Management of patients suffering from mild traumatic brain injury 2023.

OBJECTIVE: To develop a multidisciplinary French reference that addresses initial pre- and in-hospital management of a mild traumatic brain injury patient. DESIGN: A panel of 22 experts was formed on request from the French Society of Emergency Medicine (SFMU) and the French Society of Anaesthesiology and Critical Care Medicine (SFAR). A policy of declaration and monitoring of links of interest was applied and respected throughout the process of producing the guidelines. Similarly, no funding was received from any company marketing a health product (drug or medical device). The expert panel had to respect and follow the Grade® (Grading of Recommendations Assessment, Development and Evaluation) methodology to evaluate the quality of the evidence on which the recommendations were based. Given the impossibility of obtaining a high level of evidence for most of the recommendations, it was decided to adopt a "Recommendations for Professional Practice" (RPP) format, rather than a Formalized Expert Recommendation (FER) format, and to formulate the recommendations using the terminology of the SFMU and SFAR Guidelines. METHODS: Three fields were defined: 1) pre-hospital assessment, 2) emergency room management, and 3) emergency room discharge modalities. The group assessed 11 questions related to mild traumatic brain injury. Each question was formulated using a PICO (Patients Intervention Comparison Outcome) format. RESULTS: The experts' synthesis work and the application of the GRADE® method resulted in the formulation of 14 recommendations. After two rounds of rating, strong agreement was obtained for all recommendations. For one question, no recommendation could be made. CONCLUSION: There was strong agreement among the experts on important, transdisciplinary recommendations, the purpose of which is to improve management practices for patients with mild head injury.

Endovascular treatment of brain arteriovenous malformations: clinical outcomes of patients included in the registry of a pragmatic randomized trial.

OBJECTIVE: The role of endovascular treatment in the management of patients with brain arteriovenous malformations (AVMs) remains uncertain. AVM embolization can be offered as stand-alone curative therapy or prior to surgery or stereotactic radiosurgery (SRS) (pre-embolization). The Treatment of Brain AVMs Study (TOBAS) is an all-inclusive pragmatic study that comprises two randomized trials and multiple registries. METHODS: Results from the TOBAS curative and pre-embolization registries are reported. The primary outcome for this report is death or dependency (modified Rankin Scale [mRS] score > 2) at last follow-up. Secondary outcomes include angiographic results, perioperative serious adverse events (SAEs), and permanent treatment-related complications leading to an mRS score > 2. RESULTS: From June 2014 to May 2021, 1010 patients were recruited in TOBAS. Embolization was chosen as the primary curative treatment for 116 patients and pre-embolization prior to surgery or SRS for 92 patients. Clinical and angiographic outcomes were available in 106 (91%) of 116 and 77 (84%) of 92 patients, respectively. In the curative embolization registry, 70% of AVMs were ruptured, and 62% were low-grade AVMs (Spetzler-Martin grade I or II), while the pre-embolization registry had 70% ruptured AVMs and 58% low-grade AVMs. The primary outcome of death or disability (mRS score > 2) occurred in 15 (14%, 95% CI 8%-22%) of the 106 patients in the curative embolization registry (4 [12%, 95% CI 5%-28%] of 32 unruptured AVMs and 11 [15%, 95% CI 8%-25%] of 74 ruptured AVMs) and 9 (12%, 95% CI 6%-21%) of the 77 patients in the pre-embolization registry (4 [17%, 95% CI 7%-37%] of 23 unruptured AVMs and 5 [9%, 95% CI 4%-20%] of 54 ruptured AVMs) at 2 years. Embolization alone was confirmed to occlude the AVM in 32 (30%, 95% CI 21%-40%) of the 106 curative attempts and in 9 (12%, 95% CI 6%-21%) of 77 patients in the pre-embolization registry. SAEs occurred in 28 of the 106 attempted curative patients (26%, 95% CI 18%-35%, including 21 new symptomatic hemorrhages [20%, 95% CI 13%-29%]). Five of the new hemorrhages were in previously unruptured AVMs (n = 32; 16%, 95% CI 5%-33%). Of the 77 pre-embolization patients, 18 had SAEs (23%, 95% CI 15%-34%), including 12 new symptomatic hemorrhages [16%, 95% CI 9%-26%]). Three of the hemorrhages were in previously unruptured AVMs (3/23; 13%, 95% CI 3%-34%). CONCLUSIONS: Embolization as a curative treatment for brain AVMs was often incomplete. Hemorrhagic complications were frequent, even when the specified intent was pre-embolization before surgery or SRS. Because the role of endovascular treatment remains uncertain, it should preferably, when possible, be offered in the context of a randomized trial.

