Explore the vast range of titles available.

Abstract BACKGROUND Chronic subdural hematoma (SDH) is a particularly challenging pathology due to high recurrence rates (2%-37%) and complex medical comorbidities that tend to afflict the patient population. Recently, there have been several case series published describing the use of middle meningeal artery (MMA) embolization as an alternative to surgery for treatment of new or recurrent chronic SDH. OBJECTIVE To describe our first 60 cases of MMA embolization for chronic SDH. METHODS MMA embolization was performed using angiography, selective microcatheterization of the MMA, and infusion of polyvinyl alcohol particles. Outcomes were assessed clinically and with interval imaging studies at 1 d, 2 wk, and 6 wk postprocedure, and additional intervals as indicated. RESULTS MMA embolization was performed successfully on 60 total SDHs in 49 patients. This includes upfront treatment for new (not previously treated) SDH in 42, for recurrence in 8, and prophylaxis (soon after surgical evacuation) in 10. There were 3 mortalities (unrelated to the procedure), and no procedural complications. Of the 50 nonprophylactic cases, there were 4 (8.9%) cases of recurrence requiring surgical evacuation, and 31 (68.9%) that had resolution or reduction in size >50% of SDH at longest follow-up. Overall, 41 (91.1%) were stable or decreased in size and able to avoid surgery. CONCLUSION MMA embolization may represent a minimally-invasive alternative to surgery for new or recurrent chronic SDH, or as prophylaxis to reduce the risk of recurrence after surgery. Given our encouraging results with a 91% long-term success rate, a large scale clinical trial is warranted.

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 <7 mm. PED placement was successful in 99.3% (140/141) of patients. Mean number of PEDs implanted per patient was 1.1±0.26; a single PED was used in 92.9% (131/141) of patients. At 1 year, 97.9% (138/141) of patients underwent follow-up angiography with 76.8% (106/138) of patients having met the study’s primary effectiveness endpoint. The combined major morbidity and mortality rate was 2.1% (3/140).ConclusionsTreatment of wide necked small/medium aneurysms with the PED results in high rates of complete occlusion without significant parent vessel stenosis and low rates of permanent neurologic complications.Trial registration NCT02186561.

PurposeThe Pipeline Embolization Device (PED) is a routine first-line treatment option for intracranial aneurysms (IAs). The Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield) is an updated version of the PED which has been modified to include a surface phosphorylcholine biocompatible polymer. Its early technical success and safety have been reported previously. Here, we assessed the long-term safety and efficacy of the Pipeline Shield for the treatment of IAs.Materials and methodsThe Pipeline Flex Embolization Device with Shield Technology (PFLEX) study was a prospective, single-arm, multicenter study for the treatment of unruptured IAs using the Pipeline Shield. The primary endpoint was a major stroke in the territory supplied by the treated artery or neurologic death at 1-year post-procedure. Angiographic outcomes were also assessed by an independent radiology laboratory at 6 months and 1 year.ResultsFifty patients (mean age, 53 years; 82% female) with 50 unruptured IAs were treated. Mean aneurysm diameter was 8.82±6.15 mm. Of the target aneurysms, 38/50 (76%) were small (<10 mm), 11/50 (22%) were large (≥10 and<25 mm), and 1/50 (2%) was giant (≥25 mm). Forty-seven (94%) were located in the internal carotid artery and three (6%) in the vertebral artery. At 1-year post-procedure, no major strokes or neurologic deaths were reported, and complete occlusion was achieved in 27/33 (81.8%). There were no instances of aneurysm recurrence or retreatment.ConclusionsOur 1-year follow-up concerning angiographic and safety outcomes corroborate previous evidence that the Pipeline Shield is a safe and effective treatment for IAs.Trial registration number NCT02390037

During intracranial aneurysm embolization with the Pipeline embolization device (PED), ischemic and hemorrhagic complications have been observed in cases among Western populations. The postmarket multicenter registry study on the embolization of intracranial aneurysms with the PED in China, i.e., the PLUS study, was performed to assess real-world predictors of complications and functional outcomes in patients treated with the PED in a Chinese population. All patients with intracranial aneurysms who underwent embolization using the PED between November 2014 and October 2019 across 14 centers in China were included. The study endpoints included preoperative and early postoperative (< 30 days) functional outcomes (modified Rankin scale [mRS] scores) and complications related to PED treatment at early postoperative and follow-up time points (3–36 months). Multivariate analysis was performed to identify risk factors for complications. A total of 1171 consecutive patients (mean age, 53.9 ± 11.4; female, 69.6% [813/1171]) with 1322 aneurysms were included in the study. Hypertension, basilar artery aneurysms, and successful deployment after adjustment or unsuccessful device deployment were found to be independent predictors of ischemic stroke, while the use of the Flex PED and incomplete occlusion immediately after treatment were protective factors. An aneurysm size > 10 mm, distal anterior circulation aneurysms, and adjunctive coiling were found to be independent predictors of delayed aneurysm rupture, distal intraparenchymal hemorrhage, and neurological compression symptoms, respectively. The rate of PED-related complications in the PLUS study was similar to that in Western populations. The PLUS study identified successful deployment after adjustment or unsuccessful device deployment and the degree of immediate postoperative occlusion as novel independent predictors of PED-related ischemic stroke in a Chinese population. ClinicalTrial.gov Identifier: NCT03831672

