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; Orlando Diaz; Daniel Huddle; Richard J. Bellon; Joshua Seinfeld; Adam J. Polifka; David Fiorella; Rohan V. Chitale; Peter Kvamme; Jay T. Morrow; Justin Singer; Ajay K. Wakhloo; Ajit S. Puri; Vivek R. Deshmukh; Ricardo A. Hanel; L. Fernando Gonzalez; Henry H. Woo; Mohammad Ali Aziz-Sultan

doi:10.1136/neurintsurg-2020-016830

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, Orlando Diaz, Daniel Huddle, Richard J. Bellon, Joshua Seinfeld, Adam J. Polifka, David Fiorella, Rohan V. Chitale, Peter Kvamme, Jay T. Morrow, Justin SingerAjay K. Wakhloo, Ajit S. Puri, Vivek R. Deshmukh, Ricardo A. Hanel, L. Fernando Gonzalez, Henry H. Woo, Mohammad Ali Aziz-Sultan

Radiology

Research output: Contribution to journal › Article › peer-review

3 Scopus citations

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.

Original language	English (US)
Pages (from-to)	935-941
Number of pages	7
Journal	Journal of NeuroInterventional Surgery
Volume	13
Issue number	10
DOIs	https://doi.org/10.1136/neurintsurg-2020-016830
State	Published - 2021

Bibliographical note

Funding Information:
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.

Publisher Copyright:
© Author(s) (or their employer(s)) 2021.

Keywords

arteriovenous malformation
catheter
device
liquid embolic material
vascular malformation

PubMed: MeSH publication types

Journal Article
Multicenter Study

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Meyers, P. M., Fifi, J. T., Cockroft, K. M., Miller, T. R., Given, C. A., Zomorodi, A. R., Jagadeesan, B. D., Mokin, M., Kan, P., Yao, T. L., Diaz, O., Huddle, D., Bellon, R. J., Seinfeld, J., Polifka, A. J., Fiorella, D., Chitale, R. V., Kvamme, P., Morrow, J. T., ... Aziz-Sultan, M. A. (2021). Safety of the APOLLO Onyx delivery microcatheter for embolization of brain arteriovenous malformations: Results from a prospective post-market study. Journal of NeuroInterventional Surgery, 13(10), 935-941. https://doi.org/10.1136/neurintsurg-2020-016830

Meyers, PM, Fifi, JT, Cockroft, KM, Miller, TR, Given, CA, Zomorodi, AR, Jagadeesan, BD, Mokin, M, Kan, P, Yao, TL, Diaz, O, Huddle, D, Bellon, RJ, Seinfeld, J, Polifka, AJ, Fiorella, D, Chitale, RV, Kvamme, P, Morrow, JT, Singer, J, Wakhloo, AK, Puri, AS, Deshmukh, VR, Hanel, RA, Gonzalez, LF, Woo, HH & Aziz-Sultan, MA 2021, 'Safety of the APOLLO Onyx delivery microcatheter for embolization of brain arteriovenous malformations: Results from a prospective post-market study', Journal of NeuroInterventional Surgery, vol. 13, no. 10, pp. 935-941. https://doi.org/10.1136/neurintsurg-2020-016830

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title = "Safety of the APOLLO Onyx delivery microcatheter for embolization of brain arteriovenous malformations: Results from a prospective post-market study",

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",

author = "Meyers, {Philip M.} and Fifi, {Johanna T.} and Cockroft, {Kevin M.} and Miller, {Timothy R.} and Given, {Curtis A.} and Zomorodi, {Ali R.} and Jagadeesan, {Bharathi D.} and Maxim Mokin and Peter Kan and Yao, {Tom L.} and Orlando Diaz and Daniel Huddle and Bellon, {Richard J.} and Joshua Seinfeld and Polifka, {Adam J.} and David Fiorella and Chitale, {Rohan V.} and Peter Kvamme and Morrow, {Jay T.} and Justin Singer and Wakhloo, {Ajay K.} and Puri, {Ajit S.} and Deshmukh, {Vivek R.} and Hanel, {Ricardo A.} and Gonzalez, {L. Fernando} and Woo, {Henry H.} and Aziz-Sultan, {Mohammad Ali}",

note = "Funding Information: 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{\textquoteright}s bureau and as a consultant and proctor for Medtronic and Stryker, and serves on the speaker{\textquoteright}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{\textquoteright}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. Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2021.",

year = "2021",

doi = "10.1136/neurintsurg-2020-016830",

language = "English (US)",

volume = "13",

pages = "935--941",

journal = "Journal of NeuroInterventional Surgery",

issn = "1759-8478",

publisher = "BMJ Publishing Group",

number = "10",

}

TY - JOUR

T1 - Safety of the APOLLO Onyx delivery microcatheter for embolization of brain arteriovenous malformations

T2 - Results from a prospective post-market study

AU - Meyers, Philip M.

AU - Fifi, Johanna T.

AU - Cockroft, Kevin M.

AU - Miller, Timothy R.

AU - Given, Curtis A.

AU - Zomorodi, Ali R.

AU - Jagadeesan, Bharathi D.

AU - Mokin, Maxim

AU - Kan, Peter

AU - Yao, Tom L.

AU - Diaz, Orlando

AU - Huddle, Daniel

AU - Bellon, Richard J.

AU - Seinfeld, Joshua

AU - Polifka, Adam J.

AU - Fiorella, David

AU - Chitale, Rohan V.

AU - Kvamme, Peter

AU - Morrow, Jay T.

AU - Singer, Justin

AU - Wakhloo, Ajay K.

AU - Puri, Ajit S.

AU - Deshmukh, Vivek R.

AU - Hanel, Ricardo A.

AU - Gonzalez, L. Fernando

AU - Woo, Henry H.

AU - Aziz-Sultan, Mohammad Ali

N1 - Funding Information: 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. Publisher Copyright: © Author(s) (or their employer(s)) 2021.

PY - 2021

Y1 - 2021

N2 - 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.

AB - 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.

KW - arteriovenous malformation

KW - catheter

KW - device

KW - liquid embolic material

KW - vascular malformation

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U2 - 10.1136/neurintsurg-2020-016830

DO - 10.1136/neurintsurg-2020-016830

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JO - Journal of NeuroInterventional Surgery

JF - Journal of NeuroInterventional Surgery

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ER -

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

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