Commercialization of Low-Cost Portable 3D Ultrasound for Surveillance of Arteriovenous Fistula Maturation by Point-of-Care Dialysis Clinicians

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 昂贵，因为它们只能由超声专家在专门的血管实验室进行- 不是在透析诊所此外，透析患者仅12-33%依从常规外访视 由于交通和经济限制，需要进行透析治疗。由于大量的费用和后勤 尽管存在这些挑战，但目前在术后期间并不常规进行超声扫描。如果超声波 更便宜，更容易获得，并且在透析诊所中可用，它可以在成熟期间进行 阶段和消除大多数早期瘘失败，最大限度地减少导管接触时间，导致显著的临床 对患者有利，节省大量费用。 我们开发了一种基于双组分超声的解决方案，EchoMark LP和EchoSure V2， 它可以在任何地方使用，不需要专业的超声医师。我们的系统可以用来检查瘘管 在常规透析期间，由进行透析的同一透析技师进行。这意味着 在瘘管形成后的最初几周内，可以进行瘘管的超声监测， 每周3次。我们已经证明EchoSure V1在人体瘘管中有效， FDA批准，但必须对器械进行修改以获得商业可行性。具体而言，我们必须：1）降低 超声系统成本，基于对需要在透析中心安装大量系统的认识; 2)根据临床医生关于需要在不同位置之间轻松运输系统的反馈，增加便携性 (e.g.家庭血液透析）;以及3）与Epic等常见PACS/EMR集成，以实现每周精简 记录瘘管病流量数据并开具报销账单。 在这项工作中，我们建议开发一个新版本的EchoSure系统（ESV 2），以满足这些需求。这 将允许在任何环境中（例如，透析单元， 家庭、诊所等）以最大化成熟率并防止瘘管衰竭。 在本CRP提案中，我们将（1）为超声系统和3D换能器开发新的硬件解决方案 其降低了50%的成本，减小了外形尺寸和重量，并且便于运输使用 透析装置和家庭血液透析期间的EchoSure;（2）将现有EchoSure软件移植到ESV 2 硬件平台，并执行FDA批准和临床所需的所有验证和确认活动 使用;以及（3）为EchoSure创建PACS和EHR集成，直接与当前提供商系统连接 实现计费和记录存储，以支持文档编制、统一患者记录和审计合规性。 总体影响： ESV 2将允许在发生故障之前快速和早期检测动静脉瘘的问题。 成熟期这将提高瘘管成熟的成功率并减少导管接触时间， 从而使患者能够通过瘘管而不是导管接受透析，从而降低死亡率 每位患者的年成本降低23%。由于不成比例的资源用于结束 对于晚期肾病，我们的建议有可能大大降低终末期肾病的发病率。 在美国的疾病和降低成本。

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 – not in the dialysis clinic. Additionally, dialysis patients are only 12-33% compliant with visits outside of routine dialysis sessions due to transportation and financial limitations. Because of the significant expense and logistical challenges, ultrasound scans are not currently routinely performed in the postoperative period. If ultrasound were less expensive, more accessible, and available in the dialysis clinic, it could be performed during the maturation phase and eliminate most early fistula failures, minimize catheter contact time, resulting in significant clinical benefit for patients and substantial cost savings. We have developed a dual-component ultrasound-based solution, EchoMark LP and EchoSure V2, that can be utilized anywhere and does not require expert ultrasonographers. Our system can be used to examine a fistula during routine dialysis sessions by the same dialysis techs that are administering dialysis. This means that ultrasound monitoring of a fistula in the first few weeks after fistula creation can be done for little additional cost as often as 3 times per week. We have proven that EchoSure V1 works in human fistulas and we have received FDA clearance, however the device must be modified for commercial viability. Specifically, we must: 1) lower ultrasound system cost, based on recognition of a need to install a larger number of systems at dialysis centers; 2) increase portability, based on clinician feedback on the need to easily transport the system between locations (e.g. home hemodialysis); and 3) integrate with common PACS/EMRs like Epic to enable streamlined weekly documentation of fistula flow data and billing for reimbursement. In this work we propose to develop a new version of the EchoSure system (ESV2) to meet these needs. This will allow rapid, accurate and frequent surveillance of arteriovenous fistulae in any setting (e.g. dialysis unit, home, clinic, etc.) to maximize maturation rates and prevent fistula failure. In this CRP proposal, we will (1) develop a new hardware solution for the ultrasound system and 3D transducer which decreases cost by 50%, reduces form factor size and weight, and enables ease of transportation for use of EchoSure in dialysis units and during home hemodialysis; (2) port existing EchoSure software to the ESV2 hardware platform and perform all Verification & Validation activities necessary for FDA clearance and clinical use; and (3) create PACS and EHR integrations for EchoSure that interface directly with current provider systems to enable billing and records storage to support documentation, unified patient records and audit compliance. OVERALL IMPACT: ESV2 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 reduce catheter contact time, therefore enabling patients to receive dialysis via a fistula, rather than a catheter, which leads to reduced mortality and 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.