Mid-term results of “off-label” use of the Endurant stentgraft in patients with infrarenal abdominal aortic aneurysms

Abstract

Objectives

EVAR is the preferred treatment modality for patients with an infrarenal abdominal aortic aneurysm with suitable anatomy. Each manufacturer of aortic stentgrafts has specific anatomic requirements. In some patients, it is not possible to adhere to the instructions for use, but alternative treatment is also not possible. In these patients, EVAR can be performed outside instructions for use.

Methods

In this study, all consecutive patients in whom an Endurant II or IIS stentgraft was used between 1 January and 31 December were reviewed. We compared the two patient groups in whom this stentgrafts was used outside and inside instructions for use. Patients with planned adjuvant therapy, for example, chimney procedure or iliac side branches, were excluded.

Results

In 74 of 178 (41.6%) patients, the instructions for use were not adhered. The main reason was pathology of the aortic neck. There were more patients with type IA endoleak, this difference was borderline significant (p = .06). There were more patients with limb occlusion in the early postoperative period, but at the end of the follow-up period, the incidence was comparable. Aneurysm-related mortality and all-cause mortality were comparable in both groups.

Conclusion

In this study, real-life experience with the Endurant II and IIS stentgraft is described. Non-adherence with instructions for use was associated with a higher risk of endoleak type IA (p = .06). In the early postoperative period, there were more patients with limb occlusion; this finding was not observed anymore at the end of the follow-up period.

Keywords

Instructions for use abdominal aneurysm infrarenal aortic aneurysm endoleak non-adherence

Introduction

According to the guidelines of the European Society of Vascular Surgery and the Society for Vascular Surgery, EVAR is the preferred treatment modality in patients with suitable anatomy.^1,2 To acquire approval of the Food and Drug Administration (FDA), manufactures have developed instructions for use (IFU).³ The IFU limits the deployment of stentgrafts to certain anatomic parameter, for example, length of the proximal and distal fixation zone, angulation of the infrarenal aneurysm neck, and diameter of the access vessels.

In some patients, it is not possible to adhere to the IFU. In these patients, the surgeon can choose a different endovascular solution, for example, a fenestrated stentgraft or chimneys, or open surgery. In some patient, these alternatives are not possible due to comorbidities, anatomic constraints, or due to time limitation. In these patients, the stentgraft can be deployed outside IFU.

Some studies have shown that non-adherence to IFU is associated with an increased risk of reintervention, rupture, limb occlusion, and aneurysm-related mortality.^4–6 Others could not confirm these findings.^7–9 In this retrospective single center study, we will describe the incidence of non-adherence to IFU in Medtronic stentgrafts and the consequences.

Materials and methods

Patients

Between 1 January 2012 and 31 December 2020, we reviewed 369 consecutive Endurant II or IIS (Medtronic, Santa Rosa, Calif) stentgraft implantations used in patients with an aortic aneurysm. Patients in whom stents from other manufacturers were used were excluded from the analysis. Also, patients in whom chimneys, aortic tubes, or mono-iliac aortic grafts were used or an iliac side branch was implanted were excluded from the analysis (n = 84). Patients with isolated iliac aneurysms were also excluded from the analysis (n = 10). For 97 patients, a preoperative CT-angiographe with minimal 1.0 mm layer thickness was not available. A total of 178 patients were included in the study. The study was approved by the local ethics committee (Ethik-Kommission der Universität Witten-Herdecke, S-79/2023). Because of the retrospective nature of the study, the patients were not asked for informed consent (this was approved by the ethics committee).

During the study period, male patients with an AAA with a diameter >5.5 cm were eligible for EVAR. Female patients were eligible with a diameter >5.0 cm. Patients with a rapidly increasing aneurysm sac (>1 cm/year or >0.5 cm/6 months) were also advised to undergo a procedure. Patients with a ruptured aneurysm were included in the study.

Measurements

Baseline anatomic data, for example, length of the aneurysm neck, supra- and infrarenal angulation, diameter of the aneurysm neck, and length and diameter of the distal fixation zone, were recorded. The aortic neck diameter was measured outer-to-outer wall just below the lower renal artery (proximal neck) and just above the level of aneurysm formation (distal neck). Neck length was defined as the longitudinal distance from the lower renal artery to the point of aneurysm formation. Infrarenal neck angulation was measured as the angle between the aortic neck and the longitudinal axis of the aneurysm; suprarenal neck angulation was defined as the angle between the aortic neck and the suprarenal aorta. The measurements were assessed using dedicated 3D analysis software (aycan Medical Systems, Rochester, NY, USA) using center-line reconstructions. Measurements were performed by 2 vascular surgeons (DÖ and SB). In case of more than 20% disconcordance, the measurements were reviewed by a third observer (DH).

