Trial of Thrombectomy for Stroke with a Large Infarct of Unrestricted Size.

BACKGROUND: The use of thrombectomy in patients with acute stroke and a large infarct of unrestricted size has not been well studied. METHODS: We assigned, in a 1:1 ratio, patients with proximal cerebral vessel occlusion in the anterior circulation and a large infarct (as defined by an Alberta Stroke Program Early Computed Tomographic Score of ≤5; values range from 0 to 10) detected on magnetic resonance imaging or computed tomography within 6.5 hours after symptom onset to undergo endovascular thrombectomy and receive medical care (thrombectomy group) or to receive medical care alone (control group). The primary outcome was the score on the modified Rankin scale at 90 days (scores range from 0 to 6, with higher scores indicating greater disability). The primary safety outcome was death from any cause at 90 days, and an ancillary safety outcome was symptomatic intracerebral hemorrhage. RESULTS: A total of 333 patients were assigned to either the thrombectomy group (166 patients) or the control group (167 patients); 9 were excluded from the analysis because of consent withdrawal or legal reasons. The trial was stopped early because results of similar trials favored thrombectomy. Approximately 35% of the patients received thrombolysis therapy. The median modified Rankin scale score at 90 days was 4 in the thrombectomy group and 6 in the control group (generalized odds ratio, 1.63; 95% confidence interval [CI], 1.29 to 2.06; P<0.001). Death from any cause at 90 days occurred in 36.1% of the patients in the thrombectomy group and in 55.5% of those in the control group (adjusted relative risk, 0.65; 95% CI, 0.50 to 0.84), and the percentage of patients with symptomatic intracerebral hemorrhage was 9.6% and 5.7%, respectively (adjusted relative risk, 1.73; 95% CI, 0.78 to 4.68). Eleven procedure-related complications occurred in the thrombectomy group. CONCLUSIONS: In patients with acute stroke and a large infarct of unrestricted size, thrombectomy plus medical care resulted in better functional outcomes and lower mortality than medical care alone but led to a higher incidence of symptomatic intracerebral hemorrhage. (Funded by Montpellier University Hospital; LASTE ClinicalTrials.gov number, NCT03811769.).

Angioplasty, stenting, or both - rescue maneuvers and reperfusion after endovascular therapy for intracranial atherosclerosis-related occlusion.

PURPOSE: Data concerning reperfusion strategies of intracranial atherosclerosis-related occlusion (ICARO) and clinico-angiographic outcomes remain scarce, particularly in Caucasians. We aim to compare the reperfusion rate and functional outcome between reperfusion strategies in the setting of the ICARO. METHODS: Retrospective analysis of prospectively maintained endovascular thrombectomy (EVT) registries at three high-volume stroke centers were retrospectively analyzed for consecutive ICARO patients from January 2015 to December 2019. We defined ICARO as any fixed high-degree (> 70%) focal narrowing or stenosis of any degree with a perpetual tendency for reocclusion. We categorized reperfusion strategies into four groups: EVT [group 1], balloon angioplasty [(BAp), group 2], placement of self-expandable stents [(SES), group 3], and BAp combined with implantation of SES; or direct placement of balloon mounted stents (BMS) [(BAp-SES/BMS), group 4]. We evaluated the association with the successful reperfusion [mTICI 2b - 3] and favorable outcome [mRS 0-2] with logistic regression analysis. RESULTS: Out of 2550 EVT, 124 patients (median age, 70 (61-80) years; 76 men) with ICARO and 130 reperfusion attempts [36 EVT, 38 BAp, 17 SES, and 39 BAp + SES/BMS] were analyzed. SES implantation showed the highest frequency of post-procedural symptomatic intracranial hemorrhage [(18%, 3/17), p = .03]; however, we observed no significant differences in the mortality rate. Overall, we achieved successful reperfusion in 71% (92/130) and favorable outcomes in 42% (52/124) of the patients. BAp + SES/BMS was the only independent predictor of the final successful reperfusion [aOR, 4.488 (95% CI, 1.364-14.773); p = .01], which was significantly associated with the 90-day favorable outcome [aOR, 10.837 (95% CI, 3.609-32.541); p = < .001] after adjustment for confounding variables between the reperfusion strategies. CONCLUSION: Among patients with ICARO, the rescue angioplasty stenting effectively contributed to higher odds of successful reperfusion with no increased risk for intracranial hemorrhage.

