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Multiple de novo brain arteriovenous malformations (bAVM) have been reported in the literature, raising questions about the contended purely congenital nature of these lesions. We present the 15-year course of a pediatric patient, who initially presented at age 5 with a thalamic cavernous malformation and was treated with radiosurgery, and then subsequently developed a thalamic de novo bAVM immediately adjacent to the initial lesion location, discovered 2 years later. Treatment of the bAVM entailed two transarterial embolizations and one radiosurgery session which ultimately led to complete angiographic resolution. Finally, this patient’s course was complicated by intraparenchymal hemorrhage and acute obstructive hydrocephalus, and further imaging revealed two newly formed cavernous malformations, also associated with the initial lesion’s location, that have remained stable since their formation. This case likely represents the second-hit model for the formation of vascular malformations, as sparsely supported by the current literature. According to this, genetically aberrant, yet quiescent, brain areas might promote the de novo formation of vascular malformations after brain injury, including radiation.

BackgroundInvestigations into the effect of previous stroke on thrombectomy outcomes have yielded conflicting results, and are limited by small sample sizes. We present the results of a large single center retrospective study aimed at investigating the effect of chronic stroke laterality on thrombectomy outcomes.MethodsA prospectively maintained database was queried for all thrombectomy cases conducted between December 2014 and January 2020, and patient imaging was prospectively reviewed for evidence of prior supratentorial infarction. Procedural, clinical, and demographic characteristics were recorded, and good clinical outcome was defined as a 90 day modified Rankin Scale (mRS) score of 2.ResultsThe final analysis cohort included 555 patients, 79 of whom were found to have radiographic evidence of prior chronic infarcts. On univariate analysis, patients with any chronic supratentorial infarct achieved a lower rate of good clinical outcome than patients with no chronic infarct (22.8% vs 41.0%, p=0.0021). With regard to subgroups, this difference remained only in patients with ipsilateral (14.3%, p=0.0018) and bilateral (11.8%, p=0.015) lesions. Patients with chronic contralateral supratentorial infarcts were no less likely to achieve good outcomes (40.7%, p=0.98). After multivariate regression controlling for age, sex, and baseline mRS, chronic ipsilateral infarcts (OR 0.22, CI 0.07 to 0.67) and chronic bilateral infarcts (OR 0.19, CI 0.04 to 0.85) were the only independent predictors of poor outcome in endovascular thrombectomy patients.ConclusionsIn this single center retrospective study of thrombectomy patients with chronic supratentorial infarcts, the laterality of the previous stroke significantly affected the likelihood of good clinical outcomes.

Interest in performing dosimetry for clinical radiopharmaceutical therapy procedures has grown in recent years. Several approved therapies include dosimetry in the Food and Drug Administration-approved label instructions, and other therapies are best used under a patient-tailored paradigm. This paper, which is a product of the Society of Nuclear Medicine and Molecular Imaging Dosimetry Task Force, presents motivations and general workflows for radiopharmaceutical therapy dosimetry, as well as existing strategies for obtaining reimbursement for clinical activities related to dosimetry. Several specific patient examples are provided, including suggested codes for reimbursement. In addition to current reimbursement approaches, key dosimetry services that are not supported under the current coding structure are presented and suggested as areas of focus in the coming years.

Introduction The delivery of flow-diverting stents (FDS) necessitates a degree of catheter support beyond that required for endovascular coiling. The TracStar Large Distal Platform (LDP) is a novel 0.088″ platform intended for navigation into the intracranial internal carotid artery (ICA). We present an early institutional experience using the TracStar LDP in 44 cases of endovascular aneurysm embolization using FDS. Methods Inclusion criteria for this single-center retrospective review encompassed all patients >18 years of age who were treated for intracranial aneurysms. Procedural success was defined as successful stent deployment using the TracStar LDP. Other outcomes included periprocedural complications, use of an intermediate catheter, length of stay, and discharge disposition. Results The TracStar LDP was utilized in 44 consecutive FDS cases in 42 patients. Cavernous segment aneurysms constituted the majority of cases (12/42; 28.6%), followed by posterior communicating artery (8/42; 19.0%) and supraclinoid aneurysms (8/42; 19.0%). Successful FDS deployment was achieved in 43/44 cases. The LDP achieved stable positioning within the ascending cavernous ICA in 63.6% of cases. A biaxial system was utilized in 54.5% of cases. There was one complication potentially related to use of the TracStar LDP, which was an asymptomatic ICA vessel dissection managed conservatively. Conclusions The TracStar LDP is safe and effective during use in the endovascular treatment of intracranial aneurysms with a FDS. Access to the ascending portion of the cavernous ICA was regularly achieved, and the platform allowed for both biaxial and triaxial configurations.

BackgroundMost conventional 0.088 inch guide catheters cannot safely navigate intracranial vasculature. The objective of this study is to evaluate the safety of stroke thrombectomy using a novel 0.088 inch guide catheter designed for intracranial navigation.MethodsThis is a multicenter retrospective study, which included patients over 18 years old who underwent thrombectomy for anterior circulation large vessel occlusions. Technical outcomes for patients treated using the TracStar Large Distal Platform (TracStar LDP) or earlier generation TRX LDP were compared with a matched cohort of patients treated with other commonly used guide catheters. The primary outcome measure was device-related complications. Secondary outcome measures included guide catheter failure and time between groin puncture and clot engagement.ResultsEach study arm included 45 patients. The TracStar group was non-inferior to the control group with regard to device-related complications (6.8% vs 8.9%), and the average time to clot engagement was 8.89 min shorter (14.29 vs 23.18 min; p=0.0017). There were no statistically significant differences with regard to other technical outcomes, including time to recanalization (modified Thrombolysis In Cerebral Infarction (mTICI) ≥2B). The TracStar was successfully advanced into the intracranial internal carotid artery in 33 cases (73.33%); in three cases (6.67%), it was swapped for an alternate catheter. Successful reperfusion (mTICI 2B-3) was achieved in 95.56% of cases. Ninety-day follow-up data were available for 86.67% of patients, among whom 46.15% had an modified Rankin Score of 0–2%, and 10.26% were deceased.ConclusionsTracstar LDP is safe for use during stroke thrombectomy and was associated with decreased time to clot engagement. Intracranial access was regularly achieved.

