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.

Feasibility and Efficacy of Low-profile Visual Intraluminal Support Device: A Single Center Five-year Experience.

INTRODUCTION: The Low-Profile Visualized Intraluminal Support (LVIS) devices are a new generation of self-expandable, high-porosity stents approved for the treatment of large to giant wide-necked intracranial aneurysms via stent-assisted coiling. Here we report the radiographic and clinical outcomes seen with LVIS, LVIS Jr. and LVIS Blue from a single institution over a fiveyear period. METHODS: Patients with intracranial aneurysms treated by LVIS, LVIS Jr. and LVIS Blue technology over a five-year period (2012 - 2017) at our institution were retrospectively reviewed. RESULTS: Seventy-four patients (55 females and 19 males; average age = 59.2) with 74 aneurysms underwent embolization of intracranial aneurysms using LVIS (N = 10), LVIS Jr. (N = 47) or LVIS Blue (N = 12) devices at our institution over the study period. The most common location of treated aneurysms was the anterior communicating artery (31%), followed by the basilar artery (19%), and the middle cerebral artery (13%). The mean neck and dome sizes were 3.9±1.5mm and 6.6±3.2mm, respectively. The median follow-up time was 6 months. At the last radiographic follow- up, 93.1% of patients had complete occlusion (RR-I or OKM-D). In 5 cases (7%), the LVIS stent failed to open, requiring balloon angioplasty (N = 3) or stent recapture and use of a non-LVIS branded device (N = 2). Five patients had post-embolization infarcts, and 1 patient had an intra-operative dome rupture. CONCLUSION: LVIS brand of stents is a safe, effective, and technically feasible treatment strategy for wide-neck intracranial aneurysms, with high deployment success and aneurysm obliteration rates.

Bitemporal hemianopsia secondary to ischemic chiasmopathy following mechanical thrombectomy.

PURPOSE: To report a case of bitemporal hemianopsia due to ischemic chiasmopathy after mechanical thrombectomy of a right distal internal carotid artery (ICA) occlusion. OBSERVATIONS: A 60-year-old female presented with left sided weakness and difficulty speaking and was found to have suffered a right internal carotid artery occlusion 10 days after tricuspid valve replacement for severe symptomatic tricuspid valve disease. She underwent mechanical thrombectomy and in hospital and at further follow ups was noted to have a bitemporal hemianopsia, consistent with an ischemic optic chiasmopathy. CONCLUSIONS AND IMPORTANCE: The optic chiasm is vascularized by multiple arteries of the Circle of Willis. As such, ischemic optic chiasmopathy is rare. Clinicians should consider ischemic chiasmopathy following cardiac and other surgical procedures including mechanical thrombectomy of the ICA or its branches.

Is Flow Diversion the Death of Simple Coiling or Stent-assisted Coiling? A Single-center Experience.

BACKGROUND: Since the introduction of endovascular methods to treat cerebral aneurysms, several technical advances have allowed a greater number of aneurysms to be treated endovascularly as opposed to open surgical clipping. These include flow diverting stents, which do not utilize coils and instead treat aneurysms by acting as an "internal bypass." We sought to investigate whether flow diversion is replacing coiling at our institution. METHODS: A retrospective chart review on five years of data was conducted to investigate the possible increasing use of flow diversion devices compared to traditional simple or stent-assisted coiling. RESULTS: Over five years, the population revealed a trend toward an increased proportion of female patients, increased frequency of basilar tip and internal carotid artery (ICA) aneurysm location, increased hospital volume, and increased volume of patients treated by dual-trained neurosurgeons over interventional radiologists. Patients were stratified by aneurysm location and statistically significant differences were observed. Flow diversion devices were used with increasing frequency when treating aneurysms arising from the proximal internal carotid artery (Odds ratio (OR)=1.24, 95% CI: 1.02-1.50; p = 0.03), and middle cerebral artery (OR=2.60, 95% CI: 1.38-4.88; p = 0.003). Distal internal carotid artery aneurysm location came close to achieving statistical significance (OR=1.3, 95% CI: 0.99-1.72; p = 0.063). CONCLUSION: In our single center experience at Houston Methodist Hospital, flow diversion devices are being used more frequently for aneurysms arising from the proximal ICA, MCA, and likely distal ICA (though this third location barely failed to achieve statistical significance.

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.

Impact of Balloon Guide Catheter Use on Clinical and Angiographic Outcomes in the STRATIS Stroke Thrombectomy Registry.