According to the instructions for the Endurant II(S), stentgrafts should only be used if³:

• Aortic neck length of ≥10 mm without significant calcification or thrombus and ≤60 infrarenal and ≤45 suprarenal angulation.

• Aortic neck length of ≥4 mm and <10 mm in conjunction with Heli-FX EndoAnchors without significant calcification or thrombus and ≤60 infrarenal and ≤45 suprarenal angulation.

• Aortic neck length of ≥15 mm without significant calcification or thrombus and ≤75 infranal and ≤60 suprarenal angulation.

• Aortic neck diameter with a range of 19 to 30 mm.

• Iliac distal fixation length ≥15 mm.

• Iliac diameter with a range of 8 to 25 mm.

Significant calcification or thrombus were defined as ≥ 25% of the circumference. After analyzing baseline anatomic data, patients were divided as within or outside the IFU of the Endurant stentgraft.

Procedure

During the study period, EVAR was the treatment of first choice in patients with an infrarenal aortic aneurysm in our hospital. In patients in whom adherence to IFU was not possible, it was decided to perform an open procedure, to use adjunctive procedures (e.g., chimneys or iliac side branch), to use a stentgraft from another manufacturer, or to use the Endurant II or Endurant IIS outside IFU. The decision was made based on patient’s anatomic features and comorbidities.

In all patients, general anesthesia was used. All EVAR procedures were performed by a vascular surgeon. Both percutaneous and open femoral access was used, depending on surgeon’s preference and patient’s anatomic features. In the early years of the study, open femoral access was preferred. The most distal renal artery was marked and the stentgraft was deployed. Then, the internal iliac artery was marked and the iliac limbs are deployed. In all patients, an angiography was performed at the end of the procedure. In case of endoleak (EL) type IA, the stentgraft was proximally dilated. When dilatation was unsuccessful, the stentgraft was extended using a Palmaz stent or a cuff. In case of EL type IB, the iliac limb was extended or (in a later phase) an iliac side branch was implanted.

Follow-up protocol

When renal function is allowed, a computed tomography-angiography (CT-angiography) was performed during the hospital stay. The follow-up protocol consisted of duplex sonography at 6 months, 12 months, and yearly thereafter. A CT-angiography was scheduled after 5 years. In case of enlargement of the aneurysm sack, a CT-angiography was also scheduled. When CT-angiography was not possible, an angiography was performed.

Outcome measures

Outcomes were defined according to Chaikof et al.¹⁰ Technical success was defined as successful introduction and deployment of the device without surgical conversion, mortality, type I or III EL, or limb obstruction; clinical success was defined as successful deployment of the device without aneurysm-related mortality, type I or III EL, graft infection, aneurysm expansion (≥5 mm during follow-up), aneurysm rupture, or conversion to open repair. Extravasation of contrast material in the space between the prosthesis and the aneurysm was defined as endoleak. Adjunctive procedures included both endovascular and open procedures.

Statistical analysis

All statistical analyses were performed using SPSS version 27 (IBM Corp, Armonk, NY). Continuous variables were expressed as mean with standard deviation (SD) and were compared using the Student’s t-test. Categorical data were given as absolute numbers and percentages; and were compared using the Pearson X² (and Fisher´s exact test when n < 5). p-values <0.05 were considered significant. The Kaplan–Meier method was used to assess all-cause and aneurysm-related mortality. The log-rank test was used to compare Kaplan–Meier estimates.

Results

Non-adherence to instructions for use

During the study period, 501 EVAR procedures were performed. 323 procedures were excluded because stentgrafts other than the Endurant II(S) were used, adjunctive procedures (e.g., iliac side branch or chimneys) were performed, because mono-iliac or aortic tube stentgrafts were used, or because a CT-angiography layer thickness >1.0 mm was used. In 74 of the remaining 178 patients (41.6%), the IFU were not adhered. The following violations were observed: significant calcification in the aneurysm neck (n = 4), short or angulated aneurysm neck (n = 27), too large or too small diameter of the aneurysm neck (n = 18), significant thrombus in the aneurysm neck (n = 31), too short distal fixation length (n = 11), or too small iliac diameter (n = 2). In some patients, there were more than 1 violations of IFU.

