Results of the Galician registry in the treatment of complex aortoiliac aneurysms with GORE ® EXCLUDER ® Iliac Branch Endoprosthesis (GALIBER)

Abstract

Objective

The objective of this study is to report the medium-term results of GORE^® EXCLUDER^® Iliac Branch Endoprosthesis (IBE, W. L. Gore & Associates, Flagstaff, Ariz) for the treatment of aortoiliac aneurysms by using the GALIBER registry.

Methods

Patients with aortoiliac or isolated common iliac/hypogastric aneurysms treated with Iliac Branch Endoprosthesis device between January 2014 and May 2019 were prospectively collected from 5 centers. Demographic, clinical, and radiologic data were extracted from electronic databases. Technical success was defined as successful implantation of the Iliac Branch Endoprosthesis device with exclusion of aortoiliac aneurysm, as well as patency of Iliac Branch Endoprosthesis in the follow-up. Iliac Branch Endoprosthesis patency was evaluated by Doppler ultrasound and/or computed tomography based on the protocol of each participant center. Follow-up was 731 days +/− 499.

Results

Between January 2014 and May 2019, 105 iliac arteries were treated with GORE^® IBE device, in 81 patients (79 men, two women; mean age 71, range 52–91). Only seven patients (8.6%) were symptomatic. 60 patients (74%) had aortic and iliac enlargement. Thirty-three patients presented bilateral iliac aneurysms (40.7%): In twenty-four (29.6%) patients, an Iliac Branch Endoprosthesis device was implanted in both sides, and in nine patients (11.1%), one Iliac Branch Endoprosthesis was used with the embolization of the contralateral hypogastric artery. Technical success was achieved in the 99% (104/105 iliac branch device implanted). There were no procedural deaths or type I or III intraoperative endoleaks observed. During the follow-up (range 55–1789 days), 28 (34.5%) type II endoleaks were observed and one (1.2%) type Ia was observed. The patency of the hypogastric arteries treated with the iliac branch device was 98.1% during the follow-up (range 55–1789 days). In 30% of the patients with contralateral hypogastric embolization, some kind of complications was observed in the embolizated side: one developed ischemic colitis and two buttock claudication.

Conclusions

Preservation of internal iliac artery with the Iliac Branch Endoprosthesis device can be performed safely with excellent technical success and good medium-term patency rates. These results support hypogastric preservation whenever possible to prevent ischemic complications.

Keywords

Aortoiliac aneurysm internal iliac artery endovascular aneurysm repair iliac branch device Iliac Branch Endoprosthesis

Introduction

In the endovascular treatment of aortoiliac aneurysmal disease, distal sealing plays a significant role in the long-term durability and clinical success. Recent studies are being performed to evaluate distal seals even using division branches of the internal iliac artery, with safe and efficacious results in the midterm.¹ Proximal migration of the iliac limb can lead to type 1b and type 3 endoleaks that may result in abdominal aortic aneurysm (AAA) rupture.²

The presence of common iliac artery (CIA) aneurysm, which does not allow an effective seal, is one of the major anatomic challenges of conventional endovascular aneurysm repair (EVAR). Extensive iliac aneurysm repair creates the potential for two important safety issues: preservation of pelvic circulation to avoid ischemic complications and durable effective exclusion of the aneurysm to prevent risk of rupture in the long term.³

To maintain the patency of internal iliac artery (IIA) during the treatment of complex aortoiliac aneurysm disease, some techniques have been described such as “hybrid procedures,” “sandwich techniques,” “bell-bottom,” or, recently, the dedicated “iliac branch devices” (IBD). Over the past decades, the endovascular options have been in constant evolution, and the use of IBD has increased due to their improved results compared to techniques such as bell-bottom that had been shown to have a higher incidence of distal migration and type 1b endoleak.⁴ At this moment, there are three IBD options in the European market (CE Mark) (Cook Medial (Bloomington, Ind), W. L. Gore & Associates (Flagstaff, Ariz), and Jotec (Hechingen, Germany)).

The European Society for Vascular Surgery (ESVS) Clinical Practice Guidelines on the Management of Abdominal Aorto-Iliac Artery Aneurysms and The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm recommend preservation of flow to at least one internal iliac artery with level of recommendation 1B and 1A, respectively. They also recommend the branch endograft devices in anatomically suitable patients to maintain perfusion to at least one internal iliac artery.^5,6

Preservation of bilateral IIA by the use of IBD in both sides has not been frequently reported until recently.^7–9 However, treating both hypogastrics decreases the risks of ischemic complications after unilateral occlusion, so in many centers, the current aim is the bilateral preservation whenever possible.

