scholarly journals Efficacy of the Flow Re-direction Endoluminal Device for cerebral aneurysms and causes of failed deployment

2021 ◽  
Author(s):  
Kenichiro Suyama ◽  
Ichiro Nakahara ◽  
Shoji Matsumoto ◽  
Yoshio Suyama ◽  
Jun Morioka ◽  
...  

Abstract Purpose The Flow Re-direction Endoluminal Device (FRED) has recently become available for flow diversion in Japan. We have encountered cases that failed to deploy the FRED. In this study, we report our initial experience with the FRED for cerebral aneurysms and clarify the causes of failed FRED deployment. Methods A retrospective data analysis was performed to identify patients treated with the FRED between June 2020 and March 2021. Follow-up digital subtraction angiography was performed at 3 and 6 months and assessed using the O’Kelly-Marotta (OKM) grading scale. Results Thirty-nine aneurysms in 36 patients (average age: 54.4 years) were treated with the FRED. The average sizes of the dome and neck were 9.9 mm and 5.2 mm, respectively. In nine patients, additional coiling was performed. In one patient (2.6%), proximal vessel injury caused direct carotid-cavernous fistula during deployment. Ischaemic complications were encountered in one patient (2.6%) with transient symptoms. Angiographic follow-up at 6 months revealed OKM grade C or D in 86.6% of patients. FRED deployment was successful in 35 (92.1%) procedures. In the failure group, the differences between the FRED and the minimum vessel diameter (P = 0.04) and the rate of the parent vessel having an S-shaped curve (P = 0.04) were greater than those in the success group. Conclusions Flow diversion using the FRED is effective and safe for treating cerebral aneurysms. The use of the FRED for patients with an S-shaped curve in the parent vessel and oversizing of more than 2 mm should be considered carefully.

2018 ◽  
Vol 7 (5) ◽  
pp. 218-232 ◽  
Author(s):  
Li-Mei Lin ◽  
Bowen Jiang ◽  
Jessica K. Campos ◽  
Narlin B. Beaty ◽  
Matthew T. Bender ◽  
...  

Background: Flow diversion with the Pipeline embolization device (PED) is an effective neuro­endovascular method and increasingly accepted for the treatment of cerebral aneurysms. Acute in situ thrombosis is a known complication of PED procedures. There is limited experience in the flow diversion literature on the use of abciximab (ReoPro) for the management of acute thrombus formation in PED cases. Methods: Data were collected retrospectively on patients who received intra-arterial (IA) ReoPro with or without subsequent intravenous (IV) infusion during PED flow diversion treatment of intracranial aneurysms. Results: A total of 30 cases in patients with a mean age of 56.7 years (range 36–84) and a mean aneurysm size of 8.6 mm (range 2–25) were identified to have intraprocedural thromboembolic complications during PED treatment. IA ReoPro was administered in all cases, with 20 cases receiving increments of 5-mg boluses and 10 cases receiving a 0.125 mg/kg IA bolus (half cardiac dosing). Complete or partial recanalization was achieved in 100% of the cases. IV ReoPro infusion at 0.125 μg/kg/min for 12 h was administered postprocedurally in 22 cases with a residual thrombus. Postprocedurally, 18 patients were transitioned from clopidogrel (Plavix) to prasugrel (Effient). The majority of the cases (23/30; 77%) were discharged home. Periprocedural intracranial hemorrhage was noted in 2 cases (7%) and radiographic infarct was noted in 4 cases (13%), with an overall mortality of 0% at the time of initial discharge. Clinical follow-up was available for 28/30 patients. The average duration of follow-up was 11.7 months, at which time 23/28 (82%) of the patients had a modified Rankin Scale score of 0. Conclusions: IA ReoPro administration is an effective and safe rescue strategy for the management of acute intraprocedural thromboembolic complications during PED treatment. Using a dosing strategy of either 5-mg increments or a 0.125 mg/kg IA bolus (half cardiac dosing) can provide high rates of recanalization with low rates of hemorrhagic complications and long-term morbidity.


2018 ◽  
Vol 15 (6) ◽  
pp. 624-633 ◽  
Author(s):  
Fawaz Al-Mufti ◽  
Krishna Amuluru ◽  
Eric R Cohen ◽  
Vikas Patel ◽  
Mohammad El-Ghanem ◽  
...  

