Protected renal stenting with the PercuSurge GuardWire device: a pilot study.

PURPOSE: To evaluate the feasibility and safety of renal artery angioplasty and stenting utilizing a distal protection device to reduce the risk of intraprocedural atheroembolism. METHODS: Twenty-eight hypertensive patients (18 men; mean age 71.3 +/- 8.6 years, range 49-87) with atherosclerotic renal artery stenosis (4 bilateral) underwent angioplasty and stenting with distal protection in 32 renal arteries (29 ostial lesions). The lesion was crossed with a GuardWire temporary occlusion balloon, which was inflated to provide parenchymal protection. Generated debris was aspirated and analyzed. Blood pressure and serum creatinine levels were followed. RESULTS: Immediate technical success was 100%. All lesions were stented, either directly (14 ostial lesions), after predilation (15 ostial lesions), or owing to suboptimal angioplasty (3 nonostial lesions). Visible debris was aspirated from all patients. Mean particle number and diameter were 98.1 +/- 60.0 per procedure (range 13-208) and 201.2 +/- 76.0 microm (range 38-6206), respectively. Mean renal artery occlusion time was 6.55 +/- 2.46 min (range 2.29-13.21). Mean follow-up was 6.7 +/- 2.9 months (range 2-17). Systolic and diastolic blood pressure declined from 167.0 +/- 15.2 and 103.0 +/- 12.0 mm Hg, respectively, to 154.7 +/- 12.3 and 93.2 +/- 6.8 mm Hg after the procedure. The mean creatinine level dropped from 1.34 +/- 0.35 mg/dL preprocedurally to 1.22 +/- 0.36 mg/dL at 24 hours and remained constant. At 6-month follow-up, renal function did not deteriorate in any patient, whereas 5 patients with baseline renal insufficiency improved after the procedure. CONCLUSIONS: These preliminary results suggest the feasibility and safety of distal balloon occlusion during renal interventions to protect against atheroembolism. This technique's beneficial effects should be evaluated by randomized studies.