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OBJECTIVES:
Despite acceptance of endovascular intervention for peripheral arterial disease, common femoral endarterectomy (CFE) remains the preferred treatment for atherosclerotic disease of the common femoral artery (CFA). The objectives of this study are to delineate the safety of this open procedure in the endovascular era, establish contemporary benchmarks for morbidity and mortality after CFE, and identify patients at increased risk for post-operative adverse events.
METHODS:
Methods: Patients undergoing elective CFE in the 2006-2008 National Surgical Quality Improvement Project dataset were randomly assigned to a model derivation sample (80%) or validation sample (20%). Univariate analyses were used to identify factors associated with major morbidity and mortality. Significant (P<.05) variables by univariate analysis were used to create binomial multivariate logistic regression models for morbidity and mortality. Models were internally tested for goodness-of-fit and validated on a distinct sample.
RESULTS:
988 patients underwent elective CFE. The 30-day mortality rate was 1.6%. Major post-operative morbidities included cardiac (0.9%), pulmonary (2.1%), renal (0.4%), thromboembolic (0.5%), neurologic (0.5%), sepsis (2.2%), and major wound complications (2.8%). 78 patients (7.9%) experienced at least one major complication. By univariate analysis, 8 of 31 preoperative variables tested were associated with mortality, including dyspnea, heart failure (HF), angina, dependent functional status (DFS), and critical limb ischemia (CLI) with open wounds. Variables associated with major morbidity included diabetes (DM), HF, DFS, angina, open wound, and steroid use. By multivariate analysis, DFS was the only independent predictor of mortality (P< .0001, OR: 19.8[95% C.I. 3.4-99.7]). Independent predictors of morbidity included DFS (P=.018, 2.4 [1.17-5.27]) steroid use (P=.024, 2.90 [1.143-7.37]), and DM (P=.025, 1.958[1.089-3.523]). In the validation sample, mortality was 10.7% among those with DFS vs. 0% in those with independent functional status (P = 0.002), and major morbidity was significantly more common among those with DFS (25% vs. 3.9%, P=0.001). ROC curve area under the curve (AUC) analysis further delineated the predictive power of these models for mortality (P<.0001, AUC: .885 ) and major morbidity (P=.039, AUC: .67).
CONCLUSIONS:
CFE is well tolerated. Results affirm the safety of CFE in the overwhelming majority of patients, and suggest that endovascular CFA intervention is infrequently warranted. Endovascular CFA interventions must not only be compared to the proven durability of CFE, but also to the established safety of this open procedure.