GORE EXCLUDER Iliac Branch Endoprosthesis Research Articles

Mid-Term Outcomes of the Iliac Branch Endoprosthesis with Standardized Combinations of Bridging Stent-Grafts for Endovascular Treatment of Aortoiliac Disease with or Without Co-existing Hypogastric Aneurysms (The HYPROTECT Study).

To evaluate retrospectively the 2-year outcomes of the Gore Excluder Iliac Branch Endoprosthesis (IBE) in patients with and without coexisting hypogastric artery (HA) aneurysms in a large contemporary multicentric European experience using dedicated bridging devices. The study included all consecutive patients treated at participating institutions with the Gore Excluder IBE device who received a covered stent (i.e., stent-graft) from the same manufacturer. Technical success was defined as deployment of endografts with complete exclusion of the aneurysm(s), patency of target vessels, and absence of type 1 and 3 endoleak. Assessment of follow-up outcomes included freedom from HA branch instability defined as the composite cumulative endpoint of any HA branch-related complication. A total of 437 patients were included for analysis from 22 European vascular surgery centers. Patients were categorized into two subgroups: subgroup A (n = 269) if they did not have concomitant hypogastric aneurysms, otherwise they were categorized into subgroup B (n = 168). Finally, 78 (18%) had bilateral IBE with a total of 515 IBE included in the study. Balloon expandable stents were deployed in 19 (6.3%) subgroup A patients compared with 46 (21.7%,) in subgroup B, p < .001. The two-year estimate for freedom of HA branch instability was significantly higher for patients in group A as compared with patients in group B (94% vs. 90%, p = .045). At univariate regression, the number of stent-grafts used was associated with higher risk of iliac branch instability (p = .021), while in multivariate regression for the use of more than 2 bridging stent-grafts the risk of instability increased by 2.35 times. This large contemporary European multicentric experience with the use of the Gore Excluder IBE in patients with or without associated HA aneurysms shows satisfactory mid-term outcomes when the device is used in conjunction with both self-expandable and balloon-expanding stent-grafts from the same manufacturer. Although primary patency of the iliac branch was as high as 90%, caution and strict follow-up must be exercised when multiple bridging stent-grafts are used over longer distances.

Technical feasibility and device stability of the Gore Excluder iliac branch endoprosthesis as abdominal aortic bifurcated device

The aim is to describe the technical feasibility, early outcomes, and graft stability of the Excluder iliac branch endoprosthesis (W.L. Gore & Associates) used as an infrarenal abdominal bifurcated endograft in cases unsuitable for standard endovascular aortic repair. The technique was used in 13 cases with abdominal and/or iliac aneurysms (n = 6), occlusive disease (n = 3), or complex aneurysms in association with a proximal fenestrated/branched endograft (n = 4). Technical success was 100%, and there were no adverse events, with 100% graft stability at 3 months. This case series demonstrates, in extremely selected cases, the feasibility and safety of Excluder iliac branch endoprosthesis used as an infrarenal aortic bifurcated device.

Off-label use of the Gore Excluder iliac branch endoprosthesis in association with the Rotarex S catheter to achieve total endovascular recanalization of an occluded aortobifemoral bypass

We describe a successful case of hybrid revascularization of a totally occluded aortobifemoral bypass with retrograde use of the Rotarex S catheter (BD) and complete relining with a Gore Excluder iliac branch endoprosthesis (W.L. Gore & Associates). The repair procedure was performed with femoral surgical access and percutaneous brachial access. Despite left renal artery endoclamping, after the final angiography, deployment of a covered stent in the left renal artery was needed because of residual thrombotic material at the vessel ostium. The procedure was completed with reconstruction using a common femoral artery Dacron graft and bilateral complete iliac surgical branch relining using self-expanding covered stents, with recovery of distal pulses.

