A multicenter 12-month experience with a new iliac side-branched device for revascularization of hypogastric arteries

Mylonas, Spyridon N.; Rümenapf, G.; Schelzig, Hubert; Heckenkamp, J.; Youssef, Marwan; Schäfer, Jost Philipp; Ahmad, Wael; Brunkwall, Jan; Oberhuber, Alexander; Theis, Thorsten

doi:10.1016/j.jvs.2016.04.065

Cited by 29 publications

(27 citation statements)

References 26 publications

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“…18,33–35 Although Asian patients were found to have a shorter non-aneurysmal CIA compared to the literature when the CIA becomes aneurysmal it also lengthens. When comparing the aorto-iliac length we found that Japanese patients had similar lengths (181.6 ± 27.5 mm) compared to patients treated in America (183.6 ± 28.3 mm) which is somewhat surprising given Japanese patients are noted to be of a shorter average height.…”

Section: Discussionmentioning

confidence: 81%

Outcomes of Endovascular Repair of Aortoiliac Aneurysms and Analyses of Anatomic Suitability for Internal Iliac Artery Preserving Devices in Japanese Patients

Itoga

Fujimura

Hayashi

et al. 2017

Circ J

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Background Understanding common iliac arteries (CIA) are shorter in Asian patients, we investigated whether this anatomical difference affects clinical outcomes of internal iliac artery (IIA) exclusion during endovascular repair (EVAR) of aorto-iliac aneurysm and limits the use of IIA preserving devices in Japanese patients. Methods and Results From 2008–2014, 69 Japanese patients underwent EVAR of aorto-iliac aneurysms with 53 unilateral and 16 bilateral IIA exclusion. One patient had persistent-buttock claudication during follow-up; however colonic or spinal cord ischemia was not observed. Anatomic suitability was investigated for the iliac branch device (IBD) by Cook Medical and iliac branch endoprosthesis (IBE) by WL Gore. Eighty-seven aorto-iliac segments were analyzed: 17% meet criteria for the IBD and 25% meet criteria for the IBE with 40% meeting criteria for either. Main exclusions for the IBD were IIA diameter >9 mm or <6 mm, (47%) and CIA length <50 mm, (39%). Main exclusions for the IBE were proximal CIA diameter <17 mm, (44%) and aorto-iliac length <165 mm, (24%). Conclusions EVAR with IIA exclusions in Japanese patients showed low incidence of persistent-buttock claudication and no major pelvic complications. Aorto-iliac morphology demonstrated smaller proximal CIA diameters and shorter CIA lengths, limiting the use of IIA preserving devices.

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Section: Discussionmentioning

confidence: 81%

Outcomes of Endovascular Repair of Aortoiliac Aneurysms and Analyses of Anatomic Suitability for Internal Iliac Artery Preserving Devices in Japanese Patients

Itoga

Fujimura

Hayashi

et al. 2017

Circ J

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“…20 Moreover, hypogastric branch devices occlude frequently, both early and at midterm. 21,22 In the absence of clear recommendations, clinical judgement should consider the risk of endoleak by sub-optimal seal at the common iliac artery and balance this with the increased risk of occlusion when extending to the external iliac artery.…”

Section: Discussionmentioning

confidence: 99%

Iliac Seal Zone Dynamics and Clinical Consequences After Endovascular Aneurysm Repair

Gonçalves

Oliveira

Rijn³

et al. 2017

European Journal of Vascular and Endovascular Surgery

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WHAT THIS PAPER ADDS Failure after EVAR is most often associated with loss of seal and consequent re-pressurisation of the aneurysm sac. This study explores the evolution of the iliac seal zones after implantation, showing that progressive dilatation and retraction are very common occurrences, which in turn have clinical consequences. Careful attention to planning to take full advantage of the potential iliac seal, avoidance of "bell-bottom" limbs whenever possible, and attention to signs of excessive dilatation and/or retraction over the course of follow-up are practical recommendations derived from the conclusions of this study that may improve outcomes.Objective: To evaluate the dynamics of the iliac attachment zone after EVAR, and the association with clinical events. Methods: A tertiary institution's prospective EVAR database was searched to identify common iliac arteries at risk. Internally validated measurements were made, using centre lumen line reconstructions. Iliac dilatation and endograft limb retraction were the main endpoints. Associations between dilatation, retraction, oversizing, and distal seal length were investigated. Association with clinical events (sealing or occlusion) was also explored. Results: Of 452 primary EVAR patients treated from 2004 to 2012, 341 were included (mean age 72 years, 12% female, 597 common iliac arteries). Median follow-up was 4.7 years. At 30 days, the mean iliac diameter increased from 14 mm to 15 mm (p < .001). Over follow-up, it increased to 18 mm (p < .001). Iliac dilatation !20% occurred in 295 cases (49.4%) and exceeded the implanted endograft diameter in 170 (28.7%). Limb retraction !5 mm was identified in 54 patients (9.1%) and was associated with iliac seal complications (p < 0.001). Iliac endograft extension diameter !24 mm (OR 3.3, 95% CI 1.7e6.4) and iliac artery dilatation beyond the endograft (OR 2.1, 95% CI 1.2e3.8) were independent risk factors. Overall, there were 34 (5.7%) iliac seal complications. Retraction of the iliac endograft (OR 1.17 per mm, 95% CI 1.10e1.24) and baseline AAA diameter (1.04 per mm, 95% CI 1.01e1.07) were independent risk factors for seal related complications. Greater initial post-operative iliac seal length was protective (OR 0.94 per mm, 95% CI 0.90e0.97). Conclusions: Iliac dilatation and endograft retraction are common findings during follow-up, potentially leading to adverse clinical events. Optimisation of the iliac seal zone providing a long distal seal length and added attention to patients with large aneurysms or receiving !24 mm diameter iliac extensions are recommended. Also, long-term surveillance including CTA is advised to reveal and correct loss of seal at the iliac attachments before adverse clinical events occur. Ó

