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One Year Outcomes of an International Multicentre Prospective Cohort Study on the Gore Excluder Iliac Branch Endoprosthesis for Aorto-Iliac Aneurysms

Open AccessPublished:June 15, 2021DOI:https://doi.org/10.1016/j.ejvs.2021.04.006

      Objective

      The Gore Excluder Iliac Branch Endoprosthesis (IBE) was developed to preserve perfusion in the hypogastric artery after endovascular repair of aorto-iliac aneurysms. This study reports the 12 month technical and clinical outcomes of treatment with this device.

      Methods

      This study was a physician initiated international multicentre, prospective cohort study. The primary endpoint was primary patency of the hypogastric branch at 12 months. Secondary endpoints included technical and clinical outcomes. Patients with an indication for elective treatment with the Gore Excluder IBE were enrolled between March 2015 and August 2018. Baseline and procedural characteristics, imaging data, physical examinations and questionnaire data (Walking Impairment Questionnaire [WIQ], EuroQol-5-Dimensions [EQ5D], International Index of Erectile Function 5 [IIEF-5]) were collected through 12 month follow up.

      Results

      One hundred patients were enrolled of which 97% were male, with a median age of 70.0 years (interquartile range [IQR] 64.5 – 75.5 years). An abdominal aortic aneurysm (AAA) above threshold for treatment was found in 42.7% and in the remaining patients the iliac artery diameter was the indication for treatment. The maximum common iliac artery (CIA) diameter on the Gore Excluder IBE treated side was 35.5 mm (IQR 30.8 – 42.0) mm. Twenty-two patients received a bilateral and seven patients had an isolated IBE. Median procedural time was 151 minutes (IQR 117 – 193 minutes) with a median hospital stay of four days (IQR 3 – 5 days). Primary patency of the IBE at 12 month follow up was 91.3%. Primary patency for patients treated inside and outside the instructions for use were 91.8% and 85.7%, respectively (p = .059). Freedom from secondary interventions was 98% and 97% at 30 days and 12 months, respectively. CIA and AAA diameters decreased significantly through 12 months. IIEF-5 and EQ5D scores remained stable through follow up. Patency of the contralateral internal iliac artery led to better IIEF-5 outcomes. WIQ scores decreased at 30 days and returned to baseline values through 12 months.

      Conclusion

      Use of the Gore Excluder IBE for the treatment of aorto-iliac aneurysms shows a satisfactory primary patency through 12 months, with significant decrease of diameters, a low re-intervention rate, and favourable clinical outcomes.

      Keywords

      The IceBERG study has included 100 patients treated with the Gore Excluder Iliac Branch Endoprosthesis for aorto-iliac aneurysms. Besides a satisfactory primary patency of the hypogastric branch and successful aneurysm exclusion, clinical outcomes were studied. Occlusions of the hypogastric branch occurred mostly during the first month after treatment but are not related to either buttock claudication, erectile function, walking ability or health status. However, a concomitant contralateral hypogastric occlusion is related to more erectile dysfunction.

      Introduction

      Endovascular aortic repair (EVAR) has mostly replaced open surgical repair (OSR) for the treatment of abdominal aortic aneurysms (AAAs), related to its better short term mortality rate.
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      Endovascular aneurysm repair treatment of aortoiliac aneurysms: can iliac branched devices prevent gluteal claudication?.
      Buttock claudication and erectile dysfunction may result in a decreased quality of life.
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      Erectile dysfunction.
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      When the diameter of the CIA is limited to ≤ 24 – 25 mm and when there is an adequate seal length, bell bottom limbs can be used. These, however, have been related to an increased risk of late type Ib endoleak, increasing the re-intervention and complication rates.
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      EVAR with flared iliac limbs has a high risk of late type 1b endoleak.
      Iliac branched devices were developed to preserve the perfusion in the hypogastric artery, with the Cook Zenith Branch Iliac Endovascular Graft being the first receiving a CE mark in October 2006.
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      ,
      • Lin P.H.
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      • Vij A.
      Hypogastric artery preservation during endovascular aortic aneurysm repair: is it important?.
      In 2013, the Gore Excluder Iliac Branch Endoprosthesis (IBE; W. L. Gore and Associates, Flagstaff, AZ, USA) became available in Europe. It was designed to be used in combination with the Gore Excluder Endoprosthesis. Differences from the Zenith system include a smaller introducer system (20 F vs. 16 F) and the availability of a dedicated self expanding internal component. Early results of the Gore Excluder IBE showed a technical success of 93.5% – 95.2%, a re-intervention rate of 1.6% – 7.0% and a six month patency of 93.8% – 95.1%.
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      Prospective, multicenter study of endovascular repair of aortoiliac and iliac aneurysms using the Gore Iliac Branch Endoprosthesis.
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      Experience with the GORE EXCLUDER iliac branch endoprosthesis for common iliac artery aneurysms.
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      Outcomes of the GORE Iliac Branch Endoprosthesis in clinical trial and real-world registry settings.
      However, the use of the Gore Excluder IBE has not been studied previously in relation to clinical outcomes using validated scoring systems.
      The aim of the current study was to prospectively evaluate the midterm outcomes of the Gore Excluder IBE in patients with aorto-iliac aneurysms. Besides technical endpoints, like patency of the hypogastric side branch and successful aneurysm exclusion, clinical endpoints were studied, including the health status, walking capacity and erectile function.

