Evidence map›Paper›PMID 33526480›Full record

ArticleJournal of neurointerventional surgery2021

Safety of the APOLLO Onyx delivery microcatheter for embolization of brain arteriovenous malformations: results from a prospective post-market study.

Philip M Meyers, Johanna T Fifi, Kevin M Cockroft, Timothy R Miller, Curtis A Given, Ali R Zomorodi, Bharathi D Jagadeesan, Maxim Mokin, Peter Kan, Tom L Yao and 17 more

Abstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in Journal of neurointerventional surgery, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.0field-weighted citation impact, top 22% 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

8 citing papers in PubMed, 12 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors at 20 institutions in 1 country.

Philip M MeyersDepartments of Radiology and Neurological Surgery, Columbia University, New York, New York, USA pmm2002@columbia.edu.ORCID http://orcid.org/0000-0002-3250-5543
Johanna T FifiDepartment of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Kevin M CockroftDepartment of Neurosurgery, Pennsylvania State University College of Medicine, Hershey, Pennsylvania, USA.
Timothy R MillerDivision of Interventional Neuroradiology, University of Maryland Medical Center, Baltimore, Maryland, USA.
Curtis A GivenDepartment of Radiology, Baptist Health Lexington, Lexington, Kentucky, USA.
Ali R ZomorodiDivision of Neurosurgery, Duke University Medical Center, Durham, North Carolina, USA.
Bharathi D JagadeesanDepartment of Radiology, Neurosurgery and Neurology, University of Minnesota, Minneapolis, Minnesota, USA.
Maxim MokinDepartment of Neurosurgery, University of South Florida, Tampa, Florida, USA.ORCID http://orcid.org/0000-0003-4270-8667
Peter KanDepartment of Neurosurgery, Baylor College of Medicine, Houston, Texas, USA.ORCID http://orcid.org/0000-0001-6649-4128
Tom L YaoDepartment of Neurosurgery, Norton Neuroscience Institute, Norton Healthcare, Louisville, Kentucky, USA.
Orlando DiazDivision of Interventional Neuroradiology, Houston Methodist Hospital, Houston, Texas, USA.
Daniel HuddleDepartment of Brain, Spine, Physical Medicine and Rehabilitation, UC Health Medical Group (UCHMG), Colorado Springs, Colorado, USA.
Richard J BellonDepartment of Neurology, Swedish Medical Center, Englewood, Colorado, USA.
Joshua SeinfeldDepartment of Neurosurgery and Radiology, University of Colorado Medical Center, Aurora, Colorado, USA.
Adam J PolifkaDepartment of Neurological Surgery, University of Florida, Gainesville, Florida, USA.
David FiorellaDepartment of Neurosurgery, Cerebrovascular Center, Stony Brook University Hospital, Stony Brook, New York, USA.ORCID http://orcid.org/0000-0002-2677-8780
Rohan V ChitaleDepartment of Neurosurgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Peter KvammeDepartment of Radiology, The University of Tennessee Medical Center, Knoxville, Tennessee, USA.
Jay T MorrowNeuroscience Institute, Division of Neurosurgery, Michigan State University, Spectrum Health, Grand Rapids, Michigan, USA.
Justin SingerNeuroscience Institute, Division of Neurosurgery, Michigan State University, Spectrum Health, Grand Rapids, Michigan, USA.
Ajay K WakhlooDepartment of Neurointerventional Radiology, Beth Israel Lahey Health, Tufts School of Medicine, Burlington, Massachusetts, USA.
Ajit S PuriDepartment of Radiology, University of Massachusetts Medical Center, Worcester, Massachusetts, USA.
Vivek R DeshmukhProvidence Brain and Spine Institute, Portland, Oregon, USA.
Ricardo A HanelBaptist Health Research Institute, Lyerly Neurosurgery, Jacksonville, Florida, USA.
L Fernando GonzalezDepartment of Neurosurgery, Duke University, Durham, North Carolina, USA.
Henry H WooDepartment of Neurosurgery and Radiology, Zucker School of Medicine at Hofstra/Northwell Health, Manhasset, New York, USA.
Mohammad Ali Aziz-SultanDepartment of Neurosurgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Spectrum Health · USBaptist Medical Center Jacksonville · USBaylor College of Medicine · USBrigham and Women's Hospital · USCentral Baptist Hospital · USDuke Medical Center · USDuke University · USIcahn School of Medicine at Mount Sinai · USLahey Hospital and Medical Center · USMethodist Hospital · USNeurological Surgery · USNorthwell Health · USNorton Healthcare · USPennsylvania State University · USProvidence College · USStony Brook University Hospital · USSwedish Medical Center · USUniversity of Colorado Boulder · USUniversity of Colorado Health · USUniversity of Florida · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCatheter retention and difficulty in retrieval have been observed during embolization of brain arteriovenous malformations (bAVMs) with the Onyx liquid embolic system (Onyx). The Apollo Onyx delivery microcatheter (Apollo) is a single lumen catheter designed for controlled delivery of Onyx into the neurovasculature, with a detachable distal tip to aid catheter retrieval. This study evaluates the safety of the Apollo for delivery of Onyx during embolization of bAVMs.

methodsThis was a prospective, non-randomized, single-arm, multicenter, post-market study of patients with a bAVM who underwent Onyx embolization with the Apollo between May 2015 and February 2018. The primary endpoint was any catheter-related adverse event (AE) at 30 days, such as unintentional tip detachment or malfunction with clinical sequelae, or retained catheter. Procedure-related AEs (untoward medical occurrence, disease, injury, or clinical signs) and serious AEs (life threatening illness or injury, permanent physiological impairment, hospitalization, or requiring intervention) were also recorded.

resultsA total of 112 patients were enrolled (mean age 44.1±17.6 years, 56.3% men), and 201 Apollo devices were used in 142 embolization procedures. The mean Spetzler-Martin grade was 2.38. The primary endpoint was not observed (0/112, 0%). The catheter tip detached during 83 (58.5%) procedures, of which 2 (2.4%) were unintentional and did not result in clinical sequelae. At 30 days, procedure related AEs occurred in 26 (23.2%) patients, and procedure-related serious AEs in 12 (10.7%). At 12 months, there were 3 (2.7%) mortalities, including 2 (1.8%) neurological deaths, none of which were device-related.

conclusionThis study demonstrates the safety of Apollo for Onyx embolization of bAVMs. CLINICAL

trial registrationCNCT02378883.

Indexed as

Embolization, TherapeuticIntracranial Arteriovenous MalformationsAdultBrainDimethyl SulfoxideFemaleHumansMaleMiddle AgedPolyvinylsProspective StudiesTreatment OutcomeDimethyl SulfoxidePolyvinylsarteriovenous malformationcatheterdeviceliquid embolic materialvascular malformation

Identifiers

PMID33526480
OpenAlexW3127515805

What OpenQuestion holds

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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.