Alessandra Biondi

Medical management with or without interventional therapy for unruptured brain arteriovenous malformations (ARUBA): a multicentre, non-blinded, randomised trial.

BACKGROUND The clinical benefit of preventive eradication of unruptured brain arteriovenous malformations remains uncertain. A Randomised trial of Unruptured Brain Arteriovenous malformations (ARUBA) aims to compare the risk of death and symptomatic stroke in patients with an unruptured brain arteriovenous malformation who are allocated to either medical management alone or medical management with interventional therapy. METHODS Adult patients (≥18 years) with an unruptured brain arteriovenous malformation were enrolled into this trial at 39 clinical sites in nine countries. Patients were randomised (by web-based system, in a 1:1 ratio, with random permuted block design [block size 2, 4, or 6], stratified by clinical site) to medical management with interventional therapy (ie, neurosurgery, embolisation, or stereotactic radiotherapy, alone or in combination) or medical management alone (ie, pharmacological therapy for neurological symptoms as needed). Patients, clinicians, and investigators are aware of treatment assignment. The primary outcome is time to the composite endpoint of death or symptomatic stroke; the primary analysis is by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00389181. FINDINGS Randomisation was started on April 4, 2007, and was stopped on April 15, 2013, when a data and safety monitoring board appointed by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health recommended halting randomisation because of superiority of the medical management group (log-rank Z statistic of 4·10, exceeding the prespecified stopping boundary value of 2·87). At this point, outcome data were available for 223 patients (mean follow-up 33·3 months [SD 19·7]), 114 assigned to interventional therapy and 109 to medical management. The primary endpoint had been reached by 11 (10·1%) patients in the medical management group compared with 35 (30·7%) in the interventional therapy group. The risk of death or stroke was significantly lower in the medical management group than in the interventional therapy group (hazard ratio 0·27, 95% CI 0·14-0·54). No harms were identified, other than a higher number of strokes (45 vs 12, p<0·0001) and neurological deficits unrelated to stroke (14 vs 1, p=0·0008) in patients allocated to interventional therapy compared with medical management. INTERPRETATION The ARUBA trial showed that medical management alone is superior to medical management with interventional therapy for the prevention of death or stroke in patients with unruptured brain arteriovenous malformations followed up for 33 months. The trial is continuing its observational phase to establish whether the disparities will persist over an additional 5 years of follow-up. FUNDING National Institutes of Health, National Institute of Neurological Disorders and Stroke.

Surpass Flow Diverter in the Treatment of Intracranial Aneurysms: A Prospective Multicenter Study

BACKGROUND AND PURPOSE: Incomplete occlusion and recanalization of large and wide-neck brain aneurysms treated by endovascular therapy remains a challenge. We present preliminary clinical and angiographic results of an experimentally optimized Surpass flow diverter for treatment of intracranial aneurysms in a prospective, multicenter, nonrandomized, single-arm study. MATERIALS AND METHODS: At 24 centers, 165 patients with 190 intracranial aneurysms of the anterior and posterior circulations were enrolled. The primary efficacy end point was the percentage of intracranial aneurysms with 100% occlusion on 6-month DSA. The primary safety end point was neurologic death and any stroke through a minimum follow-up of 6 months. RESULTS: Successful flow-diverter delivery was achieved in 161 patients with 186 aneurysms (98%); the mean number of devices used per aneurysm was 1.05. Clinical follow-up (median, 6 months) of 150 patients (93.2%), showed that the primary safety end point occurred in 18 subjects. Permanent neurologic morbidity and mortality were 6% and 2.7%, respectively. Morbidity occurred in 4% and 7.4% of patients treated for aneurysms of the anterior and posterior circulation, respectively. Neurologic death during follow-up was observed in 1.6% and 7.4% of patients with treated intracranial aneurysms of the anterior and posterior circulation, respectively. Ischemic stroke at ≤30 days, SAH at ≤7 days, and intraparenchymal hemorrhage at ≤7 days were encountered in 3.7%, 2.5%, and 2.5% of subjects, respectively. No disabling ischemic strokes at >30 days or SAH at >7 days occurred. New or worsening cranial nerve deficit was observed in 2.7%. Follow-up angiography available in 158 (86.8%) intracranial aneurysms showed 100% occlusion in 75%. CONCLUSIONS: Clinical outcomes of the Surpass flow diverter in the treatment of intracranial aneurysms show a safety profile that is comparable with that of stent-assisted coil embolization. Angiographic results showed a high rate of intracranial aneurysm occlusion.

S100B as an additional prognostic marker in subarachnoid aneurysmal hemorrhage.

