Department of Diagnostic and Interventional Radiology and Nuclear Medicine, Charité Campus Virchow-Klinikum, Charité University Medicine Berlin, Berlin, Germany; Department of Vascular Surgery, St. Franziskus Hospital Münster, Münster, Germany.
Department of Vascular Surgery, St. Franziskus Hospital Münster, Münster, Germany.
J Vasc Surg. 2020 Sep;72(3):859-865. doi: 10.1016/j.jvs.2019.10.089. Epub 2020 Jan 19.
Until today, no dedicated bridging stent graft (BSG) has been available for use in fenestrated and branched endovascular aneurysm repair (F/BEVAR). The purpose of this study was to evaluate the clinical performance of the well-known Advanta/iCast V12 (Getinge Maquet, Rastatt, Germany) and the new Viabahn VBX (W. L. Gore & Associates, Flagstaff, Ariz) balloon-expandable stent graft in F/BEVAR.
Retrospective analysis of prospectively collected data was performed. Inclusion criteria were treatment with fenestrated or branched endografts for complex aortic diseases, implantation of at least one VBX stent graft as a BSG in one of the target vessels, and clinical or radiologic follow-up of 6 months. The primary end point of the study was technical success of all BSGs, defined as placement of the BSG in the desired position with absence of endoleak on final angiography. Secondary end points were freedom from perioperative major adverse events and freedom from reinterventions and mortality at 6 months. Procedural and postoperative data were analyzed.
Between December 2017 and July 2018, there were 50 patients (40 male; mean age, 71 years) included. A total of 145 VBX stent grafts were implanted, followed by 57 Advanta V12, 29 Viabahn, and 28 bare-metal stents. There were 126 branches (celiac trunk, 27; superior mesenteric artery, 25; renal arteries, 74) sealed exclusively with VBX. Technical success rate was 98.6%. There were six device-related reinterventions due to type IC endoleaks (n = 4), target vessel stenosis distal to the BSG, and stent graft occlusion in a left renal artery in one case. The perioperative and aneurysm-related mortality was 0%; the 6-month all-cause mortality was 2%.
The used BSGs demonstrated promising preliminary results in F/BEVAR. Further evaluation is mandatory to determine durability of the VBX.
迄今为止，尚无专用的分支型和开窗型腔内血管修复用覆膜支架移植物（BSG）。本研究旨在评估知名的 Advanta/iCast V12（Getinge Maquet，Rastatt，德国）和新型 Viabahn VBX（W. L. Gore & Associates，Flagstaff，Ariz）球扩式覆膜支架在分支型和开窗型腔内血管修复术中的临床性能。
对前瞻性收集的数据进行回顾性分析。纳入标准为：采用开窗或分支型腔内移植物治疗复杂主动脉疾病；至少在其中一条靶血管中植入 1 枚 Viabahn VBX 支架作为 BSG；临床或影像学随访 6 个月。研究的主要终点为所有 BSG 的技术成功，定义为 BSG 放置于预期位置，最终血管造影未见内漏。次要终点为围手术期无重大不良事件、无再干预和 6 个月死亡率。分析手术和术后数据。
2017 年 12 月至 2018 年 7 月，共纳入 50 例患者（男 40 例，平均年龄 71 岁）。共植入 145 枚 Viabahn VBX 支架，随后植入 57 枚 Advanta V12、29 枚 Viabahn、28 枚裸支架。126 个分支（腹腔干 27 个，肠系膜上动脉 25 个，肾动脉 74 个）仅用 VBX 封闭。技术成功率为 98.6%。因 1 型内漏（4 例）、BSG 远端靶血管狭窄和 1 例左肾动脉支架闭塞，进行了 6 次与器械相关的再干预。围手术期和动脉瘤相关死亡率为 0%；6 个月全因死亡率为 2%。
所使用的 BSG 在分支型和开窗型腔内血管修复术中显示出良好的初步结果。需要进一步评估以确定 VBX 的耐用性。
