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戈尔髂内分支覆膜支架(使用自膨式或球囊扩张式支架)治疗髂内动脉段病变的疗效分析。

Outcomes of the Gore Excluder Iliac Branch Endoprosthesis Using Self Expanding or Balloon-Expandable Stent Grafts for the Internal Iliac Artery Component.

机构信息

Division of Vascular Surgery, Department of Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.

出版信息

J Endovasc Ther. 2024 Dec;31(6):1227-1233. doi: 10.1177/15266028231169177. Epub 2023 May 6.

DOI:10.1177/15266028231169177
PMID:37148192
Abstract

OBJECTIVE

The GORE EXCLUDER Iliac Branch Endoprosthesis (IBE; W.L. Gore & Associates, Flagstaff, Arizona) was developed to be used in combination with a self-expanding stent graft (SESG) for the internal iliac artery (IIA) bridging stent. Balloon-expandable stent grafts (BESGs) are an alternative for the IIA, offering advantages in sizing, device tracking, precision, and lower profile delivery. We compared the performance of SESG and BESG when used as the IIA bridging stent in patients undergoing EVAR with IBE.

METHODS

This is a retrospective review of consecutive patients who underwent EVAR with IBE implantation at a single center from October 2016 to May 2021. Anatomic and procedural characteristics were recorded via chart review and computed tomography (CT) postprocessing software (Vitrea v7.14). Devices were assigned to SESG vs. BESG groups based on the type of device landing into the most distal IIA segment. Analysis was performed per device to account for patients undergoing bilateral IBE. The primary endpoint was IIA patency, and secondary endpoint was IBE-related endoleak.

RESULTS

During the study period, 48 IBE devices were implanted in 41 patients (mean age 71.1 years). All IBE devices were implanted in conjunction with an infrarenal endograft. There were 24 devices in each of the self-expanding internal iliac component (SE-IIC) and balloon-expandable internal iliac component (BE-IIC) groups. The BE-IIC group had smaller diameter IIA target vessels (11.6±2.0 mm vs. 8.4±1.7 mm, p<0.001). Mean follow-up was 525 days. Loss of IIA patency occurred in 2 SESG devices (8.33%) at 73 and 180 days postprocedure, and in zero BESG devices, however, this difference was not statistically significant (p=0.16). There was 1 IBE-related endoleak requiring reintervention during the study period. A BESG device required reintervention due to Type 3 endoleak at 284 days.

CONCLUSIONS

There were no significant differences in outcomes between SESG and BESG when used for the IIA bridging stent in EVAR with IBE. The BESGs were associated with using 2 IIA bridging stents and were more often deployed in smaller IIA target arteries. Retrospective study design and small sample size may limit the generalizability of our findings.

CLINICAL IMPACT

This series compares postoperative and midterm outcomes of self expanding stent grafts and balloon expandable stent grafts (BESG) when used as the internal iliac stent graft as part of a Gore® Excluder® Iliac Branch Endoprosthesis (IBE). With similar outcomes between the two stent-grafts, our series suggests that some of the advantages of BESG, device sizing, tracking, deployment, and profile, may be able to be leveraged without impacting the mid-term performance of the IBE.

摘要

目的

GORE EXCLUDER 髂动脉分支覆膜支架(IBE;W.L.戈尔与协会,Flagstaff,亚利桑那州)的开发目的是与自膨式支架移植物(SESG)一起用于髂内动脉(IIA)桥接支架。球囊扩张支架移植物(BESG)是 IIA 的另一种选择,在尺寸、器械跟踪、精度和更低的输送轮廓方面具有优势。我们比较了在接受 IBE 植入的 EVAR 中使用 SESG 和 BESG 作为 IIA 桥接支架的性能。

方法

这是一项对 2016 年 10 月至 2021 年 5 月在单一中心接受 IBE 植入的连续患者进行的回顾性研究。通过图表审查和计算机断层扫描(CT)后处理软件(Vitrea v7.14)记录解剖和程序特征。根据器械在最远端 IIA 段的着陆类型,将器械分为 SESG 与 BESG 组。基于设备对每个设备进行分析,以考虑双侧 IBE 的患者。主要终点是 IIA 通畅性,次要终点是 IBE 相关内漏。

结果

在研究期间,41 名患者共植入 48 个 IBE 装置(平均年龄 71.1 岁)。所有 IBE 装置均与肾下内脏移植物一起植入。自膨式髂内组件(SE-IIC)和球囊扩张式髂内组件(BE-IIC)组各有 24 个装置。BE-IIC 组 IIA 目标血管直径较小(11.6±2.0mm 比 8.4±1.7mm,p<0.001)。平均随访时间为 525 天。2 个 SESG 装置(8.33%)在术后 73 天和 180 天出现 IIA 通畅性丧失,而在 0 个 BESG 装置中出现该情况,但差异无统计学意义(p=0.16)。在研究期间,有 1 例 IBE 相关内漏需要再次干预。1 个 BESG 装置由于 284 天时出现 3 型内漏而需要再次干预。

结论

在接受 IBE 植入的 EVAR 中,SESG 和 BESG 用于 IIA 桥接支架时,结果无显著差异。BESG 与使用 2 个 IIA 桥接支架相关,并且更常部署在较小的 IIA 靶血管中。回顾性研究设计和小样本量可能限制了我们研究结果的普遍性。

临床影响

本系列比较了 Gore® Excluder®髂动脉分支覆膜支架(IBE)中使用自膨式支架移植物和球囊扩张支架移植物(BESG)作为髂内支架移植物的术后和中期结果。两种支架移植物的结果相似,我们的研究表明,BESG 的一些优势,如器械尺寸、跟踪、部署和轮廓,在不影响 IBE 中期性能的情况下可能能够得到利用。

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