Low-profile stent placement with the monorail technique for treatment of renal artery stenosis: midterm results of a prospective trial.

PURPOSE

To determine feasibility, safety, and midterm patency of a monorail balloon stent device for the treatment of renal artery stenosis (RAS).

MATERIALS AND METHODS

During a period of 30 months, 47 patients (with severe hypertension, n=45; renal insufficiency, n=20) with 50 cases of RAS and indications for stent implantation (calcified ostial lesion, n=41; insufficient percutaneous transluminal angioplasty, n=6; dissection, n=3) were enrolled into the prospective evaluation. After predilation, 59 stents (Rx-Herculink 4 mm, n=2; 5 mm, n=19; 6 mm, n=35; 7 mm, n=3) were implanted under manometer control with use of the long-sheath technique (5 F; 6 F for 7-mm stents) via a femoral (n=44) or transbrachial approach (n=6). Parameters of hypertension and renal insufficiency were determined before and after the procedure and for a maximum of 18 months. Restenosis rate was determined with color duplex ultrasonography.

RESULTS

Renal artery stent placement (mean diameter, 5.7 mm; mean length, 16 mm) was technically successful in all cases (100%). Mean blood pressure and serum creatinine level decreased from 177/93 mm Hg to 145/78 mm Hg and from 1.8 mg/dL to 1.5 mg/dL, respectively. Within 48 hours after the implantation, acute occlusions occurred in two patients, supposedly triggered by cholesterol embolization. Primary and primary assisted patency rates were 87% and 92% at 6 months and 75% and 84% at 18 months.

CONCLUSIONS

Renal artery stent placement with the rapid-exchange monorail system is a safe procedure with promising patency rates. In combination with the long-sheath technique, adequate control of stent deployment is guaranteed during the entire intervention. The low profile of the device facilitates the use of small sheaths (5 F) to minimize access-site complications.