Defining the optimal size of an aspiration catheter in relation to the arterial diameter during mechanical thrombectomy for stroke.

BACKGROUND: Mechanical thrombectomy for acute ischemic stroke is effective and includes different technical approaches. Operators use direct aspiration, a stent retriever, or a combination of both. Direct aspiration can be performed with various catheters of different sizes depending on the diameter of the occluded vessel. PURPOSE: We studied the relationship between the catheter diameter in regards to the occluded vessel diameter and the rate of successful recanalization. MATERIALS AND METHODS: We conducted a retrospective, monocentric study on a series of consecutive patients treated with mechanical thrombectomy. For each procedure, we extracted each attempt that used direct aspiration and rated the attempt as successful or unsuccessful. We also measured the occluded artery diameter and calculated the ratio between the occluded artery and the aspiration catheter diameters. We tested the association between the diameter ratio and the recanalization status. We also performed inter-rater agreement for the arterial diameter measurement between three interventional neuroradiologists. RESULTS: We included 119 patients with 201 attempts of direct aspiration. A higher diameter ratio was associated with a higher recanalization rate. The analysis in terciles showed that the odds of success were 4.80 higher when the ratio was >0.71 vs <0.54 (p < 0.01). Inter-rater agreement showed near-perfect intraclass correlation with 0.93 (0.91-0.94) consistency and 0.92 (0.90-0.94) absolute agreement. CONCLUSIONS: We demonstrated an association between higher recanalization and a diameter of ratio >0.71 between the aspiration catheter and the occluded artery. These results could guide intraoperative decisions regarding the appropriate selection of aspiration catheters during mechanical thrombectomy increasing the rate of successful recanalisation. A larger study could provide additional data to further specify the optimal ratio.

Endovascular Treatment of Acute Ischemic Stroke With the Penumbra System in Routine Practice: COMPLETE Registry Results.

BACKGROUND AND PURPOSE: The purpose of the COMPLETE (International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device) registry was to evaluate the generalizability of the safety and efficacy of the Penumbra System (Penumbra, Inc, Alameda) in a real-world setting. METHODS: COMPLETE was a global, prospective, postmarket, multicenter registry. Patients with large vessel occlusion-acute ischemic stroke who underwent mechanical thrombectomy using the Penumbra System with or without the 3D Revascularization Device as frontline approach were enrolled at 42 centers (29 United States, 13 Europe) from July 2018 to October 2019. Primary efficacy end points were successful postprocedure angiographic revascularization (modified Thrombolysis in Cerebral Infarction ≥2b) and 90-day functional outcome (modified Rankin Scale score 0-2). The primary safety end point was 90-day all-cause mortality. An imaging core lab determined modified Thrombolysis in Cerebral Infarction scores, Alberta Stroke Program Early CT Scores, clot location, and occurrence of intracranial hemorrhage at 24 hours. Independent medical reviewers adjudicated safety end points. RESULTS: Six hundred fifty patients were enrolled (median age 70 years, 54.0% female, 49.2% given intravenous recombinant tissue-type plasminogen activator before thrombectomy). Rate of modified Thrombolysis in Cerebral Infarction 2b to 3 postprocedure was 87.8% (95% CI, 85.3%-90.4%). First pass and postprocedure rates of modified Thrombolysis in Cerebral Infarction 2c to 3 were 41.5% and 66.2%, respectively. At 90 days, 55.8% (95% CI, 51.9%-59.7%) had modified Rankin Scale score 0 to 2, and all-cause mortality was 15.5% (95% CI, 12.8%-18.3%). CONCLUSIONS: Using Penumbra System for frontline mechanical thrombectomy treatment of patients with large vessel occlusion-acute ischemic stroke in a real-world setting was associated with angiographic, clinical, and safety outcomes that were comparable to prior randomized clinical trials with stringent site and operator selection criteria. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03464565.

Impact of Antiplatelet Therapy During Endovascular Therapy for Tandem Occlusions: A Collaborative Pooled Analysis.

