van Noort Kim, Vermeulen Jenske J M, Goudeketting Seline R, Ouriel Kenneth, Jordan William D, Panneton Jean M, Slump Cornelis H, de Vries Jean-Paul P M
1 Department of Vascular Surgery, St Antonius Hospital, Nieuwegein, the Netherlands.
2 MIRA Institute of Biomedical Technology and Technical Medicine, University of Twente, Enschede, the Netherlands.
J Endovasc Ther. 2019 Jun;26(3):369-377. doi: 10.1177/1526602819837753. Epub 2019 Mar 25.
To investigate changes in penetration depths and angles of EndoAnchor implants with initially good penetration after therapeutic use in endovascular aneurysm repair.
Patients were selected from the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR; ClinicalTrials.gov identifier NCT01534819). Inclusion criteria were (1) EndoAnchor implantation to treat intraoperative or late type Ia endoleak and (2) at least 2 postoperative computed tomography angiography (CTA) scans. Exclusion criteria were the use of adjunct procedures. Based on these criteria, 54 patients (44 men) with 360 EndoAnchor implants were eligible for this analysis. Penetration depth of each EndoAnchor implant into the aortic wall was judged as (1) good (≥2-mm penetration), (2) borderline (<2 mm or when there was a gap between the endograft and the aortic wall), or (3) no penetration. The penetration depth and longitudinal angles of EndoAnchors with good penetration were investigated on the last available postprocedure CTA scan. Endoleaks were also analyzed.
EndoAnchor penetration on the first postprocedure CTA scan was good in 187 (51.9%), borderline in 69 (19.2%), and missing in 104 (28.9%). On the last CTA scan, 182 (97.4%) of the 187 initially well-positioned EndoAnchors remained good. Five (2.6%) EndoAnchors in 4 patients changed configuration over time (4 became borderline and 1 became nonpenetrating), all without any clinical sequelae. The median orthogonal angles of the EndoAnchor implants with good penetration on the first and last CTA scans were 92° [interquartile range (IQR) 85, 98] and 90° (IQR 84, 97), respectively (p=0.822); for longitudinal angles, medians of 85° (IQR 71, 96) and 84° (IQR 70, 96) were found (p=0.043). Of the 18 (33%) patients who had a type Ia endoleak on the first postprocedure CTA, 6 resolved over time. Median follow-up was 13 months, during which no new type Ia endoleak was found.
Despite the small number of EndoAnchors analyzed, this study showed that the sustainability of EndoAnchor implants with initially good penetration is satisfactory at 1-year follow-up. The vast majority of EndoAnchor implants with good penetration initially remained in good position; <3% of implants became borderline or nonpenetrating, without any clinical consequence.
研究在血管内动脉瘤修复治疗性使用后，初始穿透良好的EndoAnchor植入物的穿透深度和角度的变化。
从使用Heli-FX主动脉固定系统全球注册研究（ANCHOR；ClinicalTrials.gov标识符NCT01534819）中选取患者。纳入标准为：（1）植入EndoAnchor以治疗术中或晚期Ia型内漏；（2）至少进行2次术后计算机断层扫描血管造影（CTA）。排除标准为使用辅助手术。基于这些标准，54例患者（44例男性）共360枚EndoAnchor植入物符合本分析条件。将每枚EndoAnchor植入物进入主动脉壁的穿透深度判断为：（1）良好（≥2mm穿透）；（2）临界（<2mm或当腔内移植物与主动脉壁之间存在间隙时）；或（3）未穿透。在最后一次可用的术后CTA扫描上，研究穿透良好的EndoAnchor的穿透深度和纵向角度。同时也分析内漏情况。
术后首次CTA扫描时，EndoAnchor穿透良好的有187枚（51.9%），临界的有69枚（19.2%），未显示的有104枚（28.9%）。在最后一次CTA扫描时，187枚最初位置良好的EndoAnchor中有182枚（97.4%）仍保持良好。4例患者中的5枚（2.6%）EndoAnchor随时间发生了构型改变（4枚变为临界，1枚变为未穿透），均无任何临床后遗症。首次和最后一次CTA扫描时穿透良好的EndoAnchor植入物的正交角中位数分别为92°[四分位间距（IQR）85，98]和90°（IQR 84，97）（p = 0.822）；纵向角中位数分别为85°（IQR 71，96）和84°（IQR 70，96）（p = 0.043）。术后首次CTA时有Ia型内漏的18例（33%）患者中，6例内漏随时间消失。中位随访时间为13个月，在此期间未发现新的Ia型内漏。
尽管分析的EndoAnchor数量较少，但本研究表明，初始穿透良好的EndoAnchor植入物在1年随访时的稳定性令人满意。绝大多数初始穿透良好的EndoAnchor植入物仍保持良好位置；<3%的植入物变为临界或未穿透，且无任何临床后果。
