ihtObtura®，一种用于改善脑动静脉畸形（AVM）治疗性栓塞的新型液体栓塞剂。
ihtObtura®, a new liquid embolic agent for improving curative embolization of brain AVMs.
作者信息
Llibre-Guerra Juan C, Siddiqui Adnan H, Guimaraens Leopoldo, Chapot Rene, Gil Alberto
机构信息
From the Department of Interventional Neurorradiology (J.C.Ll.), Hospital Universitario de Salamanca, Salamanca, Spain, and Department of Interventional Neurology (J.C.Ll.), Instituto de Neurología y Neurocirugía, Havana, Cuba. From the Department of Neurosurgery and Radiology and Canon Stroke and Vascular Research Center, and Gates Vascular Institute (A.H.S.), University at Buffalo, Buffalo, New York, USA. From the Department of Therapeutic Neuroangiography (L.G., A.G.), Hospital Universitario General de Cataluña and Hospital del Mar, Barcelona, Spain, and Department of Interventional Neuroradiology (L.G.), Hospital Universitario Vithas Arturo Soria, Madrid, Spain. From the Department of Intracranial Endovascular Therapy (R.C.), Alfried-Krupp Krankenhause, Essen, Germany. From the Department of Interventional Neurorradiology (A.G.), University Hospital Marqués de Valdecilla, Santander, Spain.
出版信息
AJNR Am J Neuroradiol. 2025 May 13. doi: 10.3174/ajnr.A8834.
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.
背景与目的
我们报告了使用ihtObtura®的初步经验，这是一种新型非粘性液体栓塞剂，栓塞后造影剂逐渐消失，用于脑动静脉畸形（bAVM）的根治性栓塞。
材料与方法
对Claridad试验进行事后分析，这是一项单中心的人体首次研究。分析了连续接受ihtObtura®治疗的脑bAVM患者（2021年11月至2022年9月）的数据。收集患者人口统计学、AVM特征、手术细节和临床治疗结果。影像学终点包括6个月时的完全闭塞率和4 - 6周时的造影剂消失情况。
结果
共有42例连续接受102次栓塞手术的脑bAVM患者纳入分析。大多数患者表现为颅内出血（83%）。平均AVM分级为Spetzler-Martin（S-M）III-IV级（90%），平均病灶大小为39±14mm。在研究期间能够完成所有治疗的26/28例患者（93%）实现了完全闭塞。在整个患者队列中，62%（26/42例患者）观察到完全闭塞。各有1例发生与手术相关的致残性永久性神经功能缺损和与手术相关的死亡。这两个事件均与栓塞后颅内出血有关。所有患者均观察到栓塞材料造影剂逐渐减少。
结论
ihtObtura®是一种新型液体栓塞剂，其性质与目前其他基于乙烯-乙烯醇（EVOH）共聚物的液体栓塞剂相似，但有一项重大创新，即栓塞材料造影剂逐渐减少。这一特性显著提高了在AVM分期治疗过程中对残留AVM成分的解剖学认识。本研究提供了初步证据，表明基于EVOH的弥散特性与造影剂逐渐消失相结合，有可能提高bAVM的完全闭塞率。
缩写
bAVM = 脑动静脉畸形；S-M = Spetzler-Martin分级；EVOH = 乙烯-乙烯醇共聚物；MRI = 磁共振成像；CT = 计算机断层扫描；LEA = 液体栓塞剂；mRS = 改良Rankin量表评分；DMSO = 二甲基亚砜溶剂；DSA = 数字减影血管造影
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