BACKGROUND:Flow disruption with WEB is an innovative endovascular approach for wide-neck bifurcation aneurysms. Initial series have shown a low complication rate with good efficacy. OBJECTIVE:To report clinical and anatomical results of the WEB treatment in the cumulated population of WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm) and French Observatory series. METHODS:WEBCAST and French Observatory are single-arm, prospective, multicenter, Good Clinical Practice studies dedicated to the evaluation of WEB treatment. Ruptured and unruptured bifurcation aneurysms located in the basilar artery, middle cerebral artery, anterior communicating artery, and internal carotid artery terminus were included in both studies. Clinical data were independently evaluated. Postoperative, 6-month (in WEBCAST), and 1-year aneurysm occlusion was independently evaluated with a 3-grade scalecomplete occlusion, neck remnant, and aneurysm remnant. RESULTS:The cumulated population was 113 patients (74 female, 65.5%) 33 to 74 years of age with 114 aneurysms with a mean neck size of 5.6 mm. There was no mortality at 1 month, and morbidity was 2.7%. A statistically significant difference in the rate of occurrence of thromboembolic events was observed between the use of any antiplatelet agent and the use of no antiplatelet agent (P < .001). At 1 year, complete aneurysm occlusion was observed in 56.0%, neck remnant in 26.0%, and aneurysm remnant in 18.0%. Worsening of aneurysm occlusion between the procedure and 12 months was observed in 2.0% and between 6 months and 1 year in 7.1%. CONCLUSION:The analysis in this large cumulated population of studies confirms favorable safety and efficacy of WEB treatment. ABBREVIATIONS:ATENA, Analysis of Treatment by Endovascular Approach of Non Ruptured AneurysmsCLARITY, Clinical and Anatomic Results in the Treatment of Ruptured Intracranial AneurysmsDSA, digital subtraction angiographyGCP, Good Clinical PracticeHELPS, HydroCoil Endovascular Aneurysm Occlusion and Packing StudyMAPS, Matrix and Platinum SciencemRS, modified Rankin Scale

Background and purposeFlow diversion is an innovative and increasingly used endovascular treatment for intracranial aneurysms. Its initial evaluation with the first devices available showed good efficacy of this treatment with variable safety results. The Flow Direction Endoluminal Device (FRED) has a specific design and was evaluated in a single-arm, multicenter, prospective, Good Clinical Practice study: SAFE (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment). This analysis reports clinical results at 1 year and anatomical results at 6 months and 1 year.MethodsPatients with unruptured and recanalized aneurysms located in the anterior circulation treated with FRED and FRED Jr were prospectively included. A Clinical Event Committee and a Core Laboratory independently evaluated clinical outcome and anatomical results.ResultsThirteen interventional neuroradiology centers included 103 patients/aneurysms. Aneurysm locations were supraclinoid internal carotid artery (ICA) in 71 (68.9%), cavernous ICA in 15 (14.6%), anterior cerebral or anterior communicating artery in 9 (8.7%), and middle cerebral artery in 8 (7.8%). Most aneurysms were small (<10 mm) in 71 patients (68.9%). Cumulative 1-year mortality and morbidity rates were 2/103 (1.9%) and 3/103 (2.9%), respectively, one death being related to cancer. At 1 year, anatomical results were: complete occlusion in 66/90 patients (73.3%), neck remnant in 7/90 patients (7.8%), and aneurysm remnant in 17/90 patients (18.9%).ConclusionsSAFE study analysis at 1 year confirms the excellent safety profile of the FRED device for aneurysm treatment, with low morbidity and mortality rates (2.9% and 1.9%, respectively) and demonstrates its efficacy (adequate occlusion in 73/90 (81.1%)).Clinical trial registrationUnique identifier: NCT02921698; Results.

