Department of Outcomes Research, St George's Vascular Institute, London, UK.
Eur J Vasc Endovasc Surg. 2013 Oct;46(4):440-5. doi: 10.1016/j.ejvs.2013.06.017. Epub 2013 Aug 1.
Endovascular aneurysm sealing (EVAS) using the Nellix system is a promising alternative to endovascular repair (EVR) and open surgery for abdominal aortic aneurysms (AAA). The aim of this study was to investigate the proportion of patients with AAA who are morphologically suitable for treatment with Nellix.
Patients presenting with AAA were investigated at two regionalised vascular units. Separate cohorts were identified, who had undergone infrarenal EVR, open aneurysm repair, fenestrated endovascular repair (FEVR) or non-operative management. Pre-operative morphology was quantified using three-dimensional computed tomography according to a validated protocol. Each aneurysm was assessed for compliance with the instructions for use (IFU) of Nellix
776 patients were identified with mean age 75 ± 9 years. 730/776 (94.1%) had undergone infrarenal EVR, 6/776 (0.8%) open repair, 27/776 (3.5%) FEVR and 13/776 (1.7%) had been managed non-operatively. 544/776 (70.1%) of all AAA were morphologically suitable for Nellix. 533/730 (73.0%) of patients who had undergone infrarenal EVR were compliant with Nellix IFU, compared with 497/730 (68.1%), 379/730 (51.9%) and 214/730 (29.3%) with the IFU for Medtronic Endurant (p = .04) or Cook Zenith (p < .01) and Gore C3 Excluder (p < .01) endografts respectively.
Nellix technology appears widely applicable to contemporary infrarenal AAA practice, and may provide an option for patients that are outside current EVR device instructions for use. However, formal outcomes study is still required, and will ultimately dictate the clinical relevance of this feasibility study. The major limitation to anatomic suitability for Nellix is currently the maximum patent lumen diameter of large AAA.
使用 Nellix 系统的血管内动脉瘤封闭（EVAS）是治疗腹主动脉瘤（AAA）的一种有前途的替代方法，可替代血管内修复（EVR）和开放手术。本研究旨在调查 AAA 患者中形态上适合 Nellix 治疗的患者比例。
在两个区域性血管单位对出现 AAA 的患者进行了调查。分别确定了接受肾下 EVR、开放动脉瘤修复、开窗血管内修复（FEVR）或非手术治疗的队列。使用三维计算机断层扫描根据经过验证的方案量化术前形态。每个动脉瘤都根据 Nellix 的使用说明（IFU）进行评估
共确定了 776 例患者，平均年龄为 75 ± 9 岁。730/776（94.1%）接受了肾下 EVR，6/776（0.8%）开放修复，27/776（3.5%）FEVR，13/776（1.7%）非手术治疗。所有 AAA 中，776 例中有 544 例（70.1%）形态上适合 Nellix。与 Medtronic Endurant（p =.04）或 Cook Zenith（p <.01）和 Gore C3 Excluder（p <.01）内支架的 IFU 相比，接受肾下 EVR 的 730 例患者中有 533 例（73.0%）符合 Nellix IFU，730 例中有 497 例（68.1%）、379 例（51.9%）和 214 例（29.3%）
Nellix 技术似乎广泛适用于当代肾下 AAA 实践，并且可能为超出当前 EVR 设备使用说明的患者提供一种选择。然而，仍需要进行正式的结果研究，这将最终决定本可行性研究的临床相关性。Nellix 对解剖学的主要限制是目前大型 AAA 的最大有效管腔直径。
