Vaddavalli Venkata Vineeth, Zheng Xinyan, Mao Jialin, Mendes Bernardo C, Scali Salvatore T, DeMartino Randall R
Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, MN.
Department of Population Health Sciences, Weill Cornell Medical College, New York, NY.
J Vasc Surg. 2025 Sep;82(3):810-818.e5. doi: 10.1016/j.jvs.2025.04.061. Epub 2025 May 6.
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.
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.
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).
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.
II型内漏（T2ELs）在血管内动脉瘤修复术（EVAR）后很常见，可能在手术完成时或随访期间出现。然而，T2EL对再次干预和生存的影响仍鲜有描述。本研究旨在使用与医疗保险索赔相关的血管质量倡议（血管质量倡议-医疗保险）数据库，评估真实世界队列中与T2EL相关的结局。
我们回顾性分析了2010年至2018年血管质量倡议-医疗保险（血管植入监测和介入结局协调注册网络的一部分）数据库中的所有择期EVAR。纳入在索引手术时享有医疗保险按服务付费资格且在随访期间持续享有资格的患者。我们排除了在手术完成或随访时存在除T2EL之外的其他内漏的患者、手术完成时T2EL状态缺失的患者以及没有影像学随访的患者。主要结局是与动脉瘤相关的再次干预、免于破裂和总体生存。基于T2EL状态的时间依赖性分析和Cox比例风险多变量模型用于评估T2EL与结局之间的关联。
最终分析共纳入8195例患者，无T2EL组6653例（81%），T2EL组1542例（19%）。T2EL组患者年龄更大（76岁对75岁；P = 0.006），主动吸烟率更低（分别为21%和26%；P < 0.001），慢性阻塞性肺疾病发生率更低（分别为28%和多32%；P = 0.003），充血性心力衰竭发生率更低（分别为9%和12%；P = 0.004），且既往血管干预史更少。5年时，T2EL组与动脉瘤相关的再次干预率显著更高（30.4%对多11%；P < 0.0001）；然而，两组之间免于破裂情况无显著差异（分别为95.6%和98.2%，调整后风险比 [aHR]，0.98，95%置信区间 [CI]，0.5 - 2.0）。两组5年时未调整的总体生存率相似（分别为74%和71%）。多变量回归分析显示，存在T2EL与死亡风险增加无关（aHR，0.83；95% CI，0.69 - 1.01；P = 0.057）。T2EL患者的亚组分析显示，再次干预与5年总体生存无显著关联（aHR，0.45；95% CI，0.1 - 1.9；P = 0.27）。
EVAR术后近五分之一的患者发生T2EL，与无T2EL的患者相比，T2EL患者再次干预率更高。然而，再次干预与更好的生存并无关联。因此，目前实践中针对孤立性T2EL进行再次干预的总体益处仍有待确定。