Outcomes of the Gore Excluder Iliac Branch Endoprosthesis for Japanese Patients With Aortoiliac Aneurysms: A Study Based on J-Preserve Registry

Purpose: To evaluate the clinical utility of the Gore Excluder iliac branch endoprosthesis (IBE) for Japanese patients with aortoiliac aneurysms. Materials and Methods: This was a multicenter retrospective cohort study (J-Preserve Registry). Patients undergoing endovascular aortic repair using the Gore Excluder IBE for aortoiliac aneurysms between August 2017 and June 2020 were enrolled. Data pertaining to the baseline and anatomical characteristics, technical details, and clinical outcomes were collected from each institution. The primary endpoints were technical success, IBE-related complications, and reinterventions. Secondary endpoints were mortality, aneurysm size change, and reintervention during follow-up. Technical success was defined as accurate deployment of the IBE without type Ib, Ic, or III endoleaks on the IBE sides on completion angiography. A change in aneurysm size of 5 mm or more was taken to be a significant change. Results: We included 141 patients with 151 IBE implantations. Sixty-five IBE implantations (43.0%) had at least one instruction for use violation. Twenty-two patients (15.6%) required internal iliac artery (IIA) embolization for external iliac artery extension on the contralateral side. Of 151 IBE implantations, 19 exhibited IIA branch landing zones due to IIA aneurysms. Mean maximum and proximal common iliac artery (CIA) diameters were 32.9±9.9 mm and 20.5±6.9 mm, respectively. The mean CIA length was 59.1±17.1 mm. The IIA landing diameter and length were 9.0±2.3 mm and 33.8±14.6 mm. The overall technical success rate was 96.7%. There were no significant differences in IBE-related complications (2.3% vs 5.3%, p=0.86) or IBE-related reinterventions (1.5% vs 5.3%, p=0.33) between the IIA trunk and IIA branch landing groups. The mean follow-up period was 635±341 days. The all-cause mortality rate was 5.0%. There were no aneurysm-related deaths or ruptures during the follow-up. Most patients (95.7%) had sac stability or shrinkage. Conclusion: The Gore Excluder IBE was safe and effective for Japanese patients in the midterm. Extending the IIA device into the distal branches of the IIA was acceptable, which may permit extending indications for endovascular aortic aneurysm repair of aortoiliac aneurysms to more complex lesions. Clinical Impact This study suggests clinical benefits of the Gore Excluder IBE for Japanese patients, despite 43% of the IBE implantations having at least one IFU violation.

Use of real-world data and clinical registries to identify new uses of existing vascular endografts: combined use of GORE EXCLUDER Iliac Branch Endoprosthesis and GORE VIABAHN VBX Balloon Expandable Endoprosthesis

ObjectiveTo assess the feasibility of collecting, examining and reporting observational, real-world evidence regarding the novel use of the GORE EXCLUDER Iliac Branch Endoprosthesis (IBE) in conjunction with the GORE VIABAHN...

Outcomes of Unilateral Versus Bilateral Use of the Iliac Branch Endoprosthesis for Elective Endovascular Treatment of Aorto-iliac Aneurysms.

The aim of the study was to evaluate outcomes after bilateral implantation of the Gore Excluder Iliac Branch Endoprosthesis (IBE) versus those achieved after unilateral implantation. All consecutive patients electively treated in a single center for aorto-iliac aneurysm using the IBE device between January 1, 2014, and December 31, 2018, were reviewed. Early outcome measures were technical success, 30days or in-hospital mortality, and major adverse events (MAE). Late outcome measures were survival, internal iliac artery (IIA) patency, and freedom from IIA branch instability. A total of 74 patients (97% males, mean age 74 ± 7years) were included. Thirteen patients (17%) received bilateral IBE implantation for a total of 85 vessels evaluated. The technical success rate was 97% and was not significantly different between the two groups (p = .32). Two patients died within 30days, both in the unilateral group (p = 1). No significant differences were seen in the rates of 30days MAE (p = .10). At one year, the overall survival rate was 95 ± 2% vs 90 ± 3% in the unilateral and bilateral group, respectively (Log-rank = .05). There were no differences in 1-year primary and secondary patency rates between groups (Log-rank = .75 and Log-rank = .34, respectively). Freedom from IIA branch instability at one year was also not significantly different (unilateral: 94 ± 3% vs. bilateral: 82 ± 9%, Log-rank = .22).. Bilateral IBE use for elective endovascular treatment of aorto-iliac aneurysms appears safe and feasible and may achieve satisfactory short-term and mid-term outcomes. Bilateral IBE use should be employed judiciously in the context of a comprehensive risk/benefit evaluation.