Patients’ characteristics and intra-operative parameter

Patients’ demographics are depicted in Table 1. In female patients, there was a significant higher incidence of non-adherence to IFU (p = .01). There were no significant differences regarding oversizing, intra-operative adjunctive procedures, and EL type IA or IB (Table 2). In none of the patients, an intra-operative conversion was necessary. During the years, the incidence of non-adherence to IFU varied between 17.6% and 60.7% (Figure 1). The highest incidence of off-label use was seen in the years 2014 to 2016. Technical success was higher in the IFU group (97.1% vs 93.9% p = .02).

Table 1.

Demographics.

	Outside IFU (n = 74)	Inside IFU (n = 104)	p-value
Male patients	62 (83.8%)	99 (95.2%)	0.01
Age	74.2 (SD 8.3)	72.7 (SD 9.0)	0.29
Cardiovascular risk factors
Hyperlipidemia	39 (52.7%)	44 (42.3%)	0.17
Smoking or ex-smoking	38 (51.4%)	41 (39.4%)	0.11
Hypertension	57 (77.0%)	74 (71.2%)	0.38
Diabetes mellitus	15 (20.3%)	14 (13.5%)	0.23
Comorbidities
Coronary artery disease	28 (37.8%)	39 (37.5%)	0.96
Cerebrovascular disease	9 (12.2%)	5 (4.8%)	0.07
Peripheral artery disease	7 (9.5%)	6 (5.8%)	0.35
Chronic obstructive pulmonary disease	17 (23.0%)	14 (13.5%)	0.10
Kidney insufficiency	2 (2.7%)	3 (2.9%)	0.94
Dialysis	0 (0.0%)	2 (1.9%)	0.23
Maximal AAA diameter	52.7 (SD 11.7)	55.2 (SD 11.9)	0.77
Rupture	1 (1.4%)	3 (2.9%)	0.50

AAA = abdominal aortic aneurysm; SD = standard deviation.

Table 2.

Intra-operative parameter.

	Outside IFU (n = 74)	Inside IFU (n = 104)	p-value
Mean proximal oversizing	24.7% (SD 19.2%)	22.6% (SD 11.6%)	0.42
Mean distal oversizing	32.6% (SD 25.0%)	30.3% (SD 25.5%)	0.62
Intra-operative adjunctive procedures	7 (9.5%)	14 (13.5%)	0.42
Neck-related adjunctive procedures	2 (2.7%)	4 (3.8%)	0.68
Distal fixation zone-related adjunctive procedures	1 (1.4%)	0 (0.0%)	0.24
Intra-operative EL type IA	4 (5.4%)	6 (5.8%)	0.92
Intra-operative EL type IB	1 (1.4%)	0 (0.0%)	0.24
Intra-operative conversion	0 (0.0%)	0 (0.0%)	—
Technical success	65 (93.9%)	101 (97.1%)	0.02

EL = endoleak.

Figure 1.

Non-adherence to IFU during the years.

First 30 postoperative days

During the first 30 postoperative days, there were significantly more adjunctive procedures in the non-adherence group (18.9% vs 4.8%) (Table 3). In one patient, an EL was seen at the postoperative CT-angiography, but not confirmed at the following angiography.

Table 3.

Outcomes.