Abstract Flow diverting devices (FDDs) have revolutionized the treatment of morphologically complex intracranial aneurysms such as wide-necked, giant, or fusiform aneurysms. Although FDDs are extremely effective, they carry a small yet significant risk of intraprocedural complications. As the implementation of these devices increases, the ability to predict and rapidly treat complications, especially those that are iatrogenic or intraprocedural in nature, is becoming increasingly more necessary. Our objective in this paper is to provide a descriptive summary of the various types of intraprocedural complications that may occur during FDDs deployment and how they may best be treated. A systematic and qualitative review of the literature was conducted using electronic databases MEDLINE and Google Scholar. Searches consisted of Boolean operators “AND” and “OR” for the following terms in different combinations: “aneurysm,” “endovascular,” “flow diverter,” “intracranial,” and “pipeline.” A total of 94 papers were included in our analysis; approximately 87 of these papers dealt with periprocedural endovascular (mainly related to FDDs) complications and their treatment; 7 studies concerned background material. The main categories of periprocedural complications encountered during deployment of FDDs are failure of occlusion, parent vessel injury and/or rupture, spontaneous intraparenchymal hemorrhage, migration or malposition of the FDDs, thromboembolic or ischemic events, and side branch occlusion Periprocedural complications occur mainly due to thromboembolic events or mechanical issues related to device deployment and placement. With increasing use and expanding versatility of FDDs, the understanding of these complications is vital in order to effectively manage such situations in a timely manner.


2019 ◽  
Vol 11 (9) ◽  
pp. 903-907 ◽  
Author(s):  
Christopher T Primiani ◽  
Zeguang Ren ◽  
Peter Kan ◽  
Ricardo Hanel ◽  
Vitor Mendes Pereira ◽  
...  

BackgroundIntracranial aneurysms located in the distal vessels are rare and remain a challenge to treat through surgical or endovascular interventions.ObjectiveTo describe a multicenter approach with flow diversion using the pipeline embolization device (PED) for treatment of distal intracranial aneurysms.MethodsCases of distal intracranial aneurysms defined as starting on or beyond the A2 anterior cerebral artery, M2 middle cerebral artery, and P2 posterior cerebral artery segments were included in the final analysis.Results65 patients with distal aneurysms treated with the PED were analyzed. Median aneurysm size at the largest diameter was 7.0 mm, 60% were of a saccular morphology, and 9/65 (13.8%) patients presented in the setting of acute rupture. Angiographic follow-up data were available for 53 patients, with a median follow-up time of 6 months: 44/53 (83%) aneurysms showed complete obliteration, 7/53 (13.2%) showed reduced filling, and 2/53 (3%) showed persistent filling. There was no association between patient characteristics, including aneurysm size (P=0.36), parent vessel diameter (P=0.27), location (P=0.81), morphology (P=0.63), ruptured status on admission (P=0.57), or evidence of angiographic occlusion at the end of the embolization procedure (P=0.49). Clinical outcome data were available for 60/65 patients: 95% (57/60) had good clinical outcome (modified Rankin Scale score of 0–2) at 3 months.ConclusionsThis large multicenter study of patients with A2, M2, and P2 distal aneurysms treated with the PED showed that flow diversion may be an effective treatment approach for this rare type of vascular pathology. The procedural compilation rate of 7.7% indicates the need for further studies as the flow diversion technology constantly evolves.


2016 ◽  
Vol 23 (1) ◽  
pp. 34-40 ◽  
Author(s):  
Sophia F Shakur ◽  
Victor A Aletich ◽  
Sepideh Amin-Hanjani ◽  
Ahmed E Hussein ◽  
Fady T Charbel ◽  
...  

Background Pipeline embolization devices (PEDs) are commonly used for endovascular treatment of cerebral aneurysms but can be associated with delayed ipsilateral intraparenchymal hemorrhage. Although intra-aneurysmal hemodynamic changes have been studied, parent vessel and intracranial hemodynamics after PED use are unknown. We examine the impact of flow diversion on parent artery and distal intracranial hemodynamics. Method Patients with internal carotid cerebral aneurysms treated with PED who had flow volume rate, flow velocities, pulsatility index, resistance index, Lindegaard ratio, and wall shear stress (WSS) obtained after treatment using quantitative magnetic resonance angiography were reviewed. Means were compared between ipsilateral and contralateral internal carotid artery (ICA) and middle cerebral artery (MCA) using paired t tests. Results A total of 18 patients were included. Mean flow volume rate was lower in the ipsilateral versus contralateral ICA ( p = 0.04) but tended to be higher in the ipsilateral versus contralateral MCA ( p = 0.08). Lindegaard ratio was higher ipsilateral to the PED in diastole ( p = 0.05). Although there was no significant difference in flow velocities, pulsatility or resistance indices, and WSS, the two cases in our cohort with hemorrhagic complications did display significant changes in MCA flows and MCA WSS. Conclusion PED placement appears to alter the elasticity of the stented ICA segment, with lower flows in the ipsilateral versus contralateral ICA. Conversely, MCA flows and MCA WSS are higher in the ipsilateral MCA among patients with hemorrhage after PED placement, suggesting the role of disrupted distal hemodynamics in delayed ipsilateral intraparenchymal hemorrhage.