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

Stent graft repair for aortic and iliac artery aneurysms has largely replaced open surgery, and modifications in the design that preserve flow to the pelvis with the Gore Excluder (W.L. Gore & Associates, Flagstaff, AZ) iliac branch endoprosthesis (IBE) device has led to improved outcomes. The IBE was developed for use in combination with a self-expanding stent graft for the internal iliac component (SE-IIC). Balloon-expandable stent grafts are an alternative for the internal iliac component (BE-IIC), offering advantages in sizing, device tracking, precision, and lower profile delivery.

Prevention of Buttock Claudication by Preserving Antegrade Bilateral Superior Gluteal Arterial Blood Flow in EVAR for Aorto-Iliac Aneurysm Accompanied by Bilateral Internal Iliac Artery Aneurysms.

Buttock claudication (BC) is a complication of surgery for aorto-iliac aneurysms (AIAs) caused by sacrificing blood flow in the internal iliac artery (IIA). However, the preservation of antegrade blood flow of IIAs is often challenging when performing both open surgery and endovascular aneurysm repair (EVAR) for AIAs accompanied by IIA aneurysms. We performed EVAR and successfully preserved the antegrade blood flow of bilateral superior gluteal arteries using the GORE EXCLUDER iliac branch endoprosthesis with the VIABAHN endograft. BC did not occur, both subjectively and objectively, after surgery. This approach can be minimally invasive yet an effective procedure to prevent BC.

Comparison Study of Iliac Branch Endoprosthesis when Used on and off Label

The aim of this study is to compare how instructions for use (IFU) affected perioperative and intermediate term outcomes for common iliac artery aneurysms (CIAA) treated with the Gore Excluder iliac branch endoprosthesis (IBE). A retrospective analysis was performed of all patients treated at two affiliated academic centers from September 2016 to May 2020. Outcomes were compared between IFU and nonIFU IBE cases. Criteria for nonIFU included: (1) use with a nonGore aortic endoprosthesis (n = 10), (2) isolated IBE (n = 3), and (3) requiring nondedicated covered stents for additional extension into a more suitable landing zone in the ipsilateral internal iliac artery or one of its branches (n = 11). Perioperative and intermediate term data were collected for both groups. The primary end points were free from the major adverse event (MAE) at 30 days and primary effectiveness at 1 year. A total of 51 CIAA (39 patients) were treated with an IBE. Overall, 15 patients were treated under IFU and 24 under nonIFU. The IFU group mean age was older (72 vs. 67 years, P = 0.03), and males (97%) were primarily treated. Comorbidities were similar except nonIFU had more patients with previous endovascular abdominal aortic aneurysm repair on presentation (0 vs. 4 cases, P = 0.04). Procedure (178 vs. 264 min, P = 0.02) and fluoroscopy (52 vs. 74 min, P = 0.04) times were longer in the nonIFU group. Technical success was 100% for both groups, and there was no difference in device related reintervention at 30 days (0 vs. 1, P = 0.44). There was no MAE in either group at 30 days. Intervention for any endoleak was similar between the groups (2 vs. 3, P = 0.94). Percent CIAA sac regression was similar between the groups (19% vs. 18%, P = 0.21). There was no difference for primary effectiveness at 1 year (93% vs. 92%, P = 0.85). There was one death per group at one year not related to an aortic or iliac cause. In properly selected patients with complex anatomy, IBE can be used with nondedicated aortic and internal iliac components with good early term outcomes.

