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 - Publisher Copyright:
© Author(s) (or their employer(s)) 2021.
PY - 2021/10
Y1 - 2021/10
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
M3 - Article
C2 - 33526480
AN - SCOPUS:85100592961
SN - 1759-8478
VL - 13
SP - 935
EP - 941
JO - Journal of NeuroInterventional Surgery
JF - Journal of NeuroInterventional Surgery
IS - 10
ER -