Pivotal trial of the Neuroform Atlas stent for treatment of posterior circulation aneurysms: one-year outcomes.

BACKGROUND: Stent-assisted coiling of wide-necked intracranial aneurysms (IAs) using the Neuroform Atlas Stent System (Atlas) has shown promising results. OBJECTIVE: To present the primary efficacy and safety results of the ATLAS Investigational Device Exemption (IDE) trial in a cohort of patients with posterior circulation IAs. METHODS: The ATLAS trial is a prospective, multicenter, single-arm, open-label study of unruptured, wide-necked, IAs treated with the Atlas stent and adjunctive coiling. This study reports the results of patients with posterior circulation IAs. The primary efficacy endpoint was complete aneurysm occlusion (Raymond-Roy (RR) class I) on 12-month angiography, in the absence of re-treatment or parent artery stenosis >50%. The primary safety endpoint was any major ipsilateral stroke or neurological death within 12 months. Adjudication of the primary endpoints was performed by an imaging core laboratory and a Clinical Events Committee. RESULTS: The ATLAS trial enrolled and treated 116 patients at 25 medical centers with unruptured, wide-necked, posterior circulation IAs (mean age 60.2±10.5 years, 81.0% (94/116) female). Stents were placed in all patients with 100% technical success rate. A total of 95/116 (81.9%) patients had complete angiographic follow-up at 12 months, of whom 81 (85.3%) had complete aneurysm occlusion (RR class I). The primary effectiveness outcome was achieved in 76.7% (95% CI 67.0% to 86.5%) of patients. Overall, major ipsilateral stroke and secondary persistent neurological deficit occurred in 4.3% (5/116) and 1.7% (2/116) of patients, respectively. CONCLUSIONS: In the ATLAS IDE posterior circulation cohort, the Neuroform Atlas Stent System with adjunctive coiling demonstrated high rates of technical and safety performance. Trial registration number https://clinicaltrials.gov/ct2/show/NCT02340585.

The professional and personal impact of the coronavirus pandemic on US neurointerventional practices: a nationwide survey.

BACKGROUND: Little is currently known about the effects of the coronavirus (COVID-19) pandemic on neurointerventional (NI) procedural volumes or its toll on physician wellness. METHODS: A 37-question online survey was designed and distributed to physician members of three NI physician organizations. RESULTS: A total of 151 individual survey responses were obtained. Reduced mechanical thrombectomy procedures compared with pre-pandemic were observed with 32% reporting a greater than 50% reduction in thrombectomy volumes. In concert with most (76%) reporting at least a 25% reduction in non-mechanical thrombectomy urgent NI procedures and a nearly unanimous (96%) cessation of non-urgent elective cases, 68% of physicians reported dramatic reductions (>50%) in overall NI procedural volume compared with pre-pandemic. Increased door-to-puncture times were reported by 79%. COVID-19-positive infections occurred in 1% of physician respondents: an additional 8% quarantined for suspected infection. Sixty-six percent of respondents reported increased career stress, 56% increased personal life/family stress, and 35% increased career burnout. Stress was significantly increased in physicians with COVID-positive family members (P<0.05). CONCLUSIONS: This is the first study designed to understand the effects of the COVID-19 pandemic on NI physician practices, case volumes, compensation, personal/family stresses, and work-related burnout. Future studies examining these factors following the resumption of elective cases and relaxing of social distancing measures will be necessary to better understand these phenomena.

Unique percutaneous direct puncture technique for occlusion of a hypoglossal canal dural arteriovenous fistula.

PURPOSE: To report percutaneous transcranial puncture, embolization and occlusion of a very symptomatic hypoglossal canal/anterior condylar vein dural arteriovenous fistula (DAVF) using syngo iGuide navigational software in a patient in whom transarterial and transvenous embolization and surgery had failed. METHODS: After unsuccessful arterial and venous embolization and surgical treatment of a symptomatic hypoglossal canal DAVF, a 47-year-old man was transferred for further management. With exquisite anatomic detail provided by C-arm cone-beam computed tomography (CBCT) equipment (Artis zee Biplane, Dyna CT VC21H, Siemens Healthcare GmbH, Germany) and syngo iGuide needle guidance navigational software (Siemens Healthcare GmbHy) for planning a safe direct approach, the hypoglossal/anterior condylar vein, the dominant outflow vein of the fistula, was needle punctured percutaneously at the hypoglossal foramen and occluded with ethylene vinyl alcohol copolymer liquid embolic agent (Onyx, Medtronic, Minneapolis, Minnesota, USA) after placing two anchoring platinum coils (Target detachable coils, Stryker Neurovascular, Fremont, California, USA). RESULTS: After a year of progressively severe left eye proptosis, chemosis and increased intraocular pressure, the symptoms quickly subsided after this embolization and the patient was symptom free at his 3-month and later checkups. CONCLUSION: With guidance and imaging provided by CBCT and syngo iGuide navigational software, an otherwise untreatable DAVF was successfully embolized and obliterated by an aggressive unique percutaneous trans-cranial needle puncture of the dominant outflow vein in the hypoglossal canal.