Outcomes of Gore iliac branch endoprosthesis with internal iliac component versus Gore Viabahn VBX

ObjectiveThe Gore Excluder iliac branch endoprosthesis (IBE; W.L. Gore & Associates, Flagstaff, AZ) is the only iliac branch device approved in the United States to preserve blood flow to the external and internal iliac arteries (IIAs). Some surgeons have used the Gore Viabahn VBX balloon expandable endoprosthesis (VBX; W.L. Gore & Associates) in the IIA rather than the self-expanding endograft designed for the IBE, the internal iliac component (IIC). The objective of the present study was to examine the outcomes for patients treated for aortoiliac artery aneurysms using the IBE with either the IIC or VBX stent. MethodsWe performed a retrospective, single-center review of patients treated for aortoiliac artery aneurysms using the Gore IBE device, with either the IIC or VBX stent into the IIA, from February 2016 to March 2021. The patient demographics, procedure details, 30-day morbidity and mortality, and 6-month and 1-year outcomes and mortality were analyzed. The categorical factors are summarized using frequencies and proportions. Continuous measures are summarized as the mean ± standard deviation. A significance level of P = .05 was assumed for all test results. The analyses were performed using SAS software, version 9.4 (SAS Institute, Cary, NC). ResultsA total of 62 patients (64 arteries) had undergone elective aortoiliac artery aneurysm repair with the IBE. The IIC was used exclusively in 35 cases (55%) and the VBX in 29 (45%). The patients who had received the VBX had had a higher American Society of Anesthesiologists class (P = .006). Upper extremity access was used for VBX delivery in 24.1% of the procedures. No return to the operating room was required in either group. No differences were found in technical success (IIC, 97.1%; VBX, 93.1%; P = .59), the presence of endoleak on completion (20.0% vs 6.9%; P = .17), readmission (97.1% vs 93.1%; P = .59), or mortality (1.6% vs 0%; P = .45) at 30 days. No differences were found in the requirement for any IBE reintervention after 30 days. No type Ia, Ib, or III endoleaks had occurred in either group at any follow-up point. No significant difference was found in internal iliac limb primary patency (IIC, 100%; VBX, 96.3%) between groups. A nonstatistically significant trend was found toward fewer trunk–ipsilateral leg type II endoleaks in the VBX group during follow-up. ConclusionsThese data suggest that the VBX is a reasonable substitute for the IIC, with a comparable safety and efficacy profile. Given its inherent conformability, greater range of diameters, and longer working length, the VBX stent offers expanded IIA branch options with the IBE.

Evaluation of electrocardiogram-gated computed tomography angiography to quantify changes in geometry and dynamic behavior of the iliac artery after placement of the Gore Excluder Iliac Branch Endoprosthesis.

The GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE) is designed to treat iliac aneurysms with preservation of blood flow through the internal iliac artery (IIA). Little is known about the influence of IBE placement on the IIA geometry. This study aimed to provide detailed insights in the dynamic behavior and geometry of the common iliac artery (CIA) and IIA trajectory and how these are influenced after treatment with an IBE. Pre- and postoperative electrocardiogram-gated computed tomography angiography (ECG-gated CTA) scans were acquired in a prospective study design and analyzed with in-house written algorithms designed for aorto-iliac and endoprosthesis deformation evaluation. Cardiac pulsatility-induced motion patterns and pathlengths were computed by tracking predefined locations on the aorto-iliac tract. Centerlines through the CIA-IIA trajectory were used to investigate the static and dynamic geometry, including curvature, torsion, length and Tortuosity Index (TI). Fourteen CIA-IIA trajectories were analyzed before and after IBE placement. Cardiac pulsatility-induced motion and pathlengths increased after IBE placement, especially at mid IIA and the first IIA bifurcation (P≤0.04). After IBE placement, static and dynamic curvature, length and TI decreased significantly (P<0.05). Furthermore, the average dynamic torsion increased significantly (P=0.030). The remaining geometrical outcomes were not statistically significant. The placement of an IBE device stiffens and straightens the CIA-IIA trajectory. Its relation with clinical outcome is yet to be investigated, which can be done thoroughly with the ECG-gated CTA algorithms used in this study.

Outcomes of Gore Iliac Branch Endoprosthesis With Internal Iliac Component Versus Gore Viabahn VBX

The Gore Excluder iliac branch endoprosthesis (IBE; W.L. Gore & Associates, Flagstaff, Ariz) is the only iliac branch device approved in the United States to preserve blood flow to the external and internal iliac arteries (IIAs). In some cases, surgeons have used the Gore Viabahn VBX balloon expandable endoprosthesis (VBX; W.L. Gore & Associates) in the IIA rather than the self-expanding endograft designed for use with the IBE, the internal iliac component (IIC). The objective of the present study was to examine the outcomes in a cohort of patients treated for iliac artery aneurysms with the IBE using either the IIC or VBX.

