Procedural and Early Outcomes of Two Re-entry Devices for Subintimal Recanalization of Aortoiliac and Femoropopliteal Chronic Total Occlusions

BACKGROUND AND OBJECTIVES: Subintimal angioplasty is a common treatment choice for chronic total occlusions (CTO) in the iliac and femoropopliteal arteries. This article describes the technical aspects and early outcomes of two different re-entry devices and comparison with manual re-entry technique. SUBJECTS AND METHODS: A retrospective review of 61 patients (re-entry group) treated with Outback or Pioneer Plus catheters was carried out. A matched cohort of patients (n=62) who underwent lower extremity interventions without the use of re-entry devices (manual re-entry group) were also analyzed (overall 123 patients were analyzed). Procedural success, procedural durations, patency estimates, ankle-brachial indices, and complications were analyzed. RESULTS: Sixty-one patients underwent Outback or Pioneer Plus guided subintimal recanalization. After the procedure, ankle-brachial indices significantly increased in all patients during follow-up. Primary patency for the entire cohort was 83% in the first month. When the re-entry device group was compared with manual re-entry group, no difference was found with respect to success, complication, and patencies between the two groups during follow-up. However, procedure duration and the amount of contrast agent used was significantly decreased in re-entry groups (p<0.001). Also, re-entry time was significantly decreased in Pioneer plus group according to Outback group (p<0.001) CONCLUSION: Recanalization of CTO using re-entry devices for aortoiliac or femoropopliteal arteries is safe and effective. These devices shorten the procedure time, the re-entry time, reduce radiation risk, and reduce the amount of contrast agent employed.