The Ancure endografting system: an update.

ABSTRACT

The Ancure endografting system (Guidant Cardiac and Vascular Division, Menlo Park, Calif) features a unibody, nonsupported woven polyester graft designed to treat abdominal aortic aneurysms. It is constructed in tube, bifurcated, and aortoiliac configurations. The attachment system consists of a frame with four independent V-shaped double hooks that penetrate the arterial wall for fixation. There are separate attachment systems at the proximal and distal ends of the endoprosthesis. In September 1999, the Food and Drug Administration (FDA) approved the tube and bifurcated devices for general use. The aortoiliac device is under present consideration of the FDA. Phase II and III clinical trials of the system enrolled over 870 patients from the end of 1995 to the summer of 1999. The device was deployed successfully in 90% to 96% of cases, depending on the configuration and the phase of the trial. Mortality rates were similar to those of concurrent open surgical control rates, but serious morbidity was reduced. Long-term follow-up of the bifurcated group from phase II showed only one migration and no ruptures. Aneurysm size reduction in this group was noted in 51.3% of patients at 1 year and 68.5% at 2 years. In the same subset, type I endoleaks were noted in 2.7% at 1 year and 1.3% at 2 years. All postoperative imaging studies were reviewed by a core laboratory facility. The advantages of the ancure system include solid fixation, flexibility in accommodating morphologic changes, and excellent long-term clinical performance. The disadvantages include a large introducer system and the potential for limb obstruction by compression or angulation. However, limb compromise responds well to intraluminal stenting. The expected FDA approval of the aortoiliac device and a larger variety of graft sizes should expand the number of patients who can be treated with this system.