Clinical Results of the Advanced Neurovascular Access Catheter System Combined With a Stent Retriever in Acute Ischemic Stroke (SOLONDA).

BACKGROUND: The Advanced Neurovascular Access (ANA) thrombectomy system is a novel stroke thrombectomy device comprising a self-expanding funnel designed to reduce clot fragmentation by locally restricting flow while becoming as wide as the lodging artery. Once deployed, the ANA device allows distal aspiration combined with a stent retriever to mobilize the clot into the funnel where it remains copped during extraction. We investigated the safety and efficacy of ANA catheter system. METHODS: SOLONDA (Solitaire in Combination With the ANA Catheter System as Manufactured by Anaconda) was a prospective, open, single-arm, multicenter trial with blinded assessment of the primary outcome by an independent core lab. Patients with anterior circulation vessel occlusion admitted within 8 hours from symptom onset were eligible. The primary end point was successful reperfusion (modified Thrombolysis in Cerebral Infarction score 2b-3) with ≤3 passes of the ANA device in combination with stent retriever, before the use of rescue therapy in the intention to treat population. Primary predefined analysis was noninferiority as compared to the performance end point observed in HERMES (High Effective Reperfusion Using Multiple Endovascular Devices). RESULTS: After enrollment of 74 patients, an interim analysis was conducted, and the trial Steering Committee decided to terminate recruitment due to safety and performance objectives were reached. Mean age was 71.6 (SD 8.9) years, 46.6% women and median National Institutes of Health Stroke Scale on admission 14 (interquartile range, 10-19). Successful reperfusion within 3 passes before rescue therapy was achieved in 60/72 (83.3% [95% CI, 74.7%-91.9%]) with a rate of complete reperfusion (modified Thrombolysis in Cerebral Infarction score 2c-3) of 60% (95% CI, 48.4%-71.1%; 43/72 patients). After noninferiority was confirmed (P<0.01), the ANA device also showed superiority in the rate of successful reperfusion with ≤3 passes (P=0.02). First-pass successful recanalization rate was 55.6% (95% CI, 44.1%-67.0%), with a first-pass complete recanalization rate of 38.9% (95% CI, 27.6%-50.1%). Rescue therapy to obtain a modified Thrombolysis in Cerebral Infarction score 2b-3 was needed in 12/72 (17%) patients. At 90 days, the rate of favorable functional outcome (modified Rankin Scale score 0-2) was 57.5% (95% CI, 46.2%-68.9%), and the rate of excellent functional outcome (modified Rankin Scale score 0-1) was 45.2% (95% CI, 33.8%-56.6%). The rate of severe adverse device related was 1.4%. CONCLUSIONS: In this clinical experience, the ANA device achieved a high rate of complete recanalization with a preliminary good safety profile and favorable 90 days clinical outcomes. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04095767.

Are modified Fisher Scale and bleeding pattern helpful predictors of neurological complications in non-aneurysmal subarachnoid hemorrhage?

PURPOSE: Non-aneurysmal subarachnoid hemorrhage (NA-SAH) is a clinical-radiological entity with a different prognosis than aneurysmal SAH (A-SAH). The purpose of this study is to assess the predictive value of the modified Fisher Scale (mFS) for neurological complications in patients with this diagnosis. METHODS: We recruited patients admitted at our hospital services between 2009 and 2017 who were diagnosed with spontaneous SAH, with either perimesencephalic (PM-SAH) or diffuse pattern (D-SAH), an initial negative angio-CT, and at least one digital subtraction angiography of brain vessels discarding underlying brain aneurysms or other vascular malformations. RESULTS: The retrospective observational study included 116 patients. The mean age was 54.4, and the sample included predominantly male subjects (62.9%). Hunt and Hess (HH) scores on admission ranged from 3 to 5 in 18.1% of patients. The prevalence of hydrocephalus requiring ventricular drainage was 18.1%. The prevalence of symptomatic vasospasm was 4.3%. A modified Rankin Scale (mRS) 0-2 at discharge was found in 95.6%. In a multivariate logistic regression for the presence of neurological complications including age, sex, admission HH 3-5 compared with < 3, mFS 4 compared with mFS < 4, D-SAH compared with PM-SAH, and mRS score at discharge of 0-2 compared with > 2, the only significant predictors were mFS 4 compared with mFS < 4 (OR 4.47 (95% CI 1.21, 16.66) p value = 0.03) and D-SAH compared with PM-SAH (OR 7.10 (95% CI 1.24, 40.8) p value = 0.03). CONCLUSION: In patients with NA-SAH, a mFS score of 4 and/or a D-SAH bleeding pattern in non-contrast cranial CT on admission predicted the development of relevant neurological complications.

