Flow redirection endoluminal device (FRED) for treatment of intracranial aneurysms: A systematic review

2021 ◽  
pp. 159101992110279
Author(s):  
Muhammad Waqas ◽  
Rimal H Dossani ◽  
Modhi Alkhaldi ◽  
Jocelyn Neveu ◽  
Justin M Cappuzzo ◽  
...  

Introduction The Flow Redirection Endoluminal Device (FRED; MicroVention) is a dual-layered flow diverter used for the treatment of intracranial aneurysms. The objective of this systematic review was to compile device-related safety and effectiveness data. Methods The literature from January 1, 2013 to April 30, 2021 was searched for studies describing use of the FRED for intracranial aneurysm treatment irrespective of aneurysm location and morphology. The review included anterior and posterior circulation ruptured and unruptured saccular, fusiform or dissection, and blister aneurysms. MeSH terms related to “flow re-direction endoluminal device” and “FRED for aneurysms” were used. Data related to indication, complications, and rates of aneurysm occlusion were retrieved and analyzed. Results Twenty-two studies with 1729 intracranial aneurysms were included in this review. Overall reported morbidity was 3.9% (range 0–20%). Overall procedure-related mortality was 1.4% (range 0–6%). Complication rates fell into 5 categories: technical (3.6%), ischemic (3.8%), thrombotic or stenotic (6%), hemorrhagic (1.5%), and non-neurological (0.8%). The aneurysm occlusion rate between 0 and 3 months (reported in 11 studies) was 47.8%. The occlusion rate between 4 and 6 months (reported in 14 studies) was 73.8%. Occlusion rates continued to increase to 75.1% at 7–12 months (reported in 10 studies) and 86.6% for follow-up beyond 1 year (reported in 10 studies). Conclusion This review indicated that the FRED is a safe and effective for the treatment of intracranial aneurysms. Future studies should directly compare the FRED with other flow diverters for a better understanding of comparative safety and effectiveness among the different devices.

2014 ◽  
Vol 20 (4) ◽  
pp. 428-435 ◽  
Author(s):  
Willem Jan van Rooij ◽  
Ratna S Bechan ◽  
Jo P. Peluso ◽  
Menno Sluzewski

Flow diverter devices became available in our department in 2009. We considered treatment with flow diverters only in patients with aneurysms not suitable for surgery or conventional endovascular techniques. This paper presents our preliminary experience with flow diverters in a consecutive series of 550 endovascular aneurysm treatments. Between January 2009 and July 2013, 550 endovascular treatments for intracranial aneurysms were performed. Of these, 490 were first-time aneurysm treatments in 464 patients and 61 were additional treatments of previously coiled aneurysms in 51 patients. Endovascular treatments consisted of selective coiling in 445 (80.8%), stent-assisted coiling in 68 (12.4%), balloon-assisted coiling in 13 (2.4%), parent vessel occlusion in 12 (2.2%) and flow diverter treatment in 12 (2.2%). Eleven patients with 12 aneurysms were treated with flow diverters. Two patients had ruptured dissecting aneurysms. One patient with a basilar trunk aneurysm died of acute in stent thrombosis and another patient died of brain stem ischaemia at 32 months follow-up. One patient had ischaemia with permanent neurological deficit. Two aneurysms are still open at up to 30 months follow-up. Flow diversion was used in 2% of all endovascular treatments. Both our own poor results and the high complication rates reported in the literature have converted our initial enthusiasm to apprehension and hesitancy. The safety and efficacy profile of flow diversion should discourage the use of these devices in aneurysms that can be treated with other techniques.


2019 ◽  
Vol 12 (3) ◽  
pp. 283-288 ◽  
Author(s):  
Michelle F M ten Brinck ◽  
Maike Jäger ◽  
Joost de Vries ◽  
J André Grotenhuis ◽  
René Aquarius ◽  
...  

Background and purposeFlow diverters are sometimes used in the setting of acutely ruptured aneurysms. However, thromboembolic and hemorrhagic complications are feared and evidence regarding safety is limited. Therefore, in this multicenter study we evaluated complications, clinical, and angiographic outcomes of patients treated with a flow diverter for acutely ruptured aneurysms.MethodsWe conducted a retrospective observational study of 44 consecutive patients who underwent flow diverter treatment within 15 days after rupture of an intracranial aneurysm at six centers. The primary end point was good clinical outcome, defined as modified Rankin Scale score (mRS) 0–2. Secondary endpoints were procedure-related complications and complete aneurysm occlusion at follow-up.ResultsAt follow-up (median 3.4 months) 20 patients (45%) had a good clinical outcome. In 20 patients (45%), 25 procedure-related complications occurred. These resulted in permanent neurologic deficits in 12 patients (27%). In 5 patients (11%) aneurysm re-rupture occurred. Eight patients died resulting in an all-cause mortality rate of 18%. Procedure-related complications were associated with a poor clinical outcome (mRS 3–6; OR 5.1(95% CI 1.0 to 24.9), p=0.04). Large aneurysms were prone to re-rupture with rebleed rates of 60% (3/5) vs 5% (2/39) (p=0.01) for aneurysms with a size ≥20 mm and <20 mm, respectively. Follow-up angiography in 29 patients (median 9.7 months) showed complete aneurysm occlusion in 27 (93%).ConclusionFlow diverter treatment of ruptured intracranial aneurysms was associated with high rates of procedure-related complications including aneurysm re-ruptures. Complications were associated with poor clinical outcome. In patients with available angiographic follow-up, a high occlusion rate was observed.


Author(s):  
Marcelo Bolcato ◽  
ana Carolina Dalmonico ◽  
Leo Ditzel ◽  
Savio Machareti ◽  
Thiago Yoshida ◽  
...  

Introduction : Endovascular flow diverters are increasingly used for the treatment of cerebral aneurysms. We assessed the safety and efficacy of the Flow Diverters in a consecutive series of 53 patients and 60 aneurysms. Methods : Inclusion criteria were wide‐neck, blister‐like, or fusiform aneurysms independent of size, treated with the FRED, PIPELINE and SILK between December 2014 and Junho 2021. Assessment criteria were aneurysm occlusion, manifest ischemic stroke, bleeding, or death. The occlusion rate was assessed at 6 months and 1 year with DSA by using the Raymond classification and the O'Kelly‐Marotta grading scale. Results : Fifty three patients (mean age 54.3 years;81.1% female) with 60 aneurysms were treated with 9 Silk, 38 FREDs and 13 Pipeline. Aneurysm size ranged from 2.5 to 30 mm. Deployment of the Flow diverters was successful in 52 aneurysms. Three patient developed mild stroke symptoms that fully receded within days, 4 patients occlusion total carotid because resistant antiagregation and another patient’s development Swelling syndrome. There has been one death. Initial follow‐up at 6 months showed complete occlusion in 90% of the overall study group and 93,33% at 1 year. Conclusions : The flow diverter is a safe device for the treatment of cerebral aneurysms of various types. Our data reveal high occlusion rates at 6 months and 1 year. Long‐term occlusion rates are expected.


2021 ◽  
pp. 1-8
Author(s):  
José E. Cohen ◽  
J. Moshe Gomori ◽  
Samuel Moscovici ◽  
Andrew H. Kaye ◽  
Yigal Shoshan ◽  
...  