Background and Purpose- Antiplatelet agents could be used in the setting of endovascular therapy for tandem occlusions to reduce the risk of de novo intracranial embolic migration, reocclusion of the extracranial internal carotid artery lesion, or in-stent thrombosis in case of carotid stent placement but have to be balanced with the intracerebral hemorrhagic transformation risk. In this study, we aim to investigate the impact of acute antiplatelet therapy administration on outcomes during endovascular therapy for anterior circulation tandem occlusions. Methods- This is a retrospective analysis of a collaborative pooled analysis of 11 prospective databases from the multicenter observational TITAN registry (Thrombectomy in Tandem Lesions). Patients were divided into groups based on the number of antiplatelet administered during endovascular therapy. The primary outcome was favorable outcome, defined as a modified Rankin Scale score of 0 to 2 at 90 days. Results- This study included a total of 369 patients; 145 (39.3%) did not receive any antiplatelet agent and 224 (60.7%) received at least 1 antiplatelet agent during the procedure. Rate of favorable outcome was nonsignificantly higher in patients treated with antiplatelet therapy (58.3%) compared with those treated without antiplatelet (46.0%; adjusted odds ratio, 1.38 [95% CI, 0.78-2.43]; P=0.26). Rate of 90-day mortality was significantly lower in patients treated with antiplatelet therapy (11.2% versus 18.7%; adjusted odds ratio, 0.47 [95% CI, 0.22-0.98]; P=0.042), without increasing the risk of any intracerebral hemorrhage. Successful reperfusion (modified Thrombolysis in Cerebral Ischemia score 2b-3) rate was significantly better in the antiplatelet therapy group (83.9% versus 71.0%; adjusted odds ratio, 1.89 [95% CI, 1.01-3.64]; P=0.045). Conclusions- Administration of antiplatelet therapy during endovascular therapy for anterior circulation tandem occlusions was safe and was associated with a lower 90-day mortality. Optimal antiplatelet therapy remains to be assessed, especially when emergent carotid artery stenting is performed. Further randomized controlled trials are needed.

Emergent Carotid Stenting Plus Thrombectomy After Thrombolysis in Tandem Strokes: Analysis of the TITAN Registry.

Background and Purpose: Emergent carotid artery stenting plus mechanical thrombectomy is an effective treatment for acute ischemic stroke patients with tandem occlusion of the anterior circulation. However, there is limited data supporting the safety of this approach in patients treated with prior intravenous thrombolysis (IVT). We aimed to investigate the safety of emergent carotid artery stenting-mechanical thrombectomy approach in stroke patient population treated with prior IVT Methods: ­We assessed patients with acute ischemic stroke because of atherosclerotic tandem occlusion that were treated with emergent carotid artery stenting-mechanical thrombectomy approach from the multicenter observational Thrombectomy in Tandem Lesions registry. Patients were divided into 2 groups based on pretreatment IVT (IVT versus no-IVT). Intracerebral hemorrhages were classified according to the European Cooperative Acute Stroke Study II criteria. Results: Among 205 patients included in the present study, 125 (60%) received prior IVT. Time from symptoms onsetto-groin puncture was shorter (234±100 versus 256±234 minutes; P=0.002), and heparin use was less in the IVT group (14% versus 35%; P<0.001); otherwise, there was no difference in the baseline characteristics. There was no significant difference between the IVT and no-IVT groups in the rate of symptomatic intracerebral hemorrhage (5% versus 8%; P=0.544), parenchymal hematoma type 1 to 2 (15% versus 18%; P=0.647), successful reperfusion (modified Thrombolysis in Cerebral Ischemia 2b­3), or 90-day favorable outcome (modified Rankin Scale score of 0­2 at 90 days). The 90-day all-cause mortality rate was significantly lower in the IVT group (8% versus 20%; P=0.017). After adjusting for covariates, IVT was not associated with symptomatic intracerebral hemorrhage or 90-day mortality Conclusions: Emergent carotid artery stenting-mechanical thrombectomy approach was not associated with an increased risk of hemorrhagic complications in tandem occlusion patients who received IVT before the intervention.

Flow Diverters for Intracranial Aneurysms: The DIVERSION National Prospective Cohort Study.

