Abstract
Objective
Contemporary commercially available endovascular devices for the treatment of abdominal aortic aneurysm (AAA) include standard endovascular aortic repair (sEVAR) or fenestrated EVAR (fEVAR) endografts. However, aortic neck dilatation (AND) can occur in nearly 25% of patients following EVAR, resulting in loss of proximal seal with risk of aortic rupture. AND has not been well characterized in fEVAR, and direct comparisons studying AND between fEVAR and sEVAR have not been performed. This study aims to analyze AND in the infrarenal and suprarenal aortic segments, including seal zone, and quantify sac regression following fEVAR implantation compared to sEVAR.
Method
A retrospective review of prospectively collected data on 20 consecutive fEVAR patients (Cook Zenith® Fenestrated) and 20 sEVAR (Cook Zenith®) patients was performed. Demographic data, anatomic characteristics, procedural details, and clinical outcome were analyzed. Pre-operative, post-operative (1 month), and longest follow-up CT scan at an average of 29.3 months for fEVAR and 29.8 months for sEVAR were analyzed using a dedicated 3D workstation (iNtuition, TeraRecon Inc, Foster City, California). Abdominal aortic aneurysm neck diameter was measured in 5 mm increments, ranging from 20 mm above to 20 mm below the lowest renal artery. Sub-analysis comparing the fEVAR to the sEVAR group at 12 months and at greater than 30 months was performed. Standard statistical analysis was done.
Results
Demographic characteristics did not differ significantly between the two cohorts. The fEVAR group had a larger mean aortic diameter at the lowest renal artery, shorter infrarenal aortic neck length, increased prevalence of nonparallel neck shape, and longer AAA length. On follow-up imaging, the suprarenal aortic segment dilated significantly more at all locations in the fEVAR cohort, whereas the infrarenal aortic neck segment dilated significantly less compared to the sEVAR group. Compared to the sEVAR cohort, the fEVAR patients demonstrated significantly greater positive sac remodeling as evident by more sac diameter regression, and elongation of distance measured from the celiac axis to the most cephalad margin of the sac. Device migration, endoleak occurrence, re-intervention rate, and mortalities were similar in both groups.
Conclusion
Compared to sEVAR, patients undergoing fEVAR had greater extent of suprarenal AND, consistent with a more diseased native proximal aorta. However, the infrarenal neck, which is shorter and also more diseased in fEVAR patients, appears more stable in the post-operative period as compared to sEVAR. Moreover, the fEVAR cohort had significantly greater sac shrinkage and improved aortic remodeling. The suprarenal seal zone in fEVAR may result in a previously undescribed increased level of protection against infrarenal neck dilatation. We hypothesize that the resultant decreased endotension conferred by better seal zone may be responsible for a more dramatic sac shrinkage in fEVAR.
Introduction
The overall pooled prevalence of abdominal aortic aneurysm (AAA) is 4.8% in the general population, 1 and contemporary commercially available treatment options for AAA encompass standard endovascular aortic repair (sEVAR) as well as fenestrated EVAR (fEVAR), for juxtarenal AAA with short infrarenal seal zones. 2 Indeed, important criteria for EVAR planning are the quality of the aortic neck, critical for proper sealing of the AAA after endograft implantation.2–4 However, as many as 25% of sEVAR patients have been observed to have aortic neck dilatation (AND) during follow-up, and this is correlated with adverse outcomes. 4 In some cases, AND may lead to loss of sealing and fixation of the endograft, resulting in type 1a endoleak and device migration.4–6 AND has not been well characterized in fEVAR, and moreover, a comparison of the degree and location of AND between fEVAR and sEVAR has not been performed. This study aims to analyze the extent of AND in infrarenal and suprarenal segments after fEVAR compared to sEVAR using the Cook Zenith platform for EVAR and fEVAR.
Materials and Methods
General Information
This study was approved by the ethical committee and the institutional review board of New York University Langone Health, and rules according to the Helsinki Declaration were followed. Given that this is a retrospective review of prospectively collected data, informed consents were waived by the institutional review board. From 2013 to 2019, 76 patients with AAA were treated with fEVAR and 213 patients were treated with sEVAR. Indications for repair such as diameter, growth rate >5 mm over 6 months, symptomatic status, and concurrent iliac aneurysm were based on discretion of the treating physician. Instructions for use from the manufacturer were followed, specifically with fEVAR used for patients with short infrarenal aortic neck of at least 4 mm, and sEVAR for those with neck 15 mm or greater. Parallel branch EVAR or physican-modified EVAR cases were excluded. Only patients with available pre-operative, 1-month post-operative, and minimum 1-year follow-up computer tomography angiogram (CTA) were included in this study. Twenty consecutive patients meeting the above inclusion criteria treated using fEVAR (Zenith® Fenestrated endograft, Cook, Bloomington, Indiana) were compared to 20 consecutive patients treated using sEVAR (Zenith® endograft, Cook, Bloomington, Indiana).
