One year outcomes of Percutaneous Deep Vein Arterialization in the Dutch LimFlow Registry.

INTRODUCTION Percutaneous deep venous arterialization (pDVA) offers an endovascular potential alternative to reduce the risk of major amputation in patients with chronic limb threatening ischemia (CLTI) with no standard revascularization options (NO-CLTI).

Methods

In this prospective, multicenter registry conducted in the Netherlands between May 2020 and June 2024, NO-CLTI patients underwent pDVA using the LimFlow™ system. The primary endpoint was amputation-free survival (AFS) at 12 months. Secondary outcomes included limb salvage, overall survival, patency, pain scores, wound healing, transcutaneous oxygen pressure (TcPO2), and quality of life (QoL).

Results

A total of 26 limbs of 23 NO-CLTI patients (mean age 64 ± 12 years; 20 men) were included, all classified as Rutherford category 5 and 17 (77.3%) as Wound Ischemia and foot Infection (WIfI) stage 4. Thirteen (53.8%) patients suffered from diabetes mellitus and six (21.7%) from renal insufficiency. Technical success was 100%. AFS was 69.2%, limb salvage 80.8% and overall survival 88.5% at 12 months. Primary patency, primary assisted patency and secondary patency rates at 12 months were 6.6%, 27.3% and 35.7% respectively. Reinterventions were performed to maintain patency in 85% of the limbs and in 58% for maturation of the pDVA. Median time to wound healing was 6.9 months, with 73.4% healed at 12 months. Pain scores decreased significantly (p <.001) in 12 months. QoL improved from a mean of 37% to 68% on the VascuQoL-25, though these analyses were based on limited available data.

Conclusion

pDVA in NO-CLTI patients is safe and effective at 12 months, preventing major amputation and mortality in the majority of patients. QoL also appeared to improve following pDVA. These observations warrant confirmation in larger studies.