Flow-Diverter Silk Stent for the Treatment of Intracranial Aneurysms: 1-year Follow-Up in a Multicenter Study

Background We assessed the safety and efficacy of flow diverter stents (FDSs) in the treatment of recanalized or residual intracranial aneurysms treated endovascularly. Materials & Methods Patients whose recanalized or residual aneurysms were treated with FDSs in five tertiary hospitals were reviewed retrospectively. The patients’ demographic data, aneurysm characteristics, types of previous treatment, and clinical complications, or serious adverse events associated with FDSs, as well as the results of neurological and angiographic follow-up assessments, were recorded. Results Eighty-six patients (37 males) with 87 aneurysms were included in this study. Eighty (91.9%) aneurysms were in the anterior and seven (8.1%) in the posterior circulation. The initial treatment methods were the primary coiling or balloon remodeling technique in 69 (79.3%) and stent-assisted coiling in 18 (20.7%) aneurysms. The endovascular procedure was successful in all patients. Complications occurred in four patients, for a total complication rate of 4.6%. A technical complication developed in one patient (1.2%). An in-stent thrombosis treated with tirofiban was seen in two cases. Late in-stent stenosis exceeding 50% was treated with balloon angioplasty in one patient. The mean length of follow-up was 21.0 months. The first angiographic follow-up (3–6 months) revealed the complete occlusion of 74 aneurysms (85.1%). While 76 aneurysms (87.4%) were occluded at the last angiographic follow-up (mean: 26.0 months), 11 aneurysms (12.6%) were still filling. Morbimortality was zero. Conclusion The drawback of endovascular treatment is aneurysmal remnants or recurrences, which is safely and durably amenable to flow diversion.

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

Interventional Neuroradiology ◽

10.1177/15910199211027991 ◽

2021 ◽

pp. 159101992110279

Author(s):

Muhammad Waqas ◽

Rimal H Dossani ◽

Modhi Alkhaldi ◽

Jocelyn Neveu ◽

Justin M Cappuzzo ◽

...

Keyword(s):

Systematic Review ◽

Intracranial Aneurysms ◽

Flow Diverter ◽

Complication Rates ◽

Mesh Terms ◽

Aneurysm Occlusion ◽

Occlusion Rate ◽

Layered Flow ◽

Comparative Safety

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.

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Abstract 120: Surpass Flow Diverter for Endovascular Treatment of Intracranial Aneurysms - A Multicenter Preliminary Clinical and Angiographic Experience in 161 Patients with 186 Aneurysms

Stroke ◽

10.1161/str.45.suppl_1.120 ◽

2014 ◽

Vol 45 (suppl_1) ◽

Author(s):

Ajay K Wakhloo ◽

Pedro Lylyk ◽

Joost de Vries ◽

Matthew J Gounis ◽

Alexandra Biondi ◽

...

Keyword(s):

Intracranial Aneurysms ◽

Experimental Studies ◽

Flow Diverter ◽

Posterior Circulation ◽

Parent Artery ◽

Anterior Circulation ◽

Neck Size ◽

Wide Range ◽

New Generation

Objective: Validated through experimental studies a new generation of flow diverters (Surpass™ FD) was evaluated for treatment of intracranial aneurysms (IA). We present our multicenter preliminary clinical and angiographic experience. METHODS: To achieve the calculated flow disruption between the parent artery and aneurysm for thrombosis, single FDs were placed endovascularly in parent arteries. Implants measured 2.5-5.3mm in diameter with a length of 10-80mm. Patients were enrolled harboring a wide range large and giant wide-neck, fusiform and multiple small and blister-type aneurysm. Clinical and angiographic follow-up were performed at 1-3, 6, and 12 months. RESULTS: A total of 186 consecutive IA in 161 patients (mean age 57.1 years) were treated at 33 centers. Fifty-three aneurysms were smaller than 5 mm, 64 were 5-9.9mm in diameter, 47 were 10-20mm in diameter, and 22 were larger than 20mm (10.4±0.7mm, neck size 6.0±0.5mm [mean±SEM]) . The aneurysms originated in 63.4% from the internal carotid artery; 22% and 14.5% of the lesions were located in the anterior circulation distal to Circle of Willis and posterior circulation respectively. Technical success was achieved in 182 aneurysms (98%); average number of devices used per aneurysm was 1.05. Permanent morbidity and mortality during the follow-up period of mean 8.4months (range 1-24 months) including periprocedural complications for patients with aneurysms of the anterior circulation were encountered in 5 (3.7%) and 2 (1.5 %) patients respectively and 1 (3.7%) and 4 (14.8%) respectively for patients with aneurysms of the posterior circulation location. One-hundred-ten patients (70.5%) harboring 127 (70.2%) were available for clinical and angiographic follow-up and showed a complete or near complete aneurysm occlusion in 63 (81.8%) of the ICA. Aneurysms of the ICA≥10mm that were completely covered by FD and not previously stent-treated with a minimum of 6 months follow-up available in 16 patients showed a complete obliteration in 81.3% (n=13) and >90% occlusion in remaining 3 patients. CONCLUSION: Preliminary data demonstrate high safety and efficacy of a new generation of FD for a wide range of IA of the anterior and posterior circulation with a single implant.

