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 进行透析使用动静脉瘘连接到透析机，但使用瘘管受到限制 创建后立即出现故障（成熟失败），最多可渲染所有创建的人的70％ 瘘管无法使用。 瘘管创建后对瘘管的超声监测可以通过检测问题来避免故障 可以使用最小的入侵门诊程序来固定。不幸的是，尽管已显示超声 将故障率降低到只有22％，用于检测这些问题的超声检查非常 昂贵，因为它们只能由超声专家在专业的血管实验室进行 - 不在透析诊所。此外，透析患者仅符合日常访问的访问率12-33％ 由于运输和财务限制而引起的透析会议。由于巨大的费用和后勤 挑战，目前在术后期间尚未进行超声扫描。如果超声是 便宜，更便宜，可以在透析诊所使用，可以在成熟期间进行 相位并消除大多数早期瘘管衰竭，最大程度地减少导管接触时间，从而产生明显的临床 对患者的好处和大量的成本节省。 我们已经开发了一个基于双组分超声的解决方案Echomark LP和Echosure V2，可以是 在任何地方使用，不需要专家超声波检查员。我们的系统可用于检查瘘管 在常规的透析过程中，由透析的相同透析技术进行。这意味着 在创建瘘管后的最初几周内，对瘘管的超声监测几乎没有成本 每周3次。我们已经证明，Echosure V1在人类瘘管中起作用，我们已经收到 FDA间隙，但是必须修改该设备以进行商业生存能力。具体来说，我们必须：1）较低 超声系统的成本是基于认识到在透析中心安装大量系统的需求； 2）根据需要轻松在位置之间轻松运输系统的临床反馈，增加便携性 （例如，家庭血液透析）； 3）与EPIC（例如EPIC）集成在一起以启用每周简化的 瘘管流数据和账单的记录。 在这项工作中，我们建议开发一个新版本的Echosure System（ESV2）来满足这些需求。 将允许在任何情况下快速，准确且经常对动脉瘘进行监测（例如，透析单位， 家庭，诊所等），以最大化成熟率并防止瘘管衰竭。 在此CRP提案中，我们将（1）为超声系统和3D传感器开发新的硬件解决方案 将成本降低50％，减少了外形尺寸和重量，并可以易于使用 透析单位和家庭血液透析期间的回波； （2）ESV2的端口现有Echosure软件 硬件平台并执行FDA清除和临床所需的所有验证和验证活动 使用; （3）创建与当前提供商系统直接接口的Echose的PAC和EHR集成 为了启用计费和记录存储以支持文档，统一的患者记录和审计合规性。 总体影响： ESV2将允许在故障之前快速和早期发现动静脉瘘的问题 成熟阶段。这两个都将提高瘘管成熟的成功率，并减少导管接触时间， 因此，使患者能够通过瘘管接受透析，而不是导管，这导致死亡率降低 每位患者的年费用降低了23％。因为专门用于结束的不成比例的资源 阶段肾脏疾病，我们的提议有可能深刻降低末期肾脏的发病率 美国疾病并降低成本。