Flow Re-Direction Endoluminal Device Research Articles

Treatment strategy for giant thrombosed aneurysm of the basilar artery with associated obstructive hydrocephalus.

There is no established adequate treatment for thrombosed aneurysm of the basilar artery with obstructive hydrocephalus. We conducted coil embolization and peritoneal shunting followed by placement of a stent expected to exert flow diversion (FD) effects to treat 2 patients with giant thrombosed aneurysms of the basilar artery with associated obstructive hydrocephalus, with good results. From April 2019 to March 2021, consecutive two cases of symptomatic hydrocephalus due to giant thrombosed aneurysms in the posterior cranial fossa at our hospital were treated. At first, coil embolization was performed to prevent aneurysm rupture. After coil embolization, ventriculoperitoneal shunting was performed. Finally, stent-assisted coil embolization was performed with flow re-direction endoluminal device (FRED) or low-profile visualized intraluminal support device (LVIS) stent. Both patients were discharged after recovering well, with no postoperative hemorrhagic or ischemic complications. Staged surgery using a FRED for flow diverter or an LVIS stent expected to have FD effects may offer an effective treatment option.

Flow Diverter Performance for the Treatment of Intracranial Aneurysms: An International Multicenter Comparative Study

Background Current evidence comparing flow diverters (FDs) for the treatment of intracranial aneurysms is limited to single‐arm head‐to‐head retrospective and prospective studies. Herein, we aimed to compare the efficacy and safety of four FDs for the treatment of intracranial aneurysms. Methods We performed a retrospective, multicenter international cohort study of adult patients treated with FDs (Pipeline embolization device, Surpass Streamline, Flow Redirection Endoluminal Device, and Silk) for intracranial aneurysms between 2015 and 2021. Efficacy was determined by aneurysm occlusion at final follow‐up. Safety was determined by ischemic/hemorrhagic events and mortality. Secondary safety was assessed by technical complications. A mixed‐effect multivariable ordinal and logistic regression were performed to evaluate variables that predicted the outcomes of interest. Results We included 235 patients with 274 aneurysms. Treatment was performed with either the Pipeline embolization device (92), Surpass Streamline (56), Flow Redirection Endoluminal Device (47), and Silk (40). Median age was 57 (47–65) years. Most patients were asymptomatic (76%), and 8% had previous rupture. Most aneurysms were saccular (85%) and anterior (94%). The Pipeline embolization device subgroup had the largest aneurysms (6 mm, P =0.005). Median follow‐up time was 9 (6–14) months. Final overall complete occlusion was 72% without significant differences between FDs ( P =0.5). Total ischemic (5%) and hemorrhagic (3%) events were also similar ( P =0.1 and P =0.06). One patient expired (0.4%, P =0.6). In multivariable analysis, device diameter predicted aneurysm persistence and ≥50% in‐stent stenosis predicted ischemic/hemorrhagic complications. Conclusions Our findings comparing 4commonly used FDs in a heterogeneous population with mainly small‐sized aneurysms confirmed a similar safety and efficacy profile between devices.

Commentary: Comparison of Flow-Redirection Endoluminal Device and Pipeline Embolization Device in the Treatment of Intracerebral Aneurysms.

*College of Medicine, University of Florida, Gainesville, Florida, USA; ‡Lillian S. Wells Department of Neurosurgery, University of Florida, Gainesville, Florida, USA Correspondence: Abeer Dagra, BS, College of Medicine, University of Florida, 1505 SW Archer Rd, Gainesville, FL32610, USA. Email: [email protected]

Abnormal foreshortening of a Flow Re-Direction Endoluminal Device caused by in-stent thrombosis immediately after deployment.

Thromboembolic complications are a concern in the treatment of cerebral aneurysms using a flow diverter. In this study, we report a case of abnormal foreshortening of a Flow Re-Direction Endoluminal Device (FRED) caused by in-stent thrombosis immediately after its deployment. A 72-year-old woman had a large cavernous carotid aneurysm, which caused ptosis and diplopia. FRED deployment was planned, and dual antiplatelet therapy was initiated 2 weeks before the procedure. Under systemic heparinization, FRED was deployed with local compaction over the aneurysm orifice. Cone-beam computed tomography subsequently revealed slightly poor wall apposition at the proximal side. While the balloon catheter was prepared for angioplasty, the stent became abnormally foreshortened, the proximal side slipped into the aneurysm, and the internal carotid artery became occluded. FRED was removed using a snare wire, and recanalization was obtained. The lumen of the removed FRED was filled with thrombus. The antiplatelet therapy was changed to triple regimen, and a Pipeline Flex embolization device was placed 1 month later. At that time, no thromboembolic complications were noted. It was considered that thrombotic occlusion was followed by foreshortening of FRED on the distal side because of antegrade blood flow. Multiple factors, such as increased mesh density by locally compacted stent deployment, slightly poor wall apposition, clopidogrel resistance, and the dual-layer structure of FRED, may have been involved in thrombus formation.