Background and Purpose- Flow diverters are used for endovascular therapy of intracranial aneurysms. We did a nationwide prospective study to investigate the safety and effectiveness of flow diversion at 12 months. Methods- DIVERSION was a national prospective cohort study including all flow diverters placement between October 2012 and February 2014 in France. The primary end point was the event-free survival rate at 12 months, defined as the occurrence of morbidity (intracranial hemorrhage, ischemic stroke, noncerebral hemorrhage, or neurological deficit due to mass effect), retreatment, or death within 12 months post-treatment. A quality control was carried out on 100% of the collected data and of at least 10% of the included patients in each center, chosen at random. All reported serious events were adjudicated by an independent Data Safety and Monitoring Board. Satisfactory occlusion was defined as 3 or 4 on Kamran scale by an independent imaging core laboratory at 12 months. Results- We enrolled 398 patients harboring 477 intracranial aneurysms. At least 1 morbidity-mortality event was noted in 95 of 408 interventions representing an event-free survival rate of 75.7% (95% CI, 71.1-79.7). The rate of permanent-related serious events and mortality was 5.9% and 1.2% at 12 months, respectively. Multivariate analysis showed that high baseline blood pressure (hazard ratio, 2.54; 95% CI, 1.35-4.79; P=0.039), diabetes mellitus (hazard ratio, 3.70; 95% CI, 1.60-8.6; P=0.0022), and larger aneurysms (hazard ratio, 1.07; 95% CI, 1.04-1.11; P<0.0001) were associated with the occurrence of a neurological deficit. The satisfactory occlusion rate at 12 months was 79.9%, and the absence of high baseline blood pressure (odds ratio, 2.01; 95% CI, 1.12-3.71; P=0.0193) and postprocedural satisfactory occlusion (odds ratio, 2.75; 95% CI, 1.49-5.09; P=0.0012) were associated with a 12-month satisfactory occlusion. Conclusions- A satisfactory occlusion was achieved in almost 80% of cases after flow diverter treatment with a permanent-related serious event and mortality rates of 5.9% and 1.2% at 12 months, respectively.

Second-Generation Hydrogel Coils for the Endovascular Treatment of Intracranial Aneurysms: A Randomized Controlled Trial.

BACKGROUND AND PURPOSE: Endovascular embolization of intracranial aneurysms with hydrogel-coated coils lowers the risk of major recurrence, but technical limitations (coil stiffness and time restriction for placement) have prevented their wider clinical use. We aimed to assess the efficacy of softer, second-generation hydrogel coils. METHODS: A randomized controlled trial was conducted at 22 centers in France and Germany. Patients aged 18 to 75 years with untreated ruptured or unruptured intracranial aneurysms measuring 4 to 12 mm in diameter were eligible and randomized (1:1 using a web-based system, stratified by rupture status) to coiling with either second-generation hydrogel coils or bare platinum coils. Assist devices were allowed as clinically required. Independent imaging core laboratory was masked to allocation. Primary end point was a composite outcome measure including major aneurysm recurrence, aneurysm retreatment, morbidity that prevented angiographic controls, and any death during treatment and follow-up. Data were analyzed as randomized. RESULTS: Randomization began on October 15, 2009, and stopped on January 31, 2014, after 513 patients (hydrogel, n=256; bare platinum, n=257); 20 patients were excluded for missing informed consent and 9 for treatment-related criteria. Four hundred eighty-four patients (hydrogel, n=243; bare platinum, n=241) were included in the analysis; 208 (43%) were treated for ruptured aneurysms. Final end point data were available for 456 patients. Forty-five out of 226 (19.9%) patients in the hydrogel group and 66/230 (28.7%) in the control group had an unfavorable composite primary outcome, giving a statistically significant reduction in the proportion of an unfavorable composite primary outcome with hydrogel coils-adjusted for rupture status-of 8.4% (95% confidence interval, 0.5-16.2; P=0.036). Adverse and serious adverse events were evenly distributed between groups. CONCLUSIONS: Our results suggest that endovascular coil embolization with second-generation hydrogel coils may reduce the rate of unfavorable outcome events in patients with small- and medium-sized intracranial aneurysms. CLINICAL TRIAL REGISTRATION: URL: https://www.drks.de/drks_web/. Unique identifier: DRKS00003132.

