title: Validation of the Society for Vascular Surgery's objective performance goals for critical limb ischemia in everyday vascular surgery practice.
abstract: BACKGROUND
  To develop standardized metrics for expected outcomes in lower extremity revascularization for critical limb ischemia (CLI), the Society for Vascular Surgery (SVS) has developed objective performance goals (OPGs) based on aggregate data from randomized trials of lower extremity bypass (LEB). It remains unknown, however, if these targets can be achieved in everyday vascular surgery practice.
  
  
  METHODS
  We applied SVS OPG criteria to 1039 patients undergoing 1039 LEB operations for CLI with autogenous vein (excluding patients on dialysis) within the Vascular Study Group of New England (VSGNE). Each of the individual OPGs was calculated within the VSGNE dataset, along with its surrounding 95% confidence intervals (CIs) and compared to published SVS OPGs using χ(2) comparisons and survival analysis.
  
  
  RESULTS
  Across most risk strata, patients in the VSGNE and SVS OPG cohorts were similar (clinical high-risk [age >80 years and tissue loss]: 15.3% VSGNE; 16.2% SVS OPG; P = .58; anatomic high risk [infrapopliteal target artery]: 57.8% VSGNE; 60.2% SVS OPG; P = .32). However, the proportion of VSGNE patients designated as conduit high-risk (lack of single-segment great saphenous vein) was lower (10.2% VSGNE; 26.9% SVS OPG;P < .001). The primary safety endpoint, major adverse limb events (MALE) at 30 days, was lower in the VSGNE cohort (3.2%; 95% CI, 2.3-4.6) than the SVS OPG cohort (6.2%; 95% CI, 4.2-8.1; P = .05). The primary efficacy OPG endpoint, freedom from any MALE or postoperative death within the first year (MALE + postoperative death [POD]), was similar between VSGNE and SVS OPG cohorts (77%; 95% CI, 74%-80%) SVS OPG, 74% (95% CI, 71%-77%) VSGNE, P = .58). In the remaining safety and efficacy OPGs, the VSGNE cohort met or exceeded the benchmarks established by the SVS OPG cohort.
  
  
  CONCLUSIONS
  Community and academic centers in everyday vascular surgery practice can meet OPGs derived from centers of excellence in LEB. Quality improvement initiatives, as well as clinical trials, should incorporate OPGs in their outcome measures to facilitate communication and comparison of risk-adjusted outcomes in the treatment of CLI.
authors.affiliation: Dartmouth Hitchcock Medical Center, Lebanon, NH 03765, USA. philip.goodney@hitchcock.org
authors.forename: Philip P
authors.initials: PP
authors.lastname: Goodney
authors.forename: Andres
authors.initials: A
authors.lastname: Schanzer
authors.forename: Randall R
authors.initials: RR
authors.lastname: Demartino
authors.forename: Brian W
authors.initials: BW
authors.lastname: Nolan
authors.forename: Nathanael D
authors.initials: ND
authors.lastname: Hevelone
authors.forename: Michael S
authors.initials: MS
authors.lastname: Conte
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Powell
authors.forename: Jack L
authors.initials: JL
authors.lastname: Cronenwett
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical; D019985:Benchmarking / Q000592:standards; D016009:Chi-Square Distribution; D005260:Female; D006040:Goals; D006801:Humans; D007511:Ischemia / Q000175:diagnosis / Q000401:mortality / Q000601:surgery*; D023821:Limb Salvage; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D009511:New England; D010043:Outcome and Process Assessment, Health Care / Q000592:standards*; D010818:Practice Patterns, Physicians' / Q000592:standards*; D058996:Quality Improvement / Q000592:standards; D019984:Quality Indicators, Health Care / Q000592:standards; D012086:Reoperation; D018570:Risk Assessment; D012307:Risk Factors; D012501:Saphenous Vein / Q000637:transplantation*; D012955:Societies, Medical / Q000592:standards*; D013997:Time Factors; D016896:Treatment Outcome; D058017:Vascular Grafting / Q000009:adverse effects / Q000401:mortality / Q000592:standards*