Multicenter Experience with FRED Jr Flow Re-Direction Endoluminal Device for Intracranial Aneurysms in Small Arteries

Möhlenbruch, Markus; Kızılkılıç, Osman; Killer‐Oberpfalzer, Monika; Baltacıoğlu, Feyyaz; Işlak, Civan; Bendszus, Martin; Çekirge, Saruhan; Saatçi, Işıl; Koçer, Naci

doi:10.3174/ajnr.a5332

Cited by 68 publications

(54 citation statements)

References 23 publications

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“…A recent metaanalysis of coil embolization techniques for distal ACA aneurysms reported morbidity and mortality of 15% and 9%, respectively 92) . The recent development of low-profile braided FDS and additional design advances in FDS and their delivery systems my make distal artery aneurysm more amenable to this promising technique 82) .…”

Section: Distal Artery Aneurysmsmentioning

confidence: 99%

“…Recent advances like duallayered weave and new cell configurations target improved wall apposition, more uniform cell configuration, improved and uniform radial force, and improved delivery and resheathing. The FRED Jr (Microvention, Tustin, CA, USA) was recently introduced specifically to address the challenges of using FDS in small distal arteries 82,93) . While it retains the dual-layered construction of its namesake, it leverages a 36wire inner layer and 16-wire outer layer to facilitate use in vessels from 2-3 mm in diameter.…”

Section: Future Directions For Fdsmentioning

confidence: 99%

See 1 more Smart Citation

The Evolution of Flow-Diverting Stents for Cerebral Aneurysms; Historical Review, Modern Application, Complications, and Future Direction

Shin

Carroll

Elghareeb

et al. 2020

J Korean Neurosurg Soc

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In spite of the developing endovascular era, large (15-25 mm) and giant (>25 mm) wide-neck cerebral aneurysms remained technically challenging. Intracranial flow-diverting stents (FDS) were developed to address these challenges by targeting aneurysm hemodynamics to promote aneurysm occlusion. In 2011, the first FDS approved for use in the United States market. Shortly thereafter, the Pipeline of Uncoilable or Failed Aneurysms (PUFS) study was published demonstrating high efficacy and a similar complication profile to other intracranial stents. The initial FDA instructions for use (IFU) limited its use to patients 22 years old or older with wide-necked large or giant aneurysms of the internal carotid artery (ICA) from the petrous segment to superior hypophyseal artery/ophthalmic segment. Expanded IFU was tested in the Prospective Study on Embolization of Intracranial Aneurysms with PipelineTM Embolization Device (PREMIER) trial. With further post-approval clinical data, the United States FDA expanded the IFU to include patients with small or medium, wide-necked saccular or fusiform aneurysms from the petrous ICA to the ICA terminus. However, IFU is more restrictive in South Korea than in United States. Several systematic reviews and meta-analyses have sought to evaluate the overall efficacy of FDS for the treatment of cerebral aneurysms and consistently identify FDS as an effective technique for the treatment of aneurysms broadly with complication rates similar to other traditional techniques. A growing body of literature has demonstrated high efficacy of FDS for small aneurysms; distal artery aneurysms; non-saccular aneurysms posterior circulation aneurysms and complication rates similar to traditional techniques. In the short interval since the Pipeline Embolization Device was first introduced, FDS has been firmly entrenched as a powerful tool in the endovascular armamentarium. As new FDS are developed, established FDS are refined, and delivery systems are improved the uses for FDS will only expand further. Researchers continue to work to optimize the mechanical characteristics of the FDS themselves, aiming to optimize deploy ability and efficacy. With expanded use for small to medium aneurysms and posterior circulation aneurysms, FDS technology is firmly entrenched as a powerful tool to treat challenging aneurysms, both primarily and as an adjunct to coil embolization. With the aforementioned advances, the ease of FDS deployment will improve and complication rates will be further minimized. This will only further establish FDS deployment as a key strategy in the treatment of cerebral aneurysms.

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Section: Distal Artery Aneurysmsmentioning

confidence: 99%

Section: Future Directions For Fdsmentioning

confidence: 99%

The Evolution of Flow-Diverting Stents for Cerebral Aneurysms; Historical Review, Modern Application, Complications, and Future Direction

Shin

Carroll

Elghareeb

et al. 2020

J Korean Neurosurg Soc

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“…Overall, 22 included studies were retrospective series, 1,2,4,[11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28] whereas 5 articles were prospective series (details in On-line Table 3). [29][30][31][32][33]…”

Section: Quality Of Studiesmentioning

confidence: 99%

Treatment of Unruptured Distal Anterior Circulation Aneurysms with Flow-Diverter Stents: A Meta-Analysis