OBJECTIVE Flow-diverter stents (FDSs) are not generally used for the management of acutely ruptured aneurysms with associated subarachnoid hemorrhage (SAH). Herein, the authors present their experience with FDSs in this scenario, focusing on the antiplatelet regimen, perioperative management, and outcome. METHODS The authors retrospectively reviewed their institutional database for the treatment and outcomes of all patients with acutely ruptured aneurysms and associated SAH from July 2010 to September 2018 who had received an FDS implant as stand-alone treatment within 4 days after diagnosis. The protocol with the use of flow diversion in these patients includes a low threshold for placement of external ventricular drains before stenting, followed by the administration of aspirin and clopidogrel with platelet testing before stent implantation. With this approach, the risk of hemorrhage and stent-related thrombus formation is limited. Demographic, clinical, technical, and imaging data were analyzed. RESULTS Overall, 76 patients (61% females, mean age 42.8 ± 11.3 years) met the inclusion criteria. FDS implantation was performed a median of 2 days after diagnosis. On average, 1.05 devices were used per procedure. There was no procedural mortality directly attributed to the endovascular intervention. Procedural device-related clinical complications were recorded in a total of 6 cases (7.9%) and resulted in permanent neurological morbidity in 2 cases (2.6%). There was complete immediate aneurysm occlusion in 11 patients (14.5%), and persistent aneurysm filling was seen in 65 patients (85.5%). Despite this, no patient presented with rebleeding from the target aneurysm. There was an excellent clinical outcome in 62 patients (81.6%), who had a 90-day modified Rankin Scale score of 0–2. Among the 71 survivors, total or near-total occlusion was observed in 64/67 patients (95.5%) with a 3- to 6-month angiographic follow-up and in all cases evaluated at 12 months. Five patients (6.6%) died during follow-up for reasons unrelated to the procedure or new hemorrhage. CONCLUSIONS Flow diversion is an effective therapeutic strategy for the management of select acutely ruptured aneurysms. Despite low rates of immediate aneurysm occlusion after FDS implantation, the device exerts an important protective effect. The authors’ experience confirmed no aneurysm rerupture, high rates of delayed complete occlusion, and complication rates that compare favorably with the rates obtained using other techniques.


Neurosurgery ◽  
2013 ◽  
Vol 73 (2) ◽  
pp. 193-200 ◽  
Author(s):  
Ignacio Arrese ◽  
Rosario Sarabia ◽  
Rebeca Pintado ◽  
Miguel Delgado-Rodriguez

Abstract BACKGROUND: Although the introduction of flow-diverter devices (FDDs) has aroused great enthusiasm, the level of evidence supporting their use has not been systematically evaluated. OBJECTIVE: To report a systematic review of medical literature up to May 2012 on FDDs to assess the morbidity, case fatality rate, and efficacy of FDDs for intracranial aneurysms. METHODS: The literature was searched by using MEDLINE, Embase, and all Evidence-Based Medicine in the OVID database. Eligibility criteria were studies including at least 10 patients, reporting duration of follow-up and number of patients lost to follow-up, and documenting the rate of aneurysm occlusion and death and neurological complications. The endpoints were angiographic success, early and late mortality, and neurological morbidity. RESULTS: Fifteen studies were analyzed consisting of 897 patients with 1018 aneurysms. The mean value of methodological quality score was 14.4 using the STROBE score. The early mortality rate was 2.8% (95% confidence interval [CI]: 1.7-3.8; I2 = 93.4%) and the late mortality rate was 1.3% (95% CI: 0.2-2.3; I2 = 36.9%). The early neurological morbidity rate was 7.3% (95% CI: 5.7-9; I2 = 91.8%) and the late morbidity rate was 2.6% (95% CI: 1.1-4; I2 = 81.3%). The Egger test for early and late morbidity and aneurysm occlusion was &lt;0.001. CONCLUSION: With the available data from the studies, both heterogeneity and publication biases imply that the current clinical use of FDDs is not supported by high-quality evidence. In the absence of reliable evidence, the use of FDDs in patients eligible for more conventional treatments should be restricted to controlled clinical trials.


2021 ◽  
pp. 159101992110240
Author(s):  
Andreas Simgen ◽  
Christine Mayer ◽  
Michael Kettner ◽  
Ruben Mühl-Benninghaus ◽  
Wolfgang Reith ◽  
...  

Purpose Flow Diverters (FD) have immensely extended the treatment of cerebral aneurysms in the past years. Complete aneurysm occlusion is a process that often takes a certain amount of time and is usually difficult to predict. Our aim was to investigate different syngo iFlow parameters in order to predict aneurysm occlusion. Methods Between 2014 and 2018 patients with unruptured cerebral aneurysms treated with a FD were reviewed. Aneurysm occlusion and complication rates have been assessed. In addition, various quantitative criteria were assessed using syngo iFlow before, after the intervention, and after short and long-term digital subtraction angiography (DSA). Results A total of 66 patients hosting 66 cerebral aneurysms were included in this study. 87.9% (n = 58) aneurysms in the anterior and 12.1% (n = 8) in the posterior circulation were treated. Adequate aneurysm occlusion at long-term follow-up (19.05 ± 15.1 months) was achieved in 90.9% (n = 60). Adequately occluded aneurysm revealed a significantly greater peak intensity delay (PI-D, p = 0.008) and intensity decrease ratio (ID-R, p < 0.001) compared to insufficiently occluded aneurysms. Increased intra-aneurysmal contrast agent intensity (>100%) after FD implantation resulted in an ID-R < 1, which was associated with aneurysm growth during follow-up DSA. Retreatment with another FD due to foreshortening and/or aneurysm growth was performed in 10.6% (n = 7). Overall morbidity and mortality rates were 1.5% (n = 1) and 0%. Conclusion The applied syngo iFlow parameters were found to be useful in predicting adequate aneurysm occlusion and foresee aneurysm growth, which might indicate the implantation of another FD.