Endovascular treatment of challenging aneurysms with FRED Jr flow diverter stents: a single-center experience.

To analyze clinical safety and efficacy of flow re-direction endoluminal device (FRED) Jr flow diverter for treatment of unruptured, ruptured, or recanalyzed aneurysms. Between October 2019 and February 2022, 25 patients with 31 aneurysms treated with FRED Jr were included in the study. Clinical and radiological records, procedural details, and follow-up outcomes were retrospectively evaluated. Eighteen (72%) patients were female. Median age was 48.8 (age range 9-85). Mean follow-up was 21months (6-28months). Location of the aneurysms were as follows; 13 in middle cerebral artery (MCA), 7 in anterior cerebral artery (ACA), 4 in posterior cerebral artery (PCA), 3 in true posterior communicating artery (PCom), 2 in anterior communicating artery (ACom), 1 in superior cerebellar artery (SCA), 1 in true ophthalmic artery. Five patients (20%) presented with acute subarachnoid hemorrhage (aSAH). In all procedures, FRED Jr was successfully deployed. Three true Pcom aneurysms and a true ophthalmic aneurysm were treated with FRED Jr. Three patients with two adjacent aneurysms were treated with a single FRED Jr. In two (8%) patients in-stent thrombosis occurred intraoperatively, they were treated with iv tirofiban and thrombectomy without any sequelae. Post-discharge 2weeks later, intraparenchymal hemorrhage occurred in a patient. He was treated with surgical drainage, the clinical course was modified Rankin score (mRS) 2. Digital subtraction angiography (DSA) was performed on 16 (64%) patients with 21 (67%) aneurysms. Near complete-complete occlusion (O'Kelly-Morata grading scale (OKM C-D) was documented in 15/16 (93.7%) patients, 20/21 (95.2%) aneurysms. In nine (36%) patients, no residual filling was observed in the magnetic resonance angiography (MRA). Good clinical outcome (mRS 0-1) was achieved in 24/25 (96%) of patients. Endovascular treatment of small cerebral aneurysms with FRED Jr is safe and effective even in complex and challenging morphologies allowing high rates of aneurysm occlusion with low periprocedural complications. Our cohort, consisting of a rate 20% acute ruptured aneurysms, is the major additive data to the published literature.

Treatment of cerebral aneurysms with the FRED Jr flow-diverting stent: A case series and meta-analysis

BackgroundWith the development of the Flow Re-Direction Endoluminal Device Junior (FRED Jr), treatment of distal aneurysms and/or aneurysms with small parent vessels has become a viable option. ObjectivesTo assess the efficacy and safety of FRED Jr in the treatment of distal aneurysms with small parent vessels. MethodsThis is a single center retrospective study and meta-analysis of patients treated with FRED Jr for intracranial aneurysms. The primary outcome was complete aneurysm occlusion at final follow-up. Secondary outcomes included stroke rates, mortality rates, need for retreatment and clinical outcomes. ResultsThere were a total of 7 patients with 7 aneurysms treated with FRED Jr. Mean aneurysm neck, width, height, and parent artery diameter were 2.6 ± 0.8 mm, 3.1 ± 0.9 mm, 2.5 ± 1.0 mm, and 1.8 ± 0.6 mm respectively. The complete occlusion rate was 57.1 % at 6 months, and favorable outcome (mRS 0–2) was observed in all patients in follow-up. Stroke complication occurred in none of the patients. Seven studies from 1360 articles were identified for inclusion in the meta-analysis, comprising 227 patients with 244 aneurysms treated with FRED Jr. Mean aneurysm height, width, neck and parent artery diameter were 6.9 ± 3.3 mm (pooled=5.6 [<0.1–11.47] mm), 6.6 ± 2.2 mm (pooled=6.6 [4.2–9.1] mm), 4.4 ± 1.4 mm (pooled=4.1 [3.3 −4.9] mm), and 2.0 ± 0.2 mm (pooled=2.1 [1.7–2.5]), respectively. At final follow-up, the pooled complete occlusion and complication rates were 69.9 % and 0 %, respectively. ConclusionFRED Jr demonstrated moderate efficacy and good safety in the treatment of distal aneurysms with small parent vessels at mid-term follow-up.

