Background: The invasive treatment of chronic lower extremity peripheral arterial disease (PAD) has become inconsistent. To standardize treatment at our institution, the Lower Extremity Grading System (LEGS) score was devised, based on arteriographic findings, symptoms, functional status, comorbid conditions, and technical factors. The scoring system was used to direct the invasive treatment approach in patients with lower extremity PAD. The purpose of this study was to prospectively assess outcomes of invasive treatment of lower extremity ischemia as directed by LEGS.
Methods: From March 2002 through December 2002, 332 limbs in 227 patients with indications for intervention were scored and treated according to the LEGS score and followed for 6 months. Of the 227 patients, 66.1% were male; median age was 65 years. Diabetes mellitus was present in 44.9% of patients, claudication in 48.5%, and limb-threatening ischemia in 51.5%. Results of treatment as directed by LEGS were judged with the treatment outcome measures of reconstruction patency, limb salvage, mortality, change in ambulatory status, change in independent living status, and change in the short-form health survey (SF-36).
Results: Of 332 limbs, 61.5% with a score of 10 to 19 underwent endovascular therapy; 34% with a score of 0 to 9 underwent open revascularization; and 4.5% with a score greater than 20 underwent primary limb amputation. Interventions for the entire cohort as directed by LEGS resulted in 6-month primary reconstruction patency of 82.4%; secondary reconstruction patency, 92.6%; limb salvage, 90%; survival, 89.1%; maintenance of ambulatory status, 85.6%; maintenance of independent living, 88.4%; and statistically significant improvement in health assessment, regardless of treatment type, as determined with the SF-36. There was no statistically significant variability when comparing results according to treatment (open surgery, 0-9 vs endovascular therapy, 10-19) or smaller score group categories (0-5, 6-9, 10-13, 14-19).
Conclusions: At 6 months, treatment as directed by LEGS score resulted in acceptable outcomes. This project is the first reported prospectively confirmed standardization tool for treatment of lower extremity PAD, and, pending independent confirmation by others, provides a comparative baseline against which other standardization efforts can be measured.