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BackgroundThe pipeline embolization device (PED; Medtronic) has presented as a safe and efficacious treatment for small- and medium-sized intracranial aneurysms. Independently adjudicated long-term results of the device in treating these lesions are still indeterminate. We present 3-year results, with additional application of a flow diverter specific occlusion scale.MethodsPREMIER (prospective study on embolization of intracranial aneurysms with pipeline embolization device) is a prospective, single-arm trial. Inclusion criteria were patients with unruptured wide-necked intracranial aneurysms ≤12 mm. Primary effectiveness (complete aneurysm occlusion) and safety (major neurologic event) endpoints were independently monitored and adjudicated.ResultsAs per the protocol, of 141 patients treated with a PED, 25 (17.7%) required angiographic follow-up after the first year due to incomplete aneurysm occlusion. According to the Core Radiology Laboratory review, three (12%) of these patients progressed to complete occlusion, with an overall rate of complete aneurysm occlusion at 3 years of 83.3% (115/138). Further angiographic evaluation using the modified Cekirge-Saatci classification demonstrated that complete occlusion, neck residual, or aneurysm size reduction occurred in 97.1%. The overall combined safety endpoint at 3 years was 2.8% (4/141), with only one non-debilitating major event occurring after the first year. There was one case of aneurysm recurrence but no cases of delayed rupture in this series.ConclusionsThe PED device presents as a safe and effective modality in treating small- and medium-sized intracranial aneurysms. The application of a flow diverter specific occlusion classification attested the long-term durability with higher rate of successful aneurysm occlusion and no documented aneurysm rupture.Trial registrationNCT02186561.

BackgroundStent-assisted coiling of wide-necked intracranial aneurysms (IAs) using the Neuroform Atlas Stent System (Atlas) has shown promising results.ObjectiveTo present the primary efficacy and safety results of the ATLAS Investigational Device Exemption (IDE) trial in a cohort of patients with posterior circulation IAs.MethodsThe 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.ResultsThe 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.ConclusionsIn 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.

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Background and purposeStent-assisted coil embolization using the new generation Neuroform Atlas Stent System has shown promising safety and efficacy. The primary study results of the anterior circulation aneurysm cohort of the treatment of wide-neck, saccular, intracranial, aneurysms with the Neuroform Atlas Stent System (ATLAS trial [Safety and Effectiveness of the Treatment of Wide Neck, Saccular Intracranial Aneurysms With the Neuroform Atlas Stent System]) are presented.MethodsATLAS IDE trial (Investigational Device Exemption) is a prospective, multicenter, single-arm, open-label study of wide-neck (neck ≥4 mm or dome-to-neck ratio 50%) at the target location. The primary safety end point was any major stroke or ipsilateral stroke or neurological death within 12 months. Adjudication of the primary end points was performed by an independent Imaging Core Laboratory and the Clinical Events Committee.ResultsA total of 182 patients with wide-neck anterior circulation aneurysms at 25 US centers were enrolled. The mean age was 60.3±11.4 years, 73.1% (133/182) women, and 80.8% (147/182) white. Mean aneurysm size was 6.1±2.2 mm, mean neck width was 4.1±1.2 mm, and mean dome-to-neck ratio was 1.2±0.3. The most frequent aneurysm locations were the anterior communicating artery (64/182, 35.2%), internal carotid artery ophthalmic artery segment (29/182, 15.9%), and middle cerebral artery bifurcation (27/182, 14.8%). Stents were placed in the anticipated anatomic location in all patients. The study met both primary safety and efficacy end points. The composite primary efficacy end point of complete aneurysm occlusion (Raymond-Roy 1) without parent artery stenosis or aneurysm retreatment was achieved in 84.7% (95% CI, 78.6%-90.9%) of patients. Overall, 4.4% (8/182, 95% CI, 1.9%-8.5%) of patients experienced a primary safety end point of major ipsilateral stroke or neurological death.ConclusionsIn the ATLAS IDE anterior circulation aneurysm cohort premarket approval study, the Neuroform Atlas stent with adjunctive coiling met the primary end points and demonstrated high rates of long-term complete aneurysm occlusion at 12 months, with 100% technical success and

BackgroundPreliminary clinical studies on the safety and efficacy of the pipeline embolization device (PED) for the treatment of small/medium aneurysms have demonstrated high occlusion rates with low complications.ObjectiveTo evaluate the safety and effectiveness of the PED for treatment of wide necked small and medium intracranial aneurysms.MethodsPREMIER is a prospective, multicenter, single arm trial. Patients were treated with the PED for unruptured wide necked aneurysms, measuring ≤12 mm along the internal carotid artery or vertebral artery, between July 2014 and November 2015. At 1 year post-procedure, the primary effectiveness endpoint was complete occlusion (Raymond grade 1) without major parent vessel stenosis (≤50%) or retreatment, and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurologic death.ResultsA total of 141 patients were treated with PEDs (mean age 54.6±11.3 years, 87.9% (124/141) women). Mean aneurysm size was 5.0±1.92 mm, and 84.4% (119/141) measured

