Tomczak Jolanta, Dzieciuchowicz Łukasz
Department of Vascular and Endovascular Surgery, Angiology and Phlebology, Poznan University of Medical Sciences, Poznan, Poland.
Department of Vascular Surgery and Vascular Diseases, Institute of Medical Sciences, University of Zielona Góra, Zielona Góra, Poland.
Postepy Kardiol Interwencyjnej. 2021 Mar;17(1):93-100. doi: 10.5114/aic.2021.104774. Epub 2021 Mar 27.
Currently, there is a wide range of commercially available devices for endovascular aneurysm repair (EVAR) that differ in terms of both anatomical requirements and the technology and technique of deployment.
To assess the applicability of currently commercially available devices for EVAR in the treatment of an asymptomatic abdominal aneurysm (AAA).
The study group included 100 patients with infrarenal AAA with a maximum diameter ≥ 50 mm, qualified for invasive treatment at the University Hospital in 2013-2014. The aortoiliac morphological characteristics of the AAA were evaluated on preoperative computed tomography angiograms using the OsiriX DICOM viewer in the 3D-MPR mode. The morphological applicability of 14 types of CE-marked and FDA-approved stent grafts was determined based on their instructions for use (IFU).
EVAR was feasible with at least one of the analysed devices in 68% of patients. The morphological applicability was as follows: Excluder Conformable (65%), Ovation iX (51%), Endurant II (47%), Treo (45%), Excluder C3 (45%), AFX 2 (45%), Incraft (44%), E-tegra (44%), Zenith Alfa (41%), Zenith Flex (40%), Anaconda (39%) Aorfix (37%), Altura (34%), and E-vita (20%). The differences in the stent graft applicability were statistically significant ( < 0.001). A wide diameter of the common iliac artery, angulated proximal neck, and diameter of proximal neck out of range constituted the most frequent causes of EVAR inapplicability.
The IFU-based applicability of currently available AAA stent graft systems differs significantly. Despite the constant evolution of EVAR technology, at least 32% of AAA will require a different therapeutic approach.
目前,有多种用于血管内动脉瘤修复(EVAR)的商用设备,它们在解剖学要求以及展开技术和工艺方面存在差异。
评估目前用于EVAR的商用设备在治疗无症状腹主动脉瘤(AAA)中的适用性。
研究组包括100例肾下AAA患者,最大直径≥50mm,于2013 - 2014年在大学医院符合侵入性治疗条件。使用OsiriX DICOM查看器在3D - MPR模式下对术前计算机断层扫描血管造影进行AAA的主髂动脉形态学特征评估。根据14种CE标志和FDA批准的支架移植物的使用说明书(IFU)确定其形态学适用性。
68%的患者使用至少一种分析设备进行EVAR是可行的。形态学适用性如下:Excluder Conformable(65%)、Ovation iX(51%)、Endurant II(47%)、Treo(45%)、Excluder C3(45%)、AFX 2(45%)、Incraft(44%)、E - tegra(44%)、Zenith Alfa(41%)、Zenith Flex(40%)、Anaconda(39%)、Aorfix(37%)、Altura(34%)和E - vita(20%)。支架移植物适用性的差异具有统计学意义(<0.001)。髂总动脉直径宽、近端颈部成角以及近端颈部直径超出范围是EVAR不适用的最常见原因。
基于IFU的当前可用AAA支架移植物系统的适用性差异显著。尽管EVAR技术不断发展,但至少32%的AAA将需要不同的治疗方法。