Multicenter Study of Pipeline Flex for Intracranial Aneurysms

Brasiliense, Leonardo B.C.; Aguilar‐Salinas, Pedro; Lopes, Demetrius K.; Nogueira, Danilo M; DeSousa, Keith; Nelson, Peter Kim; Moran, Christopher J.; Mazur, Marcus D.; Taussky, Philipp; Park, Min S; Dabus, Guilherme; Linfante, Italo; Chaudry, Imran; Turner, Ray D; Spiotta, A; Turk, Aquilla S; Siddiqui, Adnan H.; Levy, Elad I.; Hopkins, L. Nelson; Arthur, Adam S; Nickele, Christopher; Gonsales, Douglas; Sauvageau, Eric; Hanel, Ricardó A.

doi:10.1093/neuros/nyy422

Cited by 18 publications

(12 citation statements)

References 19 publications

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“…12,19 Both devices and the Pipeline Flex Embolization Device (Medtronic, Irvine, CA) are resheathable and allow repositioning. 12,19,20 Finally, the new target to reduce thromboembolic complications is the modification of the construct surface, as observed in the Pipeline Embolization Device Flex with Shield Technology. 11 The DED (Acandis, Pforzheim, Germany) is an FD consisting of 24 wires that are looped at the closed distal end and thus result in a braid of 48 wires.…”

Section: Stroke September 2019mentioning

confidence: 99%

Derivo Embolization Device for the Treatment of Intracranial Aneurysms

Trivelato

Abud

Ulhôa

et al. 2019

Stroke

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Background and Purpose— Flow diverter technology improvements are necessary to provide safe and good results and enable the treatment of a larger variety of aneurysms. We report a nationwide experience with the Derivo Embolization Device in the treatment of intracranial aneurysms. Methods— BRAIDED (Brazilian Registry of Aneurysms Assigned to Intervention With the Derivo Embolization Device) is a multicenter, prospective, interventional, single-arm trial of the Derivo Embolization Device for the treatment of intracranial aneurysms. The primary effectiveness end point was total aneurysm occlusion at 6- and 12-month angiographies. The secondary safety end point was the absence of serious adverse events during follow-up. Univariable and multivariable logistic regression was performed to identify predictors of aneurysm persistence, periprocedural complications, and adverse events during follow-up. Results— Between December 2016 and October 2018, 146 patients harboring 183 intracranial aneurysms were treated in 151 interventions at 7 centers. Derivo Embolization Device placement was technically successful in all patients. Most aneurysms (86.9%) were located at the internal carotid artery, and the mean diameter was 6.7 mm. At 6 months, 113 of 140 (80.7%) aneurysms met the study’s primary end point, and 74 of 83 (89.2%) met the study’s primary end point at 12 months. Saccular morphology of the aneurysm (odds ratio, 5.66; 95% CI, 1.01–31.77) and the presence of a branch arising from the sac (odds ratio, 6.36; 95% CI, 2.11–22.36) predicted persistence. A long duration of follow-up (odds ratio, 0.86; 95% CI, 0.78–0.95) predicted total occlusion. Of the 146 enrolled patients, 138 (94.5%) were treated without serious adverse events during follow-up. In the multivariable analysis, aneurysms located at a sidewall were less likely to experience these events than those located at bifurcations (odds ratio, 0.07; 95% CI, 0.01–0.51). Conclusions— The Derivo Embolization Device is a safe and effective treatment for intracranial aneurysms. Clinical Trial Registration— URL: http://plataformabrasil.saude.gov.br/login.jsf . Unique identifier: CAAE 77089717.7.1001.5125.

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Section: Stroke September 2019mentioning

confidence: 99%

Derivo Embolization Device for the Treatment of Intracranial Aneurysms

Trivelato

Abud

Ulhôa

et al. 2019

Stroke

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“…It received a positive response from the interventional neuroradiology community, has an acceptable safety profile, and has a high rate of successful aneurysm occlusion. 5 , 6…”

Section: Introductionmentioning

confidence: 99%

Pipeline Flex embolisation device with Shield Technology for the treatment of patients with intracranial aneurysms: periprocedural and 6 month outcomes

