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

2021 ◽  
pp. neurintsurg-2020-017262
Author(s):  
Luis Henrique de Castro-Afonso ◽  
Guilherme Seizem Nakiri ◽  
Thiago Giansante Abud ◽  
Lucas Moretti Monsignore ◽  
Rafael Kiyuze Freitas ◽  
...  

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.

2021 ◽  
pp. neurintsurg-2020-017024
Author(s):  
Luis Henrique de Castro-Afonso ◽  
Guilherme Seizem Nakiri ◽  
Thiago Giansante Abud ◽  
Lucas Moretti Monsignore ◽  
Rafael Kiyuze de Freitas ◽  
...  

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.


Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Ajay K Wakhloo ◽  
Pedro Lylyk ◽  
Joost de Vries ◽  
Matthew J Gounis ◽  
Alexandra Biondi ◽  
...  

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.


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 12 ◽  
Author(s):  
Guillaume Charbonnier ◽  
Jean-Philippe Desilles ◽  
Simon Escalard ◽  
Benjamin Maier ◽  
Gabriele Ciccio ◽  
...  

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.


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 24 (5) ◽  
pp. 482-488 ◽  
Author(s):  
Toshinori Matsushige ◽  
Shigeyuki Sakamoto ◽  
Daizo Ishii ◽  
Katsuhiro Shinagawa ◽  
Koji Shimonaga ◽  
...  

Background and purpose Current large-bore catheters can be easily and safely placed in the intracranial vessels for the stabilization of microcatheters in several neurointervention scenarios. We considered that a novel 3.4 French catheter (TACTICS, Technorat Corporation, Aichi, Japan) might be useful for intermediate/distal access in a triaxial system. Here, we present our initial experience using the TACTICS catheter for treatment of intracranial aneurysms. Materials and methods A total of 35 endovascular coils were placed to embolize unruptured intracranial aneurysms of the anterior circulation using the TACTICS catheter between December 2016 and November 2017. These procedures were retrospectively reviewed to assess aneurysmal obliteration (Raymond’s classification), the volume embolization ratio (VER) and procedural complications in comparison with 96 conventional coil treatments during the 3-year period up to 2016. Data were matched for aneurysmal morphology (location, maximum diameter and aspect ratio) by the propensity method. Results In all procedures, the TACTICS catheter was atraumatically landed beyond the carotid siphon. There were no hemorrhagic or symptomatic ischemic complications. After propensity matching, 68 procedures were assessed (34 in each group). Achievement of Raymond’s scale 1 (complete occlusion) showed the same frequency in both groups (50% vs. 50%, p = 0.23). The VER was significantly higher with the TACTICS catheter than with the conventional method (34.0% vs. 28.7%, p = 0.003). Conclusion We reviewed our initial experience of the TACTICS catheter. It can be used as an intermediate catheter for safe and effective endovascular coil embolization of anterior circulation aneurysms.


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.


Author(s):  
Laurent Thines ◽  
Philippe Bourgeois ◽  
Jean-Paul Lejeune

Background:The ISAT and ISUIA studies, along with the improvement of endovascular treatment (EVT) have strongly influenced the management of intracranial aneurysms (IAs). We present our experience in the microsurgical treatment of unruptured IAs (UIAs) in this context.Methods:We retrospectively reviewed a consecutive series of non-giant UIAs selected for surgery during a five-year period. Patients and aneurysms characteristics, surgical results and outcome assessed by the Glascow Outcome Scale (GOS) at three month follow-up were studied.Results:Eighty-five patients underwent 93 surgical procedures to obliterate 113 UIAs. Those were incidental in 89% of the cases and mainly located on the middle cerebral artery (65%). Patients were assigned to surgery according to their medical history (young, previous subarachnoid haemorrhage), aneurysm characteristics (wide neck, branch at the neck, “small” size, associated “surgical” aneurysm) or failure of EVT (5%). Operatively, 48% of UIAs had thin wall or blebs and 71% were occluded with one titanium clip. Thrombectomy or temporary clipping were necessary in 4% and 11% of the cases, three aneurysms peroperatively ruptured, four were deemed unclippable, three paraclinoid UIAs had an intracavernous residue and 16% were wrapped because of a small neck remnant (class 2). The mortality rate was 0% and 4% of the patients experienced a definitive major neurological deterioration. Final GOS was unchanged in 96% of the patients.Conclusions:Despite reduction in operative cases and in appropriately selected patients ineligible to EVT, microsurgical clipping of non-giant anterior circulation UIAs can still achieve good outcome with very low mortality and neurological morbidity.


2013 ◽  
Vol 02 (02) ◽  
pp. 182-188 ◽  
Author(s):  
Krzysztof Kadzioloka ◽  
Laurent Estrade ◽  
Laurent Pierot ◽  
Girish Rajpal

AbstractFlow diverter stents (FDS) are new neuroendovascular tools able to achieve the complete and curative treatment of aneurysm by reconstruction of the parent arteries from which the aneurysm arises. We present our initial experience with flow diverter embolization devices and follow-up results.Patients with large, giant and wide necked aneurysms, saccular, fusiform and recurrent aneurysms were selected for the treatment. All patients were pretreated with dual antiplatelet agents at least for 7 days before procedure and continued taking both agents for 3 months after treatment. A MRI was done after 3 months of treatment and digital subtraction angiogram was performed at 4 months of treatment. After 1 year both MRI and digital subtraction angiogram was performed.11 patients (age range 37 year to 79 year, mean 51.1) with 11 intracranial aneurysms were treated with 15 flow diverter stents. 9 aneurysm were located on the anterior circulation and 2 on posterior circulation. 8 aneurysms were large (10-25 mm), 2 were small (<10 mm) and 1 was giant (>25 mm) with mean largest diameter of 13.22 mm. 9 were saccular aneurysm and 2 were fusiform, out of these 3 were remnant of the previously treated aneurysm. Treatment was achieved with 10 Silk stents in 7 patients and 5 Pipeline embolization devices in 4 patients. The mean time between treatment and follow up was 9.6 months (range 4-12 months). One mortality was noted due to rebleed after 3 weeks of treatment. Complete angiographic occlusion was achieved in 9 (90%) patients after 4 months and 1 (10%) patient had near complete occlusion at 12 months. All the patients were stable clinically during follow up period.Endovascular treatment with FDS is safe, easy, and permanent treatment for the selected group of aneurysms. The complete occlusion rate in follow-up study approaches 100% with no angiographic recurrence in this study.


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