Glomus jugulare in a pediatric patient: case report and literature review.

PURPOSE: The jugular and tympanic glomus are rare neoplasms in the general population, being even more uncommon in the pediatric population. There is considerable morbidity associated with both disease and treatment. Treatment is essentially surgical, carried out in recent years in a multidisciplinary manner using preoperative embolization associated with microsurgery and eventually adjuvant radiotherapy. The outcome depends on the location of the lesion and its proximity to noble structures in addition to multidisciplinary monitoring in the postoperative period. METHODS: In this article, a literature review was carried out in the PubMed database, finding reports from 17 patients diagnosed with the disease. Only articles in English were considered. RESULTS: Moreover, we reported a case of a 14-year-old patient diagnosed with jugulotympanic glomus who underwent radical surgical treatment of the lesion. CONCLUSION: This is a rare case of jugulotympanic glomus in a pediatric patient, who underwent surgical treatment associated with multidisciplinary therapy, with a favorable postoperative outcome.

Association between draining vein diameters and intracranial arteriovenous malformation hemorrhage: a multicentric retrospective study.

PURPOSE: Intracranial arteriovenous malformations (AVMs) cause hemorrhage, and the role of draining vein diameters in rupture risk is controversial. The aims of the present study were to investigate the variables related with intracranial AVM rupture and to examine the association of draining vein diameters and AVM hemorrhage. METHODS: Two hundred three patients were included in this study, of which 117 (57%) had unruptured AVMs, and 86 (43%) had ruptured AVMs. RESULTS: In an adjusted (multivariate) analysis, the variables significantly associated with AVM hemorrhagic presentation were age (OR per year increase 0.97, 95%CI 0.95-0.99, p = 0.007), a deep nidus compared with superficial nidus (OR 3.21, 95%CI 1.13-9.06, p = 0.028), the nidus diameter (OR per each mm increase 0.95, 95%CI 0.92-0.97, p < 0.001), a single draining vein compared with multiple draining veins (OR 2.14, 95%CI 1.02-4.50, p = 0.044), the draining vein diameter (OR per mm increase 1.52, 95%CI 1.26-1.83, p < 0.001), and a draining vein diameter ≥ 5 mm compared with < 5 mm (OR 5.80, 95%CI 2.70-12.47, p < 0.001). CONCLUSION: In this study, after adjusted analysis, the variables associated with intracranial AVM hemorrhagic presentation were a young age, a small nidus diameter, a deeply located nidus, a single draining vein, and large draining vein diameters. A draining vein diameter cutoff ≥ 5 mm was positively associated with the risk of AVM rupture. A large and prospective study is now necessary to confirm if draining vein diameter is a risk factor for AVM hemorrhage.

Extended Time Window Mechanical Thrombectomy for Acute Stroke in Brazil.

BACKGROUND: Mechanical thrombectomy (MT) is the standard of care for acute ischemic stroke (AIS) caused by large vessel occlusion of the anterior circulation within 6 hours of symptoms onset and can be performed with an extended window up to 24 hours in selected patients. Nevertheless, the outcomes of MT with extended window are unknown in developing countries. OBJECTIVE: Explore the safety and efficacy of MT for AIS performed beyond 6 hours from symptoms onset in Brazil. METHODS: We reviewed data from AIS patients treated with MT beyond 6 hours of stroke onset, from 2015 to 2018 in a Brazilian public hospital. Patients had an occlusion of the intracranial internal carotid artery and/or proximal segment of the middle cerebral artery. CT Perfusion mismatch was evaluated using the RAPID® software. We evaluated the modified Rankin scale (mRS) and mortality at 90 days, and rate of symptomatic intracranial hemorrhage (sICH). RESULTS: Fifty-four patients were included, with a mean age of 65.6 ± 16.1 years, 55.6% were male, and the median NIHSS score at presentation was 17. Successful recanalization (TICI 2b to 3) was obtained in 92.6% of patients and sICH rate was 11.1%. Overall, 34% of the patients had a good outcome (mRS ≤2) at 90 days and the mortality rate was 20.3%. CONCLUSION: Our study, the first series of MT for AIS treated with extended window reported in Latin America, shows that MT can be performed with safety and lead to adequate functional outcomes in this context. Further studies should explore the barriers to broad implementation of MT for AIS in Latin America.