Patient Selection in a Pragmatic Study on the Management of Patients with Brain Arteriovenous Malformations.

BACKGROUND: The Treatment of Brain Arteriovenous Malformations Study (TOBAS) is an all-inclusive pragmatic study comprising 2 randomized clinical trials (RCTs). Patients excluded from the RCTs are followed in parallel treatment and observation registries, allowing a comparison between RCT and registry patients. METHODS: The first randomized clinical trial (RCT-1) offers 1:1 randomized allocation of intervention versus conservative management for patients with arteriovenous malformation (AVM). The second randomized clinical trial (RCT-2) allocates 1:1 pre-embolization or no pre-embolization to surgery or radiosurgery patients judged treatable with or without embolization. Characteristics of RCT patients are reported and compared to registry patients. RESULTS: From June 2014 to May 2021, 1010 patients with AVM were recruited; 498 patients were observed and 373 were included in the treatment registries. Randomized allocation in RCT-1 was applied to 139 (26%) of the 512 patients (including 127 of 222 [57%] with unruptured AVMs) considered for curative treatment. RCT-1 AVM patients differed (in rupture status, Spetzler-Martin grade and baseline modified Rankin Score) from those in the observation or treatment registries (P < 0.001). Most patients had small (<3 cm; 71%) low-grade (Spetzler-Martin I-II; 64%) unruptured (91%) AVMs. The allocated management was conservative (n = 71) or curative (n = 68), using surgery (n = 39), embolization (n = 16), or stereotactic radiosurgery (n = 13). Pre-embolization was considered for 179/309 (58%) patients allocated/assigned to surgery or stereotactic radiosurgery; 87/179 (49%) were included in RCT-2. RCT-2 patient AVMs differed in size, eloquence and grade from patients of the pre-embolization registry (P < 0.01). Most had small (<3 cm in 82%) low-grade (83%) AVMs in non-eloquent brain (64%). CONCLUSIONS: Patients included in the RCTs differ significantly from registry patients. Meaningful results can be obtained if multiple centers actively participate in the TOBAS RCTs.

Rehearsals using patient-specific 3D-printed aneurysm models for simulation of endovascular embolization of complex intracranial aneurysms: 3D SIM study.

BACKGROUND: In neurovascular treatment planning, endovascular devices to manage complex intracranial aneurysms requiring intervention are often selected based on conventional measurements and interventional neuroradiologist experience. A recently developed technology allows a patient-specific 3D-printed model to mimic the navigation experience. The goal of this study was to assess the effect of pre-procedure 3D simulation on procedural and clinical outcomes for wide-neck aneurysm embolization. MATERIALS & METHODS: In this unblinded, non-randomized, prospective, multicenter study conducted from November 18 through December 20, patients with complex intracranial aneurysms (neck > 4 mm or ratio < 21) were treated by WEB or flow diverter stents (FDS). The primary endpoint was concordance between simulation and procedure, 3D-printed model accuracy as well as embolization outcomes including complications, procedure times, and radiation dose were also assessed. Secondary endpoint was to compare versus a retrospective WEB cohort. RESULTS: Twenty-one patients were treated, 76% of cases by WEB and 24% by FDS. Concordance between post-simulation and real procedure efficiency was 0.85 [0.69 - 1.00] for size device selection and 0.93 [0.79 - 1.00] for wall-apposition/aneurysm neck closure. Geometrical accuracy of the 3D-printed model showed a mean absolute shift of 0.11 mm. Two complications without major clinical impact were reported with a post-operative mRS similar to pre-procedure mRS for all patients. CONCLUSIONS: Rehearsal using accurate 3D-printed patient-specific aneurysm models enabled optimization of embolization strategy, resulting in reduced procedure duration and cumulative fluoroscopy time which translated to reduced radiation exposure compared to procedures performed without simulation.

Surgical treatment of brain arteriovenous malformations: clinical outcomes of patients included in the registry of a pragmatic randomized trial.