      Materials and methods

      Study design

      The IceBERG study is a physician initiated, international, real world post-market, multicentre, prospective registry. Patients with an indication for elective treatment of a common iliac or aorto-iliac aneurysm using the Gore Excluder IBE were consecutive enrolled in eight hospitals in Europe and one in New Zealand between March 2015 and August 2018 and will be followed for five years.
      Inclusion criteria included an age of ≥ 18 years, written informed consent, clinical necessity for treatment (i.e., a CIA aneurysm of ≥ 35 mm), and eligible anatomy for implanting Gore Excluder IBE according to the treating physician. Exclusion criteria were inability to sign informed consent, participation in another clinical study, a life expectancy < 2 years, having a psychiatric or other condition that may interfere with the study, a known allergy to any device component, a systemic infection, coagulopathy or uncontrolled bleeding disorder, a ruptured, leaking, or mycotic aneurysm, a cerebrovascular accident (CVA) or myocardial infarction within the prior three months, pregnancy and other stents placed in the CIA of IIA than the Gore Excluder IBE.
      This study was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. Ethics approval was given according to the local regulations per hospital and country. Eligible patients who met the inclusion criteria and signed the informed consent were included. The study protocol was registered in clinicaltrials.gov (NCT02345005). The current analysis reports the 12 month outcomes of the IceBERG registry and complied with the STROBE guidelines for cohort studies.
      • von Elm E.
      • Altman D.G.
      • Egger M.
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      • Gøtzsche P.C.
      • Vandenbroucke J.P.
      The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.

      Procedure and follow up

      Device selection and implantation of the Gore Excluder IBE was performed according to standard institutional care. Patient sedation, vascular access and procedural techniques were handled at the discretion of the treating physician. Details of the procedure have been published previously.
      • van Sterkenburg S.M.
      • Heyligers J.M.
      • van Bladel M.
      • Verhagen H.J.
      • Eefting D.
      • van Sambeek M.R.
      • et al.
      Experience with the GORE EXCLUDER iliac branch endoprosthesis for common iliac artery aneurysms.
      Follow up was performed at 30 days ± two weeks, six months ± three months, and 12 months ± three months and yearly thereafter until five years after implantation and included imaging (Duplex Ultrasound, contrast enhanced computed tomography (CT) scan and/or magnetic resonance imaging), physical examination, registration of adverse events, and use of medication. In addition, the EuroQol Five Dimensions Health Questionnaire 3 level (EQ5D), the Walking Impairment Questionnaire (WIQ), and the International Index of Erectile Function (IIEF-5) were gathered at every follow up appointment. Data were captured in an online database with audit trail (“the Research Manager”, Deventer, The Netherlands). Participating sites were instructed for follow up visits. If a patient did not have a follow up visit, sites were asked to approach the patient and encouraged to perform follow up. At least three attempts were made to obtain follow up data after which follow up was registered as missing.

      Endpoints and definitions

      The primary endpoint of the study was primary hypogastric side branch patency at 12 months. Secondary endpoints included (1) technical endpoints; the presence of any type of endoleak, freedom from aneurysm sac expansion and rupture, device migration, device occlusion, conversion to open repair, secondary endovascular procedures; and (2) clinical endpoints: mortality, freedom from buttock claudication, freedom from erectile dysfunction, and freedom from bowel or spinal ischaemia.
      The endpoints were defined according to the reporting standards of the Society of Vascular Surgery.
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      • Verzini F.
      • Van Herzeele I.
      • Allaire E.
      • Bown M.
      • Cohnert T.
      • et al.
      Editor's Choice – European Society for Vascular Surgery (ESVS) 2019 clinical practice guidelines on the management of abdominal aorto-iliac artery aneurysms.
      According to the literature the IIEF-5 was divided into five categories: severe erectile dysfunction (score 1 – 7), moderate erectile dysfunction (score 8 – 11), mild to moderate erectile dysfunction (score 12 – 16), mild erectile dysfunction (score 17 – 21), and no erectile dysfunction (score 22 – 25).
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      • Vargas Souto C.A.
      The use of the simplified International Index of Erectile Function (IIEF-5) as a diagnostic tool to study the prevalence of erectile dysfunction.
      The WIQ measures the disease specific health status.
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      • Nicolaï S.P.
      • Kruidenier L.M.
      • Welten R.J.
      • Prins M.H.
      • Teijink J.A.
      Validation of the Dutch version of the Walking Impairment Questionnaire.
      WIQ scores were reported for both the categories (distance, speed and stairs) and the total score. The EQ5D is a generic measure of the health status and was reported as the percentage of patients having “no complaints”. Additionally, the health score was given as a score between 0 and 100, meaning “worst imaginable health state” and “best imaginable health state”, respectively.
      EuroQol--a new facility for the measurement of health-related quality of life.

