Evidence map›Paper›PMID 33989398›Full record

ArticleNeurosurgery2021

Postmarket American Experience With Woven EndoBridge Device: Adjudicated Multicenter Case Series.

Jacob Cherian, Stephen R Chen, Ajit Puri, Kunal Vakharia, Elad Levy, Sheila Eshraghi, Brian M Howard, Frank C Tong, C Michael Cawley, Bradley Gross and 6 more

Erratum issuedAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Neurosurgery, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
  7. Identifying risk factors for perioperative thromboembolic complications in patients treated with the Woven EndoBridge device.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2023
    Article
  8. Article
  9. Article
  10. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

Jacob CherianDepartment of Neurosurgery, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Stephen R ChenDepartment of Radiology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Ajit PuriDepartment of Radiology, University of Massachusetts Medical School, Worcester, Massachusetts, USA.
Kunal VakhariaDepartment of Neurological Surgery, Jacobs School of Medicine at Biomedical Sciences, Buffalo, New York, USA.
Elad LevyDepartment of Neurological Surgery, Jacobs School of Medicine at Biomedical Sciences, Buffalo, New York, USA.
Sheila EshraghiDepartment of Neurosurgery, Emory University, Atlanta, Georgia, USA.
Brian M HowardDepartment of Neurosurgery, Emory University, Atlanta, Georgia, USA.
Frank C TongDepartment of Neurosurgery, Emory University, Atlanta, Georgia, USA.
C Michael CawleyDepartment of Neurosurgery, Emory University, Atlanta, Georgia, USA.
Bradley GrossDepartment of Neurological Surgery, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
Matthew D AlexanderDepartment of Radiology and Imaging Sciences, University of Utah, Salt Lake City, Utah, USA.
Ramesh GrandhiDepartment of Neurosurgery, University of Utah, Salt Lake City, Utah, USA.
Visish M SrinivasanDepartment of Neurological Surgery, Barrow Neurological Institute, Phoenix, Arizona, USA.
Jan-Karl BurkhardtDepartment of Neurosurgery, Penn Medicine, Philadelphia, Pennsylvania, USA.ORCID 0000-0002-3726-4048
Jeremiah N JohnsonDepartment of Neurosurgery, Baylor College of Medicine, Houston, Texas, USA.
Peter KanDepartment of Neurosurgery, Baylor College of Medicine, Houston, Texas, USA.

Funding

Utah Center for Clinical and Translational ScienceUL1TR002538 · NCATS · UNIVERSITY OF UTAH · PI HESS, RACHEL, MAJERSIK, JENNIFER JUHL · 2018 to 2022
$26.0M
NCATS NIH HHS UL1 TR002538
6 · The paper itself

Abstract

backgroundThe Woven EndoBridge (WEB) device was granted premarket approval in the United States following results of the Woven EndoBridge Intrasaccular Therapy (WEB-IT) study. WEB-IT reported excellent adequate angiographic occlusion of treated aneurysms with a high safety profile. These results were achieved, however, in the context of a prospective study with strict inclusion criteria and rigorous training support.

objectiveTo review early as-practiced clinical experience with the WEB device in the United States.

methodsRetrospective review across 6 institutions identified 91 patients undergoing 92 treatment sessions for WEB device placement in treatment of 91 intracranial aneurysms. Details regarding demographics, aneurysm characteristics, treatment considerations, clinical outcomes, and aneurysm occlusion were obtained and analyzed in a multicenter database. Angiograms from the index procedure and follow-up studies were reviewed by a blinded and independent adjudicator.

resultsThe middle cerebral, anterior communicating, and basilar artery complexes were the commonly treated locations. Eight patients presented with ruptured aneurysms. A mean of 1.2 devices were introduced per case. Technical failure without deployment of a WEB device occurred in 2% (2/92) of sessions. Complete aneurysm occlusion for patients with imaging follow-up was 49% (mean follow-up of 8 mo). Four aneurysms were retreated. 90% of patients had modified Rankin Scale ≤ 2 at last clinical follow-up with no mortalities.

conclusionImmediate postmarket experience with the WEB device, newly introduced at American centers, confirms safe procedural use, but long-term efficacy remains unclear. Early challenges include accurate sizing and device selection.

Indexed as

Embolization, TherapeuticEndovascular ProceduresIntracranial AneurysmHumansProspective StudiesRetrospective StudiesTreatment OutcomeUnited StatesBrain aneurysmIntrasaccular flow disruptionWEB

Identifiers

PMID33989398
PMCPMC8660628

What OpenQuestion holds

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.