Introduction: History and Development of Flow Diverter Technology and Evolution

Neurosurgery ◽  
2019 ◽  
Vol 86 (Supplement_1) ◽  
pp. S3-S10 ◽  
Author(s):  
Anna Luisa Kühn ◽  
Matthew J Gounis ◽  
Ajit S Puri
Keyword(s):  
Intracranial Aneurysms ◽  
Flow Diverter ◽  
Parent Artery ◽  
Introduction History ◽  
United States Food ◽  
Diseased Vessel ◽  
States Food ◽  
Device Deployment ◽  
Bench Testing ◽  
Flow Diverters

Abstract The introduction of flow diverter technology to the field of neurointervention has revolutionized the treatment of intracranial aneurysms. The therapy approach has shifted from intrasaccular aneurysm treatment to exclusion of the aneurysm from the blood circulation with remodeling of the parent artery. Previously, “difficult”-to-treat aneurysms including fusiform and blister aneurysms, but also aneurysms arising from a diseased vessel segment, can now be safely and permanently treated with flow diverters.  A little over a decade ago, after extensive bench testing and refinement of the flow diverter concept, the device was eventually available for clinical use and today it has become a standard treatment for intracranial aneurysms. Currently, United States Food and Drug Administration (FDA)-approved flow diverters are the Pipeline Embolization Device (Medtronic) and the Surpass Streamline Flow Diverter (Stryker).  The devices can either be delivered or deployed via a standard femoral artery approach or a radial artery approach. Other considerations for catheter setup and device deployment strategies depending on aneurysm location or vessel anatomy are described.

Abstract 1122‐000071: Large and Giant Intracranial Aneurysms, Clinico‐Radiological Outcome and Predictors with Flow Diverter Stent

2021 ◽  
Vol 1 (S1) ◽  
Author(s):  
Islam El Malky ◽  
Ayman Zakaria ◽  
Essam Abdelhameed ◽  
Hazem Abdelkhalek
Keyword(s):  
Endovascular Treatment ◽  
Intracranial Aneurysms ◽  
Flow Diverter ◽  
Artery Occlusion ◽  
Parent Artery ◽  
Giant Aneurysms ◽  
Complex Aneurysms ◽  
Parent Artery Occlusion ◽  
Large And Giant Aneurysms ◽  
Flow Diverters

Introduction : Endovascular treatment for large and giant aneurysms has included either a reconstructive approach or a deconstructive approach by parent artery occlusion. 1,2 Stent‐assisted coiling and balloon‐assisted coiling were alternative techniques developed to deal with such complex aneurysms, but studies have shown less expected efficacy. This study aims to assess the safety and efficacy of the flow diverter stents for treating large and giant intracranial aneurysms and to examine possible predictors for radiological and clinical outcomes such as location and presence of branching artery, bifurcation, and adjuvant coiling. Methods : This study had been conducted on 65 consecutive patients with 65 large and giant aneurysms (size ≥ 10 mm) treated with flow diverters; Periprocedural complications were reported in all patients and clinical outcomes. Follow‐up angiography was done for 60 patients (92.3%) at 12 months. Results : The study included 65 patients who harbored 65 aneurysms. The median age was 55.5 years (IQR: 44.25 ‐ 62.75 years), the female represented 70.8 % of all patients. The clinical presentation had been reported (Headache, cranial nerve palsy, motor deficit, seizures, and visual field defect in 40 patients (61.5%), nine patients (13.8%), seven patients (10.8%), five patients (7.7%), and four patients (6.2%) respectively. The vascular risk factors had been reviewed (HTN, DM, smoking, and Hyperlipidemia in 25 patients (9.2%), Six patients (9.2%), sixteen (24.6%), and 10 patients (15.4%) respectively). The median size of aneurysms was 16.4 mm (IQR: 12.50 ‐ 23.85 mm) and the median neck width was 7.15 mm (IQR: 5.85‐10.24 mm). Fourteen aneurysms (21.4 %) had previous treatment, eleven aneurysms (16.9%) were treated by coils only, one case (1.5%) by assisted procedure, one case (1.5%) by previous FDS, and parent artery occlusion in one case (1.5%). Complete occlusion in 50 from 60 aneurysms (83.4%), neck remnant in 8 aneurysms (13.3%), and sac remnant in two aneurysms (3.3%). Periprocedural problems were encountered in 14 patients (21.5%) with morbidity in six patients (9.2%) and mortality in one patient (1.5%). Univariate and multivariate logistic regression analysis was used to discover possible predictors of combined mortality and morbidity and occlusion in Table (1). Conclusions : From this study, it could be concluded that Endovascular treatment of the large and giant aneurysms with flow diverters represents a safe method for treating this kind of complex intracranial aneurysms. Complex aneurysms with branching artery and bifurcation were associated with aneurysm persistence and complications respectively while the location of the aneurysm was the only predictor for clinical outcome.