      Statistical analysis

      A sample of 100 patients was selected to allow for a “real world” evaluation of device performance.
      Analyses were performed according to intention to treat. Normality was determined using the Shapiro–Wilk test. Continuous variables are presented as median and interquartile range (IQR). Categorical variables are presented as number and percentage. Log transformation and quadrate of the variables was applied if continuous variables were not normally distributed to determine if analysis of variance (ANOVA) for repeated measures could be used in case of non-normally distributed data. Since all these variables violated the assumption to perform ANOVA for repeated measures, the Wilcoxon Signed Rank test was used for paired samples and those variables were presented as mean and standard deviation. The Logrank test was used for anatomical instructions for use (IFU) analyses. Patency was analysed using Kaplan–Meier curves. Two sided p < .050 was considered to be statistically significant. In order to provide unbiased and informative findings, no replacement of missing values was planned for any parameters. In all applicable cases, reported analysis mention the number of missing values for each outcome relative to the considered analysis set (Intention to treat, effectiveness).
      All statistical analyses were performed using IBM SPSS Statistics version 25.0 for Windows (IBM Corporation, Armonk, NY, USA).

      Results

      One hundred patients were enrolled in the IceBERG registry. Patient and aneurysm characteristics are presented in Table 1, Table 2, respectively. Four patients were previously treated for AAA, of whom two were treated by EVAR and two others by OSR (one tube and one bifurcation prosthesis). Another patient had previously been treated by transthoracic EVAR (TEVAR) for a thoracic aortic aneurysm. Data of 99, 84, and 87 patients were available for the 30 day, six month, and 12 month analysis, respectively (Fig. 1). Some hospitals did not perform six month follow up visits because it is not standard in their hospitals, but did perform the 12 month follow up.
      Table 1Baseline characteristics of the 100 patients treated with the Gore Excluder Iliac Branch Endoprosthesis to study patency of hypogastric branch at 12 months
      CharacteristicsPatients (n = 100)
      Age – y69.57 ± 8.39
      Male gender97 (97.0)
      Body mass index – kg/m226.95 ± 4.05
      Systolic blood pressure – mmHg136.31 ± 16.54
      Diastolic blood pressure – mmHg79.61 ± 9.65
      Haemoglobin – mmol/L8.56 ± 1.01
      Creatinine – μmol/L95.07 ± 35.91
      Claudication15 (15.0)
       Buttock claudication6 (42.9)
       Thigh claudication6 (42.9)
       Calf claudication10 (66.7)
       Unlimited walking distance74 (74.0)
      Erectile dysfunction14 (14.0)
      Medical history
       Diabetes mellitus11 (11.0)
       Current smoking27 (27.3)
       Hypertension66 (66.0)
       Hyperlipidaemia60 (61.2)
       Cardiac disease27 (27.0)
       Renal impairment14 (14.0)
       Pulmonary disease26 (26.0)
       Single antiplatelet use55 (55.6)
       Double antiplatelet use7 (7.1)
       Anticoagulant therapy use14 (14.1)
       Statin use58 (59.2)
      Data are presented as n (%) or mean ± standard deviation.
      Table 2Anatomical characteristics at baseline in 100 patients treated with the Gore Excluder Iliac Branch Endoprosthesis (IBE)
      Aneurysm characteristicsPatients (n = 100)
      Max infrarenal aortic diameter – mm51.0 (42.0; 61.0)
      Infrarenal neck diameter – mm23 (21.0; 25.0)
      Infrarenal neck length – mm27 (18.0; 36.5)
      Aortic diameter above bifurcation – mm33 (28.0; 42.25)
      Proximal CIA diameter IBE treated side – mm20 (17.0; 28.0)
      Maximum CIA diameter IBE treated side – mm35.5 (30.75; 42.0)
      AAA diameter ≥30 mm75 (75.0)
      AAA with diameter above the threshold for treatment (≥55mm in men, ≥50mm in women)
      • Wanhainen A.
      • Verzini F.
      • Van Herzeele I.
      • Allaire E.
      • Bown M.
      • Cohnert T.
      • et al.
      Editor's Choice – European Society for Vascular Surgery (ESVS) 2019 clinical practice guidelines on the management of abdominal aorto-iliac artery aneurysms.
      32 (42.7)
      CIA aneurysm ≥35 mm65 (65.0)
       Left10 (10.0)
       Right40 (40.0)
       Bilateral15 (15.0)
      Data are presented as n (%) or median (interquartile range). AAA = abdominal aortic aneurysm, CIA = common iliac artery.
      Figure 1
      Figure 1Flowchart of inclusion of patients treated with the Gore Excluder Iliac Branch Endoprosthesis (IBE) to study hypogastric branch patency at 12 months. WIQ = Walking Impairment Questionnaire; EQ5D = EuroQol 5 Dimensions; IIEF-5 = International Index of Erectile Function 5.