OBJECTIVE: The Treatment of Brain Arteriovenous Malformations Study (TOBAS) is a pragmatic study that includes 2 randomized trials and registries of treated or conservatively managed patients. The authors report the results of the surgical registry. METHODS: TOBAS patients are managed according to an algorithm that combines clinical judgment and randomized allocation. For patients considered for curative treatment, clinicians selected from surgery, endovascular therapy, or radiation therapy as the primary curative method, and whether observation was a reasonable alternative. When surgery was selected and observation was deemed unreasonable, the patient was not included in the randomized controlled trial but placed in the surgical registry. The primary outcome of the trial was mRS score > 2 at 10 years (at last follow-up for the current report). Secondary outcomes include angiographic results, perioperative serious adverse events, and permanent treatment-related complications leading to mRS score > 2. RESULTS: From June 2014 to May 2021, 1010 patients were recruited at 30 TOBAS centers. Surgery was selected for 229/512 patients (44%) considered for curative treatment; 77 (34%) were included in the surgery versus observation randomized trial and 152 (66%) were placed in the surgical registry. Surgical registry patients had 124/152 (82%) ruptured and 28/152 (18%) unruptured arteriovenous malformations (AVMs), with the majority categorized as low-grade Spetzler-Martin grade I-II AVM (118/152 [78%]). Thirteen patients were excluded, leaving 139 patients for analysis. Embolization was performed prior to surgery in 78/139 (56%) patients. Surgical angiographic cure was obtained in 123/139 all-grade (89%, 95% CI 82%-93%) and 105/110 low-grade (95%, 95% CI 90%-98%) AVM patients. At the mean follow-up of 18.1 months, 16 patients (12%, 95% CI 7%-18%) had reached the primary safety outcome of mRS score > 2, including 11/16 who had a baseline mRS score ≥ 3 due to previous AVM rupture. Serious adverse events occurred in 29 patients (21%, 95% CI 15%-28%). Permanent treatment-related complications leading to mRS score > 2 occurred in 6/139 patients (4%, 95% CI 2%-9%), 5 (83%) of whom had complications due to preoperative embolization. CONCLUSIONS: The surgical treatment of brain AVMs in the TOBAS registry was curative in 88% of patients. The participation of more patients, surgeons, and centers in randomized trials is needed to definitively establish the role of surgery in the treatment of unruptured brain AVMs. Clinical trial registration no.: NCT02098252 (ClinicalTrials.gov).

CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS): 12-month angiographic results of a multicenter study.

BACKGROUND: The CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS) study has shown that the endovascular treatment of ruptured bifurcation aneurysms with the Woven EndoBridge (WEB) is safe and effective and provides protection against rebleeding at 1 month and 1 year. The 12-month angiographic follow-up is an important endpoint of the study. METHODS: The CLARYS study is a prospective multicenter study conducted in 13 European centers. The study enrolled 60 patients with 60 ruptured aneurysms of the anterior and posterior circulation. The study was conducted with an independent assessment of safety outcomes and imaging. RESULTS: Sixty patients with 60 ruptured bifurcation aneurysms to be treated with the WEB were included. Fifty-three aneurysms (88.3%) had a broad base with a dome to neck ratio <2 (mean 1.6). Of these, 46 patients were evaluated by an independent core laboratory with follow-up imaging performed at 12 months or before eventual retreatment. At 1 year, 19/46 aneurysms (41.3%) were completely occluded (Raymond-Roy grade I), 21/46 (45.7%) had a residual neck and 6/46 (13.0%) had residual aneurysm filling. Adequate occlusion was reported in 40/46 (87%) aneurysms. Six patients underwent target aneurysm retreatment. CONCLUSIONS: The CLARYS study has previously shown that the use of the WEB in the endovascular treatment of ruptured bifurcation aneurysms provides effective protection against rebleeding with a good safety profile. The angiographic occlusion rates at 1 year reported here are comparable to those already seen in previous multicenter studies which primarily included unruptured aneurysms.

CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS): results of 1-month and 1-year assessment of rebleeding protection and clinical safety in a multicenter study.

BACKGROUND: The primary goal of the CLARYS study is to assess the protection against rebleeding when treating ruptured bifurcation aneurysms with the Woven EndoBridge (WEB) device. METHODS: The CLARYS study is a prospective, multicenter study conducted in 13 European centers. Patients with ruptured bifurcation aneurysms were consecutively included between February 2016 and September 2017. The primary endpoint was defined as the rebleeding rate of the target aneurysm treated with the WEB within 30 days postprocedure. Secondary endpoints included periprocedural and postprocedural adverse events, total procedure and fluoroscopy times, and modified Rankin Scale score at 1 month and 1 year. RESULTS: Sixty patients with 60 ruptured bifurcation aneurysms to be treated with the WEB were included. A WEB device was successfully implanted in 93.3%. The rebleeding rate at 1 month and 1 year was 0%. The mean fluoroscopy time was 27.0 min. Twenty-three periprocedural complications were observed in 18 patients and resolved without sequelae in 16 patients. Two of these complications were attributed to the procedure and/or the use of the WEB, leading to a procedure/device-related intraoperative complication rate of 3.3%. Overall mortality at 1 month and 1 year was 1.7% and 3.8%, respectively and overall morbidity at 1 month and 1 year was 15% and 9.6%, respectively. WEB-related 1-month and 1-year morbidity and mortality was 0%. CONCLUSIONS: The interim results of CLARYS show that the endovascular treatment of ruptured bifurcation aneurysms with the WEB is safe and effective and, in particular, provides effective protection against rebleeding. It may induce profound change in the endovascular management of ruptured bifurcation aneurysms.