	Outside IFU (n = 74)	Inside IFU (n = 104)	p-value
30 Day outcomes
Mortality	2 (2.7%)	0 (0.0%)	0.09
Aneurysm-related mortality	0 (0.0%)	0 (0.0%)	—
Adjunctive procedures	14 (18.9%)	5 (4.8%)	<0.01
Angiography	1 (1.4%)	0 (0.0%)	0.24
Axillofemoral bypass	1 (1.4%)	0 (0.0%)	0.24
Common femoral artery endarterectomy	1 (1.4%)	0 (0.0%)	0.24
Femorofemoral bypass	3 (4.1%)	1 (1.0%)	0.17
Hematoma evacuation	2 (2.7%)	2 (1.9%)	0.73
Iliac thrombectomy	2 (2.7%)	1 (1.0%)	0.37
Laparotomy, hematoma evacuation	1 (1.4%)	0(0.0%)	0.24
Palmaz® stent	2 (2.7%)	0 (0.0%)	0.09
Renal stent	1 (1.4%)	1 (1.0%)	0.81
EL1A	2 (2.7%)	1 (1.0%)	0.37
Neck-related adjunctive procedures	2 (2.7%)	0 (0.0%)	0.09
Palmaz® stent	2 (2.7%)	0 (0.0%)	0.09
EL1B	0 (0.0%)	0 (0.0%)	—
Distal fixation zone-related adjunctive procedures	0 (0.0%)	0 (0.0%)	—
Limb occlusion	5 (6.8%)	1 (1.0%)	0.04
Mid-term outcomes
Aneurysm sack diameter regression	1.47 (SD 6.4)	1.33 (SD 8.9)	0.91
Rupture	1 (1.4%)	1 (1.0%)	0.81
Adjunctive procedures	22 (29.7%)	23 (22.1%)	0.25
EL1A	10 (13.5%)	5 (4.8%)	0.06
Neck-related adjunctive procedures^a	6 (8.1%)	5 (4.8%)	0.37
ChEVAR	1 (1.4%)	2 (1.9%)	0.77
Cuff	2 (2.7%)	1 (1.0%)	0.37
Palmaz® Stent	2 (2.7%)	0 (0.0%)	0.09
Multilayer Flow Modulator	1 (1.4%)	1 (1.0%)	0.81
Aptus®	0 (0.0%)	1 (1.0%)	0.40
Aneurysm sack coiling	0 (0.0%)	1 (1.0%)	0.40
EL1B	2 (2.7%)	5 (4.8%)	0.48
Distal fixation zone-related adjunctive procedures	1 (1.4%)	5 (3.8%)	0.21
Distal extension	1 (1.4%)	4 (3.8%)	0.32
Iliac side branch	0 (0.0%)	1 (1.0%)	0.40
Limb occlusion	10 (13.5%)	8 (7.7%)	0.20
Clinical success	61 (82.4%)	89 (85.6%)	0.57
Conversion to open surgery	1 (1.4%)	0 (0.0%)	0.24

^ain some patients more than 1 procedures were performed.

The incidence of procedures related to EL type 1A or EL type 1B was comparable in both groups (2.7% vs 1.0% and 0.0% vs 0.0%), respectively. In two patients, a Palmaz® stent was placed, which successfully treated the EL type IA. There were no patients with EL type IB in the first 30 postoperative days. In one patient, conservative treatment was planned, because a fenestrated or chimney technique was necessary. This patient was discharged and in the CT-angiography performed, 3 months postoperative did not show EL type IA; however 2 years later, EL type IA was again seen and the chimney procedure was performed.

There were significantly more limb occlusions in the non-adherence group (p = .04).

Follow-up

The mean follow-up was 22.9 months. During follow-up, there were more patients with EL1A in the non-adherence group (13.5% vs 4.8%), this difference was, however, not significant (p = .06). EL1A was treated with cuff implantation (n = 3), the chimney technique (n = 3), Genesis Palmaz stent (Cordis) (n = 2), Cardiatis Multilayer (n = 2), Aptus® EndoStaples (n = 1), and aneurysm sack coiling (n = 1). In this last patient, cuff implantation was combined with aneurysm sack coiling. Four patients declined treatment and one of these patients died shortly afterward due to rupture.

There were 7 patients with EL1B during follow-up, 2 patients in the non-adherence group (2.7%) and 5 in the adherence group (4.8%). During follow-up, 6 procedures were performed: 5 extension of the iliac limb and 1 iliac side branch implantation. One patient presented with a ruptured aneurysm due to EL1B. Despite distal extension of the iliac limb, the patient was hemodynamically instable and a conversion was performed. Thereafter, the patient lived, but was dialysis-dependent afterward. For one patient, distal extension with an iliac side branch is still planned.

There were no significant differences regarding all-cause mortality and aneurysm-related mortality (Figure 2(A) and (B)).

Figure 2.

(A) All-cause mortality (log rank 0.45, p = .50). (B) Aneurysm-related mortality (log rank 0.57 p = .45).

Discussion

In this study, mid-term results of the Endurant stent graft are described. When used according to IFU in 22.1% of the patients, adjunctive procedures were necessary. This is in concordance with other studies.^11–13

In this cohort, 41.6% of deployed Endurant stentgrafts were outside IFU, other studies have reported rates between 28% and 52%.^5,14–16 In our study, as in other studies, neck anatomy was the most important reason for use outside IFU: in only 7 patients (9.5%), iliac diameter or iliac fixation length was the sole reason for use outside IFU. The incidence of EL type IA after a mean follow-up of 22.9 months was evidently higher in the non-IFU group: 4.8% versus 13.5%. However, this difference was not significant, which could imply that there could be an underpowering of this study. Other studies with larger patient populations have reported a significantly higher risk of EL type IA after EVAR outside IFU.^17,18 In this patient cohort, there were no differences regarding aneurysm-related mortality and all-cause mortality. During the first 30 postoperative days, two patients died. Both patients were in the non-IFU group, their deaths were, however, unrelated to non-adherence of IFU. The first patient died because of pneumosepsis, the other death was due to cardiopulmonary complications.