Objective A ranula is a mucus-filled salivary pseudocyst that forms in the floor of the mouth, commonly arising from the sublingual or submandibular salivary glands following obstruction or trauma. Complete excision of the injured gland and removal of the cyst content is the first-choice therapy, but has the potential for complications related to injury to nearby structures. As such, minimally invasive approaches such as percutaneous sclerotherapy have been investigated. We aim to contribute to the literature by assessing the efficacy and safety of our technique through our experience with 18 patients over the last decade. Methods This retrospective study evaluated 18 patients with intraoral and plunging ranulas treated by percutaneous bleomycin ablation. The primary endpoint was the treatment result. Secondary endpoints included bleomycin dosage and complications. Results The study evaluated 12 males and six females with a median age of 23.5 years (range 13–39 years). At a final follow-up of at least 2 months (6.5±5.5 months), four patients demonstrated complete response (22%) and 14 patients demonstrated residual presence, recurrence, or regrowth of the lesion (78%). There were no statistically significant associations between outcomes and history of prior treatment, number of treatments, and size or type of ranula. No complications were noted. Conclusions Our findings indicate that bleomycin, while safe for use in various head and neck malformations, is of limited utility in ranula therapy when the offending gland is not addressed primarily.

IntroductionWide-necked middle cerebral artery bifurcation aneurysms pose specific challenges to endovascular management. Surgical clipping remains the standard treatment approach for these aneurysms in many centers. While recent data suggests the endovascular treatment may be comparable, a prospective datapoint has been lacking.Materials and MethodsThe Penumbra SMART registry, a prospective, multi-center, single-arm outcomes registry of Penumbra coil-treated aneurysms, was queried for endovascularly treated MCA bifurcation aneurysms with wide necks (dome:neck ratio 4 mm). Safety and efficacy outcomes were summarized for ruptured and unruptured aneurysms, including rupture, complication rate, and 1-year occlusion outcomes.ResultsSeventy-two aneurysms across 31 sites were enrolled. Of these, a total of 15 presented as ruptured aneurysms. Serious adverse events were reported in 21 (29.2%) of patients, with 8 (11.1%) attributed to the device/procedure. Immediately postoperatively, 75.0% of cases achieved “adequate” Raymond Roy Class I (40.3%) or II (34.7%) occlusion outcomes. Of the 72 patients treated, 60 (83.3%) underwent follow-up angiography at 1 year, and among these, 95.0% had 1-year occlusion outcomes of Raymond Roy Class I (71.7%) or II (23.3%). A total of 6 aneurysms (10.0%) were required or were planned for retreatment at the last follow-up.ConclusionThis study represents the most significant prospective sample of endovascularly treated wide-neck MCA bifurcation aneurysms conducted to date. It supports the safety and efficacy of endovascular treatment of these aneurysms.

This meeting abstract was removed due to the OA licensing requirements of this journal. The full abstract is listed here : https://www.svin.org/files/SVIN_2021_Abstracts_for_Web.pdf

BACKGROUND AND PURPOSE: Two-thirds of lymphatic malformations in children are found in the head and neck. Although conventionally managed through surgical resection, percutaneous sclerotherapy has gained popularity. No reproducible grading system has been designed to compare sclerotherapy outcomes on the basis of radiologic findings. We propose an MR imaging–based grading scale to assess the response to sclerotherapy and present an evaluation of its interrater reliability. MATERIALS AND METHODS: A grading system was developed to stratify treatment outcomes on the basis of interval changes observed on MR imaging. By means of this system, 56 consecutive cases from our institution with formally diagnosed head and neck lymphatic malformations treated by sclerotherapy were retrospectively graded. Each patient underwent pre- and posttreatment MR imaging. Each study was evaluated by 3 experienced neuroradiologists. Interrater reliability was assessed using the Krippendorff α statistic, intraclass coefficient, and 2-way Spearman ρ correlation. RESULTS: The overall Krippendorff α statistic was 0.93 (95% CI, 0.89–0.95), denoting excellent agreement among raters. Intraclass coefficients with respect to consistency and absolute agreements were both 0.97 (95% CI, 0.96–0.98), illustrating low variability. Every combination of individual rater pairs demonstrated statistically significant (P < .01) linear Spearman ρ correlations, with values ranging from 0.90 to 0.95. CONCLUSIONS: The proposed radiographic grading scale demonstrates excellent interrater reliability. Adoption of this new scale can standardize reported outcomes following sclerotherapy for head and neck lymphatic malformation and may aid in the investigation of future questions regarding optimal management of these lesions.

Background In December 2020, the JET7 Xtra Flex reperfusion catheter was voluntarily recalled after reports of injury and death associated with device malfunction. The FDA’s MAUDE (Manufacturer and User Facility Device Experience) database aggregates reports of adverse events and product problems involving medical devices. We present the first analytical review of all MAUDE reports involving FDA cleared reperfusion catheters in order to summarize safety events to date and characterize unique modes of device failure. Methods All publicly available MAUDE datasets were downloaded and linked, and all events associated with catheters carrying product code ‘NRY’ were extracted. Product code ‘NRY’ encompasses all devices intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. Note that this review does not include catheters used off-label for aspiration thrombectomy. Event characteristics including device type, malfunction and adverse events were collected directly as reported on MedWatch Form 3500. In order to characterize procedure-specific details, narrative information submitted in MedWatch Form 3500 Sections B and H was coded by 2 independent raters. Results Between 1/1/2003 and 8/31/2020, there were 1,808 reperfusion catheter defects and/or malfunctions reported in the MAUDE database. Of these, 93.4% did not result in any adverse effect on patients. There were 112 malfunctions associated with an adverse event, of which 98 (87.5%) resulted in injury, and 14 (12.5%) resulted in death. A summary of malfunctions is available in table 1. When interpreting these findings, it is important to note that FDA surveillance of these devices does not include data on the number of units sold, thus event rates cannot be determined or compared across devices. Of 14 reported deaths, 13 involved malfunctions of the Jet 7 Xtra Flex catheter. All of these cases reported mechanical failure at the tip of the catheter, 10 of which involved tip rupture or ballooning following contrast injection. Ballooning was unique to the Jet 7 Xtra Flex, and was also responsible for 3 patient injuries and 37 cases of malfunction that did not result in adverse outcomes. One death and 45 injuries involved the 3 MAX Reperfusion catheter. All of these events were caused by catheter fracture leading to fragment embolization or vessel injury. This mechanism of failure was not unique to the 3 MAX, and was present in 61.2% of all malfunctions resulting in injury. Among malfunctions that did not result in adverse events, the majority (59.1%) were attributable to damage that occurred on the back table during device preparation. Detailed descriptions of unique malfunction mechanisms for each catheter are omitted from this brief abstract but are available for presentation. Conclusion Reperfusion catheter failures resulting in injury or death are rare. These findings suggest that current methods of FDA surveillance have effectively identified outliers. Disclosures D. Bageac: None. B. Gershon: None. R. De Leacy: None.

