| Summary: | Objective: In 2009, the Society for Vascular Surgery established objective performance goals (OPG) for lower extremity bypass (LEB) in patients with critical limb ischemia (CLI) based on pooled data from previously performed, prospective studies in an effort to provide a benchmark and historical control for future trials. However, patients with prosthetic conduit and end stage renal disease (ESRD) were excluded from this cohort. In contemporary practice, many patients do not meet the criteria for SVS OPG inclusion, making generalization of the SVS OPG difficult. The goal of this study was to establish safety and efficacy measures for patients who were excluded from the original SVS OPG analysis.
Methods: All patients who underwent LEB for CLI in the Vascular Study Group of New England (VSGNE) from 2003-2013 were identified. Patients were stratified into OPG eligible and non-OPG cohorts. Outcomes included 30-day Major Adverse Limb Event (MALE), 30-day Major Adverse Cardiovascular Event (MACE), 1-year survival, and 1-year freedom from amputation. Using the SVS OPG methodology, new performance goals were created for the non-OPG eligible patients.
Results: 3609 patients were identified: 2360 (65%) OPG versus 1249 (35%) non-OPG and overall results were stratified as a function of OPG status. The 30-day MALE was 5.0% (5.5% non-OPG versus 4.4% OPG; p=0.34), and the 30-day MACE was 7.3% (9.2% non-OPG versus 6.2% OPG; p=0.001). 1-year survival was 84% (75.9% non-OPG versus 88.3% OPG; p<.001). 1-year freedom from amputation was 86.9% (80.9% non-OPG versus 90.1% OPG; p<.001).
Conclusions: The SVS OPG were attainable in New England for the population of patients who would have met SVS OPG study cohort inclusion criteria. However, 35% of the patients who underwent LEB for CLI in the last ten years fell outside of these criteria by having either ESRD or requiring a prosthetic conduit. Therefore, we suggest new benchmarks for these high risk populations.
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