Re-Entry Devices in the Treatment of Peripheral Chronic Occlusions

Chronic occlusions are present in up to 40% of patients who undergo treatment for symptomatic peripheral arterial disease. The primary difficulty encountered during the treatment of chronic occlusions is inability to re-enter the true lumen after subintimal crossing of the occlusion. Two devices have been designed to mitigate this limitation via controlled re-entry. Herein, we report our experience with the Outback LTD catheter and the Pioneer Plus Catheter PPlus 120 in re-entering the true arterial lumen during percutaneous intentional extraluminal revascularization for peripheral chronic occlusions involving the superficial femoral artery. In reviewing our peripheral interventions performed from February 2006 through February 2009, we evaluated angiograms, patients' characteristics, presentations, types of lesions, procedural successes, complications, and symptom-free intervals. The total study population consisted of 23 patients. The Outback catheter was used in 15 patients and the Pioneer catheter in 8 patients. The procedure was successful in all 8 Pioneer cases (100%) and in 13 of the 15 Outback cases (87%). All 8 (100%) of the patients in the Pioneer group and 12 of the 14 patients in the Outback group (86%) remained asymptomatic at an average of 12 months. Overall, there were no procedural complications, amputations, or deaths. This single-center experience demonstrates that the Outback and Pioneer re-entry catheters are safe and effective in managing peripheral chronic occlusions, with an average symptom-free interval of 12 months. This management strategy proves to be reasonable when standard techniques fail to achieve true lumen re-entry.