title: Sequential compression biomechanical device in patients with critical limb ischemia and nonreconstructible peripheral vascular disease.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Vascular and Endovascular Surgery, Western Vascular Institute, University College Hospital, Galway, Ireland. sherif.sultan@hse.ie
authors.forename: Sherif
authors.initials: S
authors.lastname: Sultan
authors.forename: Nader
authors.initials: N
authors.lastname: Hamada
authors.forename: Esraa
authors.initials: E
authors.lastname: Soylu
authors.forename: Anne
authors.initials: A
authors.lastname: Fahy
authors.forename: Niamh
authors.initials: N
authors.lastname: Hynes
authors.forename: Wael
authors.initials: W
authors.lastname: Tawfick
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical; D003362:Cost-Benefit Analysis; D016638:Critical Illness; D004867:Equipment Design; D005260:Female; D006439:Hemodynamics; D017721:Hospital Costs; D006801:Humans; D048228:Intermittent Pneumatic Compression Devices / Q000009:adverse effects / Q000191:economics; D007494:Ireland; D007511:Ischemia / Q000191:economics / Q000209:etiology / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D053208:Kaplan-Meier Estimate; D023821:Limb Salvage; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D016491:Peripheral Vascular Diseases / Q000150:complications / Q000191:economics / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D019057:Quality-Adjusted Life Years; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014945:Wound Healing