Automated 3D Ultrasound-based Surveillance of Arteriovenous Fistula Maturation for Post-operative Hemodialysis Patients

项目摘要/摘要 严重的肾脏疾病占所有医疗保险和医疗补助费用的7%。最具成本效益的方式 执行透析使用动静脉瘘连接到透析机，但瘘的使用受到 在创建后立即发生故障(成熟失败)，这可能会导致高达70%的创建 瘘管无法使用。 在形成瘘管后对其进行超声监测，可以通过检测以下问题来避免故障 可以通过微创的门诊手术来修复。不幸的是，尽管超声波已经显示出 将故障率降低到只有22%，用来检测这些问题的超声波检查非常 价格昂贵，因为它们只能在专门的血管实验室由超声波专家进行。 由于费用昂贵，目前不在术后期间进行超声扫描。 如果超声波更便宜，更容易获得，它可以在成熟期进行，并 消除大多数早期瘘管失败，减少患者的显著临床收益和大量成本 积蓄。 我们开发了一种基于双组件超声波的解决方案EchoSure，可以在任何地方使用 不需要专业的超声诊断师。我们的系统可用于常规临床检查瘘管。 由检查病人生命体征的同一医疗助理来探视。这意味着超声监测瘘管 在瘘管形成后的头几周内，几乎不需要额外的费用。我们已经证明，EchoSure 在血管中起作用。这项研究建议证明，当EchoSure系统用于血液透析时 在大型动物和患者中监测瘘管，可以大大减少成熟阶段的瘘管失效。 在这个第IIB阶段的建议中，我们将(1)构建一个流动幻影台面模型，以测试和完善 EchoSure系统在血液透析通路的参数范围内，(2)证明了精密度和准确性 EchoSure系统由非专业人员使用，并与执行的正式双工检查进行比较 (3)使用动静脉瘘的大型动物模型来测试EchoSure 以预测瘘管成熟、早期血栓形成或失败，并将这些发现与标准Duplex进行比较 超声检查，以及(4)在动静脉瘘患者中使用EchoSure系统 检测EchoSure最早在术后第二周预测成熟失败的能力。总体来说 影响：EchoSure将允许在故障之前快速和早期检测动静脉瘘问题 处于成熟期。这将提高瘘管成熟的成功率，从而使患者 最初通过瘘管接受透析，而不是使用导管，这将使每个患者的年成本降低23% 有耐心的。由于用于终末期肾病的资源不成比例，我们的提案具有 极大地降低美国终末期肾病发病率的潜力 成本。

PROJECT SUMMARY/ABSTRACT Severe kidney disease accounts for 7% of all Medicare and Medicaid costs. The most cost-effective way to perform dialysis uses an arteriovenous fistula to connect to dialysis machines, but fistula use is limited by the malfunctions immediately following creation (maturation failure), which can render up to 70% of all created fistulas unusable. Ultrasound monitoring of the fistula after it has been created can avoid malfunction by detecting problems that can be fixed with minimally invasive outpatient procedures. Unfortunately, though ultrasound has been shown to reduce the failure rate to only 22%, the ultrasounds examinations used to detect these problems are very expensive because they can only be performed at specialized vascular laboratories by ultrasound specialists. Because of the significant expensive, ultrasound scans are not currently performed in the postoperative period. If ultrasound were less expensive and more accessible, it could be performed during the maturation phase and eliminate most early fistula failures, reducing in significant clinical benefit for patients and substantial cost savings. We have developed a dual-component ultrasound-based solution, EchoSure, that can be utilized anywhere and does not require expert ultrasonographers. Our system can be used to examine a fistula during routine clinic visits by the same medical assistants that check patient vitals. This means that ultrasound monitoring of a fistula in the first few weeks after fistula creation can be done for little additional cost. We have proven that EchoSure works in blood vessels. This study proposes to prove that the EchoSure system, when used in hemodialysis fistula monitoring in large animals and patients, can substantially reduce fistula failure at the maturation stage. In this Phase IIB proposal, we will (1) construct a flow phantom benchtop model for testing and refinement of the EchoSure system within the parameters of hemodialysis access, (2) demonstrate the precision and accuracy of the EchoSure system when used by inexpert personnel and compared to a formal Duplex examination performed by expert ultrasonographers (3) use a large animal model of arteriovenous fistulae to test the ability of EchoSure to predict fistula maturation, incipient thrombosis, or failure, and to compare those findings to standard Duplex ultrasonography, and (4) use the EchoSure system in human patients undergoing arteriovenous fistula creation to test the ability of EchoSure to predict maturation failure as early as the second postoperative week. OVERALL IMPACT: EchoSure will allow rapid and early detection of problems with arteriovenous fistulas before malfunction in the maturation stage. This will both improve the success rate of fistula maturation and therefore enable patients to receive dialysis via a fistula initially, rather than a catheter, which leads to a 23% reduction in annual costs per patient. Because of the disproportionate resources devoted to end stage renal disease, our proposal has the potential to profoundly decrease the morbidity of end stage renal disease in the United States and to decrease costs.