The FRESH Study: Treatment of Intracranial Aneurysms with the New FRED X Flow Diverter with Antithrombotic Surface Treatment Technology-First Multicenter Experience in 161 Patients.

BACKGROUND AND PURPOSE: Flow diverters with antithrombotic coatings are increasingly used to improve the safety of flow diverter treatments of intracranial aneurysms. This study aimed to investigate the safety and short-term efficacy of the new FRED X flow diverter. MATERIALS AND METHODS: Medical charts and procedural and imaging data of a consecutive series of patients with intracranial aneurysms who were treated with the FRED X at 9 international neurovascular centers were retrospectively analyzed. RESULTS: One hundred sixty-one patients (77.6% women; mean age, 55 years) with 184 aneurysms (11.2% acutely ruptured) were included in this study. Most aneurysms were located in the anterior circulation (77.0%), most frequently at the ICA (72.7%). The FRED X was successfully implanted in all procedures. Additional coiling was performed in 29.8%. In-stent balloon angioplasty was necessary in 2.5%. The rate of major adverse events was 3.1%. Thrombotic events occurred in 7 patients (4.3%) with 4 intra- and 4 postprocedural in-stent thromboses, respectively (1 patient had both peri- and postprocedural thrombosis). Of these thrombotic events, only 2 (1.2%) led to major adverse events (ischemic strokes). Postinterventional neurologic morbidity and mortality were observed in 1.9% and 1.2%, respectively. The rate of complete aneurysm occlusion after a mean follow-up of 7.0 months was 66.0%. CONCLUSIONS: The new FRED X is a safe and feasible device for aneurysm treatment. In this retrospective multicenter study, the rate of thrombotic complications was low, and the short-term occlusion rates are satisfactory.

Learning Curve for Flow Diversion of Posterior Circulation Aneurysms: A Long-Term International Multicenter Cohort Study.

BACKGROUND AND PURPOSE: Flow diversion has gradually become a standard treatment for intracranial aneurysms of the anterior circulation. Recently, the off-label use of the flow diverters to treat posterior circulation aneurysms has also increased despite initial concerns of rupture and the suboptimal results. This study aimed to explore the change in complication rates and treatment outcomes across time for posterior circulation aneurysms treated using flow diversion and to further evaluate the mechanisms and variables that could potentially explain the change and outcomes. MATERIALS AND METHODS: A retrospective review using a standardized data set at multiple international academic institutions was performed to identify patients with ruptured and unruptured posterior circulation aneurysms treated with flow diversion during a decade spanning January 2011 to January 2020. This period was then categorized into 4 intervals. RESULTS: A total of 378 procedures were performed during the study period. Across time, there was an increasing tendency to treat more vertebral artery and fewer large vertebrobasilar aneurysms (P = .05). Moreover, interventionalists have been increasingly using fewer overlapping flow diverters per aneurysm (P = .07). There was a trend toward a decrease in the rate of thromboembolic complications from 15.8% in 2011-13 to 8.9% in 2018-19 (P = .34). CONCLUSIONS: This multicenter experience revealed a trend toward treating fewer basilar aneurysms, smaller aneurysms, and increased usage of a single flow diverter, leading to a decrease in the rate of thromboembolic and hemorrhagic complications.

Treatment of Ruptured Blister-Like Aneurysms with the FRED Flow Diverter: A Multicenter Experience.

