Multicenter Study

. 2021 Oct;13(10):935-941.

doi: 10.1136/neurintsurg-2020-016830. Epub 2021 Feb 1.

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

Philip M Meyers¹, Johanna T Fifi², Kevin M Cockroft³, Timothy R Miller⁴, Curtis A Given⁵, Ali R Zomorodi⁶, Bharathi D Jagadeesan⁷, Maxim Mokin⁸, Peter Kan⁹, Tom L Yao¹⁰, Orlando Diaz¹¹, Daniel Huddle¹², Richard J Bellon¹³, Joshua Seinfeld¹⁴, Adam J Polifka¹⁵, David Fiorella¹⁶, Rohan V Chitale¹⁷, Peter Kvamme¹⁸, Jay T Morrow¹⁹, Justin Singer¹⁹, Ajay K Wakhloo²⁰, Ajit S Puri²¹, Vivek R Deshmukh²², Ricardo A Hanel²³, L Fernando Gonzalez²⁴, Henry H Woo²⁵, Mohammad Ali Aziz-Sultan²⁶

Affiliations

¹ Departments of Radiology and Neurological Surgery, Columbia University, New York, New York, USA pmm2002@columbia.edu.
² Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
³ Department of Neurosurgery, Pennsylvania State University College of Medicine, Hershey, Pennsylvania, USA.
⁴ Division of Interventional Neuroradiology, University of Maryland Medical Center, Baltimore, Maryland, USA.
⁵ Department of Radiology, Baptist Health Lexington, Lexington, Kentucky, USA.
⁶ Division of Neurosurgery, Duke University Medical Center, Durham, North Carolina, USA.
⁷ Department of Radiology, Neurosurgery and Neurology, University of Minnesota, Minneapolis, Minnesota, USA.
⁸ Department of Neurosurgery, University of South Florida, Tampa, Florida, USA.
⁹ Department of Neurosurgery, Baylor College of Medicine, Houston, Texas, USA.
¹⁰ Department of Neurosurgery, Norton Neuroscience Institute, Norton Healthcare, Louisville, Kentucky, USA.
¹¹ Division of Interventional Neuroradiology, Houston Methodist Hospital, Houston, Texas, USA.
¹² Department of Brain, Spine, Physical Medicine and Rehabilitation, UC Health Medical Group (UCHMG), Colorado Springs, Colorado, USA.
¹³ Department of Neurology, Swedish Medical Center, Englewood, Colorado, USA.
¹⁴ Department of Neurosurgery and Radiology, University of Colorado Medical Center, Aurora, Colorado, USA.
¹⁵ Department of Neurological Surgery, University of Florida, Gainesville, Florida, USA.
¹⁶ Department of Neurosurgery, Cerebrovascular Center, Stony Brook University Hospital, Stony Brook, New York, USA.
¹⁷ Department of Neurosurgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
¹⁸ Department of Radiology, The University of Tennessee Medical Center, Knoxville, Tennessee, USA.
¹⁹ Neuroscience Institute, Division of Neurosurgery, Michigan State University, Spectrum Health, Grand Rapids, Michigan, USA.
²⁰ Department of Neurointerventional Radiology, Beth Israel Lahey Health, Tufts School of Medicine, Burlington, Massachusetts, USA.
²¹ Department of Radiology, University of Massachusetts Medical Center, Worcester, Massachusetts, USA.
²² Providence Brain and Spine Institute, Portland, Oregon, USA.
²³ Baptist Health Research Institute, Lyerly Neurosurgery, Jacksonville, Florida, USA.
²⁴ Department of Neurosurgery, Duke University, Durham, North Carolina, USA.
²⁵ Department of Neurosurgery and Radiology, Zucker School of Medicine at Hofstra/Northwell Health, Manhasset, New York, USA.
²⁶ Department of Neurosurgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.

PMID: 33526480
DOI: 10.1136/neurintsurg-2020-016830

Multicenter Study

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

Philip M Meyers et al. J Neurointerv Surg. 2021 Oct.

. 2021 Oct;13(10):935-941.

doi: 10.1136/neurintsurg-2020-016830. Epub 2021 Feb 1.