Tumor-infiltrating lymphocytes and breast cancer: Beyond the prognostic and predictive utility.

The importance of the immune system as a potent anti-tumor defense has been consolidated in recent times, and novel immune-related therapies are today demonstrating a strong clinical benefit in the setting of several solid neoplasms. Tumor-infiltrating lymphocytes reflect the attempt of the host to eradicate malignancies, and during the last decades, they have been shown to possess an interesting prognostic utility for breast cancer, especially in case of HER2 positive and triple-negative molecular subtypes. In parallel, the clinical evaluation of tumor-infiltrating lymphocytes has been shown to effectively predict treatment outcomes in both neoadjuvant and adjuvant settings. Currently, tumor-infiltrating lymphocytes are promising further predictive utility in view of novel immune-related therapeutic strategies which are coming into the clinical setting launching a solid rationale for the future next-generation treatment options. In this scenario, tumor-infiltrating lymphocytes might represent an important resource for the selection of the most appropriate therapeutic strategy, as well as further evaluations of the molecular mechanisms underlying tumor-infiltrating lymphocytes and the immunoediting process would eventually provide new insights to augment therapeutic success. Considering these perspectives, we review the potential utility of tumor-infiltrating lymphocytes in the definition of breast cancer prognosis and in the prediction of treatment outcomes, along with the new promising molecular-based therapeutic discoveries.

GREAT-a randomized controlled trial comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment: procedural safety and core-lab-assessedangiographic results.

INTRODUCTION: Hybrid hydrogel-platinum coils (HydroCoil) have proven effective for endovascular aneurysm treatment. To overcome technical limitations (coil stiffness, time restriction for placement), a second generation of softer hydrogel coils has been brought to clinical practice (HydroSoft, HydroFrame). We report on procedural safety and core-lab-assessed angiographic results from an open-label multicenter randomized controlled trial. METHODS: Web-based randomization occurred in 15 medical centers in France and seven in Germany between coil embolization with second-generation hydrogel coils and treatment with any bare platinum coil. Assist devices could be used as clinically required. Primary endpoint is a composite outcome including major aneurysm recurrence and poor clinical outcome at 18 months follow-up. RESULTS: Five hundred thirteen patients were randomized (hydrogel n = 256, bare platinum n = 257). Twenty patients were excluded for missing informed consent and nine patients for treatment related criteria. Four hundred eighty-four patients were analyzed as randomized (hydrogel n = 243, bare platinum n = 241). Two hundred eight had ruptured aneurysms (43 %). Prespecified procedural complications occurred in 58 subjects (hydrogel n = 28, bare platinum n = 30, p = 0.77). The 14-day mortality rate was 2.1 % in both arms of the study. The median calculated packing densities for aneurysms assigned to hydrogel and bare platinum were 39 and 31 % respectively (p < 0.001). No statistically significant differences were found between arms in the post procedural angiographic occlusion rate (p = 0.8). CONCLUSION: Second-generation hydrogel coils can be used in a wide spectrum of aneurysms with a risk profile equivalent to bare platinum. Packing density was significantly higher in aneurysms treated with hydrogel coils. TRIAL REGISTRATION: http://www.germanctr.de , DRKS00003132.

Endovascular techniques for the management of wide-neck intracranial bifurcation aneurysms: A critical review of the literature.

Endovascular treatment is the first line treatment for intracranial aneurysms, but wide-neck aneurysms are often difficult to treat due to the difficulty in stabilizing the coils inside the aneurysm. It is singularly true for wide-neck bifurcation aneurysms (WNBA) as bifurcation branches often arise from the aneurysm neck. To overcome these difficulties, several approaches are available to treat both ruptured and unruptured aneurysms (balloon-assisted coiling and intra-aneurysmal flow disruption), while some techniques are essentially restricted to unruptured aneurysms due to the need of concomitant use of antiplatelet medications (stent-assisted coiling and flow diversion). Several ways of performing balloon-assisted coiling have been proposed for WNBA. Two stent-assisted techniques are available for WNBA (Y-stenting and the waffle-cone technique), but these techniques have yet to be evaluated in large, prospective series. Off-label use of flow diverters in WNBA has been proposed but efficacy has still to be established, and the technique presents unique potential safety issues (the potential modifications of bifurcation branches covered by the flow diverter) that has to be assessed. Intrasaccular flow disruption devices are promising tools for the endovascular treatment of WNBA. The WEB device has been extensively evaluated with prospective, multicenter studies showing high safety and good efficacy.

