Late outcomes of different hypogastric stent grafts in aortoiliac endografting with iliac branch device: Results from the pELVIS Registry

Verzini, Fabio; Parlani, Gianbattista; Varetto, Gianfranco; Gibello, Lorenzo; Boero, Michele; Donas, Konstantinos P.; Austermann, Martin; Inchingolo, Mirjam; Bisdas, Theodosios; Torsello, Giovanni; Pratesi, Giovanni; Barbante, Matteo; Cao, Piergiorgio; Ferrer, Ciro; Pratesi, Carlo; Fargion, Aaron; Masciello, Fabrizio; Kölbel, Tilo; Tsilimparis, Nikolaos; Haulon, Stéphan; Branzan, Daniela; Schmidt, Andrej; Scheinert, Dirk

doi:10.1016/j.jvs.2019.09.065

Cited by 33 publications

(15 citation statements)

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“…Although direct comparison of bilateral implantations against unilateral procedures was not the primary focus of this article, immediate postoperative results as well as midterm outcomes in this series seem largely similar to those achieved in the whole pELVIS cohort as reported in prior publications, 22,23 although procedural metrics would indicate an expected higher complexity of repair. In light of these findings, it is the authors’ opinion that when IBD are employed by well-trained physicians in adequately selected patients, procedural complexity should not be the only reason to deny bilateral repair other reasons might ultimately affect the decision-making process.…”

Section: Discussionsupporting

confidence: 65%

Bilateral Use of Iliac Branch Devices for Aortoiliac Aneurysms Is Safe and Feasible, and Procedural Volume Does Not Seem to Affect Technical or Clinical Effectiveness: Early and Midterm Results From the pELVIS International Multicentric Registry

et al. 2021

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Objective To evaluate early and follow-up outcomes following bilateral use of iliac branch devices (IBD) for aortoiliac endografting and assess the impact of center volume. We used data from the pELVIS international multicentric registry. Methods For the purpose of this study, only those patients receiving concomitant bilateral IBD implantation were analyzed. To assess the impact that procedural volume of bilateral IBD implantation could have on early and follow-up outcomes, participating institutions were classified as Site(s) A if they had performed >10 and/or >20% concomitant bilateral IBD procedure, otherwise they were classified as Site(s) B. Endpoints of the analysis included early (ie, 30-day) mortality and morbidity, as well as all-cause and aneurysm-related mortality during follow-up. Additional endpoints that were evaluated included IBD-related reinterventions, IBD occlusion or stenosis requiring reintervention (ie, loss of primary patency), and IBD-related type I endoleak. Results Overall, 96 patients received bilateral IBD implantation (out of 910 procedures collected in the whole pELVIS cohort), of whom 65 were treated at Site A (ie, Group A) and 31 were treated at Site(s) B (ie, Group B). In total, only 1 death occurred within 30 days from bilateral IBD implantation, and 9 patients experienced at least 1 major complication without any significant difference between subjects in Group A versus those in Group B (10.8% vs 6.5%, p=0.714). In the overall cohort, the 2-year freedom from IBD-related type I endoleaks and IBD primary patency were 96% and 92%, respectively; no significant differences were seen in those rates between Group A or Group B (95% vs 100%, p=0.335; 93% vs 88%, p=0.470). Freedom from any IBD-related reinterventions was 83% at 2 years, with similar rates between study groups (85% vs 83%, p=0.904). Conclusions Within the pELVIS registry, concomitant bilateral IBD implantation is a safe and feasible technique for management of aortoiliac aneurysms in patients with suitable anatomy. Despite increased technical complexity, effectiveness of the repair is satisfactory with low rates of IBD-related adverse events at mid-term follow-up. Procedural volume does not seem to affect technical or clinical outcomes after bilateral use of IBD, which remains a favorable treatment option in selected patients.

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Section: Discussionsupporting

confidence: 65%

Bilateral Use of Iliac Branch Devices for Aortoiliac Aneurysms Is Safe and Feasible, and Procedural Volume Does Not Seem to Affect Technical or Clinical Effectiveness: Early and Midterm Results From the pELVIS International Multicentric Registry

et al. 2021

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“…The freedom from reintervention and conversion was 90.4% and 71.0% one and five years. 26 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%.…”

Section: Discussionmentioning

confidence: 99%

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

Veen

Holewijn

Bellosta

et al. 2021

European Journal of Vascular and Endovascular Surgery

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WHAT THIS PAPER ADDSThe 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.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 e 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 e 42.0) mm. Twenty-two patients received a bilateral and seven patients had an isolated IBE. Median procedural time was 151 minutes (IQR 117 e 193 minutes) with a median hospital stay of four days (IQR 3 e 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 ¼ .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.

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“…27 A recent study from the pELVIS registry indicates that results of IBD for endovascular treatment of aortoiliac aneurysms are equally favorable with both balloon-expandable and self-expanding stent-grafts. 28 However, the authors did not specifically investigate whether the site of distal landing had any influence on outcomes. • • When the repair is to be extended beyond the IIA bifurcation and more stents are necessary to bridge the longer distance to the distal landing zone, our preference is to use balloon-expandable stents (typically Gore Viabahn VBX 8L) or the IBE internal iliac limb proximally to provide stability, with self-expanding stents distally to ensure flexibility.…”

Section: • • a Wide Range Of Balloon-expandable And Self-mentioning

confidence: 99%

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

et al. 2020

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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.

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Late outcomes of different hypogastric stent grafts in aortoiliac endografting with iliac branch device: Results from the pELVIS Registry

Cited by 33 publications

References 19 publications

Bilateral Use of Iliac Branch Devices for Aortoiliac Aneurysms Is Safe and Feasible, and Procedural Volume Does Not Seem to Affect Technical or Clinical Effectiveness: Early and Midterm Results From the pELVIS International Multicentric Registry

Bilateral Use of Iliac Branch Devices for Aortoiliac Aneurysms Is Safe and Feasible, and Procedural Volume Does Not Seem to Affect Technical or Clinical Effectiveness: Early and Midterm Results From the pELVIS International Multicentric Registry

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

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

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