TY - JOUR
T1 - Efficacy and safety of the PHIL embolic agent in the treatment of intracranial dural arteriovenous fistulas
T2 - results of the PHIL-dAVF study
AU - Marnat, Gaultier
AU - Barreau, Xavier
AU - Januel, Anne-Christine
AU - Spelle, Laurent
AU - Piotin, Michel
AU - Mounayer, Charbel
AU - Borota, Ljubisa
AU - González, Alejandro
AU - Casasco, Alfredo
AU - Keston, Peter
AU - Lobotesis, Kyriakos
AU - Cronqvist, Mats
AU - Holtmannspötter, Markus
AU - Guimaraens, Leopoldo
AU - Boccardi, Edoardo
AU - Valvassori, Luca
AU - Espinosa de Rueda, Mariano
AU - Cognard, Christophe
AU - PHIL-dAVF study investigators
N1 - Holtmanspötter: externe Aff.
PY - 2025/1/8
Y1 - 2025/1/8
N2 - 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.
AB - 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.
U2 - 10.1136/jnis-2024-022630
DO - 10.1136/jnis-2024-022630
M3 - Original Article
C2 - 39778931
SN - 1759-8478
JO - JOURNAL OF NEUROINTERVENTIONAL SURGERY
JF - JOURNAL OF NEUROINTERVENTIONAL SURGERY
ER -