scholarly journals Flow Diverters for Intracranial Aneurysms

2014 ◽  
Vol 2014 ◽  
pp. 1-12 ◽  
Author(s):  
Yazan J. Alderazi ◽  
Darshan Shastri ◽  
Tareq Kass-Hout ◽  
Charles J. Prestigiacomo ◽  
Chirag D. Gandhi
Keyword(s):  
Antiplatelet Therapy ◽  
Intracranial Aneurysms ◽  
Evidence Base ◽  
Flow Diverter ◽  
Parent Artery ◽  
Comparative Efficacy ◽  
Parent Vessel ◽  
Wide Neck ◽  
Endovascular Devices ◽  
Flow Diverters

Flow diverters (pipeline embolization device, Silk flow diverter, and Surpass flow diverter) have been developed to treat intracranial aneurysms. These endovascular devices are placed within the parent artery rather than the aneurysm sac. They take advantage of altering hemodynamics at the aneurysm/parent vessel interface, resulting in gradual thrombosis of the aneurysm occurring over time. Subsequent inflammatory response, healing, and endothelial growth shrink the aneurysm and reconstruct the parent artery lumen while preserving perforators and side branches in most cases. Flow diverters have already allowed treatment of previously untreatable wide neck and giant aneurysms. There are risks with flow diverters including in-stent thrombosis, perianeurysmal edema, distant and delayed hemorrhages, and perforator occlusions. Comparative efficacy and safety against other therapies are being studied in ongoing trials. Antiplatelet therapy is mandatory with flow diverters, which has highlighted the need for better evidence for monitoring and tailoring antiplatelet therapy. In this paper we review the devices, their uses, associated complications, evidence base, and ongoing studies.

scholarly journals Safety and efficacy results of the Flow Redirection Endoluminal Device (FRED) stent system in the treatment of intracranial aneurysms: US pivotal trial

2021 ◽  
pp. neurintsurg-2021-017469
Author(s):  
Cameron G McDougall ◽  
Orlando Diaz ◽  
Alan Boulos ◽  
Adnan H Siddiqui ◽  
Justin Caplan ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Flow Diverter ◽  
Multicenter Trial ◽  
Parent Artery ◽  
Stent System ◽  
Safety Endpoint ◽  
Performance Benchmarks ◽  
Registration Number ◽  
The Usa ◽  
Effectiveness Endpoint

ObjectiveTo evaluate the safety and effectiveness of the Flow Redirection Endoluminal Device (FRED) flow diverter in support of an application for Food and Drug Administration approval in the USA.Methods145 patients were enrolled in a prospective, single-arm multicenter trial. Patients with aneurysms of unfavorable morphology for traditional endovascular therapies (large, wide-necked, fusiform, etc) were included. The trial was designed to demonstrate non-inferiority in both safety and effectiveness, comparing trial results with performance goals (PGs) established from peer-reviewed published literature. The primary safety endpoint was death or major stroke (National Institutes of Health Stroke Scale score ≥4 points) within 30 days of the procedure, or any major ipsilateral stroke or neurological death within the first year. The primary effectiveness endpoint was complete occlusion of the target aneurysm with ≤50% stenosis of the parent artery at 12 months after treatment, and in which an alternative treatment of the target intracranial aneurysm had not been performed.Results145 patients underwent attempted placement of a FRED device, and one or more devices were placed in all 145 patients. 135/145 (93%) had a single device placed. Core laboratory adjudication deemed 106 (73.1%) of the aneurysms large or giant. A safety endpoint was experienced by 9/145 (6.2%) patients, successfully achieving the safety PG of <15%. The effectiveness PG of >46% aneurysm occlusion was also achieved, with the effectiveness endpoint being met in 80/139 (57.6%)ConclusionAs compared with historically derived performance benchmarks, the FRED flow diverter is both safe and effective for the treatment of appropriately selected intracranial aneurysms.Clinical registration numberNCT01801007

L-Arginine reduces downstream vascular contractility after flow-diverting device deployment: A preliminary study in a rabbit model