Mechanical Thrombectomy in Acute Stroke Due to Carotid Occlusion: A Series of 153 Consecutive Patients.

BACKGROUND: Strokes due to carotid artery occlusion (CAO) are associated with bad clinical prognosis and poor response to intravenous thrombolysis. Several studies in the past have shown the benefits of mechanical thrombectomy (MT) and compared bridging therapy (BT) and primary MT (PMT) in large vessel occlusions, but only a few studies have focused on the specific population of CAO and their response to endovascular treatment. METHODS: Retrospective review of patients treated at our center between January 2010 and June 2017 that (1) presented with acute ischemic stroke caused by CAO in the first 4.5 h since symptom onset, and (2) were treated with MT (BT or PMT). Baseline characteristics of the population, comparison between BT and PMT, intrahospital mortality, symptomatic intracranial hemorrhage, and functional outcome were investigated. RESULTS: A total of 153 patients were included. Baseline characteristics: 51.6% were male, and the median age was 71 years. The most frequent risk factor was hypertension (71.9%). The main stroke etiology was atherothrombotic (40.5%). The mean admission National Institute of Health Severity Score (NIHSS) was 19, mean discharge NIHSS was 7. Isolated occlusion of the Extracranial or Intracranial Internal Carotid Artery was the most frequent occlusion location (52.3%). TICI 2b-3 was achieved in 87.6%, intrahospital mortality was 26.8%, symptomatic hemorrhage was 8.5%, and 3 months-modified Rankin Score (mRS) 0-2 was 26.8%. Definitive carotid stenting was needed in 33.3% of the cases. BT versus PMT: Patients treated with PMT presented a higher incidence of atrial fibrillation, anticoagulation, and cardioembolic stroke compared to those treated with BT. No differences in TICI 2b-3, 3 months-mRS or symptomatic hemorrhage were found between both groups. Intrahospital mortality: Poor perfusion-CT mismatch (p = 0.005), isolated Internal carotid artery location (p = 0.024), and symptomatic hemorrhage (p < 0.001) were independent predictors. Symptomatic intracranial hemorrhage: Patients with post-treatment symptomatic hemorrhage had higher intrahospital mortality (p < 0.001) and worse 3 months-mRS (p = 0.033). Functional outcome: Admission NIHSS (p = 0.012) independently predicted 3 months-mRS. CONCLUSIONS: In our population, patients with CAO clinically present with severe strokes. Isolated occlusions of the extra- or intracranial segments of the carotid are more frequent than tandem occlusions. Successful recanalization after thrombectomy is achieved in most of the patients, but association with favorable functional outcome is poor. Clinical evolution is similar in patients treated with PMT and BT. Intracranial symptomatic hemorrhage after treatment is associated with higher intrahospital mortality and worse 3 months-mRS. Poor perfusion-CT mismatch, symptomatic hemorrhage, and isolated CAO are independent predictors of intrahospital mortality. Admission NIHSS is an independent predictor of 3 months-mRS.

Cerebral vasospasm and wernicke encephalopathy secondary to adult cyclic vomiting syndrome: the role of magnesium.

BACKGROUND: Magnesium has a regulatory role in the excitability of cell membranes, and is also a cofactor in the phosphorylation of thiamine. Hypomagnesemia has been associated with coronary vasospasm, but its role in cerebrovascular pathology is controversial, and cerebral vasospasm exclusively attributable to hypomagnesemia has not been reported in humans. CASE PRESENTATION: We report the case of a 51-year-old man in whom uncontrollable vomiting, treatment with omeprazole and thiazide, and renal impairment lead to a severe hypomagnesemia (magnesium below the level of detection in blood tests), which secondarily caused Wernicke's encephalopathy and vasospasm in multiple cerebral arteries (seen with cerebral angiography and CT angiography) that presented with a complete right hemisphere neurological deficit. These disturbances completely resolved when magnesium levels were normalized and subsequent neuroimaging tests confirmed the resolution of angiographic changes. CONCLUSION: Our case suggests that hypomagnesemia should be considered in the differential diagnosis of patients with neurological symptoms and predisposing causes.