This chapter discusses the evolution of devices and techniques in endovascular stroke therapy, beginning with the development of effective intra-arterial thrombolysis in the late 1990s. We discuss the subsequent rise of early mechanical devices such as the Merci Retriever and Penumbra System, which, despite culminating in a series of failed trials in 2013, set the stage for the modern thrombectomy era. These first-generation devices gave way to the stent retriever, which would change the standard of care for acute large vessel occlusion stroke following a series of landmark trials in 2015. Finally, we discuss the more recent establishment of aspiration thrombectomy as an alternative to stent retrievers, as well as current investigations into novel devices and techniques that might further improve patient outcomes. Throughout, attention is paid to the regulatory landscape and evidentiary standards that shaped the field during its development in order to better understand how lessons from this history can guide future studies.

Background There is little evidence in scientific literature assessing the safety and efficacy of dual-lumen balloon catheters (DLBCs) and their performance compared to single-lumen catheters (SLCs). Methods In this PROSPERO-registered, PRISMA-compliant systematic review, we identified all MEDLINE and EMBASE single-arm (DLBCs) and double-arm (DLBCs vs SLCs) cohorts where DLBCs were used for the treatment of cerebral arteriovenous malformations (AVMs) or dural arteriovenous fistulas (dAVFs). Immediate angiographic outcome, vascular complications, technical failures, reflux episodes and entrapment were the primary outcomes. A meta-analysis of the double-arm studies summarized the primary outcomes of total procedural time and immediate angiographic outcome. Results The authors identified 18 studies encompassing 209 treated lesions with reported outcomes. Complete occlusion was achieved in 108/132 treated dAVFs (81.8%, 95% CI: [74–87.8%]) and in 45/77 treated AVMs (58.4%, [46.7–69.4%]). The proportion of completely occluded dAVFs was statistically significantly higher than that of AVMs, p < .001. There were eight reported vascular complications (3.8%, [1.8–7.7%]), five technical failures (2.4%, [0.9–5.8%]), 14 reflux events (6.7%, [3.9–11.2%]), two entrapment events (1%, [0.2–3.8%]) and 0 deaths (mortality rate 0%, [0–2.3%]). In a meta-analysis for the treatment of dAVFs, the total procedural time was significantly less for DLBCs compared to SLCs (64.9 vs 125.7 min, p < .0001). The odds of complete immediate occlusion were significantly higher with DLBCs compared to SLCs (odds ratio (OR) 4.6, [1.5–14.3], p = .008). Conclusion Dual-lumen balloon catheters are safe and effective for the embolization of cerebral AVMs and dAVFs and can achieve faster and potentially superior results compared to SLCs. Registration-URL https://www.crd.york.ac.uk/prospero/ Unique Identifier: CRD42021269096

Neuroendocrine tumors (NETs) are rare, but the incidence and prevalence of NETs are increasing in the United States. While surgery is the preferred treatment for NETs, it is not a viable option for metastatic disease. Lutathera (177Lu-DOTATATE) is approved by the United States Food and Drug Administration and the European Medicines Agency for the treatment of gastroenteropancreatic (GEP)-NETs in adults. There is limited information on GEP-NET treatment responses to Lutathera.Our institution launched a peptide receptor radionuclide therapy (PRRT) service line using Lutathera with involvement from a multidisciplinary team and complete collaboration between hospital administration and clinical providers. A prospective registry study was also established in order to collect patient demographics and clinical data regarding the treatment of GEP primary NETs with Lutathera.Between August 2018 and July 2020, 35 GEP-NET patients were treated with Lutathera, of which 65.71% received 4 complete cycles and 25.71% received 3 cycles; 5.71% and 2.86% received 2 and 1 cycles of PRRT, respectively. Most adverse events during the course of our study were low grade using the common terminology criteria for adverse events system. Of the patients who completed all 4 cycles: 22% showed partial response to Lutathera, 44% showed stable disease, and 13% showed disease progression based on a qualitative assessment of positron emission tomography/computed tomography imaging.From our experience, Lutathera was well tolerated in patients with GEP-NET. Additional studies are needed to examine long-term clinical and patient-reported outcomes associated with GEP-NET treatment as well as financial considerations for hospitals embarking on a PRRT program.

BackgroundOver the past several years there has been increased interest in the use of the Sofia aspiration system (MicroVention, Tustin, California) as a primary aspiration catheter.ObjectiveTo perform a multicenter retrospective study examining the efficacy of the Sofia aspiration catheter as a standalone aspiration treatment for large vessel occlusion.MethodsConsecutive cases in which the Sofia catheter was used for aspiration thrombectomy for large vessel occlusion were included. Exclusion criteria were the following: (1) Sofia not used for first pass, and (2) a stent retriever used as an adjunct on the first pass. The primary outcome of the study was first pass recanalization (Thrombolysis in Cerebral Infarction (TICI) 2c/3). Secondary outcomes included first pass TICI 2b/3, crossover to other thrombectomy devices, number of passes, time from puncture to recanalization, and complications.Results323 patients were included. First pass TICI 2c/3 was achieved in 49.8% of cases (161/323). First pass TICI 2b/3 was achieved in 69.7% (225/323) of cases. 74.8% had TICI 2b/3 with the Sofia alone. Crossover to other thrombectomy devices occurred in 29.1% of cases (94/323). The median number of passes was 1 (IQR=1–3). Median time from puncture to recanalization was 26 min (IQR=17–45). Procedure related complications occurred in 3.1% (10/323) of cases.ConclusionOur study highlights the potential advantage of the Sofia aspiration catheter for primary aspiration thrombectomy in acute ischemic stroke. High rates of first pass recanalization with low crossover rates to other thrombectomy devices were achieved. Median procedure time was low, as were procedural complications.

