study and a clinical trial

Background and purpose:Stent retriever thrombectomy is the standard therapeutic approach for ischemic stroke with acute large-vessel occlusion.This study evaluated the safety and efficacy of a new thrombectomy device(Skyflow)in the treatment of acute ischemic stroke.Methods:After an arterial occlusion model was established,stent-retriever thrombectomy was performed.Digital subtraction angiography(DSA)and autopsy were carried out immediately after thrombectomy in six animals in the acute experimental group.Simulated stent-retriever thrombectomy was performed for three animals in the subacute experimental group,and follow-up angiography and vascular pathological examination were assessed 90 days after the operation.In the clinical trial,192 patients with intracranial anterior circulation large vessel occlusion,within 8 h of symptom onset,were included to undergo thrombectomy with either Skyflow or Solitaire FR stent retriever.Efficacy and safety endpoints were recorded(including successful reperfusion,favorable clinical outcomes,time from puncture to reperfusion,instrument operation success rates and National Institutes of Health Stroke Scale(NIHSS)scores at 7 days for efficacy endpoints,and symptomatic intracranial hemorrhage(sICH),subarachnoid hemorrhage(SAH)and all-cause mortality rates for safety endpoints).Results:All blood vessels achieved successful recanalization in the animal models.In the clinical trial,successful recanalization was attained in 88.4%of patients of the Skyflow group,which was comparable to that of the Solitaire FR group(82.5%)in the full analysis set of the clinical trial.There were no severe complications on DSA,an animal autopsy,or vessel pathological examination in animal experiments.Additionally,no statistically significant difference was observed between the Skyflow and Solitaire FR groups in the clinical trial regarding the safety endpoints.Conclusion:This study showed that the new Skyflow stent retriever is safe and effective for the treatment of acute large vessel occlusion,as demonstrated in our animal study and human trial.

Endovascular transvenous treatment for superficial intracranial arteriovenous malformations

Objective:The objective of this study was to evaluate the feasibility and outcomes of transvenous endovascular embolization(TVE) for superficial intracranial arteriovenous malformations(AVMs).Methods:After collecting clinical and imaging data,a prospective series of 11 patients presenting with superficial AVMs were treated by endovascular embolization using a transvenous approach between November 2016 and October 2018.Results:Ten patients(90.9%) had ruptured AVMs before TVE.The mean nidus size was 3.27 ± 1.47 cm,and the median Spetzler-Martin grade was II.The rate of immediate angiographic occlusion of the AVMs was 90.9%(10/11).One patient was treated with transarterial embolization since TVE was not achieved due to an unsuccessful positioning of the microcatheter.Two patients(cases 8 and 11) suffered a intracranial hemorrhage and a cerebral infarction with encephaledema,respectively,but no procedure-related mortalities were observed.Eight patients(72.7%) were independent with a modified Rankin Score(mRS) 2 at discharge and the m RSs of all patients,which were collected 30 days postintervention,were not more than 2.The mean follow-up period was 17 months.There were no nidus recurrences during the follow-up period.Conclusions:The curative transvenous embolization of superficial AVMs seems feasible and effective while carefully monitoring for embolization-related complications.

A novel cerebrovascular drug-coated balloon catheter for treating symptomatic intracranial atherosclerotic stenosis lesions:Study protocol for a prospective,multicenter,single-arm,target-value clinical trial

Background:Previous single-center studies have demonstrated that drug-coated balloons(DCBs)may reduce restenosis rates,which is an important factor affecting the prognosis for intracranial interventional therapy.However,currently available cardiac DCBs are not always suitable for the treatment of intracranial atherosclerotic stenosis(ICAS).This study aimed to evaluate the safety and efficacy of a novel DCB catheter designed for patients with severely symptomatic ICAS.Methods:This prospective,multicenter,single-arm,target-value clinical trial was conducted in 9 Chinese stroke centers to evaluate the safety and efficacy of a novel DCB catheter for treating symptomatic severe ICAS.Primary metrics and other indicators were collected and analyzed using SAS version 9.4(SAS Institute,Cary,NC,USA).Results:A total of 155 patients were enrolled in this study.The preliminary collection of follow-up data has been completed,while data quality control is ongoing.Conclusion:Results of this study demonstrated the patency rate,safety,and effectiveness of a novel on-label paclitaxel DCB designed for the treatment of ICAS.Ethics and dissemination:This study,involving human participants,was reviewed and approved by the Ethics Committee of Drugs(Devices)Clinical Experiment at Henan Provincial People’s Hospital(reference number:2020-145-03)and other research centers participating in the clinical trial.The results of this study will be presented at international conferences and sent to peer-reviewed journals for publication.Standard protocol items:The Recommendations for Interventional Trials checklist was used when drafting the study protocol.Trial registration number:Registered with the Chinese Clinical Trial Registry on June 11,2021(Chi CTR2100047223).