2021 ◽  
Author(s):  
Jian Liu ◽  
Wenqiang Li ◽  
Yisen Zhang ◽  
Kun Wang ◽  
Xinjian Yang ◽  
...  

Abstract BackgroundWe compared the treatment of small unruptured intracranial aneurysms (UIAs) with flow diverter and LVIS assisted coiling to determine the effects of hemodynamic changes caused by different stent and coil packing in endovascular treatment.MethodsFifty-one UIAs in 51 patients treated with pipeline embolization device (PED) were included in this study, and defined as the PED group. We matched controls 1:1 and enrolled 51 UIAs who treated with LVIS stent, which defined as the LVIS group. Computational fluid dynamics were performed to assess hemodynamic alterations between PED and LVIS. Clinical analysis was also performed between these two groups after the match.ResultsThere was no difference in procedural complications between two groups (P=0.558). At the first angiographic follow-up, the complete occlusion rate was significantly higher in the LVIS group compared with that in the PED group (98.0% vs 82.4%, P = 0.027). However, during the further angiographic follow-up, the complete occlusion rate in PED group achieved 100%, which was higher than that in LVIS group (98.0%). Compared with the LVIS group after treatment, cases in PED group showed a higher value of velocity in the aneurysm (0.03 ± 0.09 vs 0.01 ± 0.01, P=0.037) and WSS on the aneurysm (2.32 ± 5.40 vs 0.33 ± 0.47, P=0.011). Consequently, the reduction ratios of these two parameters were also showed statistical differences. These parameters in LVIS group showed much higher reduction ratios. However, the reduction ratio of the velocity on the neck plane was comparable between two groups. ConclusionsBoth LVIS and PED were safe and effective for the treatment of small UIAs. However, LVIS-assisted coiling produced greater hemodynamic alterations in the aneurysm sac compared with PED. The hemodynamics in the aneurysm neck may be a key factor for aneurysm outcome.


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Jian Liu ◽  
Wenqiang Li ◽  
Yisen Zhang ◽  
Kun Wang ◽  
Xinjian Yang ◽  
...  

Abstract Background We compared the treatment of small unruptured intracranial aneurysms (UIAs) with flow diverter and LVIS-assisted coiling to determine the effects of hemodynamic changes caused by different stent and coil packing in endovascular treatment. Methods Fifty-one UIAs in 51 patients treated with pipeline embolization device (PED) were included in this study and defined as the PED group. We matched controls 1:1 and enrolled 51 UIAs who were treated with LVIS stent, which were defined as the LVIS group. Computational fluid dynamics were performed to assess hemodynamic alterations between PED and LVIS. Clinical analysis was also performed between these two groups after the match. Results There was no difference in procedural complications between the two groups (P = 0.558). At the first angiographic follow-up, the complete occlusion rate was significantly higher in the LVIS group compared with that in the PED group (98.0% vs. 82.4%, P = 0.027). However, during the further angiographic follow-up, the complete occlusion rate in the PED group achieved 100%, which was higher than that in the LVIS group (98.0%). Compared with the LVIS group after treatment, cases in the PED group showed a higher value of velocity in the aneurysm (0.03 ± 0.09 vs. 0.01 ± 0.01, P = 0.037) and WSS on the aneurysm (2.32 ± 5.40 vs. 0.33 ± 0.47, P = 0.011). Consequently, the reduction ratios of these two parameters also showed statistical differences. These parameters in the LVIS group showed much higher reduction ratios. However, the reduction ratio of the velocity on the neck plane was comparable between two groups. Conclusions Both LVIS and PED were safe and effective for the treatment of small UIAs. However, LVIS-assisted coiling produced greater hemodynamic alterations in the aneurysm sac compared with PED. The hemodynamics in the aneurysm neck may be a key factor for aneurysm outcome.


