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基于真实解剖数据的现行腔内主动脉修复装置适用性研究。

Suitability study of current endovascular aortic repair devices based on real-life anatomic data.

机构信息

a First Department of Surgery, Vascular Unit , National & Kapodistrian Universtiy of Athens , Athens , Greece.

b Surgery Working Group, Society of Junior Doctors , Athens , Greece.

出版信息

Expert Rev Med Devices. 2019 Feb;16(2):165-171. doi: 10.1080/17434440.2019.1561268. Epub 2018 Dec 28.

DOI:10.1080/17434440.2019.1561268
PMID:30569766
Abstract

BACKGROUND

There are a number of stent-grafts in the market, designed to handle difficult anatomies during endovascular aortic repair. The aim of this study is to determine which stent-graft is the most appropriate to accommodate the majority of infra-renal aortic aneurysms cases. An additional aim is to determine what stent-graft characteristics influence the suitability of the stent-graft.

RESEARCH DESIGN AND METHODS

Retrospective cohort study on the suitability of available stent-grafts for infrarenal aneurysm (AAA) repair based on real-life anatomic data. The anatomical characteristics of 235 AAA were measured manually using specialized software. All measurements were compared to the official instructions-for-use (IFU) using a purpose-specific server-side script. The proper function of the script was additionally confirmed.

RESULTS

The highest suitability rate was achieved by Medtronic Endurant. The majority of stent-grafts failed to meet the respective AAA anatomy by one IFU characteristic. Stent-grafts that failed by only one IFU characteristic by ≥80% of unsuitable cases tend to have higher suitability rates. Neck dimensions and CIA diameter are the two characteristics significantly influencing the suitability rate.

CONCLUSIONS

Any stent-graft with high suitability rates should be available off-the-shelf in any vascular department in order to cover the majority of cases. For challenging cases, special advantages of the stent-grafts should be taken under consideration.

摘要

背景

市场上有许多支架移植物,旨在处理血管内主动脉修复过程中的困难解剖结构。本研究旨在确定哪种支架移植物最适合处理大多数肾下型主动脉瘤病例。另一个目的是确定哪些支架移植物特征会影响支架移植物的适用性。

研究设计与方法

这是一项基于真实解剖数据的回顾性队列研究,旨在评估现有支架移植物在肾下型动脉瘤(AAA)修复中的适用性。使用专门的软件手动测量 235 个 AAA 的解剖特征。将所有测量值与官方使用说明(IFU)使用特定于目的的服务器端脚本进行比较。此外,还确认了脚本的正确功能。

结果

美敦力 Endurant 的适用性最高。大多数支架移植物在一个 IFU 特征上未能满足相应的 AAA 解剖结构。只有一个 IFU 特征不符合≥80%不适用病例的支架移植物往往具有更高的适用性率。颈尺寸和 CIA 直径是显著影响适用性率的两个特征。

结论

任何具有高适用性率的支架移植物都应在任何血管部门随时可用,以覆盖大多数病例。对于具有挑战性的病例,应考虑支架移植物的特殊优势。

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