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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.
Abstract:
Background: Aim of this study was to assess the influence of intermitted negative pressure (INP) therapy on the foot microcirculation in patients with no-option CLTI. Patients and methods: CLTI patients defined as no option for revascularization on the basis of an interdisciplinary vascular board decision (interventional radiology, vascular surgery) were included in this study. INP therapy was performed at home. Therapy regime was: 1 hour twice daily. Follow-up was after 6 weeks and 3 months. Microcirculation measurement was performed by laser Doppler flowmetry and white light spectrometry (oxygen to see, O2CTM). Following parameters were evaluated: oxygen saturation (sO2 in%), relative hemoglobin (rHb) and flow (in arbitrary units A.U.). Additionally the clinical outcome of the patients was assessed. Results: From September 2020 to June 2022, 228 patients were screened. In total 19 patients (13 men, 6 women, mean age was 73.95 years) were included. 6 weeks after INP therapy the microcirculation showed a significant improvement for the parameter sO2 (%) (p=0.004). After 3 months a non-significant decrease compared to 6 weeks follow-up was seen for the parameter sO2; however, the perfusion was still improved compared to baseline measurement. With regard to the microperfusion values flow (AU) and hemoglobin (AU), the changes were not significant. Clinically, the patients reported a significant reduction of rest pain after therapy (p=0.005). Conclusions: INP therapy in no-option CLTI patients showed a significant improvement of the skin perfusion after 6 weeks. Therefore, INP therapy might have therapeutic potential in these critical ill patients.
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