Vakhitov Damir, Chakfé Nabil, Heim Frédéric, Chaudhuri Arindam
GEPROMED, Strasbourg, France.
Vascular Centre, Tampere University Hospital and Tampere University, Tampere, Finland.
EJVES Vasc Forum. 2024 Sep 10;62:72-77. doi: 10.1016/j.ejvsvf.2024.09.001. eCollection 2024.
The physical impact of the application of Heli-FX EndoAnchors (EA; Medtronic, Minneapolis, USA) on endograft (EG) material is unclear. This study aimed to examine the possible EG membrane alterations after EA implantation.
Heli-FX EndoAnchors were applied into four aortic endocuffs: AFX2 (Endologix Inc., Irvine, USA); Endurant II (Medtronic, Minneapolis, USA); Gore Excluder (W.L. Gore and Assoc., Flagstaff, USA); and Zenith Renu (Cook Aortic Interventions, Bloomington, USA). Two of these, Endurant II and Renu, are made of polyethylene terephthalate (PET), while Excluder and AFX2 are made of expanded polytetrafluoroethylene (ePTFE). The penetration angle was measured for each EA. The EAs were then carefully removed, and perforations examined with digital and fluorescent microscopy. The area and perimeter of the holes were digitally calculated, and material alterations were analysed.
Of the 13 EAs applied, 12 remained in place. The mean penetration angle was 79°. The ePTFE perforations had oval openings, while PET perforations were round. After EA removal, comparisons between ePTFE and PET material perforations suggested a larger hole area ( = 0.011) and perimeter ( = 0.003) in the former. The ePTFE perforations in the AFX2 were the largest compared with the holes in other endocuffs ( = 0.050). The perforation channel of the ePTFE membrane of the Excluder cuff retained its form after EA removal. Local dissection like layer damage extended further. The perforations in both the Endurant II and the Renu endocuffs shared similar characteristics, with multiple fibres of PET elongated, distorted, or ruptured.
During EA placement, the EG membrane undergoes local alteration and or destruction. Expanded PTFE, particularly AFX2 endocuffs (for which EA use is not recommended), are characterised by a more extensive degree of material alteration compared with PET. Additional studies are required to chronologically supplement these findings in fatigue tests.
Heli-FX 内固定器（EA；美敦力公司，美国明尼阿波利斯）应用于血管内移植物（EG）材料后的物理影响尚不清楚。本研究旨在检查 EA 植入后 EG 膜可能发生的改变。
将 Heli-FX 内固定器应用于四个主动脉内套管：AFX2（美国恩多洛吉克斯公司，尔湾）；Endurant II（美敦力公司，美国明尼阿波利斯）；戈尔覆膜支架（美国戈尔公司，弗拉格斯塔夫）；以及 Zenith Renu（美国库克主动脉介入公司，布卢明顿）。其中两个，Endurant II 和 Renu，由聚对苯二甲酸乙二酯（PET）制成，而 Excluder 和 AFX2 由膨体聚四氟乙烯（ePTFE）制成。测量每个 EA 的穿透角度。然后小心取出 EA，并用数字显微镜和荧光显微镜检查穿孔情况。通过数字计算孔的面积和周长，并分析材料改变情况。
在应用的 13 个 EA 中，12 个留在原位。平均穿透角度为 79°。ePTFE 穿孔有椭圆形开口，而 PET 穿孔是圆形的。取出 EA 后，ePTFE 和 PET 材料穿孔之间的比较表明前者的孔面积更大（P = 0.011）且周长更大（P = 0.003）。与其他内套管中的孔相比，AFX2 中的 ePTFE 穿孔最大（P = 0.050）。取出 EA 后，Excluder 内套管的 ePTFE 膜穿孔通道保持其形状。局部剥离如层损伤进一步扩展。Endurant II 和 Renu 内套管中的穿孔具有相似特征，PET 的多根纤维拉长、扭曲或断裂。
在放置 EA 期间，EG 膜会发生局部改变和/或破坏。与 PET 相比，膨体聚四氟乙烯，特别是 AFX2 内套管（不建议使用 EA）的材料改变程度更广泛。需要进一步的研究按时间顺序补充疲劳试验中的这些发现。
