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October 22, 2013

Iliac Bifurcation Devices Studied for Endovascular Aortoiliac Aneurysm Repair

October 16, 2013—In the Journal of Vascular Surgery (JVS), Shen Wong, MD, et al published midterm results in the treatment of common and internal iliac artery (CIA and IIA) aneurysms with a helical iliac branch device (H-IBD) and present outcomes with a bifurcated-bifurcated (BB) IBD to treat disease in short CIAs (2013;58:861–869).

The investigators noted that there are two available IBD devices—the H-IBD, which is evaluated in this study, and a straight IBD; however, IBD treatment of CIA and IIA aneurysms has been controversial in the context of available embolization techniques or off-label adjunctive procedures. Dr. Wong and colleagues are from the Cleveland Clinic Foundation in Cleveland, Ohio.

As summarized in JVS, the investigators prospectively collected data from IBD-treated patients with infrarenal aortoiliac or thoracoabdominal aortoiliac aneurysms. Preoperative aneurysmal characteristics were collected in accordance with the endovascular reporting standards document, including presence of IIA stenosis, CIA diameters, and the presence of an IIA aneurysm. Technical success was defined as IBD device placement, branch placement, and patency without type I or III endoleak at implantation in addition to 24-hour survival.

Follow-up CT scans at 1, 6 (optional), and 12 months, and annually thereafter, were performed, and reinterventions, sac morphology changes, and endoleaks were noted. Survival and patency were evaluated with life-table analyses. Differences among anatomic groups were compared with log-rank tests, whereas t-tests and Fisher exact tests were used to compare simple variables.

Between 2003 and 2012, 138 IBD devices (98 H-IBD, 40 BB-IBD) were placed into 130 patients. Median follow-up was 20.3 months (range, 1–72 months), with 30-day, 12-month, 3- and 5-year survival rates of 99%, 90%, 79%, and 62%, respectively. Technical success was 94%, and branch patency was 94.6% at 30 days and 81.8% at 5 years.

In JVS, the investigators reported that 35% of branches were placed into patients with IIA aneurysms (in addition to their proximal disease), 20% into stenotic IIAs, and 46% into iliac systems with narrow (< 16 mm) CIAs. Technical success was significantly lower in patients with IIA stenosis (81.5% vs 96.4%; Fisher exact test, P = .015), but was not affected by the presence of an IIA aneurysm or narrow CIA. Branch patency was similar in all groups throughout follow-up. No stent fractures or component separations were noted in the IBDs or mating devices throughout the study period.

The H-IBD and BB-IBD configurations have high technical success and acceptable long-term patency for the treatment of CIA and IIA aneurysms, including those with challenging anatomy difficult to treat with the straight branch design, concluded the investigators in JVS.

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October 23, 2013

European Commission Adopts New Safety Measures for Medical Devices

October 23, 2013

European Commission Adopts New Safety Measures for Medical Devices


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