Mid-Term Outcomes of Percutaneous Deep Venous Arterialization Using the LimFlow System

Abstract

Background & objectives:

Chronic limb-threatening ischaemia (CLTI) not amenable to conventional revascularization options (no-option CLTI) is associated with high rates of major amputation and mortality. Promising results were reported following percutaneous deep venous arterialization (pDVA) using the LimFlow system. This study reports mid-to-long-term clinical and patency outcomes of pDVA in real-life single-centre settings.

Design:

Retrospective, single-arm cohort study.

Methods:

The study included patients with no-option CLTI (Rutherford classes 5 and 6) who underwent pDVA using the LimFlow between January 2020 and June 2024. Patients were designated “no-option” by a multidisciplinary team after exhausting conventional revascularization options. Primary outcome was amputation-free survival (AFS). Secondary outcomes included technical success, limb salvage (LS), primary and secondary patency (PP/SP), freedom from reintervention (FFR) and wound healing rates.

Results:

Thirty-four patients (median age of 67 years; 79.4% diabetic) were included, with a median follow-up of 21 months (4–62 months). Technical success was 100%. At 24 months, AFS was 72% and LS was 88.6%. Full wound healing was achieved in 66% of patients, with a median time of 262 days from the index procedure. Kaplan-Meier analysis showed 24-month PP and SP rates of 46.3% and 76%, respectively. Freedom from reintervention was 58% at 24 months. Four major amputations (11.7%) were required.

Conclusion:

Percutaneous deep venous arterialization using the LimFlow system provides acceptable mid-term outcomes. Satisfactory AFS, LS, PP, SP and wound healing rates were achieved in these no-option CLTI options. Strict post-procedure surveillance and reintervention protocols are essential to maintain satisfactory outcomes.

Clinical Impact

The LimFlow system introduces a novel option for patients with no revascularization alternatives. It enables limb salvage in severe CLTI cases previously destined for amputation. By creating arterial flow through the venous system, it redefines vascular intervention strategies. Clinicians gain a new tool for “no-option” patients, expanding treatment eligibility. This may reduce major amputation rates and improve quality of life. The approach requires new technical skills and multidisciplinary collaboration. It shifts practice toward advanced endovascular innovation rather than palliative care. Patient selection and procedural expertise become critical for success. The study highlights the feasibility and safety of transcatheter arterialization. Overall, it represents a paradigm shift in managing advanced peripheral artery disease.

Keywords

LimFlow percutaneous deep venous arterialization (pDVA)critical lower limb-threatening ischaemia (CLTI)

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