Summary 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.
Objectives
3D-fluid attenuation inversion recovery (FLAIR) collected 4 h after intravenous gadolinium injection can delineate the perilymphatic space (PLS) from the endolymphatic space (ELS) to ...capture endolymphatic hydrops, the pathological counterpart of Ménière’s disease. We aimed to optimize visualization of such inner ear internal anatomy using 3D-FLAIR without injection.
Methods
3D-FLAIR signal from different fluid compartments such as PLS and ELS was first simulated. Then, twenty-two healthy subjects were scanned at 3.0-T MRI with non-injected 3D-FLAIR using variable T2 preparations (T2Preps) (OFF, 200, 400, and 600 ms) and variable inversion times (TIs) (from 224 to 5000 ms) and different resolutions (1.0 × 1.0 × 1.5, 0.6 × 0.6 × 0.8, and 0.6 × 0.6 × 0.6 mm
3
). The relative contrast between PLS and ELS and the visibility of the saccule and utricle were assessed. Additionally, non-injected 3D-FLAIR with the optimal setting was tested in a Ménière patient and compared with gadolinium-injected 3D-FLAIR.
Results
The PLS and ELS were differentiated when T2Prep was used but not without. The relative contrast was larger with T2Prep at 400 ms than at 200 or 600 ms (0.72 ± 0.22
vs.
0.44 ± 0.11,
p
= 0.019; and 0.72 ± 0.22
vs.
0.46 ± 0.28,
p
= 0.034, respectively). The saccule and utricle were best delineated in 87. % cases with T2Prep = 400 and TI = 2100 ms at the highest resolution. Visualization of the saccule and utricle in the optimized non-injected 3D-FLAIR was similar to conventional injected 3D-FLAIR in a patient.
Conclusions
Combining a specific T2Prep and TI in non-injected 3D-FLAIR could separate PLS and ELS and even the saccule and utricle, paving the way toward future application to diagnose Ménière’s disease.
Key Points
•
MRI can capture the internal anatomy of inner ear without injection of contrast media.
•
Specific parameters consisting of a T2 preparation of 400 ms and an inversion time of 2100 ms must be used to visualize the saccule and utricle on non-injected 3D-FLAIR.
Introduction
Hybrid hydrogel-platinum coils (HydroCoil) have proven effective for endovascular aneurysm treatment. To overcome technical limitations (coil stiffness, time restriction for placement), ...a second generation of softer hydrogel coils has been brought to clinical practice (HydroSoft, HydroFrame). We report on procedural safety and core-lab-assessed angiographic results from an open-label multicenter randomized controlled trial.
Methods
Web-based randomization occurred in 15 medical centers in France and seven in Germany between coil embolization with second-generation hydrogel coils and treatment with any bare platinum coil. Assist devices could be used as clinically required. Primary endpoint is a composite outcome including major aneurysm recurrence and poor clinical outcome at 18 months follow-up.
Results
Five hundred thirteen patients were randomized (hydrogel
n
= 256, bare platinum
n
= 257). Twenty patients were excluded for missing informed consent and nine patients for treatment related criteria. Four hundred eighty-four patients were analyzed as randomized (hydrogel
n
= 243, bare platinum
n
= 241). Two hundred eight had ruptured aneurysms (43 %). Prespecified procedural complications occurred in 58 subjects (hydrogel
n
= 28, bare platinum
n
= 30,
p
= 0.77). The 14-day mortality rate was 2.1 % in both arms of the study. The median calculated packing densities for aneurysms assigned to hydrogel and bare platinum were 39 and 31 % respectively (
p
< 0.001). No statistically significant differences were found between arms in the post procedural angiographic occlusion rate (
p
= 0.8).
Conclusion
Second-generation hydrogel coils can be used in a wide spectrum of aneurysms with a risk profile equivalent to bare platinum. Packing density was significantly higher in aneurysms treated with hydrogel coils.
Trial registration
http://www.germanctr.de
, DRKS00003132
Background
The occurrence of persistent intra-device filling (BOSS 1, using the Bicêtre Occlusion Scale Score (BOSS)) in aneurysms treated with a Woven Endobridge (WEB) device is infrequent based on ...angiographic follow-up. To date, three monocentric case series were published studying BOSS 1 cases. Through a multicenter retrospective study, we aimed to report the incidence, and risk factors of intra-WEB persistent filling.