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Treatment of Intracranial Aneurysms Using Flow-Diverting Silk Stents (BALT): A Single Centre Experience

Interventional Neuroradiology ◽

10.1177/159101991101700305 ◽

2011 ◽

Vol 17 (3) ◽

pp. 306-315 ◽

Cited By ~ 47

Author(s):

M. Leonardi ◽

L. Cirillo ◽

F. Toni ◽

M. Dall'Olio ◽

C. Princiotta ◽

...

Keyword(s):

Intracranial Aneurysms ◽

Major Complication ◽

Mass Effect ◽

Time Frame ◽

Post Treatment ◽

Parent Artery ◽

Silk Stent ◽

Single Centre Experience ◽

Age Range

The Silk stent (Balt, Montmorency, France) is a retractable device designed to achieve curative reconstruction of the parent artery associated with an intracranial aneurysm. We present our initial experience with the Silk flow-diverting stent in the management and follow-up of 25 patients presenting with intracranial aneurysms. Twenty-five patients (age range, 34–81 years; 24 female) were treated with the Silk flow-diverting device. Aneurysms ranged in size from small (5), large (10) and giant (10) and included wide-necked aneurysms, multiple, nonsaccular, and recurrent intracranial aneurysms. Nine aneurysms were treated for headache, 14 for mass effect. None presented with haemorrhage. All patients were pretreated with dual antiplatelet medications for at least 72 hours before surgery and continued taking both agents for at least three months after treatment. A total of 25 Silk stents were used. Control MR angiography and/or CT angiography was typically performed prior to discharge and at one, three, six and 12 months post treatment. A follow-up digital subtraction angiogram was performed between six and 19 months post treatment. Complete angiographic occlusion or subtotal occlusion was achieved in 15 patients in a time frame from three days to 12 months. Three deaths and one major complication were encountered during the study period. Two patients, all with cavernous giant aneurysms, experienced transient exacerbations of preexisting cranial neuropathies and headache after the Silk treatment. Both were treated with corticosteroids, and symptoms resolved completely within a month. In our experience the Silk stent has proven to be a valuable tool in the endovascular treatment of intracranial giant partially thrombosed aneurysms and aneurysms of the internal carotid artery cavernous segment presenting with mass effect. The time of complete occlusion of the aneurysms and the risk of the bleeding is currently not predictable.

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Intracranial Aneurysms Treated with Coil Placement: Test Characteristics of Follow-up MR Angiography—Multicenter Study

Radiology ◽

10.1148/radiol.10091528 ◽

2010 ◽

Vol 256 (1) ◽

pp. 209-218 ◽

Cited By ~ 46

Author(s):

Joanna D. Schaafsma ◽

Birgitta K. Velthuis ◽

Charles B. L. M. Majoie ◽

René van den Berg ◽

Patrick A. Brouwer ◽

...

Keyword(s):

Multicenter Study ◽

Intracranial Aneurysms ◽

Mr Angiography ◽

Placement Test ◽

Test Characteristics

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Neurovascular reconstruction with flow diverter stents for the treatment of 87 intracranial aneurysms: Clinical results

Interventional Neuroradiology ◽

10.1177/1591019915582153 ◽

2015 ◽

Vol 21 (3) ◽

pp. 292-299 ◽

Cited By ~ 12

Author(s):

Leonardo Giacomini ◽

Ronie L Piske ◽

Carlos E Baccin ◽

Marcelo Barroso ◽

Andrei F Joaquim ◽

...