BACKGROUND AND PURPOSE: Treatment of ruptured blister-like aneurysms is technically challenging. This study aimed at analyzing the safety and efficacy of the Flow-Redirection Endoluminal Device (FRED) in the treatment of ruptured blister-like aneurysms. MATERIALS AND METHODS: In a retrospective multicenter study, all patients treated with the FRED due to a ruptured intracranial blister-like aneurysm between January 2013 and May 2019 were analyzed. The primary end points for clinical safety were mRS 0-2 at 6 months after treatment and the absence of major ipsilateral stroke or death. The primary end points for efficacy were the absence of rebleeding after treatment and complete angiographic occlusion according to the O'Kelly-Marotta classification at 6 months after treatment. RESULTS: In total, 30 patients with 30 ruptured blister-like aneurysms were treated. Immediate complete aneurysm obliteration (O'Kelly-Marotta classification D) with the FRED was achieved in 10 patients (33%). Of the 26 patients with follow-up, complete obliteration was achieved in 21 patients (80%) after 6 months and in 24 patients (92%) in the final follow-up (median, 22 months). Twenty-three patients (77%) achieved mRS 0-2 at 6 months. Major stroke or death occurred in 17%. Two patients died due to pneumonia, and 2 patients died due to infarction following cerebral vasospasm. There was no case of rebleeding after FRED implantation. There was 1 case of delayed asymptomatic stent occlusion. CONCLUSIONS: Treatment of ruptured blister-like aneurysms with the FRED is safe and effective.

The FRED for Cerebral Aneurysms of the Posterior Circulation: A Subgroup Analysis of the EuFRED Registry.

BACKGROUND AND PURPOSE: Flow diversion for the posterior circulation remains a promising treatment option for selected posterior circulation aneurysms. The Flow-Redirection Intraluminal Device (FRED) system has not been previously assessed in a large cohort of patients with posterior circulation aneurysms. The purpose of the present study was to assess safety and efficacy of FRED in this location. MATERIALS AND METHODS: Consecutive patients with posterior circulation aneurysms treated at 8 centers participating in the European FRED study (EuFRED) between April 2012 and January 2019 were retrospectively reviewed. Complication and radiographic and functional outcomes were evaluated. RESULTS: Eighty-four patients (median age, 54 years) with 84 posterior circulation aneurysms were treated with the FRED. A total of 25 aneurysms (29.8%) had previously ruptured, even though most aneurysms were diagnosed incidentally (45.2%). The intradural vertebral artery was the most common location (50%), and saccular, the most common morphology (40.5%). The median size was 7 mm. There were 8 (9.5%) symptomatic thromboembolic and no hemorrhagic complications. Thromboembolic complications occurred mostly (90.9%) in nonsaccular aneurysms. On last follow-up at a median of 24 months, 78.2% of aneurysms were completely occluded. Functional outcome at a median of 27 months was favorable in 94% of patients. All mortalities occurred in patients with acute subarachnoid hemorrhage and its sequelae. CONCLUSIONS: The largest cohort of posterior circulation aneurysms treated with the FRED to date demonstrated favorable safety and efficacy profiles of the device for this indication. Treatment in the setting of acute subarachnoid hemorrhage was strongly related to mortality, regardless of whether procedural complications occurred.

European Multicenter Study for the Evaluation of a Dual-Layer Flow-Diverting Stent for Treatment of Wide-Neck Intracranial Aneurysms: The European Flow-Redirection Intraluminal Device Study.

BACKGROUND AND PURPOSE: Endoluminal reconstruction with flow-diverting stents represents a widely accepted technique for the treatment of complex intracranial aneurysms. This European registry study analyzed the initial experience of 15 neurovascular centers with the Flow-Redirection Intraluminal Device (FRED) system. MATERIALS AND METHODS: Consecutive patients with intracranial aneurysms treated with the FRED between February 2012 and March 2015 were retrospectively reviewed. Complications and adverse events, transient and permanent morbidity, mortality, and occlusion rates were evaluated. RESULTS: During the defined study period, 579 aneurysms in 531 patients (median age, 54 years; range, 13-86 years) were treated with the FRED. Seven percent of patients were treated in the acute phase (≤3 days) of aneurysm rupture. The median aneurysm size was 7.6 mm (range, 1-36.6 mm), and the median neck size 4.5 mm (range, 1-30 mm). Angiographic follow-up of >3 months was available for 516 (89.1%) aneurysms. There was progressive occlusion witnessed with time, with complete occlusion in 18 (20%) aneurysms followed for up to 90 ± 14 days, 141 (82.5%) for 180 ± 20 days, 116 (91.3%) for 1 year ± 24 days, and 122 (95.3%) aneurysms followed for >1 year. Transient and permanent morbidity occurred in 3.2% and 0.8% of procedures, respectively. The overall mortality rate was 1.5%. CONCLUSIONS: This retrospective study in real-world patients demonstrated the safety and efficacy of the FRED for the treatment of intracranial aneurysms. In most cases, treatment with a single FRED resulted in complete angiographic occlusion at 1 year.

