Clinical Outcomes of Balloon-Only Venous Arterialization for Chronic Limb-Threatening Ischemia After Failed or Unfeasible Revascularization.

PURPOSE: To evaluate the efficacy and safety of balloon-only venous arterialization (BOVA) in patients with chronic limb-threatening ischemia (CLTI) and refractory ischemic ulcers after failed or no feasible conventional revascularization.

MATERIALS AND

METHODS

This multicenter retrospective cohort study included 56 limbs treated with BOVA at five Japanese institutions between May 2021 and December 2023. The primary efficacy outcome was 12-month complete wound healing, and the primary safety outcomes were 12-month freedom from major amputation and overall survival.

RESULTS

The cohort was high-risk: 76.8% had diabetes, 87.5% were on hemodialysis, 50.0% were Rutherford category 6, and 85.7% were Wound, Ischemia, and foot Infection stage 4. All pedal arteries were occluded in 80.4% of limbs. The 12-month complete wound healing rate was 45.5% (median time: 128 days). Freedom from major amputation, overall survival, and amputation-free survival were 83.5%, 54.6%, and 43.9%, respectively. Reintervention incidence was 5.58 procedures per person-year.

CONCLUSION

BOVA appears to be a feasible limb salvage strategy for patients with CLTI without conventional revascularization options.

LEVEL OF EVIDENCE: Level 3b.