The goal of this study was to evaluate the safety and the efficacy of the Iliac Branch Endoprosthesis (IBE) device treating unilateral and bilateral aortoiliac aneurysms, in our usual clinical practice.

Materials and methods

This is a retrospective, multicenter, single- arm study, designed to evaluate the results with the IBE device in patients with aortoiliac aneurysms. In each participating center, the implant of the device was decided according to its usual protocol. Each contributing author collected the data at their center for a subsequent join study, and the registry focused specifically in the study of patients with implantation of the IBE device. The principal investigator of the reference center was the coordinator of the study, compiling all the information for its subsequent statistical study.

All patients were enrolled after the procedure; therefore, the hospital’s internal database was used for data collection. The database used only variables collected in the medical reviews performed by usual clinical practice, without major implications on the part of the patients. The study follows the principles of the Declaration of Helsinki, and its methodology was assessed and approved by the Institutional Review Board-Hospital Ethics Committee, considering that the compilation of an informed consent is not mandatory due to the retrospective data collection.

Eighty-one patients (105 iliac arteries) were evaluated after the treatment with the GORE^® EXCLUDER^® IBE at five hospital centers at five hospital centers in Galicia, from January 2014 to May 2019.

Efficacy was assessed by technical success at the time of surgery and was defined as successful implantation of the IBE device with exclusion of aortoiliac aneurysm, as well as patency of IBE in the follow-up. Morbidity and mortality was also analyzed after the procedure to include occlusion, presence of endoleak, rupture, aneurysm growth, migration, need for secondary procedures, and evidence of pelvic ischemia.

Evaluations were performed according to usual protocol in each center, as well as the recommended postoperative treatment. In most of the cases, double antiplatelet therapy (aspirin plus clopidogrel) was recommended for 6 months, followed by simple antiplatelet therapy. The patients who were under previous anticoagulant treatment continued their treatment adding aspirin for 6 months.

Data analysis

Statistical analysis was completed using SPSS statistical package version 20.0 (SPSS, Chicago, IL, USA). Qualitative variables were presented as total number and percentage. A p value <0.05 was considered to indicate statistical significance and continuous data are presented as means +/− standard deviation (SD). Categorical data are presented with percentage.

Results

105 Iliac Branch Endoprostheses were implanted in 81 patients (2 female and 79 male), with a mean age of 76.2 years (range 52–91 years). The patients were treated in five hospitals between January 2014 and May 2019. Baseline characteristics of the patients are listed in Table 1.

Table 1.

Baseline characteristics of patients (N = 81).

Demographics
Age, years	76.2 +/− 6.9
Male	79 (97.5%)
Female	2 (2.5%)
Comorbidities
Diabetes mellitus	13 (16%)
Arterial hypertension	51 (63%)
Smokers	13 (16%)
Ex-smoker	38 (47%)
Heart disease	29 (35.8%)
Renal disease	16 (19.8%)
Obesity	37 (45%)
Malignancy	31 (38.3%)
COPD	14 (17.3%)
PAD	12 (14.8%)
Symptomatic aneurysm	6 (7.4%)
ASA
II	14 (17.3%)
III	48 (59.3)
IV	8 (9.9)

Note: COPD: chronic obstructive pulmonary disease; PAD: peripheral artery disease; ASA: American Society of Anesthesiologists.

Patient aneurysm characteristics

Forty-eight patients (59.3%) had iliac aneurysmal disease in only one side and bilateral was present in the 33 remaining patients (40.7%). Abdominal aortic aneurysm was associated in 60 patients (74%). Eleven (8.6%) patients presented with a hypogastric aneurysm (Figure 1). Two patients (2.5%) also had an associated common femoral aneurysm. The mean common iliac treated diameter was 39.4 mm (range 23–100 mm) and aneurysmal infrarenal aortic diameters ranged from 30 to 100 mm (mean 52.4 mm). Surgical indication is presented in Table 2.

Table 2.

Surgical indication over time of the study.

Aortic enlargement alone (greater than 5.5 cm)	13 (16.04%)
Iliac enlargement alone (greater than 3 cm)	43 (53.08%)
Both arteries in treated diameter range (aortic and iliac)	25 (30.86%)

In the patients treated during the first 2 years (30% of the total sample size), the iliac tortuosity index was calculated to evaluate the conformability of the IBE in the cases of very tortuous iliac arteries. The iliac tortuosity index was very high in the vast majority of patients: between 0 and 1 in the 83.3%.¹⁰ No differences in patency were observed in patients with the highest tortuosity index.

