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IntroductionThe Woven EndoBridge Intrasaccular Therapy (WEB-IT) Study is a pivotal, prospective, single-arm, investigational device exemption study designed to evaluate the safety and effectiveness of the WEB device for the treatment of wide-neck bifurcation aneurysms.MethodsOne-hundred and fifty patients with wide-neck bifurcation aneurysms were enrolled at 21 US and six international centers. Angiograms from the index procedure, and 6-month and 1-year follow-up visits were all reviewed by a core laboratory. All adverse events were reviewed and adjudicated by a clinical events adjudicator. A data monitoring committee provided oversight during the trial to ensure subject safety.ResultsOne-hundred and forty-eight patients received the WEB implant. One (0.7%) primary safety event occurred during the study—a delayed ipsilateral parenchymal hemorrhage—on postoperative day 22. No primary safety events occurred after 30 days through 1 year. At the 12-month angiographic follow-up, 77/143 patients (53.8%) had complete aneurysm occlusion. Adequate occlusion was achieved in 121/143 (84.6%) subjects.ConclusionsThe prespecified safety and effectiveness endpoints for the aneurysms studied in the WEB-IT trial were met. The results of this trial suggest that the WEB device provides an option for patients with wide-neck bifurcation aneurysms that is as effective as currently available therapies and markedly safer.Trial registration number NCT02191618

Dural arteriovenous fistula (dAVF) accounts for approximately 10% of all intracranial vascular malformations. While they can be benign lesions, the presence of retrograde venous drainage and cortical venous reflux makes the natural course of these lesions aggressive high risk of haemorrhage, neurological injury and mortality. Endovascular treatment is often the first line of treatment for dAVF. Both transarterial and transvenous approaches are used to cure dAVF. The selection of treatment approach depends on the angioarchitecture of the dAVF, the location, the direction of venous flow. Surgery and, to a lesser extent, stereotactic radiosurgery are used when endovascular approaches are impossible or unsuccessful.

Abstract BACKGROUND Posterior circulation cerebral aneurysms are at higher risk of rupture and are more symptomatic than those in the anterior circulation. Existing treatments carry significant morbidity. Early reports of flow diversion for posterior circulation aneurysms have suggested high complication and low occlusion rates. OBJECTIVE To report safety and efficacy of flow diversion with the pipeline embolization device (ev3, Medtronic Inc, Dublin, Ireland) for aneurysms located throughout the posterior circulation. METHODS A prospective, institutional review board-approved database was analyzed for all patients with posterior circulation aneurysms treated by flow diversion at our institution. RESULTS Fifty-nine embolization procedures were performed on 55 patients. Average aneurysm size was 9.4 mm. Morphology was saccular (45%), fusiform (29%), or dissecting/pseudo-aneurysms (25%). Sixty-two percent of aneurysms arose along the vertebral artery. There were 7 mid-basilar (13%) and 7 basilar apex (13%) aneurysms. Procedural success was 98%; 1 Pipeline embolization device was placed in 85%; and coiling was performed in 17% of cases. There were 5 major complications (8%), all strokes. Patients with major stroke had modified Rankin Scale score at last follow-up of 1, 3, 4, 6, and 6 (2 mortalities). There were zero intracerebral or subarachnoid hemorrhages. No variable predicted complications on univariate or multivariate analysis. Follow-up digital subtraction angiography was performed for 43 patients (78%). Complete occlusion was 68% at 6 mo and 78% at 12 mo. Average follow-up was 11.8 mo. Fusiform or dissecting morphology and large or giant aneurysm size were predictors of aneurysm persistence at 6 mo on multivariate logistic regression. CONCLUSION This is a large single-institution series of Pipeline (Medtronic Inc) for posterior circulation aneurysms and demonstrates acceptable safety and effectiveness in these challenging cases.

BackgroundFlow modulation is the newest endovascular technique for treatment of cerebral aneurysms.ObjectiveTo investigate changes in aneurysm treatment practice patterns in the USA.MethodsFrom the 2007 to 2016, the National Inpatient Sample databases, hospital discharges associated with unruptured aneurysms (UA), and/or ruptured aneurysms (RA) having undergone surgical clipping (SC) and/or endovascular treatments (EVT) were identified using the International Classification of Diseases codes. Patient demographics, hospital characteristics, and clinical outcomes were reviewed. Five year subgroup analyses were performed for treatment differences.ResultsA total of 39 282 hospital discharges were identified with a significant increase in EVT (UA: SC n=7847 vs EVT n=12 797, p<0.001; RA: SC n=8108 vs EVT n=10 530, p<0.001). Hospitals in the South demonstrated the most significant EVT use regardless of aneurysm status (UA: SC n=258.5±53.6 vs EVT n=480.7±155.8, p<0.001; RA: SC n=285.6±54.3 vs EVT n=393.3±102.9, p=0.003). From 2007 to 2011, there was no significant difference in the mean number of cases for the treatment modalities (UA: SC n=847.4±107.7 vs EVT n=1120.4±254.1, p=0.21; RA: SC n=949.4±52.8 vs EVT n=1054.4±219.6, p=0.85). Comparatively, from 2012 to 2016, significantly more UA and RA were treated endovascularly (UA: SC n=722.0±43.4 vs EVT n=1439.0±419.2, p<0.001; RA: SC n=672.2±61.4 vs EVT n=1051.6±330.2, p=0.02).ConclusionsAs technological innovations continue to advance the neuroendovascular space, the standard of care for treatment of cerebral aneurysms is shifting further towards endovascular therapies over open surgical approaches in the USA.

