Development of a New Intravascular Low-Profile Device for Exclusion of Aortic Aneurysm: An Experimental Pilot Study
- Diakonissen-Hospital, Department of Imaging, Interventional Radiology and Nuclear Medicine (Germany)
- University Clinics, Surgical Research (Germany)
- University of Heidelberg, Institute of Anatomy and Cell Biology III (Germany)
- University Clinics, Department of Radiology (Germany)
- University of Caceres, Minimally Invasive Surgery Center (Spain)
Purpose: 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 overdilation 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. Conclusion: This new device was found to be flexible, low profile and useful in excluding abdominal aortic aneurysm in the experimental setting.
- OSTI ID:
- 21088262
- Journal Information:
- Cardiovascular and Interventional Radiology, Vol. 27, Issue 3; Other Information: DOI: 10.1007/s00270-004-0065-x; Copyright (c) 2004 Springer-Verlag; Article Copyright (c) 2004 Springer-Verlag New York, Inc; Country of input: International Atomic Energy Agency (IAEA); ISSN 0174-1551
- Country of Publication:
- United States
- Language:
- English
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