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The objective of this study was to compare the perioperative and midterm results of Zenith Bifurcated Iliac Side (ZBIS; Cook Medical, Bloomington, Ind) and Gore Iliac Branch Endoprosthesis (IBE; W. L. Gore & Associates, Flagstaff, Ariz) iliac branch devices (IBDs) in treatment of dilated iliac bifurcations in patients with similar anatomic and clinical preoperative features. Between July 2007 and May 2018, 190 IBDs were implanted at two high-volume Italian vascular and endovascular centers. Among the series, preoperative propensity score matching based on preoperative anatomic and clinical factors was performed, and two homogeneous groups were created: group 1, 35 Cook ZBIS IBD implants; and group 2, 35 Gore IBE devices. Early results were analyzed in terms of technical success, death, conversion to open surgery, and occurrence of major local and systemic complications. Follow-up results were analyzed in terms of patency of the IBD, freedom from type I and type III endoleaks, aneurysm-related reintervention, and aneurysm-related death. Technical success was achieved in all implants from both groups. Perioperative IBD-related complications and major complications occurred in one case from group 1 (P =.49). No perioperative mortality was recorded in the two groups. Mean postoperative follow-up was 46.7 months in group 1 (standard deviation, ± 36.3) and 20.8 months in group 2 (standard deviation, ± 15.9; P <.0001). None of the IBDs or target hypogastric arteries occluded during follow-up in this series. Estimated 36-month freedom from type I and type III endoleaks was 97% (standard error [SE], 0.03) in group 1 and 87% (SE, 0.09) in group 2 (P =.34; log-rank, 0.9). Estimated freedom from IBD-related reintervention was 97% (SE, 0.03) in group 1 and 93% (SE, 0.06) in group 2 (P =.81; log-rank, 0.05). The estimated rates of overall survival at 36 months from the IBD implantation were 95% (SE, 0.04) in group 1 and 88% (SE, 0.08) in group 2 (P =.03; log-rank, 4.7); freedom from aneurysm-related death was 100% in group 1 and 93% (SE, 0.06) in group 2 (P =.19; log-rank, 1.7). The propensity score-matched comparison between the Cook ZBIS and Gore IBE devices showed similar, satisfying perioperative and midterm results in the experience of two high-volume Italian vascular centers. [ABSTRACT FROM AUTHOR]

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. 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. 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 thrombo-embolism in the external iliac artery. Thus, for the EIA, primary and secondary patency rates were 98% and 100%, respectively. 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. [ABSTRACT FROM AUTHOR]

Objectives: To study the safety and feasibility of the E-liac Stent Graft System® in patients with aorto/iliac aneurysms.Methods: A prospective multicentric European registry of patients receiving the E-liac Stent Graft System® was conducted. Endpoints of the study included the technical success as well as periprocedural events and 30-day endoleaks, reinterventions, internal and external iliac artery patency and mortality.Results: Between July 2014 and June 2016, a total of 45 patients (93% men, mean age 72 years, range 53-90 years) were enrolled at 11 sites in four European countries. Five patients received an isolated iliac treatment. Thirty-seven patients were treated with a combination of an abdominal stent graft and a unilateral E-liac and three in combination with bilateral E-liac. All E-liac Stent Grafts (48) were implanted in the intended position and the internal iliac arteries were successfully bridged. Two patients did not receive clinical success, due to endoleak type Ia of the aortic stent graft. At 30-day follow-up, clinical success rate was 96%. Three successful endovascular reinterventions were performed within the 30-day follow-up: one due to a type Ia endoleak in the common iliac artery, one due to type Ia endoleak of the aortic stent graft, and one due to bilateral lower limb claudication provoked by stent graft limb stenosis. At 30-day, a 100% survival rate and complete absence of pelvic or buttock ischemia/claudication were reported. Primary patency at 30 days was 100% for the internal iliac artery and 98% for the external iliac artery with an assisted patency of 100% in the latter.Conclusions: The high clinical success rate, low rates of device-related reinterventions (2%), and excellent patency rate demonstrate the safety and feasibility of the E-liac Stent Graft System. Long-term results are awaited to state efficacy and durability. Clinical Trials.gov. Identifier no. NCT02209194. [ABSTRACT FROM AUTHOR]