Medical management with or without interventional therapy for unruptured brain arteriovenous malformations (ARUBA): a multicentre, non-blinded, randomised trial.

BACKGROUND: The clinical benefit of preventive eradication of unruptured brain arteriovenous malformations remains uncertain. A Randomised trial of Unruptured Brain Arteriovenous malformations (ARUBA) aims to compare the risk of death and symptomatic stroke in patients with an unruptured brain arteriovenous malformation who are allocated to either medical management alone or medical management with interventional therapy. METHODS: Adult patients (≥18 years) with an unruptured brain arteriovenous malformation were enrolled into this trial at 39 clinical sites in nine countries. Patients were randomised (by web-based system, in a 1:1 ratio, with random permuted block design [block size 2, 4, or 6], stratified by clinical site) to medical management with interventional therapy (ie, neurosurgery, embolisation, or stereotactic radiotherapy, alone or in combination) or medical management alone (ie, pharmacological therapy for neurological symptoms as needed). Patients, clinicians, and investigators are aware of treatment assignment. The primary outcome is time to the composite endpoint of death or symptomatic stroke; the primary analysis is by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00389181. FINDINGS: Randomisation was started on April 4, 2007, and was stopped on April 15, 2013, when a data and safety monitoring board appointed by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health recommended halting randomisation because of superiority of the medical management group (log-rank Z statistic of 4·10, exceeding the prespecified stopping boundary value of 2·87). At this point, outcome data were available for 223 patients (mean follow-up 33·3 months [SD 19·7]), 114 assigned to interventional therapy and 109 to medical management. The primary endpoint had been reached by 11 (10·1%) patients in the medical management group compared with 35 (30·7%) in the interventional therapy group. The risk of death or stroke was significantly lower in the medical management group than in the interventional therapy group (hazard ratio 0·27, 95% CI 0·14-0·54). No harms were identified, other than a higher number of strokes (45 vs 12, p<0·0001) and neurological deficits unrelated to stroke (14 vs 1, p=0·0008) in patients allocated to interventional therapy compared with medical management. INTERPRETATION: The ARUBA trial showed that medical management alone is superior to medical management with interventional therapy for the prevention of death or stroke in patients with unruptured brain arteriovenous malformations followed up for 33 months. The trial is continuing its observational phase to establish whether the disparities will persist over an additional 5 years of follow-up. FUNDING: National Institutes of Health, National Institute of Neurological Disorders and Stroke.

EVIDENCE trial: design of a phase 2, randomized, controlled, multicenter study comparing flow diversion and traditional endovascular strategy in unruptured saccular wide-necked intracranial aneurysms.

INTRODUCTION: Endovascular treatment of large, wide-necked intracranial aneurysms with coils is associated with low rates of initial angiographic occlusion and high rates of recurrence. The Pipeline™ Embolization Device has shown high rates of complete occlusion in uncontrolled clinical series. METHODS: The study is a prospective, controlled, randomized, multicenter, phase 2 open-label trial. Intention-to-treat population includes age ≥18, unruptured saccular aneurysm located in the intra-dural area, neck diameter ≥4 and ≤10 mm, sac diameter ≥7 mm and ≤20 mm, "dome/neck" ratio is ≥1, diameter of the parent artery ≥2 mm and ≤5 mm, and no prior treatment of the aneurysm. Site can only participate if five patients have been previously treated with the Pipeline device. The primary end point of the study is complete occlusion of the aneurysm on angiogram performed 12 months after the endovascular procedure. Complete aneurysm occlusion is defined as the absence of visible blood flow, grade 1 according to the Raymond scale for the standard procedure group and grade 4 according to the grading scale of Kamran for the flow diverter group. RESULTS: The trial is currently enrolling and results of the data are pending the completion of enrollment and follow-up. CONCLUSION: This paper details the trial design of the French EVIDENCE phase 2 trial, a blinded, controlled randomized trial of wide-neck intra-dural aneurysms amenable to either traditional endovascular strategy or flow diversion with Pipeline device.