Late age onset of amyotrophic lateral sclerosis is often not considered in elderly people.

INTRODUCTION: Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease causing an upper and lower motor neuron loss. It is neurology textbook knowledge that the mean age of onset is about 60 years. However, recent investigations show an increasing incidence in older persons. We therefore evaluated whether ALS is potentially not considered in elderly people with ALS symptoms, respectively, not recognized. MATERIALS AND METHODS: We included retrospectively all patients with ALS diagnoses after work-up that were admitted to our neurological and geriatric departments from 2007 to 2010 and collected their clinical data. The diagnosis of ALS was based on the El Escorial criteria. Patients were grouped into three categories according to age (<50, between 50 and 70, >70), and differences in clinical and/ or biographical factors were investigated. RESULTS: We identified 35 patients (18 men and 17 women) with a median age at onset of 71.5 years (range: 36-87 years). When establishing the diagnosis, 51% were older than 70 years, 40% (14/35) between 50 and 70, and only 9% younger than 50. Only in 46 per cent of patients who were sent to our departments with ALS symptoms ALS was considered by the referring physician. CONCLUSION: Late age onset of ALS seems to be more common than formerly assumed and is presumably under-recognized in elderly patients. ALS needs to be considered as a differential diagnosis in older patients. Potential factors accounting for older people being underdiagnosed with ALS relate to frequent presentation with symptoms like dysphagia, frailty or general weakness for other reasons.

Multicenter Experience with FRED Jr Flow Re-Direction Endoluminal Device for Intracranial Aneurysms in Small Arteries.

BACKGROUND AND PURPOSE: Flow diverters are emerging as an endovascular treatment alternative for proximally located intracranial aneurysms. However, treatment of aneurysms at and beyond the circle of Willis is not well-established. We assessed the clinical safety and efficacy of the Flow Re-Direction Endoluminal Device Jr (FRED Jr) dedicated to small-vessel diameters between 2.0 and 3.0 mm. MATERIALS AND METHODS: This was a multicenter observational clinical study of 42 patients with 47 aneurysms treated by a flow-direction technique with the FRED Jr. The primary end point for clinical safety was the absence of death, major or minor stroke, and TIA. The primary end point for treatment efficacy was complete and near-complete occlusion according to the O'Kelly-Marotta grading scale at follow-up after 1, 6, and 12 months. RESULTS: The FRED Jr deployment was technically successful in all cases. In 39/42 (93%) patients, the primary safety end point was reached; in the 3 remaining patients, 1 disabling ischemic stroke, 1 minor stroke with complete recovery at discharge, and 1 TIA were observed. Two asymptomatic, completely reversible side-branch occlusions occurred. Angiographic (DSA or flat panel CT) and clinical follow-up were available after 1 month in 41/47 (87%), 6 months in 27/47 (57%), and 12 months in 11/47 (23%) aneurysms. The primary efficacy end point was reached at 1 month in 27/41 (66%), at 6 months in 21/27 (78%), and at 12 months in 11/11 (100%) aneurysms. CONCLUSIONS: Deployment of the FRED Jr is safe and effective in the treatment of intracranial aneurysms located in small vessels.

Ultra-distal access of the M1 segment with the 5†Fr Navien distal access catheter in acute (anterior circulation) stroke: is it safe and efficient?