Final 5-Year Results of the U.S. Prospective, Multicenter Study of Endovascular Repair of Iliac Aneurysms Using the Gore Iliac Branch Endoprosthesis

We have reported the 5-year results of the IBE 12-04 (Evaluation of the GORE EXCLUDER Iliac Branch Endoprosthesis) U.S. pivotal prospective, multicenter study designed to evaluate the Gore Excluder iliac branch endoprosthesis (IBE; W. L. Gore & Associates, Flagstaff, Ariz) for endovascular repair of aortoiliac aneurysms and common iliac artery (CIA) aneurysms (CIAAs).

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

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. 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. 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. 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.

Conformability of the GORE EXCLUDER iliac branch endoprosthesis is associated with freedom from adverse iliac events

ObjectiveThe GORE EXCLUDER iliac branch endoprosthesis (IBE; W.L. Gore & Associates, Flagstaff, Ariz) is designed to preserve internal iliac artery (IIA) patency during endovascular treatment of aneurysms involving the common iliac artery. The device is intended to conform to iliac tortuosity, which may decrease adverse iliac events (AIE). The objective of this study was to evaluate risk factors for AIE after IBE implantation. MethodsThis was a post hoc analysis of the prospective, multicenter GORE 12-04 IBE pivotal trial. Patients with preoperative and postoperative axial imaging were included, with analysis based on each treated iliac system. An independent core laboratory performed all scan measurements, including iliac diameters, lengths, and tortuosity. Conformability was analyzed by the changes in tortuosity after IBE deployment, with less change indicating greater conformation. The end point was AIE, defined as ipsilateral radiographic or clinical complications. Critical nonconformation was defined as a threshold change in tortuosity associated with a significant increase in AIE. ResultsWe included 98 patients with 101 treated iliac systems. There were eight AIE (8%; six IIA component occlusions, one iliac branch component occlusion, and one EIA dissection requiring reintervention). Patients with AIE had smaller IIA diameters and less IBE conformability. After multivariable logistic regression analysis, an IIA diameter of less than 10 mm and a change in total iliac tortuosity beyond –15% were independently associated with AIE (odds ratio, 12 [interquartile range, 1.4-110] and odds ratio, 8.2 [interquartile range, 1.5-46], respectively), and the latter was used to define critical nonconformation. Critical nonconformation occurred in 11% of treated systems, and was associated with a high rate of AIE (36% vs 4%; P = .004). ConclusionsEndograft conformation is a novel device property and technical outcome that, along with a larger IIA diameter, is associated with freedom from AIE after IBE deployment. An evaluation of these risk factors may better inform the management of patients with iliac aneurysmal disease. Further research on endograft conformation and patient outcomes is warranted, particularly for those with challenging anatomy undergoing complex procedures.

Outcomes after Standalone Use of Gore Excluder Iliac Branch Endoprosthesis for Endovascular Repair of Isolated Iliac Artery Aneurysms

