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外周栓塞用 EASYX 液体栓塞剂的安全性和疗效:一项多中心前瞻性研究。

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

机构信息

Department of Vascular and Oncological Interventional Radiology, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France; Université de Paris, PARCC, INSERM, Paris, France.

Interventional Radiology Section, Department of Medical Imaging, University Hospital Timone, AP-HM, Marseille, France; LiiE, Aix Marseille University, Marseille, France; CERIMED, Aix Marseille University, Marseille, France.

出版信息

J Vasc Interv Radiol. 2021 Aug;32(8):1136-1143. doi: 10.1016/j.jvir.2021.05.014. Epub 2021 Jun 5.

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.

摘要

目的

评估新型非粘附性沉淀液体栓塞剂 EASYX 的临床安全性和疗效,该产品基于带有碘分子标记的聚乙烯醇醚聚合物。本研究旨在评估 EASYX 在外周栓塞中的应用。

材料和方法

这是一项开放标签的前瞻性多中心研究,纳入了 2018 年 4 月至 2019 年 7 月期间在 3 所学术医院接受 EASYX 栓塞治疗的 50 例连续患者。栓塞的适应证包括症状性精索静脉曲张(n=15)、II 型内漏(n=8)、急性出血(n=16)、门静脉栓塞(PVE;n=9)或血管平滑肌脂肪瘤(AML;n=2)。评估了患者特征、技术和临床成功率、注射时的疼痛以及介入放射科医生的满意度。使用超声检查精索静脉曲张(1 个月时)和其他适应证(3 或 6 个月时)进行随访影像学检查。

结果

即刻技术成功率为 98%。急性出血和 II 型内漏的临床成功率为 100%,PVE 的临床成功率为 89%,精索静脉曲张为 86%,AML 为 50%。行 PVE 的患者在随访时显示出显著的肝未来残余组织肥大(P <.001),55.6%的患者行肝切除术。II 型内漏患者的成像无伪影,可改善对动脉瘤囊的监测。介入放射科医生对 7 项评估指标中的 5 项的满意度>90%。

结论

作为一种新型共聚物液体栓塞剂,EASYX 在外周栓塞中安全有效。缺乏钽可减少成像随访中的 CT 伪影,这在 II 型内漏患者中特别有用。

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