BACKGROUND AND AIM: The importance of mechanical thrombectomy in acute stroke treatment has grown over recent years. Mechanical thrombectomy comprises many different techniques. Technical improvements in the catheter material have led to the development of large-bore distal access catheters which can enter tortuous intracranial vessels. This has promising applications for endovascular stroke treatment. This study evaluated the safety and success rate of ultra-distal access of the middle cerebral artery (MCA) M1 segment with the 5 Fr Navien 58 distal access catheter in the treatment of acute stroke in combination with stent retrievers. METHODS: We retrospectively analyzed 81 patients with an acute stroke of the anterior circulation in whom ultra-distal access to the M1 segment was carried out using the Navien 58 catheter with an anchoring technique with a stent retriever for mechanical thrombectomy. Technical complications, success rates of catheter placement, success rates of thrombectomy using the modified Thrombolysis In Cerebral Infarction (mTICI) score, and the procedure times were evaluated. RESULTS: Ultra-distal access with the Navien 58 was successful in 75% (61/81) of cases. Recanalization success with a mTICI score of 2b and better was achieved in 83% overall (67/81), in 90% (55/61) of cases with successful ultra-distal access and in 60% (12/20) of cases without ultra-distal access. No severe adverse effects such as dissections or perforations occurred as a result of the ultra-distal catheter placement in the M1 segment. In 4% (3/81) of the cases a reversible MCA vasospasm occurred. CONCLUSIONS: Ultra-distal placement of the Navien 58 distal access catheter into the M1 segment in acute anterior circulation stroke can be achieved consistently, is safe in practice, and results in good recanalization success rates.

Multicenter experience with the new SOFIA Plus catheter as a primary local aspiration catheter for acute stroke thrombectomy.

INTRODUCTION: The direct aspiration first pass technique (ADAPT) has been introduced as a rapid and safe endovascular treatment strategy in patients with ischemic stroke. OBJECTIVE: To determine the technical feasibility, safety, and functional outcome with ADAPT using the new large-bore 6F SOFIA Plus catheter. METHODS: A retrospective analysis of prospectively collected data from six university hospitals was performed. The following parameters of all acute stroke procedures (June 2015- January 2016) using the SOFIA Plus catheter were analyzed: accessibility of the thrombus with the catheter, recanalization success (Thrombolysis in Cerebral Infarction ≥2b), time to recanalization, procedure-related complications. Furthermore, National Institutes of Health Stroke Scale (NIHSS) scores at presentation and discharge and the modified Rankin scale (mRS) score at 90 days were recorded. RESULTS: 85 patients were treated using the SOFIA Plus catheter. The occlusion site was the anterior circulation in 94.1%. Median baseline NIHSS score was 18. In 64.7%, ADAPT alone was successful after a median procedure time of 21 min. With additional use of stent retrievers in the remaining cases, the recanalization rate was 96.5%. No catheter-related complications such as dissections were observed. Thrombus migration to a new vascular territory occurred in 4.7% and symptomatic hemorrhage in 4.7%. After 3 months, mRS 0-2 was achieved in 49.4%. Mortality rate was 20%. CONCLUSIONS: In the majority of cases, thrombus aspiration using the SOFIA Plus catheter results in successful recanalization after a short procedure time. With additional use of stent retrievers, a high recanalization rate can be achieved (96.5%). The complication rate was in line with those of previous publications.

Endovascular stroke therapy in Austria: a nationwide 1-year experience.

