Outcomes of the Gore ® Excluder ® Iliac Branch Endoprosthesis Using Self Expanding or Balloon-Expandable Stent Grafts for the Internal Iliac Artery Component

Abstract

Objective:

The GORE^® EXCLUDER^® Iliac Branch Endoprosthesis (IBE; W.L. Gore & Associates, Flagstaff, Arizona) was developed to be used in combination with a self-expanding stent graft (SESG) for the internal iliac artery (IIA) bridging stent. Balloon-expandable stent grafts (BESGs) are an alternative for the IIA, offering advantages in sizing, device tracking, precision, and lower profile delivery. We compared the performance of SESG and BESG when used as the IIA bridging stent in patients undergoing EVAR with IBE.

Methods:

This is a retrospective review of consecutive patients who underwent EVAR with IBE implantation at a single center from October 2016 to May 2021. Anatomic and procedural characteristics were recorded via chart review and computed tomography (CT) postprocessing software (Vitrea^® v7.14). Devices were assigned to SESG vs. BESG groups based on the type of device landing into the most distal IIA segment. Analysis was performed per device to account for patients undergoing bilateral IBE. The primary endpoint was IIA patency, and secondary endpoint was IBE-related endoleak.

Results:

During the study period, 48 IBE devices were implanted in 41 patients (mean age 71.1 years). All IBE devices were implanted in conjunction with an infrarenal endograft. There were 24 devices in each of the self-expanding internal iliac component (SE-IIC) and balloon-expandable internal iliac component (BE-IIC) groups. The BE-IIC group had smaller diameter IIA target vessels (11.6±2.0 mm vs. 8.4±1.7 mm, p<0.001). Mean follow-up was 525 days. Loss of IIA patency occurred in 2 SESG devices (8.33%) at 73 and 180 days postprocedure, and in zero BESG devices, however, this difference was not statistically significant (p=0.16). There was 1 IBE-related endoleak requiring reintervention during the study period. A BESG device required reintervention due to Type 3 endoleak at 284 days.

Conclusions:

There were no significant differences in outcomes between SESG and BESG when used for the IIA bridging stent in EVAR with IBE. The BESGs were associated with using 2 IIA bridging stents and were more often deployed in smaller IIA target arteries. Retrospective study design and small sample size may limit the generalizability of our findings.

Clinical Impact

This series compares postoperative and midterm outcomes of self expanding stent grafts and balloon expandable stent grafts (BESG) when used as the internal iliac stent graft as part of a Gore® Excluder® Iliac Branch Endoprosthesis (IBE). With similar outcomes between the two stent-grafts, our series suggests that some of the advantages of BESG, device sizing, tracking, deployment, and profile, may be able to be leveraged without impacting the mid-term performance of the IBE.

Keywords

iliac artery balloon-expandable stents self-expanding stent abdominal aortic aneurysm endograft endoleak

Objective

A significant improvement in endovascular aortic aneurysm repair (EVAR) for patients with aortoiliac aneurysms emerged in 2016 with the US Food and Drug Administration’s (FDA) approval of the Gore^® Excluder^® Iliac Branch Endoprosthesis (IBE; W.L. Gore & Associates, Flagstaff, Ariz).^1,2 The Gore IBE is a 2-piece bifurcated endograft that allows for the preservation of the internal iliac artery (IIA) during EVAR and presents an alternative to embolization and coverage of the IAA, a classical technique that predisposes patients to complications, such as buttock claudication, sexual dysfunction, and a small, yet devastating risk of acute pelvic ischemia or spinal cord ischemia.^3–8 The FDA-approved Gore^® IBE instructions for use (IFU) describes the use of the proprietary Gore^® Excluder^® internal iliac component (IIC), a self-expanding stent graft (SESG), for the IIA branch.⁹ Unfortunately, this device has technical limitations and is only available in 3 diameters with fixed lengths of 7 cm, limiting the feasibility of EVAR with IBE in patients with complex IIA anatomy. Balloon-expandable stent grafts (BESG), such as the Gore^® Viabahn^® Balloon-Expandable Stent Graft (VBX, W.L. Gore) represent a possible alternative for the IIA branch and offers numerous advantages over SESG concerning sizing options, device tracking, lower profile delivery, and deployment accuracy.¹⁰

