A prospective analysis of fenestrated endovascular grafting: intermediate-term outcomes

Abstract

Purpose: To assess the intermediate-term outcomes following fenestrated grafting for juxtarenal aneurysms.

Materials and methods: A prospective trial was conducted on patients with short proximal necks, who were considered to be high-risk for open repair and unacceptable for conventional endovascular repair. Devices were designed from reconstructed CT data. Follow-up studies included CT, duplex ultrasound, and KUB and occurred at hospital discharge, 1, 6, and 12 months and annually thereafter.

Results: One hundred and nineteen patients were treated (2001-2005). Mean age and aneurysm size were 75 years and 65 mm, respectively, and 82% were male. A total of 302 visceral vessels were inferior to the fabric seal (a mean of 2.5 vessels per patient), with the most common design incorporating two renal arteries and the SMA (58%). All prostheses were implanted successfully without any acute visceral artery loss. The mean follow-up was 19 months (0-42 months). One patient died within 30 days of device implantation. Kaplan-Meier estimates of survival at 1, 12, 24, and 36 months are 0.99, 0.92, 0.83 and 0.79. There were no ruptures or conversions. Pre-discharge imaging noted 11 type I and type III endoleaks. The 30-day endoleak rate was 10% (all type II). Aneurysm sac size decreased (>5 mm) in 51, 79 and 77% at 6, 12 and 24 months, respectively. One patient had sac enlargement within the first year, associated with a persistent type II endoleak. In-stent stenoses occurred in 12 renal arteries and one SMA. Six renal arteries and the SMA stenosis were treated and two renal stenoses are awaiting treatment. Ten of 231 stented renal arteries occluded (three prior to discharge), one of which was recanalized. One component separation was treated with an extension at 2 years.

Conclusions: The placement of endovascular prostheses with graft material incorporating the visceral arteries is safe and appears to be effective at preventing rupture. Continued follow-up to assess the long-term benefit, aneurysm sac behavior and effect of stenting upon the visceral ostia remains critical.