Two patients, separated by 1 year, underwent mechanical thrombectomy using next generation, highly navigable 0.088-inch large bore catheters, which were navigated to and aspirated within the M1 middle cerebral artery segment. Case 1 demonstrates the first reported clinical application of this technique used in conjunction with stent retriever and direct aspiration through an intermediate catheter, resulting in modified thrombolysis in cerebral infarction (mTICI) score 3 recanalisation, and a 90-day modified Rankin Score of 1. In case 2, direct on-clot aspiration was applied through a 0.088-inch guide catheter in the left M1 segment, resulting in mTICI score 3 recanalisation and a National Institutes of Health Stroke Scale score of 1 at discharge. There was no evidence of untoward events in either case. Advancement of a 0.088-inch catheter into the M1 segment offers potential benefits to thrombectomy by improving device-thrombus interaction, inducing local flow arrest and protecting proximal vessels from embolus to new territories.

Endovascular thrombectomy has revolutionized the management of acute ischemic stroke from emergent large vessel occlusion. Continued technological advancement in the field, as evidenced by successive introduction of large bore aspiration catheters with enhanced trackability and large inner diameter, has played a major role in achieving fast and robust recanalization and improved clinical outcome. Here, we present three patients with intraprocedural device malfunction related to the JET 7 XTRA Flex reperfusion catheter.

OBJECTIVES Gadolinium deposition is widely believed to occur, but questions regarding accumulation pattern and permanence remain. We conducted a retrospective study of intracranial signal changes on monthly triple-dose contrast-enhanced magnetic resonance imaging (MRI) examinations from the previously published Betaseron vs. Copaxone in Multiple Sclerosis With Triple-Dose Gadolinium and 3-Tesla MRI Endpoints Trial (N = 67) to characterize the dynamics of gadolinium deposition in several deep brain nuclei and track persistence versus washout of gadolinium deposition on long-term follow-up (LTFU) examinations (N = 28) obtained approximately 10 years after enrollment in the Betaseron vs. Copaxone in Multiple Sclerosis With Triple-Dose Gadolinium and 3-Tesla MRI Endpoints Trial. MATERIALS AND METHODS Using T2 and proton density images and using image analysis software (ITK-SNAP), manual regions of interest were created ascribing boundaries of the caudate nucleus, dentate nucleus, globus pallidus, pulvinar, putamen, white matter, and air. Intensity analysis was conducted on T1-weighted fat-saturated (fat-sat) images using the FSL package. A linear rigid-body transform was calculated from the fat-sat image at each target time point to the region of interest segmentation reference time point fat-sat image. Serial MRI signal was analyzed using linear mixed regression modeling with random intercept. Annual MRI signal changes including LTFU scans were assessed with t test. RESULTS During monthly scanning, all gray matter structures demonstrated a significant (P < 0.0001) increase in contrast-to-noise ratio. Yearly changes in deposition showed distinctive patterns for the specific nucleus: globus pallidus showed complete retention, pulvinar showed partial washout, while dentate, caudate, and putamen returned to baseline (ie, complete washout). CONCLUSIONS Monthly increased contrast-to-noise ratio in gray matter nuclei is consistent with gadolinium deposition over time. The study also suggests that some deep gray matter nuclei permanently retain gadolinium, whereas others demonstrate washout of soluble gadolinium.

Two patients, separated by 1 year, underwent mechanical thrombectomy using next generation, highly navigable 0.088-inch large bore catheters, which were navigated to and aspirated within the M1 middle cerebral artery segment. Case 1 demonstrates the first reported clinical application of this technique used in conjunction with stent retriever and direct aspiration through an intermediate catheter, resulting in modified thrombolysis in cerebral infarction (mTICI) score 3 recanalisation, and a 90-day modified Rankin Score of 1. In case 2, direct on-clot aspiration was applied through a 0.088-inch guide catheter in the left M1 segment, resulting in mTICI score 3 recanalisation and a National Institutes of Health Stroke Scale score of 1 at discharge. There was no evidence of untoward events in either case. Advancement of a 0.088-inch catheter into the M1 segment offers potential benefits to thrombectomy by improving device-thrombus interaction, inducing local flow arrest and protecting proximal vessels from embolus to new territories.

Introduction Mechanical thrombectomy is the treatment of choice for ischemic stroke due to large vessel occlusion. One common reason for failure or prolonged procedure time is vascular touristy inhibiting access to the site of occlusion. A novel device -the TracStar Large Distal Platform (LDP) -may offer improved navigation of tortuous vasculature as well as more distal final positioning when compared to commonly used guide catheters. We investigate the safety and efficacy of the TracStar LDP when used during mechanical thrombectomy. Methods We perform a multicenter retrospective review of mechanical thrombectomy procedures during which the TracStar LDP was utilized. Procedural information, complications, and key timepoints (groin puncture, clot-first-touch, etc.) were recorded as detailed in the operative note. Vascular tortuosity was assessed via pre-procedural CTA. Distal-most position achieved with TracStar was determined by review of intraprocedural imaging. Linear regression was performed to investigate the potential relationship between vascular tortuosity and procedure time. Results In a preliminary analysis of 20 cases, successful reperfusion (TICI 2b/3) was achieved in 88% of cases, requiring 1.8 passes on average (rage 1–5). Average NIHSS at presentation was 17.8 ± 6. Anterior circulation emboli were encountered in 15 cases. Average time to clot-first touch was 12± 7 minutes and average time to final reperfusion was 50 ± 27.6 minutes. Good functional outcome (mRS 0–2) at 90 days was achieved in 35% of cases. There was no association between vascular tortuosity and procedure time. There were no procedural complications, and TracStar LDP was exchanged for an alternative guide catheter in two cases due to failure to maintain positing. Conclusion Mechanical thrombectomy with the Tracstar LDP is safe and effective. Access beyond the horizonal petrous segment of the ICA was achieved in the majority of cases. Interestingly, ICA tortuosity was not associated with an increased time to clot-first-touched. Final analysis of 30 patients in this multi-center retrospective study will be available for presentation at the SNIS Annual Meeting 2020. Disclosures D. Bageac: None. R. De Leacy: None.

