Department of Vascular Surgery, St. Franziskus Hospital, Münster, Germany.
Department of Vascular Surgery, Azienda Ospedaliera Policlinico Sant'Orsola Malpighi, Bologna, Italy.
J Vasc Surg. 2023 Dec;78(6):1376-1382.e2. doi: 10.1016/j.jvs.2023.07.061. Epub 2023 Aug 11.
This post-market multicenter registry aimed to evaluate the safety and performance of the GORE VIABAHN VBX balloon expandable endoprosthesis (VBX stent) implanted in peripheral vessels. In this subgroup analysis, we assessed the outcomes of the VBX stent as a bridging stent graft for visceral vessels during branched endovascular aortic repair at 1 year.
A single cohort from a prospective, multicenter, observational, 16-site European registry. Patients were enrolled from November 2018 to March 2022. Endpoints included 1-year primary patency (PP), primary assisted patency (PAP), and secondary patency (SP), stent graft-related death and serious adverse events through 30 days.
Seventy-three patients were enrolled in this registry sub-cohort, 57 (78.1%) were male, and the mean age was 73 ± 8.1 years. Thoracoabdominal aneurysms predominated the cohort with 68 patients (93.2%), followed by five patients (6.8%) with pararenal and infrarenal aneurysms. Overall, 233 target vessels were treated with the index bridging graft. The overall per stent graft analysis demonstrated a PP of 95.8% at 1 year; PAP was 95.8%, and SP reached 97.9%. The per-target vessel analysis demonstrated a PP, PAP, and SP in the celiac trunk of 100%, 100%, and 100%; in the superior mesenteric artery of 96.0%, 96.0%, and 100%, and in the renal arteries of 94.2%, 94.2%, and 95.1%, respectively. Four patients (5%) died at 1 year; none of the deaths were device-related. The composite endpoint of target vessel technical success and freedom from VBX stent-related serious adverse events through 30 days was achieved in 98.6% of patients.
In this prospective post-market multicenter registry, the VBX stent demonstrated excellent results at 1 year, with almost 96% primary patency and 98% secondary patency. Patency in the renal arteries seems to be lower. Nevertheless, the VBX stent appears to be a reliable bridging stent for branched endovascular aortic repair.
本上市后多中心注册研究旨在评估 Gore VIABAHN VBX 球囊扩张式覆膜支架（VBX 支架）在周围血管中的安全性和性能。在这项亚组分析中，我们评估了 VBX 支架在分支腔内主动脉修复期间作为内脏血管桥接支架移植物的 1 年结果。
这是一项来自前瞻性、多中心、观察性、16 个地点的欧洲注册研究的单一队列。患者于 2018 年 11 月至 2022 年 3 月入组。主要终点包括 1 年通畅率（PP）、主要辅助通畅率（PAP）和次要通畅率（SP）、支架相关死亡和 30 天内严重不良事件。
本注册研究亚组共纳入 73 例患者，其中 57 例（78.1%）为男性，平均年龄为 73±8.1 岁。胸主动脉瘤是最主要的病变类型，占 68 例（93.2%），其次为 5 例（6.8%）肾下型和肾周型腹主动脉瘤。总体上，有 233 个靶血管接受了指数桥接移植物治疗。支架移植物整体分析显示 1 年时 PP 为 95.8%；PAP 为 95.8%，SP 达到 97.9%。靶血管分析显示，腹腔干的 PP、PAP 和 SP 分别为 100%、100%和 100%；肠系膜上动脉的 PP、PAP 和 SP 分别为 96.0%、96.0%和 100%；肾动脉的 PP、PAP 和 SP 分别为 94.2%、94.2%和 95.1%。4 例患者（5%）在 1 年内死亡；均与器械无关。98.6%的患者达到了靶血管技术成功和 30 天内无 VBX 支架相关严重不良事件的复合终点。
在这项前瞻性上市后多中心注册研究中，VBX 支架在 1 年时表现出优异的结果，通畅率接近 96%，次要通畅率为 98%。肾动脉的通畅率似乎较低。然而，VBX 支架似乎是分支腔内主动脉修复的一种可靠的桥接支架。
