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

Ahmed M Morshed1,2, Narayanan Thulasidasan3, Harishankar Nair1

  • 1Department of Vascular Surgery, St Thomas' Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK.

Insights

Percutaneous deep venous arterialization (pDVA) with the LimFlow system offers a new hope for chronic limb-threatening ischemia (CLTI) patients without other options. This procedure shows promising amputation-free survival and limb salvage rates, potentially reducing amputations.

Area of Science:

  • Vascular Surgery
  • Interventional Cardiology
  • Regenerative Medicine

Background:

  • Chronic limb-threatening ischemia (CLTI) without revascularization options leads to high amputation and mortality rates.
  • Percutaneous deep venous arterialization (pDVA) using the LimFlow system shows promise for these 'no-option' CLTI patients.
  • Real-world, mid-to-long-term outcomes of pDVA are crucial for understanding its clinical utility.

Purpose of the Study:

  • To evaluate the mid-to-long-term clinical and patency outcomes of pDVA with the LimFlow system in a real-world, single-center setting.
  • To assess amputation-free survival (AFS), limb salvage (LS), and wound healing rates in patients with no-option CLTI.
  • To determine technical success, patency rates (primary and secondary), and freedom from reintervention (FFR).

Main Methods:

  • Retrospective, single-arm cohort study of patients with no-option CLTI (Rutherford classes 5 and 6).
  • Patients underwent pDVA using the LimFlow system between January 2020 and June 2024.
  • Primary outcome: AFS. Secondary outcomes: LS, technical success, PP/SP, FFR, and wound healing.

Main Results:

  • Thirty-four patients (79.4% diabetic, median age 67) with a median follow-up of 21 months were included.
  • 100% technical success; 24-month AFS was 72%, and LS was 88.6%.
  • 66% achieved full wound healing; 24-month PP was 46.3%, SP was 76%, and FFR was 58%.

Conclusions:

  • pDVA with the LimFlow system demonstrates acceptable mid-term outcomes for no-option CLTI patients.
  • The procedure achieved satisfactory AFS, LS, patency, and wound healing rates.
  • Strict post-procedure surveillance and reintervention protocols are essential for maintaining outcomes and represent a paradigm shift in managing advanced PAD.
Abstract

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