# Automated 3D Ultrasound-based Surveillance of Arteriovenous Fistula Maturation for Post-operative Hemodialysis Patients

> **NIH NIH R44** · SONAVEX, INC. · 2020 · $999,997

## Abstract

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.
Because of the significant expensive, ultrasound scans are not currently performed in the postoperative period.
If ultrasound were less expensive and more accessible, it could be performed during the maturation phase and
eliminate most early fistula failures, reducing in significant clinical benefit for patients and substantial cost
savings.
We have developed a dual-component ultrasound-based solution, EchoSure, that can be utilized anywhere and
does not require expert ultrasonographers. Our system can be used to examine a fistula during routine clinic
visits by the same medical assistants that check patient vitals. This means that ultrasound monitoring of a fistula
in the first few weeks after fistula creation can be done for little additional cost. We have proven that EchoSure
works in blood vessels. This study proposes to prove that the EchoSure system, when used in hemodialysis
fistula monitoring in large animals and patients, can substantially reduce fistula failure at the maturation stage.
In this Phase IIB proposal, we will (1) construct a flow phantom benchtop model for testing and refinement of the
EchoSure system within the parameters of hemodialysis access, (2) demonstrate the precision and accuracy of
the EchoSure system when used by inexpert personnel and compared to a formal Duplex examination performed
by expert ultrasonographers (3) use a large animal model of arteriovenous fistulae to test the ability of EchoSure
to predict fistula maturation, incipient thrombosis, or failure, and to compare those findings to standard Duplex
ultrasonography, and (4) use the EchoSure system in human patients undergoing arteriovenous fistula creation
to test the ability of EchoSure to predict maturation failure as early as the second postoperative week. OVERALL
IMPACT: EchoSure 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 therefore enable patients
to receive dialysis via a fistula initially, rather than a catheter, which leads to a 23% reduction in annual costs per
patient. Because of the disproportionate resources d...

## Key facts

- **NIH application ID:** 9936243
- **Project number:** 5R44HL147423-05
- **Recipient organization:** SONAVEX, INC.
- **Principal Investigator:** Stephen Hohmann
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $999,997
- **Award type:** 5
- **Project period:** 2019-06-01 → 2022-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9936243

## Citation

> US National Institutes of Health, RePORTER application 9936243, Automated 3D Ultrasound-based Surveillance of Arteriovenous Fistula Maturation for Post-operative Hemodialysis Patients (5R44HL147423-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9936243. Licensed CC0.

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