BackgroundFlow diverters are increasingly used for the treatment of intracranial aneurysms. Understanding cavernous internal carotid artery (cICA) tortuosity may help to predict procedural complexities of deploying flow diverters.MethodsPipeline embolization device (PED) neurointerventions for ICA aneurysms proximal to the ICA termination were reviewed. Cavernous ICA tortuosity was measured as a ratio D/AP, where D=height difference of the anterior and posterior genus, AP=sum of the angles of the anterior (A) and posterior (P) genus. Four types of cICA tortuosity were proposed. An analysis of variance regression and Fisher's exact test were performed to analyze differences among the types.ResultsCavernous ICA tortuosity was categorized into minimal (type I, n=28), moderate (type II–III, n=29), and severe (type IV, n=26). The groups were comparable for patient age (mean ± SEM years, type I: 55.6±10.4, II–III: 56.4±14.4, IV: 55±12.8) and aneurysm size (mean±SEM mm, type I: 6.25±3.5, II–III: 7.6±4.9, IV: 9.11±4.9). Analysis of variance demonstrated significant differences in procedural fluoroscopy time (mean ± SEM min, type I: 29.8±8.4, II–III: 44.9±34.1, IV: 52.6±17.2, p<0.005) and mean ± SEM D/AP (type I: 0.008±0.0008, II–III: 0.141±0.07, IV: 0.482±0.365, p<0.0001). Procedural complexity was also statistically significant (p<0.005) with 4%, 28%, and 35% of cases in types I, II–III, and IV, respectively, requiring intraprocedural PED removal or balloon post-processing of the implanted PED.ConclusionsWe propose a classification system for cICA tortuosity based on measurements of the anterior and posterior genu geometry. This classification correlates strongly with markers of PED procedural complexity and may be helpful in pre-procedure prognostication.

BackgroundFlow diversion is an established technique for treatment of cerebral aneurysms. The Pipeline embolization device (PED) is the only FDA-approved flow diverting stent in the USA. A second-generation device, PED Flex, has recently been released with modifications to the delivery system. Published reports of experience with this new device are limited.ObjectiveTo describe the initial outcomes from the first North American series using the PED Flex—a single-center experience of 44 cases.MethodsAll patients consecutively treated with the PED Flex embolization device from February 2015 through April 2015 were included in the study. Data were collected for patient demographics, aneurysm characteristics, technical procedural details, and early outcomes.ResultsPED Flex treatment was attempted in 42 patients (mean 56.6±2.0 years) with 44 aneurysms (mean size 6.5±0.6 mm), 41/44 (93%) of which were anterior circulation and 3/44 (7%) were posterior circulation. PED Flex was successfully implanted in 43/44 cases (98%). A single device was used in 41/43 cases (95%), with a mean of 1.07±0.05 devices implanted per case. Resheathing was performed in 4/44 cases (9%). Mean postprocedure hospital length of stay was 1.3±0.2 days. One significant neurological complication (2.3%) occurred, which was a stroke in a patient non-compliant with the prescribed antiplatelet regimen.ConclusionsPipeline Flex is a second-generation flow diverter with enhanced features compared with the first-generation PED. These modifications allow for more reliable deployment with continued improvements in procedural safety.

The use of periprocedural dual antiplatelet therapy (DAPT) has significantly evolved along with innovations in the endovascular management of intracranial aneurysms. Historically, aspirin and clopidogrel have been the most commonly employed regimen due to its safety and efficacy. However, recent studies highlight the importance of tailoring DAPT regimens to individual patient characteristics which may affect clopidogrel metabolism, such as genetic polymorphisms. In the present report, a systematic review of the literature was performed to determine optimal antiplatelet use with flow diverting stents, intracranial stents, intrasaccular devices, and stent-assisted coiling. Studies were analyzed for the number of aneurysms treated, DAPT regimen, and any thromboembolic complications. Based on inclusion criteria, 368 studies were selected, which revealed the increasing popularity of alternative DAPT regimens with the aforementioned devices. Thromboembolic or hemorrhagic complications associated with antiplatelet medications were similar across all medications. DAPT with ticagrelor, tirofiban, or prasugrel are effective and safe alternatives to clopidogrel and do not require enzymatic activation. Further clinical trials are needed to evaluate different antiplatelet regimens with various devices to establish highest-level evidence-based guidelines and recommendations.