Derivo Embolization Device for the Treatment of Intracranial Aneurysms.

Background and Purpose- Flow diverter technology improvements are necessary to provide safe and good results and enable the treatment of a larger variety of aneurysms. We report a nationwide experience with the Derivo Embolization Device in the treatment of intracranial aneurysms. Methods- BRAIDED (Brazilian Registry of Aneurysms Assigned to Intervention With the Derivo Embolization Device) is a multicenter, prospective, interventional, single-arm trial of the Derivo Embolization Device for the treatment of intracranial aneurysms. The primary effectiveness end point was total aneurysm occlusion at 6- and 12-month angiographies. The secondary safety end point was the absence of serious adverse events during follow-up. Univariable and multivariable logistic regression was performed to identify predictors of aneurysm persistence, periprocedural complications, and adverse events during follow-up. Results- Between December 2016 and October 2018, 146 patients harboring 183 intracranial aneurysms were treated in 151 interventions at 7 centers. Derivo Embolization Device placement was technically successful in all patients. Most aneurysms (86.9%) were located at the internal carotid artery, and the mean diameter was 6.7 mm. At 6 months, 113 of 140 (80.7%) aneurysms met the study's primary end point, and 74 of 83 (89.2%) met the study's primary end point at 12 months. Saccular morphology of the aneurysm (odds ratio, 5.66; 95% CI, 1.01-31.77) and the presence of a branch arising from the sac (odds ratio, 6.36; 95% CI, 2.11-22.36) predicted persistence. A long duration of follow-up (odds ratio, 0.86; 95% CI, 0.78-0.95) predicted total occlusion. Of the 146 enrolled patients, 138 (94.5%) were treated without serious adverse events during follow-up. In the multivariable analysis, aneurysms located at a sidewall were less likely to experience these events than those located at bifurcations (odds ratio, 0.07; 95% CI, 0.01-0.51). Conclusions- The Derivo Embolization Device is a safe and effective treatment for intracranial aneurysms. Clinical Trial Registration- URL: http://plataformabrasil.saude.gov.br/login.jsf. Unique identifier: CAAE 77089717.7.1001.5125.

Collateral Scores and Outcomes after Endovascular Treatment for Basilar Artery Occlusion.

BACKGROUND: Basilar artery occlusion (BAO) is a rare stroke subtype with high mortality rates. Best BAO reperfusion strategy is still controversial. OBJECTIVE: We aim to describe outcomes of BAO patients submitted to mechanical thrombectomy (MT) in a comprehensive stroke center in Brazil and analyze which previous published computed tomography angiography (CTA) collateral score better predict functional outcomes. METHODS: Retrospective analysis of consecutive BAO patients. CTA was used to evaluate the posterior circulation collateral score (PC-CS), the basilar artery on CTA score, and for the presence of posterior communicating arteries. A favorable outcome was defined as modified Rankin Score ≤3 at 90-days. After univariate analyses, multivariate logistic regression was used to identify if any collateral score independently predicts favorable outcomes. RESULTS: Between January 2011 and April 2017, 27 (85% male) BAO patients with median NIHSS 26 (IQR 15-32) were identified. Twenty-five (93%) patients were treated with MT devices, and only 2 (7%) patients were treated with angioplasty and stenting. Successful recanalization rate was 85%, and only 1 (3.7%) patient had symptomatic hemorrhagic transformation. Favorable outcomes were reached in 10 (37%) patients. In univariate analysis, female sex, NIHSS, Glasgow coma scale, mild-to-moderate symptoms on admission, onset-to-groin time, and PC-CS predicted favorable outcomes. In multivariate analysis, PC-CS (OR 1.69; 95% CI 1.10-2.60; p = 0.016) and NIHSS (OR 0.84; 95% CI 0.77-0.93; p = 0.001) remained the only independent predictors of favorable outcomes. The PC-CS AUC was 0.80 (95% CI 0.62-0.98; p = 0.012). CONCLUSIONS: MT is a promising strategy for BAO treatment. Among collateral scores, PC-CS was the only independent predictor of favorable outcomes in the present study.

