《Nellix 使用说明书修订版对血管内动脉瘤封闭术后结果的影响》。
Influence of the Revised Nellix Instructions for Use on Outcomes After Endovascular Aneurysm Sealing.
机构信息
1 Department of Vascular and Endovascular Surgery, Klinikum Augsburg, Germany.
出版信息
J Endovasc Ther. 2018 Aug;25(4):418-425. doi: 10.1177/1526602818781353. Epub 2018 Jun 13.
PURPOSE
To evaluate the impact of the revised Nellix instructions for use (IFU) from 2016 on clinical outcomes and anatomic applicability by retrospectively applying them to a cohort treated with endovascular aneurysm sealing according to the original IFU 2013.
METHODS
A single-center study was conducted of 100 consecutive patients (mean age 72±8 years, range 46-91; 89 men) treated electively with standard bilateral EVAS from July 2013 to August 2015 and followed through December 2017. Procedures previously classified within and outside the original IFU from 2013 (75 and 25, respectively) were reclassified according to the revised IFU 2016 (34 and 66, respectively). Stepwise backward logistic regression analysis was performed to evaluate the prognostic value of specific anatomic features for the development of endoleak and/or migration.
RESULTS
The single most important morphologic feature disqualifying patients from being within IFU 2016 was a thrombus ratio >1.4 (36 of 41 reclassified patients). Overall technical success was 98% (100% within vs 97% outside IFU 2016, p=0.323) and 30-day mortality was 3% (0% within vs 5% outside IFU 2016, p=0.251). During a median follow-up of 31 months (range 0-53), overall mortality was 21% (15% within vs 24% outside IFU 2016, p=0.469); aneurysm-related mortality was 8% (3% within vs 11% outside IFU 2016, p=0.533). Twenty-six patients developed an endoleak (6 within vs 20 outside IFU 2016, p=0.172) and 23 had migration (4 within vs 19 outside IFU 2016, p=0.088). Both proximal neck length <10 mm and neck angulation >60° were positive predictors for the development of endoleak and/or migration. A reintervention was performed in 26 patients (7 within vs 19 outside IFU 2016, p=0.376). While a significant difference was found between the within vs outside IFU 2016 groups with regard to freedom from migration (p=0.026) and the composite freedom from endoleak and/or migration (p=0.021), there were no significant differences in survival (p=0.201) or freedom from reintervention (p=0.505), suggesting a limited effectiveness of the new IFU 2016.
CONCLUSION
The IFU 2016 reduced the anatomic applicability to 34% from 75% for the original IFU 2013. The lack of significant intergroup differences in terms of survival and reinterventions suggests a limited effectiveness of the new IFU 2016.
目的
通过回顾性地将 2016 年修订后的 Nellix 使用说明（IFU）应用于根据原始 IFU 2013 治疗的血管内动脉瘤密封的队列，评估其对临床结果和解剖适用性的影响。
方法
对 2013 年 7 月至 2015 年 8 月期间接受标准双侧 EVAS 择期治疗的 100 例连续患者（平均年龄 72±8 岁，范围 46-91；89 名男性）进行了单中心研究，并随访至 2017 年 12 月。根据 2016 年修订后的 IFU，先前被分类为原始 IFU 2013 内（75 例）和外（25 例）的手术分别重新分类为内（34 例）和外（66 例）。采用逐步向后逻辑回归分析评估特定解剖特征对发生内漏和/或迁移的预测价值。
结果
将患者排除在 2016 年 IFU 之外的唯一最重要的形态特征是血栓比率>1.4（41 例重新分类患者中有 36 例）。总体技术成功率为 98%（内 100%，外 97%IFU 2016，p=0.323），30 天死亡率为 3%（内 0%，外 5%IFU 2016，p=0.251）。在中位随访 31 个月（0-53 个月）期间，总体死亡率为 21%（内 15%，外 24%IFU 2016，p=0.469）；与动脉瘤相关的死亡率为 8%（内 3%，外 11%IFU 2016，p=0.533）。26 例患者发生内漏（内 6 例，外 20 例 IFU 2016，p=0.172），23 例发生迁移（内 4 例，外 19 例 IFU 2016，p=0.088）。近端颈部长度<10mm 和颈部成角>60°是发生内漏和/或迁移的阳性预测因素。26 例患者（内 7 例，外 19 例 IFU 2016，p=0.376）进行了再次干预。虽然内组与外组在迁移的无迁移率（p=0.026）和内漏和/或迁移的无复合率（p=0.021）方面存在显著差异，但在生存（p=0.201）或无再次干预率（p=0.505）方面无显著差异，表明 2016 年新 IFU 的有效性有限。
结论
IFU 2016 将原始 IFU 2013 的解剖适用性从 75%降低到 34%。在生存和再次干预方面，内组与外组之间无显著差异，表明新 IFU 2016 的有效性有限。
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