In 2018, the Society for Vascular Surgery practice guidelines issued a level 1A recommendation for the preservation of at least 1 IIA during EVAR with an FDA-approved endograft, where anatomically feasible.¹¹ Studies in Europe have shown that BESG in IBE and fenestrated/branched EVAR is both safe and feasible^12,13; however, the collective experience within the US populations that describes the performance of BESG when used as the IIA stent for Gore^® IBE remains limited.^14,15 This study aims to compare short-term and mid-term results between SESG and BESG when used as the IIA bridging stent as part of an IBE.

Methods

A retrospective chart review of all consecutive cases involving endovascular abdominal aortic aneurysm repair with unilateral or bilateral IBE was performed at a single institution between May 1, 2016 and October 31, 2021. The Institutional Review Board approved the study with a waiver of informed consent. Patients were included if they met IFU criteria for the Gore IBE. Those with prior iliac interventions or prior endograft treatment of the visceral or thoracic aorta were excluded. Balloon-expandable stent grafts were used outside of IFU in patients who were not anatomically suitable for IBE with SESG, such as in cases of short IIA, extension into IIA divisions, or smaller diameter IIA landing zones at the discretion of the treating surgeon.

Patients who had technically successful IBE implantation were divided into 2 groups for comparison: SE-IIC or BE-IIC, based on the type of stent graft implanted into the IIA. For cases with 2 or more stent grafts implanted into the IIA, the cohort was assigned based on which stent graft was deployed most distally into the IIA. The Gore^® Excluder^® IIC was the only SESG and the VBX was the only BESG used for the IIA device in this study. A retrospective data set was compiled documenting demographics, indication for repair, and procedural data, including the number and type of stent grafts used per IBE, and landing zone of the IIA, and perioperative complications. Preoperative CT scans were evaluated using postprocessing software (Vitrea^® v7.14) to measure IIA landing zone length as well as maximal orthogonal diameters of the common iliac artery, IIA, and IIA landing zone. Sizing measurements were recorded and verified by 2 trained investigators in vascular imaging (E.M. and N.C.) via digital cursor measurement relative to the centerline of flow.

The study’s primary outcomes were the patency of the IIA and freedom from IBE-related endoleak. Secondary endpoints were aneurysm-related mortality and freedom from buttock claudication. Patients were followed retrospectively using postrepair surveillance, which most often included arterial-phase CT scans initially at 6 months and then annually imaging with CT or ultrasound thereafter at the discretion of the treating surgeon. Completeness of follow-up was assessed via mean length of time in months and follow-up index (FUI) as described by von Allmen et al.¹⁶

Clinical data and outcomes were analyzed with consideration toward reporting standards for the Society of Vascular Surgery for complex EVAR.¹⁷ Statistical analysis of mid-term results was performed per device to account for patients undergoing bilateral IBE. Categorical variables were reported as an absolute number with their percentages and statistical analysis was undertaken with Fischer’s exact test or Pearson’s χ² test. Means with standard deviation were reported for continuous variables, and one-way analysis of variance (ANOVA) for normally or Kruskal-Wallis test for non-normally distributed continuous variables were applied. Statistical significance was determined by a p-value less than 0.05. Analysis for time-dependent results was performed with Kaplan-Meier. The log-rank test was used to test the differences between internal component patency on Kaplan-Meier analysis. Statistical analysis processing was performed with STATA 17.0 software (College Station, TX).

