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

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 and 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.