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

低成本便携式 3D 超声的商业化，用于护理点透析临床医生监测动静脉瘘的成熟度

• 批准号: 10480217
• 负责人: Xin Kang
• 金额: $ 50万
• 依托单位: SONAVEX, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10480217
• 关键词: 3-Dimensional; 3D ultrasound; Adoption; Adult; Algorithms; American; Arteriovenous fistula; Blood Vessels; Budgets; Catheters; Chronic Kidney Failure; Clinic; Clinical; Computer software; Consumption; Cost Savings; Custom; Data; Detection; Devices; Dialysis patients; Dialysis procedure; Disease; Documentation; Early Diagnosis; Economics; End stage renal failure; Failure; Feedback; Fistula; Health Care Costs; Hemodialysis; Home; Home Hemodialysis; Home visitation; Human; Image; Implant; Kidney; Kidney Diseases; Laboratories; Location; Logistics; Medicare/Medicaid; Methods; Monitor; Morbidity - disease rate; Outpatients; Patients; Phase; Postoperative Period; Prevalence; Procedures; Provider; Records; Resources; Specialist; Surgeon; System; Time; Transducers; Transportation; Ultrasonography; United States; United States Centers for Medicare and Medicaid Services; Visit; Weight; Work; base; commercialization; cost; cost effective; cost efficient; early phase clinical trial; image processing; improved; infection rate; minimally invasive; mortality; point of care; portability; prevent; rapid detection; success; ultrasound; verification and validation

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.

项目概要/摘要 严重肾脏疾病占所有 Medicare 和 Medicaid 费用的 7%。最经济有效的方法 进行透析使用动静脉瘘连接透析机，但动静脉瘘的使用受到以下因素的限制： 创建后立即出现故障（成熟失败），这可能导致高达 70% 的创建 瘘管不能用。 瘘管形成后对其进行超声监测可以通过检测以下问题来避免故障： 可以通过微创门诊手术来修复。不幸的是，尽管超声波已被证明可以 将故障率降低至仅22%，用于检测这些问题的超声波检查非常有效 昂贵，因为它们只能由超声专家在专门的血管实验室进行 – 不在透析诊所。此外，只有 12-33% 的透析患者愿意进行常规就诊 由于交通和财务限制而进行透析治疗。由于巨大的费用和后勤保障 面对挑战，目前在术后期间并未常规进行超声扫描。如果超声波是 更便宜，更容易获得，并且可以在透析诊所进行，可以在成熟期间进行 阶段并消除大多数早期瘘管失败，最大限度地减少导管接触时间，从而产生显着的临床效果 为患者带来好处并节省大量成本。 我们开发了基于双组件超声的解决方案 EchoMark LP 和 EchoSure V2， 可在任何地方使用，不需要专业超声医师。我们的系统可用于检查瘘管 在由负责透析的同一透析技术人员进行的常规透析过程中。这意味着 在瘘管形成后的最初几周内对瘘管进行超声监测，只需很少的额外费用 每周多达 3 次。我们已经证明 EchoSure V1 对人类瘘管有效，并且我们已收到 FDA 批准，但该设备必须进行修改才能实现商业可行性。具体来说，我们必须：1）降低 超声系统成本，基于对在透析中心安装大量系统的需求的认识； 2) 根据临床医生对在不同地点之间轻松运输系统的需求的反馈，提高便携性 （例如家庭血液透析）； 3) 与 Epic 等常见的 PACS/EMR 集成，以实现每周简化 记录瘘管流量数据和报销账单。 在这项工作中，我们建议开发新版本的 EchoSure 系统 (ESV2) 来满足这些需求。这 将允许在任何环境下（例如透析室、 家庭、诊所等）以最大限度地提高成熟率并防止瘘管失败。 在此 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 成本降低 50%，减小外形尺寸和重量，并且易于运输和使用 EchoSure 在透析室和家庭血液透析期间的应用； (2) 将现有的EchoSure软件移植到ESV2 硬件平台并执行 FDA 许可和临床所需的所有验证和确认活动 使用; (3) 为 EchoSure 创建 PACS 和 EHR 集成，直接与当前提供商系统连接 支持计费和记录存储，以支持文档记录、统一患者记录和审计合规性。 总体影响： ESV2 将允许在动静脉瘘出现故障之前快速、早期地发现动静脉瘘问题。 成熟阶段。这既可以提高瘘管成熟的成功率，又可以减少导管接触时间， 因此，患者能够通过瘘管而不是导管接受透析，从而降低死亡率 每个患者的年度费用减少 23%。由于投入到最终目标的资源不成比例 阶段肾病，我们的建议有可能大大降低终末期肾病的发病率 疾病在美国并降低成本。