Evidence map›Paper›PMID 38242183›Full record

SynthesisJournal of stroke and cerebrovascular diseases : the official journal of National Stroke Association2024

Safety and efficacy profile of off-label use of the Pipeline Embolization Device: A systematic review and meta-analysis.

Yigit Can Senol, Atakan Orscelik, Cem Bilgin, Hassan Kobeissi, Sherief Ghozy, Santhosh Arul, David F Kallmes, Ramanathan Kadirvel

Abstract readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

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

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. 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

8 authors.

Yigit Can SenolDepartment of Neurologic Surgery, Mayo Clinic, Rochester, MN, USA. Electronic address: ygtsenol@gmail.com.
Atakan OrscelikDepartment of Neurosurgery, Medical University of South Carolina, SC, USA.
Cem BilginDepartment of Radiology, Mayo Clinic, Rochester, MN, USA.
Hassan KobeissiDepartment of Radiology, Mayo Clinic, Rochester, MN, USA.
Sherief GhozyDepartment of Radiology, Mayo Clinic, Rochester, MN, USA.
Santhosh ArulDepartment of Neurologic Surgery, Mayo Clinic, Rochester, MN, USA.
David F KallmesDepartment of Radiology, Mayo Clinic, Rochester, MN, USA.
Ramanathan KadirvelDepartment of Neurologic Surgery, Mayo Clinic, Rochester, MN, USA; Department of Radiology, Mayo Clinic, Rochester, MN, USA.

Funding

Computational and Biological Approach to Flow DiversionR01NS076491 · NINDS · MAYO CLINIC ROCHESTER · PI Juan R Cebral, DAVID F KALLMES · 2011 to 2026
$7.4M
NINDS NIH HHS R01 NS076491
6 · The paper itself

Abstract

objectiveThe off-label utilization of the Pipeline Embolization Device (PED) is a common practice in numerous medical centers globally. Therefore, we conducted a systematic review and meta-analysis to evaluate the overall outcomes of this off-label usage of PEDs.

methodsPubMed, Web of Science, Ovid Medline, Ovid Embase, and Scopus were searched up to February 2023 using the Nested Knowledge platform to identify studies assessing the off-label use of PEDs. Any use of PED outside of the FDA-approved indication granted in 2018 is considered off-label use. Overall angiographic occlusion rates, ischemic and hemorrhagic complications, mortality, retreatment rates, and favorable clinic outcomes were included. Statistical analyses were performed to compare the overall outcome rates of anterior cerebral artery(ACA) vs. middle cerebral artery(MCA) and anterior vs posterior circulation subgroups.

resultsWe included 26 studies involving a total of 1,408 patients. The overall rate of complete occlusion was 80.3 % (95 % CI= 76.0-84.1). Subgroup analysis demonstrated a statistically significant difference in the rate of complete occlusion between anterior circulation (78.9 %) and posterior circulation (69.2 %) (p value=0.02). The rate of good clinical outcomes was 92.8 % (95 % CI= 88.8-95.4). The mortality rate was 1.4 % (95 % CI= 0.5-2.7). The overall rate of ischemic complications was 9.5 % (95 % CI= 7.7-11.6), with a comparable difference between anterior circulation (7.7 %) and posterior circulation (12.8 %) (p value=0.07). There was no statistically significant difference in MCA vs ACA subgroups in all parameters.

conclusionsOff-label use of PEDs can be a safe and effective treatment option for intracranial aneurysms. However, there is a need for more prospective, high-quality, non-industry-funded registry studies and randomized trials to test the efficacy and safety of off-label usage of PEDs and to expand its indications.

Indexed as

Embolization, TherapeuticIntracranial AneurysmOff-Label UseAdultAgedEndovascular ProceduresFemaleHumansMaleMiddle AgedRisk AssessmentRisk FactorsTreatment OutcomeFlow diverterOff-labelOn-labelPEDPipeline

Identifiers

PMID38242183
PMCPMC10939757

What OpenQuestion holds

Textmetadata
LicenceTDM
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.