Background and Purpose There are a myriad of aspiration catheters used for primary aspiration for mechanical embolectomy for acute ischemic stroke. Over the past several years there has been increased interest in the use of the 6Fr Sofia Plus aspiration catheter as a primary aspiration catheter due to its trackability and navigability. We performed a multicenter retrospective study examining the efficacy of the Sofia aspiration catheter as a stand-alone aspiration treatment for large vessel occlusion. Materials and Methods This was an investigator initiated study and no study funding was received. Following Institutional Review Board Approval, consecutive cases in which the Sofia catheter was used for aspiration thrombectomy for treatment of large vessel occlusion were included. Exclusion criteria were the following: 1) Sofia not used for first pass, and 2) stent-triever used as an adjunct on the first pass. The primary outcome of the study was first pass recanalization (TICI 2b/3). Secondary outcomes included first pass TICI 2c/3, final TICI using Sofia alone, cross-over to other thrombectomy devices, number of passes, time from puncture to recanalization and complications. Results From the six centers, a total of 323 patients were included. First pass recanalization with TICI 2b/3 was achieved in 69.7% of cases. First pass recanalization with TICI 2c/3 was achieved in 48.9% of cases. 74.8% patients achieved a TICI 2b/3 with the Sofia alone. Cross-over to other thrombectomy devices occurred in 29.1% of cases. The median number of passes performed was 1.5 (IQR=1–3). Median time from puncture to recanalization was 25 (IQR=15–35). Procedure related complications occurred in 2.8% of cases. Conclusion Our study highlights the potential advantage of the 5Fr and 6Fr Sofia aspiration catheters for primary aspiration thrombectomy in acute ischemic stroke. We were able to achieve high rates of first pass recanalization with low cross-over rates to other thrombectomy devices. Median procedure time was low as were procedural complications. Disclosures W. Brinjikji: 1; C; NIH/NINDS, Cerenovus. 2; C; Microvention, Cerenovus. 4; C; Marblehead Medical LLC. R. DeLeacy: None. D. Meila: None. M. Mokin: None. E. Samaniego: None. A. Cora: None. M. Shapiro: None. S. Agarwal: None. D. Bageac: None. J. Roa: None. Z. Ren: None. W. Li: None. L. Rinaldo: None. H. Cloft: None. D. Volders: None. T. Huynh: None. E. Raz: None.

Introduction Increased procedure time during endovascular treatment of cerebral aneurysms is associated with increased anesthesia related complications and radiation exposure. Elimination of the need for intermediate catheters during aneurysm treatment may decrease procedure time and increase cost effectiveness. A novel device -the TracStar Large Distal Platform (LDP) -may offer more distal final positioning when compared to commonly used guide catheters, thus decreasing the need for guide catheter use. We investigate the safety and efficacy of the TracStar LDP when used during endovascular aneurysm treatment. Methods We perform a multicenter retrospective review of endovascular cerebral aneurysm embolizations during which the TracStar LDP was utilized. Aneurysm location, procedural information, and complications were recorded as detailed in the operative note. Vascular tortuosity was assessed via pre-procedural CTA. Distal-most position achieved with TracStar was determined by review of intraprocedural imaging. Results A preliminary analysis of 30 cases was performed. Flow diversion was performed in 25 cases (83%), and stent assisted coiling was performed in the remainder. The target aneurysm was located in the ICA in 27 cases (90%), the MCA bifurcation in 2 cases (7%), and the ACA in 1 case (3%). An intermediate catheter was required in 18 cases (60%). TracStar LDP achieved stable access to the Cavernous ICA in 70% of cases. Average procedure time was 67± 33 minutes.There were no procedural complications or new neurologic defects after treatment. TracStar LDP was exchanged for an alternative guide catheter in one case due to catheter kinking, and in two cases due to lack of support. Conclusion Use of Tracstar LDP during flow-diversion and sent-assisted coiling of cerebral aneurysms is safe and effective. Access to the cavernous segment of the ICA was achieved in the majority of cases, and use of an intermediate catheter was not required in 40% of cases. Final analysis of the the full 60 patient multi-center study will be available for presentation at SNIS Annual 2020. Disclosures D. Bageac: None. R. De Leacy: None.

BACKGROUND AND PURPOSE: In recent years, the transradial approach has become more widely adopted for neuroendovascular procedures. The purpose of this study was to evaluate the safety and feasibility of a transradial approach and distal transradial access for neuroendovascular procedures in a single center. MATERIALS AND METHODS: Retrospective analysis was performed for all patients who underwent transradial approach or distal transradial access neuroendovascular procedures from January 2016 to August 2019 at a single center. Exclusion criteria included a Barbeau D waveform, a radial artery of

OBJECTIVES We retrospectively analyzed data of the BECOME trial to investigate whether serial administration of triple-dose (3-dose) gadopentetate dimeglumine would result in the development of T1 signal-to-noise (S/N) changes in the cranial diploic space and whether S/N changes correlated with on-study hypophosphatemia. METHODS Signal intensity analysis was performed on the first year's data of the BECOME trial using 3-dose Gd (14 months, maximum number of doses, 39, mean: 36). Routine blood and urine tests were obtained each month for safety monitoring. Linear mixed regression modeling with random intercept was used to analyze monthly signal-to-noise ratio (S/N = Bone/Air) using an ROI of the diploic space created from T2W images and overlaid on T1FS (T1 fat-saturated) images. Incidence of phosphate abnormalities was analyzed using the general estimation equation; correlation of phosphate and S/N change was achieved with type 3 test of fixed effects. RESULTS Cranial diploic space T1FS S/N increased over 14 months: S/N = 0.039 mean monthly increase (S.E. 0.008; p

OBJECTIVE: The clinical diagnosis of primary lateral sclerosis can only be made after upper motor neuron symptoms have progressed for several years without developing lower motor neuron signs. The goal of the study was to identify neuroimaging changes that occur early in primary lateral sclerosis, prior to clinical diagnosis. METHODS: MRI scans were obtained on 13 patients with adult-onset progressive spasticity for five years or less who were followed longitudinally to confirm a clinical diagnosis of primary lateral sclerosis. Resting state functional MRI, diffusion tensor imaging, and anatomical images were obtained. These ‘pre-PLS’ patients were compared to 18 patients with longstanding, established primary lateral sclerosis and 28 controls. RESULTS: Pre-PLS patients had a marked reduction in seed-based resting-state motor network connectivity compared to controls and patients with longstanding disease. White matter regions with reduced fractional anisotropy were similar in the two patient groups compared to controls. Patients with longstanding disease had cortical thinning of the precentral gyrus. A slight thinning of right precentral gyrus was detected in initial pre-PLS patients’ scans. Follow-up scans in 8 pre-PLS patients 1-2 years later showed increasing motor connectivity, thinning of the precentral gyrus, and no change in diffusion measures of the corticospinal tract or callosal motor region. CONCLUSIONS: Loss of motor functional connectivity is an early imaging marker in primary lateral sclerosis. This differs from literature descriptions of amyotrophic lateral sclerosis, warranting further studies to test whether resting-state functional MRI can differentiate between amyotrophic lateral sclerosis and primary lateral sclerosis at early disease stages.