GREAT-a randomized aneurysm trial. Design of a randomized controlled multicenter study comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment.

The effectiveness of a hybrid hydrogel platinum detachable coil (HydroCoil; MicroVention Inc., Tustin, CA) for endovascular aneurysm treatment has been proven in a recently published RCT. Due to technical restrictions (coil stiffness, time restriction for placement), the HydroSoft coil as well as a corresponding 3D framing coil, the HydroFrame coil (MicroVention Inc., Tustin, CA), a class of new softer coils containing less hydrogel and swelling more slowly than the HydroCoil, have been developed and brought to clinical practice. The present study aims to compare the effectiveness of endovascular aneurysm treatment with coil embolization between patients allocated HydroSoft/HydroFrame versus bare platinum coiling. GREAT is a randomized, controlled, multicentre trial in patients bearing cerebral aneurysms to be treated by coil embolization. Eligible patients were randomized to either coil embolization with HydroSoft/HydroFrame coils (>50 % of administered coil length), or bare platinum coils. Inclusion criteria were as follows: age 18-75, ruptured aneurysm (WFNS 1-3) and unruptured aneurysm with a diameter between 4 and 12 mm. Anatomy such that endovascular coil occlusion deemed possible and willingness of the neurointerventionalist to use either HydroSoft/HydroFrame or bare platinum coils. Exclusion criteria were as follows: aneurysms previously treated by coiling or clipping. Primary endpoint is a composite of major aneurysm recurrence on follow-up angiography and poor clinical outcome (modified Rankin scale 3 or higher), both assessed at 18 months post treatment. Risk differences for poor outcomes will be estimated in a modified intention-to-treat analysis stratified by rupture status (DRKS-ID: DRKS00003132).

Transfontanellar contrast enhanced ultrasound in infants: initial experience.

BACKGROUND AND PURPOSE: Transfontanellar contrast enhanced ultrasound (TCEUS) in infants with neurological diseases has not been previously reported. Thus, the objective of our study was to describe the imaging findings of transfontanellar contrast enhanced ultrasound (TCEUS) performed in various neurological conditions in infants and to compare the findings with non-enhanced transfontanellar ultrasound (TFUS) and MRI. METHODS: Local institutional review board approval was obtained and, because of the need to catheterize children for contrast media administration, written informed consent of parents was obtained prior to all performed TCEUS. Twelve infants who underwent 12 TCEUS were included in this study from June 2009 to June 2012. Second generation contrast material was used (Bracco). TCEUS imaging findings were compared with those of conventional transfontanellar ultrasound in each case and with MRI. RESULTS: In 10 out of the 12 performed examinations, TCEUS showed abnormalities which were not depicted on non-enhanced TFUS. Accurate diagnosis of TCEUS compared with MRI was found in 10 out of 12 initial TCEUS. No adverse events during or immediately after contrast media injection occurred. CONCLUSION: TCEUS appears to be a potential bedside accessible non-ionizing alternative imaging modality in the assessment of neonatal brain injury. It provides additional information when compared to non-enhanced transfontanellar US, especially in the field of brain perfusion assessment. Moreover, the information provided seems to be accurate when compared with those of MRI.

Telestroke network to robotic telestroke network: How to upgrade regional stroke care to include remote robotics?

