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.
- vascular malformation
- arteriovenous malformation
- liquid embolic material
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Contributors All authors made substantial contributions to the conception and design, analysis, and interpretation of data; drafted or critically revised the article; and gave final approval of the version to be published.
Funding This study was sponsored by Medtronic, Inc.
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.
Patient consent for publication Not required.
Ethics approval The institutional review board at each center approved the study.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information. All data relevant to the study are included in the article or uploaded as supplementary information.
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