Shaunak S Adkar1, Megan C Turner2, Harold J Leraas3, Brian F Gilmore2, Uttara Nag2, Ryan S Turley4, Cynthia K Shortell2, Leila Mureebe2. 1. Duke University School of Medicine, Duke University Medical Center, Durham, NC. Electronic address: shaunak.adkar@dm.duke.edu. 2. Department of Surgery, Duke University Medical Center, Durham, NC. 3. Duke University School of Medicine, Duke University Medical Center, Durham, NC. 4. Department of Surgery, Duke University Medical Center, Durham, NC; Cardiothoracic Vascular Surgeons, Austin, Tex.
Abstract
OBJECTIVE: The 2010 endovascular aneurysm repair (EVAR) trial 2 (EVAR 2) reported that patients with comorbidity profiles rendering them unfit for open aneurysm repair who underwent EVAR did not experience a survival advantage compared with those who did not undergo intervention. These patients experienced a 30-day mortality of 7.3%, whereas reports from similar cohorts reported far lower mortality rates. The primary objective of our study was to compare the incidence of 30-day mortality in low- and high-risk patients undergoing EVAR in a contemporary data set, using patient risk stratification criteria from EVAR 2. Secondarily, we sought to identify risk factors associated with a disproportionate contribution to 30-day mortality risk. METHODS: Data were obtained from the 2005 to 2013 American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) Participant Use Data Files (N = 24,813). Patients were included in the high-risk cohort with the presence of renal, respiratory, or cardiac preoperative criteria alone or in combination. Renal impairment criteria were defined as dialysis and creatinine concentration >2.26 mg/dL. Respiratory impairment criteria included history of chronic obstructive pulmonary disease and preoperative ventilator support. Cardiac impairment criteria included history of myocardial infarction, congestive heart failure, angina, and prior coronary intervention. Patient and procedural characteristics and 30-day postoperative outcomes were compared using Pearson χ2 tests for categorical variables and Wilcoxon rank sum tests for continuous variables. RESULTS: Among 24,813 patients undergoing EVAR, 12,043 (48%) patients were characterized as high risk (at least one impairment criterion); 12,770 (52%) patients were stratified as low risk. The 30-day mortality rate was 1.9% in the high-risk cohort compared with the 7.3% reported by EVAR 2, and it was higher in the high-risk cohort compared with the low-risk cohort (1.9% vs 0.9%; P < .001). Whereas the presence of each comorbidity increased the odds of 30-day mortality (respiratory odds ratio [OR], 1.62; 95% confidence interval [CI], 1.16-2.26; P = .005; cardiac OR, 1.55; 95% CI, 1.14-2.10; P = .005), the presence of renal criteria disproportionately increased the odds of mortality threefold (OR, 3.42; 95% CI, 2.31-5.09; P < .001). CONCLUSIONS: Contemporary 30-day mortality after EVAR in high-risk patients is substantially lower than that reported in the EVAR 2 trial. Whereas low- and high-risk stratification by current comorbidity criteria is appropriate, attention needs to be paid to disproportionate risk contribution from renal disease to mortality compared with cardiac and pulmonary comorbidities. Given the lower mortality risk than previously described, patients stratified as high risk should be thoughtfully considered for definitive EVAR.
OBJECTIVE: The 2010 endovascular aneurysm repair (EVAR) trial 2 (EVAR 2) reported that patients with comorbidity profiles rendering them unfit for open aneurysm repair who underwent EVAR did not experience a survival advantage compared with those who did not undergo intervention. These patients experienced a 30-day mortality of 7.3%, whereas reports from similar cohorts reported far lower mortality rates. The primary objective of our study was to compare the incidence of 30-day mortality in low- and high-risk patients undergoing EVAR in a contemporary data set, using patient risk stratification criteria from EVAR 2. Secondarily, we sought to identify risk factors associated with a disproportionate contribution to 30-day mortality risk. METHODS: Data were obtained from the 2005 to 2013 American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) Participant Use Data Files (N = 24,813). Patients were included in the high-risk cohort with the presence of renal, respiratory, or cardiac preoperative criteria alone or in combination. Renal impairment criteria were defined as dialysis and creatinine concentration >2.26 mg/dL. Respiratory impairment criteria included history of chronic obstructive pulmonary disease and preoperative ventilator support. Cardiac impairment criteria included history of myocardial infarction, congestive heart failure, angina, and prior coronary intervention. Patient and procedural characteristics and 30-day postoperative outcomes were compared using Pearson χ2 tests for categorical variables and Wilcoxon rank sum tests for continuous variables. RESULTS: Among 24,813 patients undergoing EVAR, 12,043 (48%) patients were characterized as high risk (at least one impairment criterion); 12,770 (52%) patients were stratified as low risk. The 30-day mortality rate was 1.9% in the high-risk cohort compared with the 7.3% reported by EVAR 2, and it was higher in the high-risk cohort compared with the low-risk cohort (1.9% vs 0.9%; P < .001). Whereas the presence of each comorbidity increased the odds of 30-day mortality (respiratory odds ratio [OR], 1.62; 95% confidence interval [CI], 1.16-2.26; P = .005; cardiac OR, 1.55; 95% CI, 1.14-2.10; P = .005), the presence of renal criteria disproportionately increased the odds of mortality threefold (OR, 3.42; 95% CI, 2.31-5.09; P < .001). CONCLUSIONS: Contemporary 30-day mortality after EVAR in high-risk patients is substantially lower than that reported in the EVAR 2 trial. Whereas low- and high-risk stratification by current comorbidity criteria is appropriate, attention needs to be paid to disproportionate risk contribution from renal disease to mortality compared with cardiac and pulmonary comorbidities. Given the lower mortality risk than previously described, patients stratified as high risk should be thoughtfully considered for definitive EVAR.
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