{"title":"Heli-FX EndoAnchor 应用对内植体材料的影响:实验研究","authors":"Damir Vakhitov , Nabil Chakfé , Frédéric Heim , Arindam Chaudhuri","doi":"10.1016/j.ejvsvf.2024.09.001","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><div>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.</div></div><div><h3>Methods</h3><div>Heli-FX EndoAnchors were applied <em>in vitro</em> 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.</div></div><div><h3>Results</h3><div>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 (<em>p</em> = 0.011) and perimeter (<em>p</em> = 0.003) in the former. The ePTFE perforations in the AFX2 were the largest compared with the holes in other endocuffs (<em>p</em> = 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.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":36502,"journal":{"name":"EJVES Vascular Forum","volume":"62 ","pages":"Pages 72-77"},"PeriodicalIF":1.4000,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The Impact of Heli-FX EndoAnchor Application on Endograft Material: An Experimental Study\",\"authors\":\"Damir Vakhitov , Nabil Chakfé , Frédéric Heim , Arindam Chaudhuri\",\"doi\":\"10.1016/j.ejvsvf.2024.09.001\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objective</h3><div>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.</div></div><div><h3>Methods</h3><div>Heli-FX EndoAnchors were applied <em>in vitro</em> 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.</div></div><div><h3>Results</h3><div>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 (<em>p</em> = 0.011) and perimeter (<em>p</em> = 0.003) in the former. The ePTFE perforations in the AFX2 were the largest compared with the holes in other endocuffs (<em>p</em> = 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.</div></div><div><h3>Conclusion</h3><div>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.</div></div>\",\"PeriodicalId\":36502,\"journal\":{\"name\":\"EJVES Vascular Forum\",\"volume\":\"62 \",\"pages\":\"Pages 72-77\"},\"PeriodicalIF\":1.4000,\"publicationDate\":\"2024-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"EJVES Vascular Forum\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2666688X24001412\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"PERIPHERAL VASCULAR DISEASE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"EJVES Vascular Forum","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2666688X24001412","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PERIPHERAL VASCULAR DISEASE","Score":null,"Total":0}
引用次数: 0
摘要
目的应用 Heli-FX EndoAnchors(EA;美敦力,美国明尼阿波利斯)对内膜移植物(EG)材料的物理影响尚不清楚。本研究旨在检查 EA 植入后 EG 膜可能发生的变化。方法在体外将 Heli-FX EndoAnchors 应用于四种主动脉内膜腔:AFX2 (Endologix Inc., Irvine, USA);Endurant II (Medtronic, Minneapolis, USA);Gore Excluder (W.L. Gore and Assoc., Flagstaff, USA);Zenith Renu (Cook Aortic Interventions, Bloomington, USA)。其中 Endurant II 和 Renu 由聚对苯二甲酸乙二醇酯 (PET) 制成,而 Excluder 和 AFX2 则由膨体聚四氟乙烯 (ePTFE) 制成。测量了每种 EA 的穿透角度。然后小心地取出 EA,用数码显微镜和荧光显微镜检查穿孔。对穿孔的面积和周长进行了数字计算,并对材料的变化进行了分析。平均穿透角度为 79°。ePTFE 穿孔为椭圆形,而 PET 穿孔为圆形。去除 EA 后,ePTFE 和 PET 材料穿孔的比较结果表明,前者的穿孔面积更大(p = 0.011),周长更大(p = 0.003)。与其他内塞相比,AFX2 的 ePTFE 穿孔面积最大(p = 0.050)。切除 EA 后,Excluder 袖套 ePTFE 膜的穿孔通道仍保持原样。局部剥离层损伤进一步扩大。Endurant II 和 Renu 内充气罩囊的穿孔具有相似的特征,PET 的多条纤维拉长、扭曲或破裂。与 PET 相比,膨胀聚四氟乙烯,尤其是 AFX2 内塞(不建议使用 EA),具有更广泛的材料变化特征。需要进行更多的研究,以按时间顺序补充这些疲劳测试结果。
The Impact of Heli-FX EndoAnchor Application on Endograft Material: An Experimental Study
Objective
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.
Methods
Heli-FX EndoAnchors were applied in vitro 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.
Results
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 (p = 0.011) and perimeter (p = 0.003) in the former. The ePTFE perforations in the AFX2 were the largest compared with the holes in other endocuffs (p = 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.
Conclusion
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.