1 Department of Vascular Surgery, St Antonius Hospital, Nieuwegein, the Netherlands.
2 MIRA Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, the Netherlands.
J Endovasc Ther. 2018 Dec;25(6):719-725. doi: 10.1177/1526602818808296. Epub 2018 Oct 25.
To identify preoperative anatomical aortic characteristics that predict seal failures after endovascular aneurysm sealing (EVAS) and compare the incidence of events experienced by patients treated within vs outside the instructions for use (IFU).
Of 355 patients treated with the Nellix EndoVascular Aneurysm Sealing System (generation 3SQ+) at 3 high-volume centers from March 2013 to December 2015, 94 patients were excluded, leaving 261 patients (mean age 76±8 years; 229 men) for regression analysis. Of these, 83 (31.8%) suffered one or more of the following events: distal migration ⩾5 mm of one or both stent frames, any endoleak, and/or aneurysm growth >5 mm. Anatomical characteristics were determined on preoperative computed tomography (CT) scans. Patients were divided into 3 groups: treated within the original IFU (n=166), outside the original IFU (n=95), and within the 2016 revised IFU (n=46). Categorical data are presented as the median (interquartile range Q1, Q3).
Neck diameter was significantly larger in the any-event cohort vs the control cohort [23.7 mm (21.7, 26.3) vs 23.0 mm (20.9, 25.2) mm, p=0.022]. Neck length was significantly shorter in the any-event cohort [15.0 mm (10.0, 22.5) vs 19.0 mm (10.0, 21.8), p=0.006]. Maximum abdominal aortic aneurysm (AAA) diameter and the ratio between the maximum AAA diameter and lumen diameter in the any-event group were significantly larger than the control group (p=0.041 and p=0.002, respectively). Regression analysis showed aortic neck diameter (p=0.006), neck length (p=0.001), and the diameter ratio (p=0.011) as significant predictors of any event. In the comparison of events to IFU status, 52 (31.3%) of 166 patients in the inside the original IFU group suffered an event compared to 13 (28.3%) of 46 patients inside the 2016 IFU group (p=0.690).
Large neck diameter, short aortic neck length, and the ratio between the maximum AAA and lumen diameters are preoperative anatomical predictors of the occurrence of migration (⩾5 mm), any endoleak, and/or aneurysm growth (>5 mm) after EVAS. Even under the refined 2016 IFU, more than a quarter of patients suffered from an event. Improvements in the device seem to be necessary before this technique can be implemented on a large scale in endovascular AAA repair.
确定血管内动脉瘤密封（EVAS）后预测密封失败的术前解剖主动脉特征，并比较在使用说明（IFU）内和外治疗的患者发生事件的发生率。
在 2013 年 3 月至 2015 年 12 月期间，在 3 个高容量中心使用 Nellix 血管内动脉瘤密封系统（第 3SQ+代）治疗了 355 名患者，其中 94 名患者被排除在外，留下 261 名患者（平均年龄 76±8 岁；229 名男性）进行回归分析。其中 83 名（31.8%）发生了以下一种或多种事件：一个或两个支架框架的远端迁移≥5mm，任何内漏和/或动脉瘤生长>5mm。解剖特征在术前计算机断层扫描（CT）扫描上确定。患者分为 3 组：在原始 IFU 内治疗（n=166）、原始 IFU 外治疗（n=95）和 2016 年修订 IFU 内治疗（n=46）。分类数据以中位数（四分位数范围 Q1、Q3）表示。
与对照组相比，任何事件组的颈部直径明显更大[23.7mm（21.7、26.3）比 23.0mm（20.9、25.2）mm，p=0.022]。任何事件组的颈部长度明显较短[15.0mm（10.0、22.5）比 19.0mm（10.0、21.8）mm，p=0.006]。最大腹主动脉瘤（AAA）直径和最大 AAA 直径与管腔直径之比在任何事件组中均明显大于对照组（p=0.041 和 p=0.002）。回归分析显示，主动脉颈直径（p=0.006）、颈长度（p=0.001）和直径比（p=0.011）是任何事件的显著预测因素。在比较 IFU 状态与事件的结果中，在原始 IFU 内组的 166 名患者中有 52 名（31.3%）发生了事件，而在 2016 年 IFU 内组的 46 名患者中有 13 名（28.3%）发生了事件（p=0.690）。
大的颈部直径、短的主动脉颈部长度以及最大 AAA 与管腔直径之比是 EVAS 后迁移（≥5mm）、任何内漏和/或动脉瘤生长（>5mm）发生的术前解剖预测因素。即使在经过细化的 2016 年 IFU 下，超过四分之一的患者仍发生了事件。在将该技术大规模应用于血管内 AAA 修复之前，似乎需要改进设备。