Objective: Selected patients with large vessel occlusion (LVO) strokes can benefit from endovascular therapy (EVT). However, the effectiveness of EVT is largely dependent on how quickly the patient receives treatment. Recent technological developments have led to the first neurointerventional treatments using robotic assistance, opening up the possibility of performing remote stroke interventions. Existing telestroke networks provide acute stroke care, including remote administration of intravenous thrombolysis (IVT). Therefore, the introduction of remote EVT in distant stroke centers requires an adaptation of the existing telestroke networks. The aim of this work was to propose a framework for centers that are potential candidates for telerobotics according to the resources currently available in these centers. Methods: In this paper, we highlight the future challenges for including remote robotics in telestroke networks. A literature review provides potential solutions. Results: Existing telestroke networks need to determine which centers to prioritize for remote robotic technologies based on objective criteria and cost-effectiveness analysis. Organizational challenges include regional coordination and specific protocols. Technological challenges mainly concern telecommunication networks. Conclusions: Specific adaptations will be necessary if regional telestroke networks are to include remote robotics. Some of these can already be put in place, which could greatly help the future implementation of the technology.

How to use the Contour intrasaccular device: two illustrative cases.

Contour (Stryker, Kalamazoo, MI) is a relatively new endosaccular device for the treatment of intracranial aneurysms.1 2 Its unique cup-like shape permits treatment of most lesions, including wide-necked, irregular, and shallowed-shaped aneurysms. The sizing of the device only requires two parameters: neck size and equatorial plane (width). It must be positioned at the neck of the aneurysm with the device proximal marker in the parent artery. In our experience, dual antiplatelet therapy is usually not required for intrasaccular devices and this is also an advantage of the Contour device. We report two illustrative cases of wide-neck aneurysms in the anterior and posterior circulation, respectively (video 1). In this video we demonstrate the feasibility of this treatment in a middle cerebral artery bifurcation with atypical triangular shape and typical tip-basilar aneurysm. neurintsurg;16/3/225/V1F1V1Video 1 .

Contour Neurovascular System for endovascular embolization of cerebral aneurysms: a multicenter cohort study of 10 European neurovascular centers.

BACKGROUND: Intrasaccular devices have become increasingly popular in the treatment of cerebral aneurysms, particularly at the bifurcation. Here we evaluate the Contour Neurovascular System, an intrasaccular device for the endovascular treatment of cerebral aneurysms, in a multicenter cohort study, the largest to the best of our knowledge. METHODS: Consecutive patients with intracranial aneurysms treated with the Contour Neurovascular System between February 2017 and October 2022 at 10 European neurovascular centers were prospectively collected and retrospectively reviewed. Patient and aneurysm characteristics, procedural details, and angiographic and clinical outcomes were evaluated. RESULTS: During the study period, 279 aneurysms (median age of patients 60 years, IQR 52-68) were treated with Contour. In 83.2% of patients the device was placed electively, whereas the remaining patients were treated in the setting of acute subarachnoid hemorrhage. The most common locations were the middle cerebral artery (26.5%) followed by the anterior communicating region (26.2%). Median aneurysm dome and neck size were 5.2 mm (IQR 4.2-7) and 3.9 mm (IQR 3-5). Contour size 7 (39%) and 9 (25%) were most used. Thromboembolic and hemorrhagic complications occurred in 6.8% and 0.4% of aneurysms, respectively. Raymond-Roy 1 and 2 occlusions at last follow-up were achieved in 63.2% and 28.3%, respectively, resulting in adequate occlusion of 91.5% of aneurysms. CONCLUSION: This is the largest multicenter study reporting the outcome on the Contour Neurovascular System. At 1 year, the self-evaluated data on safety and efficacy are comparable to data of existing intrasaccular devices. Contour is a promising technology in the treatment of cerebral aneurysms.

Conservative management of brain arteriovenous malformations: results of the prospective observation registry of a pragmatic trial.

