• Vascular Annual Meeting
• Call for Abstracts
• General Information
• Exhibitor Information
• Alumni Association Information
• 2009 Meeting Information
• Future Meeting Dates
• Contact Us

Home > Vascular Annual Meeting > LB4. Intermediate Results of a US Multicenter Trial...

LB4. Intermediate Results of a US Multicenter Trial of Fenestrated Endograft Repair for Juxtarenal Abdominal Aortic Aneurysms

Roy K. Greenberg 1, W. Charles Sternbergh, III2,  Michel Makaroun3, Takao Ohki4, Timothy Chuter5, Priya Bharadwaj6, Alan Saunders7, for the Fenestrated Investigators
1Cleveland Clinic Foundation, Cleveland, OH; 2Oschner Clinic, New Orleans, LA; 3University of Pittsburgh Medical Center, Pittsburgh, PA; 4Jikei University School of Medicine, Tokyo, Japan; 5University of California, San Francisco, CA; 6MED Institute, Inc, West Lafayette, IN

OBJECTIVES: To report the intermediate-term (24-month) outcomes of a prospective multi-center trial designed to evaluate the Zenith Fenestrated AAA Endovascular Graft for treating juxtarenal abdominal aortic aneurysms.

METHODS: Six centers in the US enrolled 30 patients with juxtarenal aortic aneurysms with ≥ 50 mm diameter and short proximal necks. The aims of the study were to evaluate the safety and preliminary effectiveness of the device, assess the physician learning curve, refine patient selection criteria, and develop experienced physicians. Devices were custom-designed for each patient based on measurements from reconstructed CT data. Follow-up studies included physical examinations, laboratory studies, CT imaging, mesenteric-renal duplex ultrasound, and KUB at hospital discharge, 1 month, 6 months, 12 months, and yearly thereafter up to 5 years.

RESULTS: Thirty patients (80% male, mean age 75 years, mean aneurysm size 61.4 mm) were enrolled over a period of one year. A total of 77 visceral vessels in these 30 patients were accommodated by fenestrations located within the sealing segment of the grafts. The most common design accommodated two renal arteries and the superior mesenteric artery (66.7%). All prostheses were implanted successfully without any acute loss of visceral arteries. Of the 30 patients treated, 27 were available for 12-month follow-up and 23 were available for 24-month follow-up. No aneurysm-related deaths, aneurysm ruptures, or conversions were observed through 24 months of follow-up. No type I or type III endoleaks were observed at any time point. Type II endoleaks were noted in 26.1% (6/23) and 20.0% (4/20) of the patients at 12 and 24 months, respectively. There were no cases of aneurysm growth > 5 mm. Aneurysm size decreased in 69.6% (16/23) of the patients and was stable in the remaining patients at 24 months. Eight patients experienced evidence of some renal event (4 renal artery stenoses, 2 renal artery occlusions, and 2 renal infarcts), and among them, 5 underwent secondary interventions. None of the patients developed renal failure requiring dialysis.

CONCLUSIONS: The placement of fenestrated endovascular grafts is feasible at centers with experience in endovascular aneurysm repair and renal/mesenteric stent placement. The intermediate-term (24-month) results are concordant with other studies at single centers and support the concept that this technology is safe, effective, and transferable across multiple centers.  

AUTHOR DISCLOSURES: R.K. Greenberg, Grants/Research Support: Cook, W.L. Gore, Terrarecon, Consultant: Cook, Other Financial/Material Support: Cook, Intellectual Property Rights; W.C. Sternbergh, III, Consultant: Cook, W.L. Gore; M. Makaroun, None; T. Ohki, None; T. Chuter, Grants/Research Support: Cook Medical, Inc, Consultant: Cook Medical, Inc, Other Financial/Material Support: Cook Medical, Inc; P. Bharadwaj, Other Financial/Material Support: Cook Incorporated; A. Saunders, Other Financial/Material Support: Cook Incorporated.