System used for endovascular repair of iliac, aortoiliac aneurysms safe, effective

A system consisting of an iliac branch graft and a covered stent showed initial favorable results for treatment of certain patients with iliac or aortoiliac aneurysms, according to data from the PRESERVE II study.

The system combining the graft (Zenith Iliac Branch Graft, Cook Medical) and the covered stent (Atrium iCAST, Cook Medical) was tested in a prospective, nonrandomized study of 40 patients (38 men; mean age, 68 years) with iliac or aortoiliac aneurysms (62.5% with bilateral iliac aneurysms) and an unsuitable landing zone within the common iliac artery.

According to an abstract presented at the Society for Vascular Surgery Vascular Annual Meeting, the system is designed to maintain perfusion to the hypogastric artery during endovascular repair of iliac or aortoiliac aneurysms and is delivered via a 20F sheath including a preloaded catheter to aid cannulation of the side branch.

The primary endpoint was freedom from patency-related reintervention for the hypogastric artery at 6 months. Mean follow-up was 12.2 months.

Deployment success was 100% and mean procedure time was 167 minutes, Woongchae A. Lee, MD, from Boca Raton Regional Hospital, Florida, and colleagues reported.

Woongchae A. Lee

There were no deaths at 30 days and one death at day 167 due to preexisting congestive HF, according to the researchers.

Lee and colleagues also reported that there were no cases of ruptured aneurysm, conversion to open repair, type I endoleak, type III endoleak, device migration, stent fracture, renal insufficiency, renal failure necessitating dialysis or buttock claudication. There were two cases of new impotence, one at 9 days and one at 196 days.

Among patients with available CT follow-up, the rate of hypogastric artery side branch patency was 100%. Of the four patients who required a second intervention, none had a need related to the hypogastric artery side branch, according to the researchers.

The overall patency rate at 6 months was 95%.

“Initial results are favorable in supporting the safety and effectiveness of the [Zenith Iliac Branch Graft] in combination with the Atrium iCAST covered stent in preserving [hypogastric artery] perfusion,” Lee and colleagues wrote in the abstract. – by Erik Swain

Reference:

Lee WA, et al. Plenary Session 7/Late-Breaking: SS28. Presented at: Society for Vascular Surgery Vascular Annual Meeting; June 8-11, 2016; National Harbor, Md.

Disclosure: Lee reports receiving consultant fees, speaking fees and research grants from Cook Medical.