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.

Fibronectin degradation as biomarker for Trypanosoma cruzi infection and treatment monitoring in mice.

Biomarkers (coming from host or parasite) to monitor Chagas disease (CD) progression as well as the therapeutic response in chronic CD are critically needed, since seronegativization, which may be considered the best indicator of therapeutic cure, takes several years to be observed in adults. Several molecules have been suggested as biomarkers for CD, however, they have to be validated. Taking advantage of mouse models of Trypanosoma cruzi infection, we investigated changes in the degradation profile of fibronectin in plasma. The degradation profile of fibronectin was different in the acute phase compared to the chronic phase of the infection. Fibronectin fragments of approximately 150, 100, 40 and 30 kDa were identified. Furthermore, those degradation profiles correlated with acute parasitaemia as well as with cardiac parasite burden and tissue damage during the infection. The usefulness of fibronectin degradation as a biomarker for therapeutic response following drug treatment and immunotherapeutic vaccination also was evaluated and a decreased fibronectin degradation profile was observed upon benznidazole or a vaccine candidate treatment.

Safety and efficacy of intracranial aneurysm embolization using the "combined remodeling technique": low-profile stents delivered through double lumen balloons: a multicenter experience.

PURPOSE: Since appearance of the balloon-remodeling technique and stent-assisted coiling, complex aneurysms have been treated successfully by endovascular means worldwide. Although these two techniques have been widely proven, the combination of both traditionally made the procedures more complicated technically. The aim of our study was to determine the technical success, safety, and efficacy of the low-profile stents delivered through double lumen balloons. METHODS: Clinical, procedural, and angiographic data were analyzed. RESULTS: Eighty-four patients (55 women; age range 20-81 years) harboring 86 aneurysms were included in this study. Aneurysm maximal diameter ranged from 2 to 26 mm, with mean 7.5 mm. There were 62 unruptured, 15 recanalized, and 9 acutely ruptured aneurysms. Aneurysm locations were ACoA (31), MCA (36), supraclinoid ICA (4), carotid bifurcation (2), basilar (7), PCA (3), PICA (2), and VA (1). Ninety-three devices were implanted (63 LVIS jr, 15 LEO Baby, 14 ACCLINO Flex and 1 Neuroform Atlas) through the double lumen balloons (Scepter C or XC and Eclipse 2 L). We found 2 minor clinical events (2.4%) and 1 major event (1.2%). Total intra-procedural technical complication rate was 11.6%. Follow-up was available for 71 patients with an average follow-up of 7 months. Complete and near complete occlusion was 90.1%. Residual aneurysms were seen in 9.9%. CONCLUSION: The "combined remodeling technique" with low-profile stents delivered through double-lumen balloons is technically feasible, safe, and effective for the treatment of intracranial aneurysms. This technique allows the operator to avoid extra maneuvers.

Normal development imaging pitfalls and injuries in the pediatric shoulder.

The skeletal maturation of the shoulder has been well documented on radiographic and cadaveric studies. Recent increased use of MRI has provided increased understanding of the soft-tissue and osseous changes that occur during development. Thus recognizing normal maturation, imaging manifestations and pitfalls is crucial when evaluating the pediatric shoulder joint. At birth, the humeral diaphysis, midportion of the clavicle, and the body of the scapula are ossified, while the remainder of the bones of the shoulder are composed of non-ossified cartilaginous precursors. During growth, cartilaginous apophyses and epiphyses of the shoulder develop numerous secondary ossification centers, which fuse with the primary ossification centers to form the complete bony components of the shoulder. Additionally changes in the morphology of the growth plates as well as marrow signal occur in an organized manner. This paper affords the reader with an understanding of the normal development of three major components of skeletal maturation in the shoulder: ossification centers, growth plates and marrow signal. These topics are further subdivided into the glenoid, proximal humerus and acromioclavicular joint. We also provide a focus on distinguishing normal anatomy from imaging pitfalls related to skeletal maturation.

Health-Related Quality of Life and Fatigue After Transient Ischemic Attack and Minor Stroke.