Objectives:Studies of new neuroprotective approaches in patients with subarachnoid aneurysmal hemorrhage and better family information would benefit from the development of laboratory markers of brain ischemia. The goal of this study was to evaluate mean 15-day S100B for predicting outcomes after subarachnoid aneurysmal hemorrhage. Design:Single center prospective cohort with consecutive inclusions. Setting:Anesthesiology and Critical Care Neurosurgical Unit of a university hospital. Patients:One hundred nine patients admitted within 48 hrs after subarachnoid aneurysmal hemorrhage onset and treated by surgical clipping or coiling within 48 hrs following admission. Interventions:We recorded initial World Federation of Neurologic Surgeons and Fisher grades; comorbidities; initial severity; aneurysm location; presence of acute hydrocephalus; presence of intraventricular hemorrhage; initial seizures and neurogenic lung edema; initial troponin values; treatment of aneurysm; and occurrence of vasospasm. Measurements and Main Results:S100B was assayed daily over the first 15 days. Glasgow Outcome Scores were recorded at intensive care unit discharge and after 6 and 12 months. The main outcome criterion was the 12-month Glasgow Outcome Scale score dichotomized as poor (Glasgow Outcome Scale 1–3) or good (Glasgow Outcome Scale 4–5). Seventy percent of patients had good 12-month outcome. Poor outcome was associated with higher initial World Federation of Neurologic Surgeons and Fisher scores, neurogenic lung edema, high mean 15-day S100B but not initial, troponin initial value, intraventricular hemorrhage, angiographically documented vasospasm, all in an univariate manner. After multivariate analysis, only mean 15-day S100B value significantly predicted outcome (p < 0.0005). The best cutoff for the mean 15-day S100B value was 0.23 &mgr;g/L (specificity 0.90, 95% confidence interval [CI] 0.81–0.95; sensitivity 0.91, 95% CI 0.75–0.98; area under the curve 0.98, 95% CI 0.87−0.99). Conclusion:S100B elevation over the first 15 days after subarachnoid aneurysmal hemorrhage is associated with poor outcome after subarachnoid aneurysmal hemorrhage. This result supports the use of S100B as a surrogate marker for brain ischemia in patients with subarachnoid aneurysmal hemorrhage.

Endovascular techniques for the management of wide-neck intracranial bifurcation aneurysms: A critical review of the literature.

Endovascular treatment is the first line treatment for intracranial aneurysms, but wide-neck aneurysms are often difficult to treat due to the difficulty in stabilizing the coils inside the aneurysm. It is singularly true for wide-neck bifurcation aneurysms (WNBA) as bifurcation branches often arise from the aneurysm neck. To overcome these difficulties, several approaches are available to treat both ruptured and unruptured aneurysms (balloon-assisted coiling and intra-aneurysmal flow disruption), while some techniques are essentially restricted to unruptured aneurysms due to the need of concomitant use of antiplatelet medications (stent-assisted coiling and flow diversion). Several ways of performing balloon-assisted coiling have been proposed for WNBA. Two stent-assisted techniques are available for WNBA (Y-stenting and the waffle-cone technique), but these techniques have yet to be evaluated in large, prospective series. Off-label use of flow diverters in WNBA has been proposed but efficacy has still to be established, and the technique presents unique potential safety issues (the potential modifications of bifurcation branches covered by the flow diverter) that has to be assessed. Intrasaccular flow disruption devices are promising tools for the endovascular treatment of WNBA. The WEB device has been extensively evaluated with prospective, multicenter studies showing high safety and good efficacy.

Glossopharyngeal neuralgia associated with a vascular loop demonstrated by magnetic resonance imaging.

Summary We report two cases of glossopharyngeal neuralgia associated with a vascular loop of the postero-inferior cerebellar artery, diagnosed by magnetic resonance imaging. Reviewing the literature, we found this to be the first report of a magnetic resonance-validated vascular abnormality related to such a condition. One patient was cured by surgical decompression, confirming the role of the abnormal vessel in the pain. As with trigeminal neuralgia, a possible vascular aetiology should be considered in glossopharyngeal neuralgia.

Spontaneous closure of intracranial dural arteriovenous fistulas: A report of 3 cases

Spontaneous closures of dural arteriovenous fistulas (dAVFs) are rare. We present spontaneous occlusion of dAVFs in 3 cases (one type IIa dAVF, one type IIb and one type III). Patients were 3 males with a mean age of 55 years (range 45-61). For two patients, the dAVF was revealed by hemorrhage. No head trauma was recorded at the interrogatory. Mean delay for spontaneous closure was 4 months (3-5 months). Review of the literature about this rare occurrence is presented and the factors that may lead to spontaneous occlusion of dAVFs are discussed.

Distant and delayed (>7 days) hemorrhage after treatment by flow-diverter stents in intracranial aneurysms: a rare but potentially serious complication.