There is evidence that the Endurant stentgraft has a relatively high incidence of limb occlusion when compared to other stentgrafts.^19–21 In this study, there was an explicit difference in incidence of limb occlusion at 30 days: 1.0% versus 6.8% (p = .04). In the mid-term results, this difference had disappeared. Further analyses showed that the iliac diameter in the non-IFU group was smaller (12.6 mm vs 13.5 mm p = .07); consequently, the distal diameter of the implanted stentgrafts was also smaller (16.1 mm vs 17.5 mm p = .02). Mean oversizing was comparable in both groups (36% vs 31% p = .25). In three patients, iliac diameter was the reason for non-IFU use, none of these patients presented with limb occlusion. The smaller iliac diameter is the most plausible cause for the higher incidence of limb occlusion, as a small iliac diameter seems to be a risk factor for limb occlusion.²²

Although we saw more patients with EL1A and more limb occlusion within the first 30 days in the non-IFU group, there were no differences regarding perioperative mortality, freedom from aneurysm rupture, and freedom from aneurysm-related mortality. Similar findings were recently presented in a systematic review with meta-analysis in 2020.²³

Another interesting point is the fact that significantly more female patients were treated outside IFU. This observation was also made in the systematic review performed by Antoniou et al.²³ Further analysis showed that female patients more often had an infrarenal neck angulation >60 degrees (25.0% vs 5.6% p = < 0.01). The length of the aneurysm neck was comparable in male and female patients (23.7 mm vs 26.6 mm p = .41) in our cohort. Others have also reported more extensive aortic neck pathology in female patients when compared to their male counterparts.²⁴ Hultgren et al. reported more female patients with proximal angulation, more female patients with a short aortic neck, and more often a wide proximal aortic neck.²⁴

Limitations

First and foremost limitation of this study is its retrospective design, with its associated bias. Secondly, lost to follow-up was considerable. This finding is in concordance with other studies, which have also described non-compliance to surveillance program of 40–60%.^25,26 This has also attributed to a mean follow-up of approximately 2 years despite a study period of 9 years.

Due to the limited amount of included patients, it was not possible to study the influence of each specific violation of IFU.

Conclusions

This study reflects the real-life experience with the Endurant stentgraft in real-life conditions in a community hospital. Non-adherence to IFU in this cohort was associated with a higher risk of EL type IA (although no significant difference). The incidence of EL1B and distal fixation zone-related adjunctive procedures and all-cause and aneurysm-related mortality were comparable. We advise caution when considering EVAR outside IFU, other options, for example, fenestrated stent grafts and open procedures have to be considered. If treated outside IFU, patients should be informed accordingly and strict follow-up is necessary.

Footnotes

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iD

Denise Michelle Danielle Özdemir-van Brunschot

Appendix

References

Wanhainen

Verzini

Van Herzeele

, et al. Editor’s choice – European society for vascular surgery (ESVS) 2019 clinical practice guidelines on the management of abdominal aorto-iliac artery aneurysms. Eur J Vasc Endovasc Surg 2019; 57(1): 8–93.

Chaikof

Dalman

Eskandari

, et al. The society for vascular surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg 2018; 67(1): 2–77.

https://europe.medtronic.com/xd-en/healthcare-professionals/products/cardiovascular/aortic-stent-grafts/endurantii.html?cmpid=PPC:GOOG:Brand:WE_EN_AORTIC_AlwaysOn-WBS900%7CTX%7CGS%7CAbdominal_GEN_NOV22

Abbruzzesse

Kwolek

Brewster

, et al. Outcomes following endovascular abdominal aortic aneurysm repair (EVAR): an anatomic and device-specific analysis. J Vasc Surg 2008; 48: 19–28.

Donas

Torsello

Weiss

, et al. Performance of the Endurant stent graft in patients with abdominal aortic aneurysms independent of their morphologic suitability for endovascular aneurysm repair based on instructions for use. J Vasc Surg 2015; 62: 848–854.

Hahl

Protto

Järvenpää

, et al. Long-term outcomes of endovascular aneurysm repair according to instructions for use adherence status. J Vasc Surg 2022; 76: 699–706.e2.