Variables and Outcomes
Pre-operative, 1-month post-operative, and the longest available follow-up CTA at an average of 29.3 months for fEVAR and 29.8 months for sEVAR were analyzed using a dedicated 3D workstation (iNtuition, TeraRecon Inc, Foster City, California). Baseline demographic and radiographic characteristics, procedural details, and clinical outcomes were abstracted and analyzed. The primary outcome was changed in suprarenal and infrarenal aortic neck dilatation, as well as the change in the maximum sac diameter in the fEVAR group and the sEVAR group over time. Similar to other authors who have studied aortic neck dilatation following EVAR, we chose to use the 1-month post-operative CTA as baseline measurement for aortic neck in all patients. In this manner, we are able to standardize measurements and avoid inconsistencies which can occur when measuring native aorta at various points in the cardiac cycle. A sub-analysis was performed comparing patients with CTA at 12 months, and at greater than 30 months, who underwent fEVAR versus sEVAR. The aortic neck and the para-renal aorta were mapped and analyzed in 5 mm increments, ranging from 20 mm above to 20 mm below the lowest renal artery reference point (Figure 1). Secondary radiographic outcomes included changes over time in the distance between celiac artery to the proximal extent of the aneurysm, a surrogate for sac remodeling, as well as celiac artery to the top of graft fabric, an estimate for graft migration. Secondary clinical outcomes included type 1a endoleak and type 2 endoleak, branch vessel occlusion, device-related re-intervention, aortic-related mortality, and all-cause mortality. Graphic representation of mapping of the infrarenal neck and the para-renal aorta. 5 mm increments were measured and compared with respect to the lowest renal artery, under centerline analysis.
Infrarenal aortic neck length, morphology, degree of thrombus, and calcification were assessed based on the pre-operative CTA. Nonparallel neck shape was defined as change in neck diameter >10% in proximal landing zone. Severe neck thrombus was defined as circumferential thrombus or greatest thickness of 5 mm or greater. Severe neck calcification was defined as circumferential calcification or greatest thickness of 3 mm or greater. Mean device oversizing was calculated from (device diameter - average proximal landing zone diameter)/average proximal landing zone diameter, using the pre-operative CTA.
Statistical Analysis
All diameters and lengths were presented as percent change over time; this was caculated by taking the absolute difference between the follow-up CTA measurement and the 1-month (baseline) post-operative CTA measurement, and dividing this by the 1-month post-operative CTA measurement. The average absolute changes in diameter or distance were also measured. The difference in categorical variables and frequencies between the fEVAR and sEVAR groups was analyzed using Fisher’s exact test. Difference in continuous variables between the two groups was analyzed using Student’s T test. Difference was considered as statistically significant for p values < 0.05 (two sided). Statistical analyses were performed by using SPSS software (version 25.0, IBM Corp, Armonk, NY).
Results
Demographics and baseline radiographic data.
Demographic and baseline radiographic data between fEVAR and sEVAR group. CAD: coronary artery disease; COPD: chronic obstructive pulmonary disease; DM: diabetes mellitus; HTN: hypertension; AAA: abdominal aortic aneurysm.
Radiographic and clinical outcome in fEVAR versus sEVAR.
Radiographic and clinical outcome between fEVAR and sEVAR group. The latest follow CT scan is compared to the first post-operative CT scan using dedicated workstation (iNtuition, TeraRecon Inc, Foster City, Calif). CA: celiac axis; MA: superior mesenteric artery; TOG: top of graft.
Radiographic change in fEVAR versus sEVAR at 12 and >30 months.
Radiographic measurements between fEVAR and sEVAR group at 12 months follow-up and at more than 30 months follow-up, compared to the first post-operative CT scan. Of note, the 12 months and >30 months group do not contain all of the same patients, as some had follow-up CT at 12 months but not >30 months, or vice versa. Both the percentage of change from the baseline measurements and the absolute change in parenthesis are presented.
Discussion
AND has been described following both endovascular and open repair of AAA.7,8 In sEVAR, proposed risk factors for AND include large or unfavorable aortic neck, use of self-expanding stent grafts, and excessive device oversizing.9–12 A meta-analysis by Kouvelos et al. 4 showed that AND can occur in up to 25% of patients undergoing sEVAR, and is associated with adverse outcomes such as type 1a endoleak, device migration, and re-intervention. Others have also shown that AND is associated with device migration, re-intervention, and late type 1a endoleak.13–15 However, there are only a few studies on AND in fEVAR alone, and no direct comparison exists between fEVAR and sEVAR with respect to AND and its effect on sac remodeling. A study by Qaderi and collegues on physician-modified endografts showed that AND was not associated with adverse outcomes, and that these devices dilated to their nominal diameter and not beyond. 16 Similarly, Tran et al. 17 have studied AND in 43 patients who underwent fEVAR using commercially available devices and shown significant dilatation of the suprarenal aorta which was not associated with endoleak. Notably, the latter study mapped the seal zone according to the fEVAR sealing stents, whereas in our study we chose to examine the native aorta relative to the lowest renal artery, the most commonly accepted reference point for proximal seal. In this manner, we are focusing on the anatomy of the seal zone itself versus the location of the stent graft. In addition, measuring aortic dilatation based on sealing stents may be problematic in the setting of stent migration and aortic remodeling.