Poly(2-methoxyethyl acrylate) (PMEA) improves the thromboresistance of FRED flow diverters: a thrombogenic evaluation of flow diverters with human blood under flow conditions.

Surface modification of flow-diverting stents has been explored to reduce thrombus-related complications that may arise under clinical use. This study investigated the thromboresistant properties of the flow redirection endoluminal device (FRED) X, a flow diverter treated with a copolymer of poly(2-methoxyethyl acrylate) (PMEA; X Technology). The performance of FRED, FRED X, and Pipeline Flex with Shield Technology (sPED) was evaluated in an in vitro blood loop model. Blood activation level was assessed by the concentration of thrombin-antithrombin complex (TAT), β-thromboglobulin (β-TG), and platelet count, and qualitatively by scanning electron microscopy (SEM). Cellular adhesion characteristics were measured using human aortic endothelial cells that were seeded on flat sheets mimicking the surface of FRED, FRED X, and sPED, and evaluated with fluorescence microscopy. Statistical comparisons were conducted using one-way analysis of variance (ANOVA) with Tukey post hoc tests. FRED X, sPED, and control blood loops showed significantly reduced blood activation levels (TAT and β-TG) compared with FRED (p<0.01). Consequently, FRED showed a significant decrease in platelet count compared with FRED X, sPED, and control loops (p<0.01). SEM imaging showed the lowest accumulation of blood cell-like deposits on FRED X compared with sPED and FRED, while FRED had the highest accumulation. Endothelial cells adhered and were widely spread on X Technology-treated sheets, while minimal cell adhesion was observed on phosphorylcholine-treated sheets. The X Technology surface modification of FRED X demonstrated superior thromboresistant properties over untreated FRED while maintaining comparable cellular adhesion. Taken together, these properties may help mitigate material-related thromboembolic complications.

Comparison of Flow-Redirection Endoluminal Device and Pipeline Embolization Device in the Treatment of Intracerebral Aneurysms.

The use of flow diverters for treating intracranial aneurysms has been widely used in the past decade; however, data comparing pipeline embolization device (PED; Medtronic Inc) and flow-redirection endoluminal device (FRED; MicroVention) in the treatment of intracranial aneurysms remain scarce. To compare the outcomes of PED and FRED in the treatment of intracranial aneurysms. This is a single-center retrospective review of aneurysms treated with PED and FRED devices. Patients treated with PED or FRED were included. Cases requiring multiple or adjunctive devices were excluded. Primary outcome was complete aneurysm occlusion at 6 months. Secondary outcomes included good functional outcome, need for retreatment, and any complication. The study cohort comprised 150 patients, including 35 aneurysms treated with FRED and 115 treated with PED. Aneurysm characteristics including location and size were comparable between the 2 cohorts. 6-month complete occlusion rate was significantly higher in the PED cohort (74.7% vs 51.5%; P = .017) but lost significance after inverse probability weights. Patients in the PED cohort were associated with higher rates of periprocedural complications (3.5% vs 0%; P = .573), and the rate of in-stent stenosis was approximately double in the FRED cohort (15.2% vs 6.9%; P = .172). Compared with PED, FRED offers modest 6-month occlusion rates, which may be due to aneurysmal and baseline patient characteristics differences between both cohorts. Although not significant, FRED was associated with a higher complication rate mostly because of in-stent stenosis. Additional studies with longer follow-up durations should be conducted to further evaluate FRED thrombogenicity.

