首页> 外文期刊>Journal of vascular surgery >Refinement of anatomic indications for the Nellix System for endovascular aneurysm sealing based on 2-year outcomes from the EVAS FORWARD IDE trial
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Refinement of anatomic indications for the Nellix System for endovascular aneurysm sealing based on 2-year outcomes from the EVAS FORWARD IDE trial

机译:基于EVAS前瞻性试验的2年成果的血管内动脉瘤密封的细节骨质抗性细化

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BackgroundThe Nellix System (Endologix, Inc, Irvine, Calif) for endovascular aneurysm sealing (EVAS) is a novel approach to abdominal aortic aneurysm treatment and conceptually different from endovascular aneurysm repair, whereby polymer is employed to fill and actively manage the abdominal aortic aneurysm sac. One-year safety and effectiveness results of the Nellix pivotal trial demonstrated encouraging outcomes with very low morbidity and mortality and high procedural and treatment success. Two-year imaging revealed a signal of migration, leading to a field safety notification issued by the manufacturer on October 21, 2016, and a dedicated root cause analysis, resulting in refinements to the instructions for use (IFU). We report the 2-year results of the investigational device exemption pivotal trial stratified according to the new and original criteria for selection of patients. MethodsComprehensive engineering evaluations, statistical analyses, and clinical assessments were conducted looking at patients enrolled in the pivotal trial (N?= 150), roll-in cohort (N?= 29), and continued access program (N?= 154). All patients in all cohorts were treated on-IFU at the time of enrollment. Logistic regression models supported the mechanism that migration with Nellix is associated with a small aortic flow lumen relative to a large aneurysm thrombus burden and large aortic neck diameters. Based on these findings, refinements to the IFU criteria were applied, excluding patients with a thrombus index (maximum aneurysm sac/maximum flow lumen diameter) >1.4, aortic neck diameter >28?mm, and aortic neck conicity (>10% diameter change along the infrarenal neck) and requiring a 10-mm distal seal zone in the iliac artery. ResultsFreedom from all-cause mortality at 2?years was 94%. Patient outcomes were then stratified on the refined morphologic criteria and analyzed retrospectively. Two-year freedom from composite endoleak was high among both cohorts (95% on-IFU vs 92% off-IFU). Freedom from migration was 97.7% on-IFU vs 93.2% off-IFU (P?= .0125). Freedom from aneurysm enlargement was 98.1% on-IFU vs 93.5% off-IFU (Pvalue is not available because of failure of log-rank test assumptions). Composite freedom from migration, type IA endoleak, or aneurysm expansion was 95.9% among the on-IFU cohort vs 85.1% in the off-IFU cohort (P?= .0017). ConclusionsConsistent with the introduction of a novel therapy, the presentation of failure modes of EVAS over time was inevitable. Using detailed imaging as well as engineering and statistical analysis, we were able to understand risk factors for adverse events specific to EVAS and defined those patients best suited for Nellix. With this EVAS-specific approach to defining IFU, on-IFU patients were identified as those with large aneurysms with little thrombus that would be prone to type II endoleaks and sac expansion with traditional devices. When treated with Nellix, these patients were predicted to experience exceptional results, especially with regard to a low composite endoleak rate and low all-cause mortality.
机译:背景技术内血管内动脉瘤密封(EVA)的Nellix系统(Endologix,Inc,Irvine,Calif)是一种新的腹主动脉瘤治疗方法,概念性地与血管内动脉瘤修复的概念性不同,由此使用聚合物来填充和积极管理腹主动脉瘤囊。 Nellix关键试验的一年安全性和有效性结果表明了令人鼓舞的发病率和死亡率以及高程序性和治疗成功的结果。为期两年的成像揭示了迁移的信号,导致制造商于2016年10月21日发出的现场安全通知,以及专用的根本原因分析,导致改进用于使用说明(IFU)。我们报告了根据选择患者选择的新和原始标准分层的调查设备豁免枢轴试验的2年结果。方法对工程评估,统计分析和临床评估进行临床评估,观察患有枢轴试验(N?= 150),滚动队队(n?= 29)和持续访问程序(n?= 154)。所有群组中的所有患者都在入学时在IFU上进行治疗。 Logistic回归模型支持与Nellix迁移的机制相对于大型动脉瘤血栓负荷和大主动脉颈直径的小主动脉腔。基于这些发现,应用了IFU标准的改进,不包括血栓指数的患者(最大动脉瘤囊/最大流动腔直径)> 1.4,主动脉颈直径>28Ωmm,主动脉颈部(> 10%直径变化)沿着Incraenal颈部)并在髂动脉中需要一个10mm远端密封区。来自2个年的所有原因死亡率的结果Freedom是94%。然后对精制形态学标准分层并回顾性分析患者结果。两年的复合肌统称的自由在两个队列中都有很高(95%的IFU与IFU 92%)。迁移的自由为97.7%,而IFU为93.2%(P?= .0125)。来自动脉瘤增大的自由为98.1%,IFU vs-93.5%OFF-IFU(由于日志排名试验假设失败,Pvalue不可用)。来自迁移的综合自由,IA型Endoleak或动脉瘤扩展为On-IFU队列中的95.9%,在off-IFU队列中的85.1%(p?= .0017)。结论在引入新疗法的情况下,随着时间的推移,EVA的失败模式的呈现是不可避免的。使用详细的成像以及工程和统计分析,我们能够了解对EVA的不良事件的风险因素,并定义最适合Nellix的患者。通过这种特异性方法来定义IFU,ON-IFU患者被鉴定为具有小血栓的大动脉瘤的患者,其易于用传统装置易患II型螺旋淋坏和囊膨胀。当用Nellix治疗时,预计这些患者将经历异议的结果,特别是对于低复合止吐率和低的全导致死亡率。

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