Surveillance priorities and outcomes for Veterans treated with endovascular abdominal aortic aneurysm repair

接受腹主动脉瘤腔内修复术治疗的退伍军人的监测重点和结果

• 批准号: 10673672
• 负责人: Philip P Goodney
• 金额: --
• 依托单位: WHITE RIVER JUNCTION VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10673672
• 关键词: Abdominal Aortic Aneurysm; Acute; Acute Renal Failure with Renal Papillary Necrosis; Adherence; Affect; Aging; Aorta; Area; Arteries; Attitude; Belief; Blood Vessels; Blood flow; Caregivers; Caring; Categories; Cessation of life; Chronic; Clinical Data; Complex; Cox Models; Dangerousness; Data; Data Sources; Decision Analysis; Decision Making; Dyes; Elderly; Ensure; Equilibrium; Family; Funding; Future; Guidelines; Health Personnel; Image; Incidence; Incidental Findings; Injury to Kidney; Intervention; Interview; Intestines; Kidney; Knowledge; Learning; Long-Term Care; Lung; Measures; Medical Care Team; Methodology; Methods; Modality; Modeling; Nodule; Online Systems; Operative Surgical Procedures; Outcome; Pathway interactions; Patient Recruitments; Patients; Population; Procedures; Protocols documentation; Provider; Quality of life; Regimen; Research Design; Risk; Rupture; Rural; Scanning; Societies; Stents; Subgroup; Telephone; Testing; Textiles; United States Food and Drug Administration; Variant; Veterans; Work; X-Ray Computed Tomography; adverse outcome; cohort; comorbidity; contrast enhanced computed tomography; data warehouse; design; experience; follow-up; improved; innovation; markov model; member; nephrotoxicity; podcast; pressure; primary outcome; recruit; repaired; secondary outcome; serial imaging; surveillance imaging; surveillance strategy; ultrasound

Background: More than 8,000 Veterans undergo abdominal aortic aneurysm (AAA) repair each year. Nearly 70% are treated with endovascular abdominal aortic aneurysm repair (EVAR), where a covered stent is used to reinforce the weakened aorta. Most national guidelines and regulatory directives mandate annual life-long surveillance imaging after EVAR, typically provided via a once-yearly contrast-enhanced CT scan. Surveillance imaging evaluates for blood flowing around the stent into the aorta, called an “endoleak”. While most endoleaks are harmless, 1-3% are high-pressure “Type I” endoleaks, which lead to rupture and require repair. However, a point may be reached where continued annual surveillance imaging may not be the best choice for elderly Veterans after EVAR. Imaging-associated risks include acute kidney injury from contrast dye used during the CT scan (3-10%), the identification of harmless endoleaks which require no treatment (10-20%), and incidental findings such as lung or kidney nodules which trigger further invasive testing or treatment (10-15%). Our scientific rationale in this project centers on better understanding a key gap in knowledge: the tradeoffs between imaging-associated risks and the chance of identifying a dangerous form of endoleak (1-3%) can be difficult, especially for aging Veterans with multiple co-morbidities. Significance: This evidence gap surrounding when to stop surveillance is especially important for Veterans, who are more frail, elderly, and rural than non-Veteran EVAR populations. We estimate that more than 10,000 Veterans are currently alive with an EVAR in place. This suggests that more than 10,000 scans will be performed each year based on our preliminary cohort assembly, and more than 500 Veterans will have complications such as nephrotoxicity. Because it affects a chronic condition among our oldest Veterans, our study is aligned with the HRD&D Topic Category “Management of Chronic Conditions” and the HSR&D Specific Priority Area “Long-term Care and Aging”. Innovation and Impact: There is an absence of guidelines to help Veterans and their clinicians decide when surveillance imaging should occur, and when its utility may be limited. Developing and disseminating this evidence would bring an innovative approach towards limiting unnecessary testing and harms among elderly Veterans. Specific Aims: We propose a mixed-methods study with two Specific Aims. Aim 1 will qualitatively assess Veteran, family, and health care team members’ attitudes and beliefs surrounding surveillance imaging after EVAR. Aim 2 will quantitatively characterize observational data sources to understand surveillance imaging outcomes after EVAR. Our Dissemination Plan will integrate these findings to create evidence for when surveillance imaging should continue, and when it may have limited utility. We hypothesize that imaging associated risks may outweigh the benefits of ongoing surveillance in older Veterans with significant comorbidities. Methodology: Our study design leverages a parallel approach: qualitative assessment of stakeholder beliefs about cessation of imaging surveillance (Aim 1) and quantitative analysis of retrospective clinical data to evaluate the use, outcomes, and risks of imaging surveillance (Aim 2). Next Steps/Implementation: Our project involves leaders from organizations such as the VA’s national VA Surgery Advisory Board, the Society for Vascular Surgery, a nationally recognized web-based forum for geriatric care, and other organizations to ensure effective dissemination of our evidence. The evidence generated in our proposal will be shared using innovative pathways, such as podcasts, to ensure our project’s deliverables and impact are sustained.

