Endovascular placement of a nitinol-ePTFE stent-graft for abdominal aortic aneurysms: initial and midterm results.
OBJECTIVE
Because first-generation stent-grafts did not meet initial expectations, a recently designed nitinol-expanded polytetrafluoroethylene (ePTFE) stent-graft was tested for treatment of abdominal aortic aneurysms (AAAs) in a prospective clinical study. The primary study endpoints were technical success and safety.


METHODS
A nitinol-ePTFE self-expandable stent-graft (Excluder) was used to treat 72 patients with AAAs. The median follow-up period was 21.5 months +/- 13 (range, 1-46 mo).


RESULTS
Primary technical success in accurate placement of the device was achieved in 70 of 72 patients (97%). Complete exclusion of the aneurysm from arterial flow was achieved in 57 of 72 patients (79.2%). Three type I leaks were observed during implantation and were immediately corrected with a proximal cuff prosthesis in two patients. Fourteen of 72 patients (19.4%) had a type II leak. Major complications were observed in three patients (4.1%), including one death in the early postinterventional period (one of 72, 1.4%). At 3 months, aneurysms were excluded in 70 of 71 patients (98.6%), and at 12 months, aneurysms were occluded in 29 of 30 patients (96.7%). The maximum diameter of the aneurysm decreased from 55 mm +/- 11 (median +/- SD) before intervention to 53 mm +/- 13 at 6 and 12 months. None of the patients showed aneurysm growth.


CONCLUSIONS
This newly designed stent-graft proved to be effective and safe for treatment of AAAs.
Cartes-Zumelzu
Fabiola
F
Department of Angiography and Interventional Radiology, Universitätsklinik für Radiodiagnostik, University Clinic-Vienna, Waehringer Guertel 18-20, 1090-Vienna, Austria. fabiola.cartes-zumelzu@rad.akh.magwien.gv.at
Lammer
Johannes
J
Hoelzenbein
Thomas
T
Cejna
Manfred
M
Schoder
Maria
M
Thurnher
Siegfried
S
Kretschmer
Georg
G
D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys / Q000627:therapeutic use*; D017544:Aortic Aneurysm, Abdominal / Q000401:mortality / Q000601:surgery*; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000401:mortality / Q000601:surgery; D019917:Blood Vessel Prosthesis Implantation; D002097:C-Reactive Protein / Q000378:metabolism; D020099:Coated Materials, Biocompatible / Q000627:therapeutic use; D003131:Combined Modality Therapy; D023381:Endpoint Determination; D004869:Equipment Safety; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007083:Iliac Artery / Q000000981:diagnostic imaging; D007249:Inflammation / Q000097:blood / Q000209:etiology; D007902:Length of Stay; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D011138:Polytetrafluoroethylene / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000209:etiology / Q000401:mortality; D011446:Prospective Studies; D011474:Prosthesis Design; D015641:Radiography, Interventional; D015607:Stents; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome; D014655:Vascular Resistance / Q000187:drug effects / Q000502:physiology
D000497:Alloys; D020099:Coated Materials, Biocompatible; C013616:nitinol; D011138:Polytetrafluoroethylene; D002097:C-Reactive Protein