Kouvelos George N, Nana Petroula, Bouris Vasilios, Peroulis Michalis, Drakou Aikaterini, Rousas Nikolaos, Giannoukas Athanasios, Matsagkas Miltiadis I
Vascular Surgery Unit, Department of Surgery, School of Medicine, University of Ioannina, Ioannina, Greece; Department of Vascular Surgery, General University Hospital of Larissa, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece.
Vascular Surgery Unit, Department of Surgery, School of Medicine, University of Ioannina, Ioannina, Greece.
Vasc Specialist Int. 2017 Mar;33(1):16-21. doi: 10.5758/vsi.2017.33.1.16. Epub 2017 Mar 31.
The newly designed unibody AFX endograft system for endovascular aortic aneurysm repair is the only graft with anatomical fixation to the aortic bifurcation in comparison to most other grafts that use the infrarenal neck as the main fixation point. The aim of this study was to assess the preliminary results of the AFX stent-graft system used with infrarenal aortic component and compare them with those obtained in patients treated with a well established endograft of the same material and pure infrarenal fixation as the Gore Excluder.
A retrospective analysis of prospectively collected data from March 2014 to December 2014 identified 10 elective abdominal aortic aneurysm patients treated with the AFX endograft, in comparison to a matched group of 20 patients treated with the Excluder stent-graft. Endpoints included technical and clinical success, freedom from any secondary intervention, any type of endoleak and aneurysm related death.
Primary technical success was achieved in all patients and no 30-day device related complications or deaths were occurred. The two groups were similar in terms of radiation burden, contrast media, duration of the procedure, post implantation syndrome and in-hospital stay. During a median follow-up period of 23 months (range, 18-26 months) there were no differences in clinical success, freedom from reintervention and aneurysm related death. No type I endoleak was observed in either group. Five of the 6 type II endoleaks (1 in the AFX and 4 in the Excluder group) spontaneously resolved, while in only one patient (Excluder) the endoleak remained without however any change in aneurysm sac diameter (log rank=0.34).
The initial experience with the AFX stent graft system is promising, with successful aneurysm exclusion and good short-term results. Further and larger studies are needed to fully evaluate the sort as well as the long-term results.
新设计的一体式AFX血管内移植物系统用于血管内腹主动脉瘤修复，与大多数以肾下颈部作为主要固定点的其他移植物相比，它是唯一一种在主动脉分叉处有解剖学固定的移植物。本研究的目的是评估使用肾下主动脉组件的AFX支架移植物系统的初步结果，并将其与使用相同材料且与戈尔Excluder一样为单纯肾下固定的成熟血管内移植物治疗的患者所获得的结果进行比较。
对2014年3月至2014年12月前瞻性收集的数据进行回顾性分析，确定了10例接受AFX血管内移植物治疗的择期腹主动脉瘤患者，与之匹配的是20例接受Excluder支架移植物治疗的患者。观察指标包括技术和临床成功、无需任何二次干预、任何类型的内漏以及与动脉瘤相关的死亡。
所有患者均取得了初次技术成功，未发生30天内与器械相关的并发症或死亡。两组在辐射剂量、造影剂用量、手术持续时间、植入后综合征和住院时间方面相似。在中位随访期23个月（范围18 - 26个月）内，临床成功、无需再次干预以及与动脉瘤相关的死亡方面无差异。两组均未观察到I型内漏。6例II型内漏中有5例（AFX组1例，Excluder组4例）自发消失，仅1例患者（Excluder组）内漏持续存在，但动脉瘤囊直径无任何变化（对数秩检验=0.34）。
AFX支架移植物系统的初步经验令人鼓舞，成功排除了动脉瘤且短期结果良好。需要进一步开展更大规模的研究以全面评估其分类以及长期结果。