Seven patients (8.6%) were symptomatic. Almost all patients were treated on a scheduled surgery, with only one emergent case due to a ruptured abdominal aortic aneurysm. One patient had an inflammatory aneurysm.

Surgical technical data

The procedure was performed in one stage in all patients, including cases in which the contralateral hypogastric was embolized. Six patients (7.4%) had a chronic occlusion in the contralateral hypogastric artery.

The access techniques included: percutaneous access in 99 femoral arteries (94.3%) and open surgical access in 6 femoral arteries (5.7%). In addition, there were six cases (5.7%) in which the left brachial access was also necessary.

A complete record of data on the amount of contrast used and the operative time could not be established. We have data from a small sample, where we observed that the use of contrast increased slightly in cases of bilateral IBE implantation. We also did not observe a significant increase in the time of the procedure with IBE implantation versus embolization.

Technical success, defined as aneurysm exclusion without complications, successful deployment, and patency of all components were achieved in 99% of implanted devices (104/105 iliac branch device implanted). In some cases, a covered stent was used instead of the internal iliac component (IIC), specifically when it was not possible to deliver the IIC from femoral approach. Therefore, the technical success following the “instructions for use (IFU)” where both IBE components were used (Gore Excluder iliac branch component and IIC) was achieved in 91.43% of implanted devices (96/105). In the additional nine iliac arteries, treatment was completed with a WL GORE^® VIABAHN^® Self-Expandable Endoprosthesis (Viabahn) or GORE^® VIABAHN^® VBX Balloon-Expandable Endoprosthesis (VBX) instead of IIC. The additional indications for choosing the use of an alternative covered stent for the hypogastric component were in four of these cases, IBEs were implanted in patients treated previously because of an aortic aneurysm with an endoprosthesis other than the GORE^® EXCLUDER^® AAA (GORE^® C3^®), so access from the arm was needed in this second intervention; other four implants were because of the IIC did not fit to the anatomical requirements: due to insufficient distance to perform bilateral IBE and/or short hypogastric length. In other case, we ran out of stock of internal components.

The sealing of the hypogastric artery was achieved distally via a covered stent extension in 19 sides, with seven cases using a self-expandable and two cases using the balloon-expandable covered stent BeGraft (Bentley^®, Hechingen, Germany) (Figure 2). There were 10 cases with sealing in gluteal branches, using Viabahn self-expandable or VBX. Contralateral hypogastric embolization was performed in one surgical step in 10 patients. This was planned in nine of these patients and due to intraoperative complication in one patient.

Within the GORE^® EXCLUDER^® Iliac Branch Endoprosthesis (GALIBER) registry, nine (8.57%) of the IBEs included the implantation of a covered stent instead of the internal component, without complications in the follow-up. There were no procedural deaths and no type I or type III intraoperative endoleaks observed within the dataset.

We have evaluated the economic implications of the intervention in one of the participating centers. Comparing cost, unilateral embolization is 7.5% cheaper than preservation with IBE in material-related cost (one-step procedure). But in cases of embolization, we must calculate the long-term cost since patients have potentially higher rate of complications and reinterventions. In bilateral cases, embolization is more complex and expensive than preservation (especially due to the recommendation to perform embolization in two surgical steps).

Follow-Up

A standardized follow-up for the procedure was used at each center for this study. Clinical follow-up and radiographic imaging (contrast enhanced computed tomography (CT) scan) was completed at approximately 1 month and thereafter annually, to include a contrast enhanced CT scan, with or without Doppler ultrasound and abdominal radiography. The follow-up obtained in this study was up to 5 years (range 55–1789 days), with a median follow-up of 734 days.

Patency

In the first follow-up CT scan (performed in the first month), the primary patency of the internal iliac artery was 98.1%, data that remained unchanged throughout the follow-up (Figure 3). All patients were free from new-onset buttock claudication (BC) in the IBE side, through the follow-up (range 55–1789 days). There were two occlusions of the external iliac artery in the first month follow-up scan.

Complications

During the follow-up (range 55–1789 days), five patients needed a reintervention (5/81, 6.2%), with two (2.5%) determined by the treating physicians to be related with the IBE (Figure 4).

The two occlusions of the external iliac artery were symptomatic. Both cases were at the beginning of the learning curve, in extremely tortuous external iliac arteries, so the thrombosis seems to be related with the IBE because of an inadequate sealing zone (despite the fact that in one case, intraoperative relining was performed with two self-expandable stents). One patient needed revascularization due to claudication at short distance and a femoral–femoral bypass was performed. The second patient presented long claudication at long distance and no revascularization was performed.

