Zenith Bifurcated Iliac Side Branch Device: Mid-term Results and Assessment of Risk Factors for Intraoperative Thrombosis

Delay, Christophe; Déglise, Sebastien; Lejay, Anne; Georg, Yannick; Roussin, Mathieu; Schaeffer, Mickaël; Saucy, François; Thaveau, Fabien; Corpataux, Jean Marc; Chakfé, Nabil

doi:10.1016/j.avsg.2016.08.048

Cited by 26 publications

(20 citation statements)

References 22 publications

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“…18 Indeed, if the device is satisfactorily deployed and the IIA or its distal branches are well preserved, long-term stability can be expected. 19 If any kink or compression is detected, prompt revision should be carried out to ensure optimal outcomes. 20 Our group uses postimplant cone beam CT intraoperatively to allow immediate assessment and revision of technical problems for IBDs and other complex endovascular aortic procedures.…”

Section: Discussionmentioning

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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Section: Discussionmentioning

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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“…In this study, there were no deaths during the 12 month follow up, which compares well with the retrospective study of the device 5 and the very recent retrospective study of the Zenith Iliac Branch System including 30 patients, in which the overall survival was 96% at one year. 8 The results compare favourably with the outcomes in two studies (covering a mean of 17 and 26 months) using the Zenith Iliac Branch System, 7,12 with 100 and 140 patients, respectively. Three of the overall 34 deaths were procedure related.…”

Section: Discussionmentioning

confidence: 69%

“…All reinterventions were performed within the first 30 days. 8 In a prospective study of the Gore IBD, none of the 61 evaluated patients received IBD related re-interventions through a follow up period of six months. However, one patient was treated for an external iliac artery dissection distal to the IBD and a second patient received a re-intervention for a type II endoleak.…”

Section: Discussionmentioning

confidence: 99%

Prospective Study of the Iliac Branch Device E-liac in Patients with Common Iliac Artery Aneurysms: 12 Month Results

Brunkwall

Vaquero-Puerta

Heckenkamp

et al. 2019

European Journal of Vascular and Endovascular Surgery

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WHAT THIS PAPER ADDS New dedicated iliac branch devices (IBDs) help to minimise ischaemic complications by preserving internal iliac artery (IIA) flow. There are currently three dedicated IBDs available on the market, including the E-liac Stent Graft System. The present study evaluates the safety and efficacy of this stent graft and is the first and largest prospective trial on this iliac side branch device. The favourable results demonstrate its promising performance and safe application. Objectives: At 12 months follow up of the PLIANT study, clinical success and efficacy of the E-liac Stent Graft System (JOTEC GmbH, Hechingen, Germany) were evaluated. Clinical success was defined as aneurysm exclusion (no type I, III, IV endoleak) with primary patency of the internal iliac artery (IIA) and external iliac artery (EIA) on the E-liac implantation side. Methods: In this prospective multicentre European observational study, clinical and morphological data of 45 patients (93% male, mean age 72 y) were prospectively collected in 11 European centres between July 2014 and June 2016. Forty patients underwent an aorto-iliac (three patients bilaterally) treatment and five an isolated iliac treatment. Results: At 12 months follow up, data were available for 42 patients. Overall clinical success at 12 months was 90%, with a survival rate of 100%. Four patients (10%) did not achieve clinical success, one with an internal iliac artery (IIA) occlusion on the E-liac implantation side, one with an infrarenal type Ia endoleak, and two with type Ib endoleaks in IIA. At 12 months the primary patency rate in the internal iliac artery on the iliac side branch implantation side was 98%. Two patients (5%) received E-liac related re-interventions: one caused by an edge stenosis at the distal end of the graft limb in the external iliac artery (EIA) and one caused by thromboembolism in the external iliac artery. Thus, for the EIA, primary and secondary patency rates were 98% and 100%, respectively. Conclusions: The low device related re-intervention rate of 5%, the high survival rate of 100%, and the high primary patency rates of 98% for the IIA and EIA at 12 month follow up demonstrate the safety and efficacy of the E-liac Stent Graft System. Long term 36 month results are awaited to confirm the efficacy and durability.

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“…58 Although many anatomical factors may influence the success of IBDs, IIA patency, and presence of IIA, ostial stenosis seem to be crucial to the risk of early and late failure. 59 The major disadvantages of IBDs still are the anatomical requirements. 60,61 Nevertheless, there has been more liberal use of IBDs since their availability.…”

Section: Discussionmentioning

confidence: 99%

Perioperative Outcomes After Use of Iliac Branch Devices Compared With Hypogastric Occlusion or Open Surgery for Elective Treatment of Aortoiliac Aneurysms in the NSQIP Database

D’Oria

Mendes

Bews

et al. 2020

Annals of Vascular Surgery

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Zenith Bifurcated Iliac Side Branch Device: Mid-term Results and Assessment of Risk Factors for Intraoperative Thrombosis

Cited by 26 publications

References 22 publications

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

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

Prospective Study of the Iliac Branch Device E-liac in Patients with Common Iliac Artery Aneurysms: 12 Month Results

Perioperative Outcomes After Use of Iliac Branch Devices Compared With Hypogastric Occlusion or Open Surgery for Elective Treatment of Aortoiliac Aneurysms in the NSQIP Database

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