Applicability of the Society for Vascular Surgery's Objective Performance Goals for Critical Limb Ischemia to Current Practice of Lower-Extremity Bypass

Background: In 2009, the Society for Vascular Surgery (SVS) established objective performance goals (OPGs) for critical limb ischemia (CLI) based on data from previous, randomized, controlled trials of lower-extremity bypass (LEB). These OPG sought to establish a benchmark of outcomes to which one could compare future endovascular therapy. However, the cohort used to develop the OPG excluded all patients who required prosthetic conduit and those with end-stage renal disease (ESRD), possibly limiting the generalizability of these results and the subsequent guidelines. The goal of this study was to determine if the SVS OPG are applicable to the current population of patients undergoing LEB.

Methods: All patients who underwent infrainguinal LEB for CLI from January 2010 to December 2013 were identified in a prospectively maintained database. Patients were stratified into OPG eligible and ineligible (non-OPG) groups based on their demographic and operative characteristics. OPG eligible patients were further stratified into high risk and average risk. Outcomes included 30-day major adverse limb events (MALEs), 30-day major adverse cardiovascular events (MACE), 1-year survival, and 1-year freedom from amputation.

Results: A total of 89 individual patients were identified. Only 43 (48%) patients met OPG inclusion criteria and 46 (52%) were not OPG eligible (non-OPG). The 30-day MALE was 8.7% (13.0% non-OPG vs. 7.0% OPG, P = 0.34). The 30-day MACE was 11.2% (13.0% non-OPG vs. 9.3% OPG, P = 0.58). One-year survival was 80.3% ± 4.5% (71.2% non-OPG vs. 90.0% OPG, P = 0.21). One-year freedom from amputation was 71.7% ± 5.5% (58.8% non-OPG vs. 84.0% OPG, P = 0.03).

Conclusions: The SVS OPG for LEB are likely not generalizable to current practice as 51% of patients would have been excluded from the SVS cohort because of ESRD and prosthetic conduit. Most SVS OPG (30-day MALE, 1-year survival, and 1-year limb salvage) were attainable in patients who met SVS OPG inclusion criteria; but for the patients who are not OPG eligible, new benchmarks are needed.