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 in traprocedural atheroembolism. Methods: Twenty-eight hypertensive patients (18 men; mean age 71.3 +/-8.6 y ears, range 49-87) with atherosclerotic renal artery stenosis (4 bilateral) underwent angioplasty and stenting with distal protection in 32 renal arte ries (29 ostial lesions). The lesion was crossed with a GuardWire temporary occlusion balloon, which was inflated to provide parenchymal protection. G enerated debris was aspirated and analyzed. Blood pressure and serum creati nine levels were followed. Results: Immediate technical success was 100%. All lesions were stented, ei ther directly (14 ostial lesions), after predilation (15 ostial lesions), o r 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 mum (range 38-6206) , respectively. Mean renal artery occlusion time was 6.55 +/-2.46 min (rang e 2.29-13.21). Mean follow-up was 6.7 +/-2.9 months (range 2-17). Systolic and diastolic b lood pressure declined from 167.0 +/- 15.2 and 103.0 +/- 12.0 mm Hg, respec tively, to 154.7 +/- 12.3 and 93.2 +/-6.8 mm Hg after the procedure. The me an 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, ren al function did not deteriorate in any patient, whereas 5 patients with bas eline renal insufficiency improved after the procedure. Conclusions: These preliminary results suggest the feasibility and safety o f distal balloon occlusion during renal interventions to protect against at heroembolism. This technique's beneficial effects should be evaluated by ra ndomized studies.