Abstract 3838: Renal Angioplasty and Stenting Under Protection. Limitations. First human Study with a 3D filter: The FiberNet TM
Background: It is clear that atheroemboli are the rule in any intervention in atherosclerotic disease and the leading cause of complications during PCI, carotid angioplasty, but probably also after renal angioplasty stenting (RAS) which could explain the renal function deterioration after RAS observed in 20–30 % of the cases. Several series of RAS under protection were reported using different embolic protection devices (EPD), but current EPD have significant limitations: vessel wall apposition, blood flow blockage, deliverability, long landing zone requirements. These limitations may be addressed by a new EPD, the FiberNetTM (Lumen Biomedical Inc, Plymouth MN).
Methods: The system consists of a 3 dimensional expandable filter made of unique fibers, which expand radially to fill the vessel lumen, mounted onto a 190 cm long 0.014 wire and an aspiration catheter. The filter can fill vessels ranging from 1.75 to 7 mm in diameter without requiring a disease free landing zone. On the bench this filter had a capture efficiency of 96 % of emboli with captured particles as small as 40 microns.
Results: After a series of 113 protected renal angioplasties performed with current EPDs, we began the first human study with FiberNetTM. 4 ostial lesions were treated in 4 hypertensive patients. Mean age 58 years, average stenosis 79 %. FiberNet crossed all lesions without predilatation. Technical success 100 %. No complication. All samples visually contained significant amount of emboli. Mean debris area: 117 mm2. Debris analysis will be reported as well as comparative data with others EPD in a larger series of patients treated with FiberNet.
Conclusion: The first human use of this new novel EPD in RAS is encouraging. The FiberNet was easy to use and confirmed the ability to capture particles less than 100 microns without compromising the flow. Additional patients will demonstrate the overall performance of this new EPD.