Background and objectiveStent-assisted coil embolization is a well-established treatment of intracranial wide-necked aneurysms. The Neuroform Atlas Stent System is a new generation microstent designed to enhance coil support, conformability, deliverability, and improve deployment accuracy. We present the 1-year efficacy and angiographic results of the Humanitarian Device Exemption (HDE) cohort from the Atlas Investigational Device Exemption (IDE) clinical trial.MethodThe Atlas IDE trial is a prospective, multicenter, single-arm, open-label study of unruptured wide-necked intracranial aneurysms treated with the Neuroform Atlas stent and approved coils. The primary efficacy endpoint was the rate of 12-month complete aneurysm angiographic occlusion (Raymond class I) without target aneurysm retreatment or significant parent artery stenosis (>50%) at the target location. The primary safety endpoint was the rate of major ipsilateral stroke or neurological death within 12 months. Imaging core laboratory and Clinical EventsCommittee adjudicated the primary endpoints.Results30 patients were enrolled at eight US centers, with 27 patients completing the 12-month angiographic follow-up. The mean age was 59.4±11.8 years and 24/30 patients (80%) were women. The mean aneurysm size was 5.3±1.7 mm and the dome:neck ratio was 1.1±0.2. Procedural technical success of Neuroform Atlas Stent deployment was 100%. 27 patients completed 12-month angiographic follow-up and 30 patients completed their 6-month follow-up. When applying the last observation carried forward method, the primary efficacy endpoint was observed in 26/30 patients (86.7%, 95% CI 69.3% to 96.2%) compared with 25/27 patients (92.6%, 95% CI 75.7% to 99.1%) who completed the 12-month angiographic follow-up. The primary safety endpoint of stroke occurred in one patient (3.3%), who made a complete clinical recovery at discharge. There were no neurological deaths.ConclusionThe Neuroform Atlas stent in conjunction with coils demonstrated a high rate of complete aneurysm occlusion at 12-month angiographic follow-up, with an improved safety profile in the HDE cohort.Clinical trialgov registration numberNCT0234058;Results.

Objective: We aimed to assess the impact of time to endovascular thrombectomy (EVT) on clinical outcomes in the DAWN trial, while also exploring the potential effect modification of mode of stroke onset on this relationship. Methods: The association between every 1‐h treatment delay with 90‐day functional independence (modified Rankin Scale [mRS] score 0–2), symptomatic intracranial hemorrhage, and 90‐day mortality was explored in the overall population and in three modes of onset subgroups (wake‐up vs. witnessed vs. unwitnessed). Results: Out of the 205 patients, 98 (47.8%) and 107 (52.2%) presented in the 6 to 12 hours and 12 to 24 hours time window, respectively. Considering all three modes of onset together, there was no statistically significant association between time last seen well to randomization with either functional independence or mortality at 90 days in either the endovascular thrombectomy (mRS 0–2 1‐hour delay OR 1.07; 95% CI 0.93–1.24; mRS 6 OR 0.84; 95% CI 0.65–1.03) or medical management (mRS 0–2 1‐hour delay OR 0.98; 95% CI 0.80–1.14; mRS 6 1‐hour delay OR 0.94; 95% CI 0.79–1.09) groups. Moreover, there was no significant interaction between treatment effect and time (p = 0.439 and p = 0.421 for mRS 0–2 and 6, respectively). However, within the thrombectomy group, the models that tested the association between time last seen well to successful reperfusion (modified Treatment in Cerebral Infarction ≥2b) and 90‐day functional independence showed a significant interaction with mode of presentation (p = 0.013). This appeared to be driven by a nominally positive slope for both witnessed and unwitnessed strokes versus a significantly (p = 0.018) negative slope in wake‐up patients. There was no association between treatment times and symptomatic intracranial hemorrhage. Interpretation: Mode of onset modifies the effect of time to reperfusion on thrombectomy outcomes, and should be considered when exploring different treatment paradigms in the extended window. ANN NEUROL 2024;96:356–364 [ABSTRACT FROM AUTHOR]

