Development of a new intravascular low-profile device for exclusion of aortic aneurysm: an experimental pilot study.
OBJECTIVE
To present a new intravascular device for the treatment of aorto-iliac aneurysms.


METHODS
This new device was tested in five dogs with abdominal aortic aneurysm created experimentally by over-dilation of a balloon-expandable stent with a 16 or 18 mm wide PTA balloon catheter. The design of the device is based on a self-expanding aortic stent which consists of two stretchable circular frames filled with a textile Dacron mesh membrane that is suspended horizontally into the infrarenal abdominal aorta proximally to the aneurysm. The frames are part of a preshaped double helical structure that is introduced longitudinally through a catheter in a parallel fashion and forming the desired shape at the vessel site to be occluded. Two iliac stent-grafts are introduced in a low-profile status through the membrane sealing the aneurysm sac and holding the stent-grafts in place. After stent-graft expansion, a new bifurcation located more proximally than the natural one is created. The follow-up of the dogs was performed clinically and angiographically, and specimens were evaluated histomorphologically.


RESULTS
The membrane device can be introduced through a 9 Fr vascular sheath. Technical success was achieved in four of five dogs. Nine of ten stent-grafts could be fixed securely within the membrane, thus preventing dislocation. Aneurysms were excluded immediately, and blood flow to the external iliac arteries was restored by the stent-grafts. At 6-9 months follow-up of technically successful implanted devices, there were no endoleaks, no migration, no stenoses at contact sites between the implant material and vascular wall, and no stenosis or occlusion of the stent-grafts. At microscopic evaluation, the interspace between the membranes was filled with thrombotic material, thus ensuring exclusion of the aneurysm.


CONCLUSIONS
This new device was found to be flexible, low profile and useful in excluding abdominal aortic aneurysm in the experimental setting.
Strecker
Ernst-Peter
EP
Department of Imaging, Interventional Radiology and Nuclear Medicine, Diakonissen-Hospital, Karlsruhe, Germany.
Haberstroh
Jörg
J
Boos
Irene
I
Metz
Stephan
S
Langer
Mathias
M
Moliner
Manuel Maynar
MM
D000818:Animals; D017544:Aortic Aneurysm, Abdominal / Q000000981:diagnostic imaging / Q000628:therapy*; D021721:Balloon Occlusion / Q000295:instrumentation*; D019917:Blood Vessel Prosthesis Implantation / Q000379:methods; D004195:Disease Models, Animal; D004285:Dogs; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D008297:Male; D010865:Pilot Projects; D018583:Pliability; D011859:Radiography; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D015607:Stents; D016896:Treatment Outcome