The aim of our study was to describe outcomes of stand-alone use (i.e., without concomitant implantation of an aortic stent graft) of the Gore Excluder iliac branch endoprosthesis (IBE) for elective endovascular repair of isolated iliac artery aneurysms. We evaluated all consecutive patients electively treated for isolated iliac artery aneurysms using standalone Gore Excluder IBE (January 2014-December 2018). Early (i.e., 30-day) endpoints were technical success, mortality, major adverse events (MAEs), and major access-site complications. Late endpoints were survival, freedom from aortic-related mortality (ARM), internal iliac artery (IIA) primary patency, IIA branch instability, graft-related adverse events (GRAEs), secondary interventions, endoleaks (ELs), aneurysm sac behavior, and new-onset buttock claudication (BC). A total of 11 consecutive patients (10 men; median age 75years) were included. The technical success rate was 100%. At 30days, mortality, MAEs, and major access-site complications were all 0%. Survival and freedom from ARM were 91% and 100%, respectively; only one nonaortic related death was recorded during follow-up. At a median follow-up of 14months, IIA primary patency, IIA branch instability, and GRAEs were 100%, 0%, and 0%, respectively. No instances of graft migration ≥10mm were detected. No graft-related secondary interventions were recorded, and 2 patients required a procedure-related secondary intervention 3months after the index procedure (1 common femoral artery endarterectomy and 1 external iliac artery stenting). Although new-onset type 1 or type 3 ELs were never noted, one patient developed a new-onset type 2 EL. Aneurysm sac regression ≥5mm was noted in 6 patients (55%), whereas in the remaining ones, the sac size was stable. No instances of new-onset BC were noted. Use of standalone Gore Excluder IBE for elective endovascular repair of isolated iliac artery aneurysms is a safe, feasible, and effective treatment option. These results may support use of the technique as an effective means of endovascular reconstruction in patients with suitable anatomy.

Outcomes of the Gore Excluder Iliac Branch Endoprosthesis Using Division Branches of the Internal Iliac Artery as Distal Landing Zones

Purpose: To evaluate the outcomes of the Gore Excluder Iliac Branch Endoprosthesis (IBE) using division branches of the internal iliac artery (IIA) as distal landing zones. Materials and Methods: Between January 1, 2014, and December 31, 2018, 74 patients (mean age 74±7 years; 72 men) treated for aortoiliac or common iliac artery aneurysms had an IBE deployed with distal landing of the side branch within the main trunk (n=60) of the internal iliac artery (IIA) vs within a division branch (n=25). Thirteen (17%) patients received bilateral IBE implantations for a total of 85 vessels evaluated. Early endpoints were technical success, 30-day mortality, 30-day major adverse events (MAEs), and 30-day major access complications. Late endpoints were survival, primary and secondary IIA patency, freedom from IIA branch instability, freedom from new-onset buttock claudication, and aneurysm sac diameter changes. Time-dependent outcomes were reported as Kaplan-Meier curves with differences assessed using the log-rank test. Estimates are presented with the 95% confidence interval (CI). Results: The overall technical success rate was 97%, with 1 technical failure per group (p=0.43). Two patients, one from each group, died within 30 days (p=0.43). No significant differences were seen in the rates of 30-day MAEs (7% vs 17%, p=0.35) or major access complications (9% vs 11%, p>0.99) for patients receiving distal landing in the main trunk vs a division branch, respectively. The mean follow-up for the entire cohort was 19±12 months. The overall 1-year survival rate was 94% (95% CI 74% to 99%). The primary and secondary patency rates at 1 year were 98% (95% CI 88% to 99%) vs 95% (95% CI 72% to 99%, p=0.72) and 98% (95% CI 88% to 99%) vs 100% (p=0.41) for the main trunk vs division branch groups, respectively. Freedom from IIA branch instability estimates were also similar at 1-year follow-up [93% (95% CI 82% to 97%) vs 90% (95% CI 66% to 97%), p=0.29], as were the freedom from new-onset buttock claudication estimates [98% (95% CI 86% to 99%) and 94% (95% CI 67% to 99%), respectively; p=0.62]. Mean sac diameter change was 5.4±5.3 mm, not significantly different between the groups (p=0.85). Conclusion: Use of the posterior or anterior division of the IIA as a distal landing zone for the Gore Excluder IBE was safe and efficacious in the midterm. This technique may permit extending indications for endovascular repair of aortoiliac aneurysms to cases with unsuitable anatomy within the IIA main trunk. Long-term assessment is needed to affirm the efficacy of this technique.

One Technique to Modulate a Device Implantation Path in a Short Treatment Length Using the Gore IBE Device.

The GORE EXCLUDER Iliac Branch Endoprosthesis (IBE; W. L. Gore and Associates, Flagstaff, AZ, USA) applicability is limited by the aorto-iliac length (AOL). The shortage may be a major exclusion criterion. An 85-year-old male presented with an abdominal aortic and left common iliac arterial aneurysm. The left-side AOL was 146-mm, which was deemed 19-mm too short for IBE usage. To increase implantation length, the contra-lateral connection stent graft was deployed along the implantation line, wound half-circumferentially around the ipsilateral limb. Any form of endoleak, limb occlusion, and device migration has not been observed for twelve months.