BACKGROUND: Studies suggest that fatigue and cognitive impairment may be present after transient ischemic attack (TIA) or minor stroke, but little is known about consequences in daily life. The main aim was to explore the presence of fatigue, cognitive impairment, and consequences in daily life after minor stroke-TIA. METHODS: Patients (n = 92) were consecutively recruited from the Stroke Unit and were assessed within 2 weeks of hospital admission for first-ever and 3 months later. Control participants (n = 89) were recruited from the same population as the patients. Measures included the Fatigue Assessment Scale (FAS), Montreal Cognitive Assessment (MoCA), and The European Quality of Life index (EQ-5D-5L). RESULTS: The prevalence of substantial fatigue was 65.2% (confidence interval [CI] 95%: 54.6%-74.8%) and extreme fatigue was 20.7% (CI 95%: 12.9%-30.4%) in minor stroke-TIA patients. The prevalence of substantial fatigue in controls was 23.5% (CI95%: 15.0%-34.0%) and extreme fatigue was 4.5% (CI 95%: 1.8%-11.0%). The mean (SD) score on the MoCA was 24.1 (3.2) for the patients group and 27.3 (2.4) for controls (P < .001). FAS showed the strongest negative correlation score with the EQ-5D-5L index (r = -0.480; P < .0001), higher levels of mental and physical fatigue are associated with lower EQ-5D-5L index (r = -0.376; P < .001 and r = -0.497; P <.001, respectively). The correlations between the FAS and the MoCA measures were no significant. MoCA was not significantly correlated with EQ-5D-5L. CONCLUSIONS: Fatigue was a very common symptom in TIA/minor stroke patients. The fatigue had a significant impact on the health-related quality of life construct in its entirety, even after accounting for the influence of several factors.

Efficacy and safety of eberconazole 1% otic solution compared to clotrimazole 1% solution in patients with otomycosis.

PURPOSE: To demonstrate non-inferiority of eberconazole 1% otic solution to clotrimazole 1% solution, and to compare their safety profiles in the treatment of otomycosis. MATERIALS AND METHODS: Multicenter, randomized, double-blind, active treatment-controlled phase 3 clinical trial. One hundred and ninety patients with diagnosis of otomycosis were randomly assigned to eberconazole 1% otic solution or clotrimazole 1% solution. RESULTS: Baseline characteristics were comparable between both groups for age, gender, ethnicity, and clinical variables. Both study groups had high complete response rates: 81.8% in the eberconazole group and 83.5% in the clotrimazole group. Although non-inferiority of eberconazole relative to clotrimazole could not be demonstrated, a post-hoc sensitivity analysis demonstrated that eberconazole 1% otic solution was not inferior to clotrimazole 1% solution for the primary efficacy endpoint. Secondary endpoints also demonstrated that eberconazole 1% and clotrimazole 1% solutions were therapeutically similar at the end of the study. The incidence of adverse events was similar in both groups, and none had related AEs and withdrawals due to an AE. CONCLUSIONS: Eberconazole 1% otic solution is an efficacious and safe option to treat otomycosis-affected patients in the general practice.

Safety and Efficacy of Mechanical Thrombectomy in Acute Ischemic Stroke of Anticoagulated Patients-A Prospective Observational Study.

BACKGROUND: Anticoagulated patients (APs) are excluded from the acute stroke management with alteplase in Europe, not in the United States. They could benefit from mechanical thrombectomy (MT), which was not undoubtedly proven. There are scarce data about its results in such patients. The authors' aim is to analyze the efficacy and safety of MT in APs presenting with an acute stroke in our institution. METHODS: Prospective observational study comparing 30 APs and 109 non-anticoagulated patients (N-APs) underwent direct MT without alteplase. Demographic data, clinical severity (National Institutes of Health Stroke Scale [NIHSS]), efficacy (recanalization thrombolysis in cerebral infarction [TICI] ≥ 2b and modified Rankin Scale score ≤ 2 at 3 months), and security (symptomatic intracranial hemorrhage [SICH], mortality at 3 months) were compared between both groups. RESULTS: In both groups men were more frequent (63.3% of APs were men and 61.5% of N-APs were men). Mean age was 73 in APs and 67.2 in N-APs. Median NIHSS was similar (17 APs; 16 N-APs), also TICI greater than or equal to 2b (93.3% APs; 89.9% N-APs). The 3-month modified Rankin Scale score less than or equal to 2 was 46.7% in APs and 55.2% in N-APs (P = .40). SICH was present in 16.7% of APs and 8.3% of N-APs (P = .15). Mortality at 3 months was 6.7% in APs and 19% in N-APs (P = .08). CONCLUSIONS: MT is a valid treatment option in APs. It achieves an efficacy as in N-APs with a tendency to suffer more from SICH, but lower mortality. We hypothesize that cardioembolic clots may be easier to be removed than atherotrombotics, and that embolic stroke in APs might be less severe than that in N-APs or might suffer less of other complications than atherotrombotics.