Abstract BACKGROUND: Intraoperative angiography (IA) is used to evaluate the adequacy of clip reconstruction of intracranial aneurysms. Alternative imaging such as indocyanine green videoangiography (ICG-VA) has been proposed. The additional benefit of ICG-VA when IA is routinely used has not been previously determined. OBJECTIVE: To report our experience with the use of ICG-VA in combination with IA vs IA alone. METHODS: We retrospectively reviewed cases of aneurysm clipping during a 21-month period by a single surgeon in which ICG-VA was performed after clip reconstruction prior to IA, or IA alone was performed to verify optimal clipping. Records were reviewed for age, sex, race, length of stay, rupture status, Hunt and Hess grade, aneurysm size, location, and temporary clipping. Intraoperative decision making was determined for each group. RESULTS: Ninety-four patients who underwent 97 craniotomies for 128 aneurysms met inclusion criteria for this study. ICG-VA+IA was performed in 37 craniotomies; IA alone was performed for 60 craniotomies. Baseline characteristics were similar with the exception that median aneurysm size was slightly larger in the ICG-VA group (5.6 mm vs 4.3 mm, P = .04). ICG-VA produced 4 false negatives, which required clip adjustments following IA (10.8%), vs 7 patients (11.7%) in the IA-alone group requiring clip adjustments (P = .897). CONCLUSION: When IA is routinely performed, the additional use of ICG-VA does not eliminate the need for post-IA clip adjustments owing to the possibility of false negatives. When ICG-VA suggests optimal clipping, but is followed by IA, the rate of post-IA modifications in this study did not differ significantly than if ICG-VA had not been performed.

Osteogenesis imperfecta (OI) predisposes individuals to easy bone fracture, vessel fragility, and platelet dysfunction. We report the first known case of neurointerventional treatment with flow diversion of intracranial aneurysms in a patient with OI. A 62 year-old female with known OI Type I, history of >40 lifetime bone fractures and hypertension, underwent workup for transient ischemic attacks revealing a 4-mm right A1 segment aneurysm in 2016. Perioperative dual antiplatelet therapy was aspirin 81 mg and clopidogrel 37.5 mg daily. Tri-axial access was utilized to deploy a 3.5 × 16-mm Pipeline Flex device without complication. Two-month follow-up revealed Raymond I (O’Kelly Marotta I) obliteration of the aneurysm. Five-year follow-up revealed a de novo left-sided 3-mm A1–A2 junction aneurysm. A 4 × 12-mm Surpass Evolve was placed without complication. Six-month follow-up revealed Raymond I (O’Kelly Marotta I) obliteration of the second aneurysm. The patient remained asymptomatic at all follow-up visits.

Background Successful neuroendovascular treatments rely on microcatheter stability from guide catheter support. We present our experience using a new large-bore 0.058 inch or 0.072 inch inner diameter (ID) hyperflexible access catheter placed deep within the intracranial circulation during the neurointervention. Methods We retrospectively reviewed all neurointerventions performed by the senior author during an 18-month period to identify patients in whom the Navien intracranial catheter was placed in an ultra-distal position, defined as beyond the clinoidal internal carotid artery (ICA) or V3 segment of the vertebral artery. Procedural data collected included parent artery tortuosity, technique for Navien advancement, intraprocedural Navien position and periprocedural complications. Results The Navien, either 6 F 0.072 inch ID or 5 F 0.058 inch ID, provided ultra-distal large-bore access in the following 11 intracranial interventions: anterior circulation aneurysm treatment with Pipeline embolization device (PED) (n=3); posterior circulation aneurysm single-stage stent coiling (n=5); liquid embolization of arteriovenous malformations (n=2); PED coiling of posterior circulation aneurysm (n=1). The Navien was tracked into position over a Marksman microcatheter in 10/11 cases and a Headway 27 microcatheter in one case. Intraprocedural Navien positions were as follows: supraclinoid ICA (n=2); mid M1 (n=1); V3–V4 junction (n=2) (both using 6 F Navien); distal V4 (n=3); proximal basilar (n=1); proximal-mid basilar (n=1); mid basilar (n=1). No significant catheter-related complications occurred. Conclusions The Navien is the newest hyperflexible access catheter that is highly trackable into ultra-distal intracranial positions. It maneuvers atraumatically, providing improved distal intracranial support for a variety of complex cerebrovascular interventions and preserves necessary ID for quality intraprocedural roadmaps and angiography.