Dual-lumen balloon to increase onyx venous penetration in the treatment of spinal dural arteriovenous fistulas.

PURPOSE: Spinal dural arteriovenous fistulas (sDAVF) are the most common spinal vascular lesions. The arterialization of the recipient vein results in venous hypertension and chronic ischemia. Intravascular injection of acrylic glue in order to occlude the draining vein is the principle of endovascular treatment, but a significant portion of embolization procedures do not succeed. We present our initial experience of endovascular balloon augmented embolization of sDAVF using a dual-lumen balloon. CLINICAL PRESENTATION: Three patients harboring sDAVF were submitted to endovascular treatment by onyx injection assisted by a double-lumen balloon as the sole therapy. Control angiography demonstrated complete obliteration of the fistula in all cases with clinical improvement. CONCLUSION: Dual-lumen balloon onyx embolization of spinal dural arteriovenous fistulas appears to be an acceptable and feasible alternative.

Pipeline embolization device for the treatment of a traumatic intracranial aneurysm in a child.

INTRODUCTION: Traumatic intracranial aneurysms in children are rare and may occur as the result of closed or penetrating head trauma. Their natural history seems to be more aggressive. Most traumatic aneurysms have complex shape, tending to have a large neck or even a fusiform morphology. CASE REPORT: We present a case of a traumatic carotid artery aneurysm in a 9-year-old girl that was successfully treated with pipeline embolization device. DISCUSSION: Due to its dissecting nature, wall friability and lack of a substantial neck can make surgical clipping and selective coiling difficult and risky. Although endovascular parent artery occlusion is the best approach in the acute phase, in some situations it is not possible or very risky. In such scenario the use of flow diverter devices would be an alternative approach. Additionally, we discuss the potential advantages and risks of flow diverter deployment inside a developing vessel.

Clinical Outcomes of Patients with Acute Basilar Artery Occlusion in Brazil: An Observational Study.

BACKGROUND: Intravenous thrombolysis (IVT) and endovascular therapy (EVT) were proven safe and effective for anterior circulation proximal occlusions. However, the most appropriate recanalization strategy in patients with acute basilar artery occlusion (BAO) is still controversial. This study aimed to assess outcomes of patients with BAO at an academic stroke center in Brazil. METHODS: This is a retrospective analysis of consecutive patients with BAO from a prospective stroke registry at Ribeirão Preto Medical School. Primary outcomes were mortality and favorable outcome (modified Rankin score [mRS] ≤3) at 90 days. After univariate analyses, multivariate logistic regressions were used to identify independent predictors of primary outcomes. RESULTS: Between August 2004 and December 2015, 63 (65% male) patients with BAO and median National Institutes of Health Stroke Scale (NIHSS) score of 31 (interquartile range: 19-36) were identified. Twenty-nine (46%) patients received no acute recanalization therapy, 15 (24%) received IVT, and 19 (30%) received EVT (68% treated with stent retrievers). Twenty-four (83%) patients treated conservatively died, and only 2 (7%) achieved an mRS less than or equal to 3. Among patients treated with acute recanalization therapies, 15 (44%) died, and 9 (26.5%) had a favorable outcome. On multivariate analysis, baseline systolic blood pressure (odds ratio [OR] = .97; 95% confidence interval [CI]: .95-0.99; P = .023), posterior circulation Alberta Stroke Program Early CT score (OR = .62; 95% CI: .41-0.94; P = .026), and successful recanalization (OR = .18; 95% CI: .04-0.71; P = .015) were independent predictors of lower mortality. Baseline NIHSS (OR = 1.40; 95% CI: 1.08-1.82; P = .012), prior use of statins (OR = .003; 95% CI: .001-0.28; P = .012), and successful recanalization (OR = .05; 95% CI: .001-0.27; P = .009) were independent predictors of favorable outcome. There was no significant difference between the IVT group and the EVT group on primary outcomes. CONCLUSIONS: BAO is associated with high morbidity and mortality in Brazil. Access to acute recanalization therapies may decrease mortality in those patients.

