ENDOVASCULAR GRAFTING OF ABDOMINAL AORTIC-ANEURYSMS - A PRELIMINARY-STUDY

Objective The authors report the experience of a single investigationa l center involving two Phase I and a Phase II clinical trials approved by the Food and Drug Administration (FDA) for the transfemoral implan tation of woven Dacron grafts for abdominal aortic aneurysms. Summary Background Data In 1993, EndoVascular Technologies, Inc. ([EVT]; Menlo Park, CA), began an FDA-approved clinical trial of repair of abdomina l aortic aneurysms by transfemoral placement of a tube endograft. Subs equently, a bifurcated endograft trial was started, This is the first single institution report using the EVT endograft for both tube and bi furcated aortic replacement. Methods Seventeen patients were enrolled in two Phase I and one Phase II clinical trials. The Phase I tube graf t trial and the Phase I bifurcated graft trial were nonrandomized stud ies. The Phase II tube graft trial consisted of a randomized prospecti ve control trial of open endoaneurysmorrhaphy versus transfemoral plac ement of an endograft. Results Seventeen patients were enrolled in the trial. The graft was placed successfully in all but one patient. Five patients randomized to open procedure and one declined to participate . Eleven patients with endografts are available for follow-up. One gra ft has been explanted for attachment system migration. One patient is a late failure because of persistent filling of the aneurysm sac. Conc lusion Transfemoral placement of an endovascular graft is a viable and effective treatment of abdominal aortic aneurysms in the short term. Use of a bifurcated endograft will open the procedure to more patients . The ideal attachment system and graft material await long-term impla ntation follow-up.