Methods
We reached out to European academic centers that treat patients using WEB devices and requested de-identified data of patients treated with a WEB device and underwent angiographic follow-up, at least 3 months after embolization, to assess the BOSS 1 occlusion score. We compared baseline characteristics, treatment modalities, and aneurysm data of the included BOSS 1 patients with those of a control group consisting of non-BOSS 1 patients (n = 116) who had an available angiographic follow-up. Univariable and multivariable models were employed for analysis.
Results
Among the pooled sample of 591 aneurysms treated with WEB, the rate of persistent flow (BOSS 1) at angiographic follow-up was 5.2% (n = 31 out of 591), performed after an average of 8.7 ± 6.3 months. In the multivariable-adjusted analysis, dual antiplatelet therapy in the postoperative period (adjusted odds ratio aOR 4.3 95% CI 1.3–14.2), and WEB undersizing (aOR 10.8 95% CI 2.9–40) were independently associated with a BOSS 1 persistent flow result.
Conclusion
Persistent blood flow within the WEB device during angiographic follow-up (BOSS 1) is an uncommon occurrence. Our findings indicate that post-procedural dual antiplatelet therapy and undersizing of the WEB device are independently associated with the presence of BOSS 1 at follow-up.
Background Vertebral artery compression by cervical osteophyte is a rare cause of vertebrobasilar ischemic stroke. This mechanism of stroke has been reported as the Bow Hunter syndrome defined by ...vertebrobasilar insufficiency because of mechanical stenosis of the vertebral artery at the cervical level triggered by head movement. The most common treatment is surgical decompression. However, in most cases, a dominant vertebral artery is involved, and its dynamic extrinsic compression is demonstrated on angiography. Case report We report a patient with recurrent posterior circulation infarctions because of the compression of a nondominant vertebral artery by a cervical osteophyte. The dynamic angiography did not show any worsening of the vertebral stenosis by head movements but an irregularity of the vertebral artery with regard to the osteophyte compression, suggesting a direct artery wall injury. We concluded to an embolic mechanism through thrombus formation from the artery wall injury at the stenosed site. Because neither surgical decompression nor stenting was deemed to be a relevant treatment option, endovascular coil embolization of the compressed vertebral artery was performed after a clamping test to check the efficiency of the collateral circulation. The procedure was a success. During the 12-month follow-up, the patient did not have any recurrent stroke. Conclusions In case of recurrent symptomatic extrinsic compression of a nondominant vertebral artery, endovascular embolization after a clamping test may be considered.
Whether thrombectomy alone is equally as effective as intravenous alteplase plus thrombectomy remains controversial. We aimed to determine whether thrombectomy alone would be non-inferior to ...intravenous alteplase plus thrombectomy in patients presenting with acute ischaemic stroke.
In this multicentre, randomised, open-label, blinded-outcome trial in Europe and Canada, we recruited patients with stroke due to large vessel occlusion confirmed with CT or magnetic resonance angiography admitted to endovascular centres. Patients were randomly assigned (1:1) via a centralised web server using a deterministic minimisation method to receive stent-retriever thrombectomy alone or intravenous alteplase plus stent-retriever thrombectomy. In both groups, thrombectomy was initiated as fast as possible with any commercially available Solitaire stent-retriever revascularisation device (Medtronic, Irvine, CA, USA). In the combined treatment group, intravenous alteplase (0·9 mg/kg bodyweight, maximum dose 90 mg per patient) was administered as early as possible after randomisation for 60 min with 10% of the calculated dose given as an initial bolus. Personnel assessing the primary outcome were masked to group allocation; patients and treating physicians were not. The primary binary outcome was a score of 2 or less on the modified Rankin scale at 90 days. We assessed the non-inferiority of thrombectomy alone versus intravenous alteplase plus thrombectomy in all randomly assigned and consenting patients using the one-sided lower 95% confidence limit of the Mantel-Haenszel risk difference, with a prespecified non-inferiority margin of 12%. The main safety endpoint was symptomatic intracranial haemorrhage assessed in all randomly assigned and consenting participants. This trial is registered with ClinicalTrials.gov, NCT03192332, and is closed to new participants.