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“…The anatomic prerequisites of both devices were described. 11,16 The indication for treatment in this cohort was the presence of a unilateral or bilateral CIA ≥35 mm in diameter or an aneurysmal CIA ≥20 mm in diameter associated with an AAA ≥55 mm in diameter. When the abdominal aortic diameter was ≥35 mm or in the absence of a suitable proximal CIA neck, the IBD implantation was associated with a bifurcated EVAR stent-graft.…”

Section: Parameters For Ibd Usementioning

confidence: 99%

“…Several studies evaluating the feasibility and short-and midterm results of commercially available IBDs have documented excellent performance of these devices. [8][9][10][11][12] Nevertheless, only a few studies have directly compared the performance of 2 IBDs, [13][14][15] namely, the Zenith Branch Endovascular Graft-Iliac Bifurcation (ZBIS; Cook Medical Inc, Bloomington, IN, USA) and the Gore Excluder Iliac Branch Endoprosthesis (IBE; W.L. Gore & Associates Inc, Flagstaff, AZ, USA).…”

Section: Introductionmentioning

confidence: 99%

Comparison of Two Iliac Branch Devices and Their Midterm Performance in Maintaining Blood Flow to the Internal Iliac Artery

et al. 2020

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Purpose: To compare and contrast the midterm outcomes of the E-liac and Zenith (ZBIS) iliac branch devices (IBDs) for the preservation of the internal iliac artery (IIA) in aneurysms involving the iliac bifurcation. Materials and Methods: Between January 2014 and December 2018, 84 consecutive patients (median age 74 years; 76 men) were electively treated with the E-liac (n=44) or ZBIS (n=40) IBDs and were retrospectively analyzed to evaluate the technical success, patency, need for reintervention, and mortality associated with these devices. Results: Technical success was achieved in 95 of 99 implantations (95.9%) without any statistically significant difference between the groups (93.7% vs 98.0%, p=0.114). During the first 30 days, 3 occlusions in the ZBIS group and 1 in the E-liac group were identified. There was 1 perioperative death in the ZBIS group. The median follow-up was 37 months for the ZBIS group and 28 months for the E-liac group (p=0.657). Six patients from the ZBIS group and 7 from the E-liac group were lost to follow-up. Among the remaining, there were 2 further deaths recorded, 1 in each group. Four further reinterventions in the E-liac group and 2 in the ZBIS group were performed during follow-up. The Kaplan-Meier estimates of freedom from reintervention were 87.2% (95% CI 82.6% to 90.2%) for the ZBIS group and at 86.0% (95% CI 83.7% to 89.1%) for the E-liac group (p=0.563); the freedom from occlusion estimates were 89.7% (95% CI 85.8% to 94.5%) and 95.3% (95% CI 92% to 98.7%; p=0.317), respectively. Conclusion: The E-liac and the ZBIS IBDs showed equally high technical success, midterm patency, and low reintervention rates.

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A multicenter 12-month experience with a new iliac side-branched device for revascularization of hypogastric arteries

Abstract: This first ever 1-year study reports the results with the new E-liac device and shows that it can be safely applied for the treatment of aortoiliac aneurysmatic disease with low reintervention rates and high patency rates. Long-term data are needed to confirm the durability of the device.

Cited by 29 publications

References 26 publications

Outcomes of Endovascular Repair of Aortoiliac Aneurysms and Analyses of Anatomic Suitability for Internal Iliac Artery Preserving Devices in Japanese Patients

Outcomes of Endovascular Repair of Aortoiliac Aneurysms and Analyses of Anatomic Suitability for Internal Iliac Artery Preserving Devices in Japanese Patients

Iliac Seal Zone Dynamics and Clinical Consequences After Endovascular Aneurysm Repair

Comparison of Two Iliac Branch Devices and Their Midterm Performance in Maintaining Blood Flow to the Internal Iliac Artery

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