Background and Purpose- Mechanical thrombectomy has been shown to improve clinical outcomes in patients with acute ischemic stroke. However, the impact of balloon guide catheter (BGC) use is not well established. Methods- STRATIS (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) was a prospective, multicenter study of patients with large vessel occlusion treated with the Solitaire stent retriever as first-line therapy. In this study, an independent core laboratory, blinded to the clinical outcomes, reviewed all procedures and angiographic data to classify procedural technique, target clot location, recanalization after each pass, and determine the number of stent retriever passes. The primary clinical end point was functional independence (modified Rankin Scale, 0-2) at 3 months as determined on-site, and the angiographic end point was first-pass effect (FPE) success rate from a single device attempt (modified Thrombolysis in Cerebral Infarction, ≥2c) as determined by a core laboratory. Achieving modified FPE (modified Thrombolysis in Cerebral Infarction, ≥2b) was also assessed. Comparisons of clinical outcomes were made between groups and adjusted for baseline and procedural characteristics. All participating centers received institutional review board approval from their respective institutions. Results- Adjunctive technique groups included BGC (n=445), distal access catheter (n=238), and conventional guide catheter (n=62). The BGC group had a higher rate of FPE following first pass (212/443 [48%]) versus conventional guide catheter (16/62 [26%]; P=0.001) and distal access catheter (83/235 [35%]; P=0.002). Similarly, the BGC group had a higher rate of modified FPE (294/443 [66%]) versus conventional guide catheter (26/62 [42%]; P<0.001) and distal access catheter (129/234 [55%]; P=0.003). The BGC group achieved the highest rate of functional independence (253/415 [61%]) versus conventional guide catheter (23/55 [42%]; P=0.007) and distal access catheter (113/218 [52%]; P=0.027). Final revascularization and mortality rates did not differ across the groups. Conclusions- BGC use was an independent predictor of FPE, modified FPE, and functional independence, suggesting that its routine use may improve the rates of early revascularization success and good clinical outcomes. Clinical Trial Registration- URL: https://www.clinicaltrials.gov . Unique identifier: NCT02239640.

Augmented Reality with Virtual Cerebral Aneurysms: A Feasibility Study.

OBJECTIVE: Advanced magnetic resonance imaging (MRI) acquisition methods such as 4D phase contrast magnetic resonance imaging (4D pcMRI) have found widespread applications in assessing hemodynamics in cerebral aneurysms. One of the goals is the identification of a hemodynamic scenario predictive of aneurysm rupture. Because of the technical complexity the 4D pcMRI technology, challenges exist in extracting and communicating the wealth of information contained in the MRI image data, in particular, to a multidisciplinary team of health professionals and basic scientists. METHODS: Here we introduce a new resource in the form of a commercially available optical see-through head-mounted display, which allows augmenting the real world by computer-generated virtual objects. RESULTS: An image processing algorithm was presented for integrating 3D surface models derived from 3D rotational angiography data, 3D time-of-flight MRI data, and 4D pcMRI data into the augmented reality environment. This new approach was successfully evaluated on blood flow data acquired before and after flow diverter treatment in 6 patients harboring a cerebral aneurysm. CONCLUSIONS: Augmented reality may become an additional means for visualizing complex medical data, in particular complex flows as illustrated here.

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.

Interhospital Transfer Before Thrombectomy Is Associated With Delayed Treatment and Worse Outcome in the STRATIS Registry (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke).

BACKGROUND: Endovascular treatment with mechanical thrombectomy (MT) is beneficial for patients with acute stroke suffering a large-vessel occlusion, although treatment efficacy is highly time-dependent. We hypothesized that interhospital transfer to endovascular-capable centers would result in treatment delays and worse clinical outcomes compared with direct presentation. METHODS: STRATIS (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) was a prospective, multicenter, observational, single-arm study of real-world MT for acute stroke because of anterior-circulation large-vessel occlusion performed at 55 sites over 2 years, including 1000 patients with severe stroke and treated within 8 hours. Patients underwent MT with or without intravenous tissue plasminogen activator and were admitted to endovascular-capable centers via either interhospital transfer or direct presentation. The primary clinical outcome was functional independence (modified Rankin Score 0-2) at 90 days. We assessed (1) real-world time metrics of stroke care delivery, (2) outcome differences between direct and transfer patients undergoing MT, and (3) the potential impact of local hospital bypass. RESULTS: A total of 984 patients were analyzed. Median onset-to-revascularization time was 202.0 minutes for direct versus 311.5 minutes for transfer patients (P<0.001). Clinical outcomes were better in the direct group, with 60.0% (299/498) achieving functional independence compared with 52.2% (213/408) in the transfer group (odds ratio, 1.38; 95% confidence interval, 1.06-1.79; P=0.02). Likewise, excellent outcome (modified Rankin Score 0-1) was achieved in 47.4% (236/498) of direct patients versus 38.0% (155/408) of transfer patients (odds ratio, 1.47; 95% confidence interval, 1.13-1.92; P=0.005). Mortality did not differ between the 2 groups (15.1% for direct, 13.7% for transfer; P=0.55). Intravenous tissue plasminogen activator did not impact outcomes. Hypothetical bypass modeling for all transferred patients suggested that intravenous tissue plasminogen activator would be delayed by 12 minutes, but MT would be performed 91 minutes sooner if patients were routed directly to endovascular-capable centers. If bypass is limited to a 20-mile radius from onset, then intravenous tissue plasminogen activator would be delayed by 7 minutes and MT performed 94 minutes earlier. CONCLUSIONS: In this large, real-world study, interhospital transfer was associated with significant treatment delays and lower chance of good outcome. Strategies to facilitate more rapid identification of large-vessel occlusion and direct routing to endovascular-capable centers for patients with severe stroke may improve outcomes. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02239640.

Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke: Primary Results of the STRATIS Registry.

BACKGROUND AND PURPOSE: Mechanical thrombectomy with stent retrievers has become standard of care for treatment of acute ischemic stroke patients because of large vessel occlusion. The STRATIS registry (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) aimed to assess whether similar process timelines, technical, and functional outcomes could be achieved in a large real world cohort as in the randomized trials. METHODS: STRATIS was designed to prospectively enroll patients treated in the United States with a Solitaire Revascularization Device and Mindframe Capture Low Profile Revascularization Device within 8 hours from symptom onset. The STRATIS cohort was compared with the interventional cohort of a previously published SEER patient-level meta-analysis. RESULTS: A total of 984 patients treated at 55 sites were analyzed. The mean National Institutes of Health Stroke Scale score was 17.3. Intravenous tissue-type plasminogen activator was administered in 64.0%. The median time from onset to arrival in the enrolling hospital, door to puncture, and puncture to reperfusion were 138, 72, and 36 minutes, respectively. The Core lab-adjudicated modified Thrombolysis in Cerebral Infarction ≥2b was achieved in 87.9% of patients. At 90 days, 56.5% achieved a modified Rankin Scale score of 0 to 2, all-cause mortality was 14.4%, and 1.4% suffered a symptomatic intracranial hemorrhage. The median time from emergency medical services scene arrival to puncture was 152 minutes, and each hour delay in this interval was associated with a 5.5% absolute decline in the likelihood of achieving modified Rankin Scale score 0 to 2. CONCLUSIONS: This largest-to-date Solitaire registry documents that the results of the randomized trials can be reproduced in the community. The decrease of clinical benefit over time warrants optimization of the system of care. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02239640.

Four-Dimensional Phase Contrast Magnetic Resonance Imaging Protocol Optimization Using Patient-Specific 3-Dimensional Printed Replicas for In Vivo Imaging Before and After Flow Diverter Placement.

OBJECTIVE: Hemodynamics in cerebral aneurysms are currently investigated toward clinical efficacy using nonstandardized computational simulation techniques. At the same time, flow patterns and velocities are accessible by 4-dimensional phase contrast magnetic resonance imaging (4D pcMRI). Complexity of protocol design and imaging duration has limited the use of this technique in clinical imaging. A new approach is presented to overcome these limitations. METHODS: Three-dimensional (3D) replicas of 2 cerebral aneurysms were fabricated by fused deposition prototyping (3D printing) and imaged using 4D pcMRI while connected to a magnetic resonance imaging-compatible continuous flow loop. Acquisition parameters were optimized with imaging times not to exceed 10 minutes. Six patients harboring cerebral aneurysms with sizes ranging from 4.7 to 13.8 mm were imaged with the optimized 4D pcMRI protocol. After treatment with the pipeline embolization device (PED), 4D pcMRI examinations were repeated in 3 patients. RESULTS: In all cases, major flow patterns were visualized well; smaller aneurysms posed a challenge because of limited spatial resolution, whereas larger aneurysms contained regions of low velocity resulting in limited contrast in the flow-sensitive images. After PED placement, ordered aneurysmal flow was disrupted and intra-aneurysmal velocity was reduced on average by 24.5% (range, 12.9-31.5%). Exploratory statistical analysis yielded a positive significant correlation (P < 0.01) between changes in inflow velocity and posttreatment intra-aneurysmal flow velocity. CONCLUSIONS: 4D pcMRI flow imaging in cerebral aneurysms within a time frame suitable for clinical imaging applications is feasible with optimized acquisition parameters, thereby enabling quantification of intra-aneurysmal flow changes after flow diverter device treatment.