2014 ◽  
Vol 20 (4) ◽  
pp. 428-435 ◽  
Author(s):  
Willem Jan van Rooij ◽  
Ratna S Bechan ◽  
Jo P. Peluso ◽  
Menno Sluzewski

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.


Author(s):  
Laura Croce ◽  
Cristina Pallavicini ◽  
Silvia Crotti ◽  
Francesca Coperchini ◽  
Linda Minnelli ◽  
...  

Abstract Purpose The relationship between thyroid function and obesity is a widely investigated one. The impact of thyroid hormones in determining the outcome of dietary/lifestyle interventions remains to be fully elucidated. The aim of this study was to compare basal and post dietary-intervention circulating thyroid-function parameters, lipid profile and fasting-glucose in euthyroid obese patients according to a success or failure of a dietary intervention program. Methods In a retrospective longitudinal case–control study we enrolled 50 euthyroid obese patients who experienced a success in dietary intervention, as defined by a BMI reduction of at least 5% from baseline (Success Group) and 50 sex and age-matched euthyroid obese patients who experienced failure in dietary intervention as defined by either stable or increased body weight throughout the follow-up (Failure Group). Serum thyroid function parameters and metabolic profile at baseline and at the end of follow-up were collected. Results At baseline, the two groups showed similar BMI, total-cholesterol, HDL-cholesterol and fasting-blood-glucose, but patients in Success Group had a significantly higher TSH as compared with Failure Group (2.20 ± 0.97 vs 1.66 ± 0.73, respectively, p < 0.001). Throughout a mean follow-up of 21.4 months TSH significantly decreased in Success Group (2.20 ± 0.97 vs 2.06 ± 0.98; p = 0.029) and increased in Failure Group (1.63 ± 0.72 vs 2.01 ± 0.99; p < 0.001). Multiple regression analysis showed that the outcome of the dietary intervention was significantly and independently related to baseline BMI (0.925; 0.861–0.993), age (0.957; 0.922–0.993), TSH (0.531; 0.290–0.973) and TSH-changes (1.011; 1.000–1.022) during follow-up. Conclusions Baseline serum TSH level is related to the final outcome of a dietary intervention program in obese patients. Level of evidence III Evidence obtained from a retrospective cohort or case–control analytic studies.


Author(s):  
Marcelo Bolcato ◽  
ana Carolina Dalmonico ◽  
Leo Ditzel ◽  
Savio Machareti ◽  
Thiago Yoshida ◽  
...  

Introduction : Endovascular flow diverters are increasingly used for the treatment of cerebral aneurysms. We assessed the safety and efficacy of the Flow Diverters in a consecutive series of 53 patients and 60 aneurysms. Methods : Inclusion criteria were wide‐neck, blister‐like, or fusiform aneurysms independent of size, treated with the FRED, PIPELINE and SILK between December 2014 and Junho 2021. Assessment criteria were aneurysm occlusion, manifest ischemic stroke, bleeding, or death. The occlusion rate was assessed at 6 months and 1 year with DSA by using the Raymond classification and the O'Kelly‐Marotta grading scale. Results : Fifty three patients (mean age 54.3 years;81.1% female) with 60 aneurysms were treated with 9 Silk, 38 FREDs and 13 Pipeline. Aneurysm size ranged from 2.5 to 30 mm. Deployment of the Flow diverters was successful in 52 aneurysms. Three patient developed mild stroke symptoms that fully receded within days, 4 patients occlusion total carotid because resistant antiagregation and another patient’s development Swelling syndrome. There has been one death. Initial follow‐up at 6 months showed complete occlusion in 90% of the overall study group and 93,33% at 1 year. Conclusions : The flow diverter is a safe device for the treatment of cerebral aneurysms of various types. Our data reveal high occlusion rates at 6 months and 1 year. Long‐term occlusion rates are expected.


Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Marc A Lazzaro ◽  
Omar Katib ◽  
Behrad Golshani ◽  
Osama O Zaidat

