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采用主动控制系统的戈尔可顺应性腔内修复装置用于血管内动脉瘤修复的单中心研究结果

Single-center results of the Gore Excluder Conformable Endoprosthesis with active control system in endovascular aneurysm repair.

作者信息

Zuidema Roy, Bastianon Martina, Mena Vera Jorge M, DI Gregorio Sara, Mozzetta Gaddiel, de Vries Jean-Paul Pm, Schuurmann Richte Cl, Pratesi Giovanni

机构信息

Department of Surgery, Division of Vascular Surgery, University Medical Center Groningen, Groningen, the Netherlands -

Department of Surgical and Integrated Diagnostic Sciences (DISC), University of Genoa, Genoa, Italy.

出版信息

J Cardiovasc Surg (Torino). 2023 Apr;64(2):150-158. doi: 10.23736/S0021-9509.23.12589-4. Epub 2023 Mar 10.

Abstract

BACKGROUND

The GORE EXCLUDER Conformable Endoprosthesis with active control (CEXC) was developed to treat challenging aortic neck anatomy. This study investigated the clinical results and changes in endograft (ap)position during follow-up.

METHODS

Patients treated with the CEXC between 2018 and 2022 were included in this prospective single-center study. Computed tomography angiography (CTA) follow-up was grouped into three categories: 0 to 6 (FU1), 7 to 18 (FU2), and 19 to 30 (FU3) months. Clinical end points were endograft-associated complications and reinterventions. CTA analysis included the shortest apposition length (SAL) between the endograft fabric and the first slice where circumferential apposition was lost, shortest fabric distance (SFD) between both renal arteries and the endograft fabric, and maximum infrarenal and suprarenal aortic curvature. FU2 and FU3 were compared with FU1 to establish changes.

RESULTS

Included were 46 patients, of whom 36 (78%) had at least one hostile neck feature and 13 (28%) were treated outside instructions for use. Technical success was 100%. Median CTA follow-up was 10 months (2-20 months); 39 patients had a CTA available at FU1, 22 at FU2, and 12 at FU3. At FU1, the median SAL was 21.4 mm (13.2-27.4 mm), which did not significantly change during follow-up. No type I endoleaks, and one type III endoleak at an IBD occurred during follow-up. Two cases of endograft migration (SFD increase >10 mm) were seen during follow-up (one treated outside the instructions for use). Maximum infrarenal and suprarenal aortic curvature did not significantly change during follow-up.

CONCLUSIONS

The use of the CEXC in challenging aortic necks enables stable apposition without significant changes in aortic morphology at short-term follow-up.

摘要

背景

带有主动控制功能的GORE EXCLUDER顺应性内支架(CEXC)旨在治疗具有挑战性的主动脉颈部解剖结构。本研究调查了随访期间的临床结果及内支架(轴向和前后位)位置的变化。

方法

本前瞻性单中心研究纳入了2018年至2022年期间接受CEXC治疗的患者。计算机断层扫描血管造影(CTA)随访分为三类:0至6个月(FU1)、7至18个月(FU2)和19至30个月(FU3)。临床终点为内支架相关并发症和再次干预。CTA分析包括内支架织物与圆周贴合丧失的第一层面之间的最短贴合长度(SAL)、双肾动脉与内支架织物之间的最短织物距离(SFD),以及肾下和肾上主动脉的最大曲率。将FU2和FU3与FU1进行比较以确定变化情况。

结果

纳入46例患者,其中36例(78%)至少有一项不利的颈部特征,13例(28%)在使用说明范围外接受治疗。技术成功率为100%。CTA随访的中位时间为10个月(2 - 20个月);39例患者在FU1时有CTA检查结果,22例在FU2时有CTA检查结果,12例在FU3时有CTA检查结果。在FU1时,中位SAL为21.4毫米(13.2 - 27.4毫米),随访期间无显著变化。随访期间未出现I型内漏,1例IBD发生III型内漏。随访期间发现2例内支架移位(SFD增加>10毫米)(1例在使用说明范围外接受治疗)。随访期间肾下和肾上主动脉的最大曲率无显著变化。

结论

在具有挑战性的主动脉颈部使用CEXC可实现稳定贴合,在短期随访中主动脉形态无显著变化。

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