In a recent meta-analysis, intraparenchymal hemorrhage secondary to treatment by a flow-diverter stent (FDS) was reported in 3% of the cases.[1][1] Most of these hemorrhages were periprocedural complications. More surprising cases of delayed ipsilateral hemorrhage have been reported lately in

PulseRider for Treatment of Wide-Neck Bifurcation Intracranial Aneurysms: 6-Month Results

BACKGROUND/OBJECTIVE PulseRider is a new endovascular stent dedicated to treat bifurcation intracranial aneurysms with a wide neck. Our purpose was to evaluate 6-month clinical and anatomic results of the device when used to facilitate endovascular coiling of wide-neck bifurcation aneurysms. METHODS Unruptured intracranial aneurysms coiled with PulseRider, in 6 European centers and 1 U.S. center, were retrospectively reviewed from June 2014 to October 2015. Immediate and 6-month results were evaluated independently by using the Raymond classification scale. Recanalization was defined as worsening, and progressive thrombosis was defined as improvement on the Raymond scale. RESULTS Nineteen patients (10 women, 9 men; mean age, 63 years) harboring 19 bifurcation aneurysms (mean dome size, 8.8 mm; mean neck size, 5.8 mm) were included. Immediate angiographic outcome showed 11 complete aneurysm occlusions, 6 neck remnants, and 2 residual aneurysms. Follow-up at 6 months, obtained in all patients, included 12 complete aneurysm occlusions (63.1%), 6 neck remnants (31.6%), and 1 residual aneurysm (5.3%). Adequate occlusion (defined as complete occlusion and neck remnant combined) was observed in 94.7%. Progressive thrombosis was observed in 2 cases (10.6%) and recanalization in 1 case (5.3%). There was no in-stent stenosis or jailed branch occlusion. No bleeding was observed during the follow-up period. Permanent morbidity rate was 5.3% (1/19), and the mortality rate was 0% at 6 months. CONCLUSIONS The PulseRider allows endovascular treatment of wide-neck bifurcation intracranial aneurysms. Larger series are needed to confirm our preliminary results.

O-036 Treatment of Intracranial Aneurysms with the LUNA AES: Midterm Clinical and Angiographic Follow-Up

Purpose The LUNA is a self-expanding ovoid device that serves as an intra saccular flow diverter as well as a scaffold for endothelization across the neck. The objective of this prospective clinical study (9 European centers) aiming to include a total of 63 patients was to evaluate the ability of the AES to occlude intracranial aneurysms while maintaining patency of the parent artery. Methods Immediate post-implantation occlusion grade, near-complete, or incomplete, and parent vessel compromise were evaluated. Patients underwent neurological testing with the NIHSS at baseline and time of discharge. Follow-up included clinical assessment at one, 3, 6, 9 and 12 months, and angiographic follow-up at 6 and 12 months. Results In 5 cases, the LUNA AES placement was carried out with balloon microcatheter assistance. In 2 cases, the LUNA AES placement was carried out with a stent (Table 1). Clinical and angiographic immediate results and at follow up are summarised in Table 2. Adverse events are summarised in Table 3. Conclusion Preliminary results demonstrate good safety profile. Angiographic follow up are promising. The clinical and angiographic follow-up will be extended to 36 months. Abstract O-036 Table 1 Abstract O-036 Table 2 Abstract O-036 Table 3 Disclosures M. Piotin: 2; C; Covidien, Stryker, Balt, MicroVention, Reverse Medical, Neuravi, Penumbra. A. Biondi: None. N. Sourour: 2; C; Covidien, Penumbra. R. Blanc: 2; C; Covidien, Stryker, Balt, MicroVention, Reverse Medical, Neuravi, Penumbra.

Is a high initial World Federation of Neurosurgery (WFNS) grade really associated with a poor clinical outcome in elderly patients with ruptured intracranial aneurysms treated with coiling

Background Coiling of ruptured intracranial aneurysms in elderly patients remains debatable in terms of technical feasibility and clinical outcome. Aims In this observational cohort study we aimed to assess the technical feasibility, complication profile and clinical outcomes of elderly patients with subarachnoid hemorrhage (SAH) treated with endovascular therapy. Methods The study included 59 consecutive patients (47 women) aged ≥70 years (mean age 76 years, range 71–84) admitted to our institution with SAH from January 2002 to July 2011. The patients were treated for 66 aneurysms (regular coiling: n=62 (94%), balloon-assisted technique: n=2 (3%), stent and coil technique: n=2 (3%)). World Federation of Neurosurgery (WFNS) grade at admission was 1 in 13 patients, 2 in 23 patients, 3 in 8 patients, 4 in 11 patients and 5 in 4 patients. We analysed data by univariate and multivariate statistical analyses with an emphasis on the initial clinical situation, complications and clinical outcome. Results The technical success rate was 98% with a procedure-related deficit rate of 10% and procedure-related death rate of 5%. The Glasgow Outcome Scale score at 6 months was 1 in 15 patients (25.4%), 2 in 8 patients (13.6%), 3 in 14 patients (23.7%), 4 in 11 patients (18.6%) and 5 in 11 patients (18.6%). Patients admitted with a high initial WFNS grade did not differ statistically in terms of clinical outcome. The final clinical outcome was not significantly correlated with age, initial Fisher score or procedure-related complications. Conclusions Endovascular treatment of elderly patients with ruptured cerebral aneurysms is feasible, safe and beneficial regardless of the presenting WFNS score.