Safe surgical zone during TORS radical tonsillectomy:An anatomical and radiological study

Objective:Parapharyngeal space contains intricate vascular anatomy(external and internal carotid arteries)that might be inadvertently injured during the dissection in this plane.None of the bony landmarks can be used during the transoral robotic surgery(TORS)radical tonsillectomy as these landmarks lie lateral to the internal carotid artery(ICA)and external carotid artery(ECA)in transoral approach.Our study aims to identify the safe surgical limits during the dissection of parapharyneal space in TORS radical tonsillectomy and to correlate the same with radiological study.Material and methods:Fifteen cadavers(30 head and neck regions)and 50 CT-Angiogram of neck(100 head and neck regions)were included in the anatomical and radiological study respectively.The vertical midpoint of anterior tonsillar pillar(palatoglossus muscle)was taken as the reference point and all the measurements were done at the level of reference point both for anatomical and radiological study.Distance between tonsillar fossa and ECA,distance between tonsillar fossa and ICA,relation between ECA and styloglossus and relation between ICA and stylopharyngeus at reference level were studied.Results:The mean distance of ECA from the tonsillar fossa at the reference point was 18.2 mm in the anatomical study and 16.2 mm in the radiological study.The mean distance of ICA from the tonsillar fossa was 23.4 mm and 23.3 mm in the anatomical study and radiological study.There was no significant difference between the anatomical and radiological findings for both the mean distance between ECA and ICA to the tonsillar fossa(p value was 0.45 and 0.30 respectively).ECA was located posterolateral to styloglossus in 24 cases(80.0%)and 79 cases(79.0%)in the anatomical and radiological study respectively.ICA was found posterolateral to stylopharyngeus in 21 cases(70.0%)and 69 cases(69.0%)in the anatomical and radiological study respectively.Conclusion:The muscular plane between styloglossus and stylopharyngeus can be used as an envelope to locate the ECA and ICA that lie medial to these critical vascular structures during TORS.We propose to divide the parapharyngeal space into two compartments(anterior and posterior)based on the surgical perspective of inside-out anatomy.The anterior compartment houses styloglossus muscle with ECA posterolateral to it and the posterior compartment has stylopharyngeus and ICA posterolateral to it.

Hemodynamic investigations in intracranial aneurysms:a commentary

Intracranial aneurysms(IAs)are abnormal bulges in a blood vessel in the brain that have a potential to rupture and even causing a stroke,which can lead to lasting brain damage,long-term disability,or even loss of life.It has been widely acknowledged that hemodynamic factors,e.g.,instantaneous wall shear stress,time-averaged wall shear stress,wall shear stress gradient,gradient oscillatory number,oscillatory shear index,pulsatile blood flow waveform(flow rate magnitude and shape,physical flow period),relative residence time/turnover time,blood pressure.

Impact of neutrophil-to-lymphocyte ratio on the effect of hyperglycemia at admission on clinical outcomes after endovascular thrombectomy

Background:The neutrophil-to-lymphocyte ratio(NLR)is highly associated with stress responses to acute disorders and may be useful for differentiating hyperglycemia after stroke that is induced by stress or other causes.This study aims to evaluate whether the NLR modifies the effect of hyperglycemia at admission on clinical outcome after thrombectomy.Methods:We retrospectively enrolled 343 patients that underwent endovascular thrombectomy for acute anterior circulation large-vessel occlusion between January 2019 and June 2022.NLR at admission was used to dichotomize patients into low-NLR and high-NLR groups according to its median value.The primary outcome was 90-day functional independence(modified Rankin Scale Score 0–2).Secondary outcomes were 24 h symptomatic intracranial hemorrhage and 90-day mortality.Results:Overall,hyperglycemia at admission decreased the likelihood of functional independence(adjusted odds ratio[OR]:0.34,95%confidence interval[95%CI]:0.19–0.60,p<0.001).There was a significant interaction between the NLR and hyperglycemia at admission on functional independence(p=0.024).Hyperglycemia at admission was negatively associated with functional independence in low-NLR patients(adjusted OR:0.18,95%CI:0.07–0.42,p<0.001),but not in high-NLR patients(adjusted OR:0.67,95%CI:0.30–1.48,p=0.320).Interactions between the NLR and hyperglycemia at admission on 24 h symptomatic intracerebral hemorrhage(p=0.734)and 90-day mortality(p=0.657)were not significant.Conclusions:The NLR modified the detrimental effect of hyperglycemia at admission on functional independence after thrombectomy.Low-NLR patients with hyperglycemia were at a high risk of poor outcomes,and might more likely benefit from aggressive glucose-lowering treatment.

