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意大利 Fenestrated Anaconda™ 血管内移植物治疗复杂腹主动脉瘤的多中心登记研究。

The Italian Multicentre Registry of Fenestrated Anaconda™ Endografts for Complex Abdominal Aortic Aneurysms Repair.

机构信息

Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale Policlinico Sant'Orsola-Malpighi, Bologna, Italy.

Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale Policlinico Sant'Orsola-Malpighi, Bologna, Italy.

出版信息

Eur J Vasc Endovasc Surg. 2020 Aug;60(2):181-191. doi: 10.1016/j.ejvs.2020.04.032. Epub 2020 Jul 21.

DOI:10.1016/j.ejvs.2020.04.032
PMID:32709467
Abstract

OBJECTIVE

The aim was to describe the outcomes of the Anaconda™ Fenestrated endograft Italian Registry for complex aortic aneurysms (AAAs), unsuitable for standard endovascular aneurysm repair (EVAR).

METHODS

Between 2012 and 2018 patients with a proximal neck unsuitable for standard EVAR, treated with the fenestrated Anaconda™ endograft, were prospectively enrolled in a dedicated database. Endpoints were peri-operative technical success (TS) and evaluation of type Ia/b or 3 endoleaks (T1/3 EL), target visceral vessel (TVV) occlusion, re-interventions, and AAA related mortality at 30 days, six months, and later follow up.

RESULTS

One hundred twenty seven patients (74 ± 7 years, American Society Anesthesiology (ASA) II/III/IV: 12/85/30) were included in the study in 49 Italian Vascular Surgery Units (83 juxta/para-renal AAA, 13 type IV thoraco-abdominal AAA, 16 T1aEL post EVAR, and 15 short neck AAA). Configurations with one, two, three, and four fenestrations were used in 5, 56, 39, and 27 cases, respectively, for a total of 342 visceral vessels. One hundred and eight (85%) bifurcated and 19 (15%) tube endografts were implanted. In 35% (44/127) of cases the endograft was repositioned during the procedure, and 37% (128/342) of TVV were cannulated from brachial access. TS was 87% (111/127): five T1EL, six T3EL (between fenestration and vessel stent), and six loss of visceral vessels (one patient with a Type Ia EL had also a TVV loss) occurred. Thirty day mortality was 4% (5/127). Two of the five T1EL resolved spontaneously at 30 days. The overall median follow up was 21 ± 16 months; one T1EL (5%) occurred at six months and one T3EL (4%) at the three year follow up. Another two (3%) TVV occlusions occurred at six months and five (3%) at three years. The re-intervention rate at the 30 days, six months, and three year follow up was 5%, 7%, and 18 ± 5%, respectively.

CONCLUSION

The fenestrated Anaconda™ endograft is effective in the treatment of complex AAA. Some structure properties, such as the re-positionability and the possibility of cannulation from above, are specific characteristics helpful for the treatment of some complex anatomies.

摘要

目的

描述 Anaconda™ 分支型覆膜支架在治疗不适合标准血管内修复术(EVAR)的复杂主动脉瘤(AAA)中的结果。

方法

2012 年至 2018 年间,采用 Fenestrated Anaconda™ 覆膜支架治疗近端瘤颈不适合标准 EVAR 的患者,前瞻性纳入专用数据库。终点为围手术期技术成功(TS)和评估Ⅰa/b 或 3 型内漏(T1/3 EL)、目标内脏血管(TVV)闭塞、再干预和 30 天、6 个月和后期随访的 AAA 相关死亡率。

结果

在 49 个意大利血管外科单位(83 个近/旁肾 AAA、13 个 IV 型胸腹主动脉瘤、16 个 EVAR 后 T1aEL 和 15 个短颈 AAA)中,共纳入 127 例患者(74±7 岁,美国麻醉医师学会(ASA)Ⅱ/Ⅲ/Ⅳ级:12/85/30)。使用 5、56、39 和 27 例分别为 1、2、3 和 4 个开窗的覆膜支架,总共为 342 个内脏血管。108 例(85%)植入分叉支架,19 例(15%)植入直管支架。35%(44/127)的支架在手术过程中重新定位,37%(128/342)的 TVV 从肱动脉入路进行穿刺。TS 为 87%(111/127):发生 5 例 T1EL、6 例 T3EL(在开窗和血管支架之间)和 6 例内脏血管丢失(1 例 T1EL 患者同时发生 TVV 丢失)。30 天死亡率为 4%(5/127)。5 例 T1EL 中的 2 例在 30 天内自发缓解。中位随访时间为 21±16 个月;6 个月时有 1 例 T1EL(5%),3 年随访时有 1 例 T3EL(4%)。6 个月时有 2 例(3%)TVV 闭塞,3 年时有 5 例(3%)。30 天、6 个月和 3 年的再干预率分别为 5%、7%和 18±5%。

结论

开窗型 Anaconda™ 覆膜支架在治疗复杂 AAA 中是有效的。一些结构特性,如可重新定位和经肱动脉入路穿刺的可能性,是治疗一些复杂解剖结构的特定特征。

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