背景：每年有超过 8,000 名退伍军人接受腹主动脉瘤 (AAA) 修复术。 70% 接受腹主动脉瘤血管内修复术 (EVAR) 治疗，其中使用了覆膜支架 大多数国家和监管指令都要求每年进行一次终生治疗。 EVAR 后的监视成像，通常通过每年一次的对比增强 CT 监视提供。 成像评估支架周围流入主动脉的血液，称为“内漏”。 内漏是无害的，1-3% 是高压“I 型”内漏，会导致破裂并需要修复。 然而，可能会达到这样一个程度：持续的年度监测成像可能不是最佳选择 EVAR 后的老年退伍军人与成像相关的风险包括因使用对比染料而导致的急性肾损伤。 在 CT 扫描期间 (3-10%)，识别不需要治疗的无害内漏 (10-20%)，以及 偶然发现的疾病，例如引发进一步侵入性检测或治疗的肺部或肾脏结节（10-15%）。 我们在这个项目中的科学原理集中于更好地理解知识中的一个关键差距：权衡 成像相关风险和识别危险形式内漏的机会 (1-3%) 之间可以 困难，特别是对于患有多种合并症的老年退伍军人来说。 意义：关于何时停止监视的证据差距对于退伍军人来说尤其重要， 与非退伍军人 EVAR 人群相比，他们更加体弱、年老和来自农村。我们估计超过 10,000 人。 目前，退伍军人还活着，并进行了 EVAR，这表明将进行超过 10,000 次扫描。 每年都会根据我们的初步队列集会进行，超过 500 名退伍军人将参加 因为它会影响我们最年长的退伍军人的慢性病，​​例如肾毒性。 研究与 HRD&D 主题类别“慢性病管理”和 HSR&D 保持一致 具体优先领域“长期护理和老龄化”。 创新和影响：缺乏指导方针来帮助退伍军人及其现任者决定何时 应该进行监视成像，并且其用途可能会受到限制。 证据将带来一种创新方法来限制老年人不必要的测试和伤害 退伍军人。 具体目标：我们提出一项混合方法研究，其中两个具体目标 1 将进行定性评估。 退伍军人、家人和医疗保健团队成员对监测成像的态度和信念 EVAR。目标 2 将定量表征观测数据源以了解监视成像。 EVAR 后的结果。我们的传播计划将整合这些发现，为何时进行提供证据。 监视成像应该继续下去，并且当它的效用可能有限时。 相关风险可能超过对老年退伍军人进行持续监测的好处 合并症。 方法：我们的研究设计采用并行方法：对利益相关者信念进行定性评估 关于停止影像学监测（目标 1）和回顾性临床数据的定量分析 评估影像监测的使用、结果和风险（目标 2）。 后续步骤/实施：我们的项目涉及来自 VA 国家 VA 等组织的领导人 手术咨询委员会，血管外科学会，一个全国公认的网络论坛 老年护理和其他组织，以确保有效传播我们的证据。 我们提案中生成的内容将通过播客等创新途径进行分享，以确保我们的项目 可交付成果和影响得以持续。