OBJECTIVE: To evaluate the procedural safety and filter efficiency of Lumen Biomedical FiberNet® embolic protection system in conjunction with primary stenting of ostial atherosclerotic renal artery lesions. BACKGROUND: There is limited data regarding the utility of distal embolic protection devices in renal artery angioplasty and stenting. METHODS: Patients with angiographically severe (≥70%) renal artery stenosis were prospectively enrolled if one or more inclusion criteria met: resistant hypertension, progressive chronic kidney disease, unexplained heart failure, or flash pulmonary edema. Patients underwent renal artery angioplasty and stenting with utilization of the Lumen Biomedical FiberNet® EPS. The protection devices and aspirate were analyzed for degree of atheromatous particles. Procedural safety and clinical outcomes were assessed through 6 months. RESULTS: Twenty patients were prospectively enrolled at five centers; average age 73.8 (±9.5) years, mean baseline eGFR 60.8 cm(3) min(-1). Twenty-five renal artery stenting procedures were performed. Device and procedural success were achieved in 100% of cases. All patients tolerated the procedure without any adverse events. Embolic debris was captured in all cases. Debris analysis of the distal protection system displayed an average post procedure atheroma area of 51.31 mm(2). There was no clinical evidence of peripheral atheroembolization through 30-days follow-up. No subjects progressed to temporary or permanent renal replacement therapy. Favorable trends in blood pressure control were observed at 6 months. CONCLUSION: The Lumen Biomedical FiberNet® embolic protection system is a safe and feasible method to prevent atheroembolization associated with angioplasty and stenting of renal artery ostial lesions.
OBJECTIVE: To evaluate the procedural safety and filter efficiency of Lumen Biomedical FiberNet® embolic protection system in conjunction with primary stenting of ostial atherosclerotic renal artery lesions. BACKGROUND: There is limited data regarding the utility of distal embolic protection devices in renal artery angioplasty and stenting. METHODS:Patients with angiographically severe (≥70%) renal artery stenosis were prospectively enrolled if one or more inclusion criteria met: resistant hypertension, progressive chronic kidney disease, unexplained heart failure, or flash pulmonary edema. Patients underwent renal artery angioplasty and stenting with utilization of the Lumen Biomedical FiberNet® EPS. The protection devices and aspirate were analyzed for degree of atheromatous particles. Procedural safety and clinical outcomes were assessed through 6 months. RESULTS: Twenty patients were prospectively enrolled at five centers; average age 73.8 (±9.5) years, mean baseline eGFR 60.8 cm(3) min(-1). Twenty-five renal artery stenting procedures were performed. Device and procedural success were achieved in 100% of cases. All patients tolerated the procedure without any adverse events. Embolic debris was captured in all cases. Debris analysis of the distal protection system displayed an average post procedure atheroma area of 51.31 mm(2). There was no clinical evidence of peripheral atheroembolization through 30-days follow-up. No subjects progressed to temporary or permanent renal replacement therapy. Favorable trends in blood pressure control were observed at 6 months. CONCLUSION: The Lumen Biomedical FiberNet® embolic protection system is a safe and feasible method to prevent atheroembolization associated with angioplasty and stenting of renal artery ostial lesions.