Rastogi Vinamr, de Bruin Jorg L, Varkevisser Rens R B, Oliveira Nelson F G, Bouwens Elke, Hoeks Sanne E, Ten Raa Sander, van Rijn Marie Josee, Goncalves Frederico Bastos, Schermerhorn Marc L, Fioole Bram, Verhagen Hence J M
Department of Vascular Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands; Department of Surgery, Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass.
Department of Vascular Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands.
J Vasc Surg. 2022 May;75(5):1521-1529.e1. doi: 10.1016/j.jvs.2021.12.061. Epub 2022 Jan 4.
Although proximal neck dilatation following infrarenal endovascular aneurysm repair (EVAR) is common and is associated with proximal graft failure, little is known about sealing zone dilatation and its clinical relevance following fenestrated EVAR (FEVAR). We studied proximal seal dilatation (PSD) dynamics following FEVAR and assessed its clinical significance.
We included all consecutive patients treated for a juxta-/supra-renal aneurysm with fenestrated EVAR using the Zenith Fenestrated Endovascular Graft (Cook Medical, Bloomington, Ind) from 2008 to 2018 in two large teaching hospitals in the Netherlands. The primary outcome was PSD over time and was determined using a linear mixed-effects model. Secondary outcomes included associations for early PSD and difference in aortic dilatation at the level of the covered stent compared with the bare stent. Proximal seal-related adverse events were also obtained.
Our cohort included 84 patients with a median computed tomography angiography follow-up time of 24.5 months (interquartile range [IQR], 17-42 months). Maximum aneurysm diameter was 60.1 mm (IQR, 56.9-67.2 mm). Mean proximal seal diameter at baseline was 26.2 mm (standard deviation [SD], ±2.8 mm), mean stent oversizing was 20.1% (SD, ±9.1%), and mean proximal seal length was 29.5 mm (SD, ±11.7 mm). Proximal seal dilatation of 1.7 mm (95% confidence interval [CI], 1.4-2.1 mm) was found in the first year, decelerating thereafter (second year, 0.9 mm/year; 95% CI, 0.7-1.1 mm/y). Over 10% PSD at 1 year occurred in 22 patients (27%) and was associated with stent graft oversizing (odds ratio, 1.1; 95% CI, 1.03-1.2; P = .008) and a lower number of target vessels (four fenestrations/ref two fenestrations: odds ratio, 0.13; 95% CI, 0.02-0.74; P = .029). At last available imaging, dilatation difference was higher at the level of the covered stent compared with the bare stent (3.0 mm [IQR, 1.3-5.1 mm] vs 1.6 mm [IQR, 0.8-2.5 mm]; P < .001). During the study period, only one patient (1.2%) developed a proximal seal-related adverse event (type IA endoleak).
PSD is present following FEVAR, occurring at a faster rate in the first year and subsequently decelerating thereafter, similarly to neck dilatation after standard infrarenal EVAR. Although its clinical implication seems to remain limited in the first years following implantation, further research is required to assess the effect of PSD on long-term FEVAR outcomes.
虽然肾下腔内血管修复术（EVAR）后近端颈部扩张很常见且与近端移植物失败相关，但关于开窗EVAR（FEVAR）后密封区扩张及其临床相关性知之甚少。我们研究了FEVAR后近端密封扩张（PSD）动态变化并评估其临床意义。
我们纳入了2008年至2018年在荷兰两家大型教学医院使用Zenith开窗血管内移植物（库克医疗公司，印第安纳州布卢明顿）接受开窗EVAR治疗 juxta-/肾周动脉瘤的所有连续患者。主要结局是随时间的PSD，使用线性混合效应模型确定。次要结局包括早期PSD的相关性以及与裸支架相比，覆膜支架水平处主动脉扩张的差异。还获取了近端密封相关的不良事件。
我们的队列包括84例患者，计算机断层扫描血管造影术的中位随访时间为24.5个月（四分位间距[IQR]，17 - 42个月）。最大动脉瘤直径为60.1毫米（IQR，56.9 - 67.2毫米）。基线时平均近端密封直径为26.2毫米（标准差[SD]，±2.8毫米），平均支架过大尺寸为20.1%（SD，±9.1%），平均近端密封长度为29.5毫米（SD，±11.7毫米）。第一年发现近端密封扩张1.7毫米（95%置信区间[CI]，1.4 - 2.1毫米），此后扩张速度减慢（第二年，0.9毫米/年；95% CI，0.7 - 1.1毫米/年）。22例患者（27%）在1年时PSD超过10%，这与支架移植物过大尺寸相关（比值比，1.1；95% CI，1.03 - 1.2；P = 0.008）以及较少的靶血管数量（四个开窗/参考两个开窗：比值比，0.13；95% CI，0.02 - 0.74；P = 0.029）。在最后一次可用成像时，与裸支架相比，覆膜支架水平处的扩张差异更高（3.0毫米[IQR，1.3 - 5.1毫米]对1.6毫米[IQR，0.8 - 2.5毫米]；P < 0.001）。在研究期间，仅1例患者（1.2%）发生了近端密封相关的不良事件（IA型内漏）。
FEVAR后存在PSD，第一年发生率较快，此后逐渐减慢，与标准肾下EVAR后的颈部扩张情况类似。虽然在植入后的最初几年其临床意义似乎仍然有限，但需要进一步研究以评估PSD对FEVAR长期结局的影响。