Abstract: Background: Iliac branch device (IBD) technique has been introduced as an appealing and effective solution to avoid complications occurring during repair of aorto-iliac aneurysm with extensive iliac involvement. Nevertheless, no large series with long-term follow-up of IBD are available. The aim of this study was to analyse safety and long-term efficacy of IBD in a consecutive series of patients. Methods: Between 2006 and 2011, 100 consecutive patients were enrolled in a prospective database on IBD. Indications included unilateral or bilateral common iliac artery aneurysms combined or not with abdominal aneurysms. Patients were routinely followed up with computed tomography. Data were reported according to the Kaplan–Meier method. Results: There were 96 males, mean age 74.1 years. Preoperative median common iliac aneurysm diameter was 40 mm (interquartile range (IQR): 35–44 mm). Sixty-seven patients had abdominal aortic aneurysm >35 mm (IQR: 40–57 mm) associated with iliac aneurysm. Eleven patients presented hypogastric aneurysm. Twelve patients underwent isolated iliac repair with IBD and 88 patients received associated endovascular aortic repair. Periprocedural technical success rate was 95%, with no mortality. Two patients experienced external iliac occlusion in the first month. At a median follow-up of 21 months (range 1–60) aneurysm growth >3 mm was detected in four iliac (4%) arteries. Iliac endoleak (one type III and two distal type I) developed in three patients and buttock claudication in four patients. Estimated patency rate of internal iliac branch was 91.4% at 1 and 5 years. Freedom from any reintervention rate was 90% at 1 year and 81.4% at 5 years. No late ruptures occurred. Conclusions: Long-term results show that IBD use can ensure persistent iliac aneurysm exclusion at 5 years, with low risk of reintervention. This technique can be considered as a first endovascular option in patients with extensive iliac aneurysm disease and favourable anatomy. [Copyright &y& Elsevier]

Abstract Objective We evaluated the short- and long-term results of off-label use of iliac branch devices (IBDs) in isolated common iliac artery aneurysms compared with the manufacturer-recommended configuration with additional extension in the infrarenal aorta based on the pELVIS Registry (pErformance of iLiac branch deVIces for aneurysmS involving the iliac bifurcation). Methods Between January 2005 and April 2017, 804 patients underwent endovascular aneurysm repair with 910 IBDs owing to aneurysmal involvement of the iliac bifurcation in nine high-volume European vascular centers. Among this cohort, 231 IBDs were implanted in 207 patients to treat an isolated common iliac aneurysm; 91 IBDs (group 1) were implanted without proximal aortic extension in the infrarenal aorta, and in the remaining cases (n = 140; group 2) an aortic bifurcated stent graft was deployed proximally as stated in the instructions for use. Primary outcomes were IBD and target hypogastric artery occlusions, type I and III endoleaks, procedure-related reinterventions, and aneurysm-related deaths. Results Technical success was achieved in 90 cases (98.9%) in group 1 versus 137 cases (97.8%) in group 2 (P =.55). The overall aneurysm-related early reintervention rate for the two groups was 4.4% (4 of 91) and 2.1% (3 of 140), respectively (P =.33). The 30-day mortality was 1.1% in group 1 (n = 1), and 0% in group 2 (P =.21). The median postoperative follow-up in groups 1 and 2 were 34.1 months (range, 1-108 months) and 17.5 months (range, 1-90 months), respectively. The estimated rates of freedom from IBD occlusion at 60 months were 86% in group 1 and 83% in group 2 (P =.69). The estimated rates of freedom from target hypogastric artery occlusion at 60 months were 98.3% in group 1 and 91.3% in group 2 (P =.45). The estimated freedom from reintervention rates at 60 months for types I, types III, and IBD stenosis-occlusion were 78.2% in group 1 and 79.9% in group 2 (P =.79). The estimated freedom from all cause reintervention at 60 months was 64.5% in group 1 and 66.1% in group 2 (P =.44). The estimated freedom from aneurysm-related death at 60 months was 97.9% in group 1 and 100% in group 2 (P =.83). Conclusions Single IBD placement for isolated common iliac artery aneurysms seems to be a safe and effective treatment option, when a proper anatomic patient selection is provided. Major benefits are represented by the decrease in X ray exposure, overall procedural time, and use of contrast medium, without affecting perioperative and long-term results in comparison with more extensive procedures. [ABSTRACT FROM AUTHOR]