Loffroy Romaric, Kobeiter Hicham, Vidal Vincent, Frandon Julien, Pellerin Olivier, Dean Carole, Sammoud Skander, Vernhet-Kovacsik Hélène, Derbel Haytham, Aho-Glélé Ludwig-Serge, Chevallier Olivier, Sapoval Marc
Department of Vascular and Interventional Radiology, Image-Guided Therapy Center, François-Mitterrand University Hospital, 21079 Dijon, France; ICMUB Laboratory, UMR CNRS 6302, University of Burgundy, 21000 Dijon, France.
Medical Imaging Department, Hôpital Henri-Mondor, AP-HP, 94000 Créteil, France.
Diagn Interv Imaging. 2025 Jun;106(6):226-236. doi: 10.1016/j.diii.2025.02.001. Epub 2025 Feb 13.
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 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.
本研究旨在评估一种新型的基于乙烯-乙烯醇共聚物的非粘性液体栓塞剂用于经导管动脉栓塞术（TAE）治疗腹部和/或盆腔动脉出血患者的安全性和有效性。
一项前瞻性观察性多中心研究（Clinicaltrials.gov标识符：NCT04787120）纳入了2021年至2023年在四家大学医院接受使用新型基于乙烯-乙烯醇共聚物的非粘性液体栓塞剂（SQUID 18）进行TAE治疗的连续患者。TAE的适应症包括来自内脏（n = 63）、肌肉（n = 23）或胃肠道（n = 29）腹部/盆腔动脉的急性症状性出血或即将出血的风险，并伴有血管造影异常。评估了患者特征、临床成功率以及介入放射科医生对每次TAE的满意度。1个月和6个月时的临床成功定义为无需对最初栓塞部位再次出血进行再次干预的存活。进行单变量和多变量分析以确定与TAE临床失败相关的变量。
在纳入的110例患者中，104例有1个月的数据，98例有6个月的数据。110例患者中有108例的目标血管成功闭塞，技术成功率为98.2%。1个月和6个月时的临床成功率分别为72.1%（75/104例患者）和64.3%（63/98例患者）。1个月时死亡率为20/104（19.2%），6个月时为26/98（26.5%）。1例患者在TAE期间发生不良事件。1个月时不良事件和严重不良事件的发生率分别为31.4%（32/102）和22.5%（23/102）。在单变量和多变量分析中，年龄较大是1个月时与TAE临床失败相关的唯一变量。在超过90%的TAE中，介入放射科医生对七个问卷项目中的五个表示满意。
新型基于乙烯-乙烯醇共聚物的非粘性液体栓塞剂对于腹部/盆腔动脉急性症状性出血患者的TAE是安全有效的。