The other patient who required reintervention (IBE related) was the one in whom technical success was not achieved: Since the IBE device could not be correctly implanted due to an intraoperative technical mistake, it required embolization and femoral–femoral bypass, ending up in thrombosis during follow-up. Finally, reintervention for limb amputation was needed.

Contralateral hypogastric embolization occurred during the procedure in 10 cases. Among those 10 cases, complications were observed in three (30%). In one case, ischemic colitis was observed (left IIA embolization) prior to hospital discharge and solved with medical treatment without sequelae. The other two cases had functional limitations due to BC (due to right IIA embolization). Throughout the follow-up, the claudication distance improved slightly and did not resolve (one of this patients was the one who finally ended up on limb amputation).

Within the 1 year follow-up, one type Ia endoleak (GORE^® C3^® proximal bifurcated endograft) was observed and was found not to be related with the IBE. The patient was treated with a proximal cuff. There were 28 (34.5%) type II endoleaks observed in the first month follow-up CT scan. During the follow-up, in two cases, the type II endoleak disappears (26 (32%) type II endoleak over the time), and in two cases, it causes aortic sac enlargements that needed reintervention (inferior mesenteric artery embolization). No type III endoleaks, no aneurysm ruptures, and no device migrations were observed in the follow-up. The main outcomes are listed in Table 3.

Table 3.

Outcomes over follow-up period (55–1789 days).

Technical success	104 (105) – 99%
Percutaneous access	99 (105) – 94.28%
Type I endoleak	1 (81) – 1.2%
Type II endoleak
After first FU CT scan	28 (81) – 34.5%
Persistent endoleak over time	26 (81) – 32%
Aortic sac expansion	2 (28) – 7%
Type III endoleak	0
Primary patency of the internal iliac artery	103 (105) – 98.1%
Primary patency of external iliac artery	103 (105) – 98.1%
Hospitalization days (SD)	3.38 ± 5.9
Overall mortality	12 (81) – 14.8%
Aneurysmal related death	0

SD: standard deviation; CT: computed tomography.

Note: Categorical variables are presented as number (%). Continuous variables are presented as mean +/− standard deviation.

During the 5 year follow-up of this study, there were a total of 12 deaths (14.8%), with no aneurysm-related deaths observed. Within the 5 year follow-up, two cases presented with endoprosthetic infection. The infection was detected in one patient with a contrast enhanced CT scan 3 months after surgery (October 2014) and was successfully treated with antibiotherapy. The second patient was diagnosed with an infection 9 months after surgery, with a CT showing a prosthetic infection in addition to the transformation of chronic lymphoid leukemia to lymphoma. Due to comorbidities the patient was not a candidate for active lymphoma treatment and the patient died after 1 month of palliative treatment.

Discussion

This study represents one of the longest evaluating the IBE results for treating iliac and aortoiliac aneurysms by the endovascular technique. The medium-term follow-up and the great size of the sample show that this procedure with the GORE IBE is safe and effective. The use of this device has also shown a high technical success.

However, published literature focused on this issue^11–13 has shown good results in terms of freedom from reintervention and IIA patency with IBD; however, in our knowledge, the GALIBER registry represents the greatest in size using exclusively the GORE IBE, supporting its use in this setting.

Previous authors¹⁴ had shown promise with the IBE for CIA aneurysms but with a short-term follow-up. Recently, Schneider et al.¹⁵ published the results of IBE in the American study using this device under an investigational device exemption trial. They compared 99 implants in the United States with the results of the Gore Global Registry for Endovascular Aortic Treatment (GREAT registry) with 92 IBE, to investigate the performance of this specific endoprosthesis. It was reported excellent outcomes for iliac aneurysm exclusion up to 2 years of follow-up.

It should be noted that our GALIBER registry presents good results using the device in a larger sample size (105 implants). As previously mentioned, this work has not only a bigger number of IBE implants than in the most important published but a longer follow-up was carried out, reaching almost 5 years in the first treated cases.