Combined Multimodal Computed Tomography Score Correlates With Futile Recanalization After Thrombectomy in Patients With Acute Stroke.

BACKGROUND AND PURPOSE: Futile recanalization after acute ischemic stroke occurs in almost half of the patients despite optimal angiographic results. Multimodal neuroimaging may help to improve patient's selection but is still dismissed by many interventionalists. Our aim was to evaluate the accuracy of each parameter of multimodal computed tomography (CT) and their combination for predicting futile recanalization after successful thrombectomy. METHODS: We retrospectively reviewed a cohort of consecutive patients with anterior circulation stroke, fully assessable multimodal CT, and successful recanalization. Nonenhanced CT, CT angiography source images, cerebral blood volume (CBV), cerebral blood flow (CBF), and mismatch CBV-CBF maps were studied by Alberta Stroke Program Early CT Score (ASPECTS); collaterals on CT angiography were graded as poor or good (≤50% or >50% of the middle cerebral artery territory). Futile recanalization was defined as modified Rankin Scale score >2 at 3 months despite successful recanalization. RESULTS: One hundred fifty patients were included and 57% of them had futile recanalization. They had lower ASPECTS on nonenhanced CT, CT angiography source images, CBV, CBF, and mismatch CBV-CBF and presented more frequently poor collaterals (all P<0.001). Among them, CBV showed the highest area under the curve (0.83; 95% confidence interval, 0.76-0.88). In multivariate analyses, CT angiography source images ≤5 (odds ratio, 5.1; 95% confidence interval, 1.2-21.9), CBV≤6 (odds ratio, 3.5; 95% confidence interval, 1.2-9.7), and poor collaterals (odds ratio, 8.6; 95% confidence interval, 1.8-41.7) were independent predictors of futile recanalization. A combined score of these 3 parameters added complementary information: 57% of the patients with score-1, 89% with score-2, and 100% with score-3 had futile recanalization. Reclassification analyses indicated that this score improved prediction of futile recanalization. CONCLUSIONS: In this population, a combined multimodal CT score predicted futile recanalization.

Thrombectomy aspiration post-market study in acute stroke with the Q aspiration catheter: the TAPAS study.

BACKGROUND: The Q Aspiration Catheter (MIVI Neuro) has demonstrated greater aspiration flow rates and ingestion forces compared with conventional catheters in vitro. The safety and performance of the Q Catheter was assessed using a direct aspiration first pass technique in patients with acute ischemic stroke at four neurointerventional centers in Spain. METHODS: We included adult patients who underwent mechanical thrombectomy between March 2019 and March 2020 using the Q Catheter as first-line therapy. Performance endpoints included final successful revascularization of the target vessel (defined as modified thrombolysis in cerebral infarction (mTICI) grade 2B/3), first pass revascularization, and overall Q Catheter revascularization. Safety endpoints were symptomatic intracranial hemorrhage (sICH), embolization to new territory (ENT), and procedural complications. Modified Rankin Scale (mRS) score and all-cause mortality were also assessed. RESULTS: Forty-five subjects were enrolled. The Q Catheter successfully navigated to the lesion in 95.5% (43/45) of patients. Final successful mTICI 2B/3 revascularization was achieved in 93.3% (42/45), first pass mTICI 2B/3 revascularization with the Q Catheter was 55.3% (21/38), and overall with Q Catheter mTICI 2B/3 revascularization was 65.8% (25/38). Favorable clinical outcome of mRS 0-2 was achieved in 55.6% (25/45). There were no cases of ENT. sICH and mortality rates were 2.2% (1/45) and 13.3% (6/45), respectively. CONCLUSION: In this multicenter, observational study, the Q Aspiration Catheter used as first-line therapy demonstrated a good and safe profile in terms of navigation, revascularization, and safety in patients with acute ischemic stroke.

Derivo embolization device for intracranial aneurysms: a Spanish multicenter retrospective study.