In this study, we found that the suprarenal aorta dilated significantly more, whereas the infrarenal segment dilated significantly less in the fEVAR group compared to the sEVAR group. This finding was true when comparing the overall cohorts, as well as in the sub-analysis segregating the scohort into those with 12 months follow-up CTA and with greater than 30 months follow-up CTA. Presumably, the fEVAR group had more diseased and aneurysmal para-renal and para-visceral aorta compared to the sEVAR, which may explain the more significant suprarenal AND over time, suggesting a chronic degenerative process intrinsic to the diseased aortic wall. A significant proportion of patients in both the sEVAR and the fEVAR groups had two consecutive aortic segments that dilated beyond the stent graft diameter, suggesting that aortic degeneration, in addition to stent graft radial force from oversizing, may contribute to AND. AND also became more pronounced at greater than 30 months, indicating that it is a chronic process, again indicating that a mechanism intrinsic to the aneurysmal degeneration might be contributing.
Moreover, fEVAR induced more sac regression compared sEVAR in this analysis, despite having similar device oversizing and length of sealing, and having larger diameter at the level of the lowest renal artery, shorter infrarenal neck length, higher frequency of nonparallel neck shape, and longer AAA length. Others have also demonstrated positive sac remodeling in fEVAR: one group showed that the mean aneurysm sac diameter decreased from 60.2 ± 9.3 mm pre-operatively to 53.2 ± 12.8 mm at mean follow-up of 21 ± 15.9 months (p < 0.001) with repair using Cook Zenith Fenestrated Endograft. 18 fEVAR with Anaconda demonstrated 94% sac regression or stabilization at short–medium term follow-up. 19 Tran et al. 17 observed that 72% of fEVAR patients demonstrated >5 mm sac shrinkage in their midterm follow-up. Our study adds to the existing literature by comparing and quantifying the AND and sac remodeling in fEVAR compared to sEVAR and further suggests an inverse relationship between infrarenal AND and sac shrinkage in fEVAR. It has been shown that sac regression may correlate with decreased adverse events and mortality in both fEVAR and sEVAR.20,21
There were no differences in clinical outcomes such as type 1a or type 2 endoleak occurrence, device-related re-intervention, and aortic-related or all-cause mortalities between the fEVAR and the sEVAR group, although our study was not powered to detect differences in these secondary endpoints. Others have shown an association between infrarenal AND and type 1a endoleak, migration, and re-intervention; however, the impact of suprarenal AND on clinical outcome has not been thoroughly investigated.4,17 It is worth noting that by taking the seal to the para-renal and para-visceral level, the fEVAR cohort in this investigation achieved no type 1a or 3 endoleak and comparable clinical outcomes to the sEVAR group that altogether had a more favorable aortic anatomy for endovascular repair. Other studies on fEVAR and physician modified endografts also support the protective effects of the longer seal zones on AND and subsequent clinical outcome.16,17
This study is limited by its retrospective design; therefore, the conclusion is hypothesis-generating only. The sample size is limited to detect and quantify aortic neck morphological changes in fEVAR compared to sEVAR, and was insufficient to detect clinical outcome differences. All of the measurements were taken by a single investigator on centerline mode; although this created consistency across the whole dataset, inter-observer differences were not accounted for. Despite having sealing stents at different locations in fEVAR and sEVAR, we chose to map the aortic neck with respect to the aorta itself instead of the sealing stents from the endograft, as we hypothesize that AND, especially in the long term is largely attributed by the aortic disease itself instead of the radial force from the stent graft. This approach at quantifying AND is unique to this study, whereas others attempted to quantify based on the stent graft instead. 17 Our average follow-up imaging was limited to 30 months and may under-appreciate more delayed AND which others have shown may appear after 3 years 22 Not every patient had consistent annual CT scans; therefore, year-by-year comparison in neck and aneurysmal changes and Kaplan–Meier analysis were not performed. This study only included devices from Cook Medical, and did not investigate AND in standard or fenestrated devices from other manufacturers.
Conclusion
Compared to sEVAR, patients undergoing fEVAR had greater extent of suprarenal AND, consistent with a more diseased native proximal aorta. However, the infrarenal neck, which is shorter and also more diseased in fEVAR patients, appears more stable in the post-operative period as compared to sEVAR cases. Moreover, the fEVAR cohort had significantly greater sac shrinkage and improved sac remodeling. The suprarenal seal zone in fEVAR may confer a previously undescribed increased level of protection against infrarenal neck dilatation and lessen endotension, resulting in more dramatic sac shrinkage. AND should be studied in a larger cohort with consistent imaging intervals and longer follow-up in order to better understand its effect on durability of standard and fenestrated EVAR devices.
Footnotes
Declaration of conflicting interests
The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: TSM, NC and KG are consultants for Cook Medical. The other authors have no conflict of interest to disclose.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