脑动脉粥样硬化的颅内血管成形和支架置入术：美国介入和治疗神经放射学学会、介入放射学学会和美国神经放射学学会的立场声明

在北美、欧洲和亚洲，卒中是第3位死亡原因和成人残疾的首要病因。颅内动脉粥样硬化所致的卒中约占所有缺血性卒中的8％～10％，据报道，在亚洲、非洲和西班牙裔人群中这一比例更高。其危险因素包括胰岛素依赖性糖尿病、高胆固醇血症、高血压和吸烟。在美国，估计每年有40000～60000例新发卒中是由于颅内动脉粥样硬化所致。

机械血栓切除术综合性卒中中心的要求和卒中血管内治疗医疗体系：血管和介入神经病学学会（SVIN）卒中血管内治疗标准委员会的推荐意见

最近，5项具有里程碑意义的多中心、前瞻性、随机、开放标签、盲法终点的临床试验证实，在伴有颅内大血管闭塞的急性缺血性卒中（acute ischemic stroke，AIS）患者中，应用机械血栓切除术进行血管内治疗具有显著的临床获益。血管和介入神经病学学会（Society of Vascular and Interventional，SVIN）任命了一个专业写作委员会来总结这些新证据，并就如何应用这些数据指导AIS患者的急诊血管内治疗提出了推荐意见。

Updates in the management of cranial dural arteriovenous fistula

Dural arteriovenous fistula(dAVF)accounts for approximately 10%of all intracranial vascular malformations.While they can be benign lesions,the presence of retrograde venous drainage and cortical venous reflux makes the natural course of these lesions aggressive high risk of haemorrhage,neurological injury and mortality.Endovascular treatment is often the first line of treatment for dAVF.Both transarterial and transvenous approaches are used to cure dAVF.The selection of treatment approach depends on the angioarchitecture of the dAVF,the location,the direction of venous flow.Surgery and,to a lesser extent,stereotactic radiosurgery are used when endovascular approaches are impossible or unsuccessful.

Development and validation of a novel nomogram to predict aneurysm rupture in patients with multiple intracranial aneurysms:a multicentre retrospective study

Background and purpose Approximately 15%–45%of patients with unruptured intracranial aneurysms have multiple intracranial aneurysms(MIAs).Determining which one is most likely to rupture is extremely important for treatment decision making for MIAs patients.This study aimed to develop and validate a nomogram to evaluate the per-aneurysm rupture risk of MIAs patients.Methods A total of 1671 IAs from 700 patients with MIAs were randomly dichotomised into derivation and validation sets.Multivariate logistic regression analysis was used to select predictors and construct a nomogram model for aneurysm rupture risk assessment in the derivation set.The discriminative accuracy,calibration performance and clinical usefulness of this nomogram were assessed.We also developed a multivariate model for a subgroup of 158 subarachnoid haemorrhage(SAH)patients and compared its performance with the nomogram model.Results Multivariate analyses identified seven variables that were significantly associated with IA rupture(history of SAH,alcohol consumption,female sex,aspect ratio>1.5,posterior circulation,irregular shape and bifurcation location).The clinical and morphological-based MIAs(CMB-MIAs)nomogram model showed good calibration and discrimination(derivation set:area under the curve(AUC)=0.740 validation set:AUC=0.772).Decision curve analysis demonstrated that the nomogram was clinically useful.Compared with the nomogram model,the AUC of multivariate model developed from SAH patients had lower value of 0.730.Conclusions This CMB-MIAs nomogram for MIAs rupture risk is the first to be developed and validated in a large multi-institutional cohort.This nomogram could be used in decision-making and risk stratification in MIAs patients.