BACKGROUND: Flow diverters have emerged in recent years as a safe and effective treatment for intracranial aneurysms, with expanding indications. The Derivo embolization device (DED) is a second-generation flow diverter with a surface finish that may reduce thrombogenicity. We report our multicenter experience evaluating its safety and efficacy. METHODS: We retrospectively analyzed all patients treated with the DED in eight centers in Spain between 2016 and 2020. Demographics, clinical data, procedural complications, morbidity and aneurysm occlusion rates were collected. RESULTS: A total of 209 patients with 250 aneurysms were treated (77.5% women). The majority of aneurysms were located in the internal carotid artery (86.8%) and most (69.2%) were small (<10 mm) with a median maximum diameter of 5.85 mm and median neck size of 4 mm. DED deployment was successful in all cases, despite two malfunctioning devices (1%). Major complications occurred in nine patients (4.3%), while mild neurologic clinical events were registered in 23 (11%); four patients died (1.9%). A total of 194 aneurysms had an angiographic follow-up at 6 months and showed complete aneurysm occlusion in 75% of cases. Twelve-month follow-up was available for 112 of the treated aneurysms, with a total occlusion rate of 83%. CONCLUSION: The DED is a second-generation surface-modified flow diverter that presents an option for treatment of intracranial aneurysms with comparable safety and efficacy to other available flow diverter devices. Nonetheless, risks are not negligible, and must be balanced against the natural history risk of cerebral aneurysms, considering the tendency to widen indications for treatment of smaller and less complex lesions in day-to-day use.

Economic impact of the first pass effect in mechanical thrombectomy for acute ischaemic stroke treatment in Spain: a cost-effectiveness analysis from the national health system perspective.

OBJECTIVE: The mechanical thrombectomy (MT) benefit is related to the degree of reperfusion achieved. First pass effect (FPE) is defined as complete/near revascularisation of the large-vessel occlusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2c-3) after a single device pass. This study assessed the health benefit and economic impact of achieving FPE for acute ischaemic stroke (AIS) patients from the Spanish National Health System (NHS) perspective. DESIGN: A lifetime Markov model was used to estimate incremental costs and health outcomes (measured in quality-adjusted life-years (QALYs)) of patients that achieve FPE. A subanalysis of the Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischaemic Stroke (STRATIS) registry was performed to obtain clinical outcomes. The base case included all patients that achieved at least a final mTICI ≥2 b, while the alternative scenario included all patients regardless of their final mTICI (0-3). Treatment costs were updated to reflect current practice based on expert panel consensus, while other acute and long-term costs were obtained from a previous cost-effectiveness analysis of MT performed in Spain. Sensitivity analyses were performed to assess the model's robustness. SETTING: Spanish healthcare perspective. PARTICIPANTS: AIS patients in Spain. INTERVENTIONS: FPE following MT. OUTCOME MEASURES: The model estimated QALYs, lifetime costs and net monetary benefit for the FPE and non-FPE group, depending on the inclusion of reperfusion groups and formal care costs. RESULTS: STRATIS subanalysis estimated significantly better clinical outcomes at 90 days for the FPE group in all scenarios. In the base case, the model estimated lifetime cost saving per patient of €16 583 and an incremental QALY gain of 1.2 years of perfect health for the FPE group. Cost savings and QALY gains were greater in the alternative scenario (-€44 289; 1.75). In all scenarios, cost savings were driven by the long-term cost reduction. CONCLUSION: Achieving FPE after MT can lead to better health outcomes per AIS patient and important cost savings for the Spanish NHS.

ADAPT technique with ACE68 and ACE64 reperfusion catheters in ischemic stroke treatment: results from the PROMISE study.

BACKGROUND AND PURPOSE: The recent randomized trials demonstrated the benefit of mechanical thrombectomy in stroke therapy. However, treatment using different strategies is an ongoing area of investigation. The PROMISE study analyzed the safety and effectiveness of the Penumbra System with the ACE68 and ACE64 reperfusion catheters in aspiration thrombectomy of stroke, using A Direct Aspiration First Pass Technique (ADAPT). METHODS: PROMISE was a prospective study which enrolled 204 patients with intracranial anterior circulation large vessel occlusion (LVO) ischemic stroke in 20 centers from February 2016 to May 2017. Initial treatment was with the ACE68/ACE64 catheters within 6 hours of symptom onset. Imaging and safety review was performed by an independent Core Laboratory and a Clinical Events Committee. The primary angiographic outcome was revascularization to mTICI 2b-3 at immediate post-procedure and the primary clinical outcome was 90-day modified Rankin Scale (mRS) score ≤2. Safety assessment included device- and procedure-related serious adverse events (SAEs), symptomatic intracranial hemorrhage (sICH), mortality, and embolization of new territory (ENT). RESULTS: Enrolled patients had a median age of 74 (IQR 65-80) years and a median admission NIHSS of 16 (IQR 11-20). The post-procedure mTICI 2b-3 revascularization rate was 93.1% and the 90-day mRS 0-2 rate was 61%. Device- and procedure-related SAEs at 24 hours occurred in 1.5% and 3.4%, respectively, 90-day mortality was 7.5%, sICH occurred in 2.9% while ENT occurred in 1.5%. CONCLUSIONS: For frontline therapy of LVO stroke, the ACE68/ACE64 catheters for aspiration thrombectomy were found to be safe and showed similar efficacy to randomized trials using other revascularization techniques. CLINICAL TRIAL REGISTRATION: NCT02678169; Pre-results.