Factors predicting effective aneurysm early obliteration after flow re-direction endoluminal device placement for unruptured intracranial cerebral aneurysms

ObjectiveThere have been few reports of the outcomes of flow re-direction endoluminal device (FRED) treatment for unruptured cerebral aneurysms, and patient factors associated with effective aneurysm obliteration have yet to be determined. Flow diverters also have problems with delayed rupture. The objective of this study was to investigate associations between the cases of early obliteration of aneurysm after FRED treatment and a range of factors. MethodA retrospective analysis of 75 aneurysms in 72 patients whose response to treatment was evaluated by cerebral angiography 6 months after FRED treatment was conducted. The aneurysm obliteration rate was classified according to the O'Kelly-Marotta grading scale (OKM grade). The patients were classified into those assessed as OKM Grade A or Grade B with poor aneurysm obliteration (poor obliteration), and those assessed as Grade C or Grade D with good aneurysm obliteration (good obliteration). The parameters evaluated were age, sex, medical history, immediate postoperative eclipse sign, P2Y12 reaction units (PRU), aspirin reaction units (ARU), operating time, maximum aneurysm diameter measured on cerebral angiography, and aneurysm location. ResultsAt 6 months post-treatment, 19 aneurysms (25.3%) were OKM Grade A, 15 (20%) were Grade B, 10 (13.3%) were Grade C, and 31 (41.3%) were Grade D. Age ≥67.5 years was significantly associated with a poor obliteration [odds ratio (OR): 0.1; 95% confidence interval (95%CI): 0.2-0.4; p=0.002] and intracranial side wall aneurysm [OR: 21.7; 95%CI: 1.6–284.5; p=0.01]. ConclusionsThe results of this study demonstrated that age was associated with aneurysm obliteration after FRED treatment. This finding may be useful for further studies investigating factors predictive of the aneurysm obliteration rate and the residual aneurysm rate after FRED treatment.

Commentary: The Pennsylvania Postmarket Multicenter Experience With Flow Redirection Endoluminal Device.

*Neurosurgery Division, Department of Clinical Neurosciences, Spectrum Health, Grand Rapids, Michigan, USA; ‡Department of Neurosurgery, College of Human Medicine, Michigan State University, Grand Rapids, Michigan, USA Correspondence: Justin Singer, MD, Division of Neurological Surgery, Department of Clinical Neurosciences, Spectrum Health Medical Group, Michigan State University, 25 Michigan St NE, Suite 6100, Grand Rapids, MI49503, USA. Email: [email protected] Twitter: @JustinSingerMD Andres F. Restrepo, MD, Division of Neurological Surgery, Department of Clinical Neurosciences, Spectrum Health/Michigan State University – College of Human Medicine, 25 Michigan St NE, Suite 6100, Grand Rapids, MI49503, USA. Email: [email protected] Twitter: @AndresRestrepMD

National Survey on Flow-Diverting Stents for Intracranial Aneurysms in the United States

The Pipeline Embolization Device (PED) has been the only flow-diverting device (FDD) approved by the Food and Drug Administration (FDA) in the U.S. market for nearly a decade, with more FDD choices in the United States following recent FDA approval of the Flow Redirection Endoluminal Device and Surpass. We sought to explore the integration patterns of these devices into practice by U.S. neurointerventionalists. A 34-question electronic survey was distributed to the U.S. neurointerventional community from different backgrounds (neurosurgery, neurology, radiology) through different organizational links, focusing on technical aspects of device selection and personal preferences/experiences regarding FDD in aneurysms treatment. Responses were collected from 120 neurointerventionalists across the United States; operators from a neurosurgery background constituted the majority of respondents (47.5%; 85% of dual-trained). The largest age block was early-to mid-career operators (70.8% aged 36-50 years). Most participants (78.8%) treated a range of 25-100 aneurysms/year with FDDs, with 49.2% of respondents having all the FDA-approved FDDs available in their centers (80.8% academic practice). Femoral access was used by the 67.7% of respondents, without impact of FDD-device on access-type (89.2%). PED was the most commonly used device (70.9%), with 66.7% of respondents reporting using different FDD based on case specifics. Comparing devices preferences by training backgrounds, more neurosurgical operators endorsed PED as their most commonly used device, whereas more interventional neuroradiologists/neurologists reported Surpass and Flow Redirection Endoluminal Device as their most commonly used devices. The results of this survey identify common themes in FDD choices among neurointerventionalists in the U.S. market, along with their integration patterns of the newly introduced devices into clinical practice.

Predicting difficulty in Flow Re-direction Endoluminal Device (FRED) deployment using angiography: A technical note

The Flow Re-direction Endoluminal Device (FRED) is widely used to treat large intracranial unruptured cerebral aneurysms; however, some cases of deployment failure have been observed. Most of these cases occur in internal carotid artery aneurysms around the siphon. We report a method that we developed to predict the success of FRED deployment by using a preoperative angiography in simple lateral view.