Results

Demographics and Clinical Characteristics

During the study period, 42 consecutive patients underwent 48 successful Gore IBE implantations with 24 IBE in the SESG group (SE-IIC) and 24 IBE in BESG group (BE-IIC) (see Table 1). One patient (2.4%) was excluded from analysis due to technical failure secondary intraoperative thrombosis of a stenotic internal iliac artery ostium which occurred before introduction of the IIA stent graft. With this, the cohort consisted of 41 patients with 48 IBE devices due to 7 patients with bilateral IBE (see Figure 1). Among the patients treated, 38 (92.6%) were male with a mean age of 71.1 years (SD=8.6) with no differences with respect to age per cohort. All IBE implants were performed for intact aneurysms, however, in 1 patient, the indication was for symptomatic aneurysm with abdominal pain. There were 14 patients (34.1%) presenting with isolated iliac aneurysms (8 unilateral and 7 bilateral), and 27 (65.9%) with aortoiliac aneurysm. There were 15 patients (36.6%) who had contralateral internal iliac occlusion or embolization at the time of IBE implant. Of these patients, 11 (26.8%) had a contralateral internal iliac artery occlusion diagnosed preoperatively and 4 (9.7%) patients consisting of 2 in each cohort underwent planned contralateral IIA embolization. Comparisons between each cohort with respect to the baseline characteristics are detailed in Table 1.

Table 1.

Demographic and preoperative characteristics of BE-IIC and SE-IIC groups.

Demographic and clinical characteristicsReported as mean [SD] or absolute n (%)	Total	BE-IIC	SE-IIC	p value
Number	48	24	24
Mean age (years)	70.7 [9.4]	71.7 [9.1]	69.3 [9.2]	0.36
Over age 80	8 (16.7)	4 (16.7)	4 (16.7)
Male sex	43 (89.6)	21 (87.5)	22 (91.6)	0.57
Dual antiplatelet	7 (14.6)	5 (20.8)	2 (8.3)	0.41
Anticoagulant at time of last follow-up	7 (14.6)	3 (12.5)	4 (16.7)	0.68
Elective	47 (97.9)	24 (100.0)	23 (95.8)	0.32
Aortoiliac aneurysm	32 (66.7)	17 (70.8)	15 (62.5)	0.55
Isolated iliac aneurysm	13 (27.1)	7 (29.2)	9 (37.5)	0.55
Ipsilateral internal iliac aneurysm	3 (6.3)	2 (8.3)	1 (4.2)	0.59
Ipsilateral internal iliac artery stenosis >50%	7 (14.6)	4 (16.7)	3 (12.5)	0.68
Contralateral IIA occlusion or embolization	15 (31.3)	6 (25.0)	9 (37.5)	0.37
Bilateral IBE implant	12 (25.0)	6 (25.0)	6 (25.0)

Abbreviations: BE-IIC, balloon-expandable internal iliac component; SE-IIC, self-expanding internal iliac component; IIA, internal iliac artery; IBE, iliac branch endoprosthesis.

Anatomic and Operative Procedure Characteristics

Table 2 compares characteristics of each cohort with respect to anatomic and procedural factors. Percutaneous access was performed in 39 of 41 (95.1%) patients and any form of open access was performed in 2 (4.9%) patients in the BE-IIC cohort, including 1 unplanned open femoral exposure due to percutaneous closure device failure. Technical success, defined as deployment of the IBE and planned IIA stent graft without Type 3 or Type 1C endoleak was 100.0% in both the BE-IIC and SE-IIC cohorts. The diameters of the treated common iliac aneurysm as well as the IIA target diameter are denoted in Table 2, of which the BE-IIC showed a trend toward smaller target arteries (SE-IIC 11.6±2.0 mm vs. BE IIC 8.4±1.7 mm, p<0.001). In addition, the BE-IIC more often had the bridging stent deployed into a first order branch of the IIA, consisting of either the anterior or posterior internal iliac division (SE-IIC=0 vs. BE-IIC=4, p<0.05). More than 1 IIA component was deployed in 13 IBE implants in total, with 12 such instances occurring within BE-IIC (12/24) and 1 occurring in the SE-IIC (1/24). For the BE-IIC cohort, 11 IBE implants received 2 IIA stent grafts and 1 IBE implant received 3 IIA stent grafts. All IBE implants occurred in conjunction with a modular bifurcated infrarenal endograft.

Table 2.

