Safety of the APOLLO Onyx delivery microcatheter for embolization of brain arteriovenous malformations: results from a prospective post-market study.
(Journal Article;Multicenter Study)
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.
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
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