Immediate post-operative aneurysm occlusion after endovascular treatment of intracranial aneurysms with coiling or balloon-assisted coiling in a prospective multicenter cohort of 1189 patients: Analysis of Recanalization after Endovascular Treatment of intracranial Aneurysm (ARETA) Study.

BACKGROUND: Coiling, including balloon-assisted coiling (BAC), is the first-line therapy for ruptured and unruptured aneurysms. Its efficacy can be clinically evaluated by bleeding/rebleeding rate after coiling, and anatomically evaluated by aneurysm occlusion post-procedure and during follow-up. We aimed to analyze immediate post-coiling aneurysm occlusion and associated factors within the Analysis of Recanalization after Endovascular Treatment of intracranial Aneurysm (ARETA) population. METHODS: Between December 2013 and May 2015, 16 neurointerventional departments prospectively enrolled participants treated for ruptured and unruptured aneurysms (ClinicalTrials.gov: NCT01942512). Participant demographics, aneurysm characteristics, and endovascular techniques were recorded. In patients with aneurysms treated by coiling or BAC, immediate post-operative aneurysm occlusion was independently evaluated by a core lab using a 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant. RESULTS: Of 1135 participants (age 53.8±12.8 years, 754 women (66.4%)), 1189 aneurysms were analyzed. Treatment modality was standard coiling in 645/1189 aneurysms (54.2%) and BAC in 544/1189 (45.8%). Immediate post-operative aneurysm occlusion was complete occlusion in 57.8%, neck remnant in 34.4%, and aneurysm remnant in 7.8%. Adequate occlusion (complete occlusion or neck remnant) was significantly more frequent in aneurysms with size <10 mm (93.1% vs 86.3%; OR 1.8, 95% CI 1.1 to 3.2; p=0.02) and in aneurysms with a narrow neck (95.8% vs 89.6%; OR 2.5, 95% CI 1.5 to 4.1; p=0.0004). Patients aged <70 years had significantly more adequate occlusion (92.7% vs 87.2%; OR 1.9, 95% CI 1.1 to 3.4; p=0.04). CONCLUSIONS: Immediately after aneurysm coiling, including BAC, adequate aneurysm occlusion was obtained in 92.2%. Age <70 years, aneurysm size <10 mm, and narrow neck were factors associated with adequate occlusion. TRIAL REGISTRATION NUMBER: NCT01942512, http://www.clinicaltrials.gov.

Delayed thromboembolic events after coiling of unruptured intracranial aneurysms in a prospective cohort of 335 patients.

BACKGROUND: Coiling is the first-line treatment for the management of unruptured intracranial aneurysms (UIAs), but delayed thromboembolic events (TEEs) can occur after such treatment. ARETA (Analysis of Recanalization after Endovascular Treatment of Intracranial Aneurysm) is a prospective multicenter study conducted to analyze aneurysm recanalization. We analyzed delayed TEEs in the UIA subgroup. METHODS: Sixteen neurointerventional departments prospectively enrolled patients treated for ruptured and unruptured aneurysms between December 2013 and May 2015. Participant demographics, aneurysm characteristics, and endovascular techniques were recorded. Data were analyzed from participants with UIA treated by coiling or balloon-assisted coiling. We assessed the rates, timing, management, clinical outcomes, and risk factors for delayed TEEs using univariable and multivariable analyses. RESULTS: The rate of delayed TEEs was 2.4% (95% CI 1.0% to 4.6%) in patients with unruptured aneurysms, with all events occurring in the week following the procedure. In multivariate analysis, two factors were associated with delayed TEEs: autosomal dominant polycystic kidney disease (ADPKD): 20.0% in patients with ADPKD vs 1.9% in patients without ADPKD (OR 27.3 (95% CI 3.9 to 190.2), p=0.0008) and post-procedure aneurysm remnant: 9.4% in patients with post-procedure aneurysm remnant vs 1.6% in patients with adequate occlusion (OR 9.9 (95% CI 1.0 to 51.3), p=0.006). We describe modalities of management as well as clinical outcomes. CONCLUSIONS: Delayed TEE is a relatively rare complication after coiling of UIAs. In this series, all occurred in the week following the initial procedure. Two factors were associated with delayed TEE: ADPKD and aneurysm remnant at procedure completion. CLINICAL TRIAL REGISTRATION: NCT01942512.