The Pennsylvania Postmarket Multicenter Experience With Flow Redirection Endoluminal Device.

The flow redirection endoluminal device (FRED) is a novel self-expanding double-layer nitinol braided flow diverter that recently received FDA approval. However, early postmarket studies from the United States are lacking. To report our short-term multicenter experience. Series of consecutive patients undergoing FRED treatment for intracranial aneurysms were queried from prospectively maintained registries at 4 North-American Centers in Pennsylvania (February 2020-June 2021). The pertinent baseline demographics, aneurysmal characteristics, and procedural outcomes were collected and analyzed, with primary outcome of aneurysmal occlusion and secondary outcome of safety and complications. Sixty-one patients (median age 58 years, 82% female) underwent 65 FRED treatment procedures for 72 aneurysms. Most (86.1%) of the aneurysms were unruptured; 80.5% were saccular in morphology, and 87.5% were located along the internal carotid artery, with a median size of 7.1 mm (IQR 5.2-11.9 mm). Radiographic follow-up was available in 86.1% of the aneurysms, showing complete occlusion in 74.2% (80% in catheter angiography-only group), and near-complete occlusion in 11.3% of the cases (median 6.3 months), with 2.8% re-treated. Permanent ischemic complications were encountered in 2.8% of the cases, with no procedural mortality. A modified Rankin Scale of 0 to 2 was documented in 98.1% of the patients at the last clinical follow-up (median 6.1 months). The results of the early postmarket experience with the FRED device show reasonable safety and adequate aneurysmal occlusion rates comparable with other flow diverters. However, more extensive multicenter studies with more extended follow-up data are needed to assess the long-term safety and durability of the device.

A Single Flow Re-direction Endoluminal Device for the Treatment of Large and Giant Anterior Circulation Intracranial Aneurysms.

PurposeThe purpose of this study was to report the author’s experiences in treating large (10–25 mm) and giant (>25 mm) intracranial aneurysms (IAs) using a single Flow Re-direction Endoluminal Device (FRED) without assistant coiling, with a focus on procedure-related complications.Materials and MethodsA total of 33 patients who were treated with FRED between January 2018 and July 2020 were retrospectively reviewed. The timing of procedure-related complications was chronologically categorized as acute (within 7 days), subacute (8 to 21 days), and delayed (after 21 days) periods. Follow-up angiography was performed at 2 to 27 months (mean 9.7 months), and clinical follow-up was performed at 1 to 31 months (mean 14.1 months) in all patients.ResultsSix (18.2%) patients experienced procedure-related complications, including 2 (6.1%) in acute period, 1 (3.0%) in subacute period, and 3 (9.1%) in delayed period. Thromboembolic complications occurred in 5 (15.2%) patients and hemorrhagic complications in 1 (3.0%). Permanent morbidity and mortality rates were 3.0% each. Non-internal carotid artery (ICA) location of IAs (odds ratio 6.532; 95% confidence interval, 1.335–17.816; p=0.034) was the only independent risk factor for procedure-related complications on multivariate logistic regression analysis.ConclusionThe procedure-related complication rate was 18.2% in this study. Procedure-related complications might increase when treating large and giant IAs located on a non-ICA, especially on the middle cerebral artery. Therefore, it may be suggested that neurointerventionists and endovascular neurosurgeons should pay attention to the location of IAs when treating large and giant IAs with a single FRED.

Endovascular Therapy of 103 Aneurysms in the Internal Carotid Artery with Flow Re-Direction Endoluminal Device

Abstract Objective Intracranial aneurysms (AIs) are acquired vascular abnormalities that cause sacculations in the arterial wall and are present in ~2 to 5% of the population. Among the treatment options are endovascular interventions with the use of flow-redirecting stents. In the present study, we analyzed the flow re-direction endoluminal device (FRED). Methods The present study aims to describe the results obtained from treatment with FRED in a series of patients affected by aneurysms in intracranial segments of the internal carotid artery. This is a cross-sectional, epidemiological, and observational study, whose data were obtained from the medical records of 81 patients from July 2018 to July 2019. Results One hundred and three internal carotid artery aneurysms were observed in 81 patients, with a prevalence of women (91.35%), small (&lt; 10 mm) (89.33%), and located at the C6 level (73.78%) of the internal carotid artery. Of the 81 patients, 16 had multiple aneurysms in the same artery. One hundred and three FRED stents were used in the treatment. These patients underwent angiography 6 months after the surgery, using the O'Kelly-Marotta classification (OKM) to assess the effectiveness of the device, and it was observed that: in 91 of the 103 procedures (88.34%), the FRED was fully open and well positioned, thus restoring the arterial flow and leading to a statistically significant result. In addition, a low complication rate (4.85%) was found, with ischemic stroke being the main complication (1.94%). Conclusion This device can be an effective option in the treatment of internal carotid aneurysms since the aneurysm occlusion rate is excellent with a low rate of complications.

