ihtObtura®, a new liquid embolic agent for improving curative embolization of brain AVMs.

Juan C Llibre-Guerra, Adnan H Siddiqui, Leopoldo Guimaraens, Rene Chapot, Alberto Gil
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Abstract

Background and purpose: We report our initial experience with ihtObtura®, a novel non-adhesive liquid embolic agent with progressive post-embolization loss of radiopacity for curative embolization of brain arteriovenous malformations (bAVMs).

Materials and methods: A post-hoc analysis of the Claridad trial, a single center, first-in-man study was performed. Collected data on consecutive brain bAVMs patients treated with ihtObtura® (between November 2021 to September 2022) were analyzed. Patient demographics, AVM characteristics, procedure details, and clinical treatment outcomes were collected. Imaging endpoints included complete occlusion rate at 6 months and loss of radiopacity at 4 -6 weeks.

Results: A total of 42 consecutive brain bAVM patients who underwent 102 embolization procedures were included in the analysis. Most patients presented with intracranial hemorrhage (83%). The mean AVM classification was Spetzler-Martin (S-M) grade III-IV (90%), with a mean nidus size of 39 ± 14 mm. Complete occlusion was achieved in 26/28 patients (93%) who were able to complete all treatments during the study period. In the entire patient cohort, complete occlusion was observed in 62% (26/42 patients). Procedure-related disabling permanent neurological deficit and procedure-related death were observed in one case each. Both events were related to postembolization intracranial hemorrhages. Progressive reduction of embolic material radiopacity was observed in all patients.

Conclusions: ihtObtura® is a new liquid embolic agent with similar properties as currently available other ethylene vinyl alcohol (EVOH) copolymer based liquid embolics with one major innovation, progressive reduction in embolic material radiopacity. This feature significantly improves anatomical understanding of residual AVM components during staged treatment of AVMs. This study provides initial evidence that combination of EVOH based diffusion properties with progressive loss of radiopacity allows for the potential improvement in rates of complete obliteration for bAVMs.

Abbreviations: bAVMs = Brain arteriovenous malformations; S-M = Spetzler-Martin Scale; EVOH = Ethylene vinyl alcohol copolymer; MRI = Magnetic resonance imaging; CT = Computed Tomography; LEA = Liquid embolic agents; mRS = Modified Rankin Scale scores; DMSO = Dimethyl sulpha-oxide solvent; DSA = Digital subtraction angiography.

ihtotura®,一种新型液体栓塞剂,用于改善脑动静脉畸形的治疗性栓塞。
背景和目的:我们报告了我们使用ihtObtura®的初步经验,ihtObtura®是一种新型的无粘性液体栓塞剂,栓塞后放射性逐渐丧失,用于治疗脑动静脉畸形(bavm)的栓塞。材料和方法:对Claridad试验进行事后分析,这是一项单中心的首次人体研究。对连续接受ihtotura®治疗的脑bAVMs患者(2021年11月至2022年9月)收集的数据进行分析。收集患者人口统计资料、动静脉畸形特征、手术细节和临床治疗结果。成像终点包括6个月时的完全闭塞率和4 -6周时的放射不透丧失。结果:共有42例连续接受102次栓塞手术的脑bAVM患者被纳入分析。大多数患者表现为颅内出血(83%)。AVM平均分级为Spetzler-Martin (S-M) III-IV级(90%),平均病灶大小为39±14 mm。在研究期间完成所有治疗的患者中,有26/28(93%)实现了完全闭塞。在整个患者队列中,62%(26/42)的患者观察到完全闭塞。手术相关致残、永久性神经功能缺损和手术相关死亡各1例。这两个事件都与栓塞后颅内出血有关。所有患者均观察到栓塞性物质放射性逐渐减少。结论:ihtObtura®是一种新型液体栓剂,其性能与目前可用的其他基于乙烯乙烯醇(EVOH)共聚物的液体栓剂相似,具有一个主要的创新,即栓塞材料的放射透明度逐步降低。这一特征显著提高了在分阶段治疗动静脉畸形时对残余动静脉畸形成分的解剖学理解。该研究提供了初步证据,表明基于EVOH的扩散特性与渐进式放射不透性丧失相结合,可以潜在地提高bavm的完全闭塞率。缩写:bAVMs =脑动静脉畸形;S-M =斯佩茨勒-马丁量表;乙烯乙烯醇共聚物;磁共振成像;计算机断层扫描;LEA =液体栓塞剂;mRS =修正兰金量表评分;二甲基亚硫氧化物溶剂;数字减影血管造影。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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