Modified pressure cooker technique: An easier way to control onyx reflux.

The use of onyx enabled the treatment of various intracranial vascular diseases more effectively than cyanoacrylate. The pressure cooker technique allowed definitive control of reflux and was made possible via detachable microcatheters. We present a variation of this technique called the modified pressure cooker to make reflux control easier and more reproducible and thus simplifying the procedure. We also extended the application of the technique to other diseases beyond arteriovenous malformations including dural arteriovenous fistulas and hypervascular tumors.

High prevalence of intracranial arterial stenosis among acute ischemic stroke patients in a Brazilian center: a transcranial color-coded duplex sonography study.

BACKGROUND: There is limited data available regarding the prevalence of intracranial arterial stenosis (ICAS) among acute ischemic stroke (AIS) patients in Brazil and Latin America. OBJECTIVE: The present study sought to investigate the frequency and predictors of ICAS among patients with AIS or transient ischemic attack (TIA) in a Brazilian center, with transcranial color-coded duplex sonography (TCCS) technique. METHODS: Consecutive AIS and TIA patients, admitted to an academic public comprehensive stroke center in Brazil from February to December 2014, evaluated by TCCS were prospectively selected. Vascular narrowings > 50% were considered as ICAS, based on ultrasound criteria previously defined in the literature. RESULTS: We assessed 170 consecutive patients with AIS or TIA, of whom 27 (15.9%) were excluded due to an inadequate transtemporal acoustic bone window. We confirmed ICAS in 55 patients (38.5%). The most common location was the proximal segment of the middle cerebral artery (28.2%), followed by the vertebral (15.4%), posterior cerebral (13.6%), terminal internal carotid (9.1%) and basilar (8.2%) arteries. On multivariate models adjusting for potential confounders, systolic blood pressure (OR: 1.03, 95%CI: 1.01-1.04; p = 0.008) was independently associated with ICAS. CONCLUSION: We found significant ICAS in approximately ⅓ of patients admitted with symptoms of AIS or TIA in a public tertiary academic stroke center in Brazil. The TCCS is an accessible and noninvasive technique that can be used to investigate the presence of moderate and severe ICAS, especially in patients who cannot be exposed to more invasive exams, such as the use of intravenous contrast agents.

ANTECEDENTES: Dados acerca da prevalência da estenose arterial intracraniana (EAIC) entre os pacientes com acidente vascular isquêmico (AVCi) agudo no Brasil e América Latina são limitados. OBJETIVO: O presente estudo pretendeu investigar a frequência e os preditores da EAIC nos pacientes AVCi ou ataque isquêmico transitório (AIT) em um centro brasileiro utilizando o Doppler transcraniano colorido (duplex transcraniano). MéTODOS: Pacientes consecutivos com AVCi ou AIT, admitidos entre fevereiro e dezembro de 2014 em um centro acadêmico brasileiro especializado em doenças cerebrovasculares, foram avaliados prospectivamente com duplex transcraniano. Os estreitamentos vasculares > 50% foram considerados como EAIC, baseado em critérios ultrassonográficos definidos previamente na literatura. RESULTADOS: Foram avaliados 170 pacientes com AVCi ou AIT, dos quais 27 (15,9%) foram excluídos em decorrência da janela óssea transtemporal acústica inadequada. Confirmamos EAIC em 55 pacientes (38,5%). A localização mais comum foi o segmento proximal da artéria cerebral média (28,2%), seguida pelas artérias vertebral (15,4%), cerebral posterior (13,6%), carótida interna terminal (9,1%) e basilar (8,2%). No modelo multivariado, ajustado para os potenciais confundidores, a pressão arterial sistólica aumentada (OR: 1,03; IC 95%: 1,01­1,04; p = 0,008) foi independentemente associada a EAIC. CONCLUSãO: Foi identificada EAIC significativa em quase ⅓ dos pacientes admitidos com sintomas de AVCi ou AIT em um serviço acadêmico público de atendimento especializado em doenças cerebrovasculares. O Doppler transcraniano colorido é uma ferramenta acessível e não invasiva que pode ser utilizada com segurança para a investigação da presença de EAIC moderada ou grave, especialmente nos pacientes que não podem ser expostos a exames complementares mais invasivos com uso de contraste intravenoso.

