Safety and Efficacy of Flow Diverter Treatment for Aneurysm in Small Cerebral Vessels: A Systematic Review and Meta-Analysis

Yan, Yazhou; Zhu, Deyuan; Tang, Haishuang

doi:10.1016/j.wneu.2018.04.009

Cited by 38 publications

(25 citation statements)

References 35 publications

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“…In 2018 Yan et al4 conducted a meta-analysis which demonstrated that FD treatment of small vessel aneurysms was technically feasible and effective with a 70% complete occlusion rate. Procedure-related morbidity and mortality rates were 9% and 4% respectively.…”

Section: Discussionmentioning

confidence: 99%

Periprocedural safety and technical outcomes of the new Silk Vista Baby flow diverter for the treatment of intracranial aneurysms: results from a multicenter experience

Martínez‐Galdámez

Biondi

Kalousek

et al. 2019

J NeuroIntervent Surg

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PurposeThe aim of our study was to assess the technical success and the safety of this new low-profile flow diverter Silk Vista Baby (SVB) by evaluating the intraprocedural and periprocedural complication rate.Material/methodsClinical, procedural, and angiographic data were analyzed.Results: 41 consecutive patients (28 women; age average 50.5 years) with 43 aneurysms were treated with SVB. Aneurysm sizes were classified by their maximum diameter, with an average size of 9.5 mm (range 2–30 mm). Thirty-four cases were unruptured. five aneurysms previously ruptured, had recurrence after the initial coiling. There were two ruptured cases. Aneurysms' locations were: M1 segment (five cases), M2 segment (three cases), M3 segment (one case), middle cerebral artery (MCA) bifurcation (six cases), carotid-T (two cases), anterior communicating artery/A1/A2 (11 cases), pericallosal artery (four cases), supraclinoid ICA (two cases), PCom (one case), V4 segment (three cases), PCA (three cases), SCA (one case), and PICA (one case). We had five intraprocedural complications which resolved without clinical consequences and three events postprocedural events. Initial occlusion rates were: eight aneurysms (18.6%) were completely occluded, five aneurysms (11.6%) showed near-complete occlusion, four cases (9.3%) showed incomplete filling, and 26 cases (60.4%) showed persisting filling. The mRS score at discharge from the hospital did not change from the admission mRS score.ConclusionOur study demonstrated that the use of the new low-profile flow diverter, SVB device, for the treatment of intracranial aneurysms is feasible and technically safe.

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Section: Discussionmentioning

confidence: 99%

Periprocedural safety and technical outcomes of the new Silk Vista Baby flow diverter for the treatment of intracranial aneurysms: results from a multicenter experience

Martínez‐Galdámez

Biondi

Kalousek

et al. 2019

J NeuroIntervent Surg

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“…With published reports of safe off label use for aneurysms beyond the petrous to ophthalmic ICA and development of second generation FDS, the IFU has since expanded to small (<7 mm) and medium (7-15 mm), wide neck aneurysms of the entire intracranial ICA. To date, safe off-label use has been reported for cerebral aneurysms in most cerebrovascular territories with a parent vessel diameter of 2-5 mm 6,9,10,16,18,21,26,47,73,94,107,120,121) .…”

Section: Development Of Flow-diverting Stents (Fds)mentioning

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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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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“…The metal coverage of the devices varies as a parabolic function of the ratio between the vessel and the device and typically oversizing of a FDS will result in reduced metal coverage and increased porosity that could theoretically result in a reduced aneurysm occlusion rate [28,29]. The inherent oversizing that would have been unavoidable with previous iterations of flow diverter, therefore, may have accounted for the relative low aneurysm occlusion rates seen in the study of Yan et al [27] as well as the higher rate of occlusion seen when overlapping stents were used. Similarly, inappropriate sizing may alter the patency of any covered side branches which is more likely to occur when these devices are used in the distal circulation [30].…”

Section: Discussionmentioning

confidence: 98%

“…All patients had a good functional outcome (mRS 0-2) and there were 2 cases of perforator vessel stroke (4.3%) but no hemorrhagic complications. Yan et al [27] sought to determine the efficacy of flow diversion in small caliber vessels. In their meta-analysis, comprising 26 non-comparative studies and 572 aneurysms, the overall technical success rate of the FDS treatment reached 96% (95% confidence interval, CI = 0.93-1.00) with good long-term clinical outcome seen in 96% (95% CI = 0.93-0.99).…”

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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Safety and Efficacy of Flow Diverter Treatment for Aneurysm in Small Cerebral Vessels: A Systematic Review and Meta-Analysis

Cited by 38 publications

References 35 publications

Periprocedural safety and technical outcomes of the new Silk Vista Baby flow diverter for the treatment of intracranial aneurysms: results from a multicenter experience

Periprocedural safety and technical outcomes of the new Silk Vista Baby flow diverter for the treatment of intracranial aneurysms: results from a multicenter experience

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

The p48MW Flow Diverter—Initial Human Experience

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