Schanzer

Greenberg

Hevelone

, et al. Predictors of abdominal aortic aneurysm sac enlargement after endovascular repair (erratum in Circulation 2012;125:e266). Circulation 2011; 123: 2848–2855.

Walker

Tucker

Goodney

, et al. Adherence to endovascular aortic aneurysm repair device instructions for use guidelines has no impact on outcomes. J Vasc Surg 2015; 61: 1151–1159.

Hoshina

Ishimaru

Sasabuchi

, et al. Outcomes of endovascular repair for abdominal aortic aneurysms: a nationwide survey in Japan. Ann Surg 2019; 269: 564–573.

10.

Chaikof

Blankensteijn

Harris

, et al. Reporting standards for endovascular aortic aneurysm repair. J Vasc Surg 2002; 35(5): 1048–1060.

11.

Khan

Salata

, et al. A systematic review and meta-analysis of the long-term outcomes of endovascular versus open repair of abdominal aortic aneurysm. J Vasc Surg 2019; 70(3): 954–969.

12.

Wanken

Barnes

Trooboff

, et al. A systematic review and meta-analysis of long-term reintervention after endovascular abdominal aortic aneurysm repair. J Vasc Surg 2020; 72(3): 1122–1131.

13.

Columbo

Kang

Hoel

, et al. A comparison of reintervention rates after endovascular aneurysm repair between the Vascular Quality Initiative registry, Medicare claims, and chart review. J Vasc Surg 2019; 69(1): 74–79.

14.

Herman

Charbonneau

Hongku

, et al. Any nonadherence to instructions for use predicts graft-related adverse events in patients undergoing elective endovascular aneurysm repair. J Vasc Surg 2018; 67: 126–133.

15.

Torsello

Troisi

Donas

, et al. Evaluation of the Endurant stent graft under instructions for use vs off-label conditions for endovascular aortic aneurysm repair. J Vasc Surg 2011; 54: 300–306.

16.

AbuRahma

Yacoub

Mousa

, et al. Aortic neck anatomic features and predictors of outcomes in endovascular repair of abdominal aortic aneurysms following vs not following instructions for use. J Am Coll Surg 2016; 222(4): 579–589.

17.

Ramirez

Govsyeyev

Sorber

, et al. Proximal instructions for use violations in elective endovascular aneurysm repair in the vascular quality initiative: retrospective analysis. J Am Coll 2023; 237(4): 633–643.

18.

Barry

Turley

Mwipatayi

, et al. The impact of endograft selection on outcomes following treatment outside of instructions for use (IFU) in endovascular abdominal aortic aneurysm repair (EVAR). Cureus 2021; 13(5): e14841.

19.

Mantas

Antonopoulos

Sfyroeras

, et al. Factors predisposing to endograft limb occlusion after endovascular aortic repair. Eur J Vasc Endovasc Surg 2015; 49(1): 39–44.

20.

Chacko

Hans

Nahirniak

, et al. Clinical patterns, predictors, and results of graft limb occlusion following endovascular aneurysm repair. Ann Vasc Surg 2023; 94: 341–346.

21.

van Gerwen

Gallala

Kerselaers

, et al. Stentgraft limb occlusion after endovascular aneurysm repair: incidence and risk factors. Vasc Endovasc Surg 2024; 58(1): 34–41.

22.

Catanese

Sangiorgi

Sotgiu

, et al. Clinical and anatomical variables associated in the literature to limb occlusion after endovascular aneurysm repair compared to the experience of a tertiary referral center. Minerva Chirg 2020; 75(1): 5159.

23.

Antoniou

Juszczak

Nasr

, et al. Prognosis review and time-to-event data meta-analysis of endovascular aneurysm repair outside versus within instructions for use of aortic endograft devices. J Vasc Surg 2020; 71: 1415–1431.

24.

Hultgren

Vishnevskaya

Wahlgren

. Women with abdominal aortic aneurysms have more extensive aortic neck pathology. Ann Vasc Surg 2013; 27(5): 547–552.

25.

Schanzer

Messina

Ghosh

, et al. Follow-up compliance after endovascular abdominal aortic aneurysm repair in Medicare beneficiaries. J Vasc Surg 2015; 61: 16–22.

26.

Garg

Baker

Mell

. Postoperative surveillance and long-term outcomes after endovascular aneurysm repair among Medicare beneficiaries. JAMA Surg 2015; 150(10): 957–963.