Department of Vascular Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands; MIRA Institute of Biomedical Technology and Technical Medicine, University of Twente, Enschede, The Netherlands.
Department of Vascular Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands; MIRA Institute of Biomedical Technology and Technical Medicine, University of Twente, Enschede, The Netherlands.
J Vasc Surg. 2019 Jun;69(6):1726-1735. doi: 10.1016/j.jvs.2018.09.035. Epub 2018 Dec 19.
The aim of this study was to analyze the penetration depth, angles, distribution, and location of deployment of individual EndoAnchor (Medtronic Vascular, Santa Rosa, Calif) implants.
Eighty-six primary and revision arm patients (procedural success, 53; persistent type IA endoleak, 33) treated for type IA endoleaks with a total of 580 EndoAnchor implants from a subset of the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR) were included in this study. Procedural success was defined as the absence of a type IA endoleak on the first postprocedural computed tomography scan after the EndoAnchor implantation procedure. Endograft malapposition along the circumference was assessed at the first postoperative computed tomography scans and expressed as clock-face range and width in degrees and normalized such that the center was translated to 0 degrees. The position and penetration of each EndoAnchor implant were measured as the clock-face orientation. EndoAnchor implant penetration into the aortic wall was categorized as follows: good penetration, ≥2 mm; borderline penetration, <2 mm or ≥2-mm gap between the endograft and aortic wall; or no penetration. The orthogonal and longitudinal angles between the EndoAnchor implant and the interface plane of the aortic wall were determined. Location of deployment was investigated for each EndoAnchor implant and classified as maldeployed when it was above the fabric or in a gap >2 mm between the endograft and aortic wall due to >2-mm thrombus or positioning of the EndoAnchor implant below the aortic neck.
A total of 170 (29%) EndoAnchor implants had maldeployment and were therefore beyond recommended use and not useful. After EndoAnchor implantation, the procedural success and persistent type IA endoleak groups had 3 (1%) and 4 (2%) EndoAnchor implants positioned above the fabric as well as 60 (18%) and 103 (42%) placed in a gap >2 mm, respectively. The amount of EndoAnchor implants with good, borderline, and no penetration was significantly different between both groups (success vs type IA endoleak) after exclusion of maldeployed EndoAnchor implants (235 [87.4%], 14 [5.2%], and 20 [7.4%] vs 97 [68.8%], 18 [12.8%], and 26 [18.4%], respectively; P < .001). Good penetration EndoAnchor implants were more closely aligned with a 90-degree orthogonal angle than the borderline penetration and nonpenetrating EndoAnchor implants. The longitudinal angle was more distributed, which was observed through all three penetration groups.
In this subcohort of ANCHOR patients, almost 30% of the EndoAnchor implants had maldeployment, which may be prevented by careful preoperative planning and measured intraoperative deployment. If endoleaks are due to >2-mm gaps, EndoAnchor implants alone may not provide the intended sealing, and additional devices should be considered.
本研究旨在分析单个 EndoAnchor（美敦力血管，加利福尼亚州圣罗莎）植入物的穿透深度、角度、分布和部署位置。
在一项使用 Heli-FX 主动脉固定系统全球注册研究（ANCHOR）的亚组中，共纳入 86 例接受治疗的初次和再次手臂患者（程序成功 53 例；持续性 1A 型内漏 33 例），共植入 580 个 EndoAnchor 植入物治疗 1A 型内漏。程序成功定义为在 EndoAnchor 植入程序后的第一次术后计算机断层扫描（CT）扫描中没有 1A 型内漏。在第一次术后 CT 扫描中评估沿周长的移植物贴附不良，并以时钟面范围和角度表示，以度表示，并归一化，使中心移至 0 度。每个 EndoAnchor 植入物的位置和穿透性均以时钟面方向测量。将每个 EndoAnchor 植入物的穿透性分为以下几类：良好穿透性，≥2mm；边界穿透性，<2mm 或移植物和主动脉壁之间存在≥2mm 的间隙；或无穿透性。确定 EndoAnchor 植入物与主动脉壁界面平面之间的正交和纵向角度。调查每个 EndoAnchor 植入物的部署位置，并将其分类为部署不当，如果它位于织物上方或移植物和主动脉壁之间的间隙>2mm，这是由于>2mm 的血栓或 EndoAnchor 植入物的定位在主动脉颈下方。
共有 170 个（29%）EndoAnchor 植入物的部署不当，因此超出了推荐使用范围，且无法使用。在植入 EndoAnchor 后，程序成功和持续性 1A 型内漏组分别有 3 个（1%）和 4 个（2%）EndoAnchor 植入物位于织物上方，分别有 60 个（18%）和 103 个（42%）位于>2mm 的间隙中。在排除部署不当的 EndoAnchor 植入物后，两组之间（成功与 1A 型内漏）具有良好、边界和无穿透性的 EndoAnchor 植入物的数量存在显著差异（235[87.4%]，14[5.2%]和 20[7.4%]与 97[68.8%]，18[12.8%]和 26[18.4%]；P<.001）。与边界穿透性和无穿透性的 EndoAnchor 植入物相比，具有良好穿透性的 EndoAnchor 植入物与 90 度正交角更吻合。纵向角度分布更广泛，在所有三个穿透组中均有观察到。
在本亚组的 ANCHOR 患者中，近 30%的 EndoAnchor 植入物的部署不当，这可以通过术前仔细规划和术中测量植入物的部署来预防。如果内漏是由于>2mm 的间隙引起的，则单独使用 EndoAnchor 植入物可能无法提供预期的密封效果，应考虑使用其他装置。
