scholarly journals The FRED Flow-Diverter Stent for Intracranial Aneurysms: Clinical Study to Assess Safety and Efficacy

2015 ◽  
Vol 36 (6) ◽  
pp. 1155-1161 ◽  
Author(s):  
M.A. Möhlenbruch ◽  
C. Herweh ◽  
L. Jestaedt ◽  
S. Stampfl ◽  
S. Schönenberger ◽  
...  
2018 ◽  
Vol 11 (1) ◽  
pp. 68-73 ◽  
Author(s):  
Bastian Kraus ◽  
Lukas Goertz ◽  
Bernd Turowski ◽  
Jan Borggrefe ◽  
Marc Schlamann ◽  
...  

BackgroundThe Derivo Embolization Device (DED) is a novel flow diverter stent that provides increased x-ray visibility, an improved delivery system, and potentially reduced thrombogenicity. The objective of this study was to evaluate the early safety and efficacy of the second-generation DED.MethodsWe retrospectively analyzed all patients with unruptured intracranial aneurysms (UIAs) treated with the DED between November 2015 and December 2017 in three German tertiary care centers. Procedural details, complications, and morbidity within 30 days after treatment, as well as the aneurysm occlusion rates after 6 months (O’Kelly–Marotta scale, OKM), were evaluated.ResultsImplantation of the DED was attempted in 42 patients with 42 aneurysms. All procedures were technically successful. Multiple DEDs were used in three aneurysms (7.2%) and adjunctive coiling in 11 (26.2%). Procedure-related complications occurred in four cases (9.5%) including three thromboembolic events and one aneurysm perforation. The morbidity rate was 2.4% and there was no mortality. One patient suffered an ischemic stroke with persistent aphasia at 30-day follow-up due to a thromboembolic infarct (modified Rankin Scale score 1). Among 33 patients (78.6%) available for angiographic follow-up, complete (OKM D) and favorable (OKM C+D) aneurysm occlusion was obtained in 72.7% (24/33) and 87.9% (29/33), respectively.ConclusionsEndovascular treatment of UIAs with the DED is associated with high procedural safety and adequate occlusion rates. Examinations at 1- and 2-year follow-up will provide data on the long-term safety and angiographic outcomes of this device.


Stroke ◽  
2010 ◽  
Vol 41 (10) ◽  
pp. 2247-2253 ◽  
Author(s):  
Boris Lubicz ◽  
Laurent Collignon ◽  
Gaï Raphaeli ◽  
Jean-Pierre Pruvo ◽  
Michaël Bruneau ◽  
...  

2015 ◽  
Vol 21 (3) ◽  
pp. 292-299 ◽  
Author(s):  
Leonardo Giacomini ◽  
Ronie L Piske ◽  
Carlos E Baccin ◽  
Marcelo Barroso ◽  
Andrei F Joaquim ◽  
...  

Background Flow diverter stents represent a new endovascular tool to treat complex aneurysms, such as giant, large, wide-necked and fusiform. The highly dense mash of these stents reduces inflow and outflow inside the aneurysm, resulting in intra aneurysmal thrombosis and stent endothelialization. Objectives To present the results of treatment of intracranial aneurysms with flow diverter stents in a single center. Methods Retrospective review of 77 patients with 87 aneurysms treated using two different types of flow diverter stent, the Pipeline Embolization Device and SILK stent, between October 2010 and September 2013 in an interventional neuroradiology center. Results Flow diverter stent placement was successful in 98% of the lesions and resulted in an immediate major stasis within most of the treated aneurysms. The overall aneurysm occlusion rate at six months and 18 months was 80% and 84% respectively. Symptomatic complications occurred in 11 patients (14.3%) with morbidity in eight (10.4%) and mortality in three patients (3.9%). Conclusion Flow diversion is a promising technique for treatment of challenging intracranial aneurysms with acceptable morbidity. A high rate of complete occlusion for small large necked aneurysms, a low morbidity and mortality rate and no recanalization encourage their use in these aneurysms. Further studies accessing long-term aneurysm occlusion and recanalization are required.


2014 ◽  
Vol 56 (5) ◽  
pp. 389-395 ◽  
Author(s):  
M. Möhlenbruch ◽  
C. Herweh ◽  
L. Behrens ◽  
L. Jestaedt ◽  
H. Amiri ◽  
...  

2020 ◽  
Vol 133 (1) ◽  
pp. 174-181 ◽  
Author(s):  
Mariangela Piano ◽  
Luca Valvassori ◽  
Emilio Lozupone ◽  
Guglielmo Pero ◽  
Luca Quilici ◽  
...  