Efficacy of the Flow Re-direction Endoluminal Device for cerebral aneurysms and causes of failed deployment

PurposeThe Flow Re-direction Endoluminal Device (FRED) has recently become available for flow diversion in Japan. We have encountered cases that failed to deploy the FRED. In this study, we report our initial experience with the FRED for cerebral aneurysms and clarify the causes of failed FRED deployment.MethodsA retrospective data analysis was performed to identify patients treated with the FRED between June 2020 and March 2021. Follow-up digital subtraction angiography was performed at 3 and 6 months and assessed using the O’Kelly-Marotta (OKM) grading scale.ResultsThirty-nine aneurysms in 36 patients (average age: 54.4 years) were treated with the FRED. The average sizes of the dome and neck were 9.9 mm and 5.2 mm, respectively. In nine patients, additional coiling was performed. In one patient (2.6%), proximal vessel injury caused direct carotid-cavernous fistula during deployment. Ischaemic complications were encountered in one patient (2.6%) with transient symptoms. Angiographic follow-up at 6 months revealed OKM grade C or D in 86.6% of patients. FRED deployment was successful in 35 (92.1%) procedures. In the failure group, the differences between the FRED and the minimum vessel diameter (P = 0.04) and the rate of the parent vessel having an S-shaped curve (P = 0.04) were greater than those in the success group.ConclusionsFlow diversion using the FRED is effective and safe for treating cerebral aneurysms. The use of the FRED for patients with an S-shaped curve in the parent vessel and oversizing of more than 2 mm should be considered carefully.

Safety and Efficacy of the FRED Jr Flow Re-Direction Endoluminal Device for Intracranial Aneurysms: Retrospective Multicenter Experience With Emphasis on Midterm Results.

Background and Purpose: Flow diversion is increasingly used as an endovascular treatment for intracranial aneurysms. In this retrospective multicenter study, we analyzed the safety and efficacy of the treatment of intracranial, unruptured, or previously treated but recanalized aneurysms using Flow Re-Direction Endoluminal Device (FRED) Jr with emphasis on midterm results.Materials and Methods: Clinical and radiological records of 150 patients harboring 159 aneurysms treated with FRED Jr at six centers between October 2014 and February 2020 were reviewed and consecutively included. Clinical outcome was measured by using the modified Rankin Scale (mRS). Anatomical results were assessed according to the O'Kelly-Marotta (OKM) scale and the Cekirge-Saatci Classification (CSC) scale.Results: The overall complication rate was 24/159 (16%). Thrombotic-ischemic events occurred in 18/159 treatments (11%). These resulted in long-term neurological sequelae in two patients (1%) with worsening from pre-treatment mRS 0–2 and mRS 4 after treatment. Complete or near-complete occlusion of the treated aneurysm according to the OKM scale was reached in 54% (85/158) at 6-month, in 68% (90/133) at 1-year, and in 83% (77/93) at 2-year follow-up, respectively. The rates of narrowing or occlusion of a vessel branch originating from the treated aneurysm according to the CSC scale were 11% (12/108) at 6-month, 20% (17/87) at 1-year, and 23% (13/57) at 2-year follow-up, respectively, with all cases being asymptomatic.Conclusions: In this retrospective multicenter study, FRED Jr was safe and effective in the midterm occlusion of cerebral aneurysms. Most importantly, it was associated with a high rate of good clinical outcome.

Long-term results and comparison of flow re-direction endoluminal device and pipeline embolization device in endovascular treatment of intracranial carotid aneurysms.

