Showing papers by "Blayne A. Roeder published in 2016"

Commentary: Proximal Uncovered Stent Disconnections With the Standard and Low-Profile Zenith AAA Stent-Grafts.

Abstract: In this issue of the JEVT, Torres-Blanco and colleagues and Lindstrom and colleagues alert us to the disconnection of the proximal suprarenal uncovered stent in the Zenith abdominal aortic aneurysm (AAA) stent-grafts (Cook Medical, Bloomington, IN, USA). Disconnections of the proximal uncovered stent are indeed infrequent but were noted with the first generation of the stent prior to 2002. At that time, the device was modified with double suture reinforcement to secure the uncovered stent. Since this modification was introduced, the problem of uncovered stent disconnection has become very rare. Failure of aortic stent-grafts is most often multifactorial (Figure 1). Although there is usually a leading cause, stentgraft failure is often due to overlapping factors. These can be grouped in 3 categories: patient (eg, poor anatomy or progression of aortic disease), physician (eg, selection of improper treatment, faulty or inaccurate deployment or device selection), and device factors (eg, integrity or design issues). The proximal suprarenal stent was designed to optimize seal by adding fixation to the aorta to stop migration. The problem highlighted in this issue of the JEVT reflects a device integrity issue, ultimately disconnection of the uncovered stent. An aortic stent-graft is subjected to longterm cyclic forces acting to displace the stent-graft. Moreover, these forces must be overcome in the setting of continual changes in aortic neck configuration. Albeit rare, this structural failure highlights the importance of continued lifelong surveillance of endografts, regardless of specific type or manufacturer. It is critical that we analyze device successes or failures in the context of the specific anatomic conditions for which the devices are approved. The Cook Zenith AAA stent-graft was tested clinically and approved for use in normal aortic segments of at least 15-mm length with <60° angulation. Although these requirements represent ideal conditions, numerous reports indicate that technical and clinical success can sometimes be achieved outside these strict anatomic recommendations. It is important to note that prospective trials of AAA devices to support Food and Drug Administration (FDA) approval include only patients treated within the instructions for use (IFU). These patients are followed for 5 years. There is a paucity of prospective clinical data on outside IFU use of any AAA device. Use of any AAA device outside the IFU should be undertaken with extreme caution. 636029 JETXXX10.1177/1526602816636029Journal of Endovascular TherapyOderich and Roeder research-article2016