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. 2025 Jan 8:jnis-2024-022630.
doi: 10.1136/jnis-2024-022630. Online ahead of print.

Efficacy and safety of the PHIL embolic agent in the treatment of intracranial dural arteriovenous fistulas: results of the PHIL-dAVF study

Gaultier Marnat  1 , Xavier Barreau  2 , Anne-Christine Januel  3 , Laurent Spelle  4   5 , Michel Piotin  6 , Charbel Mounayer  7 , Ljubisa Borota  8 , Alejandro González  9 , Alfredo Casasco  10   11 , Peter Keston  12 , Kyriakos Lobotesis  13 , Mats Cronqvist  14 , Markus Holtmannspötter  15 , Leopoldo Guimaraens  16 , Edoardo Boccardi  17 , Luca Valvassori  18 , Mariano Espinosa de Rueda  19 , Christophe Cognard  20 ; PHIL-dAVF study investigators
Collaborators, Affiliations

Efficacy and safety of the PHIL embolic agent in the treatment of intracranial dural arteriovenous fistulas: results of the PHIL-dAVF study

Gaultier Marnat et al. J Neurointerv Surg. .

Abstract

Background and purpose: Embolization is the first-line treatment for dural arteriovenous fistulas (dAVF). The precipitating hydrophobic injectable liquid (PHIL) embolic agent is a non-adhesive copolymer with specific features and endovascular behavior. This study assessed its safety and efficacy in a prospective real-life cohort.

Methods: The PHIL-dAVF study was a prospective single-arm open-label observational multicenter study conducted between October 2017 and November 2019 in 14 European centers. Patients with a single intracranial dAVF intended for PHIL embolization were included. Previously partially treated or multiple dAVFs were excluded. Additional devices and embolic agents were permitted as complementary techniques or second-line strategies. Primary endpoints were functional outcome changes from baseline and complete cure rate at 3-6 months after the last embolization. Safety was assessed by adverse events (AE) incidence.

Results: A total of 67 patients (77 endovascular procedures; 70.1% men, mean age 61±14 years) were included. Most DAVFs were unruptured (71.6%), located in the transverse/sigmoid sinus (53.7%) and Cognard grade III or IV (56.7%). Sixty patients (89.6%) received one single embolization. Additional devices were used in 31.2% of procedures. Complete angiographic cure rate was 86.9% at the 3-6 month DSA follow-up after the last endovascular treatment. At least one AE was recorded in 37.3% of patients during follow-up, of which 52.9% were related to the procedure. The procedural rates of AE and serious AE were 32.5% and 15.6%, respectively. Five AEs were related to PHIL. Transient functional deterioration occurred in three patients (4.5%), all resolved by the last follow-up.

Conclusion: The PHIL-dAVF study provides evidence about the efficacy and safety of PHIL in the treatment of intracranial dAVFs, with outcomes comparable to existing liquid embolic agents reported in the literature.

Keywords: Fistula; Intervention; Liquid Embolic Material.

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Conflict of interest statement

Competing interests: GM: consulting fees (Microvention Europe, Balt SAS, Stryker Neurovascular), paid lectures (Cerenovus, Phenox, Penumbra, Bracco, Medtronic); XB: consulting fees (Microvention Europe, Balt SAS, Stryker Neurovascular); PK: consulting fees (Microvention Europe, Phenox, Stryker Neurovascular); EB and LV: advisory board (Microvention Europe); CC: consulting fees (Microvention Europe). The others authors have no conflict of interest to declare.