The role of intravenous thrombolysis before mechanical Thrombectomy: A subgroup analysis of the RESILIENT trial.

BACKGROUND: Randomized trials have recently evaluated the non-inferiority of direct thrombectomy versus intravenous thrombolysis (IVT) followed by endovascular therapy in anterior circulation large vessel occlusion (LVO) stroke in patients eligible for IVT within 4.5 h from stroke onset with controversial results. We aimed to assess the effect of IVT on the clinical outcome of mechanical thrombectomy (MT) in the RESILIENT trial. METHODS: RESILIENT was a randomized, prospective, multicenter, controlled trial assessing the safety and efficacy of thrombectomy versus medical treatment alone. A total of 221 patients were enrolled. The trial showed a substantial benefit of MT when added to medical management. All eligible patients received intravenous tPA within the 4.5-h-window. Ordinal logistic and binary regression analyses using intravenous tPA as an interaction term were performed with adjustments for potential confounders, including age, baseline NIHSS score, occlusion site, and ASPECTS. A p-value <0.05 was considered statistically significant. RESULTS: Among 221 randomized patients (median NIHSS, 18 IQR [14-21]), 155 (70%) were treated with IVT. There was no difference in the mRS ordinal shift and frequency of functional independence between patients who received or not IV tPA; the odds ratio for the ordinal mRS shift was 2.63 [1.48-4.69] for the IVT group and 1.54 [0.63-3.74] for the no IVT group, with a p-value of 0.42. IVT also did not affect the frequency of good recanalization (TICI 2b or higher) and hemorrhagic transformation. CONCLUSIONS: The large effect size of MT on LVO outcomes was not significantly affected by IVT. TRIAL REGISTRATION: RESILIENT ClinicalTrials.gov number, NCT02216643.

Management of brain AVM procedural hemorrhagic complication by the "security" catheter technique.

Since the introduction of Onyx as a liquid embolic agent for the treatment of brain arteriovenous malformation (AVM), higher endovascular cure rates have been achieved. This may be partially attributed to its non-adhesive property, which allows longer intranidal progression of the embolic agent before solidification. However, Onyx reflux around the microcatheter can form a highly viscous plug, thereby constraining the microcatheter during its retrieval. Also, during the maneuver, arterial stretching can lead to vascular rupture and result in acute bleeding, a potentially fatal complication that demands immediate treatment. This report describes a new treatment strategy for the rapid management of such a complication. The technique consists of the placement of a second microcatheter about 2 cm proximal to the AVM nidus in the same artery containing the intranidal microcatheter. After conclusion of embolization, if rupture occurs during intranidal microcatheter retrieval, the second microcatheter that is already in place can promptly be used to control the bleeding.

Carotid artery stenting performed with a flow-reversal technique: improved technical performance.

OBJECTIVE: To report our experience in carotid artery stenting (CAS) with GORE flow reversal system, focusing the assessment of its efficacy, security and practice procedure evolution. METHODS: Twelve patients treated for atherosclerotic carotid stenosis were prospectively evaluated. All patients were symptomatic. Carotid symptoms were embolic stroke in eight, watershed stroke in two and transient ischemic attack (TIA) in two patients. All patients underwent carotid ultrasound, brain magnetic resonance image and magnetic resonance angiography before CAS procedure. The procedure time and the flow reversal time were registered. Neurological outcome was evaluated before treatment, during the first 48 hours post-treatment and after 3 months. RESULTS: CAS was successful in all cases. Mean procedure time was 33.8 minutes. Mean flow reversal time was 7.3 minutes. Temporary bradycardia occurred with six patients without associated hemodynamic instability. NIHSS patients' scores ranged from 0 to 5 (average 1.1) on admission and remained unchanged during 48 hours after treatment. mRS patients' scores ranged from 0 to 3 (average 1.6) on admission and remained unchanged during the follow-up of 3 months. There were no complications concerning groin puncture, or general anesthesia, or myocardial infarct or death. CONCLUSION: In our present selected subjects, the CAS procedure using the GORE flow reversal system appeared to be safe and effective, with improved technical performance of the procedure. This was observed in particular with the flow-reversal times achieved. Thus, studies comparing the GORE system and other protection devices are suggested to ascertain all of the benefits of flow reversal during CAS.