Recovery of injured corticospinal tracts after late recanalisation of basilar artery occlusion

In this study,we performed emergency stent angioplasty in a patient with basilar artery occlusion(BAO)at 21 hours after onset.Serial diffusion tensor tract imaging revealed that the ischaemic corticospinal tracts(CSTs),which passed through pontine infarct,rapidly recovered to normal level even after delayed reperfusion.This case provided in vivo evidences that ischaemic white matter was still salvageable even after prolonged ischaemia.It also provided a new method(diffusion tensor tract imaging)and a novel therapeutic target(white matter)in the evaluation and treatment of acute BAO.

Acute Ischaemic Stroke Cooperation Group of Endovascular Treatment (ANGEL) registry: study protocol for a prospective, multicentre registry in China

Background and purpose Endovascular treatment could improve functional outcomes and reduce mortality in patients with intracranial large artery occlusion. This registry aims to evaluate the endovascular treatment delivery and to improve endovascular treatment algorithm in clinical practice for patients with stroke in China. Methods and analysis This multicentric, nationwide, prospective registry plans to include 20 stroke centres and recruit 900 consecutive AIS patients with large- artery occlusion under endovascular treatment. This registry will enrol acute large vessel occlusion patients suitable for endovascular treatment and the inclusion and exclusion criteria. In this study, 90 days functional independence (modified Rankin Scale score ≤2) is the primary efficacy endpoint. The procedural efficacy endpoint of this registry is target artery recanalisation defined by modified Thrombolysis in Cerebral Infarction score 2b or 3 after endovascular therapy. Symptomatic intracranial haemorrhage with 24±3 hours after the procedure is the primary safety endpoint of this registry. Ethics and dissemination Beijing Tiantan Hospital’s Ethics committee and all other participating centres approved the protocol and data collection of Acute Ischaemic Stroke Cooperation Group of Endovascular Treatment registry. Each participant or representative had a written informed consent.

急性缺血性卒中血管内治疗质量改进的多学会共识

目的这份国际性多学科共识文件将对急性缺血性卒中诊治过程和临床转归的质量标准进行定义，并希望在质量保证程序中使用这些标准，从而评估和改善急性卒中血运重建的过程和转归。材料和方法写作组成员由美国神经放射学学会、加拿大介入放射学协会、欧洲心血管和介入放射学学会、心血管造影和介入学会、介入放射学学会、神经介入外科学会、欧洲微创神经病学治疗学会以及血管和介入神经病学学会认命。写作组回顾了1986年至2012年2月期间的相关文献，对急性缺血性卒中的诊疗过程和转归进行总结形成一份证据表，然后通过共识设立性能指标和阈值。本指南得到发起学会的批准，并计划在3年后进行全面更新。结果这份国际性多学科共识文件对诊治过程和临床转归的质量标准进行了定义，包括从入院到进行影像学检查、动脉穿刺和血运重建的时间间隔以及90d时的临床转归评估标准。结论本文件为急性缺血性卒中血管内血运重建程序提供了质量改进指南。

Safety and efficacy of oral antiplatelet for patients who had acute ischaemic stroke undergoing endovascular therapy

Background and purpose To investigate the safety and efficacy of oral antiplatelet therapy(APT)for patients who had acute ischaemic stroke(AIS),receiving endovascular therapy(EVT).Methods Patients were divided into non-APT group and APT(single APT or dual APT(DAPT)group.The safety and efficacy endpoints at 3-month follow-up were symptomatic intracranial haemorrhage(sICH),recanalisation rate,clinical outcome and mortality.Results Among 915 patients who had AIS,those in APT group(n=199)showed shorter puncture-to recanalisation time,lower frequency of intravenous thrombolysis and more use of tirofiban compared with those in non-antiplatelet group(n=716)(p<0.05 for all).Oral APT was found to be associated with superior clinical outcome compared with non-APT(APT(44.2%)versus non-APT(41.1%)),adjusted OR=2.605,95% CI 1.244 to 5.455,p=0.011).DAPT showed superior clinical outcome compared with non-APT(DAPT(56.5%)versus non-APT(41.1%),adjusted OR=5.405,95% CI 1.614 to 18.102,p=0.006)and lower risk of mortality at 3-month follow-up(DAPT(4.8%)versus non-DAPT(17.7%),adjusted OR=0.008,95%CI 0.000 to 0.441,p=0.019).There was no significant difference in sICH between the two groups.Conclusions Oral APT prior to undergoing EVT is safe and may accompany with superior clinical outcomes.DAPT may associate with superior clinical outcomes and lower risk of mortality.