基于乙烯-乙烯醇共聚物的非粘性液体栓塞剂用于腹/盆腔动脉出血患者的经导管动脉栓塞：一项前瞻性、单臂、多中心队列研究

IF 8.1 2区医学 Q1 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING

Diagnostic and Interventional Imaging Pub Date : 2025-06-01 DOI:10.1016/j.diii.2025.02.001

Romaric Loffroy , Hicham Kobeiter , Vincent Vidal , Julien Frandon , Olivier Pellerin , Carole Dean , Skander Sammoud , Hélène Vernhet-Kovacsik , Haytham Derbel , Ludwig-Serge Aho-Glélé , Olivier Chevallier , Marc Sapoval

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引用次数: 0

摘要

目的：本研究的目的是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腹腔和/或盆腔动脉出血患者经导管动脉栓塞（TAE）的安全性和有效性。NCT04787120)纳入了2021年至2023年在四所大学医院连续接受TAE治疗的患者，这些患者使用了一种新型的基于乙烯-乙烯醇共聚物的非粘性液体栓塞剂（SQUIDPERI 18）。TAE的适应症包括急性症状性出血或内脏（n = 63）、肌肉（n = 23）或胃肠道（n = 29）腹腔/盆腔动脉出血并血管造影异常。评估每位TAE患者的特征、临床成功率和介入放射科医师的满意度。1个月和6个月的临床成功被定义为没有因最初栓塞部位再出血而再次干预的生存。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。结果：入组的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例成功闭塞靶血管，技术成功率为98.2%。1个月和6个月的临床成功率分别为72.1%（75/104例）和64.3%（63/98例）。1个月死亡率为20/104(19.2%)，6个月死亡率为26/98（26.5%）。1例患者在TAE期间出现不良事件。1个月不良事件发生率为31.4%(32/102)，严重不良事件发生率为22.5%（23/102）。在单变量和多变量分析中，年龄是与1个月TAE临床失败相关的单一变量。在超过90%的TAEs中，介入放射科医师对7个问卷项目中的5个项目感到满意。结论：新型乙烯-乙烯醇共聚物基无粘连液体栓塞剂对急性腹腔/盆腔动脉出血的TAE患者安全有效。

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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

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.

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来源期刊

Diagnostic and Interventional Imaging Medicine-Radiology, Nuclear Medicine and Imaging

CiteScore

8.50

自引率

29.10%

发文量

126

审稿时长

11 days

期刊介绍： Diagnostic and Interventional Imaging accepts publications originating from any part of the world based only on their scientific merit. The Journal focuses on illustrated articles with great iconographic topics and aims at aiding sharpening clinical decision-making skills as well as following high research topics. All articles are published in English. Diagnostic and Interventional Imaging publishes editorials, technical notes, letters, original and review articles on abdominal, breast, cancer, cardiac, emergency, forensic medicine, head and neck, musculoskeletal, gastrointestinal, genitourinary, interventional, obstetric, pediatric, thoracic and vascular imaging, neuroradiology, nuclear medicine, as well as contrast material, computer developments, health policies and practice, and medical physics relevant to imaging.