The Ancure endografting system: An update

The Ancure endografting system (Guidant Cardiac and Vascular Division, Menl o Park, Calif) features a unibody, non-supported woven polyester graft desi gned to treat abdominal aortic aneurysms. It is constructed in tube, bifurc ated, and aortoiliac configurations. The attachment system consists of a fr ame with four independent V-shaped double hooks that penetrate the arterial wall for fixation, There are separate attachment systems at the proximal a nd distal ends of the endoprosthesis. In September 1999, the Food and Drug Administration (FDA) approved the tube and bifurcated devices for general u se. The aortoiliac device is under present consideration of the PDA. Phase II and III clinical trials of the system enrolled over 870 patients from th e end of 1995 to the summer of 1999. The device was deployed successfully i n 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 co ntrol rates, but serious morbidity was reduced. Long-term follow-up of the bifurcated group from phase II showed only one migration and no ruptures. A neurysm size reduction in this group was noted in 51.3% of patients at 1 ye ar 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 syste m 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 compressi on or angulation. However, limb compromise responds well to intraluminal st enting. The expected FDA approval of the aortoiliac device and a larger var iety of graft sizes should expand the number of patients who can be treated with this system.