Anatomical Suitability of the GORE EXCLUDER Iliac Branch Endoprosthesis in Japanese Patients with Common Iliac Aneurysms Treated by Standard EXCLUDER Endografts

The EXCLUDER iliac branch endoprosthesis (IBE) is designed to exclude a common iliac artery (CIA) aneurysm (CIAA), preserving the internal iliac artery (IIA) during endovascular aneurysm repair (EVAR). We assessed the anatomical suitability of the IBE in patients whose aortoiliac aneurysms (AIAs) had already been treated with a standard EXCLUDER endograft, compromising their IIAs. From June 2007 to January 2017, 202 patients underwent elective EVAR for AIAs with the EXCLUDER endograft at our institute. Among them, patients whose IIAs were embolized for the external iliac artery (EIA) landing were included in this study. Patients with solitary or small CIAAs of <25mm in diameter were excluded. Preoperative computed tomography scans were analyzed using a 3D workstation to evaluate the suitability of the IBE when following its instructions for use. Twelve patients with bilateral CIAAs and 24 patients with unilateral CIAAs were enrolled in this study. Among the 48 iliac segments, 15 (31.3%) were eligible for unilateral IBE implantation. A total of 40% of the CIAAs did not have a large enough luminal diameter, which was the most common barrier to the use of the unilateral IBE in our patients. Among the iliac segments of the 12 patients with bilateral CIAAs, 2 (16.7%) were suitable for bilateral implantation. An insufficient length between the renal artery (RA) and the IIA was the major barrier to the use of bilateral IBE. A total of 31.3% of the compromised IIAs could have been preserved if the IBE was used. Bilateral implantation seemed possible in a limited number of cases. In addition to a small CIA lumen, an insufficient length between the RA and the IIA was also a predominant anatomical limitation, especially when bilateral implantation was planned.

Isolated Common Iliac Artery Aneurysms Treated Solely With Iliac Branch Stent-Grafts: Midterm Results of a Multicenter Registry

Purpose: To assess early and midterm outcomes of iliac branch device (IBD) implantation without an aortic stent-graft for the treatment of isolated common iliac artery aneurysm (CIAA). Methods: From December 2006 to June 2016, 49 isolated CIAAs in 46 patients were treated solely with an IBD at 7 vascular centers. Five patients were lost to follow-up, leaving 41 male patients (mean age 72.5±7.8 years) for analysis. Mean CIAA diameter was 39.1±10.5 mm (range 25–65). Thirty-two patients (2 with bilateral CIAAs) were treated with a Cook Zenith iliac branch device; 9 patients (1 bilateral) received a Gore Excluder iliac branch endoprosthesis. Primary endpoints were technical success, survival, aneurysm exclusion, device patency, and freedom from reintervention at 1 and 5 years. Freedom from major adverse events and aneurysm shrinkage at 1 year were also assessed. Results: Thirty-day mortality and the IBD occlusion rate were 2.4% and 2.3%, respectively. At a mean follow-up of 40.2±33.9 months, no patient presented buttock claudication, erectile dysfunction, or bowel or spinal cord ischemia. Three patients died within 6 months after the procedure. Estimates of cumulative survival, device patency, and freedom from reintervention were 90.2%, 95.2%, and 95.7%, respectively, at 1 and 5 years. At 1 year, CIAA shrinkage ≥5 mm was recorded in 21 of 38 survivors. No evidence of endoleak, device migration, or disconnection was found on imaging follow-up. Conclusion: The use of IBDs without an aortic stent-graft for isolated CIAAs resulted in excellent patency, with low morbidity and mortality. This, in conjunction with no endoleak or migration and a low reintervention rate, supports the use of isolated IBDs as a stable and durable means of endovascular reconstruction in cases with suitable anatomy. Longer follow-up and a larger cohort are needed to validate these results.