BACKGROUND AND PURPOSE: Based on a tight network of stroke units (SUs) and interventional centres, endovascular treatment of acute major intracranial vessel occlusion has been widely implemented in Austria. Documentation of all patients in the nationwide SU registry has thereby become mandatory. METHODS: Demographic, clinical and interventional characteristics of patients who underwent endovascular treatment for acute ischaemic stroke in 11 Austrian interventional centres between 1 October 2013 and 30 September 2014 were analysed. RESULTS: In total, 301 patients (50.5% women; median age 70.5 years; median National Institutes of Health Stroke Scale score 17) were identified.193 patients (64.1%) additionally received intravenous thrombolysis. The most frequent vessel occlusion sites were the M1 segment of the middle cerebral artery (n = 161, 53.5%), the intracranial internal carotid artery (n = 60, 19.9%) and the basilar artery (n = 40, 13.3%). Stent retrievers were used in 235 patients (78.1%) and adequate reperfusion (modified Thrombolysis in Cerebral Infarction scores 2b and 3, median onset to reperfusion time 254 min) was achieved in 242 patients (81.4%). Symptomatic intracranial haemorrhage occurred in 7%. 43.8% of patients (n = 132) had good functional outcome (modified Rankin Scale score 0-2) and the mortality rate was 20.9% (n = 63) after 3 months. Compared to the anterior circulation, vertebrobasilar stroke patients had higher mortality. Patients with secondary hospital transportation had better outcomes after 3 months than in-house treated patients. CONCLUSION: Our results document nationwide favourable outcome and safety rates of endovascular stroke treatment comparable to recent randomized trials. The ability to provide such data and the need to further optimize such an approach also underscore the contribution of respective registries.

PulseRider Stent-Assisted Coiling of Wide-Neck Bifurcation Aneurysms: Periprocedural Results in an International Series.

The PulseRider is a novel endovascular device specifically designed to treat bifurcation intracranial aneurysms with wide necks. In an international series, we report the results of PulseRider stent-assisted coiling of 15 patients (9 women and 6 men; mean age, 62.6 years) with 15 unruptured wide-neck (median dome size, 8 mm; median neck size, 5 mm) bifurcation aneurysms. Failure of PulseRider treatment occurred in 1 case, and 1 intraprocedural thromboembolic complication was observed. There was no mortality or neurologic permanent morbidity at discharge and at 1 month. Immediate angiographic outcome showed 12 complete occlusions and 2 neck remnants. Follow-up at 6 months was available for 3 aneurysms and demonstrated 2 complete aneurysm occlusions and 1 growing neck remnant. In this small series of selected patients, PulseRider stent-assisted coiling of wide-neck bifurcation aneurysms was feasible with low procedural complication rates. Angiographic follow-up will be required to evaluate the efficacy of the PulseRider device.

Comparison of stent-retriever devices versus the Merci retriever for endovascular treatment of acute stroke.

BACKGROUND AND PURPOSE: Revascularization of large cerebral artery occlusion is the therapeutic goal in stroke therapy. Currently, many recanalization devices are in clinical use. This study compares the outcome parameters, efficacy, and safety of the new generation of stent-retriever devices with the well-established Merci retriever. MATERIALS AND METHODS: All patients who received endovascular mechanical recanalization therapy were prospectively registered. One hundred twenty-two patients were treated with either new stent retrievers, including the Trevo and Solitaire devices, or the Merci retriever system. Recanalization of the occluded vessel was assessed in accordance with the modified TICI score, and outcome parameters, including the NIHSS and mRS scores, were documented. Clinical status was recorded after neurointervention, at time of discharge, and after 90 days. RESULTS: The mean age of all patients was 68 years; 54% were male, with no statistical differences in demographics between both groups. Successful recanalization (TICI 3 and TICI 2b) was achieved in 82% of patients treated with stent retrievers compared with 62% of patients treated with Merci retrievers (P = .016). In the 90-day follow-up, 65% of patients treated with stent retrievers and 35% of those treated with the Merci had achieved a good (mRS = 0-2) clinical outcome (P = .002). Patients treated with stent retrievers had a significantly shorter treatment time (72 versus 122 minutes, P < .01) and less severe intracerebral hemorrhages (10% versus 28%, P < .01). CONCLUSIONS: Patients treated with Trevo and Solitaire stents had a better revascularization rate, better clinical outcome, and lower complication rate than patients treated with the Merci retriever.

Coiling after treatment with the woven EndoBridge cerebral aneurysm embolization device. A case report.