Rebleeding and bleeding in the year following intracranial aneurysm coiling: analysis of a large prospective multicenter cohort of 1140 patients-Analysis of Recanalization after Endovascular Treatment of Intracranial Aneurysm (ARETA) Study.

BACKGROUND: Endovascular treatment is the first line therapy for the management of ruptured and unruptured intracranial aneurysms, but delayed aneurysm rupture leading to bleeding/rebleeding can occur subsequently. ARETA (Analysis of Recanalization after Endovascular Treatment of intracranial Aneurysm) is a prospective, multicenter study conducted to analyze aneurysm recanalization. We analyzed delayed bleeding and rebleeding in this large cohort. METHODS: 16 neurointerventional departments prospectively enrolled patients treated for ruptured and unruptured aneurysms between December 2013 and May 2015 (ClinicalTrials.gov: NCT01942512). Participant demographics, aneurysm characteristics and endovascular techniques were recorded. Data were analyzed from participants with ruptured or unruptured aneurysms treated by coiling or balloon-assisted coiling. Rates of bleeding and rebleeding were analyzed and associated factors were studied using univariable and multivariable analyses. RESULTS: The bleeding rate was 0.0% in patients with unruptured aneurysms and 1.0% (95% CI 0.3% to 1.7%) in patients with ruptured aneurysms. In multivariate analysis, two factors were associated with rebleeding occurrence: incomplete aneurysm occlusion after initial treatment (2.0% in incomplete aneurysm occlusion vs 0.2% in complete aneurysm occlusion, OR 10.2, 95% CI 1.2 to 83.3; p=0.03) and dome-to-neck ratio (1.5±0.5 with rebleeding vs 2.2±0.9 without rebleeding, OR 0.2, 95% CI 0.04 to 0.8; p=0.03). Modalities of management of aneurysm rebleeding as well as clinical outcomes are described. CONCLUSIONS: Aneurysm coiling affords good protection against bleeding (for unruptured aneurysms) and rebleeding (for ruptured aneurysms) at 1 year with rates of 0.0% and 1.0%, respectively. Aneurysm occlusion and dome-to-neck ratio are the two factors that appear to play a role in the occurrence of rebleeding.

Intraoperative Complications of Endovascular Treatment of Intracranial Aneurysms with Coiling or Balloon-assisted Coiling in a Prospective Multicenter Cohort of 1088 Participants: Analysis of Recanalization after Endovascular Treatment of Intracranial Aneurysm (ARETA) Study.

Background Thromboembolic events and intraoperative rupture are the most frequent neurologic complications of intracranial aneurysm coiling. Their frequency has not been evaluated in recent series. Purpose To provide an analysis of complications, clinical outcome, and participant and aneurysm risk factors after aneurysm coiling or balloon-assisted coiling within the Analysis of Recanalization after Endovascular Treatment of Intracranial Aneurysm, or ARETA, cohort. Materials and Methods Sixteen neurointerventional departments prospectively enrolled participants treated for ruptured and unruptured aneurysms between December 2013 and May 2015. Participant demographics, aneurysm characteristics, and endovascular techniques were recorded. Data were analyzed from participants within the overall cohort treated with coiling or balloon-assisted coiling for a single aneurysm. Rates of neurologic complications were analyzed, and associated factors were studied by using univariable analyses (Student t test, χ2 test, or Fisher exact test, as appropriate) and multivariable analyses (logistic regressions). Results A total of 1088 participants (mean age ± standard deviation, 54 years ± 13; 715 women [65.7%]) were analyzed. Thromboembolic events and intraoperative rupture were reported in 113 of 1088 participants (10.4%) and 34 of 1088 participants (3.1%), respectively. Poor clinical outcome (defined as modified Rankin Scale score of 3-6) was reported in 29 of 113 participants (25.7%) with thromboembolic events and in 11 of 34 participants (32.4%) with intraoperative rupture (P = .44). Factors associated with thromboembolic events were female sex (odds ratio [OR], 1.7; 95% confidence interval [CI]: 1.1, 2.8; P = .02) and middle cerebral artery location (OR, 1.9; 95% CI: 1.2, 3.0; P = .008). Factors associated with intraoperative rupture were anterior communicating artery location (OR, 2.2; 95% CI: 1.1, 4.7; P = .03) and small aneurysm size (OR, 3.0; 95% CI: 1.5, 6.3; P = .003). Conclusion During aneurysm coiling or balloon-assisted coiling, thromboembolic events were more frequent than were intraoperative rupture. Both complications were associated with poor clinical outcome in a similar percentage of participants. Risk factors for thromboembolic events were female sex and middle cerebral artery location. Risk factors for intraoperative rupture were small aneurysm size and anterior cerebral or communicating artery location. © RSNA, 2020.