Background Mechanical thrombectomy (MT) has become standard for large vessel occlusions, but rates of complete recanalization are suboptimal. Previous reports correlated radiographic signs with clot composition and a better response to specific techniques. Therefore, understanding clot composition may allow improved outcomes. Methods Clinical, imaging, and clot data from patients enrolled in the STRIP Registry from September 2016 to September 2020 were analyzed. Samples were fixed in 10% phosphate-buffered formalin and stained with hematoxylin-eosin and Martius Scarlett Blue. Percent composition, richness, and gross appearance were evaluated. Outcome measures included the rate of first-pass effect (FPE, modified Thrombolysis in Cerebral Infarction 2c/3) and the number of passes. Results A total of 1430 patients of mean±SD age 68.4±13.5 years (median (IQR) baseline National Institutes of Health Stroke Scale score 17.2 (10.5-23), IV-tPA use 36%, stent-retrievers (SR) 27%, contact aspiration (CA) 27%, combined SR+CA 43%) were included. The median (IQR) number of passes was 1 (1-2). FPE was achieved in 39.3% of the cases. There was no association between percent histological composition or clot richness and FPE in the overall population. However, the combined technique resulted in lower FPE rates for red blood cell (RBC)-rich (P<0.0001), platelet-rich (P=0.003), and mixed (P<0.0001) clots. Fibrin-rich and platelet-rich clots required a higher number of passes than RBC-rich and mixed clots (median 2 and 1.5 vs 1, respectively; P=0.02). CA showed a trend towards a higher number of passes with fibrin-rich clots (2 vs 1; P=0.12). By gross appearance, mixed/heterogeneous clots had lower FPE rates than red and white clots. Conclusions Despite the lack of correlation between clot histology and FPE, our study adds to the growing evidence supporting the notion that clot composition influences recanalization treatment strategy outcomes. [ABSTRACT FROM AUTHOR]

Background: Traditional endovascular treatments of giant intracranial aneurysms are associated with high rates of complications and retreatment. Our objective was to examine the safety and long-term efficacy of the Pipeline Embolization Device for treatment of these aneurysms. Methods: This retrospective study using the IntrePED database included all patients with giant intracranial aneurysms treated with the Pipeline device between July 2008 and February 2013. Efficacy outcomes were stratified by using the Raymond-Roy Occlusion Classification. Predefined safety outcomes included spontaneous rupture of the target aneurysm; ipsilateral intracranial hemorrhage; ischemic stroke; parent artery stenosis; and sustained cranial neuropathy. Results: Sixty-six embolizations were performed to treat 63 giant intracranial aneurysms (including 2 ruptured): 49 (77.8%) in the anterior and 14 (22.2%) in the posterior circulation. The median follow-up was 22.4 (0.1–60.5) months. Class I angiographic occlusion was achieved in 72.0% (36/50). The neurological morbidity/mortality rate was 23.8% (15/63), with higher rates in the posterior circulation than in the anterior circulation (22.4% vs. 28.6%). Among seven deaths, five had neurological causes. The procedure-related neurological morbidity and mortality rates were 22.7% (15/66) and 7.6% (5/66), respectively. The spontaneous rupture rate was 4.5% (3/66). Two spontaneous ruptures (1 death), 4/4 postprocedural intracranial hemorrhages, and 6/9 ischemic events occurred within 30 days. In-stent stenosis and new-onset cranial neuropathy were not observed during the angiographic follow-up period. Conclusions: Although procedure-related neurological morbidity/mortality rates were not insignificant, this study confirms the feasibility and long-term efficacy of the Pipeline Embolization Device to treat giant intracranial aneurysms. [ABSTRACT FROM AUTHOR]

Background The Pipeline Flex embolization device with Shield technology (PED Shield) is the first flow diverter for brain aneurysm treatment approved in the United States using surface-modified technology. The effect of PED Shield on decreasing perioperative diffusion-weighted imaging positive (DWI+) hits, as a marker for in-human decrease thrombogenicity, is unclear. Objective To determine if the number of periprocedural DWI+ lesions differs between patients with an aneurysm treated with PED Flex and PED Shield. Methods This retrospective study compares the outcomes of consecutive patients with an aneurysm treated with PED Flex and PED Shield. The primary outcome of interest was the occurrence of DWI+ lesions. We also assessed potential predictors of DWI+ lesions and compared the outcomes between on-label and off-label treatment indications. Results 89 patients were included, 48 (54%) treated with PED Flex and 41 (46%) with PED Shield. After matching, the incidence of DWI+ lesions was 61% and 62% for the PED Flex and PED Shield groups, respectively. Results were consistent across each model with no significant differences in DWI+ lesions between treatment groups, and effect sizes ranging from OR=1.08 (95% CI 0.41 to 2.89) after propensity score matching to OR=1.84 (95% CI 0.65 to 5.47) after multivariable regression. Multivariable models demonstrated reduced DWI+ lesions with balloon-assisted therapies and posterior circulation treatment, while a significant linear relationship was encountered with fluoroscopy time. Conclusion There was no significant difference in the incidence of perioperative DWI+ lesions between patients with an aneurysm treated with PED Flex and PED Shield. Larger cohorts are likely needed to demonstrate differences between the devices. [ABSTRACT FROM AUTHOR]

This document is an abstract of a study comparing the outcomes of direct and indirect bypass surgeries for moyamoya disease, a cerebrovascular condition. The study, conducted across multiple academic institutions, found that both surgical approaches had comparable rates of symptomatic strokes. However, direct bypass surgery had a higher rate of perioperative major strokes, while indirect bypass surgery had a higher rate of follow-up ischemic and hemorrhagic strokes. The document also mentions other studies with mixed results on the effectiveness of the two procedures. The choice of surgery should be based on individual factors and preferences. [Extracted from the article]