      Procedure

      Procedural details are shown in Table 3. Procedure time and fluoroscopy time was significantly longer in bilateral procedures compared with single sided procedures (p < .001 and p = .002, respectively. In total, 14 patients were treated outside the IFU. According to the IFU the Gore Excluder IBE should be placed together with the Gore Excluder Endoprosthesis; however, seven were placed in isolation without the main endoprosthesis. The other seven patients were anatomically outside the requirements of the IFU; one patient was treated with a short length between the lowest renal artery and the IIA, three had a CIA diameter < 17 mm, two had an IIA diameter > 13.5 mm, and one had a short length on the IBE side.
      Table 3Procedural characteristics of 100 patients treated with the Gore Excluder Iliac Branch Endoprosthesis (IBE)
      Patients (n = 100)
      Anaesthesia
       General54 (54.5)
       Regional33 (33.3)
       Local10 (10.1)
       Local with general2 (2.0)
      Access
       Bilateral percutaneous48 (48.5)
       Bilateral cutdown47 (47.5)
       Ipsilateral cutdown3 (3.0)
       Contralateral cutdown1 (1.0)
      Treated outside anatomical requirements of the IFU7 (7.0)
      Implanted devices
       Gore Excluder IBE in combination with Gore Excluder Endoprosthesis92 (92.0)
       Only Gore Excluder Endoprosthesis
      Technical failure.
      1 (1.0)
       Bilateral Gore Excluder IBE in combination with Gore Excluder Endoprosthesis22 (22.2)
       Isolated Gore Excluder IBE7 (7.0)
      Contralateral hypogastric artery
       Patent and preserved60 (60.0)
       Embolised and overstented during procedure13 (13.0)
       Not patent before procedure5 (5.0)
      Landed in main branch IIA85 (85.9)
      Procedural time – min151 (117; 193)
      Used contract volume – mL130 (100; 180)
      Hospital stay – days4 (3; 5)
      Data are presented as n (%) or median (interquartile range). IIA = internal iliac artery; IFU = instructions for use.
      Technical failure.
      The primary and assisted primary technical success rates were 97% and 99%, respectively. On completion angiography there were 18 residual endoleaks of which two were type Ia, one was a type Ib, and 15 were type II endoleaks. One of the two type Ia endoleaks was successfully treated immediately by repeated ballooning and the other patient, treated with an isolated Gore Excluder IBE, was treated using a proximal cuff in the left CIA three months after the index procedure. The type Ib endoleak was observed on the contralateral side and successfully treated with additional balloon dilatation during the same session. Other procedural complications included thrombosis of the common femoral artery (n = 1), bleeding in the IIA treated by embolisation and overstenting (n = 1), failure of a closure device (n = 1), partial coverage of a renal artery (n = 1), and dislodgement of a bridging stent (n = 1). All of these complications were resolved during the procedure. The peri-operative endoleak and complication rate was 18% (n = 18 patients) and 5% (five patients), respectively.
      After the procedure 28.3% of patients were on double, 58.6% on single antiplatelet therapy and 15.2% on anticoagulant therapy.

      Complications and secondary endovascular procedures

      At 30 day follow up, there were no new onset type I or III endoleaks, and a type II endoleak was present in 18 patients. A lumbar and an inferior mesenteric artery (IMA) type II endoleak was seen in seven and eight patients, respectively. Three patients had a combined type II endoleak of the IMA and lumbar artery. One patient had a decline in renal function that fully recovered within one month. This patient had also a permanent weakness of the left leg after the procedure that might have been related to neural ischaemia. This patient was treated with a left sided Gore Excluder IBE in combination with an Excluder of which the hypogastric branch was occluded at 12 month follow up, but patent at earlier time points. There were no patients with colonic ischaemia. One patient had compression of the bridging EVAR stent in the distal aorta caused by competition of the contralateral leg and was treated with balloon angioplasty. Another patient suffered from a new onset type B aortic dissection 15 days after the procedure. The 30 day endoleak and complication rate was 18% (18 patients) and 4% (three patients). There were no 30 day deaths.
      At 12 months, there were no new type I endoleaks. A persistent type II endoleak was present in 15 patients. All patients with a type II endoleak were treated with both a Gore Excluder IBE and Gore Excluder Endoprosthesis. Median aortic aneurysm diameters were 48.0 (IQR 31.5 – 53.5) and 26.5 (IQR 30.0 – 54.0) for baseline and 12 months, respectively, p = .51. Median CIA aneurysm diameters were 35.0 (IQR 33.0 – 42.5) and 30.5 (IQR 27.0 – 40.0) for baseline and 12 months, respectively, p = .14. One patient developed a type III endoleak three months after the procedure and was treated with an iliac extension between the main body and bridging stent. The patient that was treated with a TEVAR before the procedure, suffered from a thoracic rupture at 32 days, treated endovascularly, and developed permanent renal impairment, requiring dialysis, because of occlusion of the left renal endograft. A suspected endograft infection, five months after the procedure, was successfully treated with long term antibiotics and aneurysm sac drainage. The six and 12 month endoleak rate was 18% (18 patients) and 15% (15 patients). The six and 12 month complication rate was 3% (two patients) and 0%, respectively. There were no conversions to open repair through 12 month follow up. The freedom from secondary interventions was 98% and 97% at 30 days and 12 months, respectively.
      At six and 12 month follow up 23.8% and 14.9% of patients were on double antiplatelet therapy, 59.5% and 69.0% on single antiplatelet therapy, and 14.3% and 17.2% on anticoagulant therapy, respectively.
      Two patients died through the 12 month follow up. The cause of death was unknown for one patient and the other died of respiratory insufficiency. The one year freedom from all cause mortality and freedom from AAA related mortality were 94.7% and 100%, respectively.