Introduction: The effect of oversized intracranial stent implantation, and the potential for excessive neointimal hyperplasia from the resulting chronic outward radial force, has not been previously reported. We sought to compare the angiographic narrowing associated with implantation of oversized Neuroform stents overlapping vessels of different diameters. Methods: We reviewed an aneurysm database and identified patients treated with stent-assisted coil embolization involving stent placement overlapping a vessel size transition. Patient demographics and lesion characteristics were extracted from chart review. A submillimeter digital caliper was used for angiogram measurement of lumen diameter at four sites ( figure ). The relationship between lumen diameter and stent oversizing was compared with student’s t-test and Pearson’s correlation. Results: Twenty vessels were identified in 18 patients, providing 80 paired data points. Mean age was 52 years (SD 12), with mean follow-up time of 8 months (SD 6). The distribution of vessel transitions included BA to PCA (n = 8), A1 to A2 or M1 to M2 (n = 8), ICA to ACA or MCA (n = 3), and Vertebral artery to PICA (n = 1). Stent diameter ranged from 3 mm to 4.5 mm, and the average oversizing in the smaller diameter parent vessel landing-zone was 1.75 mm (range 0.8 to 2.9 mm) greater than the vessel diameter. The mean change in lumen size from pre-stent implantation to follow-up was not significantly different for any of the four sites; the proximal end-stent decreased by 5.5% (SD 19.7), proximal mid-stent increased by 7.3% (SD 18.8), distal mid-stent increased by 14.7% (SD 13.8), and the distal end-stent decreased by 0.9% (SD 13.1). Stent oversizing by less than a factor of 1.65 resulted in a mean lumen loss of 4.1% (SD 15.6), while oversizing by greater than a factor of 1.65 resulted in a mean lumen gain of 11.1% (SD = 17.2), (p = 0.006). Conclusions: These data suggest oversized Neuroform stent implantation within the intracranial vasculature does not lead to increased stenosis. Stent oversizing by a factor of 1.65 or more leads to significant persistent luminal gain. The non-significant trend toward lumen loss at the stent tines suggests diminished radial force or greater neointimal hyperplasia at these sites, however persistent luminal gain from the oversized stent radial force likely predominates over any neointimal hyperplasia. Figure . A NF stent overlapping the M1 and M2 segments (A, tines indicated by white arrows). Four points of measurement (B), proximal tines (1.), mid-stent in proximal landing zone (2.), mid-stent in distal landing zone (3.), and distal tines (4.).


2017 ◽  
Vol 42 (6) ◽  
pp. E7 ◽  
Author(s):  
Craig Kilburg ◽  
Philipp Taussky ◽  
M. Yashar S. Kalani ◽  
Min S. Park

The use of flow-diverting stents for intracranial aneurysms has become more prevalent, and flow diverters are now routinely used beyond their initial scope of approval at the proximal internal carotid artery. Although flow diversion for the treatment of cerebral aneurysms is becoming more commonplace, there have been no reports of its use to treat flow-related cerebral aneurysms associated with arteriovenous malformations (AVMs). The authors report the cases of 2 patients whose AVM-associated aneurysms were managed with flow diversion. A 40-year-old woman presented with a history of headaches that led to the identification of an unruptured Spetzler-Martin Grade V, right parietooccipital AVM associated with 3 aneurysms of the ipsilateral internal carotid artery. Initial attempts at balloon-assisted coil embolization of the aneurysms were unsuccessful. The patient underwent placement of a flow-diverting stent across the diseased vessel; a 6-month follow-up angiogram demonstrated complete occlusion of the aneurysms. In the second case, a 57-year-old man presented with new-onset seizures, and an unruptured Spetzler-Martin Grade V, right frontal AVM associated with an irregular, wide-necked anterior communicating artery aneurysm was identified. The patient underwent placement of a flow-diverting stent, and complete occlusion of the aneurysm was observed on a 7-month follow-up angiogram. These 2 cases illustrate the potential for use of flow diversion as a treatment strategy for feeding artery aneurysms associated with AVMs. Because of the need for dual antiplatelet medications after flow diversion in this patient population, however, this strategy should be used judiciously.


2019 ◽  
Vol 26 (1) ◽  
pp. 61-67 ◽  
Author(s):  
Jean Raymond ◽  
Anne-Christine Januel ◽  
Daniela Iancu ◽  
Daniel Roy ◽  
Alain Weill ◽  
...  

Background Wide-necked bifurcation aneurysms (WNBA) are a difficult subset of aneurysms to successfully repair endovascularly, and a number of treatment adjuncts have been designed to improve on the results of coiling, including stenting and flow diversion of the parent vessel. Surgical clipping is commonly performed for certain WNBAs, such as middle cerebral aneurysms, in some centres. Intra-saccular flow diversion (ISFD) using the Woven Endo-Bridge (WEB) or similar devices, has been developed as a new endovascular alternative to coiling for WNBAs. Meta-analyses of case series suggest satisfactory results, both in terms of safety and efficacy, but in the absence of randomized evidence, whether ISFD leads to better outcomes for patients with WNBA remains unknown. There is a need to offer ISFD within the context of a randomized care trial. Methods The proposed trial is a multicentre, randomized controlled care trial comparing ISFD and best conventional management option (surgical or endovascular), as determined by the treating physician prior to randomized allocation. At least 250 patients will be recruited in at least 10 centres over a four-year period, and followed for one year, to show that ISFD can increase the incidence of successful therapy from 75 to 90% of patients, defined as complete or near-complete occlusion of the aneurysm AND a good clinical outcome (mRS ≤ 2) at one year. The trial will be followed by an independent data safety monitoring committee to assure the safety of participants. Conclusion Introduction of intra-saccular flow diversion can be accomplished within a care trial context.


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