Michel S. Makaroun, MD, Professor and Chief, Division of Vascular Surgery at the University of Pittsburgh Medical Center and primary scientific advisor for the Endurant Stent Graft IDE study, presented the study findings at the 2010 VEITHsymposium™. Vascular Disease Management speaks with Dr. Makaroun about the IDE study.
You just completed the 1-year IDE study involving the Endurant Stent Graft system for EVAR. What were your findings?
The investigational device exemption (IDE) study involved 150 patients treated for AAAs with the Endurant stent graft (Medtronic, Inc., Minneapolis, Minnesota). The technical success rate was 99.3%, with zero mortality and a 4% major adverse event rate, which are remarkable figures for such a patient population. At 1 year, there have been no migrations, fractures, conversions to open surgery or any aneurysm-related mortalities. Nearly half the patients had significant shrinkage of their aneurysm around the endograft (47%). None increased in size. There were no Type I or III endoleaks, which are the serious types of endoleaks.
Will this stent graft be a game-changer, and why?
This graft will offer some advantages over previous grafts. Its stent structure and very accurate deployment system will allow patients with rather short necks of 10 mm or longer to be safely treated. Its low profile will make it suitable for many patients with iliac disease. The stent graft will still require certain anatomic characteristics to be usable and will apply to infrarenal aneurysms.
How has the Endurant Stent Graft performed in Europe, where it has been commercially available for some time?
The Endurant has performed remarkably well. A worldwide registry has now enrolled nearly 900 patients with a mortality rate of
Tell us about the learning curve with this stent. Will U.S. Physicians have any difficulties adopting it?
The endograft is remarkably user-friendly and will have a very short learning curve for experienced operators.
VASCULAR DISEASE MANAGEMENT 2011;8:E8