An in situ adjustable endovascular graft for the treatment of abdominal aortic aneurysms.
Twenty-nine patients underwent placement of the Teramed Ariba Endovascular Graft System (Maple Grove, Minn) as part of a European Feasibility study (14 patients) and a US phase I trial (15 patients). Salient features of this modular endograft system include a crimped seamless polyester bifurcation graft supplied in three diameters and three iliac limb lengths, three types of nitinol stents including a suprarenal stent with aortic barbs, a flexible delivery system capable of controlled incremental sheath retraction, a flexible tapered lead balloon, and a telescoping technique for adjusting the length of graft coverage during surgery over a range of 3 cm. Twenty-eight of the 29 patients met the primary objective of this evaluation, which was to confirm the safety of the system, defined as the absence of major device-related adverse events and type I, III, or IV endoleaks within 1 month of implantation. Three major adverse events occurred within 1 month of discharge: renal failure, which was related to deployment of the device close to the renal arteries; pulmonary edema, which was related to the procedure but not the device; and peripheral ischemia, which was related to the patient's pre-existing condition. Seven patients had type II endoleaks noted by means of computed tomography scanning at 1 month; the endoleaks were identified by means of angiography and classified at the time of surgery. There were no deaths, aneurysm ruptures, stent-graft migrations, stent fractures, graft ruptures, graft thromboses, or surgical conversions at 1 month. This early clinical experience indicates that the Ariba Bifurcated Endovascular System can be safely implanted.
Brener
Bruce J
BJ
Newark Beth Israel Medical Center, 201 Lyons Ave., Newark, NJ 07112, USA. bbrener@sbhcs.com
Faries
Peter
P
Connelly
Timothy
T
Sefranek
Vladmir
V
Hertz
Steven
S
Kirksey
Lee
L
Hollier
Larry
L
Marin
Michael L
ML
D000368:Aged; D000369:Aged, 80 and over; D000792:Angiography; D001012:Aorta, Abdominal / Q000000981:diagnostic imaging / Q000601:surgery; D017544:Aortic Aneurysm, Abdominal / Q000000981:diagnostic imaging / Q000601:surgery*; D019917:Blood Vessel Prosthesis Implantation / Q000295:instrumentation*; D004724:Endoscopy; D004867:Equipment Design / Q000295:instrumentation; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017755:Prosthesis Fitting; D015607:Stents; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D014656:Vascular Surgical Procedures / Q000295:instrumentation*