      Patency

      The primary patency of the IIA 12 months after the procedure was 91.3% (Fig. 2). The primary patency for patients inside and outside the anatomical requirements of the IFU was 91.8% and 85.7%, respectively, p = .059. Overall, there were nine occlusions and all of them were left untreated, rendering the secondary patency equal to the primary. Seven occlusions occurred within the 30 day follow up. Three of these patients had no complaints at 12 month follow up, and one patient had new bilateral buttock claudication at 12 months. At 12 month follow up another patient had ipsilateral buttock claudication and a worsened score on the IIEF-5 questionnaire, and two patients had a worsened score on the IIEF-5 questionnaire only. Since these symptoms and scores did not affect the patients’ lives all were left untreated. There were two new occlusions at 12 month follow up, both without clinical symptoms. The causes of the first seven occlusions occurring within 30 days were unknown in two patients. Probable causes of occlusion in the other patients included: kinking of the hypogastric artery in two patients, a moderate outflow in one patient, compression of the iliac component due to a stenosis of the origin of the IIA in one patient, and the last patient did not take his antiplatelet therapy. Two occlusions occurred between 30 days and 12 months and one was probably related to a clot above the IIA and the other cause was unknown.
      Figure 2
      Figure 2Cumulative Kaplan–Meier estimate of the primary patency of hypogastric component of the Gore Excluder Iliac Branch Endoprosthesis (IBE) device overall, when used according to the instructions for use (IFU), or outside the anatomical requirements of IFU.

      Aneurysm diameters

      Figure 3A shows the change in the maximum aneurysm diameter of the CIA at every follow up point, demonstrating a significant decrease of the CIA diameter of 4.5 mm (IQR −8.0 – −1.0 mm) through 12 months. Also, the diameter of the infrarenal aorta significantly decreased with 2.0 mm (IQR −8.75 – −2.0 mm) for those with an AAA at baseline (Fig. 3B) through 12 months.
      Figure 3
      Figure 3Change in mean diameters during follow up of the (A) iliac branch endoprosthesis (IBE) treated common iliac artery (CIA), and (B) infrarenal aorta of patients with an aneurysmal infrarenal aorta before implant of the IBE device. ∗p < .001 between baseline and one year. Dashed lines indicate standard deviation.

      Clinical endpoints

      Before the procedure 15 patients already suffered from intermittent claudication (buttock n = 6, thigh n = 6, calf n = 10). At 30 day follow up there was one patient with new onset buttock claudication, not related to failure of the Gore Excluder IBE or the procedure. Furthermore, at 30 day follow up, the WIQ score for distance and the total WIQ score were significantly inferior compared with baseline (p = .041 and p = .037, respectively) (Fig. 4A). The WIQ total score thereafter returned towards baseline level (p = .043). After correction for patients with a pre-existing impaired walking ability all significant differences disappeared. At 12 month follow up there were two patients with new onset contralateral buttock claudication, both unrelated to Gore Excluder IBE failure. No patients who developed a hypogastric occlusion suffered from ipsilateral intermittent claudication.
      Figure 4
      Figure 4Clinical outcomes after treatment with the iliac branch endoprosthesis demonstrated in boxplots with median and interquartile range of the (A) Walking Impairment Questionnaire (WIQ) total score, (B) International Index of Erectile Function (IIEF-5) score, (C) the EuroQol Five Dimensions Health Questionnaire (EQ5D) health score, and as (D) percentages of the persons that report no problems in the EQ5D.
      Table 4 describes the outcomes of the WIQ total score, EQ5D score and IIEF-5 score at baseline and 12 months for those with an occlusion of the hypogastric branch at 12 months. There was no significant impact of the procedure on the erectile function in males through 12 month follow up, as measured by the IIEF-5 scores (Fig. 4B). A contralateral occlusion of the IIA at baseline had a significant negative impact on the erectile function at baseline, 30 days, six and 12 months (p = .004, p = .036, p = .049, and p = .047, respectively). There were no significant changes in the EQ5D scores after the procedure and through 12 months follow up (Fig. 4C,D).
      Table 4Questionnaire outcomes on patency of the Gore Excluder Iliac Branch Endoprosthesis (IBE) in 100 patients
      Patent IBE at 12 monthsNon-patent IBE at 12 months
      Median (IQR)nMedian (IQR)np
      Baseline
       WIQ total score72.9 (41.3; 95.4)8078.0 (75.5; 94.2)9.65
       EQ5D score80.0 (62.5; 85.0)8468.5 (63.0; 85.0)8.21
       IIEF-5 score12.5 (3.5; 20.5)8011.5 (1.0; 18.5)8.89
      12 months
       WIQ total score84.2 (46.8; 100.0)5568.2 (43.1; 93.3)6.47
       EQ5D score80.0 (70.0; 90.0)6370.0 (70.0; 80.0)6.55
       IIEF-5 score12.0 (1.0; 20.0)6213.0 (2.0; 16.0)5.47
      IQR = interquartile range; WIQ = Walking Impairment Questionnaire; EQ5D = EuroQol 5 Dimensions; IIEF-5 = International Index of Erectile Function 5.

