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The FRED flow-diverter stent for intracranial aneurysms: clinical study to assess safety and efficacy.

ABSTRACT:

Background and purpose

Flow-diverter stents are emerging for the endovascular treatment of difficult-to-treat or otherwise untreatable cerebral aneurysms (wide-neck, fusiform, dissecting, blisterlike, or giant). We assessed the clinical safety and efficacy of the Flow-Redirection Endoluminal Device.

Materials and methods

This was an institutional review board-approved single-center observational clinical study in 29 patients with 34 aneurysms elected to be treated by endovascular intervention. After providing informed consent, patients were included according to the following criteria: aneurysm fundus-to-neck ratio <2 or neck diameter >4 mm, fusiform, dissecting, or giant aneurysms. The primary end point for clinical safety was the absence of death, absence of major or minor stroke, and absence of transient ischemic attack. The primary end point for treatment efficacy was complete angiographic occlusion according to the O'Kelly Marotta grading scale immediately after the procedure and at follow-up after 3 and 6 months (O'Kelly Marotta D: complete occlusion).

Results

The Flow-Redirection Intraluminal Device deployment was technically successful in all cases. In 26/29 (89%) of patients, the primary end point of safety was reached; in the 3 remaining patients, 1 disabling ischemic stroke and 2 minor strokes with complete recovery at follow-up were observed. Angiographic (DSA and MRA) and clinical follow-up were available after 3 months in 29/29 (100%) and after 6 months in 25/29 (86%) patients (after 6 months, only MRA follow-up was performed according to our study protocol and institutional standard). At 3-month follow-up, complete occlusion was reached in 19/34 aneurysms (O'Kelly Marotta D: 19/34; 56%). At 6-month follow-up, aneurysm occlusion was complete in 22/30 aneurysms (O'Kelly Marotta D: 22/30; 73%).

Conclusions

Deployment of the Flow-Redirection Intraluminal Device flow-diverter stent is safe and effective in the treatment of difficult-to-treat or otherwise untreatable intracranial aneurysms.

SUBMITTER: Mohlenbruch MA

PROVIDER: S-EPMC8013015 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe implantation of flow-diverter stents for the treatment of ruptured intracranial aneurysms required further investigation.PurposeOur aim was to analyze the outcomes after flow diversion of ruptured intracranial aneurysms.Data sourcesA systematic search of 3 databases was performed for studies published from 2006 to 2018.Study selectionAccording to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we included studies (from 2010 to 2018) reporting acutely ruptured intracranial aneurysms treated with flow diversion.Data analysisRandom-effects meta-analysis was used to pool the following: aneurysm occlusion rate, complications, rebleeding, and factors influencing the studied outcomes.Data synthesisWe included 20 studies evaluating 223 patients with acutely ruptured intracranial aneurysms treated with flow-diverter stents. Immediate angiographic occlusion was obtained in 32% (29/86; 95% CI, 15.4%-48%; I2 = 79.6%) of aneurysms, whereas long-term complete/near-complete aneurysm occlusion was 88.9% (162/189; 95% CI, 84%-93.5%; I2 = 20.9%) (mean radiologic follow-up of 9.6 months). The treatment-related complication rate was 17.8% (42/223; 95% CI, 11%-24%; I2 = 52.6%). Complications were higher in the posterior circulation (16/72 = 27%; 95% CI, 14%-40%; I2 = 66% versus 18/149 = 11.7%; 95% CI, 7%-16%; I2 = 0%) (P = .004) and after treatment with multiple stents (14/52 = 26%; 95% CI, 14%-45%; I2 = 59%) compared with a single stent (20/141 = 10%; 95% CI, 5%-15%; I2 = 0%) (P = .004). Aneurysm rebleeding after treatment was 4% (5/223; 95% CI, 1.8%-7%; I2 = 0%) and was higher in the first 72 hours.LimitationsSmall and retrospective series.ConclusionsFlow-diversion treatment of ruptured intracranial aneurysms yields a high rate of long-term angiographic occlusion with a relatively low rate of aneurysm rebleeding. However, treatment is associated with a complication rate of 18%. When coiling or microsurgical clipping are not feasible strategies, anterior circulation ruptured aneurysms can be effectively treated with a flow-diversion technique, minimizing the number of stents deployed. Given the 27% rate of complications, flow diversion for ruptured posterior circulation aneurysms should be considered only in selected cases not amenable to other treatments.