2021 ◽  
pp. 159101992110251
Author(s):  
Jennifer Ayers-Ringler ◽  
Praveen Kolumam Parameswaran ◽  
Zenith Khashim ◽  
Daying Dai ◽  
Yong-Hong Ding ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Rabbit Model ◽  
Organ Bath ◽  
Potential Mechanism ◽  
Vascular Contractility ◽  
Arginine Hydrochloride ◽  
Preliminary Study ◽  
Cox 2 ◽  
Device Deployment ◽  
Flow Diverters

Background Flow diverters (FDs) are an effective treatment for intracranial aneurysms, though not free from hemorrhagic complications. A previous study demonstrated increased vascular contractility after FD-implantation as a potential mechanism of distal complications. Our study aimed to investigate whether L-arginine medication affects vascular contractility following FD deployment in a rabbit model. Methods FDs were implanted in the aorta of normal rabbits (+FD, n = 10), with sham-operated aorta as controls (n = 5). L-Arginine was given in the drinking water (2.25% L-arginine hydrochloride) of half of the +FD animals (+FD/+Arg). Force contraction vascular contractility studies were performed on the aortic rings proximal and distal to the FD using an organ bath. Total eNOS, eNOS(pS1177), eNOS(pT495), COX-2, and S100A4 were quantified by western analysis on total protein lysates from aortic segments, normalizing to GAPDH. Results Mean vascular contractility was 53% higher in distal relative to proximal aortic segments (P = 0.0038) in +FD animals, but were not significantly different in +FD/+Arg animals, or in sham-operated controls. The +FD animals expressed significantly reduced levels of eNOS(pS1177) than sham-operated controls (P = 0.0335), while both the +FD and +FD/+Arg groups had reduced levels of eNOS(pT495) relative to sham-operated controls (P = 0.0331 and P = 0.0311, respectively). Conclusion These results suggest that L-arginine medication reduces distal vascular contractility after FD treatment via nitric oxide production and thus might mitigate risk for downstream complications.

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 ◽  
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.

scholarly journals Re-treatment of residual aneurysms after flow diversion: An experimental study

2018 ◽  
Vol 31 (3) ◽  
pp. 270-279 ◽  
Author(s):  
Robert Fahed ◽  
Tim E Darsaut ◽  
Marc Kotowski ◽  
Igor Salazkin ◽  
Jean Raymond
Keyword(s):  
Flow Diverter ◽  
Artery Occlusion ◽  
Flow Diversion ◽  
Embolic Agent ◽  
Parent Artery ◽  
Arterial Lumen ◽  
Parent Artery Occlusion ◽  
Liquid Embolic ◽  
Liquid Embolic Agent ◽  
Flow Diverters

Aim Flow diverters are increasingly used to treat aneurysms, but treatment is not always effective. The management of aneurysms that fail to occlude following flow diversion is problematic. We aimed to reproduce failures in an animal model and study re-treatment with additional flow diverters alone or with flow diverters and liquid embolic agent. Material and methods Twenty wide-necked aneurysms were created at the carotid-lingual bifurcation in 10 dogs, and were treated with flow diverters 4–6 weeks later. Follow-up angiography was performed at three months. Suitable residual aneurysms were randomly allocated: re-treatment with flow diverters alone ( n = 6), or with the injection of liquid embolic between two layers of flow diverters ( n = 4) or no re-treatment ( n = 2). Angiography was repeated three months later, followed by euthanasia, photography and pathology. Results Patent wide-necked aneurysms were produced in 17/20 attempts (85%); three months after flow diversion there were 15/17 (88%) residual aneurysms. In three cases, re-treatment was not possible because the flow diverter had prolapsed into the aneurysm, leaving 12 aneurysms to study. Re-treated aneurysms showed improved angiographic results at six months (median score of 2; P = 0.03), but residual aneurysms were present in all cases. Parent artery occlusion occurred in two aneurysms treated with flow diverter plus liquid embolic. At pathology, aneurysms were only partially filled with thrombus; leaks through the flow diverters were found in the neointima connecting the arterial lumen to residual aneurysms. Conclusion Re-treatment of residual flow-diverted experimental aneurysms with additional flow diverters did not lead to aneurysm occlusion.