Two year follow-up of distal unruptured intracranial aneurysms treated with a surface modified flow diverter under prasugrel monotherapy.

BACKGROUND: A new generation of modified surface flow diverters (FDs) and monotherapy using new antiplatelets may reduce both ischemic and hemorrhagic complications during the treatment of intracranial aneurysms. Previous preliminary safety analysis of distal unruptured intracranial aneurysms treated with the FD p48 MW HPC (phenox-Wallaby, Bochum, Germany) under antiplatelet monotherapy with prasugrel showed promising results. However, the long term outcomes of distal intracranial aneurysms treated with FDs under antiplatelet monotherapy are not known. METHODS: This was a single center, prospective, pivotal, open single arm study. The primary (safety) endpoint was absence of any new neurological deficits after treatment until the 24 month follow-up. The primary (efficacy) endpoint was the incidence of complete aneurysm occlusion 24 months after treatment. The secondary (efficacy) endpoints were any incidence of aneurysm dome reduction 24 months after treatment. RESULTS: 21 patients harboring 27 distal aneurysms of the anterior circulation were included. No patient had neurologic deficits in the time from treatment to the 24 month follow-up. Complete aneurysm occlusion occurred in 20 (74%) of 27 aneurysms at the 24 month follow-up. Four aneurysms (14.8%) had dome reduction, and three aneurysms (11.1%) remained unchanged. CONCLUSIONS: In this pilot trial, treatment of distal unruptured intracranial aneurysms with an FD under monotherapy with prasugrel, followed by monotherapy with aspirin, appeared to be safe and effective. Randomized studies with long term follow-up are needed to confirm these results.

What the radiologist should know about the role of percutaneous gastrostomy: a pictorial essay.

The image-guided gastrostomy techniques, as transoral and transabdominal, can be performed when there is a failure of the endoscopic procedure or in some specific clinical scenarios. This pictorial essay intends to show the percutaneous gastrostomy techniques, indications, technical approaches, post-procedure care, and complications.

As técnicas de gastrostomia guiadas por imagem, por via transoral e transabdominal podem ser realizadas quando há falha na técnica endoscópica ou em cenários clínicos em que a endoscopia não pode ser realizada. Este ensaio iconográfico pretende mostrar as técnicas de gastrostomia percutânea, suas indicações, aspectos técnicos, cuidados pós-procedimento e complicações.

Analysis of 565 thrombectomies for anterior circulation stroke: A Brazilian registry.

INTRODUCTION: The benefits of mechanical thrombectomy in the treatment of patients with acute stroke due to large vessel occlusions (LVOs) have been extensively demonstrated by randomized trials and registries in developed countries. However, data on thrombectomy outside controlled trials are scarce in developing countries. The aim of this study was to assess the safety and efficacy, and to investigate the predictors for good and poor outcomes of thrombectomy for treatment of AIS due to anterior circulation LVOs in Brazil. MATERIALS AND METHODS: This was a single center registry of thrombectomy in the treatment of stroke caused by anterior circulation LVOs. Between 2011 and 2019, a total of 565 patients were included. RESULTS: the mean baseline NIHSS score on admission was 17.2. The average baseline ASPECTS was 8, and 91.0% of patients scored ≥6. Half of the patients received intravenous thrombolysis. The mean time from symptom onset to arterial puncture was 296.4 minutes. The mean procedure time was 61.4 minutes. The rates of the main outcomes were recanalization (TICI 2b-3) 85.6%, symptomatic intracranial hemorrhage (sICH) 8,1%, good clinical outcome (mRS=0-2) 43,5%, and mortality 22.1% at three months. CONCLUSIONS: This study demonstrates the efficacy and safety of mechanical thrombectomy for treatment of patients with AIS of the anterior circulation in real-life conditions under limited facilities and resources. The results of the present study were relatively similar to those of large trials and population registers of developed countries.