Cagnazzo

Perrini²,

Dargazanli

et al. 2019

AJNR Am J Neuroradiol

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BACKGROUND: The safety and efficacy of flow diversion among distal anterior circulation aneurysms must be proved. PURPOSE: Our aim was to analyze the outcomes after flow diversion among MCA, anterior communicating artery, and distal anterior cerebral artery aneurysms. DATA SOURCES: A systematic search of 3 databases was performed for studies published from 2005 to 2018. STUDY SELECTION: According to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we included studies reporting flow diversion of distal anterior circulation aneurysms. DATA ANALYSIS: Random-effects meta-analysis was used to pool aneurysm occlusion and complication rates. From the individual patient data, univariate and multivariate analyses were used to test predictors of occlusion and complications. DATA SYNTHESIS: We included 27 studies (484 aneurysms). The long-term adequate occlusion rate (O'Kelly-Marotta scale, C-D) was 82.7% (295/364; 95% CI, 77.4%-87.9%; I 2 ϭ 52%). Treatment-related complications were 12.5% (63/410; 95% CI, 9%-16%%; I 2 ϭ 18.8%), with 5.4% (29/418; 95% CI, 3.2%-7.5%; I 2 ϭ 0%) morbidity. MCA location was an independent factor associated with lower occlusion (OR ϭ 0.5, P ϭ .03) and higher complication rates (OR ϭ 1.8, P ϭ .02), compared with anterior communicating artery and distal anterior cerebral artery aneurysms. The Pipeline Embolization Device (versus other stents) gave better occlusion rates (OR ϭ 2.6, P ϭ .002), whereas large/giant aneurysms were associated with higher odds of complications (OR ϭ 2.2, P ϭ .03). The rates of occlusion and narrowing of arteries covered by flow-diverter stents were 6.3% (29/283; 95% CI, 3.5%-9.1%; I 2 ϭ 4.2%) and 23.8% (69/283; 95% CI, 15.7%-32%; I 2 ϭ 80%), respectively. Symptoms related to occlusion and narrowing of the jailed arteries were 3.5% (6/269; 95% CI, 1.1%-5%; I 2 ϭ 0%) and 3% (6/245; 95% CI, 1%-4%; I 2 ϭ 0%), respectively. LIMITATIONS: We reviewed small and retrospective series. CONCLUSIONS: Flow diversion among distal anterior circulation aneurysms is effective, leading to adequate aneurysm occlusion in 83% of cases. However, this strategy has some limitations among MCA and larger lesions, especially related to the higher rate of complications. Compared with the other devices, the Pipeline Embolization Device seems to be associated with a higher occlusion rate.

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“…To date, there are limited data on both the FRED Jnr and the Silk Vista Baby. Möhlenbruch et al [31] published their multicenter results of 42 patients with 47 aneurysms. The FRED Jnr was successfully deployed in 39/42 (93%) and the vast majority of the aneurysms treated arose from the anterior circulation (42/47, 89.4%) with 18 aneurysms located on the MCA and 24 located on the ACA.…”

Section: Discussionmentioning

confidence: 99%

The p48MW Flow Diverter—Initial Human Experience

et al. 2019

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Background and Purpose The use of flow diverters to treat aneurysms arising from small caliber parent vessels has been reported. This article reports the results of the first in experiences with the p48MW (p48 Movable Wire) in humans, a device specifically designed to target vessels 1.75-3 mm in diameter. Methods This monocentric study retrospectively reviewed the prospectively maintained database to identify all patients treated with the p48MW device between January 2017 and January 2019 at this institution. Patient demographics, aneurysm characteristics, angiographic and clinical follow-up were recorded as well as complications. Results A total of 25 patients (20 female) with an average age of 55 ± 12.9 years (range 34-84) with 25 aneurysms were identified. The majority of the aneurysms was located in the anterior circulation (19/25, 76%). The average aneurysm dome width was 3.98 ± 3.6 mm (range 1.2-13 mm). Complete occlusion was seen in 18/24 (75%) aneurysms with neck remnants in 1/24 (4.2%) and continued aneurysm filling seen in the remaining cases (5/24, 20.8%). Adequate occlusion was seen in 79.2% of aneurysms (Raymond Roy Classification [RRC] grade I or II) during the follow-up period. There was a single technical complication with inappropriate deployment of the first p48MW. There was a single clinical complication (4%); however, the patient made a complete recovery (modified Rankin Scale [mRS] 0) and one patient died secondary to uncontrollable status epilepticus following acute subarachnoid hemorrhage unrelated to the treatment. Conclusion The p48MW is safe and effective for the treatment of aneurysms including those arising from distal vessels.

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Multicenter Experience with FRED Jr Flow Re-Direction Endoluminal Device for Intracranial Aneurysms in Small Arteries

Abstract: Deployment of the FRED Jr is safe and effective in the treatment of intracranial aneurysms located in small vessels.

Cited by 68 publications

References 23 publications

The Evolution of Flow-Diverting Stents for Cerebral Aneurysms; Historical Review, Modern Application, Complications, and Future Direction

The Evolution of Flow-Diverting Stents for Cerebral Aneurysms; Historical Review, Modern Application, Complications, and Future Direction

Treatment of Unruptured Distal Anterior Circulation Aneurysms with Flow-Diverter Stents: A Meta-Analysis

The p48MW Flow Diverter—Initial Human Experience

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