Lower extremity bypass and endovascular intervention for critical limb ischemia fail to meet Society for Vascular Surgery's objective performance goals for limb-related outcomes in a contemporary national cohort

Abstract

ObjectiveIn 2009, the Society for Vascular Surgery (SVS) developed objective performance goals (OPGs) to define the therapeutic benchmarks in critical limb ischemia (CLI) based on outcomes from randomized trials of lower extremity bypass (LEB). Current performance relative to these benchmarks in both LEB and infrainguinal endovascular intervention (IEI) remains unknown. The objective of this study was to determine whether LEB and IEI performed for CLI in a contemporary national cohort met OPG 30-day safety thresholds. MethodsSVS OPG criteria were applied to 11,043 revascularizations for CLI performed from 2011 to 2015 in the National Surgical Quality Improvement Program (NSQIP) vascular targeted modules. Primary 30-day safety OPGs including major adverse cardiovascular events (MACEs), major adverse limb events (MALEs), and amputation were calculated for the NSQIP LEB (n = 3833) and IEI (n = 3526) cohorts as well as for subgroups at “high anatomic risk” (infrapopliteal revascularization) and “high clinical risk” (age >80 years and tissue loss). These were compared with SVS OPG benchmarks using χ2 comparisons. ResultsCompared with the SVS OPG cohort, both the NSQIP LEB and IEI cohorts had fewer patients at high anatomic risk (LEB, 51%; IEI, 27%; SVS OPG, 60%; both P < .0001). The LEB cohort had fewer patients with high clinical risk than the SVS OPG cohort (LEB, 11%; SVS OPG, 16%; P < .0001). The 30-day MALE was significantly higher in the NSQIP LEB (9.0% [8.7%-9.2%]) and IEI (9.7% [9.4%-10.0%]) cohorts compared with the SVS OPG cohort (6.1% [4.7%-9.0%]; both P ≤ .007), including significantly higher rates of amputation. MACE was significantly lower in the NSQIP LEB (4.2% [4.1%-4.3%]) and IEI (3.1% [3.0%-3.2%]) cohorts compared with the SVS OPG cohort (6.1% [4.7%-8.1%]; both P ≤ .013). Among patients at high anatomic risk, 30-day MALE was significantly higher after LEB (9.5% [9.1%-9.8%]) and IEI (11.1% [10.4-11.8%]) compared with the SVS OPG cohort (6.1% [4.2%-8.6%]; P ≤ .002). Among patients with high clinical risk, IEI was associated with lower MACE compared with the SVS OPG cohort, with similar limb-related outcomes. ConclusionsIn contemporary real-world practice, LEB and IEI for CLI failed to meet SVS OPG limb-related 30-day safety benchmarks for the entire CLI cohort as well as for the patients at high anatomic risk. Additional investigation using SVS OPGs as consistent end points is required to determine why limb-related outcomes after revascularization for CLI remain suboptimal. LEB and IEI surpassed OPG benchmarks for 30-day cardiovascular morbidity and mortality. OPGs for cardiovascular morbidity in patients undergoing revascularization for CLI deserve re-evaluation using contemporary data.