Percutaneous recanalization of lower limb chronic total occlusions via tibial artery access using the BeBack™ crossing catheter.

Objectives: The study aims to evaluate the safety and efficacy of the BeBack™ crossing catheter for percutaneous recanalization of lower limb chronic total occlusions (CTO) via tibial artery access in patients with chronic limb-threatening ischemia (CLTI).

Methods: This single-center, retrospective study included 21 patients who underwent 22 limb recanalization procedures between May 2021 and April 2024. The BeBack™ catheter was utilized after traditional methods of recanalization failed. Patients aged 18 years or older with peripheral artery disease (PAD) and treated exclusively through the tibialis anterior artery were included. Data on demographics, occlusion characteristics, procedural details, and outcomes were collected from hospital records. Procedural success was defined as achieving less than 30% residual stenosis and an improvement in the ankle-brachial index (ABI) by at least 0.2 within 24 h.

Results: The median patient age was 77 years (IQR 73-81.5), with the majority being male (71%). Technical success was achieved in 95% of cases (21/22), and procedural success was achieved in 91% (20/22) cases. The device was primarily used for re-entry (77%), with a minority of cases (23%) where it was used as a crossing device. The most frequently treated artery was the superficial femoral artery (95%). One procedural failure was noted due to an inability to traverse a heavily calcified occlusion. Complications included one case of intra-procedural acute thrombosis, which was resolved, and one instance of post-procedural pulmonary edema, treated with diuretics. No reinterventions or amputations were required during the 30-day follow-up, although there were three mortalities (14%).

Conclusions: The BeBack™ crossing catheter demonstrated high technical success and a low complication rate for recanalizing lower limb CTOs via a single tibial artery access. These findings suggest that the BeBack™ catheter could be an effective and safe option for managing complex CTOs, particularly when traditional approaches are not feasible. Further prospective studies are needed to validate these results and compare them with other crossing and re-entry devices.