Aneurysm Treatment With Woven EndoBridge in the Cumulative Population of 3 Prospective, Multicenter Series: 2-Year Follow-Up.

BACKGROUND: Woven EndoBridge (WEB; Sequent Medical) treatment is an innovative endovascular approach for treatment of wide-neck bifurcation aneurysms. Initial studies have shown high safety with good efficacy at short term confirmed by trials conducted in United States (WEB-Intrasaccular Therapy) and in Europe (WEB Clinical Assessment of Intrasaccular Aneurysm Therapy [WEBCAST], French Observatory, and WEBCAST-2). OBJECTIVE: To report the 2-yr clinical and anatomical results of WEB treatment in the combined population of 3 European trials. METHODS: In a French Observatory, 2-yr clinical and anatomical data were collected. In WEBCAST and WEBCAST-2, 2-yr follow-up was optional, and data were collected when follow-up was performed. Aneurysm occlusion was evaluated using a 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant. RESULTS: The population for safety was 138/168 patients (82.1%), including 89 females (64.5%), with mean age of 55.5 ± 10.2 yr. The population for efficacy was 121/169 aneurysms (71.6%). Aneurysm locations were middle cerebral artery in 65/121 aneurysms (53.7%), anterior-communicating artery in 25/121 (20.7%), basilar artery in 17/121 (14.0%), and internal carotid artery terminus in 14/121 (11.6%). No clinically relevant adverse events occurred between years 1 and 2. At 2 yr, complete occlusion was observed in 62/121 (51.2%) aneurysms, neck remnant in 36/121 (29.8%) aneurysms, and aneurysm remnant in 23/121 (19.0%) aneurysms. The global retreatment rate at 2 yr was 9.3%. CONCLUSION: This analysis confirms the high safety profile of WEB treatment at 2 yr. Aneurysm occlusion is generally stable at 2 yr, and the retreatment rate between 1 yr and 2 yr is low (2.0%).

SAFE study (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment): 1-year clinical and anatomical results.

BACKGROUND AND PURPOSE: Flow 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. METHODS: Patients 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. RESULTS: Thirteen 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%). CONCLUSIONS: SAFE 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 REGISTRATION: Unique identifier: NCT02921698; Results.

Predictive Factors of Silent Brain Infarcts after Asymptomatic Carotid Endarterectomy.

BACKGROUND: The optimization of medical treatment regularly challenges the role of carotid surgery for asymptomatic patients. Current research seeks to determine which of these patients will benefit most from surgery. The goal of this study was to identify in a multicenter study, using magnetic resonance imaging (MRI), the risk factors for postoperative silent cerebral ischemic lesions after carotid surgery for asymptomatic stenosis. METHODS: The multicenter, retrospective study included patients with asymptomatic severe carotid stenosis suitable for surgical treatment and who did not have a history of cerebral ischemia. A diffusion MRI scan was performed the day before and in the 3 days after the procedure. An analysis by an independent neuroradiologist determined the presence of preoperative silent ischemia and the appearance of new lesions postoperatively. The analysis also took into account the plaque type, lesions of supra-aortic trunks, the circle of Willis, the type of surgery, and anesthesia, shunt use, and clamp time. RESULTS: Between April 2011 and November 2015, 141 patients were included. The mean degree of carotid stenosis in the patients who underwent surgery was 78.2% ± 6.5, with 9 (6.4%) cases of contralateral stenosis ≥70% and 6 (4.3%) of which were thrombosis. The circle of Willis was incomplete in 23 (16.3%) patients. Twenty-one (14.9%) plaques were of high embolic risk. The preoperative MRI found 34 (24.1%) patients with embolic ischemic lesions. The majority of procedures were eversions performed under general anesthesia, 7 (5%) required a shunt, and the mean clamp time was 39 ± 16 min. The postoperative MRI revealed that 10 (7%) patients had a new ischemic lesion on the operated side. None of these lesions were symptomatic. On multivariate analysis, the risk factors for appearance of a new ischemic lesion on the operated side were significant severe stenosis of the vertebral artery ipsilateral to the lesion (odds ratio [OR] = 9.2, 95% confidence interval [CI] [2.1-39.8], P = 0.003) and insertion of a shunt (OR = 9.1, 95% CI [1.1-73.1], P = 0.039). The 30-day follow-up showed one death at D4 due to hemorrhagic stroke on the operated side and one contralateral stroke. None of the study patients had a myocardial infarction. CONCLUSIONS: In this multicenter study, the rate of silent ischemic lesions in asymptomatic carotid surgery showed 43.3% of preoperative silent ischemic lesions and 9.2% of new silent lesions after surgery. The use of a shunt and presence of ipsilateral vertebral stenosis are risk factors for perioperative embolism.

