内利克斯血管内动脉瘤封堵系统：当前观点
The Nellix endovascular aneurysm sealing system: current perspectives.
作者信息
Choo Xin Y, Hajibandeh Shahab, Hajibandeh Shahin, Antoniou George A
机构信息
Department of Vascular and Endovascular Surgery, The Royal Oldham Hospital, Pennine Acute Hospitals NHS Trust, Manchester, UK,
Division of Cardiovascular Sciences, School of Medical Sciences, University of Manchester, Manchester, UK.
出版信息
Med Devices (Auckl). 2019 Feb 19;12:65-79. doi: 10.2147/MDER.S155300. eCollection 2019.
BACKGROUND
The Nellix endovascular aneurysm sealing (EVAS) system is a novel approach for the treatment of abdominal aortic aneurysm (AAA). We aimed to evaluate the efficacy of EVAS in the management of patients with AAA.
MATERIALS AND METHODS
We searched PubMed/MEDLINE, CINAHL, and bibliographic reference lists to identify studies reporting clinical outcomes in patients with asymptomatic, non-ruptured AAA treated with EVAS with the Nellix device. We pooled dichotomous outcome data using random-effects models.
RESULTS
We identified 14 single-arm observational studies, reporting a total of 1,510 patients. The pooled estimate of technical success was 99% (95% CI =98-100; heterogeneity: =0.869, =0%). Adjunctive procedures were carried out in 39% (95% CI =19-63; heterogeneity: <0.0001, =88%). Two cases of aneurysm rupture were reported within 30 days of treatment (0.7%, 95% CI =0.3-1.6; heterogeneity: =0.923, =0%) and another five cases of rupture occurred during follow-up (0.8%, 95% CI =0.4-1.6; heterogeneity: =0.958, =0%). The pooled estimates of early (within 30 days) and late (during follow-up) type I endoleak were 2.8 % (95% CI =1.8-4.2; heterogeneity: =0.254, =18%) and 1.9% (95% CI =1.3-2.8; heterogeneity: =0.887, =0%), respectively. Sac enlargement was noted in 3.1% (95% CI =1.8-5.4; heterogeneity: =0.419, =0%) and device migration in 2.1% (95% CI =0.8-5.3; heterogeneity: =0.004, =65%). The early and late reintervention rates were 2.7% (95% CI =1.7-4.2; heterogeneity: =0.183, =27%) and 3.5% (95% CI =2.3-5.5; heterogeneity: =0.061, =42%), respectively. The pooled estimate of 30-day mortality was 1.5% (95% CI =0.9-2.6; heterogeneity: =0.559, =0%) and the pooled estimate of aneurysm-related death during follow-up was 1.0% (95% CI =0.6-1.9; heterogeneity: =0.872, =0%).
CONCLUSION
Reported outcomes of EVAS are acceptable. Type I endoleak, sac enlargement, device migration, and aneurysm rupture are recognized complications. High-level research is required to investigate potential advantages of EVAS over conventional treatments.
背景
内利克斯血管内动脉瘤封堵（EVAS）系统是一种治疗腹主动脉瘤（AAA）的新方法。我们旨在评估EVAS治疗AAA患者的疗效。
材料与方法
我们检索了PubMed/MEDLINE、CINAHL以及参考文献列表，以确定报告使用内利克斯装置进行EVAS治疗无症状、未破裂AAA患者临床结果的研究。我们使用随机效应模型汇总二分结果数据。
结果
我们确定了14项单臂观察性研究，共报告了1510例患者。技术成功率的汇总估计为99%（95%置信区间=98 - 100；异质性：I² = 0.869，P = 0%）。39%的患者进行了辅助手术（95%置信区间=19 - 63；异质性：I² < 0.0001，P = 88%）。治疗后30天内报告了2例动脉瘤破裂（0.7%，95%置信区间=0.3 - 1.6；异质性：I² = 0.923，P = 0%），随访期间又发生了5例破裂（0.8%，95%置信区间=0.4 - 1.6；异质性：I² = 0.958，P = 0%）。早期（30天内）和晚期（随访期间）I型内漏的汇总估计分别为2.8%（95%置信区间=1.8 - 4.2；异质性：I² = 0.254，P = 18%）和1.9%（95%置信区间=1.3 - 2.8；异质性：I² = 0.887，P = 0%）。发现3.1%的患者瘤体增大（95%置信区间=1.8 - 5.4；异质性：I² = 0.419，P = 0%），2.1%的患者装置移位（95%置信区间=0.8 - 5.3；异质性：I² = 0.004，P = 65%）。早期和晚期再次干预率分别为2.7%（95%置信区间=1.7 - 4.2；异质性：I² = 0.183，P = 27%）和3.5%（95%置信区间=2.3 - 5.5；异质性：I² = 0.061，P = 42%）。30天死亡率的汇总估计为1.5%（95%置信区间=0.9 - 2.6；异质性：I² = 0.559，P = 0%），随访期间动脉瘤相关死亡的汇总估计为1.0%（95%置信区间=0.6 - 1.9；异质性：I² = 0.872，P = 0%）。
结论
报告的EVAS结果是可接受的。I型内漏、瘤体增大、装置移位和动脉瘤破裂是公认的并发症。需要进行高水平研究以探究EVAS相对于传统治疗的潜在优势。
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