No aspect of neurointerventional practice has been associated with as longstanding contention and debate as to its effectiveness as has vertebroplasty (VP). Four blinded randomized controlled trials published since 2009 have demonstrated conflicting results regarding a conferred benefit in pain reduction and functional improvement for patients who undergo VP for osteoporotic vertebral compression fractures. Significant heterogeneity exists between each of these trials, which has resulted in difficulty for interventionalists and surgeons to translate the trial findings into routine clinical practice. In addition, patients and their families are ever more enlightened and enabled via the internet and social media to review both medical literature and websites. Without the proper background and context, their decisions may be lacking appropriate and necessary scientific discussion. This review article summarizes the randomized controlled trial data to date, with particular focus on the aforementioned four blinded studies. We will also evaluate the profound impact of the decrease in vertebral augmentation utilization on short- and long-term patient morbidity and mortality using available national and administrative datasets from both within the USA and internationally. We also consider future trial design to help evaluate this procedure and determine its role in modern neurointerventional practice.

Inhibitory transcranial magnetic stimulation, of which continuous theta burst stimulation (cTBS) is a common form, has been used to inhibit cortical areas during investigations of their function. cTBS applied to the primary motor area (M1) depresses motor output excitability via a local effect and impairs procedural motor learning. This could be due to an effect on M1 itself and/or to changes in its connectivity with other nodes in the learning network. To investigate this issue, we used functional magnetic resonance imaging to measure changes in brain activation and connectivity during implicit procedural learning after real and sham cTBS of M1. Compared to sham, real cTBS impaired motor sequence learning, but caused no local or distant changes in brain activation. Rather, it reduced functional connectivity between motor (M1, dorsal premotor & supplementary motor areas) and visual (superior & inferior occipital gyri) areas. It also increased connectivity between frontal associative (superior & inferior frontal gyri), cingulate (dorsal & middle cingulate), and temporal areas. This potentially compensatory shift in coupling, from a motor-based learning network to an associative learning network accounts for the behavioral effects of cTBS of M1. The findings suggest that the inhibitory transcranial magnetic stimulation affects behavior via relatively subtle and distributed effects on connectivity within networks, rather than by taking the stimulated area “offline.”

BACKGROUND CONTEXT Currently, there is no standard of care regarding the management of osteoporotic, malignant or traumatic vertebral compression fractures (VCFs). It is unclear which clinical parameters constitute sufficient indication for proceeding beyond conservative treatment. The criteria for surgical intervention are also not well defined. Recently, the SpineJack (Stryker, Kalamazoo, MI, USA) implantable device for the reduction of VCFs has gained FDA clearance for marketing in the United States. To date, there have not been any large reports describing early use cases, outcomes, or adverse events with SpineJack in the United States. Of immediate relevance is the use of the device in cases of osteoporotic compression fractures (for which it is FDA approved) and malignant compression fractures (for which it is not). The present study is a retrospective analysis of the largest international multicenter registry for vertebral augmentation using SpineJack. PURPOSE To review the efficacy of vertebral height restoration for painful VCFs using the SpineJack implantable device in a large international sample of real-world cases. STUDY DESIGN/SETTING Retrospective analysis is conducted utilizing a multicenter retrospective registry comprised of 180 patients who underwent vertebral augmentation using SpineJack in the United States and Europe. PATIENT SAMPLE The inclusion criteria of this study encompass any patient who underwent vertebral augmentation in whom the SpineJack device was used for the treatment of painful osteoporotic, malignant, or traumatic VCFs. OUTCOME MEASURES Primary outcomes measures include: (1) vertebral height restoration (mm), (2) change in NRS pain score, (3) rate of adjacent level fractures, and (3) rate of serious adverse events (SAEs). Secondary outcome measures include: (1) change in kyphotic angle, and (2) change in opioid utilization. METHODS Case enrollment began in August 2019. Pre- and postprocedural pain was recorded using the Numeric Rating Scale (NRS). Functional recovery is measured using the Oswestry Disability Index, and change in opioid utilization postprocedurally is measured in morphine equivalent units. Vertebral height is measured at the anterior vertebral body on pre- and postprocedural imaging. Loss of vertebral height due to VCF is calculated using prefracture imaging when available, or the average of vertebral height at the adjacent levels above and below the VCF. In a preliminary analysis of 27 cases, local kyphotic angle is measured as the angle of intersection between planes drawn along the superior and inferior endplates of the affected vertebrae. Final analysis will include segmental kyphotic angle, measured by the method of cobb utilizing the superior endplate of the level above the fracture and the inferior endplate of the level below. Follow-up for all outcome measures in conducted in the immediate postoperative period, 1 month, 3 months and 6 months after the procedure. RESULTS Case enrollment is schedule to close in August 2020. In a preliminary analysis of 27 patients who underwent vertebral augmentation with SpineJack at 34 separate levels, patients experienced an average vertebral height recovery of 74% (loss of 30±19% to 13±25% post procedurally). Local kyphotic angle was reduced by an average of 50% (7.5±7.5° to 4.0±5.3° post procedurally). 33% of patients (n=9) achieved complete restoration of prefracture vertebral height. 49% of patients achieved pain reduction (NRS decrease >50%) within the first 24 hours post-operatively. There were no SAEs or adjacent level fractures in this prelimary cohort, and the rate of opioid utilization remained unchaged in the immediate postoperative period. CONCLUSIONS The present study presents real-world evidence for the safety and efficacy of SpineJack as used in six centers in the United States and Europe. Preliminary results suggest excellent vertebral height restoration and reduction in local kyphotic angle. There were no SAEs or adjacent level fractures. FDA DEVICE/DRUG STATUS SpineJack (Not approved for this indication)