CT angiography for one-year follow-up of intracranial aneurysms treated with the WEB device: Utility in evaluating aneurysm occlusion and WEB compression at one year.

BACKGROUND AND PURPOSE: The WEB is an innovative flow disruption device for cerebral aneurysm embolization with rapidly expanding indications. Our purpose was to evaluate the diagnostic performance of computed tomography angiography (CTA) at 1-year follow-up of aneurysms treated with the WEB. MATERIALS AND METHODS: Between April 2014 and May 2016, the study prospectively included patients treated with the WEB at our institution, and followed up within 24hours by CTA and at 1year by CTA, time-of-flight magnetic resonance angiography (TOF MRA) and digital subtraction angiography (DSA). The diagnostic quality of imaging data was assessed based on the confidence index, artifacts, and WEB shape depiction. The imaging diagnostic performance was assessed using 3 criteria at 1year: aneurysm occlusion status and worsening, and WEB shape compression. Interobserver and intermodality agreement was determined by calculating κ values. RESULTS: The study ultimately included 16 patients (9 women, mean age 53±7.6years). CTA quality confidence was scored as 2/2, artifacts 0.4/2 and WEB shape depiction 1.9/2, superior to TOF MRA for the latter two criteria. Aneurysm occlusion was adequate in 93.7% of patients, with CTA showing excellent interobserver reproducibility and agreement with DSA on a 4-grade scale (κ=1.00), while TOF MRA yielded good reproducibility (κ=0.76) and agreement with DSA (κ=0.69). CTA also identified aneurysm occlusion worsening (43.7%) and WEB compression (81.2%) in excellent agreement with DSA (κ=0.85 and 1.00). CONCLUSIONS: CTA is a reproducible and reliable technique for the follow-up of aneurysms treated with the WEB device.

Feasibility, complications, morbidity, and mortality results at 6 months for aneurysm treatment with the Flow Re-Direction Endoluminal Device: report of SAFE study.

BACKGROUND AND PURPOSE: Flow diverters are increasingly used for the treatment of intracranial aneurysms. Evaluation of the first devices available for clinical use showed high efficacy of this treatment although safety results were worse compared with coiling or balloon-assisted coiling. The Safety and Efficacy Analysis of FRED Embolic Device in Aneurysm Treatment (SAFE) trial is a single-arm, multicenter, prospective study conducted to precisely analyze the safety and efficacy of the FRED and FRED Jr devices. METHODS: Unruptured and recanalized aneurysms located in the anterior circulation treated with FRED and FRED Jr were prospectively included. Adverse events were independently evaluated by a Clinical Event Committee with a vascular neurosurgeon and an interventional neuroradiologist. Primary safety outcome measures were morbidity and mortality rates at 6 months after treatment. RESULTS: A total of 103 patients/aneurysms were included in 13 interventional neuroradiology (INR) centers. Aneurysm locations were supraclinoid internal carotid artery (ICA) in 71 (68.9%), cavernous ICA in 15 (14.6%), anterior cerebral artery or anterior communicating artery in nine (8.7%), and middle cerebral artery in eight (7.8%). Aneurysms were small (<10 mm) in 71 patients (68.9%). Treatment was successfully performed in 98/103 patients (95.1%). Thromboembolic (TE) complications occurred in 5/103 patients (4.9%), intraoperative rupture in 2/103 patients (1.9%), delayed aneurysm rupture in 1/103 patient (1.0%), and delayed hematoma occurred in 1/103 patient (1.0%). Six-months' mortality and morbidity rates were 1/102 (1.0%) and 2/102 (2.0%), respectively. CONCLUSIONS: Aneurysm treatment with the FRED device is safe with low mortality (1.0%) and morbidity (2.0%). CLINICAL TRIAL REGISTRATION: NCT02921698.

Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series.