      Discussion

      The current study shows that the use of the Gore Excluder IBE for the treatment of aorto-iliac aneurysms is associated with satisfactory primary patency through 12 month follow up, with a significant decrease in aneurysm diameters, a low re-intervention rate, and favourable clinical outcomes. The primary patency of the hypogastric component at 12 months was the primary endpoint of this study; being 91.3%, the data are in line with previous studies. Van Sterkenburg et al.
      • van Sterkenburg S.M.
      • Heyligers J.M.
      • van Bladel M.
      • Verhagen H.J.
      • Eefting D.
      • van Sambeek M.R.
      • et al.
      Experience with the GORE EXCLUDER iliac branch endoprosthesis for common iliac artery aneurysms.
      and Schneider et al.
      • Schneider D.B.
      • Matsumura J.S.
      • Lee J.T.
      • Peterson B.G.
      • Chaer R.A.
      • Oderich G.S.
      Prospective, multicenter study of endovascular repair of aortoiliac and iliac aneurysms using the Gore Iliac Branch Endoprosthesis.
      reported a primary patency rate at six months of 93.8% and 95.1%, respectively, using the Gore Excluder IBE. Other studies, including alternative devices also reported similar patency rates.
      • Schneider D.B.
      • Milner R.
      • Heyligers J.M.M.
      • Chakfe N.
      • Matsumura J.
      Outcomes of the GORE Iliac Branch Endoprosthesis in clinical trial and real-world registry settings.
      ,
      • Donas K.P.
      • Inchingolo M.
      • Cao P.
      • Pratesi C.
      • Pratesi G.
      • Torsello G.
      • et al.
      Secondary procedures following iliac branch device treatment of aneurysms involving the iliac bifurcation: the pELVIS Registry.
      ,
      • Simonte G.
      • Parlani G.
      • Farchioni L.
      • Isernia G.
      • Cieri E.
      • Lenti M.
      • et al.
      lesson learned with the use of iliac branch devices: single centre 10 year experience in 157 consecutive procedures.
      Differences in primary patency rates between patients treated within or outside IFU are not known to have been reported before. But these differences might stress the need to treat patients inside the IFU as much as possible.
      A comparison of the current results with those described for other devices should be performed with care. When compared with the Zenith Iliac Branch device (Cook), the currently studied device should be considered as a next generation device, as is reflected by the smaller profile (20 Fr vs. 16 Fr, respectively) and the design of a dedicated internal component on the same platform as the main body. A limitation of the Gore IBE device is the required minimum CIA diameter of 17 mm at the proximal implantation zone to host the 23 mm proximal part, which is not a requirement for the Zenith Iliac Branch device that has a much smaller proximal diameter of 12 mm. In comparison, another relatively new iliac branch device, the E-Iliac device (Jotec, Hechingen, Germany), requires a diameter of the CIA in the proximal landing area between 12 and 17 mm. The recently published late outcomes of the pELVIS registry, focusing on the Zenith Iliac Branch device, described a side branch patency of 97.9% and 95.1% at one and five years, respectively, without observed differences between self expanding and balloon expandable internal components. The freedom from re-intervention and conversion was 90.4% and 71.0% one and five years.
      • Verzini F.
      • Parlani G.
      • Varetto G.
      • Gibello L.
      • Boero M.
      • Torsello G.F.
      • et al.
      Late outcomes of different hypogastric stent grafts in aortoiliac endografting with iliac branch device: results from the pELVIS Registry.
      A recently published meta-analysis included 1502 patients that were treated with six different devices. In that study the 30 day patency of IBDs was 97.6%, whereas patency through follow up was 94.3%. The re-intervention rate associated with IBDs was 7.0%.
      • Giosdekos A.
      • Antonopoulos C.N.
      • Sfyroeras G.S.
      • Moulakakis K.G.
      • Tsilimparis N.
      • Kakisis J.D.
      • et al.
      The use of iliac branch devices for preservation of flow in internal iliac artery during endovascular aortic aneurysm repair.
      These data are in line with the results, although both the re-intervention rate (3.0%) and the one year patency (91.3%) appears to be at the lower end of the spectrum, when compared with these studies.
      In the current study most occlusions of the hypogastric branch occurred during the first month after treatment. This suggests that occlusions are more likely to be related to either anatomical issues (i.e., technical failures) or to the coagulation system, rather than the development of a stenosis at the edges of the endograft. In the current study 28.3% of patients were treated with a double antiplatelet regimen 30 days after the procedure. The remaining patients were on either single antiplatelet or anticoagulant therapy. After the procedure 66.7% of patients used statins. The current guidelines advocate the use of both antiplatelet therapy and statins in all patients with an abdominal aorto-iliac aneurysm.
      • Wanhainen A.
      • Verzini F.
      • Van Herzeele I.
      • Allaire E.
      • Bown M.
      • Cohnert T.
      • et al.
      Editor's Choice – European Society for Vascular Surgery (ESVS) 2019 clinical practice guidelines on the management of abdominal aorto-iliac artery aneurysms.
      Whether a standardised double antiplatelet regimen after treatment would improve patency results remains to be investigated. In addition, tortuosity and conformability of an EVAR device have been suggested as predictors of iliac limb failure.
      • Taudorf M.
      • Jensen L.P.
      • Vogt K.C.
      • Grønvall J.
      • Schroeder T.V.
      • Lönn L.
      Endograft limb occlusion in EVAR: iliac tortuosity quantified by three different indices on the basis of preoperative CTA.
      ,
      • Coulston J.
      • Baigent A.
      • Selvachandran H.
      • Jones S.
      • Torella F.
      • Fisher R.
      The impact of endovascular aneurysm repair on aortoiliac tortuosity and its use as a predictor of iliac limb complications.
      In a retrospective study on static CT scans Della Schiava et al. showed a better conformability device used here compared with the Cook device.
      • Della Schiava N.
      • Arsicot M.
      • Boudjelit T.
      • Feugier P.
      • Lermusiaux P.
      • Millon A.
      Conformability of GORE Excluder Iliac Branch Endoprosthesis and COOK Zenith bifurcated iliac side branched iliac stent grafts.
      This, however, has not led to a better patency in the cohort, when compared with the existing literature.
      The CIA and AAA diameters significantly decreased through 12 month follow up, indicating adequate exclusion of the aneurysm(s). A recent study showed that failure of an AAA to shrink after EVAR may be associated with higher long term mortality.
      • O'Donnell T.F.X.
      • Deery S.E.
      • Boitano L.T.
      • Siracuse J.J.
      • Schermerhorn M.L.
      • Scali S.T.
      • et al.
      Aneurysm sac failure to regress after endovascular aneurysm repair is associated with lower long-term survival.
      ,
      • Deery S.E.
      • Ergul E.A.
      • Schermerhorn M.L.
      • Siracuse J.J.
      • Schanzer A.
      • Goodney P.P.
      • et al.
