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PROMISE I: Early feasibility study of the LimFlow System for percutaneous deep vein arterialization in no-option

Daniel G Clair1, Jihad A Mustapha2, Mehdi H Shishehbor3

  • 1Department of Surgery, University of South Carolina, Columbia, SC.

Journal of Vascular Surgery
|May 21, 2021
PubMed

Insights

Percutaneous deep vein arterialization (pDVA) using the LimFlow System shows promising results for chronic limb-threatening ischemia (CLTI) patients. The study demonstrated high amputation-free survival and wound healing rates at 12 months, suggesting a viable treatment option.

Area of Science:

  • Vascular Surgery
  • Interventional Cardiology
  • Regenerative Medicine

Background:

  • Chronic limb-threatening ischemia (CLTI) is a severe condition often leading to major amputation.
  • No-option CLTI patients are ineligible for traditional revascularization methods.
  • Percutaneous deep vein arterialization (pDVA) offers a potential alternative for limb salvage.

Purpose of the Study:

  • To evaluate the 6- and 12-month outcomes of the PROMISE I early feasibility study.
  • To assess the safety and efficacy of the LimFlow System for pDVA in no-option CLTI patients.
  • To determine amputation-free survival and wound healing rates post-pDVA treatment.

Main Methods:

  • A single-arm, early feasibility study enrolled 32 patients with no-option CLTI.
  • Patients were treated with the LimFlow pDVA System.
  • Clinical status, pain, wound healing, and duplex ultrasound were assessed at 30 days, 6 months, and 12 months.
  • Primary endpoint was amputation-free survival (AFS) at 12 months.

Main Results:

  • Technical success was achieved in 97% of patients.
  • Amputation-free survival (AFS) rates were 91% at 30 days, 74% at 6 months, and 70% at 12 months.
  • Wound healing was observed in 67% of patients at 6 months and 75% at 12 months.
  • Reinterventions were required in 52% of patients, primarily related to the arterial inflow tract.

Conclusions:

  • The LimFlow pDVA System demonstrated a high technical success rate in treating no-option CLTI.
  • Significant amputation-free survival and wound healing rates were observed at 12 months.
  • These findings support further investigation of pDVA as a viable option for this critical patient population.
Abstract

Keywords:
AmputationChronic limb-threatening ischemiaCritical limb ischemiaNo-option chronic limb-threatening ischemiaPercutaneous deep vein arterialization

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