title: Benefit of revascularisation to critical limb ischaemia patients evaluated by a patient-oriented scoring system.
abstract: OBJECTIVE
  The concept of patency and limb salvage are physician-oriented endpoints in critical limb ischaemia (CLI). These endpoints have failed to enhance function after revascularisation. The aim of this study was to create a scoring system to predict 1-year functional status and to assess the benefit to patients possible by revascularisation.
  
  
  METHODS
  During the period 2007-2009, 480 consecutive patients (mean age ± SD, 83.2 ± 8.7 years) underwent repair for CLI. Preoperative, operative and functional status characteristics and post-operative outcomes were recorded. The following patient-oriented outcomes were investigated pre- and postoperatively: basic and instrumental activities of daily living (BADL and IADL) and ambulatory and living status. Statistical analysis was performed to assess predictors of functional benefit from revascularisation. The variables significant on multivariable analysis were used to generate a scoring system to pre and postoperatively grade individual patient risk of losing baseline functional status at 1 year (CLI functional score).
  
  
  RESULTS
  Ninety-three of 480 patients (19.3%) were in Rutherford class IV, 208 (43.3%) in class V and 179 (37.4%) in class VI. Surgical, endovascular and hybrid operations were performed in 108 (22.5%), 319 (66.5%) and 53 (11%) patients, respectively; mean follow-up was 408 ± 363 days. Improved or unchanged functional status was observed in 276 patients (57.5%). Preoperative mean ± SD BADL and IADL (4.26 ± 1.98 and 3.92 ± 2.69, respectively) were modified from mean values at 1-year follow-up (4.19 ± 2.06 and 4.12 ± 3, respectively) (p = 0.401 and p < 0.05, respectively). In the same time interval, mortality was 50%, limb salvage 50.4%, CLI-related new hospitalisations 50.8%, relief of symptoms 18.5% and tissue healing 14.5%. A CLI functional score of >80% indicates that patients are likely to lose functional abilities and require assistance for ambulation or ADL, as well as risking outcomes such as major amputation, new CLI-related hospitalisation or re-operation (p < 0.001). Preoperative poor living status, dependence in daily activities, advanced local disease (lesion >2 cm, infection and poor tibial runoff), American Society of Anesthesiologists (ASA) score > II, previous cerebrovascular event and heart disease were the strongest pre-operative negative predictors of losing baseline functional status. Major amputation was the only negative post-operative predictor.
  
  
  CONCLUSIONS
  Considering patient-oriented outcomes, our study showed that revascularisation could be worthwhile in nearly 60% of CLI patients. A non-revascularisation strategy such as primary amputation or palliation could be indicated in patients with a poor pre-operative living status, dependence for daily activities, advanced local disease, extensive comorbid conditions and a score >80%. To make our findings generalisable, the score needs to be validated in independent cohorts at different centres before it can be recommended for application.
authors.affiliation: Department of Surgery, Vascular and Endovascular Surgery Unit, University of Siena, Viale Bracci, 53100 Siena, Italy. e.chisci@gmail.com
authors.forename: E
authors.initials: E
authors.lastname: Chisci
authors.forename: A
authors.initials: A
authors.lastname: Perulli
authors.forename: F
authors.initials: F
authors.lastname: Iacoponi
authors.forename: F
authors.initials: F
authors.lastname: Setacci
authors.forename: G
authors.initials: G
authors.lastname: de Donato
authors.forename: G
authors.initials: G
authors.lastname: Palasciano
authors.forename: A
authors.initials: A
authors.lastname: Cappelli
authors.forename: C
authors.initials: C
authors.lastname: Setacci
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D057510:Endovascular Procedures; D005121:Extremities / Q000098:blood supply*; D005260:Female; D006305:Health Status Indicators; D006801:Humans; D007511:Ischemia / Q000601:surgery*; D023821:Limb Salvage; D008297:Male; D020127:Recovery of Function; D012307:Risk Factors; D016896:Treatment Outcome; D014656:Vascular Surgical Procedures