背景:血管内栓塞术常用于头颈部血管病变。较新的药物可能有助于增强可视化并改善治疗结果。
方法:CLARIDAD临床试验是一项前瞻性,单中心,首次使用新型栓塞剂ihtObtura进行神经血管栓塞的研究,以获得广泛的适应症,涵盖头颈部手术中对液体栓塞剂的需求。评估的主要结果是递送ihtObtura以栓塞导管椎弓根的治疗效果和相关的血管造影血管。以及随后的射线不透性损失。安全性终点包括手术不良事件,改良Rankin量表(MRS)评分,发病率,和死亡率。在30、90、180天进行放射学和临床随访评估,治疗后1年。
结果:连续65例患者(平均年龄37.8岁,50.8%的女性)接受了129次以上的治疗。共有42例脑动静脉畸形(AVM;90%的III级和IV级),8个硬脑膜动静脉瘘(DAVFs),和15个高血管肿瘤用ihtObtura治疗,平均每期3.9mL和每位患者7.7mL。我们在99%的导管插入中获得了治疗效果。在30天的74.3%的会议后,辐射不透明度损失完成,90天95.6%,和100%在1年的随访。严重不良事件(mRS评分>2)发生在2例(3.1%),先前已破裂的高级别AVM导致1例死亡和1例永久性致残。
结论:研究表明,ihtobtura是一部小说,安全,和治疗AVM的有效液体栓塞剂,DAVF,和高血管性肿瘤。其显著的射线不透性损失的关键特性有助于提高解剖学理解,特别是在分阶段的程序中,以及减少术后成像伪影。在损伤穿透方面,从栓塞混合物中消除钽可能有额外的益处。
BACKGROUND: Endovascular embolization is frequently used for vascular lesions of the head and neck. Newer agents may help to enhance visualization and improve treatment outcomes.
METHODS: The CLARIDAD clinical trial was a prospective, single center, first-in-man investigation of neurovascular embolization using the novel
embolic agent ihtObtura for a broad indication, covering the need for a liquid
embolic agent in head and neck procedures. The primary outcomes assessed were therapeutic efficacy to deliver ihtObtura to embolize the catheterized pedicle and associated angiographic vascularity, and subsequent loss of radiopacity. Safety endpoints included procedural adverse events, modified Rankin Scale (mRS) score, morbidity, and mortality. Radiologic and clinical follow-up evaluations were conducted at 30, 90, 180 days, and 1 year post-treatment.
RESULTS: 65 consecutive patients (mean age 37.8 years, 50.8% women) were treated over 129 sessions. A total of 42 brain arteriovenous malformations (AVMs; 90% grades III and IV), 8 dural arteriovenous fistulas (DAVFs), and 15 hypervascular tumors were treated with ihtObtura using an average of 3.9 mL per session and 7.7 mL per patient. We achieved therapeutic effectiveness in 99% of catheterizations. Radiopacity loss was complete after 74.3% of the sessions at 30 days, 95.6% at 90 days, and 100% at the 1 year follow-up. Serious adverse events (mRS score >2) occurred in two patients (3.1%) with previously ruptured high grade AVMs leading to one death and one permanent disabling morbidity.
CONCLUSIONS: The study showed that ihtObtura was a novel, safe, and effective liquid
embolic agent for the treatment of AVMs, DAVFs, and hypervascular tumors. Its key property of significant radiopacity loss contributes to improve anatomical understanding, particularly in staged procedures, as well as reduction in post-procedural imaging artifact. There may be additional benefits of eliminating tantalum from the
embolic mixture in terms of lesion penetration.