Aspirin monotherapy in the treatment of distal intracranial aneurysms with a surface modified flow diverter: a pilot study

BackgroundFlow diverters (FDs) result in high occlusion rates of aneurysms located distally to the carotid artery. However, the complications reported are not negligible. New modified surface FDs have low thrombogenic properties that may reduce ischemic complications related to the treatment. In addition, a modified surface FD may allow for the use of a single antiplatelet medication to reduce hemorrhagic risk during the procedure. The aim of this study was to assess the safety and efficacy of the p48 MW HPC (phenox, Bochum, Germany) to treat distal intracranial aneurysms under the use of aspirin monotherapy.MethodsThe primary endpoint was the incidence of any neurologic deficit after treatment after 6 months of follow-up. The secondary endpoint was the rate of the complete occlusion of the aneurysms at the 6-month follow-up. Enrollment of 20 patients was planned, but after inclusion of seven patients the study was stopped due to safety issues.ResultsSeven patients with eight aneurysms were included. Among the seven patients, three (42.8%) had ischemic complications on the second day after FD deployment. Two patients experienced complete recovery at discharge (National Institutes of Health Stroke Scale (NIHSS) score=0), while one patient maintained mild dysarthria at discharge (NIHSS score=1) which improved after 6 months (NIHSS score=0). All three patients had no new symptoms during the 6-month follow-up. Complete aneurysm occlusion occurred in six (75%) of the eight aneurysms at the 6-month follow-up.ConclusionsAntiplatelet monotherapy with aspirin for the treatment of distal intracranial aneurysms with this modified surface FD resulted in a significant incidence of ischemic complications after treatment.

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Treatment of distal unruptured intracranial aneurysms using a surface-modified flow diverter under prasugrel monotherapy: a pilot safety trial

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2020-017262 ◽

2021 ◽

pp. neurintsurg-2020-017262

Author(s):

Luis Henrique de Castro-Afonso ◽

Guilherme Seizem Nakiri ◽

Thiago Giansante Abud ◽

Lucas Moretti Monsignore ◽

Rafael Kiyuze Freitas ◽

...

Keyword(s):

Intracranial Aneurysms ◽

Flow Diverter ◽

Anterior Circulation ◽

Antiplatelet Medication ◽

Unruptured Intracranial Aneurysms ◽

Trial Treatment ◽

Ischemic Complications ◽

Carotid Aneurysms ◽

Surface Modified

BackgroundFlow diverters (FDs) are effective in the treatment of carotid aneurysms. Compared with carotid aneurysms, the treatment of distal intracranial aneurysms with FDs has been associated with a relatively high incidence of complications. Low thrombogenic modified-surface FDs may reduce ischemic complications and allow for the use of a single antiplatelet medication. The aim of this study was to assess the safety and efficacy of the p48 MW HPC Flow Modulation Device (Phenox GmbH, Bochum, Germany) to treat distal intracranial aneurysms used in combination with prasugrel monotherapy.MethodsThis was a single-center, prospective, pivotal, open, single-arm study. Patients were included in this study from December 2019 to September 2020. The primary endpoints were the incidence of any neurologic deficit after treatment until 1 month of follow-up, defined as National Institutes of Health Stroke Scale (NIHSS) ≥1, and the incidence of acute ischemic lesions in magnetic resonance imagin (MRI) images 48 hours after treatment. The secondary endpoint was the rate of complete occlusion of the aneurysms at the 1-month follow-up.ResultsTwenty-one patients harboring 27 distal aneurysms of the anterior circulation were included. Mean age was 57.8 (SD 9.7) years, and 16 patients were female (80%). No patient had neurologic symptoms at the 1-month follow-up. Four patients (20%) had asymptomatic acute brain ischemic lesions on MRI. Complete aneurysm occlusion occurred in 9/27 (33.3%) aneurysms at the 1-month follow-up.ConclusionIn this pilot safety trial, treatment of distal intracranial aneurysms with p48 MW HPC under monotherapy with prasugrel appeared to be safe.

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Timing and Spectrum of Neurological Complications After Flow Diverter Implantation for Intracranial Aneurysms

Frontiers in Neurology ◽

10.3389/fneur.2021.590383 ◽

2021 ◽

Vol 12 ◽

Author(s):

Guillaume Charbonnier ◽

Jean-Philippe Desilles ◽

Simon Escalard ◽

Benjamin Maier ◽

Gabriele Ciccio ◽

...

