Short-Term Follow-Up Results of the Application of Chocolate Balloon Catheters in Lower Limb Arterial Lesions.

BACKGROUND

Traditional percutaneous transluminal angioplasty is insufficient for treating lower limb arterial disease. More evidence is needed to support the short-term safety and efficacy of chocolate balloon.

METHODS

Retrospective study was conducted on 113 consecutive cases treated with chocolate balloon catheter for lower limb arterial disease between September 2020 and September 2022. Primary end point is primary patency (PP) at 30 days and 12 months. Secondary end points are secondary patency, freedom from clinically-driven target lesion revascularization (CD-TLR), major target limb amputation, all-cause mortality at 30 days and 12 months.

RESULTS

A total of 110 patients and 113 limbs were treated. PP was 77.8% and freedom from CD-TLR was 87.0% at 12 months. Drug-coated balloon (P = 0.014) and poor tibial vessel outflow (P = 0.032) can affect the results. Rutherford clinical category showed significant improvement between baseline and 12 months (P < 0.001).

CONCLUSION

Chocolate balloon is safe and effective in treating lower limb arterial stenosis or occlusion, with results consistent with expectations in the early stages and after 12 months of treatment.