在 EXPAND 试验中使用球囊扩张型 GORE® VIABAHN® VBX 治疗胸腹主动脉瘤的三年经验。

IF 3.9 2区 医学 Q1 PERIPHERAL VASCULAR DISEASE Journal of Vascular Surgery Pub Date : 2024-10-09 DOI:10.1016/j.jvs.2024.10.002
Marco V Usai, Mauro Gargiulo, Stéphan Haulon, Ignace Tielliu, Dittmar Böckler, Hence Verhagen, Alba Méndez Fernández, Martin J Austermann
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引用次数: 0

摘要

目的:EXPAND 登记是一项上市后多中心登记,旨在评估植入外周血管的 GORE® VIABAHN® VBX 球囊扩张内支架(VBX 支架)的安全性和性能。本亚组分析评估了 VBX 支架作为桥接支架移植物(BSG)在分支血管内主动脉修复术(BEVAR)中用于内脏血管的三年疗效:这项前瞻性、多中心、观察性登记包括16个欧洲站点。患者登记时间为 2018 年 11 月至 2022 年 3 月。终点包括三年一次通畅率(PP)、二次通畅率(SP)以及支架移植物相关死亡和严重不良事件(SAE):共纳入 73 名患者,其中 57 名(78.1%)为男性,平均年龄为 73 岁(± 8.1)岁。三年后,42 名患者(57.5%)返回进行随访。总共治疗了 223 条目标血管 (TV)。据估计,TV 一级通畅率为 93.6%。腹腔干、肠系膜上动脉、左肾动脉和右肾动脉的初次通畅率分别为 97.0%、93.9%、91.2% 和 92.5%。据估计,继发性通畅丧失的总体发生率为 96.8%,靶血管不稳定的发生率为 94.5%:结论:VBX 支架在使用三年后显示出良好的持续效果,一次通畅率接近 94%,二次通畅率达到 97%,94.5% 的患者未发生靶血管不稳定。肾动脉的通畅率低于腹腔干和 SMA。VBX 支架似乎是 BEVAR 靶血管的可靠桥接支架。
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A three-year experience with the balloon expandable GORE VIABAHN VBX in the treatment of thoraco-abdominal aortic aneurysms within the EXPAND trial.

Objective: The EXPAND registry is a post-market, multicenter registry that aims at evaluating the safety and performance of the GORE VIABAHN VBX balloon expandable endoprosthesis (VBX stent) implanted in peripheral vessels. This subgroup analysis assesses the 3-year outcomes of the VBX stent as a bridging stent graft for visceral vessels during branched endovascular aortic repair.

Methods: This prospective, multicenter, observational registry includes 16 European sites. Patients were enrolled from November 2018 to March 2022. Endpoints included 3-year primary patency (PP), secondary patency (SP), and stent graft-related death and serious adverse events.

Results: Seventy-three patients, of whom 57 (78.1%) were male, with a mean age of 73 years (±8.1 years) were included. At 3 years, 42 patients (57.5%) returned for follow-up. Overall, 223 target vessels (TVs) were treated. The estimated freedom from loss of TV PP was 93.6%. Per TV PP rates were 97.0% for the celiac trunk, 93.9% for the superior mesenteric artery, 91.2% for the left renal artery, and 92.5% for the right renal artery. The overall estimated freedom from loss of SP was 96.8%, and freedom from TV instability was 94.5%.

Conclusions: The VBX stent demonstrated excellent sustained results at 3 years with almost 94% PP, 97% SP, and 94.5% freedom from TV instability. Patency in the renal arteries was lower than in the celiac trunk and superior mesenteric artery. The VBX stent appears to be a reliable bridging stent for target vessels in branched endovascular aortic repair.

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来源期刊
CiteScore
7.70
自引率
18.60%
发文量
1469
审稿时长
54 days
期刊介绍: Journal of Vascular Surgery ® aims to be the premier international journal of medical, endovascular and surgical care of vascular diseases. It is dedicated to the science and art of vascular surgery and aims to improve the management of patients with vascular diseases by publishing relevant papers that report important medical advances, test new hypotheses, and address current controversies. To acheive this goal, the Journal will publish original clinical and laboratory studies, and reports and papers that comment on the social, economic, ethical, legal, and political factors, which relate to these aims. As the official publication of The Society for Vascular Surgery, the Journal will publish, after peer review, selected papers presented at the annual meeting of this organization and affiliated vascular societies, as well as original articles from members and non-members.
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