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Sequential compression biomechanical device in patients with critical limb ischemia and nonreconstructible peripheral
Sherif Sultan1, Nader Hamada, Esraa Soylu
1Department of Vascular and Endovascular Surgery, Western Vascular Institute, University College Hospital, Galway, Ireland. sherif.sultan@hse.ie
Insights
Sequential compression biomechanical device (SCBD) therapy offers a limb salvage option for critical limb ischemia (CLI) patients facing amputation. This cost-effective treatment significantly improves amputation-free survival and hemodynamic outcomes.
Area of Science:
- Vascular Surgery
- Biomedical Engineering
- Regenerative Medicine
Background:
- Critical limb ischemia (CLI) poses a significant risk of amputation for patients unsuitable for revascularization.
- Sequential compression biomechanical device (SCBD) therapy presents a potential limb salvage alternative.
Purpose of the Study:
- To assess the clinical efficacy and cost-effectiveness of SCBD therapy in severe CLI patients.
- To evaluate limb salvage rates, mortality, hemodynamic improvements, and patient-reported outcomes.
Main Methods:
- A cohort of 171 CLI patients (Rutherford category ≥4) unsuitable for intervention received SCBD therapy for 3 months.
- Outcomes including limb salvage, 30-day mortality, popliteal artery flow, toe pressure, and cost were analyzed over a median follow-up of 13 months.
Main Results:
- SCBD therapy resulted in a 94% limb salvage rate at 3.5 years and a median amputation-free survival of 18 months.
- Significant improvements were observed in toe pressure (mean difference 15.49 mm Hg) and popliteal artery flow (mean difference 20.47 cm/s).
- 30-day mortality was low at 0.6%, with a median per-patient treatment cost of €3988.
Conclusions:
- SCBD therapy is a clinically effective and cost-effective solution for CLI patients ineligible for revascularization.
- The treatment provides significant limb salvage, improved amputation-free survival, and relief of rest pain.
- SCBD therapy represents a viable limb salvage option when revascularization is not feasible.
Objectives:
Critical limb ischemia (CLI) patients who are unsuitable for intervention face the dire prospect of primary amputation. Sequential compression biomechanical device (SCBD) therapy provides a limb salvage option for these patients. This study assessed the outcome of SCBD in severe CLI patients who otherwise would face an amputation. Primary end points were limb salvage and 30-day mortality. Secondary end points were hemodynamic outcomes (increase in popliteal artery flow and toe pressure), ulcer healing, quality-adjusted time without symptoms of disease or toxicity of treatment (Q-TwiST), and cost-effectiveness.
Methods:
From 2004 to 2009, we assessed 4538 patients with peripheral vascular disease (PVD). Of these, 707 had CLI, 518 underwent intervention, and 189 were not suitable for any intervention. A total of 171 patients joined the SCBD program for 3 months.
Results:
All patients were Rutherford category ≥4. Median follow-up was 13 months. Mean toe pressure increased from 39.9 to 55.42 mm Hg, with a mean difference in toe pressure of 15.49 mm Hg (P = .0001). Mean popliteal flow increased from 35.44 to 55.91 cm/s, with mean difference in popliteal flow of 20.47 cm/s (P < .0001). Mortality at 30 days was 0.6%. Median amputation-free survival was 18 months. Limb salvage at 3.5 years was 94%. Freedom from major adverse clinical events (MACE) at 4.5 years was 62.5%. We treated 171 patients with SCBD at a cost of €681,948, with an estimated median per-patient cost of treatment with SCBD of €3988.
Conclusion:
SCBD therapy is a cost-effective and clinically efficacious solution in CLI patients with no option of revascularization. It provides adequate limb salvage and ameliorated amputation-free survival while providing relief of rest pain without any intervention.
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