Casper stent in the treatment of pulsatile tinnitus in fibromuscular dysplasia: Therapeutic review and case report.

Fibromuscular dysplasia (FMD) is a known cause of pulsatile tinnitus that can, on rare occasion, evolve into an incapacitating condition. It is a noninflammatory and nonatherosclerotic arteriopathy of unknown cause that affects medium-sized vessels, such as the carotid and renal arteries, occurring mainly in women. We describe a 72-year-old woman suffering from pulsatile tinnitus refractory to medical treatment who was successfully treated with Casper stent in the carotid artery. The different treatment strategies published in the literature were reviewed.

Aspirin monotherapy in the treatment of distal intracranial aneurysms with a surface modified flow diverter: a pilot study.

BACKGROUND: Flow diverters (FDs) result in high occlusion rates of aneurysms located distally to the carotid artery. However, the complications reported are not negligible. New modified surface FDs have low thrombogenic properties that may reduce ischemic complications related to the treatment. In addition, a modified surface FD may allow for the use of a single antiplatelet medication to reduce hemorrhagic risk during the procedure. The aim of this study was to assess the safety and efficacy of the p48 MW HPC (phenox, Bochum, Germany) to treat distal intracranial aneurysms under the use of aspirin monotherapy. METHODS: The primary endpoint was the incidence of any neurologic deficit after treatment after 6 months of follow-up. The secondary endpoint was the rate of the complete occlusion of the aneurysms at the 6-month follow-up. Enrollment of 20 patients was planned, but after inclusion of seven patients the study was stopped due to safety issues. RESULTS: Seven patients with eight aneurysms were included. Among the seven patients, three (42.8%) had ischemic complications on the second day after FD deployment. Two patients experienced complete recovery at discharge (National Institutes of Health Stroke Scale (NIHSS) score=0), while one patient maintained mild dysarthria at discharge (NIHSS score=1) which improved after 6 months (NIHSS score=0). All three patients had no new symptoms during the 6-month follow-up. Complete aneurysm occlusion occurred in six (75%) of the eight aneurysms at the 6-month follow-up. CONCLUSIONS: Antiplatelet monotherapy with aspirin for the treatment of distal intracranial aneurysms with this modified surface FD resulted in a significant incidence of ischemic complications after treatment.

Treatment of distal unruptured intracranial aneurysms using a surface-modified flow diverter under prasugrel monotherapy: a pilot safety trial.

BACKGROUND: Flow diverters (FDs) are effective in the treatment of carotid aneurysms. Compared with carotid aneurysms, the treatment of distal intracranial aneurysms with FDs has been associated with a relatively high incidence of complications. Low thrombogenic modified-surface FDs may reduce ischemic complications and allow for the use of a single antiplatelet medication. The aim of this study was to assess the safety and efficacy of the p48 MW HPC Flow Modulation Device (Phenox GmbH, Bochum, Germany) to treat distal intracranial aneurysms used in combination with prasugrel monotherapy. METHODS: This was a single-center, prospective, pivotal, open, single-arm study. Patients were included in this study from December 2019 to September 2020. The primary endpoints were the incidence of any neurologic deficit after treatment until 1 month of follow-up, defined as National Institutes of Health Stroke Scale (NIHSS) ≥1, and the incidence of acute ischemic lesions in magnetic resonance imagin (MRI) images 48 hours after treatment. The secondary endpoint was the rate of complete occlusion of the aneurysms at the 1-month follow-up. RESULTS: Twenty-one patients harboring 27 distal aneurysms of the anterior circulation were included. Mean age was 57.8 (SD 9.7) years, and 16 patients were female (80%). No patient had neurologic symptoms at the 1-month follow-up. Four patients (20%) had asymptomatic acute brain ischemic lesions on MRI. Complete aneurysm occlusion occurred in 9/27 (33.3%) aneurysms at the 1-month follow-up. CONCLUSION: In this pilot safety trial, treatment of distal intracranial aneurysms with p48 MW HPC under monotherapy with prasugrel appeared to be safe.