Abstract BACKGROUND The safety of PipelineTM Embolization Device (PED; Medtronic Inc, Dublin, Ireland) in posterior circulation aneurysms is still controversial. OBJECTIVE To study complications associated with the treatment of posterior circulation aneurysms by conducting a subgroup analysis from the International Retrospective Study of PED registry. METHODS Data from 91 consecutive patients with 95 posterior circulation aneurysms at 17 centers between July 2008 to February 2013 were analyzed. The primary endpoint was defined as any complication leading to neurological morbidity or death. The outcome predictors were calculated using Kaplan–Meier and Cox regression methods. RESULTS The mean aneurysm size was 13.8 mm. Aneurysm types were saccular (36.8%), fusiform (29.5%), dissecting (28.4%), and others (5.3%). The median follow-up was 21.1 mo. Twelve (13.2%) patients encountered a primary endpoint event. In multivariate analysis for the primary endpoint, use of ≥3 PEDs and fusiform shape compared with other shapes had hazard ratios (HRs) of 7.77 (95% confidence interval [CI], 2.48-25.86; P = .0007) and 3.48 (95% CI, 1.06-13.39; P = .0488), respectively. The multivariate HR of aneurysm size for neurological morbidity after PED implantation was 1.11 (95% CI, 1.04-1.18; P = .0015), and HRs of ruptured aneurysm and age for neurological mortality were 8.1 (95% CI, 1.31-41.26; P = .0197) and 1.07 (95% CI, 1.02-1.15; P = .0262), respectively. Basilar artery aneurysm had an HR of 3.54 (95% CI, 1.12-14.18, P = .0529) in the univariate analysis for major outcomes. CONCLUSION PED implantation may be considered for the treatment of posterior circulation aneurysms, especially of saccular or dissecting type. Our major complications appear to be comparable to those reported previously after clipping and coiling in the literature. Neurointerventionists should consider the shape, size, rupture, and location of complex posterior circulation aneurysms as well as age and PED number before the PED placement.

BackgroundThe first and second generations of the Pipeline Embolization Device (PED) have been widely adopted for the treatment of intracranial aneurysms (IAs) due to their high associated occlusion rates and low morbidity and mortality. The objective of this study was to evaluate the safety and effectiveness of the third- generation Pipeline Shield device (PED-Shield) for the treatment of IAs.MethodsThe SHIELD study was a prospective, single-arm, multicenter, post-market, observational study evaluating the PED-Shield device for the treatment of IAs. The primary efficacy endpoint was complete aneurysm occlusion without significant parent artery stenosis or retreatment at 1-year post-procedure and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurological death.ResultsOf 205 subjects who consented across 21 sites, 204 subjects with 204 target aneurysms were ultimately treated (mean age 54.8±12.81 years, 81.4% [166/204] female). Technical success (ie, deployment of the PED-Shield) was achieved in 98.0% (200/204) of subjects with a mean number of 1.1±0.34 devices per subject and a single device used in 86.8% (177/204) of subjects. The primary effectiveness endpoint was met in 71.7% (143/200) of subjects while the primary safety endpoint occurred in six (2.9%) subjects, two (1.0%) of which led to neurological death.ConclusionsThe findings of the SHIELD study support the safety and effectiveness of the PED-Shield for IA treatment, evidenced by high occlusion rates and low rates of neurological complications in the study population.Clinical trial registration-URL http://www.clinicaltrials.gov. Unique identifier: NCT02719522.

BackgroundArteriovenous malformations (AVMs) present a significant therapeutic challenge, as current treatment modalities frequently fail to achieve complete and rapid obliteration and are associated with substantial morbidity in both the short and long term. This underscores the critical need for innovative therapeutic strategies that enable efficient AVM obliteration while minimizing patient risk. The current review aims to comprehensively assess the role of ATME in AVM management, examining its clinical efficacy, associated risks and benefits, and the economic and ethical implications to provide valuable foundation for future studies and guiding development in treatment strategies for AVMs.ResultsAdvanced targeted microsphere embolization (ATME) has emerged as a promising therapeutic option, initially developed for the localized treatment of AVMs and unresectable tumors, including liver cancer. By providing targeted delivery, ATME offers potential advantages over conventional approaches in achieving effective local control.ConclusionsATME are safe and effective for vascular disease and cancer. Although evidence for microspheres in AVMs is scarce, results are promising. Future research could refine eligibility criteria, evaluate treatment techniques, and optimize ATME.

BackgroundEmbolization of the middle meningeal artery (MMA) has emerged as a potential treatment of chronic subdural hematomas (CSDHs).ObjectiveTo evaluate the impact on recurrence rate of postsurgical embolization of CSDH in patients with a higher than average risk of recurrence.MethodsA monocentric retrospective study was performed on retrospectively collected data. From March 2018 to December 2019, embolization of the MMA was proposed as an adjunct postoperative treatment after burr-hole surgery in patients operated for a recurrent CSDH or a CSDH with an independent recurrence risk factor, including antiplatelet therapy, full anticoagulation therapy, coagulation disorder, hepatopathy, or chronic alcoholism. Patients who had undergone postoperative embolization were compared with a historic group of patients operated between March 2016 and March 2018, selected based on the same inclusion criteria.ResultsDuring the study period, 89 patients (with 74 unilateral and 15 bilateral CSDHs) were included and underwent an embolization procedure, leading to 91 out of a total of 104 MMA being embolized (88%). These were compared with 174 patients (138 unilateral and 36 bilateral CSDH) in the historic control group. One major procedure-related adverse event was registered. Four of the 89 patients (4%) required surgery for a CSDH recurrence in the embolization group, significantly less than the 24 of 174 patients (14%) in the control group (OR=0.28, 95% CI 0.07 to 0.86, p=0.02).ConclusionsPostsurgical embolization of the MMA may reduce the recurrence rate of CSDHs with a risk factor of recurrence.