Abstract 1122‐000152: Flow Diverter Use in Acutely Presented Dissecting Aneurysms, 2 Years Follow Up of 53 Cases

2021 ◽  
Vol 1 (S1) ◽  
Author(s):  
Ossama Y Mansour ◽  
Aser Goma
Keyword(s):  
Subarachnoid Hemorrhage ◽  
Clinical Outcome ◽  
Flow Diverter ◽  
Parent Artery ◽  
Modified Rankin Scale ◽  
Alternative Treatment Option ◽  
Increased Risk ◽  
Flow Diverters ◽  
Dissecting Aneurysms

Introduction : Acute dissecting aneurysms are among the uncommon causes of subarachnoid hemorrhage. Established endovascular treatment options include parent artery occlusion and stent‐assisted coiling, but appear to be associated with an increased risk of ischemic stroke. reconstruction of the vessels with flow diverters is an alternative therapeutic option. Methods : This is a retrospective analysis of 53 consecutive acutely ruptured dissecting aneurysms treated with flow diverters. The primary end point was favorable aneurysm occlusion, defined as OKM C1‐3 and D . Secondary end points were procedure‐related complications and clinical outcome. Results : 23 aneurysms (43.4%%) arose from the intradural portion of the vertebral artery, 10 (18.8%) were located on the posterior inferior cerebellar artery and 3 (5.6%) posterior cerebral artery, 7 (13.2%) MCA, (18.8%) ICA . 45 aneurysms presented by SAH while 8 presented by Ischemic manifestation. Flow diverter placement was technically successful in all cases . immediate postoperative rerupture occurred in two case (3.7%), thromboembolic complications in 3 cases (5.7%). Median clinical follow‐up was 640 days and median angiographic follow‐up was 690 days. ten patients (18.9%) with poor‐grade subarachnoid hemorrhage died in the acute phase. Favorable clinical outcome (modified Rankin scale ≤2) was observed in 27 of 53 patients (51%) and a moderate outcome (modified Rankin scale 3/4) was observed in 12 of 53 patients (22.6%). All aneurysms showed complete occlusion at follow‐up. Conclusions : Flow diverters might be a feasible, alternative treatment option for acutely symptomatic dissecting aneurysms and may effectively prevent rebleeding in ruptured aneurysms.

scholarly journals Mechanism of Action and Biology of Flow Diverters in the Treatment of Intracranial Aneurysms

Neurosurgery ◽  
2019 ◽  
Vol 86 (Supplement_1) ◽  
pp. S13-S19 ◽  
Author(s):  
Krishnan Ravindran ◽  
Amanda M Casabella ◽  
Juan Cebral ◽  
Waleed Brinjikji ◽  
David F Kallmes ◽  
...  
Keyword(s):  
Mechanism Of Action ◽  
Flow Diverter ◽  
Parent Artery ◽  
First Line ◽  
Aneurysm Neck ◽  
First Line Therapy ◽  
Preclinical Animal Models ◽  
Computational Analyses ◽  
Flow Diverters ◽  
Present Understanding

Abstract Flow diverters have drastically changed the landscape of intracranial aneurysm treatment and are now considered first-line therapy for select lesions. Their mechanism of action relies on intrinsic alteration in hemodynamic parameters, both at the parent artery and within the aneurysm sac. Moreover, the device struts act as a nidus for endothelial cell growth across the aneurysm neck ultimately leading to aneurysm exclusion from the circulation. In silico computational analyses and investigations in preclinical animal models have provided valuable insights into the underlying biological basis for flow diverter therapy. Here, we review the present understanding pertaining to flow diverter biology and mechanisms of action, focusing on stent design, induction of intra-aneurysmal thrombosis, endothelialization, and alterations in hemodynamics.

Flow diverters for intracranial aneurysms

2015 ◽  
Vol 3 (3-4) ◽  
Author(s):  
Alice Venier ◽  
Beatrice Gardenghi ◽  
Giuseppe Lanzino ◽  
Stylianos K. Rammos
Keyword(s):  
Present Article ◽  
Intracranial Aneurysms ◽  
Flow Diversion ◽  
Parent Artery ◽  
Endovascular Management ◽  
Innovative Technologies ◽  
Unruptured Aneurysms ◽  
Flow Diverters

AbstractThe progressive establishment of endovascular management in treating intracranial aneurysms had lead to continuous technique advancements and development of innovative technologies. Flow diverters are “stent-like” devices currently used for complex unruptured aneurysms allowing endoluminal reconstruction of the parent artery and occlusion of the aneurysm sac. In the present article, we review the development of flow diversion devices through

scholarly journals 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

2014 ◽  
Vol 20 (4) ◽  
pp. 428-435 ◽  
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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