2018 ◽  
Vol 11 (3) ◽  
pp. 290-295 ◽  
Author(s):  
Lukas Goertz ◽  
Franziska Dorn ◽  
Bastian Kraus ◽  
Jan Borggrefe ◽  
Marc Schlamann ◽  
...  

BackgroundThe Derivo Embolization Device (DED) is a novel flow diverter with advanced X-ray visibility, potentially lower thrombogenicity, and an improved delivery system.ObjectiveTo evaluate the safety and efficacy of the DED for emergency treatment of ruptured intracranial aneurysms.MethodsBetween February 2016 and March 2018, 10 patients (median age 54.5 years, seven women) with 11 aneurysms were treated with the DED at three neurovascular centers. Procedural details, complications, morbidity, and aneurysm occlusion (O’Kelly-Marotta scale, OKM) were retrospectively reviewed.ResultsAmong 11 aneurysms treated, there were nine anterior circulation and two posterior circulation aneurysms. Aneurysm morphology was saccular in four cases, dissecting in three, blister-like in three, and fusiform in one. In each case, a single DED was implanted and deployment was technically successful without exception. Adjunctive coiling was performed in two aneurysms. We observed one in-stent thrombosis, presumably due to low response to clopidogrel 4 days after the procedure, which remained with a mild hemiparesis after aspiration thrombectomy. No further thromboembolic or hemorrhagic events occurred. Favorable outcome (modified Rankin scale score ≤2) at last follow-up was achieved in all patients. Among 10 aneurysms available for angiographic follow-up, complete aneurysm occlusion (OKM D) was obtained in nine cases (90.0%).ConclusionsIn this pilot study, endovascular treatment of ruptured intracranial aneurysms with the DED was feasible and not associated with any incidence of rebleeding. Larger series with longer follow-up are warranted to reach a definite conclusion about this device.


Neurosurgery ◽  
2014 ◽  
Vol 76 (2) ◽  
pp. 142-149 ◽  
Author(s):  
Ning Lin ◽  
Adam M. Brouillard ◽  
Chandan Krishna ◽  
Maxim Mokin ◽  
Sabareesh K. Natarajan ◽  
...  

ABSTRACT BACKGROUND: Coiling in conjunction with Pipeline embolization device (PED) placement could provide immediate dome protection and an intraaneurysmal scaffold to prevent device prolapse for intracranial aneurysms with high rupture risk and complex anatomy. OBJECTIVE: To report results after treatment of aneurysms with PED with coils (PED+coils group) or without (PED-only group) at a single-institution. METHODS: In this case-controlled study, records of patients who underwent PED treatment between 2011 and 2013 were retrospectively reviewed. RESULTS: Twenty-nine patients were treated with PED+coils and 75 with PED-only. No statistically significant between-group differences were found in terms of age, sex, aneurysm location, medical comorbidities, and length of follow-up. Aneurysms treated by PED+coils were larger (16.3 mm vs 12.4 mm, P = .02) and more likely to be ruptured (20.7% vs 1.3%, P = .001) or dissecting (34.5% vs 9.3%, P = .002). PED deployment was successful in all cases. At the latest follow-up (mean, 7.8 months), complete aneurysm occlusion was achieved in a higher proportion of the PED+coils group (93.1% vs 74.7%, P = .03). Device foreshortening/migration occurred in 4 patients in the PED-only group and none in the PED+coils group. Fewer patients required retreatment in the PED+coils group (3.4% vs 16.0%, P = .71). Rates of neurological complications (10.3% PED+coils vs 8.0% PED-only, P = .7) and favorable outcome (modified Rankin Scale score = 0-2; 93.1% PED+coils vs 94.7% PED-only, P = .6) were similar. CONCLUSION: PED+coils may be a safe and effective treatment for aneurysms with high risk of rupture (or rerupture) and complex anatomy. Coiling in conjunction with PED placement provided a higher aneurysm occlusion rate and reduced the need for retreatment.


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