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8,000多名退伍军人接受腹部主动脉瘤（AAA）修复。几乎 70％用腹主动脉瘤修复（EVAR）处理，其中使用了覆盖的支架 加强弱主动脉。大多数国家准则和监管指令授权年度终身 EVAR后的监视成像，通常是通过每年一次的对比度增强的CT扫描提供的。监视 对支架周围流入主动脉的血液的成像评估，称为“内左”。虽然大多数 内肢无害，1-3％是高压“ I型”胚胎，这会导致破裂并需要维修。 但是，可能会达到一个持续的年度监视成像可能不是最佳选择的观点 Evar之后的老退伍军人。与成像相关的风险包括使用的对比染料急性肾脏损伤 在CT扫描（3-10％）期间，鉴定无需治疗的无害内肢（10-20％）和 引发进一步侵入性测试或治疗的肺结节等偶然发现（10-15％）。 我们在该项目中的科学原理是更好地理解知识的关键差距：权衡 在与成像相关的风险和确定危险形式的内肢（1-3％）之间 困难，尤其是对于多种合并症的老年退伍军人。 意义：围绕何时停止监视的证据差距对于退伍军人尤其重要， 与非退伍军人人口相比，他们更脆弱，大致更加脆弱。我们估计超过10,000 退伍军人目前还活着有一个evar。这表明将有10,000多次扫描 每年根据我们的初步队列组件进行，将有500多名退伍军人 并发症，例如肾毒性。因为它会影响我们最古老的退伍军人中的慢性病，​​所以我们 研究与HRD＆D主题类别“慢性病管理”和HSR＆D一致 特定的优先领域“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临床医生决定何时 监视成像应该发生，并且何时可能会限制其效用。开发和传播这一点 证据将为限制不必要的测试和危害的创新方法 退伍军人。 具体目的：我们提出了一项具有两个特定目的的混合方法研究。 AIM 1将定性评估 资深人士，家庭和医疗团队成员的参加并相信围绕监视成像 evar。 AIM 2将定量地表征观察数据源以了解监视成像 Evar之后的结果。我们的传播计划将整合这些发现，以创建证据 监视成像应该继续进行，并且何时可能具有有限的效用。我们假设成像 相关的风险可能超过具有重大的老年退伍军人的持续监视的好处 合并症。 方法学：我们的研究设计利用了一种平行的方法：利益相关者信念的定性评估 关于停止成像监视（目标1）和回顾性临床数据的定量分析 评估成像监视的使用，结果和风险（AIM 2）。 下一步/实施：我们的项目涉及来自VA国家弗吉尼亚州等组织的领导者 外科咨询委员会，血管外科协会，一个全国认可的基于网络的论坛 老年护理和其他组织，以确保有效传播我们的证据。 我们的提案中生成的将使用创新途径（例如播客）共享，以确保我们的项目的 可交付成果和影响得以维持。