This study aims to compare the efficacy, safety, and long-term outcomes of two flow diverters, i.e., pipeline embolization device and flow re-direction endoluminal device, in the treatment of distal carotid aneurysms. A total of 138 patients with 175 aneurysms were included from February 2012 to September 2019. Ninety-nine aneurysms were treated with flow re-direction endoluminal device and 76 with pipeline embolization device. Angiographic follow-ups were at the 6th, 12th, 24th, 36th, and 60th months; the O'Kelly-Marotta grading scale was used to assess aneurysms occlusion. Outcomes of two devices were compared; possible associations regarding patient characteristics, aneurysm properties, treatment details, and adverse events were evaluated. The mean follow-up period was 33 months, with 10 patients lost to follow-up. Occlusion rates at the 6th and 12th months and during the last follow-up were similar for flow re-direction endoluminal device (81%, 84%, and 90%) and pipeline embolization device (82%, 85%, and 93%). Occlusion rates were also similar after stand-alone use without coiling. There was no significant difference regarding adverse event rates with a 10.9% overall complication rate, 3.6% mortality, and 0.7% permanent morbidity. All the mortality and morbidity were related to hemorrhagic complications. Device deployment failure was observed with five flow re-direction endoluminal devices and two pipeline embolization devices, whereas two severe in-stent stenoses occurred with each device. Both flow re-direction endoluminal device and pipeline embolization device are feasible and effective in flow diversion of distal internal carotid artery aneurysms, with similar adverse events rates and aneurysm occlusion success. Aneurysm occlusion rates increase with time, while the presence of an integrated branch significantly decreases treatment success.

Brazilian FRED Registry: A Prospective Multicenter Study for Brain Aneurysm Treatment-The BRED Study.

The development of flow diverters has changed the endovascular approach to intracranial aneurysms. On the basis of good results, the indications for flow diverters have expanded to include aneurysms of different shapes, locations, and sizes. The objective of the study was to report on the performance of the Flow Re-Direction Endoluminal Device (FRED) in intracranial aneurysm treatment at early and medium-term follow-up. This single-arm, multicentric, prospective, observational study assessed aneurysm treatment with the FRED. The primary outcome was complete aneurysm occlusion at 6 and 12 months, and the secondary outcome was to evaluate the safety of the FRED with respect to stroke and death rates. Between June 2016 and August 2018, a total of 100 consecutive patients with 131 aneurysms were treated in 107 procedures. Total occlusion rates were 91% and 95% at 6 and 12 months. There was 1 death, and the total final morbidity rate was 1.8%. The complication rate was 4.6%. As reported previously, the FRED has proved to be a safe and effective tool, with high occlusion rates. The design of the stent makes it more difficult to perform balloon angioplasty compared with similar devices. A branch arising from the aneurysm sac was found to be a predictor of nonocclusion at 12 months, though larger series are needed to estimate the magnitude of the association.

Flow Redirection Endoluminal Device (FRED) with or without Adjunctive Coiling in Treatment of Very Large and Giant Cerebral Aneurysms.

Flow diverter stents are gaining wider use in the treatment of complex intracranial aneurysms; however, there are limited data on occlusion and complication rates of flow diverters in very large and giant aneurysms. This study assessed the safety and efficacy of flow redirection endoluminal device (FRED) and FRED Jr. stents in aneurysms ≥ 20 mm. We retrospectively analyzed all aneurysms ≥ 20 mm treated with FRED/FRED Jr. between January 2010 and June 2020 from three centers. Endpoints for clinical safety were absence of major stroke, aneurysmal rupture, or death and complete or near-complete occlusion for efficacy. Atotal of 45patients with very large (28cases) and giant aneurysms (17cases) were treated with FRED (41cases), and FRED Jr. (4cases) stents. The majority of the aneurysms (40/45, 88.9%) were in the anterior circulation. Adjunctive aneurysm coiling was performed in 21aneurysms (46.7%). Technical complications were encountered in 4procedures (8.9%). Ischemic and hemorrhagic complication rates were 6.7% and 8.9%, respectively. There was no case with major stroke. The mortality rate was 8.9%, and all cases were due to hemorrhagic complications from aneurysmal rupture. Median angiographic follow-up was 21.5months (range 3-60months). Complete occlusion was achieved in 32aneurysms (71.1%), and near-complete occlusion in 5cases (11.1%). The use of FRED/FRED Jr. for the treatment of aneurysms ≥ 20 mm achieved along-term aneurysm occlusion rate and asafety profile comparable to the large series reported with other flow diverter stents.