Between Nov 29, 2017, and May 7, 2021, 5215 patients were screened and 423 were randomly assigned, of whom 408 (201 thrombectomy alone, 207 intravenous alteplase plus thrombectomy) were included in the primary efficacy analysis. A modified Rankin scale score of 0-2 at 90 days was reached by 114 (57%) of 201 patients assigned to thrombectomy alone and 135 (65%) of 207 patients assigned to intravenous alteplase plus thrombectomy (adjusted risk difference -7·3%, 95% CI -16·6 to 2·1, lower limit of one-sided 95% CI -15·1%, crossing the non-inferiority margin of -12%). Symptomatic intracranial haemorrhage occurred in five (2%) of 201 patients undergoing thrombectomy alone and seven (3%) of 202 patients receiving intravenous alteplase plus thrombectomy (risk difference -1·0%, 95% CI -4·8 to 2·7). Successful reperfusion was less common in patients assigned to thrombectomy alone (182 91% of 201 vs 199 96% of 207, risk difference -5·1%, 95% CI -10·2 to 0·0, p=0·047).
Thrombectomy alone was not shown to be non-inferior to intravenous alteplase plus thrombectomy and resulted in decreased reperfusion rates. These results do not support omitting intravenous alteplase before thrombectomy in eligible patients.
Medtronic and University Hospital Bern.
Flow disruption with the WEB device is a new technique for the endovascular treatment of wide-neck bifurcation aneurysms. To obtain precise data regarding the safety and efficacy of this treatment ...with high-quality methodology, the prospective French Observatory study was conducted. Analysis of these data is presented, including 1-year follow-up.
Patients with bifurcation aneurysms for which WEB treatment was indicated were included in this prospective, multicenter Good Clinical Practice study. Clinical data, including adverse events and clinical status at 1 month and 1 year, were collected and independently analyzed by a medical monitor. An independent core laboratory evaluated the anatomic results at 1 year following the procedure.
Ten French neurointerventional centers included 62 patients (39 women), 33-74 years of age (mean, 56.6 ± 9.80 years) with 63 aneurysms. Aneurysm locations were the middle cerebral artery in 32 aneurysms (50.8%), anterior communicating artery in 16 (25.4%), basilar artery in 9 (14.3%), and internal carotid artery terminus in 6 (9.5%). Morbidity and mortality at 1 month were, respectively, 3.2% (2/62 patients) and 0.0% (0/62). Morbidity and mortality (unrelated to the treatment) at 1 year were, respectively, 0.0% (0/59) and 3.4% (2/59 patients). At 1 year, complete occlusion was observed in 30/58 aneurysms (51.7%); neck remnant, in 16/58 aneurysms (27.6%); and aneurysm remnant, in 12/58 aneurysms (20.7%).
This prospective French Observatory study showed very good safety of aneurysm treatment with the WEB, with a high rate of adequate aneurysm occlusion at 1 year (79.3%).
The efficiency of prehospital care chain response and the adequacy of hospital resources are challenged amid the coronavirus disease 2019 (COVID-19) outbreak, with suspected consequences for patients ...with ischemic stroke eligible for mechanical thrombectomy (MT).
We conducted a prospective national-level data collection of patients treated with MT, ranging 45 days across epidemic containment measures instatement, and of patients treated during the same calendar period in 2019. The primary end point was the variation of patients receiving MT during the epidemic period. Secondary end points included care delays between onset, imaging, and groin puncture. To analyze the primary end point, we used a Poisson regression model. We then analyzed the correlation between the number of MTs and the number of COVID-19 cases hospitalizations, using the Pearson correlation coefficient (compared with the null value).
A total of 1513 patients were included at 32 centers, in all French administrative regions. There was a 21% significant decrease (0.79; 95%CI, 0.76-0.82;
<0.001) in MT case volumes during the epidemic period, and a significant increase in delays between imaging and groin puncture, overall (mean 144.9±SD 86.8 minutes versus 126.2±70.9;
<0.001 in 2019) and in transferred patients (mean 182.6±SD 82.0 minutes versus 153.25±67;
<0.001). After the instatement of strict epidemic mitigation measures, there was a significant negative correlation between the number of hospitalizations for COVID and the number of MT cases (
-0.51;
=0.04). Patients treated during the COVID outbreak were less likely to receive intravenous thrombolysis and to have unwitnessed strokes (both
<0.05).
Our study showed a significant decrease in patients treated with MTs during the first stages of the COVID epidemic in France and alarming indicators of lengthened care delays. These findings prompt immediate consideration of local and regional stroke networks preparedness in the varying contexts of COVID-19 pandemic evolution.
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