Objectives: The goal of this study was to better understand the changes in tissue microstructure that underlie white matter diffusion changes in ALS patients. Methods: Diffusion tensor imaging was carried out in postmortem brains of 4 ALS patients and two subjects without neurological disease on a 7T MRI scanner using steady-state free precession sequences. Fractional anisotropy (FA) was measured in the genu, body, and splenium of the corpus callosum in formalin-fixed hemispheres. FA of the body and genu was expressed as ratio to FA of the splenium, a region unaffected in ALS. After imaging, tissue sections of the same segments of the callosum were stained for markers of different tissue components. Coded image fields were rated for pathological changes by blinded raters. Results: The FA body/FA splenium ratio was reduced in ALS patients compared to controls. Patchy areas of myelin pallor and cells immunostained for CD68, a microglial-macrophage marker, were only observed in the body of the callosum of ALS patients. Blinded ratings showed increased CD68+ microglial cells in the body of the corpus callosum in ALS patients, especially those with C9orf72 mutations, and increased reactive astrocytes throughout the callosum. Conclusion: Reduced FA of the corpus callosum in ALS results from complex changes in tissue microstructure. Callosal segments with reduced FA had large numbers of microglia-macrophages in addition to loss of myelinated axons and astrogliosis. Microglial inflammation contributed to reduced FA in ALS, and may contribute to a pro-inflammatory state, but further work is needed to determine their role. Keywords: 7T MRI, Amyotrophic lateral sclerosis, Microglia, Motor neuron disease, Pathology, Steady-state free precession

Expansion mutations in the C9orf72 gene may cause amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), or mixtures of the two clinical phenotypes. Different imaging findings have been described for C9orf72-associated diseases in comparison with sporadic patients with the same phenotypes, but it is uncertain whether different phenotypes have a common genotype-associated imaging signature. To address this question, 27 unrelated C9orf72 expansion mutation carriers (C9 +) with varied phenotypes, 28 age-matched healthy controls and 22 patients with sporadic ALS (sALS) underwent 3T MRI scanning and clinical phenotyping. Measures of brain volumes and cortical thickness were extracted from T1 images. Compared to healthy controls and sALS patients, symptomatic C9 + subjects had greater ventricular volume loss and thalamic atrophy for age, with diffuse, patchy cortical thinning. Asymptomatic carriers did not differ from controls. C9 + ALS and ALS-FTD patients had less thinning of the motor cortex than sALS patients, but more thinning in extramotor regions, particularly in frontal and temporal lobes. C9 + ALS patients differed from sporadic ALS patients in the thickness of the superior frontal gyrus and lateral orbitofrontal cortex. Thickness of the precentral gyrus was weakly correlated with the revised ALS functional rating scale. Thickness of many cortical regions, including several frontal and temporal regions, was moderately correlated with letter fluency scores. Letter fluency scores were weakly correlated with ventricular and thalamic volume. To better understand how imaging findings are related to disease progression, nineteen C9 + subjects and 23 healthy controls were scanned approximately 6 months later. Ventricular volume increased in C9 + patients with FTD and ALS-FTD phenotypes and remained stable in asymptomatic C9 + subjects. We conclude that diffuse atrophy is a common underlying feature of disease associated with C9orf72 mutations across its clinical phenotypes. Ventricular enlargement can be measured over a 6-month time frame, and appears to be faster in patients with cognitive impairment., Highlights • Patchy cortical thinning and diffuse atrophy are a hallmark of symptomatic ALS and FTD C9orf72 mutation carriers. • Symptomatic C9orf72 carriers have more atrophy and diffuse thinning than sporadic ALS patients and healthy controls. • Ventricular enlargement can be detected over a 6-month interval in symptomatic C9orf72 carriers. • Impaired letter fluency is associated with diffuse cortical thinning. • Changes in letter fluency, but not ALSFRS-R are correlated with 6-month ventricular enlargement.

Objectives The goal of this study was to better understand the changes in tissue microstructure that underlie white matter diffusion changes in ALS patients. Methods Diffusion tensor imaging was carried out in postmortem brains of 4 ALS patients and two subjects without neurological disease on a 7 T MRI scanner using steady-state free precession sequences. Fractional anisotropy (FA) was measured in the genu, body, and splenium of the corpus callosum in formalin-fixed hemispheres. FA of the body and genu was expressed as ratio to FA of the splenium, a region unaffected in ALS. After imaging, tissue sections of the same segments of the callosum were stained for markers of different tissue components. Coded image fields were rated for pathological changes by blinded raters. Results The FA body/FA splenium ratio was reduced in ALS patients compared to controls. Patchy areas of myelin pallor and cells immunostained for CD68, a microglial-macrophage marker, were only observed in the body of the callosum of ALS patients. Blinded ratings showed increased CD68 + microglial cells in the body of the corpus callosum in ALS patients, especially those with C9orf72 mutations, and increased reactive astrocytes throughout the callosum. Conclusion Reduced FA of the corpus callosum in ALS results from complex changes in tissue microstructure. Callosal segments with reduced FA had large numbers of microglia-macrophages in addition to loss of myelinated axons and astrogliosis. Microglial inflammation contributed to reduced FA in ALS, and may contribute to a pro-inflammatory state, but further work is needed to determine their role., Highlights • Diffusion-weighted SSFP and histology were carried out on 4 ALS and 2 control brains. • The FA of the splenium, an unaffected region, was a control for differences in PMI. • The FA body/FA splenium was reduced in ALS compared to controls. • The body of the callosum had increased CD68 + activated microglia and astrogliosis.