From genome screening to creation of vaccine against Trypanosoma cruzi by use of immunoinformatics.

Chagas disease is caused by the protozoan parasite Trypanosoma cruzi, and activation of CD8(+) T cells is crucial for a protective immune response. Therefore, the identification of antigens with major histocompatibility complex class I epitopes is a crucial step for vaccine development against T. cruzi. Our aim was to identify novel antigens and epitopes by immunoinformatics analysis of the parasite proteome (12 969 proteins) and to validate their immunotherapeutic potential in infected mice. We identified 172 predicted epitopes, using NetMHC and RANKPEP. The corresponding protein sequences were reanalyzed to generate a consensus prediction, and 26 epitopes were selected for in vivo validation. The interferon γ (IFN-γ) recall response of splenocytes from T. cruzi-infected mice confirmed that 10 of 26 epitopes (38%) induced IFN-γ production. The immunotherapeutic potential of a mixture of all 10 peptides was evaluated in infected mice. The therapeutic vaccine was able to control T. cruzi infection, as evidenced by reduced parasitemia, cardiac tissue inflammation, and parasite burden and increased survival. These findings illustrate the benefits of this approach for the rapid development of a vaccine against pathogens with large genomes. The identified peptides and the proteins from which they are derived are excellent candidates for the development of a vaccine against T. cruzi.

Late spontaneous recanalization of symptomatic atheromatous internal carotid artery occlusion.

INTRODUCTION: Definitive treatment of symptomatic atheromatous internal carotid artery occlusion remains controversial, as far as in rare cases, late spontaneous recanalization has been seen. METHODS: We consecutively studied 182 patients (January 2003 to August 2012) with an ischemic stroke in the internal carotid artery territory and diagnosis of atheromatous internal carotid artery occlusion during hospitalization. FINDINGS: Seven patients presented a late spontaneous recanalization (>3 months) of the internal carotid artery. We described therapeutic attitude according to usual care in these patients. CONCLUSIONS: The authors attempt to highlight the unusual condition of recanalization after a symptomatic atheromatous chronic internal carotid artery occlusion. If these patients can be treated similar to patients with asymptomatic carotid pathology, then this needs to be clarified. However, due to the risk of ipsi- and contralateral ischemic strokes, revascularization techniques should be considered in certain cases. More studies are needed to establish the most appropriate therapeutical approach in order to avoid arbitrary treatment of these patients.

[Detection of an intrapulmonary shunt in patients with liver cirrhosis through contrast-enhanced transcranial Doppler. A study of prevalence, pattern characterization, and diagnostic validity]. / Detección del shunt intrapulmonar en pacientes con cirrosis hepática mediante doppler transcraneal con contraste. Estudio de prevalencia, caracterización del patrón y validez diagnóstica.

INTRODUCTION: Intrapulmonary vascular dilatations (IPVD) are considered a complication of cirrhosis. The technique of choice for their diagnosis is contrast-enhanced echocardiography (CEE). The aim of this study was to determine the usefulness of contrast-enhanced transcranial Doppler (CETD) in the diagnosis of IPVD. METHOD: We consecutively included patients evaluated for liver transplantation. A cross-sectional study was conducted. The investigator interpreting CETD was blind to the results of the gold standard (CEE). The accuracy of the diagnostic test was evaluated through sensitivity, specificity, positive and negative predictive values, and likelihood ratio. RESULTS: CETD (n=43) showed a right-to-left shunt in 23 patients (62.2%): 4 early, 2 indeterminate and 17 late. Nineteen (51,4%) cases were classified as IPVD. With CEE (n=37), 10 procedures (27%) were negative for shunt, 27 (73%) were positive, and 21 (56.8%) were compatible with IPVD. Patients with and without IPVD showed no differences in age, sex, etiology, severity, or MELD score, independently of the diagnostic test. In the diagnostic validity study (n=37) of CETD versus CEE, the AUC for diagnostic yield was 0.813% (95%CI: 0.666-0.959; P=.001), sensitivity was 76.2% (95%CI: 54.9-89.4) and specificity was 90% (95%CI: 63.9-96.5). The positive likelihood ratio was 6.095. CONCLUSIONS: We found a high prevalence of IPVD in candidates for liver transplantation. When a late right-to-left shunt with recirculation is observed, CETD has a high probability of detecting IPVD, with few false-positive results. Because this technique has not previously been described in this indication, similar studies are needed for comparison.