Contextualizing the first-round failure of the AHCA: down but not out.

On 8 November 2016 the American electorate voted Donald Trump into the Presidency and a majority of Republicans into both houses of Congress. Since many Republicans ran for elected office on the promise to 'repeal and replace' Obamacare, this election result came with an expectation that campaign rhetoric would result in legislative action on healthcare. The American Health Care Act (AHCA) represented the Republican effort to repeal and replace the Affordable Care Act (ACA). Key elements of the AHCA included modifications of Medicaid expansion, repeal of the individual mandate, replacement of ACA subsidies with tax credits, and a broadening of the opportunity to use healthcare savings accounts. Details of the bill and the political issues which ultimately impeded its passage are discussed here.

Initial hospital management of patients with emergent large vessel occlusion (ELVO): report of the standards and guidelines committee of the Society of NeuroInterventional Surgery.

OBJECTIVE: To summarize the current literature regarding the initial hospital management of patients with acute ischemic stroke (AIS) secondary to emergent large vessel occlusion (ELVO), and to offer recommendations designed to decrease the time to endovascular treatment (EVT) for appropriately selected patients with stroke. METHODS: Using guidelines for evidenced-based medicine proposed by the Stroke Council of the American Heart Association, a critical review of all available medical literature supporting best initial medical management of patients with AIS secondary to ELVO was performed. The purpose was to identify processes of care that most expeditiously determine the eligibility of a patient with an acute stroke for interventions including intravenous fibrinolysis with recombinant tissue plasminogen activator (IV tPA) and EVT using mechanical embolectomy. RESULTS: This review identifies four elements that are required to achieve timely revascularization in ELVO. (1) In addition to non-contrast CT (NCCT) brain scan, CT angiography should be performed in all patients who meet an institutional threshold for clinical stroke severity. The use of any advanced imaging beyond NCCT should not delay the administration of IV tPA in eligible patients. (2) Activation of the neurointerventional team should occur as soon as possible, based on either confirmation of large vessel occlusion or a prespecified clinical severity threshold. (3) Additional imaging techniques, particularly those intended to physiologically select patients for EVT (CT perfusion and diffusion-perfusion mismatch imaging), may provide additional value, but should not delay EVT. (4) Routine use of general anesthesia during EVT procedures, should be avoided if possible. These workflow recommendations apply to both primary and comprehensive stroke centers and should be tailored to meet the needs of individual institutions. CONCLUSIONS: Patients with ELVO are at risk for severe neurologic morbidity and mortality. To achieve the best possible clinical outcomes stroke centers must optimize their triage strategies. Strategies that provide patients with ELVO with the fastest access to reperfusion depend upon detail-oriented process improvement.

Use of a pressure sensing sheath: comparison with standard means of blood pressure monitoring in catheterization procedures.

PURPOSE: Monitoring of blood pressure (BP) during procedures is variable, depending on multiple factors. Common methods include sphygmomanometer (BP cuff), separate radial artery catheterization, and side port monitoring of an indwelling sheath. Each means of monitoring has disadvantages, including time consumption, added risk, and signal dampening due to multiple factors. We sought an alternative approach to monitoring during procedures in the catheterization laboratory. METHODS: A new technology involving a 330 µm fiberoptic sensor embedded in the wall of a sheath structure was tested against both radial artery catheter and sphygmomanometer readings obtained simultaneous with readings recorded from the pressure sensing system (PSS). Correlations and Bland-Altman analysis were used to determine whether use of the PSS could substitute for these standard techniques. RESULTS: The results indicated highly significant correlations in systolic, diastolic, and mean arterial pressures (MAP) when compared against radial artery catheterization (p<0.0001), and MAP means differed by <4%. Bland-Altman analysis of the data suggested that the sheath measurements can replace a separate radial artery catheter. While less striking, significant correlations were seen when PSS readings were compared against BP cuff readings. CONCLUSIONS: The PSS has competitive functionality to that seen with a dedicated radial artery catheter for BP monitoring and is available immediately on sheath insertion without the added risk of radial catheterization. The sensor is structurally separated from the primary sheath lumen and readings are unaffected by device introduction through the primary lumen. Time delays and potential complications from radial artery catheterization are avoided.

Three-dimensional printing of anatomically accurate, patient specific intracranial aneurysm models.

