Andrew J. Meltzer, Peter H. Connolly, Heather L. Gill, Douglas W. Jones, John K. Karwowski, Harry L. Bush, Darren B. Schneider
Vascular Surgery, Weill Cornell Medical College / New York-Presbyterian, New York, NY.
OBJECTIVES: The Society for Vascular Surgery's Objective Performance Goals (SVS OPGs) for critical limb ischemia (CLI) are derived from bypass surgery outcomes in a pooled cohort from 3 randomized trials. We examine the effectiveness of endovascular therapy (ET) for CLI in using OPG efficacy benchmarks.
METHODS: CLI patients undergoing ET (2006-2012) were identified in a prospectively maintained database. Unadjusted outcomes were used for comparisons to the overall OPG cohort, as well as between anatomic and clinical high-risk subgroups. ET-specific regression models for each OPG endpoint identified risk factors for poor outcome.
RESULTS: Two hundred eighty-three CLI patients underwent ET for tissue loss (77%) or rest pain. Compared to the OPG cohort (n=838), patients undergoing ET were more likely to be >80 years old (32% vs. 19%; p<0.0001), female (51% vs. 34%; p<0.0001), have end-stage renal disease (ESRD) (15% vs. 0%; p<0.0001), or anatomic high-risk features (73% vs. 60%; p=0.002). The mean reintervention rate after ET was 0.67 per limb-year. The overall effectiveness of ET, with subgroup analysis, is summarized in Table 1.
CONCLUSIONS: Although survival-based benchmarks may be difficult to achieve in "real world" practice that includes poor surgical candidates and those with ESRD, most SVS OPGs are attainable with contemporary endovascular therapy. These findings not only support the role of ET in the management of CLI, but underscore the utility of SVS OPGs for comparative effectiveness and outcomes research.
AUTHOR DISCLOSURES: H. L. Bush: Nothing to disclose; P. H. Connolly: Nothing to disclose; H. L. Gill: Nothing to disclose; D. W. Jones: Nothing to disclose; J. K. Karwowski: Nothing to disclose; A. J. Meltzer: Nothing to disclose; D. B. Schneider: Nothing to disclose.
One year results with endovascular therapy compared to suggested OPGs
|| Endo (n=283)
|| OPG (n=505)
|Major Adverse Limb Event Or Post-op Death (MALE+POD)
| Amputation Free Survival (AFS)
|Reintervention, Amputation or Stenosis (RAS)
|Reintervention or Amputation (RAO)
Rates reported as freedom from adverse events
Posted April 2013