Preclinical models suggest that focal high-dose radiation can make tumors more immunogenic. We performed a pilot study of stereotactic body radiation therapy (SBRT) followed by high-dose interleukin-2 (IL-2) to assess safety and tumor response rate and perform exploratory immune monitoring studies. Patients with metastatic melanoma or renal cell carcinoma (RCC) who had received no previous medical therapy for metastatic disease were eligible. Patients received one, two, or three doses of SBRT (20 Gy per fraction) with the last dose administered 3 days before starting IL-2. IL-2 (600,000 IU per kilogram by means of intravenous bolus infusion) was given every 8 hours for a maximum of 14 doses with a second cycle after a 2-week rest. Patients with regressing disease received up to six IL-2 cycles. Twelve patients were included in the intent-to-treat analysis, and 11 completed treatment per the study design. Response Evaluation Criteria in Solid Tumors criteria were used to assess overall response in nonirradiated target lesions. Eight of 12 patients (66.6%) achieved a complete (CR) or partial response (PR) (1 CR and 7 PR). Six of the patients with PR on computed tomography had a CR by positron emission tomography imaging. Five of seven (71.4%) patients with melanoma had a PR or CR, and three of five (60%) with RCC had a PR. Immune monitoring showed a statistically significantly greater frequency of proliferating CD4(+) T cells with an early activated effector memory phenotype (CD3(+)CD4(+)Ki67(+)CD25(+)FoxP3(-)CCR7(-)CD45RA(-)CD27(+)CD28(+/-)) in the peripheral blood of responding patients. SBRT and IL-2 can be administered safely. Because the response rate in patients with melanoma was significantly higher than expected on the basis of historical data, we believe that the combination and investigation of CD4(+) effector memory T cells as a predictor of response warrant further study.

International audience; This study focuses on the differences in the perception of business ethics across two groups of management students from France and Romania ( n = 220). Data was collected via the ATBEQ to measure preferences for three business philosophies: Machiavellianism, Social Darwinism, and Moral Objectivism. The results show that Romanian students present more favorable attitudes toward Machiavellianism than French students; whereas, French students valued Social Darwinism and Moral Objectivism more highly. For Machiavellianism and Moral Objectivism the results are consistent with the literature and our hypotheses. However, contrary to our expectations, we find that Social Darwinism is more important in France than Romania. The results indicate that religious practice does not influence preferences for the three business philosophies. In terms of gender differences, women have less favorable attitudes toward Machiavellianism and more favorable attitudes toward Moral Objectivism than men. [ABSTRACT FROM AUTHOR] Copyright of Journal of Business Ethics is the property of Springer Science & Business Media B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Contains fulltext : 86966.pdf (Publisher’s version ) (Closed access) This study focuses on the differences in the perception of business ethics across two groups of management students from France and Romania (n = 220). Data was collected via the ATBEQ to measure preferences for three business philosophies: Machiavellianism, Social Darwinism, and Moral Objectivism. The results show that Romanian students present more favorable attitudes toward Machiavellianism than French students; whereas, French students valued Social Darwinism and Moral Objectivism more highly. For Machiavellianism and Moral Objectivism the results are consistent with the literature and our hypotheses. However, contrary to our expectations, we find that Social Darwinism is more important in France than Romania. The results indicate that religious practice does not influence preferences for the three business philosophies. In terms of gender differences, women have less favorable attitudes toward Machiavellianism and more favorable attitudes toward Moral Objectivism than men. 16 p.

174 Background: The primary aim of this exploratory trial was to determine the feasibility and safety of chemoradiotherapy (CRT) with combinatorial immunotherapy in LA or BR PC. Methods: 10 patients (pts) with untreated, LA (n=6) or BR (n=4) biopsy-proven PC received gemcitabine (GEM) in combination with telomerase peptide vaccine (GV1001) and sargramostim (GM-CSF) both by intradermal injection. Tadalafil was taken once daily throughout the course of therapy for myeloid derived suppressor cell inhibition. The 2nd month of treatment included external beam radiation therapy (50.4 Gy, 28 fractions) and concurrent twice-weekly GEM 50 mg/m2. Disease response was assessed at 12 weeks. Following recovery from either concurrent CRT or resection, 8 weeks of GV1001 + GM-CSF, tadalafil and GEM completed treatment. Peripheral blood was analyzed by quantitative multiparameter whole blood flow cytometry of immune cell subtypes. Samples were also cryo-preserved for future analysis of peripheral blood mononuclear cell (PBMC) populations and ELISPOT analysis of antigen-specific T cell numbers. Tumor resection specimens were sectioned for immunohistological analysis of macrophage and T cell infiltration. Results: 9 of 10 pts completed therapy to assess response. Grade (Gr) 3-4 hematologic adverse events (AE) were observed during CRT. Immune-related AE were infrequent and mild. 3 of 4 pts with BR disease and 1 with initial LA (unresectable) disease achieved R0 resection. No unanticipated surgical complications were observed. Changes in monocytes and granulocytes occurred throughout treatment and may correlate with clinical benefit. At least 50% reduction in serum CA19-9 was observed in 8 pts. Partial response (n=2) or stable disease (n=7) was achieved in 9 pts. Conclusions: Combinatorial immunotherapy concurrent with GEM-based CRT is feasible and appears safe in LA or BR PC. Initial biochemical responses as well as disease control were observed in the majority of pts. Preliminary immune correlative data suggest a relationship between hematopoietic populations and clinical response.

Puberty is characterized by increasing plasma levels of gonadotropins, which are thought to be mediated by an increase in the pulsatile secretion of gonadotropin releasing hormone (GnRH) from the hypothalamus. Although hypothalamic content of GnRH increases with puberty, cellular levels of its precursor mRNA remain stable indicating that overall biosynthetic demand for GnRH does not change as a function of puberty. While alterations in afferent activity at the GnRH neuron have been suggested as a mechanism for modulating the release of GnRH at puberty, changes intrinsic to the GnRH neuron itself also remain as plausible governing events. Galanin is a recently described gut-brain peptide that is colocalized with GnRH in hypothalamic neurons where it is thought to play a role in the orchestration of gonadotropin release. We tested the hypothesis that the expression of the galanin gene in GnRH neurons is altered during puberty in female rats. To accomplish this, we sacrificed groups of prepubertal (25 day; n=5) and adult (70 day; n=6) female rats and utilized double in situ hybridization and image analysis to estimate and compare between groups the number of GnRH mRNA expressing neurons that coexpress galanin mRNA. While the number of GnRH neurons identified was not different between groups (prepubertal 27 ± 4 vs. adult 30 ± 3) the number of GnRH neurons coexpressing galanin mRNA was greatly increased after puberty (prepubertal 6 ± 3% vs. adult 45 ± 9%; p