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Percutaneous recanalization of lower limb chronic total occlusions via tibial artery access using the BeBack™
Boris Khaitovitch1,2, Israel Cohen1,2, Efrat K Gilat1,2
1Division of Diagnostic Imaging, Sheba Medical Center, Israel.
Insights
The BeBack™ catheter shows high success in reopening blocked leg arteries for chronic limb-threatening ischemia patients. This device offers a safe option for complex cases when other methods fail.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Endovascular Therapy
Background:
- Chronic limb-threatening ischemia (CLTI) presents significant challenges in lower limb revascularization.
- Percutaneous recanalization of chronic total occlusions (CTOs) is crucial for limb salvage.
- Tibial artery access offers an alternative route for complex lower limb interventions.
Purpose of the Study:
- To evaluate the safety and efficacy of the BeBack™ crossing catheter.
- To assess its utility in percutaneous recanalization of lower limb CTOs.
- To investigate its use via tibial artery access in CLTI patients.
Main Methods:
- Single-center, retrospective study of 21 patients (22 procedures) with CLTI.
- BeBack™ catheter used after failure of traditional recanalization methods.
- Inclusion criteria: PAD, age ≥18, tibialis anterior artery access.
Main Results:
- High technical success (95%) and procedural success (91%) achieved.
- Device primarily used for re-entry (77%) in superficial femoral artery occlusions.
- Low complication rate, with no reinterventions or amputations within 30 days.
Conclusions:
- BeBack™ catheter demonstrates high success and safety for lower limb CTO recanalization via tibial access.
- It is a viable option for complex CTOs when conventional techniques fail.
- Further prospective studies are warranted to confirm findings and compare devices.
Abstract:
ObjectivesThe 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).MethodsThis 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.ResultsThe 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%).ConclusionsThe 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.
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