Anatomic characteristics and procedure outcomes of BE-IIC and SE-IIC groups. The categories are distinguished by operative procedure methods, anatomic characteristics, 30 day outcomes, and IBE related endograft outcomes during mid-term follow-up.

Anatomic and operative procedure detailsReported as mean [SD] or absolute n (%)	BE-IIC	SE-IIC	p value
General anesthesia	24 (100.0)	24 (100.0)
Technical success	24 (100.0)	24 (100.0)
Percutaneous access	22 (91.7)	24 (100.0)	0.07
Up-and-over IIA gate cannulation	23 (95.8)	23 (95.8)
Brachial/axillary IIA gate cannulation	1 (4.2)	0	0.16
Anatomic characteristics of internal iliac artery
Mean common iliac artery diameter	36.9 [9.6]	38.2 [7.9]	0.61
Mean IIA target vessel diameter	8.4 [1.7]	11.6 [2.0]	<0.01
IIA main trunk landing zone	20 (83.3)	24 (100.0)	<0.05
IIA first order branch landing zone	4 (16.7)	0	<0.05
IIA branch vessel embolization	4 (16.7)	0	<0.05
Use of 2 or more IIC devices	12 (50.0)	1 (4.2)	<0.001
Thirty-day patient outcomes
Thirty-day or in hospital mortality	0	0
Access site complication	1 (4.2)	0	0.32
Access site complication requiring intervention	1 (4.2)	0	0.32
Acute kidney injury	0	0
Unplanned readmission	0	1 (4.2)	0.32
Venous thromboembolism	0	0
Myocardial infarction	0	0
IBE-related endoleak, occlusion, or reintervention
IBE-related endoleak	1 (4.2)	0	0.32
IBE-specific intervention	1 (4.2)	1 (4.2)
Internal iliac component occlusion/thrombosis	0	2 (8.3)	0.08
Freedom from buttock claudication	23 (95.8)	22 (91.7)	0.27
Mortality, all cause	2 (8.3)	1 (4.1)	0.27
Aortic-related mortality	0	0

Abbreviations: BE-IIC, balloon-expandable internal iliac component; SE-IIC, self-expanding internal iliac component; IIA, internal iliac artery; IBE, Iliac Branch Endoprosthesis.

Outcomes

Further described in Table 2 are the outcomes over the follow-up period. Mean follow-up was 525 days. During the index hospitalization and 30-day postoperative period, there were no instances of acute myocardial infarction, venous thromboembolism, acute kidney injury, or ischemic bowel. Median length of stay (LOS) in the cohort was 1 day (interquartile range [IQR] 1, 2). Mortality at 30 days was 0%, however, there were 3 (7.3%) non-aortic-related mortalities during the total follow-up period. One unplanned readmission occurred within 30 days due to thrombosis of the right external iliac limb of the IBE device in the SE-IIC which required re-operation for iliofemoral thromboendarterectomy and infrainguinal bypass to improve the distal outflow. Iliac Branch Endoprosthesis-specific Type 3 endoleak occurred in 1 patient in BE-IIC that required reintervention at 284 days postoperatively (IIA embolization and external iliac endograft extension) resulting in short-term ipsilateral buttock claudication postprocedure. Primary loss of IIA patency was observed in 2 IBE implants in follow-up, both occurring within the SE-IIC cohort (8.3%) and diagnosed at 73 and 180 days postoperatively with both patients experiencing ipsilateral buttock claudication on clinical assessment, however, this difference was not found to be statistically significant (p=0.16). Figure 2 represents a Kaplan-Meir plot for the IIA device patency over the follow-up period. A case by case analysis of these 2 occluded IIA devices reveals that they occurred during the first one-half of the institutional experience. In both cases, the IIA target arteries were both small diameter and severely angulated (>60 degrees). The SE-IIC had an average follow-up period that was longer than the BE-IIC cohort, M=25.6 months (SD=13.6) vs. M=17 months (SD=11.1), p<0.03. However, the follow-up indices as a measurement of completeness of follow-up were not significantly different 0.59 (SD=0.26) vs. 0.61 (SD=0.27).

