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安库拉覆膜支架用于肾下腹主动脉瘤血管内修复的疗效

Outcomes of the Ankura Stent Graft for Endovascular Repair of Infrarenal Abdominal Aortic Aneurysm.

作者信息

Tigkiropoulos Konstantinos, Abatzis-Papadopoulos Manolis, Papoutsis Ioakeim, Sidiropoulou Katerina, Stavridis Kyriakos, Karamanos Dimitrios, Lazaridis Ioannis, Saratzis Md Nikolaos

机构信息

Division of Vascular Surgery, 1st Surgical Department, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Papageorgiou General Hospital, Thessaloniki, Greece.

Division of Vascular Surgery, 5th Surgical Department, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Hippokration General Hospital, Greece.

出版信息

J Endovasc Ther. 2025 Jun;32(3):679-687. doi: 10.1177/15266028231179590. Epub 2023 Jun 11.

Abstract

OBJECTIVE

The purpose of this retrospective cohort study is to report outcomes of endovascular aortic repair (EVAR) with the novel endograft, Ankura (Lifetech Scientific, Shenzen, China).

METHODS

We identified all patients who underwent elective EVAR with Ankura stent graft in a tertiary unit from January 2015 to November 2021. Patients with ruptured infrarenal and juxtarenal aortic aneurysms were excluded from the study. All patients were anatomically suitable according to the instructions for use (IFU). Follow-up (FU) included computed tomography angiography (CTA) at 1 month, 12 months, and yearly thereafter if endoleak (EL) was not present. Primary outcomes included technical success (primary and secondary) and 30-day overall mortality and morbidity. Secondary outcomes included late overall and aneurysm-related mortality as well as influence of suprarenal fixation of the endograft on renal function at 12 months using eGFR (CKI-EPI formula).

RESULTS

The Ankura endograft was successfully implanted in 116 patients (mean age=71.1 years, 96.5% male). Mean aneurysm diameter was 62.3 mm. Median FU was 34 months (2-72 months). Primary and secondary technical success were 95.7% and 100%, respectively. Overall type I EL was 5% (2 proximal, 3 distal) and type II EL was 13%. Thirty days mortality and morbidity were 0% and 5.2%, respectively. All-cause mortality during FU was 13.9% (n=16); aneurysm-related mortality was 2.6% (n=3). Limb endograft patency was 100%. Freedom from reintervention was 98.2% at 2 years, and 97.4% at 4 and 6 years respectively. There was a statistically significant difference between preoperative (73.69 mL/min/1.73 m) and postoperative (66.66 mL/min/1.73 m) eGFR at 12 months (p<0.001).

CONCLUSION

Ankura endograft has demonstrated an efficacious durability with low aneurysm-related mortality and high iliac limb patency rate. Elective EVAR is associated with significant decline in renal function at 12 months in our study. Larger series studies are necessary to evaluate long-term safety and efficacy of Ankura endograft.Clinical ImpactAnkura stent graft is a novel PTFE endograft with suprarenal fixation for infrarenal aneurysm repair. This retrospective cohort study of 116 patients provide a first "picture" of Ankura safety and efficacy in a European tertiary vascular center. High technical success rate, low aneurysm related mortality and high limb patency rate are the main findings of the study with a negative impact of suprarenal fixation on kidney function during follow up.

摘要

目的

本回顾性队列研究旨在报告使用新型血管内移植物安库拉(中国深圳微创医疗科学有限公司)进行血管腔内主动脉修复术(EVAR)的结果。

方法

我们确定了2015年1月至2021年11月在一家三级医疗机构接受安库拉支架型人工血管择期EVAR的所有患者。肾下和肾旁主动脉瘤破裂患者被排除在研究之外。所有患者根据使用说明书(IFU)在解剖学上均适合。随访(FU)包括术后1个月、12个月时的计算机断层扫描血管造影(CTA),此后如果无内漏(EL)则每年进行一次。主要结局包括技术成功(主要和次要)以及30天总体死亡率和发病率。次要结局包括晚期总体和动脉瘤相关死亡率,以及使用估算肾小球滤过率(CKI-EPI公式)评估12个月时移植物肾上固定对肾功能的影响。

结果

安库拉血管内移植物成功植入116例患者(平均年龄=71.1岁,96.5%为男性)。平均动脉瘤直径为62.3mm。中位随访时间为34个月(2 - 72个月)。主要和次要技术成功率分别为95.7%和100%。总体I型EL为5%(2例近端,3例远端),II型EL为13%。30天死亡率和发病率分别为0%和5.2%。随访期间全因死亡率为13.9%(n = 16);动脉瘤相关死亡率为2.6%(n = 3)。肢体血管内移植物通畅率为100%。2年时免于再次干预的比例为98.2%,4年和6年时分别为97.4%。12个月时术前(73.69 mL/min/1.73 m²)和术后(66.66 mL/min/1.73 m²)估算肾小球滤过率存在统计学显著差异(p<0.001)。

结论

安库拉血管内移植物已显示出有效的耐久性,动脉瘤相关死亡率低,髂肢通畅率高。在我们的研究中,择期EVAR与12个月时肾功能显著下降相关。需要更大规模的系列研究来评估安库拉血管内移植物的长期安全性和有效性。临床影响安库拉支架型人工血管是一种用于肾下动脉瘤修复的新型带肾上固定的聚四氟乙烯血管内移植物。这项对116例患者的回顾性队列研究首次呈现了安库拉在欧洲三级血管中心的安全性和有效性情况。高技术成功率、低动脉瘤相关死亡率和高肢体通畅率是该研究的主要发现,随访期间肾上固定对肾功能有负面影响。

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