Incidence, predictors, and prognostic impact of in-hospital serious adverse events in patients ≥75 years of age undergoing elective endovascular aneurysm repair

Background: This study sought to identify the factors associated with the occurrence of in-hospital serious adverse events after elective endovascular aortic repair (EVAR) in older patients within the Global Registry for Endovascular Aortic Treatment. Methods: Consecutive patients ages ≥75 years who received GORE EXCLUDER AAA Endoprosthesis (W.L. Gore & Associates, Inc, Flagstaff, AZ) for elective EVAR. Based on the age at index elective EVAR, patients were categorized into 3 groups for subsequent analyses: those ages 75 to 79, 80 to 84, and ≥85 years. The primary end points for this study were the incidence of serious adverse events and all-cause mortality. In-hospital complications were defined according to the International Organization for Standardization 14155 standard (https://www.iso.org/standard/71690.html) and considered serious adverse events if they led to any of the following: (1) a life-threatening illness or injury, (2) a permanent impairment of a body structure or a body function, (3) in-patient or prolonged hospitalization, or (4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function. Results: Overall, 1,333 older patients (ages 75–79: n = 601; 80–84: n = 474; and ≥85: n = 258) underwent elective EVAR in the Global Registry for Endovascular Aortic Treatment data set and were included in the present analysis. In total, 12 patients (0.9%) died perioperatively, and 103 patients (7.7%) experienced ≥1 in-hospital serious adverse event, with 18 patients (1.3%) experiencing >1 in-hospital complications. No significant differences were seen between the age groups in the rates of in-hospital serious adverse events (7.3% vs 8.2% vs 7.8%; P = .86). In logistic regression analysis, a history of chronic obstructive pulmonary disease (odds ratio = 2.014; 95% confidence interval, 1.215–3.340; P = .006) and prior requirement for dialysis (odds ratio = 4.655; 95% confidence interval, 1.087–19.928; P = .038) resulted as predictors for occurrence of in-hospital serious adverse events. In the whole cohort, the 5-year survival was 63% for patients who did not experience any in-hospital serious adverse events compared with 51% for those who experienced any complications (P = .003). Using multivariable Cox proportional hazards models, it was found that the occurrence of in-hospital serious adverse events (hazard ratio = 6.2; 95% confidence interval, 1.8–21.317; P = .003) and being underweight (hazard ratio = 7.0; 95% confidence interval, 1.371–35.783; P = .019) were the only independent predictors of death in ≤30 days from the initial intervention. Although age did not independently affect the risk for all-cause mortality in ≤180 days after the initial intervention, increasing age was associated with a higher risk for long-term death (ie, ≥181 days from index elective EVAR) in the multivariable analysis (ages 75–79: hazard ratio = 0.379; 95% confidence interval, 0.281–0.512; P < .001; and 80–84: hazard ratio = 0.562; 95% confidence interval, 0.419–0.754; P < .001). Conclusion: After elective EVAR in older patients (ie, ≥75 years), the occurrence of in-hospital serious adverse events appears to increase the risk of death, particularly in ≤180 days after the initial elective EVAR intervention, and might be related to patient baseline characteristics, including history of pulmonary and renal disease.