Department of Surgery, Division of Vascular Surgery, Universitair Medisch Centrum Groningen, Groningen, The Netherlands.
Department of Vascular Surgery, Rijnstate, Arnhem, The Netherlands.
J Endovasc Ther. 2022 Jun;29(3):457-467. doi: 10.1177/15266028211047941. Epub 2021 Sep 27.
The Nellix endovascular aneurysm sealing (EVAS) system has been a topic of discussion. Early results were promising but did not deliver on the long-term and the device has been recalled from the market. This study compares literature for EVAS and conventional endovascular aneurysm repair (EVAR).
A systematic review and analysis was conducted according to the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines. PubMed, Embase, and Cochrane Library were searched and identified the eligible studies. Proportion rates for the outcomes of interest were extracted. Subgroup analyses were performed for EVAS and EVAR.
A total of 12 studies were included (EVAS n = 4, EVAR n = 8) including 10,255 patients (EVAS n = 784, EVAR n = 9441). The longest duration of follow-up was 3.4 years for EVAS and 5.0 years for EVAR studies. Throughout follow-up the overall all-cause mortality rates were 6% for EVAS and 13% for EVAR, and endoleak of any type was described in 10% of EVAS and 17% of EVAR patients. The migration rate >10 mm was 8% for EVAS and 0% for EVAR and aneurysm growth >5 mm was found in 11% of EVAS and 3% of EVAR cases. Total reintervention rate was 13% for EVAS and 7% for EVAR patients. For all analyzed outcome parameters heterogeneity was >50%.
There is a tendency toward lower mortality and overall endoleak rates for EVAS compared to EVAR but with a higher rate of migration, aneurysm growth, and reintervention. Despite lower overall endoleak rates there was a tendency toward less type II and more type I endoleaks after EVAS compared to EVAR. Substantial heterogeneity however limits robust statistical analyses, and is probably caused by significant instructions for use breach in EVAS-treated patients. We call for more high-quality and long-term follow-up studies on both EVAS and EVAR in order to confirm the trends found in this study.
Nellix 血管内动脉瘤密封（EVAS）系统一直是讨论的话题。早期结果很有希望，但没有达到长期效果，该设备已从市场召回。本研究比较了 EVAS 和传统血管内动脉瘤修复（EVAR）的文献。
根据系统评价和荟萃分析的首选报告项目（PRISMA）指南进行系统评价和分析。搜索 PubMed、Embase 和 Cochrane Library，确定合格的研究。提取感兴趣结局的比例率。对 EVAS 和 EVAR 进行亚组分析。
共纳入 12 项研究（EVAS n=4，EVAR n=8），共纳入 10255 例患者（EVAS n=784，EVAR n=9441）。EVAS 的最长随访时间为 3.4 年，EVAR 的最长随访时间为 5.0 年。在整个随访期间，EVAS 的总全因死亡率为 6%，EVAR 的总全因死亡率为 13%，EVAS 患者中有 10%描述为任何类型的内漏，EVAR 患者中有 17%描述为任何类型的内漏。EVAS 的迁移率>10mm 为 8%，EVAR 为 0%，EVAS 的动脉瘤生长>5mm 为 11%，EVAR 的动脉瘤生长>5mm 为 3%。EVAS 的总再干预率为 13%，EVAR 的总再干预率为 7%。对于所有分析的结局参数，异质性均>50%。
与 EVAR 相比，EVAS 的死亡率和总体内漏率较低，但迁移率、动脉瘤生长率和再干预率较高。尽管总体内漏率较低，但与 EVAR 相比，EVAS 后 II 型内漏倾向于减少，而 I 型内漏倾向于增加。然而，大量的异质性限制了稳健的统计分析，这可能是由于 EVAS 治疗患者的使用说明严重违反造成的。我们呼吁对 EVAS 和 EVAR 进行更多高质量和长期的随访研究，以证实本研究中发现的趋势。