Keyword(s):

Intracranial Aneurysms ◽

Interventional Neuroradiology ◽

Clinical Results ◽

Flow Diverter ◽

High Rate ◽

Complex Aneurysms ◽

Results Of Treatment ◽

Silk Stent ◽

Flow Diverter Stent ◽

Aneurysm Occlusion

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.

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Endovascular Treatment of Intracranial Aneurysms in the Flow Diverter Era: Frequency of Use and Results in a Consecutive Series of 550 Treatments in a Single Centre

Interventional Neuroradiology ◽

10.15274/inr-2014-10047 ◽

2014 ◽

Vol 20 (4) ◽

pp. 428-435 ◽

Cited By ~ 7

Author(s):

Willem Jan van Rooij ◽

Ratna S Bechan ◽

Jo P. Peluso ◽

Menno Sluzewski

Keyword(s):

Intracranial Aneurysms ◽

Flow Diverter ◽

Flow Diversion ◽

Consecutive Series ◽

Complication Rates ◽

Parent Vessel ◽

Vessel Occlusion ◽

Permanent Neurological Deficit ◽

Flow Diverters

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.

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Long-term occlusion results with SILK flow diversion in 28 aneurysms: Do recanalizations occur during follow-up?

Interventional Neuroradiology ◽

10.1177/1591019915583119 ◽

2015 ◽

Vol 21 (3) ◽

pp. 300-310 ◽

Cited By ~ 14

Author(s):

Anastasios Mpotsaris ◽

Martin Skalej ◽

Oliver Beuing ◽

Bernd Eckert ◽

Daniel Behme ◽

...

Keyword(s):

Prospective Study ◽

Intracranial Aneurysms ◽

Flow Diverter ◽

Success Rates ◽

Imaging Data ◽

Complete Occlusion ◽

Complex Aneurysms ◽

Multicenter Prospective Study

Background and purpose The purpose of this article is to report on the long-term success rates of Silk flow-diverter (FD) treatment in a multicenter prospective study for the treatment of complex aneurysms. Methods Between May 2008 and January 2011, all consecutive patients featuring complex intracranial aneurysms eligible for FD treatment with the Silk in three neurovascular centers were included. Clinical and imaging data were assessed during hospitalization and follow-up. Results Five patients were initially asymptomatic, 20 patients showed various neurological symptoms. Twenty-eight FDs were implanted in 25 patients treating 28 aneurysms. The immediate procedure-related morbidity was 8% (two of 25), mortality 0%. One procedure-related death was observed during follow-up (in-stent thrombosis). Compared to the immediate result nearly two of three aneurysms improved during follow-up; all angiographically confirmed inflow changes took place within six months after treatment. Final anatomic outcome in 24 aneurysms of 22 patients comprised 14 (59%) with complete occlusion, seven (29%) with a neck remnant, two (8%) with residual filling <50%, none with residual filling >50% and one (4%) unchanged in comparison to its pretreatment status. Postinterventional recanalizations were seen in three of 13 (23%) aneurysms treated with FD alone; none were observed in 15 aneurysms treated with adjunctive coiling. Conclusion Anatomic presentation and location are key for successful FD treatment. The rate of successful occlusion increases during follow-up. Postinterventional monitoring for at least six months is paramount, as anatomic outcome is not reliably predictable and recanalizations may occur in initially completely occluded aneurysms.

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FRED Italian Registry: a multicenter experience with the flow re-direction endoluminal device for intracranial aneurysms

Journal of Neurosurgery ◽

10.3171/2019.1.jns183005 ◽

2020 ◽

Vol 133 (1) ◽

pp. 174-181 ◽

Cited By ~ 5

Author(s):

Mariangela Piano ◽

Luca Valvassori ◽

Emilio Lozupone ◽

Guglielmo Pero ◽

Luca Quilici ◽

...

Keyword(s):

Adverse Event ◽

Endovascular Treatment ◽

Intracranial Aneurysms ◽

Cerebral Aneurysms ◽

Flow Diverter ◽

Anterior Circulation ◽

Cross Sectional ◽

Safety And Efficacy ◽

Mortality And Morbidity

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.

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