Ethylene-vinyl alcohol copolymer-based non-adhesive liquid embolic agent for transcatheter arterial embolization in patients with abdominal/pelvic arterial bleeding: A prospective, single-arm, multicenter cohort study.

Abstract

Purpose: 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 MATERIALS AND METHODS: 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 (SQUID_PERI 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.

Results: 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.

Conclusion: 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.