Placing the balloon-guide catheter in the high cervical segment of the internal carotid artery is associated with improved recanalization.

BACKGROUND: Mechanical thrombectomy (MT) is part of the standard of care for stroke treatment, and improving its efficacy is one of the main objectives of clinical investigation. Of importance is placement of the distal end of balloon-guided catheters (BGC). We aim to determine if this influences outcomes. METHODS: We analyzed data from the ASSIST Registry, an international, multicenter prospective study of 1492 patients. We divided patients treated with BGC according to the placement of the BGC: low cervical (LCG (the lower 2/3 of cervical internal carotid artery (ICA)) or high cervical (HCG (upper 1/3 of cervical ICA, petro-lacerum or higher)). We analyzed characteristics and outcomes overall and stratified on the primary MT technique: Stent-Retriever only (SR Classic), Combined use of aspiration catheter and SR (Combined), and Direct Aspiration (ADAPT). RESULTS: Our study included 704 subjects -323 in the low cervical and 381 in the high cervical groups. Statistical differences were seen in the proportion of females and tandem lesions (both higher for LCG). Placing the BGC in the high cervical segment is associated with better recanalization rates (expanded treatment in cerebral infarction (eTICI) score of 2c-3) at the end of the procedure (P<0.0001) and shorter procedures (P=0.0005). After stratifying on the three primary techniques (SR Classic, Combined, and ADAPT), placing the BGC in the high segment is associated with a better first-pass effect (FPE), less distal emboli, and better clinical outcomes in the SR Classic technique. CONCLUSIONS: Placing the distal end of the BGC at the high cervical segment or higher is associated with better recanalization.

Technique and impact on first pass effect primary results of the ASSIST global registry.

BACKGROUND: Patients treated with mechanical thrombectomy (MT) for acute ischemic strokes from large vessel occlusion (LVO) have better outcomes with effective reperfusion. However, it is unknown which technique leads to better technical and clinical success. We aimed to determine which technique yields the most effective first pass reperfusion during MT. METHODS: In a prospective, multicenter global registry we enrolled patients treated with operator preferred MT technique at 71 hospitals from January 2019 to January 2022. Three techniques were assessed: SR Classic with stent retriever (SR) and balloon guide catheter (BGC); SR Combination which employed SR with contact aspiration with or without BGC; and direct aspiration (DA) with or without BGC. The primary outcome was achieving an expanded Thrombolysis In Cerebral Infarction (eTICI) score of 2c or 3 on the first pass, with the primary technique as adjudicated by core lab. The primary clinical outcome measure was a 90-day modified Rankin Scale (mRS) score of 0-2. RESULTS: A total of 1492 patients were enrolled. Patients treated with SR Classic or SR Combination were more likely to achieve first pass eTICI 2c or 3 reperfusion (P=0.01). There was no significant difference in mRS 0-2 (P=0.46) or safety endpoints. CONCLUSIONS: The use of SR Classic or SR Combination was more likely to achieve first pass eTICI 2c or 3 reperfusion. There were no significant differences in clinical outcomes and safety endpoints.

Enhancing the First-Pass Effect in Acute Stroke: The Impact of Stent Retriever Characteristics.

