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

项目总结/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%。的最具成本效益的方式 进行透析使用动静脉瘘连接到透析机，但瘘的使用受到限制， 创建后立即出现故障（成熟失败），这可能导致高达70%的创建 瘘管无法使用。 瘘管形成后的超声监测可以通过检测以下问题来避免故障， 可以通过微创门诊手术进行修复。不幸的是，尽管超声波已经被证明 将故障率降低到22%，用于检测这些问题的超声波检查非常 因为它们只能由超声专家在专门的血管实验室进行。 由于价格昂贵，目前在术后期间不进行超声扫描。 如果超声波更便宜，更容易获得，它可以在成熟阶段进行， 消除大多数早期瘘管失败，减少患者的显著临床获益和大量成本 积蓄 我们开发了一种基于双组分超声的解决方案EchoSure，可在任何地方使用， 并不需要专业的超声波技师。我们的系统可用于在常规门诊期间检查瘘管 由同样的医疗助理来检查病人的生命体征。这意味着对瘘管的超声监测 在瘘管形成后的最初几周内，几乎不需要额外的费用。我们已经证明EchoSure 作用于血管。本研究旨在证明EchoSure系统用于血液透析时 在大型动物和患者中进行瘘管监测，可以大大减少瘘管在成熟阶段的失败。 在本IIB期提案中，我们将（1）构建一个流动体模台架模型，用于测试和改进 EchoSure系统内血液透析通路参数，（2）证明精密度和准确度 EchoSure系统由非专业人员使用，并与执行的正式Duplex检查进行比较 由专业超声医师（3）使用大型动静脉瘘动物模型测试EchoSure的能力 预测瘘管成熟、早期血栓形成或失败，并将这些结果与标准Duplex进行比较 超声检查，以及（4）在接受动静脉瘘创建的人类患者中使用EchoSure系统 测试EchoSure早在术后第二周预测成熟失败的能力。整体 影响：EchoSure将允许在故障前快速和早期检测动静脉瘘的问题 在成熟阶段。这将提高瘘管成熟的成功率，因此使患者能够 最初通过瘘管而不是导管接受透析，这导致每年费用减少23%， 病人由于用于终末期肾病的资源不成比例，我们的提案 有可能大大降低美国终末期肾病的发病率， 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.