OBJECTIVEThe introduction of flow-diverter devices (FDDs) has revolutionized the endovascular treatment of intracranial aneurysms. Here the authors present their Italian multicenter experience using the flow re-direction endoluminal device (FRED) in the treatment of cerebral aneurysms, evaluating both short- and long-term safety and efficacy of this device.METHODSBetween February 2013 and December 2014, 169 consecutive aneurysms treated using FRED in 166 patients were entered into this study across 30 Italian centers. Data collected included patient demographics, aneurysm location and characteristics, baseline angiography, adverse event and serious adverse event information, morbidity and mortality rates, and pre- and posttreatment modified Rankin Scale scores, as well as angiographic and cross-sectional CT/MRI follow-up at 3–6 months and/or 12–24 months per institutional standard of care. All images were reviewed and adjudicated by an independent core lab.RESULTSOf the 169 lesions initially entered into the study, 4 were later determined to be extracranial or nonaneurysmal by the core lab and were excluded, leaving 165 aneurysms in 162 patients treated in 163 procedures. Ninety-one (56.2%) patients were asymptomatic with aneurysms found incidentally. Of the 165 aneurysms, 150 (90.9%) were unruptured. One hundred thirty-four (81.2%) were saccular, 27 (16.4%) were fusiform/dissecting, and the remaining 4 (2.4%) were blister-like. One hundred thirty-seven (83.0%) arose from the anterior circulation.FRED deployment was impossible in 2/163 (1.2%) cases, and in an additional 4 cases (2.5%) the device was misdeployed. Overall mortality and morbidity rates were 4.3% and 7.3%, respectively, with rates of mortality and morbidity potentially related to FRED of up to 2.4% and 6.2%, respectively. Neuroimaging follow-up at 3–6 months showed complete or nearly complete occlusion of the aneurysm in 94% of cases, increasing to 96% at 12–24 months’ follow-up. Aneurysmal sac shrinkage was observed in 78% of assessable aneurysms.CONCLUSIONSThis preliminary experience using FRED for endovascular treatment of complex unruptured and ruptured aneurysms showed a high safety and efficacy profile that is comparable to those of other FDDs currently in use.


2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Shao-Wei Feng ◽  
Chao-Bao Luo ◽  
Chien-Hui Lee ◽  
Feng-Chi Chang ◽  
Chung-Jung Lin

2017 ◽  
Vol 59 (3) ◽  
pp. 263-269 ◽  
Author(s):  
Ricardo Morais ◽  
Benjamin Mine ◽  
Pierre Julien Bruyère ◽  
Gilles Naeije ◽  
Boris Lubicz

Author(s):  
Hoang Van

Background: With the approval of detachable coils in 1995, endovascular treatment of intracranial aneurysms has become an alternative to surgical clip ligation. Despite the introduction of “modified” coils and advanced techniques such as stent-assisted and balloon-assisted coiling, coil embolization has major limitations because of inability to completely and permanently occlude all aneurysms. As stents were being developed for intracranial use, it was hypothesized that stents could be utilized to divert flow “away” from the aneurysm “back” into the parent vessel, and the concept of “endovascular flow diversion” was proposed. This study aims to report our experience with cerebral aneurysms, which may improve in the treatment with the flow-diverter stent and follow up (1). Methods: This study was conducted in consecutive series of 23 patients. 23 procedures were performed for treating these patients in Ha Noi heart hospital from January 2019 to January 2020. 23 flow diverter stents (Pipeline) were used. Aneurysms morphology, stent patency and cerebral parenchyma before and after intervention were analyzed on images of digital subtraction angiography (DSA), computed tomography (CT) and magnetic resonance (MR). The follow-up data after 3–6 months and 12 months were recorded. Results: In 23 patients (8 men, 15 women), aneurysms of internal carotid artery were mostly common (95.7%), especially in cavernous segments. 13 cases (74%) had saccular aneurysms, and 2 cases (9%) had multiple aneurysms, and only 3 cases (13%) had fusiform aneurysms. Endovascular treatment was successfully performed at rate of 100%.. Mortality and morbidity rates were 0% and 0%, respectively. MRI and MSCT follow-up at 3 months showed complete or incomplete occlusions of aneurysms was 26.1% or 34.8%, respectively.  Conclusions: Deployment of flow diverter stent is safe and effective with high rate of successful and low procedural complications


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.


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