OBJECTIVE: Many patients recruited in the Treatment of Brain Arteriovenous Malformations Study (TOBAS) are managed conservatively. The aim of this study was to monitor what happened to those patients. METHODS: TOBAS comprises two randomized controlled trials and multiple prospective registries. All patients with brain arteriovenous malformations (AVMs) can participate. This report concerns patients selected for conservative management. The primary trial outcome measure is related death or dependency (modified Rankin Scale [mRS] score > 2) at 10 years. Secondary outcomes include intracranial hemorrhages, nonhemorrhagic neurological events, and serious adverse events (SAEs). For this report, outcome results are presented using patient-years, Kaplan-Meier survival curves, and Cox log-rank tests. There was no blinding. RESULTS: From June 2014 to May 2021, 1010 patients were recruited, of whom 498 (49%) were proposed the prospective observation registry. After exclusions, 434 (87%) patients remained for analysis. The majority of patients had unruptured AVMs (378/434 [87%]), of which 195 (52%) were low grade (Spetzler-Martin grade I or II). During a mean follow-up period of 3.2 years (total 1368 patient-years), the primary outcome occurred in 23 of 434 (5%) patients, corresponding to an incidence of 1.7 (95% CI 1.1-2.5) per 100 patient-years. For unruptured AVMs the incidence was 1.1 (95% CI 0.7-1.9) per 100 patient-years, and for low-grade unruptured AVMs it was 0.6 (95% CI 0.2-1.7) per 100 patient-years. Poor outcomes were more frequent in patients with a history of rupture (HR 5.6 [95% CI 2.4-13.0], p < 0.001), infratentorial AVMs (HR 2.9 [95% CI 1.1-7.3], p = 0.027), and age ≥ 55 years (HR 3.2 [95% CI 1.4-7.6], p = 0.007). Major intracranial hemorrhage occurred in 35 of 434 (8%) patients (incidence of 2.6 [95% CI 1.9-3.6] per 100 patient-years; 2.0 [95% CI 1.3-2.9] per 100 patient-years for unruptured AVMs and 1.3 [95% CI 0.6-2.6] per 100 patient-years for low-grade unruptured AVMs). Major AVM hemorrhages were more frequent in ruptured (HR 4.4 [95% CI 2.1-8.9], p < 0.001), large (HR 2.6 [95% CI 1.1-6.6], p = 0.039), and high-grade (HR 2.5 [95% CI 1.2-5.3], p = 0.013) AVMs and those with deep venous drainage (HR 2.1 [95% CI 1.1-4.2], p = 0.032). SAEs occurred in 48 of 434 (11%) patients (incidence of 3.6 [95% CI 2.7-4.8] per 100 patient-years). For unruptured AVMs the incidence was 2.8 (95% CI 2.0-4.0) per 100 patient-years, and for low-grade unruptured AVMs it was 1.8 (95% CI 1.0-3.2) per 100 patient-years. CONCLUSIONS: Nearly half of TOBAS participants were observed. Rates of untoward neurological events were within expected boundaries.

Risks of presurgical embolization of feeding arteries in 137 intracranial meningeal tumors.

BACKGROUND: Embolization of extra-axial tumors has shown its effectiveness in reducing perisurgical blood loss. However, the complication rate of this procedure is poorly reported. We aimed to evaluate the rate of procedure-related complications and their risk factors. METHODS: From 1998 to 2011, 193 consecutive patients (141 females, 52 males; mean age = 52.9 years) were referred to our institution for presurgical embolization of an extra-axial tumor (meningiomas: n = 178; solitary fibrous tumors: n = 3; other: n = 12). Of 193 patients, 137 (71 %) underwent 141 embolizations (by microparticles: n = 133; by glue: n = 8). The remaining 56 patients (29 %) were not embolized due to unstable catheterization or dangerous anastomosis. Occurrence of neurological deficit was systematically assessed during and after embolization. The risk factors of procedure-related neurological complications were evaluated. RESULTS: Neither intratumoral hemorrhage nor procedure-related death was reported. Two of the 137 patients (1.5 %) had ischemic events with permanent neurological deficit after microparticles embolization. One patient had cortical blindness and one had hemiparesis. Both complications involved the vertebrobasilar system. The first patient had direct intratumoral anastomosis between the middle and the posterior meningeal arteries (PMA); the second one had reflux in the vertebral artery during particles injection in the PMA. Occurrence of ischemic complication was not related to the size of the microparticles. CONCLUSIONS: Though embolization of meningeal tumors is considered as a safe technique, serious neurological complications may occur. Opening of dangerous anastomosis or uncontrolled reflux caused two neurological complications (1.5 %). The size of the microparticles was not associated with the occurrence of neurological event.