Discussion

The emergence of EVAR with IBE allows for IIA preservation and has improved the applicability of endovascular therapy for aortoiliac aneurysms, however, the ideal stent graft for bridging into the IIA remains a topic of debate.^18–21 This analysis shows comparable results between the Gore^® Excluder^® IIC, an SESG, and the VBX for use in the IIA with similar patency rates, freedom from buttock claudication, postprocedural endoleak, and IBE-related reintervention. This suggests that patients that do not qualify for IBE due to sizing limitations and technical feasibility related to constraints posed by using the self-expanding IIC may benefit from VBX as it allow for expanding the conditions in which IBE can be used.

In this series, BESGs, which were all VBX, were more often implanted into smaller and more complex IIA targets. The VBX is a balloon-expandable stent graft that offers numerous advantages in tracking, delivery, conformability, and perhaps most importantly, sizing. It is estimated that only 30% to 50% of patients with aortoiliac aneurysms meet strict IFU criteria for EVAR with IBE due to sizing limitations.^22–25 It is plausible that “real-world” application of BESG in this IBE cohort was performed in certain patients where the operators felt that the SESG represented a less ideal choice of bridging stent. Contrary to the Gore^® Excluder^® IIC, an SESG, the VBX is available in many lengths from 2 to 6 cm as well as a broad range of diameters where postdeployment balloon dilation offers customization of stent graft diameter within the same device.²⁶ Describing this in a detailed manner, 7-mm stent grafts can be dilated up to 11 mm and 11-mm stent grafts can be increased to 16 mm. This is an important advantage in IIA where tortuosity, short vessels, and conical vessel morphologies are frequently encountered.^27,28

Case analysis of the 2 IIA occlusions in this series that occurred in SESG group reveals that these target vessels may have been more suitable for BESG owing to their smaller diameter and tortuosity. The use of BESG for bridging into the IIA in this series revealed only 1 Type 3 endoleak during the follow-up period that required reintervention. This endoleak may be the result of the foreshortening of the device when postdilated the stent graft resulting in a shorter seal zone. This represents 1 shortcoming of the VBX when postdilating and should be planned for when during deployment. In this series, there were no significant differences in these events between groups. Rodriguez et al analyzed the impact of utilizing IBE both on and off labels, and found no significant differences in mid-term IBE performance which is consistent with our findings.²² Substitution of BESG for SESG represents a mild modification to IBE deployment technique with no apparent substantial disadvantages or increased patient risk as corroborated by the pELVIS registry that analyzed the Cook IBE.^29,30

Limitations of this current study include the retrospective design with associated selection biases. Indications for SESG or BESG were based on individual operator’s own criteria, even though the series was consecutively collected. Diversification of endograft manufacturer was limited, with patients in the BE-IIC cohort consisting of Gore^® VBX. For this indication, other commercially available balloon-expandable stent grafts may perform differently in the IIA. The small sample size of each cohort also creates the possibility that the lack of significant difference between the comparison groups was because of Type II error. Finally, the FUI is small, which may reflect some degree of attrition bias.

Conclusions

The Gore^® Excluder^® IBE can be implanted safely with either the Gore^® Excluder^® IIC, an SESG, or VBX for the IIA device with comparable mid-term outcomes. A more considerable pooled analysis incorporating multiple institutional series would increase our collective confidence in these findings by detecting rare adverse events, in which small retrospective studies cannot capture. Long-term performance outcomes (>5 years) are required to confirm the long-term safety profile of BESG when used for the IIA during EVAR with IBE.

Footnotes

Authors’ Note

Presented at the 2022 Vascular Annual Meeting Poster Session, Boston, MA.

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: Mark Eskandari, M.D., as received honoraria from Silk Road Medical, Inc. for service on the Roadster Clinical Events Committee; and from W. L. Gore & Associates as a TEVAR course director and Data Safety Monitoring Board member. The remaining authors have no relevant interests to disclose.

Funding

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

ORCID iD

Cortolillo N

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