University of Cambridge, Cambridge, United Kingdom.
University of Leicester, Leicester, United Kingdom.
Ann Surg. 2021 Dec 1;274(6):e589-e598. doi: 10.1097/SLA.0000000000003625.
EVAR for abdominal aortic aneurysm has an initial survival advantage over OR, but more frequent complications increase costs and long-term aneurysm-related mortality. Randomized controlled trials of EVAR versus OR have shown EVAR is not cost-effective over a patient's lifetime. However, in the EVAR-1 trial, postoperative surveillance may have been sub-optimal, as the importance of sac growth as a predictor of graft failure was overlooked.
Real-world data informed a discrete event simulation model of postoperative outcomes following EVAR. Outcomes observed EVAR-1 were compared with those from 5 alternative postoperative surveillance and re-intervention strategies. Key events, quality-adjusted life years and costs were predicted. The impact of using complication and rupture rates from more recent devices, imaging and re-intervention methods was also explored.
Compared with observed EVAR-1 outcomes, modeling full adherence to the EVAR-1 scan protocol reduced abdominal aortic aneurysm (AAA) deaths by 3% and increased elective re-interventions by 44%. European Society re-intervention guidelines provided the most clinically effective strategy, with an 8% reduction in AAA deaths, but a 52% increase in elective re-interventions. The cheapest and most cost-effective strategy used lifetime annual ultrasound in primary care with confirmatory computed tomography if necessary, and reduced AAA-related deaths by 5%. Using contemporary rates for complications and rupture did not alter these conclusions.
All alternative strategies improved clinical benefits compared with the EVAR-1 trial. Further work is needed regarding the cost and accuracy of primary care ultrasound, and the potential impact of these strategies in the comparison with OR.
腹主动脉瘤的 EVAR 治疗在初始阶段比 OR 治疗具有生存优势，但更频繁的并发症会增加成本并导致长期与动脉瘤相关的死亡率。EVAR 与 OR 的随机对照试验表明，从患者的整个生命周期来看，EVAR 并不具有成本效益。然而，在 EVAR-1 试验中，术后监测可能不够理想，因为忽视了囊腔生长作为移植物失败预测因素的重要性。
真实世界的数据为 EVAR 术后结果的离散事件模拟模型提供了信息。将观察到的 EVAR-1 结果与 5 种替代术后监测和再干预策略的结果进行比较。预测了关键事件、质量调整生命年和成本。还探讨了使用最近的设备、成像和再干预方法的并发症和破裂率的影响。
与观察到的 EVAR-1 结果相比，完全遵守 EVAR-1 扫描方案可使腹主动脉瘤（AAA）死亡减少 3%，并使择期再干预增加 44%。欧洲血管外科学会的再干预指南提供了最具临床效果的策略，AAA 死亡减少了 8%，但择期再干预增加了 52%。最便宜且最具成本效益的策略是在初级保健中使用终身年度超声检查，如果需要则进行计算机断层扫描确认，并使与 AAA 相关的死亡减少 5%。使用并发症和破裂的当代率并不会改变这些结论。
与 EVAR-1 试验相比，所有替代策略都改善了临床效益。还需要进一步研究初级保健超声的成本和准确性，以及这些策略在与 OR 比较中的潜在影响。
