Validation of a Bedside Automated 3D Ultrasound-based Arteriovenous Fistula Cannulation Guidance Solution to Improve AV Fistula Outcomes

项目摘要/摘要 终末期肾病(ESRD)影响全球430万患者，占所有患者的7% 医疗保险和医疗补助的成本。最流行的肾脏置换方式，血液透析， 需要进入与透析机相连的循环。首选的 介入方法是动静脉瘘，因为它的死亡率、感染率较低 和干预，然而，他们是最具挑战性的透析技术人员插管。 插管损伤是房室瘘并发症和失败的主要原因之一。 91%的患者在6个月内发生插管失败和损伤。这些伤害可能会导致 严重并发症，如血肿、感染和动脉瘤形成，包括死亡 出血，对发病率、住院率、入院改良率和丢失有继发性影响 访问权限。每年的主要渗透率为5.2%，每发生一次事件就会导致额外的97 导管依赖天数，平均2.4次诊断测试、手术预约或 干预措施。当考虑到额外的导管时间和二次干预时， 每一次重大渗入的财务影响为21,441美元。 超声已被证明通过减少CVC时间来显著改善预后 &gt；30%(50天)和37%的感染。然而，这是在肾脏内科医生的手中 在一项研究中，目前的超声选择对透析技术人员和 因此不会被使用。 我们开发了一种基于3D超声的自动化导航解决方案EchoGuide，即 专为透析技术人员改进插管而建立，无需专门培训。这 一项研究建议证明，当透析技术人员使用EchoGuide时，基本上可以 减少房室瘘的插管错误和渗入。 在此第二阶段提案中，我们将(1)开发带有定制探头/显示器的集成EchoGuide 硬件、管腔检测算法和实时交互导航；(2)迭代用户 通过人为因素开发接口，以优化导航制导；以及(3)扩展 经过验证的AVF插管模拟器支持超声兼容性，以便演示 EchoGuide在提高技术人员跨越挑战的插管成功率方面的有效性 AVF场景。 总体影响：EchoGuide将允许快速和成功地插管房室瘘。这将是 降低与主要渗入和相关导管相关的发病率和成本 时间和其他干预措施。

PROJECT SUMMARY/ABSTRACT End Stage Renal Disease (ESRD) impacts 4.3M patients worldwide and accounts for 7% of all Medicare and Medicaid costs. The most prevalent modality of renal replacement, hemodialysis, requires access to the circulation through which dialysis machinery is connected. The preferred method of access is an arteriovenous (AV) fistula as it confers lower rates of mortality, infection and interventions, however they are the most challenging for dialysis technicians to cannulate. Cannulation damage is one of the primary causes of AV fistula complications and failure. Cannulation failures and injury occur in 91% of patients within 6 months. These injuries can lead to serious complications, such as hematoma, infection, and aneurysm formation including death from hemorrhage, with a secondary impact on morbidity, hospitalization, access revision, and loss of access. The annual rate of major infiltration is 5.2%, with each incident leading to an extra 97 days of catheter dependency and a mean of 2.4 diagnostic tests, surgery appointments, or interventions. When factoring in the additional catheter time and secondary interventions, the financial impact is $21,441 per major infiltration. Ultrasound has been demonstrated to dramatically improve outcomes by reducing CVC time by >30% (50 days) and infections by 37%. However, this was in the hands of nephrology physicians in a study setting and current ultrasound options are too challenging for dialysis technicians and are therefore not used. We have developed an automated 3D ultrasound-based navigation solution, EchoGuide, that is purpose build for dialysis technicians to improve cannulation without specialized training. This study proposes to prove that EchoGuide, when used by dialysis technicians, can substantially reduce cannulation errors and infiltrations for AV fistulae. In this Phase II proposal, we will (1) develop the integrated EchoGuide with custom probe/display hardware, lumen detection algorithms, and real-time interactive navigation; (2) iterate user interface via human factors development to optimize navigation guidance; and (3) extend a validated AVF cannulation simulator to enable ultrasound compatibility in order to demonstrate EchoGuide effectiveness in improving cannulation success by technicians across challenging AVF scenarios. OVERALL IMPACT: EchoGuide will allow rapid and successful cannulation of AV fistulae. This will reduce both the morbidity and costs associated with major infiltration and the associated catheter time and additional interventions.