Authors

Affiliations

¹ Departments of Radiology and Neurological Surgery, Columbia University, New York, New York, USA pmm2002@columbia.edu.
² Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
³ Department of Neurosurgery, Pennsylvania State University College of Medicine, Hershey, Pennsylvania, USA.
⁴ Division of Interventional Neuroradiology, University of Maryland Medical Center, Baltimore, Maryland, USA.
⁵ Department of Radiology, Baptist Health Lexington, Lexington, Kentucky, USA.
⁶ Division of Neurosurgery, Duke University Medical Center, Durham, North Carolina, USA.
⁷ Department of Radiology, Neurosurgery and Neurology, University of Minnesota, Minneapolis, Minnesota, USA.
⁸ Department of Neurosurgery, University of South Florida, Tampa, Florida, USA.
⁹ Department of Neurosurgery, Baylor College of Medicine, Houston, Texas, USA.
¹⁰ Department of Neurosurgery, Norton Neuroscience Institute, Norton Healthcare, Louisville, Kentucky, USA.
¹¹ Division of Interventional Neuroradiology, Houston Methodist Hospital, Houston, Texas, USA.
¹² Department of Brain, Spine, Physical Medicine and Rehabilitation, UC Health Medical Group (UCHMG), Colorado Springs, Colorado, USA.
¹³ Department of Neurology, Swedish Medical Center, Englewood, Colorado, USA.
¹⁴ Department of Neurosurgery and Radiology, University of Colorado Medical Center, Aurora, Colorado, USA.
¹⁵ Department of Neurological Surgery, University of Florida, Gainesville, Florida, USA.
¹⁶ Department of Neurosurgery, Cerebrovascular Center, Stony Brook University Hospital, Stony Brook, New York, USA.
¹⁷ Department of Neurosurgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
¹⁸ Department of Radiology, The University of Tennessee Medical Center, Knoxville, Tennessee, USA.
¹⁹ Neuroscience Institute, Division of Neurosurgery, Michigan State University, Spectrum Health, Grand Rapids, Michigan, USA.
²⁰ Department of Neurointerventional Radiology, Beth Israel Lahey Health, Tufts School of Medicine, Burlington, Massachusetts, USA.
²¹ Department of Radiology, University of Massachusetts Medical Center, Worcester, Massachusetts, USA.
²² Providence Brain and Spine Institute, Portland, Oregon, USA.
²³ Baptist Health Research Institute, Lyerly Neurosurgery, Jacksonville, Florida, USA.
²⁴ Department of Neurosurgery, Duke University, Durham, North Carolina, USA.
²⁵ Department of Neurosurgery and Radiology, Zucker School of Medicine at Hofstra/Northwell Health, Manhasset, New York, USA.
²⁶ Department of Neurosurgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.

PMID: 33526480
DOI: 10.1136/neurintsurg-2020-016830

Abstract

Background: Catheter 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.

Methods: This 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.

Results: A 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.

Conclusion: This study demonstrates the safety of Apollo for Onyx embolization of bAVMs.

Clinical trial registration: CNCT02378883.

Keywords: arteriovenous malformation; catheter; device; liquid embolic material; vascular malformation.

PubMed Disclaimer

Conflict of interest statement

Competing interests: JF reports grants and non-financial support from Stryker, grants and other funding from Penumbra, grants from Microvention, and equity in Cerebrotech and The Stroke Project. CAG serves on the speaker’s bureau and as a consultant and proctor for Medtronic and Stryker, and serves on the speaker’s bureau for Genentech. MM serves as a consultant for Toshiba/Canon Medical. PK serves as a consultant for Stryker Neurovascular, Medtronic, and Cerenovus. TY serves as a consultant and proctor for Medtronic. OD serves as a proctor for Microvention/Terumo. DF serves as a consultant for Balt, Marblehead Medical, Medtronic, Stryker, Microvention, Penumbra, and Cerenovus, receives research support from Cerenovus, Medtronic, Stryker, Siemens, Microvention, and Penumbra, receives royalties from Codman, and is a stockholder in Marblehead, Neurogami, and Vascular simulations outside the submitted work. RVC has received research funding from Microvention, Cerenovus, and Medtronic. AKW has received research grants from Philips Medical, serves as a consultant for Stryker and Phenox, is a stockholder in InNeuroCo, EpiEP, Neural Analytics, Rist, Analytics 4 Life, and ThrombX, and serves on the speaker’s bureau for SCENT trial presentations. ASP serves as a consultant for and has received research grants from Medtronic Neurovascular and Stryker Neurovascular. RAH serves as a consultant for Medtronic, Stryker, Codman, and Microvention, and is a stockholder in InNeuroCo. LFG holds stock in Culvert Therapeutics and NeuroCool, serves as a proctor for Medtronic Neurovascular, and participates in training other physicians in the use pipeline embolization device. MAA-S serves as a proctor for Medtronic Neurovascular, and participates in training other physicians in the use of the embolic agent Onyx and the pipeline embolization device.

Comment in

How much safety is actually 'safe'? Commentary on 'Safety of the Apollo Onyx delivery microcatheter for embolization of brain arteriovenous malformations: results from a prospective post-market study' by Meyers et al.
Sirakov A, Minkin K, Sirakov S. Sirakov A, et al. J Neurointerv Surg. 2021 Oct;13(10):e22. doi: 10.1136/neurintsurg-2021-018052. Epub 2021 Sep 7. J Neurointerv Surg. 2021. PMID: 34493576 Free PMC article. No abstract available.

Publication types

Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Substances

Actions
Actions

Associated data

Actions
- Search in PubMed
- Search in ClinicalTrials.gov

LinkOut - more resources

Full Text Sources
- HighWire
- Ovid Technologies, Inc.
Other Literature Sources
- scite Smart Citations
Medical
- ClinicalTrials.gov

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Comment in

Publication types

MeSH terms

Substances

Associated data

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical