Usai Marco V, Gargiulo Mauro, Haulon Stéphan, Tielliu Ignace, Böckler Dittmar, Verhagen Hence, Fernández Alba Méndez, Austermann Martin J
Department of Vascular Surgery, St. Franziskus Hospital, Münster, Germany.
Department of Vascular Surgery, Azienda Ospedaliera Policlinico Sant'Orsola Malpighi, Bologna, Italy.
J Vasc Surg. 2025 Feb;81(2):319-323.e1. doi: 10.1016/j.jvs.2024.10.002. Epub 2024 Oct 9.
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.
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.
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%.
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.
EXPAND注册研究是一项上市后多中心注册研究,旨在评估植入外周血管的戈尔VIABAHN VBX球囊扩张式血管内支架(VBX支架)的安全性和性能。该亚组分析评估了VBX支架作为分支血管腔内主动脉修复术中内脏血管桥接支架移植物的3年结局。
这项前瞻性、多中心观察性注册研究纳入了16个欧洲研究点。患者于2018年11月至2022年3月入组。终点指标包括3年主要通畅率(PP)、次要通畅率(SP)以及与支架移植物相关的死亡和严重不良事件。
共纳入73例患者,其中57例(78.1%)为男性,平均年龄73岁(±8.1岁)。3年时,42例患者(57.5%)返回接受随访。总体而言,共治疗了223条靶血管(TV)。估计TV的PP无损失率为93.6%。各TV的PP率分别为:腹腔干97.0%,肠系膜上动脉93.9%,左肾动脉91.2%,右肾动脉92.5%。总体估计SP无损失率为96.8%;TV无失稳率为94.5%。
VBX支架在3年时显示出优异的持续效果,PP率近94%,SP率97%,TV无失稳率94.5%。肾动脉的通畅率低于腹腔干和肠系膜上动脉。VBX支架似乎是分支血管腔内主动脉修复术中靶血管可靠的桥接支架。