OBJECTIVE: To develop and validate a method for creating realistic, patient specific replicas of cerebral aneurysms by means of fused deposition modeling. METHODS: The luminal boundaries of 10 cerebral aneurysms, together with adjacent proximal and distal sections of the parent artery, were segmented based on DSA images, and corresponding virtual three-dimensional (3D) surface reconstructions were created. From these, polylactic acid and MakerBot Flexible Filament replicas of each aneurysm were created by means of fused deposition modeling. The accuracy of the replicas was assessed by quantifying statistical significance in the variations of their inner dimensions relative to 3D DSA images. Feasibility for using these replicas as flow phantoms in combination with phase contrast MRI was demonstrated. RESULTS: 3D printed aneurysm models were created for all 10 subjects. Good agreement was seen between the models and the source anatomy. Aneurysm diameter measurements of the printed models and source images correlated well (r=0.999; p<0.001), with no statistically significant group difference (p=0.4) or observed bias. The SDs of the measurements were 0.5 mm and 0.2 mm for source images and 3D models, respectively. 3D printed models could be imaged with flow via MRI. CONCLUSIONS: The 3D printed aneurysm models presented were accurate and were able to be produced inhouse. These models can be used for previously cited applications, but their anatomical accuracy also enables their use as MRI flow phantoms for comparison with ongoing studies of computational fluid dynamics. Proof of principle imaging experiments confirm MRI flow phantom utility.

MACRA: background, opportunities and challenges for the neurointerventional specialist.

The legislative branch of government took many by surprise when it announced the Medicare Access and CHIP Reauthorization Act of 2015. Once the Act was passed, President Obama quickly signed this bipartisan, bicameral effort into law. A foundational element of this legislation was the permanent repeal of the sustainable growth rate formula. Physicians and their patients were appropriately enthusiastic about this development. The Medicare Access and CHIP Reauthorization Act of 2015 included additional elements of considerable interest to neurointerventional specialists.

Comprehensive Overview of Contemporary Management Strategies for Cerebral Aneurysms.

Aneurysmal subarachnoid hemorrhage (SAH) remains an important health issue in the United States. Despite recent improvements in the diagnosis and treatment of cerebral aneurysms, the mortality rate following aneurysm rupture. In those patients who survive, up to 50% are left severely disabled. The goal of preventing the hemorrhage or re-hemorrhage can only be achieved by successfully excluding the aneurysm from the circulation. This article is a comprehensive review by contemporary vascular neurosurgeons and interventional neuroradiolgists on the modern management of cerebral aneurysms.

Transarterial Onyx Embolization of an Orbital Solitary Fibrous Tumor.

Solitary fibrous tumor (SFT) is an uncommon mesenchymal neoplasm sometimes found in the orbit. We report a case of an aggressive orbital SFT with enlarged feeding vessels that was successfully resected immediately after transarterial embolization with Onyx (ethylene vinyl alcohol copolymer). To our knowledge, this is the first report showing the histopathology of Onyx embolization material in an orbital SFT.

Mid- and long-term outcomes of carotid-cavernous fistula endovascular management with Onyx and n-BCA: experience of a single tertiary center.

INTRODUCTION: Endovascular therapy is the preferred treatment for most carotid-cavernous fistulas (CCFs). Early reports have documented excellent initial clinical and radiographic outcomes after embolization of CCFs with Onyx or n-butyl cyanoacrylate (n-BCA), but little evidence is available about the long-term durability of this technique. OBJECTIVE: To characterize the long-term durability of CCF liquid embolization. METHODS: The authors retrospectively reviewed a database of 24 CCFs in 21 consecutive patients who underwent Onyx or n-BCA embolization of a CCF from 2006 to 2013 at our institution. RESULTS: A total of 25 Onyx or n-BCA embolization procedures were attempted and 24 successfully completed during the study, resulting in complete or near-complete occlusion by the end of the study in all 24 CCFs (obliteration success, 100%). Attempted embolization in a single CCF failed initially, but was performed successfully at a later date by a different approach. None of the 24 CCFs recanalized, regrew, or required any further treatment subsequent to Onyx or n-BCA embolization throughout a mean 12.4 months of angiographic follow-up (range 1-36 months). Clinically significant complications were seen in three embolization procedures, including cranial nerve palsies (n=1), embolic infarct (n=1), and intraperitoneal hemorrhage (n=1). CONCLUSIONS: Early evidence has indicated that endovascular embolization with Onyx is relatively safe and effective at achieving an initial angiographic cure for CCFs. Results of our series suggest that angiographic and clinical outcomes of Onyx and n-BCA embolization remain stable at mid- and long-term follow-up.