Outcomes associated with type II endoleaks after infrarenal endovascular aneurysm repair in the Vascular Quality Initiative linked to Medicare claims.

Objective: Type II endoleaks (T2ELs) are commonly identified after endovascular aneurysm repair (EVAR) and may occur either at the completion of the procedure or during follow-up. However, the impact of T2EL on reintervention and survival remains poorly described. This study aims to evaluate the outcomes associated with T2EL in a real-world cohort using the Vascular Quality Initiative linked Medicare claims (Vascular Quality Initiative-Medicare) database.

Methods: We retrospectively reviewed all elective EVARs in the Vascular Quality Initiative-Medicare (part of the Vascular Implant Surveillance and Interventional Outcomes coordinated registry network) database from 2010 to 2018. Patients with Medicare fee-for-service entitlement at the time of the index procedure and continuous entitlement during follow-up were included. We excluded patients with endoleaks other than T2EL at completion or follow-up, those with missing T2EL status at completion, and patients with no imaging follow-up. The primary outcomes were aneurysm-related reintervention, freedom from rupture, and overall survival. A time-dependent analysis based on the T2EL status and Cox proportional hazards multivariable models were used to assess associations between T2EL and the outcomes.

Results: A total of 8195 patients were included in the final analysis, with 6653 (81%) in the no T2EL group and 1542 (19%) in the T2EL group. Patients in the T2EL group were older (76 years vs 75 years; P = .006) and had lower rates of active smoking (21% vs 26%; P < .001), chronic obstructive pulmonary disease (28% vs 32%; P = .003), congestive heart failure (9% vs 12%; P = .004), and a history of prior vascular intervention. At 5 years, the rate of aneurysm-related reintervention was significantly higher in the T2EL group (30.4% vs 11%; P < .0001); however, there was no significant difference in freedom from rupture between the groups (95.6% vs 98.2%, adjusted hazard ratio [aHR], 0.98, 95% confidence interval [CI]. 0.5-2.0). Unadjusted overall survival rates at 5 years were similar between the groups (74% vs 71%). On multivariate regression analysis, the presence of a T2EL was not associated with an increased risk of mortality (aHR, 0.83; 95% CI, 0.69-1.01; P = .057). Subgroup analysis in patients with T2EL showed that reintervention was not significantly associated with overall survival at 5-years (aHR, 0.45; 95% CI, 0.1-1.9; P = .27).

Conclusions: T2EL occurred in nearly one-fifth of patients after EVAR and was associated with a higher rate of reintervention compared with patients without T2EL. Yet, reinterventions were not linked to better survival. Thus, the overall benefit of reintervention for isolated T2EL in current practice remains to be defined.