Intermittent negative pressure therapy in patients with no-option chronic limb-threatening ischemia

Shatlyk Yagshyyev1, Phillip Hausmann1, Yi Li1

  • 1Department of Vascular Surgery, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Germany.

Insights

Intermittent negative pressure (INP) therapy significantly improved skin perfusion and reduced rest pain in patients with critical limb ischemia (CLTI) who had no revascularization options. This therapy shows potential for treating these severe cases.

Area of Science:

  • Vascular Medicine
  • Biomedical Engineering
  • Regenerative Medicine

Background:

  • Critical limb ischemia (CLTI) poses a significant challenge, especially for patients deemed "no-option" for revascularization.
  • Foot microcirculation is a key indicator of tissue viability and therapeutic response in CLTI.
  • Assessing novel therapeutic interventions for improving microcirculation in CLTI is crucial.

Purpose of the Study:

  • To evaluate the impact of intermittent negative pressure (INP) therapy on foot microcirculation in no-option CLTI patients.
  • To assess changes in skin perfusion parameters including oxygen saturation, hemoglobin, and flow.
  • To correlate microcirculatory changes with clinical outcomes such as rest pain reduction.

Main Methods:

  • A cohort of 19 no-option CLTI patients received home-based INP therapy (1 hour, twice daily).
  • Microcirculation was measured using laser Doppler flowmetry and white light spectrometry (O2C™) at baseline, 6 weeks, and 3 months.
  • Key parameters assessed included oxygen saturation (sO2), relative hemoglobin (rHb), and flow (AU).

Main Results:

  • Significant improvement in skin oxygen saturation (sO2) was observed at 6 weeks (p=0.004).
  • While sO2 slightly decreased at 3 months, perfusion remained higher than baseline.
  • No significant changes were noted in flow (AU) or hemoglobin (AU), but rest pain was significantly reduced (p=0.005).

Conclusions:

  • INP therapy demonstrates a significant positive effect on skin perfusion in no-option CLTI patients within 6 weeks.
  • The observed improvements suggest INP therapy holds therapeutic potential for managing critical limb ischemia.
  • INP therapy may offer a viable treatment option for patients with limited conventional therapeutic choices.

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