Introduction: Although stentrievers (SRs) have been a mainstay of mechanical thrombectomy (MT), and current guidelines recommend the use of SRs in the treatment of large vessel occlusion stroke (LVO), there is a paucity of studies in the literature comparing SRs directly against each other in terms of mechanical and functional properties. Timely access to endovascular therapy and the ability to restore intracranial flow in a safe, efficient, and efficacious manner have been critical to the success of MT. This study aimed to investigate the impact of contemporary SR characteristics, including model, brand, size, and length, on the first-pass effect (FPE) in patients with acute ischemic stroke. Methods: Consecutive patients with M1 occlusion treated with a single SR+BGC were recruited from the ROSSETTI registry. The primary outcome was the FPE that was defined as modified (mFPE) or true (tFPE) for the achievement of modified thrombolysis in cerebral infarction (mTICI) grades 2b-3 or 3 after a single device pass, respectively. We compared patients who achieved mFPE with those who achieved tFPE according to SR characteristics. Results: We included 610 patients (52.3% female and 47.7% male, mean age 75.1 ± 13.62 years). mFPE was achieved in 357 patients (58.5%), whereas tFPE was achieved in 264 (43.3%). There was no significant association between SR characteristics and mFPE or tFPE. Specifically, the SR size did not show a statistically significant relationship with improvement in FPE. Similarly, the length of the SR did not yield significant differences in the mFPE and tFPE, even when the data were grouped. Conclusions: Our data indicate that contemporary SR-mediated thrombectomy characteristics, including model, brand, size, and length, do not significantly affect the FPE.

Mechanical thrombectomy with a new intermediate balloon catheter combining the BGC and DAC features: Initial clinical experience with the iNedit device.

INTRODUCTION: The iNedit balloon distal access catheter is a novel thrombectomy device. It has an inner diameter of 0.058″, proximal outer diameter of 2.13 mm, and distal outer diameter of 1.67mm. It is compatible with a 0.088″ guide catheter and includes a balloon located 5 cm from the catheter tip, enabling proximal flow restriction and combined therapy with stent retrievers. We investigate the appraisal of the use, safety, and efficacy of the iNedit catheter in the first-in-human study. METHODS: In the preliminary cases that demanded training on the product previous to a multicentric study, prospective data were collected on 22 consecutive patients treated with the iNedit catheter to perform thrombectomy for acute ischemic stroke due to large vessel occlusion within 24 h. The outcome measures consisted of several evaluations of user experience rated on a 5-point scale ranging from 1 (bad) to 5 (excellent), as well as assessments of procedural safety outcomes such as artery perforation and arterial occlusion, procedural efficacy outcomes including first-pass effect (Thrombolysis In Cerebral Infarction [TICI] 2c/3) and final recanalization (TICI 2b/3), and clinical efficacy outcomes such as a 3-month 0-2 modified Rankin Scale (mRS). RESULTS: The mean age was 72 ± 12 years old; median National Institute Health Stroke Scale was 17 (11-19). Sites of primary occlusion were: 2 internal carotid artery, 12 M1-MCA, 7 M2-MCA, and one P1. Median score evaluation of the appraisal of use was 4- IQR [4-5]. The median number of passes was 1 [IQR 1-2]. First pass complete recanalization rate was 50% and the final recanalization rate was 94.45%. No artery perforation and arterial occlusion. Good functional outcome mRS 0-2 was achieved in 50% of patients. CONCLUSIONS: In this initial clinical experience, iNedit device achieved a high rate of first-pass effect and final recanalization rate with no safety concerns, thus favoring a high percentage of good clinical outcomes.

First clinical multicenter experience with the new Pipeline Vantage flow diverter.

BACKGROUND: Flow diversion is an innovative and increasingly used technique for the treatment of intracranial aneurysms. New flow diverters (FDs) are being introduced to improve the safety and efficacy of this treatment. The aim of this study was to assess the safety, feasibility, and efficacy of the new Pipeline Vantage (PV) FD. METHODS: Patients with intracranial aneurysms treated with the PV at 10 international neurovascular centers were retrospectively analyzed. Patient and aneurysm characteristics, procedural parameters, complications, and the grade of occlusion were assessed. RESULTS: 60 patients with 70 aneurysms (5.0% with acute hemorrhage, 90.0% located in the anterior circulation) were included. 82 PVs were implanted in 61 treatment sessions. The PV could be successfully implanted in all treatments. Additional coiling was performed in 18.6%, and in-stent balloon angioplasty (to enhance the vessel wall apposition) in 24.6%. Periprocedural technical complications occurred in 24.6% of the treatments, were predominantly FD deployment problems, and were all asymptomatic. The overall symptomatic complication rate was 8.2% and the neurological symptomatic complication rate was 3.3%. Only one symptomatic complication was device-related (perforator artery infarctions leading to stroke). After a mean follow-up of 7.1 months, the rate of complete aneurysm occlusion was 77.9%. One patient (1.7%) died due to aneurysmal subarachnoid hemorrhage which occurred before treatment, unrelated to the procedure. CONCLUSIONS: The new PV FD is safe and feasible for the treatment of intracranial aneurysms. The short-term occlusion rates are promising but need further assessment in prospective long-term follow-up studies.