Retreatment options after the use of the newly launched Woven EndoBridge cerebral aneurysm embolization device (WEB II) are mostly unknown. Nine months after WEB II implantation, a 55-year-old female patient presented with regrowth of an MCA aneurysm. For the first time, standard balloon-assisted coiling was used to close the regrown aneurysm proximal to the WEB II implant. We report on the feasibility and safety of balloon-assisted coiling after implantation of the WEB II device.

Isolated leptomeningeal infiltration of a primary CNS B-cell lymphoma diagnosed by flow cytometry and confirmed by necropsy.

BACKGROUND: The diagnosis of the isolated leptomeningeal involvement of a primary central nervous system B-cell lymphoma without parenchyma lesions may be difficult. Patients with leptomeningeal meningeosis lymphomatosa can present with various neurologic deficits. AIMS OF THE STUDY: To demonstrate the impact of cerebrospinal fluid (CSF) flow cytometry in the diagnosis of an isolated leptomeningeal manifestation of B-cell lymphoma by presenting an interesting case report. METHODS: Flow cytometric analysis of B-cell monoclonality of the CSF was performed as complementary diagnostic procedure in addition to CSF cytology. Final diagnosis was confirmed by necropsy. RESULTS: We suspected isolated leptomeningeal manifestation of B-cell lymphoma with palsy of the VI and VII cranial nerves in a 79-year-old male, because of mononuclear pleocytosis in CSF. Interestingly, the decisive diagnostic hint was given by implementation of flow cytometry of the CSF. Diagnosis was confirmed by postmortem autopsy. CONCLUSION: Our case shows that flow cytometry of the CSF in addition to conventional CSF cytology has the potential to accelerate diagnosis of lymphomeningeal infiltration of B-cell lymphoma.

Treatment of vertebral artery origin stenosis with a Pharos stent device: a single center experience.

Atherosclerotic stenosis of vertebral artery (VA) origin exceeding 70% severity accounts for one third of all vertebrobasilar strokes. For a period of one year the results of endovascular treatment of VA stenosis with the new Pharos stent device were assessed.Twenty-two patients with symptomatic VA stenosis were treated with the Pharos stent. Clinical status and stenosis grade were documented before treatment and 24 hours, one, three and twelve months after treatment via ultrasound and magnetic resonance tomography.All procedures proved to be technically successful without the occurrence of intra-procedural complications. During the observation period of more than one year, 55% of patients were documented with a mean stenosis degree of 60%: two (10%) of these patients showed a residual stenosis after angioplasty and nine patients (45%) an in-stent restenosis, whereas only two patients were documented with a hemodynamically relevant in-stent restenosis of 80%. These two patients were retreated with balloon dilatation. None of the patients showed neurological deterioration or new abnormalities at magnetic resonance tomography examination. Neither VA occlusion nor restenosis of the contralateral VA negatively affected the clinical outcome. An in-stent restenosis was developed by more female than male patients.VA origin stenting with the Pharos stent device is an effective treatment of stenosis. The good clinical results compared to the high restenosis rates have to be examined in further studies. Pin particular, it has to be determined whether the Pharos stent allows the vessel time for collateralization, whether double antiplatelet treatment prevents recurrent cerebrovascular events or whether merely the low restenosis degree is causative for the clinical outcome.

Cerebral localized marginal zone lymphoma presenting as hypothalamic-pituitary region disorder.

INTRODUCTION: Marginal zone B-cell lymphoma is a rare disease which can be considerably difficult to recognize and diagnose when signs of systemic involvement are absent. CASE PRESENTATION: We report the case of a 57-year-old woman with initial olfactory disturbance, followed by psychosis, diabetes insipidus and hypothalamic eating disorder as an uncommon clinical presentation of marginal zone B-cell lymphoma. CONCLUSION: Marginal zone B-cell lymphoma should be considered as a potential differential diagnosis in patients with hypothalamic disturbances.