Safety and Efficacy of Peripheral Embolization with EASYX Liquid Embolic Agent: A Multicenter Prospective Study

医学 多中心研究 栓塞 外围设备 前瞻性队列研究 放射科 外科 内科学 随机对照试验
作者
Marc Sapoval,Vincent Vidal,Carole Déan,Costantino Del Giudice,Farouk Tradi,Olivier Chevallier,Anaïs Charles‐Nelson,Olivier Pellerin,Romaric Loffroy
出处
期刊:Journal of Vascular and Interventional Radiology [Elsevier BV]
卷期号:32 (8): 1136-1143 被引量:13
标识
DOI:10.1016/j.jvir.2021.05.014
摘要

Abstract

Purpose

To evaluate the clinical safety and efficacy of EASYX, a new nonadhesive precipitating liquid embolic agent based on a polyvinyl alcohol ether polymer labeled with iodine molecules, for peripheral embolization.

Materials and Methods

This open-label prospective multicenter study was conducted on 50 consecutive patients treated with embolization using EASYX in 3 academic hospitals from April 2018 to July 2019. Indications for embolization were symptomatic varicocele (n = 15), type II endoleak (n = 8), acute hemorrhage (n = 16), portal vein embolization (PVE; n = 9), or angiomyolipoma (AML; n = 2). Patient characteristics, technical and clinical success rates, pain at injection, and satisfaction of the interventional radiologists were assessed. Follow-up imaging was performed using ultrasound for varicoceles (at 1 month) and computed tomography (CT) for the other indications (at 3 or 6 months).

Results

The immediate technical success rate was 98%. The clinical success rates were 100% for acute hemorrhage and type II endoleaks, 89% for PVE, 86% for varicoceles, and 50% for AMLs. Patients who underwent PVE showed significant hypertrophy of the future liver remnant at follow-up (P < .001), and 55.6% of patients proceeded to hepatectomy. The absence of artifacts on imaging allowed improved monitoring of the aneurysmal sac in patients with type II endoleaks. The satisfaction rate of the interventional radiologists was >90% for 5 of 7 items.

Conclusions

EASYX as a novel copolymer liquid embolic agent was safe and efficient for peripheral embolization. The absence of tantalum allowed reduced CT artifacts on imaging follow-up, which was especially useful in patients with type II endoleaks.
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