OBJECTIVE: To report the efficacy and safety of the Outback(®) LTD(®) Re-Entry Catheter in reentering the distal true lumen during percutaneous intentional extraluminal revascularization (PIER).

BACKGROUND: Reentry catheters are used to treat chronic, total arterial occlusions of the lower extremities when standard methods of recanalization have failed. Success and complication rates of these catheters in the real world are uncertain and variable.

METHODS: A retrospective review of our peripheral catheterization database from January 2004 to September 2009 was undertaken to identify consecutive cases of peripheral chronic total occlusions (CTOs) requiring the use of the Outback reentry catheter. Patient demographics, indication for the procedure, location and extent of occlusion, procedural success, and complications were studied.

RESULTS: A total of 51 patients were identified. Of the 51, 28 (54.9%) patients presented with nonhealing ulcer and 22 (43.1%) had lifestyle-limiting claudication. One patient presented with acute limb ischemia. There were 6 (11.8%) patients with common iliac artery occlusion, 2 (3.9%) with external iliac artery occlusion, 1 (1.9%) with common femoral artery occlusion, 35 (68.6%) with superficial femoral artery occlusion, 6 (11.8%) with popliteal artery occlusion, and 1 (1.9%) with tibioperoneal artery occlusion. Median lesion length was 230 mm. Procedural success was achieved in 49 patients (96.1%). There was 1 (1.9%) periprocedural complication.

CONCLUSION: Use of Outback(®) LTD(®) Re-Entry Catheter is a safe and valuable option for PIER/subintimal angioplasty and recanalization in patients with symptomatic lower-extremity CTOs. However, long-term patency remains unknown.