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

OBJECTIVE

The aim of this study was to investigate the 1-year safety and efficacy of a new iliac side-branched device (IBD) for revascularization of the hypogastric arteries.

METHODS

Patients receiving the E-liac (Jotec GmbH, Hechingen, Germany) side-branched device at six German vascular centers either as a stand-alone procedure or in combination with abdominal aortic aneurysm exclusion were included in a prospectively created data bank. Collected data were analyzed for baseline characteristics, procedural events, and clinical follow-up; variables included endoleaks, reinterventions, and internal iliac artery (IIA) patency.

RESULTS

Between January 2012 and January 2015, a total of 70 patients (69 men [98.6%]) with a median age of 74 years (range, 51-87 years) were consecutively treated; 66 patients had aneurysmatic disease of the iliac arteries, 2 patients had a para-anastomotic aneurysm after aortobi-iliac reconstruction, and another 2 patients had a type Ib endoleak after endovascular aneurysm repair. A total of 82 IIAs were revascularized, 12 bilaterally. Technical success was achieved in 100% (82/82) of the revascularized IIAs. All IBDs were patent at the end of the procedure. No instances of myocardial infarction, stroke, conversion to open repair, mesenteric or spinal cord infarction, or buttock necrosis were observed. There was one perioperative death (1.4%) in a 70-year-old patient with intraoperative gastrointestinal bleeding leading to multiple organ failure, which resulted in the patient's death on the fifth postoperative day. Within 30 days, one symptomatic occlusion of a treated common iliac artery (CIA) was observed. In two other patients, an asymptomatic kinking of the CIA segment of the IBD was revealed in the predischarge follow-up duplex ultrasound examination and corrected with relining. Median follow-up was 12 months (range, 6-16 months). One patient was lost during the follow-up period. Survival at 1 year was 98.5% with all IIAs remaining patent, whereas two CIA and two external iliac artery limb occlusions occurred. According to life-table analysis, the freedom from occlusion in a patient was 92% at 1 year, and freedom from type I endoleak was 87% at 1 year.

CONCLUSIONS

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.