Clinical Predictors of Hyperperfusion Syndrome Following Carotid Stenting: Results From a National Prospective Multicenter Study.

OBJECTIVES: The aim of the HISPANIAS (HyperperfusIon Syndrome Post-carotid ANgIoplasty And Stenting) study was to define CHS rates and develop a clinical predictive model for cerebral hyperperfusion syndrome (CHS) after carotid artery stenting (CAS). BACKGROUND: CHS is a severe complication following CAS. The presence of clinical manifestations is estimated on the basis of retrospective reviews and is still uncertain. METHODS: The HISPANIAS study was a national prospective multicenter study with 14 recruiting hospitals. CHS was classified as mild (headache only) and moderate-severe (seizure, impaired level of consciousness, or development of focal neurological signs). RESULTS: A total of 757 CAS procedures were performed. CHS occurred in 22 (2.9%) patients, in which 16 (2.1%) had moderate-severe CHS and 6 (0.8%) had mild CHS (only headache). The rate of hemorrhages was 0.7% and was associated with high mortality (20%). Pre-operative predictors of moderate-severe CHS in multivariate analysis were female sex (odds ratio [OR]: 3.24; 95% confidence interval [CI]: 1.11 to 9.47; p = 0.03), older patients (OR: 1.09; 95% CI: 1.01 to 1.17; p = 0.02), left carotid artery treated (OR: 4.13; 95% CI: 1.11 to 15.40; p = 0.03), and chronic renal failure (OR: 6.29; 95% CI: 1.75 to 22.57; p = 0.005). The area under the curve of this clinical and radiological model was 0.86 (95% CI: 0.81 to 0.92; p = 0.001). CONCLUSIONS: The rate of CHS in the HISPANIAS study was 2.9%, with moderate-severe CHS of 2.1%. CHS was independently associated with female sex, older age, history of chronic kidney disease, and a treated left carotid artery. Although further investigations are needed, the authors propose a model to identify high-risk patients and develop strategies to decrease CHS morbidity and mortality in the future.

Appropriateness of lumbar spine magnetic resonance imaging in Spain.

OBJECTIVES: To determine the minimum percentage of lumbar spine magnetic resonance imaging (LSMRI) which are inappropriately prescribed in routine practice. METHODS: LSMRI performed prospectively on 602 patients in 12 Radiology Services across 6 regions in Spain, were classified as "appropriate", "uncertain" or "inappropriate" based on the indication criteria established by the National Institute for Clinical Excellence, the American College of Physicians and Radiology, and current evidence-based clinical guidelines. Studies on patients reporting at least one "red flag" were classified as "appropriate". A logistic regression model was developed to identify factors associated with a higher likelihood of inappropriate LSMRI, including gender, reporting of referred pain, health care setting (private/public), and specialty of prescribing physician. Before performing the LSMRI, the radiologists also assessed the appropriateness of the prescription. RESULTS: Eighty-eight percent of LSMRI were appropriate, 1.3% uncertain and 10.6% inappropriate. The agreement of radiologists' assessment with this classification was substantial (k=0.62). The odds that LSMRI prescriptions were inappropriate were higher for patients without referred pain [OR (CI 95%): 13.75 (6.72; 28.16)], seen in private practice [2.25 (1.20; 4.22)], by orthopedic surgeons, neurosurgeons or primary care physicians [2.50 (1.15; 5.56)]. CONCLUSION: Efficiency of LSMRI could be improved in routine practice, without worsening clinical outcomes.

Hematoma cervical y mediastínico por lesión carotídea al canalizar la vena yugular resuelta con un stent / Cervical and mediastinal hematoma caused by a carotid injury after jugular vein cannulation treated with a stent

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