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.

Cognitive improvement following endovascular embolization in patients with intracranial dural arteriovenous fistula: The Neuropsychology in dural ArterIal Fistula (NAIF) Study.

BACKGROUND: Cognitive improvement after endovascular embolization of an intracranial dural arteriovenous fistula (dAVF) remains unexplored. We aim to investigate cognitive changes following endovascular embolization of dAVFs. METHODS: Neuropsychology in dural ArterIal Fistula (NAIF) was a prospective multicentric study including patients with an angiographic diagnosis of dAVF who underwent endovascular embolization over the course of 4 years. A complete neuropsychological evaluation comprising five cognitive domains (attention and executive functions, memory, language, praxis, gnosis) was performed at baseline and 3 months follow-up. Mean Z scores for cognitive tests were compared pre- and post-treatment using paired sample t-tests, where higher Z scores indicate better cognition. Effect sizes were computed as Cohen's d. RESULTS: A total of 32 patients (mean age 61.1±15.4 years, 10 (31.3%) females) were included. Patients exhibited improved performance in attention and executive functions: executive functions-attention (+0.282, P=0.009, d=0.29), executive functions-fluencies (+0.283, P=0.029, d=0.4), and executive functions-processing speed (+0.471, P=0.039, d=0.41). There was an increase in memory: verbal learning and verbal delayed recall scores (+0.513, P<0.001, d=0.55, and +0.385, P=0.001, d=0.41, respectively), while verbal recognition parameters (+0.839, P=0.086, d=0.37) and visual memory (delayed recall) (+0.430, P=0.060, d=0.35) displayed trends toward improved performance. Regarding language, there was significant overall improvement (+0.300, P=0.014, d=0.24), but neither praxis nor gnosis changed significantly. These cognitive outcomes were independent of the severity (measured as Cognard classification), and no patient experienced cognitive worsening. CONCLUSION: This study suggests that endovascular embolization confers cognitive benefits on dAVF patients undergoing endovascular embolization and may be beneficial even for patients with a low risk of hemorrhage.

Initial Experience with the Solitaire X 3 mm Stent Retriever for the Treatment of Distal Medium Vessel Occlusions.

Endovascular therapy (EVT) is the standard treatment for ischemic stroke caused by a large vessel occlusion (LVO). The effectiveness of EVT for distal medium vessel occlusions (MDVOs) is still uncertain, but newer, smaller devices show potential for EVT in MDVOs. The new Solitaire X 3 mm device offers a treatment option for MDVOs. Our study encompassed consecutive cases of primary and secondary MDVOs treated with the Solitaire X 3 mm stent-retriever as first-line EVT device between January and December 2022 at 12 European stroke centers. The primary endpoint was a first-pass near-complete or complete reperfusion, defined as a modified treatment in cerebral infarction (mTICI) score of 2c/3. Additionally, we examined reperfusion results, National Institutes of Health Stroke Scale (NIHSS) scores at 24 h and discharge, device malfunctions, complications and procedural technical parameters. Sixty-eight patients (38 women, mean age 72 ± 14 years) were included in our study. Median NIHSS at admission was 11 (IQR 6-16). In 53 (78%) cases, a primary combined approach was used as the frontline technique. Among all enrolled patients, first-pass mTICI 2c/3 was achieved in 22 (32%) and final mTICI 2c/3 in 46 (67.6%) patients after a median of 1.5 (IQR 1-2) passes. Final reperfusion mTICI 2b/3 was observed in 89.7% of our cases. We observed no device malfunctions. Median NIHSS at discharge was 2 (IQR 0-4), and no symptomatic intracranial hemorrhages were reported. Based on our analysis, the utilization of the Solitaire X 3 mm device appears to be both effective and safe for performing EVT in cases of MDVO stroke.