Evidence map›Paper›PMID 32005761›Full record

SynthesisJournal of neurointerventional surgery2020

How safe and effective are flow diverters for the treatment of unruptured small/medium intracranial aneurysms of the internal carotid artery? Meta-analysis for evidence-based performance goals.

David Fiorella, Larry Gache, Diana Frame, Adam S Arthur

Open access · hybridAbstract readMeta-Analysis
In one paragraph

Synthesis in Journal of neurointerventional surgery, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 5 pooled it
3.0field-weighted citation impact, top 7% of its field
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

25 citing papers in PubMed, 5 syntheses or guidelines pooled it, 50 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Patient outcomes after treatment of brain aneurysm in small diameter vessels with the silk vista baby flow diverter: A systematic review.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2024
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Article
  8. Article
  9. Observational
  10. Article
  11. Observational
  12. Observational
  13. Article
  14. Article
  15. Article
  16. Article
  17. Long-term results and comparison of flow re-direction endoluminal device and pipeline embolization device in endovascular treatment of intracranial carotid aneurysms.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2022
    Article
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 3 institutions in 1 country.

David FiorellaStony Brook University Hospital, Stony Brook, New York, USA.
Larry GacheCTI Clinical Trial and Consulting Services, Covington, Kentucky, USA.
Diana FrameCTI Clinical Trial and Consulting Services, Covington, Kentucky, USA.
Adam S ArthurNeurosurgery, University of Tennessee Health Science Center, Memphis, Tennessee, USA aarthur@semmes-murphey.com.ORCID http://orcid.org/0000-0002-1536-1613
Clinical Trial and Consulting · USStony Brook University Hospital · USUniversity of Tennessee Health Science Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe objective of this meta-analysis was to establish safety and effectiveness benchmarks for endovascular therapy of unruptured small-to-medium internal carotid artery (ICA) aneurysms using flow diverters.

methodsA systematic literature review and subsequent meta-analysis were performed using best research methods. Studies of any design with at least 10 patients treated with flow diverters for predominantly (≥90%) unruptured small/medium ICA aneurysms and ≥6 month follow-up were included. The primary effectiveness endpoint was complete aneurysm occlusion rate at 12 months. The primary safety endpoint was a composite measure of cumulative events that could indicate a stroke or neurologic death: any death, stroke, intracranial hemorrhage, or worsening on the modified Rankin Scale.

results41 studies (2614 patients) met eligibility criteria for the meta-analysis. The core lab adjusted complete occlusion rate was 74.9% (95% CI 69.6% to 79.8%) at 12 months for studies using any flow diverter. With an aim of generating performance goals for a US Investigational Device Exemption (IDE) study, a pre-specified analysis was conducted using only studies with flow diverters commercially available in the USA. In this cohort, 12 month complete occlusion was 74.6% (95% CI 66.8% to 81.7%). The primary safety event rate for flow diverters commercially available in the USA was 7.8% (95% CI 4.8% to 11.4%).

conclusionsThe treatment of small and medium-sized aneurysms with flow diverters is effective in achieving curative reconstruction in most cases and is associated with low rates of morbidity and mortality. This meta-analysis informs robust performance goals for evaluating new flow diverters in small/medium unruptured carotid aneurysms.

Indexed as

GoalsSelf Expandable Metallic StentsAdultAgedCarotid Artery, InternalCohort StudiesEmbolization, TherapeuticEndovascular ProceduresEvidence-Based MedicineFemaleHumansIntracranial AneurysmMaleMiddle AgedTreatment Outcomeendovascular therapyflow divertersintracranial aneurysm

Identifiers

PMID32005761
PMCPMC7476367
OpenAlexW3003534303

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.