2020

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Background and purpose The Pipeline Flex embolisation device with Shield Technology (Pipeline Shield) is a novel flow diverter which reduces intra-vessel thrombogenicity. This study summarises periprocedural outcomes and 6-month follow-up results following its introduction in a tertiary interventional neuroradiology centre. Materials and methods This prospective, single-arm study assessed 32 aneurysms treated over a 21-month time period from the time of procedure to 6 months post-procedure. Data collected included patient demographics, aneurysm features and intraprocedural and 6-month post-procedural complications. Results The mean age of the cohort was 58.8 ± Standard Deviation 8.5 years. Twenty-eight aneurysms were treated electively and four acutely. The elective cases received dual antiplatelet therapy post-procedure. The acute cases received single antiplatelet therapy post-procedure. Of the target aneurysms, 16/32 (50%) were small (<10 mm), 13/32 (41%) were large (10–25 mm) and 3/32 (9%) were giant (≥25 mm). There was no mortality in the series. There were two periprocedural complications (2/32, 6.2%): a stroke and a dissection. There were no post-procedural complications. At 6 months post-procedure, satisfactory occlusion (defined as Raymond–Roy 1 or 2) was achieved in 90.6% and 93.8% by way of magnetic resonance angiography and digital subtraction angiography assessment, respectively. There was no implant migration, no significant intraluminal hyperplasia or in-stent stenosis and no cases of aneurysm recurrence. Conclusion The Pipeline Shield has an excellent 6- month safety profile with an acceptable rate of intraprocedural complications, no post-procedure complications and no mortality in this case series of 32 acute and elective cases.

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“…The PED Flex device is the second refined version approved in 2015 to address the disadvantages of the previous-generation device, with improved releasing system, improved resheathing capability, and modified pusher wire ( 42 , 43 ). Studies have shown improved clinical outcomes of the PED Flex device, with decreases in the surgical time, technical failure, and procedural complications ( 44 – 46 ). With the development of science and technology, flow diverters may be further refined, and the risk profile of flow diverters may be decreased over the years with newer iteration of the devices, resulting in better clinical outcomes.…”

Section: Discussionmentioning

confidence: 99%

Effects of stent-assisted coiling in comparison with flow diversion on intracranial aneurysms

Guo

Liu

et al. 2022

Front. Neurol.

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ObjectiveThe aim of this study was to investigate the efficacy and complications of stent-assisted coiling in comparison with flow diversion for wide-necked intracranial aneurysms.MethodsPatients with wide-necked intracranial aneurysms who were treated with stent-assisted coiling or flow diversion were respectively, enrolled into the stent-assisted coiling or flow diversion treatment group. The clinical and angiographic data were analyzed.ResultsA total of 61 patients with intracranial aneurysms underwent stent-assisted coiling, including 35 (57.4%) female and 26 (42.6%) male patients with 21 (34.4%) ruptured and 40 (65.6%) unruptured aneurysms. Also, 53 patients underwent deployment of flow-diverting devices, including 30 (56.6%) female and 23 (43.4%) male patients with 25 (47.2%) ruptured and 28 (52.8%) unruptured aneurysms. Stent-assisted coiling was performed successfully in 60 patients with 63 stents deployed, and immediate aneurysm occlusion was complete occlusion in 38 (62.3%) aneurysms, residual neck in 12 (19.7%), and residual aneurysm in 10 (16.4%). Procedure-related complications included in-stent thrombosis in three (4.9%) patients, coil protrusion in three (4.9%), and re-rupture of one (1.6%) aneurysm, with a total complication rate of 11.5%. In the flow diversion group, a pipeline embolization device alone was deployed in each of the 24 (45.3%) patients, adjunctive coiling combined with a pipeline device in 29 (54.7%), and double pipeline devices in each of the 6 (11.3%) patients. Immediately after treatment, complete occlusion was achieved in 3 (5.7%) patients with adjunctive coiling, residual neck in 3 (5.7%), and residual aneurysm in 47 (88.7%). Procedure-related complications included aneurysm rebleeding in one patient (1.9%). Clinical and angiographic follow-up was performed 13–49 months (median 29) after the procedure for 49 (80.3%) patients with stent-assisted coiling, with complete aneurysm occlusion in 27 (55.1%) aneurysms, residual neck in 3 (6.1%), residual aneurysm in 5 (10.2%), and recurrence in 14 (28.6%). Follow-up was performed for 14–37 (median 25) months in 45 (84.9%) patients with flow diversion treatment, with complete occlusion in 39 (86.7%) patients, residual neck in 5 (11.1%), residual aneurysm in 1 (2.2%), and no aneurysm recurrence.ConclusionsStent-assisted coiling comes with more complications but fewer permanent aneurysm occlusions than flow diverters, and flow diverters are superior to stent-assisted coiling in the treatment of wide-necked intracranial aneurysms, especially in the long-term effect.

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Multicenter Study of Pipeline Flex for Intracranial Aneurysms

Cited by 18 publications

References 19 publications

Derivo Embolization Device for the Treatment of Intracranial Aneurysms

Derivo Embolization Device for the Treatment of Intracranial Aneurysms

Pipeline Flex embolisation device with Shield Technology for the treatment of patients with intracranial aneurysms: periprocedural and 6 month outcomes

Effects of stent-assisted coiling in comparison with flow diversion on intracranial aneurysms

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