Background: A forward-looking, fiberoptic guided device (Safe-Cross System, Intraluminal Therapeutics, Carlsbad, CA) has been used with guided radiofrequency energy to open chronic total occlusions (CTOs). This report describes the use of optical coherent reflectometry (OCR) system to assess safety and efficacy of opening CTOs in native peripheral arteries in the lower extremities: iliac, femoral, and popliteal.
Methods: 18 CTOs in native peripheral arteries in 17 patients were treated with OCR after failed attempts with conventional wires (minimum 10 min of fluoroscopic time). When the CTO was crossed, routine angioplasty with or without stent was performed. Efficacy was defined as achievement of distal lumen position. Safety was defined as device success without perforation, dissection (> or =Grade C), or distal embolization. The mean patient age was 72 years with 8 females and 10 males. Lesion characteristics included a mean vessel diameter of 5.8 mm and a mean lesion length of 22.4 cm. Ankle-brachial indices was < or =0.8 in all patients.
Results: The OCR system was successful in crossing 100% of the CTOs in patients that failed conventional wire crossing, whereas clinical success occurred in 94% of these patients. Complications consisted of a single dissection > or =Grade C. No perforations or distal embolization occurred.
Conclusions: The Safe-Cross OCR System is both efficacious and safe in the treatment of CTOs that failed crossing with conventional wires and indirect visualization of the intraluminal position by using OCR technology appears to minimize vessel trauma, dissection, perforation, and distal embolization.
(c) 2007 Wiley-Liss, Inc.