Ramot Yuval, Steiner Michal, Vazana Udi, Nyska Abraham, Horev Anat
Department of Dermatology, Hadassah Medical Center, Jerusalem 9112001, Israel.
Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem 7661041, Israel.
J Clin Med. 2025 Jul 3;14(13):4721. doi: 10.3390/jcm14134721.
Venous sinus stenting is a promising treatment for intracranial venous disorders, such as idiopathic intracranial hypertension and pulsatile tinnitus, associated with transverse sinus stenosis. The VIVA Stent System (VSS) is a novel self-expanding braided venous stent designed to navigate tortuous cerebral venous anatomy. This preclinical study assessed the safety, thrombogenicity, and performance of the VSS in a swine model. Fifteen swine underwent bilateral internal mammary vein stenting with either the VSS ( = 9) or the PRECISE PRO RX stent ( = 6, reference). Fluoroscopy and thrombogenicity assessments were conducted on the day of stenting, clinical pathology analysis was carried out throughout the in-life phase, and CT Venography was performed before sacrifice. Animals were sacrificed at 30 ± 3 or 180 ± 11 days post-stenting for necropsy and histological evaluation. Fluoroscopic angiography confirmed the successful VSS deployment with complete venous wall apposition and no vessel damage. The VSS achieved the highest scores on a four-point Likert scale for most performance parameters. No thrombus formation was observed on either delivery system. CT Venography confirmed vessel patency, no stent migration, and complete stent integrity. Histopathology showed a mild, expected foreign body reaction at 30 days, which resolved by 180 days, indicating normal healing progression. Both stents showed increased luminal diameter and decreased wall thickness at 180 days, suggesting vessel recovery. No adverse reactions were observed in non-target organs. The VSS exhibited favorable safety, procedural performance, and thromboresistance in a swine model, supporting its potential clinical use for treating transverse sinus stenosis and related conditions.
静脉窦支架置入术是治疗与横窦狭窄相关的颅内静脉疾病（如特发性颅内高压和搏动性耳鸣）的一种有前景的治疗方法。VIVA支架系统（VSS）是一种新型的自膨胀编织静脉支架，设计用于适应迂曲的脑静脉解剖结构。这项临床前研究评估了VSS在猪模型中的安全性、血栓形成性和性能。15头猪接受了双侧乳内静脉支架置入术，其中9头使用VSS，6头使用PRECISE PRO RX支架（作为对照）。在支架置入当天进行荧光透视和血栓形成性评估，在整个实验期进行临床病理分析，并在处死前进行CT静脉造影。在支架置入后30±3天或180±11天处死动物进行尸检和组织学评估。荧光透视血管造影证实VSS成功置入，静脉壁完全贴合且无血管损伤。对于大多数性能参数，VSS在四点李克特量表上获得了最高分。在两种输送系统上均未观察到血栓形成。CT静脉造影证实血管通畅，无支架移位，支架完整性良好。组织病理学显示在30天时出现轻度、预期的异物反应，到180天时消失，表明愈合进程正常。两种支架在180天时均显示管腔直径增加，管壁厚度减小，提示血管恢复。在非靶器官未观察到不良反应。VSS在猪模型中表现出良好的安全性、操作性能和抗血栓性，支持其在治疗横窦狭窄及相关疾病方面的潜在临床应用。