Compared with the IBD device, the results are not inferior, so the literature support that both are a good options to treat this pathology, but we have to highlight the conformability of the IBE device in cases with high iliac tortuosity. In our study, the iliac tortuosity index was very high in the vast majority of patients: between 0 and 1 in the 83.3% (calculated in the cases performed in the first 2 years).¹⁰

Nowadays, it is considered mandatory to look for the long durability of an EVAR procedure with the lowest complication rate. It is advisable to try to find the best landing zone in order to decrease the risk of endoleak or graft migration. Bell-bottom technique, although apparently effective in the short term, has a questionable long-term durability, with type 1b endoleak rating between 3.4 and 7.8% and with a high rate of reinterventions.¹⁶ Provided that, sometimes, CIA does not allow a durable sealing in EVAR, it turns necessary to extend the landing zone into the external iliac artery, which implies preserving hypogastric vessels. Current ESVS guidelines recommend the use of IBE in anatomically suitable patients to maintain perfusion of at least one IIA.^7,8

Iliac branch devices have demonstrated better long-term outcomes than other preservation strategies for the IIA, even though when the patients treated with IBE did not meet IFU criteria.^17,18 Pearce et al.¹⁹ note the common reason for this exclusion is the internal iliac landing zone. In the GALIBER registry, when it was necessary to look for further distal sealing, a covered stent extension was used in 18% of vessels (19/105) with optimal results.

After comparing patients undergoing iliac branch device repair versus iliac exclusion at the same time of EVAR, Verzini et al.²⁰ demonstrated no difference in procedural outcomes such as contrast administration, operative time, technical success, external iliac limb occlusion, or reintervention.

Pelvic ischemia after occlusion of the IIA is not unfrequent and may lead to fatal intestinal consequences. BC can reach as high as 25.3% of cases with hypogastric occlusion, and although some of them improve in the long run, many may lead to a poorer functional capacity, walking ability, and quality of life compared with those with resolved BC or those who never had claudication.^21–23 In our study, it was found three hypogastric occlusions out of 10 IIA embolizations (30%), with limiting BC in two cases, and ischemic colitis in 1 (10%). There was no new-onset BC in the group of IBE, neither in those cases with occlusion of the IIC (2/105).

Concomitant hypogastric artery embolization with EVAR is associated with longer and more complicated hospital stays, increasing the risk of ischemic colitis and renal failure requiring dialysis.^24,25

The decision to preserve bilateral hypogastrics is also supported as there is a potential benefit with minimal extra fluoro rates and procedural time, when compared with a unilateral approach.⁸ In the current analysis of the GALIBER registry, it was observed in patients that the second iliac branch did not increase operative risk and there was no significative difference in patency or reintervention between uni- and bilateral treatment. Of the 81 patients, 24 (30%) were treated with bilateral IBE and showed positive results that were comparable to those treated unilaterally. A limitation in our study, as it is retrospective, is that we lack complete data record on the amount of contrast used and the operative time. We were able to make the comparison only in a small sample of bilateral cases, and we observed that the results were comparable between the cases of bilateral IBE implantation and those of one side embolization: with adequate technical skills, the use of contrast is insignificantly increased, as well as we did not observe an increase in the procedure time with IBE implantation versus embolization.

In economic terms, the results also promote bilateral preservation. We know the economic implications of only one of the centers, where it was possible to compare embolization versus IBE implantation. One side embolization is 7.5% cheaper than preservation in cost related to material (if we take into account the procedure, in only one step), but the impact of the potentially higher complication ratio or redo procedure for the embolization technique can make this even more expensive. In bilateral cases, embolization is more complex and expensive than preservation.

Regarding the infection graft cases, in our study, we observed this complication in a case with bilateral IBE and another one was one of the patients who needed reintervention. At the moment, there is not enough information in the literature about endoprosthetic infections in cases of iliac branch, so we could relate the use of more material in bilateral cases as the causal agent.

Despite the good results, this is a retrospective study, so more long-term studies are necessary (prospective, randomized), especially in a younger population with longer life expectancy.

Conclusions

Preservation of the internal iliac artery with the GORE^® EXCLUDER^® Iliac Branch Endoprosthesis^® can be performed safely with excellent technical success and promising medium-term patency rates, based on the results in the experience of five vascular centers, GALIBER registry. Device and vessel thrombotic events were limited and concentrated in the first 3 months after implantation. Promising results were observed even in complex anatomies where other devices usually have greater restrictions on use.

Footnotes

Acknowledgements

The authors would like to thank Dr Diego Caicedo Valdés, from Hospital Universitario de Santiago de Compostela, for providing his help in reviewing the manuscript.

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: Alba Méndez Fernández, Jorge Vidal Rey, Pablo Calvín Álvarez, Francisco Franco Meijide, and Rosa Villardefrancos Gil have no conflicts of interest. Jorge Fernández Noya and Nilo J Mosquera Arochena have been paid a consulting fee and fees for speaking by GORE COMPANY.

Funding

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

ORCID iD

Alba Méndez Fernández

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