Safety of the APOLLO Onyx delivery microcatheter for embolization of brain arteriovenous malformations: results from a prospective post-market study
| Autor: | Mohammad Ali Aziz-Sultan, Adam J. Polifka, Curtis A. Given, D Huddle, Jay T. Morrow, Ajay K. Wakhloo, R Bellon, Bharathi D. Jagadeesan, Henry H. Woo, Vivek R. Deshmukh, Peter Kvamme, L. Fernando Gonzalez, Johanna T Fifi, Ricardo A. Hanel, Ajit S. Puri, Peter Kan, Kevin M. Cockroft, Justin Singer, Maxim Mokin, Philip M. Meyers, Ali R. Zomorodi, Rohan V. Chitale, Orlando M. Diaz, David Fiorella, Timothy R Miller, Joshua Seinfeld, Tom L. Yao |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Single lumen catheter business.industry medicine.medical_treatment Vascular malformation Arteriovenous malformation General Medicine medicine.disease 030218 nuclear medicine & medical imaging Surgery Clinical trial 03 medical and health sciences Catheter 0302 clinical medicine Clinical endpoint Medicine Neurology (clinical) Embolization Adverse effect business 030217 neurology & neurosurgery |
| Zdroj: | Journal of NeuroInterventional Surgery. 13:935-941 |
| ISSN: | 1759-8486 1759-8478 |
| Popis: | BackgroundCatheter 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.MethodsThis 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.ResultsA 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.ConclusionThis study demonstrates the safety of Apollo for Onyx embolization of bAVMs.Clinical trial registrationCNCT02378883. |
| Databáze: | OpenAIRE |
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