Keyword(s):

Intracranial Aneurysms ◽

Neurological Complication ◽

Neurological Complications ◽

Flow Diverter ◽

Factors Associated ◽

Long Term Follow Up ◽

Ischemic Complications ◽

Ischemic Events

Background and Purpose: The aim of this study was to characterize neurological complications after flow diverter (FD) treatment on a long follow-up cohort and identify predictive factors associated with these complications.Methods: This study was conducted on a monocentric cohort of patients treated for intracranial aneurysms by FD.Results: Between September 2008 and July 2018, 413 patients were treated for 514 aneurysms: 18% of the patients presented with at least one neurological complication during a median follow-up of 446 days (IQR 186–1,210). Sixty-one patients presented with ischemic complications, 13 with hemorrhagic ones and 10 with compressive processes. Among 89 neurological complications 64.5% were peri-operative (occurring within the 30 days following the procedure) and 35.5% were delayed after 1 month.Conclusions: Overall, neurological complications after FD implantation were overrepresented by cerebrovascular ischemic events occurring during the peri-operative period, but also in a delayed manner after 1 year. Long-term follow-up is relevant after aneurysm intervention using FD.

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Flow diverter stents in the treatment of recanalized intracranial aneurysms

Interventional Neuroradiology ◽

10.1177/1591019921990507 ◽

2021 ◽

pp. 159101992199050

Author(s):

Erol Akgul ◽

Hasan Bilen Onan ◽

Irem Islek ◽

Mehmet Tonge ◽

Yavuz Durmus ◽

...

Keyword(s):

Intracranial Aneurysms ◽

Demographic Data ◽

Previous Treatment ◽

Flow Diverter ◽

Serious Adverse Events ◽

Clinical Complications ◽

Tertiary Hospitals ◽

The Mean ◽

Technical Complication

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

American Journal of Neuroradiology ◽

10.3174/ajnr.a2907 ◽

2012 ◽

Vol 33 (6) ◽

pp. 1150-1155 ◽

Cited By ~ 132

Author(s):

J. Berge ◽

A. Biondi ◽

P. Machi ◽

H. Brunel ◽

L. Pierot ◽

...

Keyword(s):

Multicenter Study ◽

Intracranial Aneurysms ◽

Flow Diverter ◽

Silk Stent

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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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The sensitivity and specificity of TOF-MRA compared with DSA in the follow-up of treated intracranial aneurysms

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2020-016788 ◽

2021 ◽

pp. neurintsurg-2020-016788

Author(s):

Sishi Xiang ◽

Fu Fan ◽

Peng Hu ◽

Kun Yang ◽

Xiaodong Zhai ◽

...

Keyword(s):

Sensitivity And Specificity ◽

Predictive Value ◽

Intracranial Aneurysms ◽

Imaging Modality ◽

Three Dimensional ◽

Interventional Therapy ◽

Flow Diverter ◽

Tof Mra ◽

Specificity And Sensitivity

BackgroundTime-of-flight magnetic resonance angiography (TOF-MRA) is widely used in detecting intracranial aneurysms (IA), but it is limited and controversial for use during follow-up to assess the outcome of interventional coiling or clipping surgery.MethodsTo evaluate the specificity and sensitivity of using TOF-MRA as an imaging follow-up for IA with different treatments. A total of 280 patients with 326 treated IA underwent simultaneous TOF-MRA and digital subtraction angiography (DSA) as follow-up imaging on the same day. All images were independently reviewed by two neurosurgeons and two radiologists. The consensus evaluation of intra-arterial DSA as a reference test was used to evaluate the result of aneurysm occlusions. The aneurysmal embolization status was assessed with two ratings involving complete or incomplete occlusions. We calculated the sensitivity, specificity, negative predictive value, and positive predictive value of three-dimensional-TOF-MRA to investigate the diagnostic performance.ResultsOverall sensitivity and specificity of TOF-MRA for diagnosing the remnant were 83.3% and 95.2%, respectively. The sensitivity and specificity of interventional therapy was 90.0% and 94.2%, respectively, while the clipping group showed sensitivity and specificity of 50.0% and 100%, respectively. For additional groups, involving coil only, stent-assisted, and flow diverter, the analysis of interventional therapy showed sensitivities and specificities of 100.0% and 90.1%, 66.7% and 95.1%, and 91.7% and 100%, respectively.ConclusionsTOF-MRA can be used as a first-line noninvasive imaging modality during follow-up, especially for the patients treated with a pipeline embolization device and coils only. But it may not be enough for clipped aneurysms.

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