Résumé
•SQUIDPERI 18 is safe and effective for transcatheter arterial embolization in patients with acute bleeding or an imminent risk of bleeding from abdominal and/or pelvic arteries.•Interventional radiologist satisfaction regarding the use of SQUIDPERI 18 is very high in terms of ease of use, ease of injection, embolic agent cohesion, and radiopacity/visibility.
The purpose of this study was to evaluate the safety and efficacy of a novel ethylene-vinyl alcohol copolymer-based non-adhesive liquid embolic agent for transcatheter arterial embolization (TAE) in patients with bleeding from abdominal and/or pelvic arteries
A prospective observational multicenter study (Clinicaltrials.gov Identifier: NCT04787120) included consecutive patients treated with TAE using a novel ethylene-vinyl alcohol copolymer-based non-adhesive liquid embolic agent (SQUIDPERI 18) at four university hospitals from 2021 to 2023. The indication for TAE included acute symptomatic bleeding or imminent risk of bleeding from visceral (n = 63), muscular (n = 23), or gastrointestinal (n = 29) abdominal/pelvic arteries combined with angiographic abnormalities. Patient characteristics, clinical success rates, and interventional-radiologist satisfaction with each TAE were assessed. Clinical success at 1- and 6 months was defined as survival without reintervention for rebleeding from the initially embolized site(s). Univariable and multivariable analyses were performed to identify variables associated with clinical failure of TAE.
Of the 110 patients enrolled, 104 had 1-month and 98 had 6-month data. Target vessel(s) were successfully occluded in 108 of the 110 patients, resulting in a technical success rate of 98.2 %. Clinical success rates at 1 and 6 months were 72.1 % (75/104 patients) and 64.3 % (63/98 patients), respectively. Mortality was 20/104 (19.2 %) at 1 month and 26/98 (26.5 %) at 6 months. One patient experienced an adverse event during TAE. The rates of adverse events and serious adverse events at 1 month were 31.4 % (32/102) and 22.5 % (23/102), respectively. Older age was the single variable associated with clinical failure of TAE at 1 month in both univariable and multivariable analysis. In more than 90 % of TAEs, the interventional radiologists were satisfied for five of the seven questionnaire items.
The novel ethylene-vinyl alcohol copolymer-based non-adhesive liquid embolic agent is safe and effective for TAE in patients presenting with acute symptomatic bleeding from abdominal/pelvic arteries.