BACKGROUND: Flow disruption with the WEB is an innovative endovascular approach for treatment of wide-neck bifurcation aneurysms. Initial studies have shown a low complication rate with good efficacy. PURPOSE: To report clinical and anatomical results of the WEB treatment in the cumulative population of three Good Clinical Practice (GCP) studies: WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm), French Observatory, and WEBCAST-2. METHODS: WEBCAST, French Observatory, and WEBCAST-2 are single-arm, prospective, multicenter, GCP studies dedicated to the evaluation of WEB treatment. Clinical data were independently evaluated. Postoperative and 1-year aneurysm occlusion was independently evaluated using the 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant. RESULTS: The cumulative population comprised 168 patients with 169 aneurysms, including 112 female subjects (66.7%). The patients' ages ranged between 27 and 77 years (mean 55.5±10.2 years). Aneurysm locations were middle cerebral artery in 86/169 aneurysms (50.9%), anterior communicating artery in 36/169 (21.3%), basilar artery in 30/169 (17.8%), and internal carotid artery terminus in 17/169 (10.1%). The aneurysm was ruptured in 14/169 (8.3%). There was no mortality at 1 month and procedure/device-related morbidity was 1.2% (2/168). At 1 year, complete aneurysm occlusion was observed in 81/153 aneurysms (52.9%), neck remnant in 40/153 aneurysms (26.1%), and aneurysm remnant in 32/153 aneurysms (20.9%). Re-treatment was carried out in 6.9%. CONCLUSIONS: This series is at the moment the largest prospective, multicenter, GCP series of patients with aneurysms treated with WEB. It shows the high safety and good mid-term efficacy of this treatment. CLINICAL TRIAL REGISTRATION: French Observatory: Unique identifier (NCT18069); WEBCAST and WEBCAST-2: Unique identifier (NCT01778322).

What semantic dementia teaches us about the functional organization of the left posterior fusiform gyrus.

After demonstrating the relative preservation of fruit and vegetable knowledge in patients with semantic dementia (SD), we sought to identify the neural substrate of this unusual category effect. Nineteen patients with SD performed a semantic sorting task and underwent a morphometric 3T MRI scan. The grey-matter volumes of five regions within the temporal lobe were bilaterally computed, as well as those of two recently described areas (FG1 and FG2) within the posterior fusiform gyrus. In contrast to the other semantic categories we tested, fruit and vegetable scores were only predicted by left FG1 volume. We therefore found a specific relationship between the volume of a subregion within the left posterior fusiform gyrus and performance on fruits and vegetables in SD. We argue that the left FG1 is a convergence zone for the features that might be critical to successfully sort fruits and vegetables. We also discuss evidence for a functional specialization of the fusiform gyrus along two axes (lateral medial and longitudinal), depending on the nature of the concepts and on the level of processing complexity required by the ongoing task.

Endovascular treatment of acute ischemic stroke with ERIC device.

BACKGROUND AND PURPOSE: After 6 positive randomized trials, mechanical thrombectomy with stent-retriever is now recommended as a first-line treatment for acute ischemic stroke (AIS). The ERIC device is a device with several interlinked cage-like spheres fixed on a pusher wire. Neurothrombectomy France (NTF) is a registry conducted in France to analyze the results of mechanical thrombectomy. In order to analyze its performances, the subgroup of patients treated with the ERIC device was analyzed. MATERIALS AND METHODS: NTF is a prospective, multicenter registry dedicated to the evaluation of endovascular treatment for AIS. Primary endpoint was modified Rankin Scale (mRS) at 3months. Secondary endpoints were revascularization at the end of the procedure evaluated with the Thrombolysis In Cerebral Infarction (TICI) scale and rate of procedural complications. Patients treated with the ERIC device were extracted from the NTF registry and analyzed. RESULTS: From April 2013 to May 2014, 230 patients were included in the NTF registry. Thirty-one patients (13.5%) were treated with ERIC (male: 64.5%; median age: 61years). Median baseline NIHSS was 16. Median ASPECTS was 6. Occlusion location was internal carotid artery (51.6%), middle cerebral artery-M1 (45.2%), and basilar artery (3.2%). Cervical occlusion was associated in 16.1%. Revascularization (TICI 2b-3) was obtained in 87.1%. Good clinical outcome (mRS 0-2) at 3months was obtained in 55.2%. Death rate was 6.9% related to the stroke. CONCLUSION: This prospective, multicenter series shows good performances of the ERIC device in the treatment of acute ischemic stroke with revascularization in 87.1% and favorable clinical outcome in 55.2%.