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Published on: September 22, 2020
Sequential compression biomechanical device versus primary amputation in patients with critical limb ischemia
Wael A Tawfick1, Nader Hamada, Esraa Soylu
11Department of Vascular and Endovascular Surgery, Western Vascular Institute, University College Hospital, Galway (UCHG), Galway, Ireland.
Insights
Sequential compression biomechanical device (SCBD) therapy offers a limb salvage option for critical limb ischemia (CLI) patients unsuitable for intervention. This cost-effective treatment significantly improves limb salvage rates and clinical outcomes.
Area of Science:
- Vascular Surgery
- Medical Devices
- Regenerative Medicine
Background:
- Critical Limb Ischemia (CLI) poses a significant risk of amputation for patients ineligible for revascularization.
- Sequential Compression Biomechanical Device (SCBD) therapy presents a limb salvage alternative.
Purpose of the Study:
- To evaluate the efficacy of SCBD in severe CLI patients who cannot undergo revascularization.
- Primary endpoints included limb salvage and 30-day mortality rates.
Main Methods:
- A cohort of 189 patients with severe CLI, unsuitable for revascularization, was studied between 2005 and 2012.
- 171 patients underwent SCBD therapy, compared against 75 matched patients who had primary amputations.
Main Results:
- Sustained clinical improvement was observed in 68% of patients at 1 year.
- Significant increases in mean toe pressure (19.9 to 35.42 mm Hg) and popliteal flow (35.44 to 55.91 cm/sec) were noted (P < .0001).
- Limb salvage reached 94% at 5 years, with a 30-day mortality of only 0.6%. SCBD therapy was substantially more cost-effective than primary amputation.
Conclusions:
- SCBD therapy is a clinically effective and cost-efficient treatment for CLI patients lacking revascularization options.
- It achieves significant limb salvage and pain relief without invasive procedures.
Introduction:
Patients with critical limb ischemia (CLI), who are unsuitable for intervention, face the consequence of primary amputation. Sequential compression biomechanical device (SCBD) therapy provides a limb salvage option for these patients.
Objectives:
To assess the outcome of SCBD in patients with severe CLI who are unsuitable for revascularization. Primary end points were limb salvage and 30-day mortality.
Methods:
From 2005 to 2012, 189 patients with severe CLI were not suitable for revascularization. In all, 171 joined the SCBD program. We match controlled 75 primary amputations.
Results:
All patients were Rutherford category 4 or higher. Sustained clinical improvement was 68% at 1 year. Mean toe pressure increased from 19.9 to 35.42 mm Hg, P < .0001. Mean popliteal flow increased from 35.44 to 55.91 cm/sec, P < .0001. The 30-day mortality was 0.6%. Limb salvage was 94% at 5 years. Freedom from major adverse clinical events was 62.5%. All-cause survival was 69%. Median cost of managing a primary amputation patient is €29,815 compared to €3,985 for SCBD. We treated 171 patients with artassist at a cost of €681,965. However, primary amputation for 75 patients cost €2,236,125.
Conclusion:
The SCBD therapy is a cost-effective and clinically effective solution in patients with CLI having no option of revascularization. It provides adequate limb salvage while providing relief of rest pain without any intervention.
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