      Aneurysm sac expansion is independently associated with late mortality in patients treated with endovascular aneurysm repair.
      Therefore, the current results may be considered as favourable, also in relation to the low re-intervention rate. Other studies have also observed a significant shrinkage of CIA diameters after treatment with a Gore Excluder IBE
      • Schneider D.B.
      • Matsumura J.S.
      • Lee J.T.
      • Peterson B.G.
      • Chaer R.A.
      • Oderich G.S.
      Prospective, multicenter study of endovascular repair of aortoiliac and iliac aneurysms using the Gore Iliac Branch Endoprosthesis.
      • van Sterkenburg S.M.
      • Heyligers J.M.
      • van Bladel M.
      • Verhagen H.J.
      • Eefting D.
      • van Sambeek M.R.
      • et al.
      Experience with the GORE EXCLUDER iliac branch endoprosthesis for common iliac artery aneurysms.
      • Schneider D.B.
      • Milner R.
      • Heyligers J.M.M.
      • Chakfe N.
      • Matsumura J.
      Outcomes of the GORE Iliac Branch Endoprosthesis in clinical trial and real-world registry settings.
      at six month follow up.
      In the current study there were no conversions to open repair, and no AAA related mortality. Schneider et al.
      • Schneider D.B.
      • Matsumura J.S.
      • Lee J.T.
      • Peterson B.G.
      • Chaer R.A.
      • Oderich G.S.
      Prospective, multicenter study of endovascular repair of aortoiliac and iliac aneurysms using the Gore Iliac Branch Endoprosthesis.
      reported no major adverse events (death, stroke, myocardial infarction, bowel ischaemia, paraplegia, respiratory failure, renal failure, or conversion to open surgical repair) at 30 days, and nine patients (14.3%) suffered from serious adverse events, the majority of complications being urinary tract infection. In the current study most short term events were vascular or procedure related. The 30 day and 12 month mortality of the current study is similar to other studies.
      • Schneider D.B.
      • Matsumura J.S.
      • Lee J.T.
      • Peterson B.G.
      • Chaer R.A.
      • Oderich G.S.
      Prospective, multicenter study of endovascular repair of aortoiliac and iliac aneurysms using the Gore Iliac Branch Endoprosthesis.
      • van Sterkenburg S.M.
      • Heyligers J.M.
      • van Bladel M.
      • Verhagen H.J.
      • Eefting D.
      • van Sambeek M.R.
      • et al.
      Experience with the GORE EXCLUDER iliac branch endoprosthesis for common iliac artery aneurysms.
      • Schneider D.B.
      • Milner R.
      • Heyligers J.M.M.
      • Chakfe N.
      • Matsumura J.
      Outcomes of the GORE Iliac Branch Endoprosthesis in clinical trial and real-world registry settings.
      While intentional overstenting of the IIA was a conventional treatment for an iliac artery aneurysm, it is now preferred to preserve at least one IIA.
      • Wanhainen A.
      • Verzini F.
      • Van Herzeele I.
      • Allaire E.
      • Bown M.
      • Cohnert T.
      • et al.
      Editor's Choice – European Society for Vascular Surgery (ESVS) 2019 clinical practice guidelines on the management of abdominal aorto-iliac artery aneurysms.
      ,
      • Chaikof E.L.
      • Dalman R.L.
      • Eskandari M.K.
      • Jackson B.M.
      • Lee W.A.
      • Mansour M.A.
      • et al.
      The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm.
      This may lead to a lower incidence of buttock claudication and erectile dysfunction.
      • Lin P.H.
      • Chen A.Y.
      • Vij A.
      Hypogastric artery preservation during endovascular aortic aneurysm repair: is it important?.
      ,
      • Schneider D.B.
      • Matsumura J.S.
      • Lee J.T.
      • Peterson B.G.
      • Chaer R.A.
      • Oderich G.S.
      Prospective, multicenter study of endovascular repair of aortoiliac and iliac aneurysms using the Gore Iliac Branch Endoprosthesis.
      ,
      • Saengprakai W.
      • van Herwaarden J.A.
      • Georgiadis G.S.
      • Slisatkorn W.
      • Moll F.L.
      Clinical outcomes of hypogastric artery occlusion for endovascular aortic aneurysm repair.
      At 12 months the WIQ and EQ5D scores were in line with those before the procedure. The total WIQ score at 30 days, however, was inferior to baseline. No relationship with the type of vascular access in the groin was observed, but other comorbidities might play a role. Thereafter, the walking capacity fully normalised. In the current study the IIEF-5 scores were stable during the first year after treatment, but a contralateral hypogastric occlusion was related to more erectile dysfunction. This might suggest that, within this perspective, bilateral preservation could be the preferred strategy. Previously, Maldonado et al. demonstrated that the use of bilateral Gore Excluder IBEs is safe with excellent technical success, short term patency, and rarely occlusions.
      • Maldonado T.S.
      • Mosquera N.J.
      • Lin P.
      • Bellosta R.
      • Barfield M.
      • Moussa A.
      • et al.
      Gore Iliac Branch Endoprosthesis for treatment of bilateral common iliac artery aneurysms.
      However, erectile function was not an endpoint in that study. In the current study, 22 patients were treated bilaterally and both procedural and fluoroscopy time were longer in these patients, with a similar post-operative hospital stay. Also, bilaterally treated patients showed a significantly better outcome on IIEF-5 scores at 12 month follow up, compared with unilaterally treated patients. In addition, healthcare costs may also be an important factor here.
      The study is limited by its non-randomised design, assessing the institutional standard of care. Therefore, a comparison with alternative devices, strategies and the decision making process between the different treatment modalities was not available and might be difficult as the populations might not be similar. Another limitation of the study might be that the selection of patients for endovascular repair could have been different between the various sites since local standard of care was being followed. This information was not gathered during this study and may have influenced the results of the procedure. This study approached a difference between patients treated within or outside the anatomical requirements of the IFU. The inclusion of patients treated outside the anatomical requirements of the IFU may induce a negative selection bias. The IFU analysis was done with a relatively small subgroup of patients treated outside the anatomical requirements of the IFU (7/100) and this effect should be confirmed in larger studies, although use outside the IFU is not recommended. Moreover, the use of solitary IBE is not within the IFU of the device. When these are considered outside the IFU as well, there was also no difference between the groups. However, the strength of this study is that clinical outcomes were studied which gives a more total and detailed view of this patient group.
      In conclusion, the use of the Gore Excluder IBE demonstrates satisfactory primary patency of the hypogastric component through 12 month follow up. Treatment is related to a significant decrease in diameters, a low re-intervention rate, and favourable clinical outcomes, as reported in the EQ5D, WIQ and IIEF-5 questionnaires. In addition, contralateral patency leads to better outcomes on the IIEF-5 questionnaire for erectile function.

      Conflict of interest

      None.

      Funding

      This work was supported by an unrestricted grant from W.L. Gore and associates.

      Appendix.

      The IceBERG study collaboration
      Department of Surgery, Rijnstate: Daphne van der Veen; Suzanne Holewijn; Steven M.M. van Sterkenburg; Jan-Willem H.P. Lardenoije; Luuk Smeets; Michel M.P.J. Reijnen. Vascular Surgery, Poliambulanza Foundation Hospital: Raffaello Bellosta; Luca Attisani; Luca Luzzani. Vascular Surgery: Elisabeth Tweesteden Ziekenhuis; Jan M.M. Heyligers; Koen van Hees. Vascular Surgery, Cardarelli Hospital: Ilaria Ficarelli; Carlo Ruotolo. Department of Angiology and Vascular Surgery, Doctor Peset University Hospital: Francisco J. Gómez Palonés; Vicente A. Sala Almonacil; Vascular Surgery, San Filippo Neri Hospital: Nicola Mangialardi; Sonia Ronchey; Matteo Orrico. Department of Angiology and Vascular Surgery, Complexo Hospitelario Universitario de Ourense: Nilo J. Mosquera; Rosa Villardefrancos. Department of Interventional Radiology, Auckland City Hospital: Andrew Holden.

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      Linked Article

      • Should Bilateral Iliac Branch Devices Become the Standard of Care for Aorto-iliac Aneurysm Repair?
        European Journal of Vascular and Endovascular SurgeryVol. 62Issue 2
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          Endovascular techniques for aortic aneurysms involving the iliac artery have evolved during the last decades from routine embolisation of the internal iliac artery (IIA) to preservation of the IIA, with iliac branch devices having become the first line treatment option whenever anatomically feasible.1,2 Although clinical studies and systematic reviews have shown excellent technical success, with extremely low morbidity and mortality rates in the peri-operative period, satisfactory device integrity, and target vessel patency in the midterm, there is a scarcity of data related to the long term clinical benefits of IIA patency.
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