Dialysis is a major financial burden with a large and growing population.

Vascular access is the “lifeline” for hemodialysis patients.1 Vascular access is a major cause of hospitalizations and morbidity in patients with end stage renal disease. Easily obtained and accurate data assessing vascular access could lead to improved outcomes and substantial savings to the healthcare system.

Sonavex dialysis graphic

Following surgical creation, arteriovenous fistulae (AVF) must undergo a process of maturation to allow for higher flow rate and successful cannulation with dialysis needles.

30-50%
of arteriovenous
fistulae fail to
mature6, 7

 

4x
increase in vascular access
costs per year for patients
with unusable AVF vs.
patients with functional AVF8

 

80%
of patients initiate
dialysis on a catheter9

 

57%
of patients who initiate dialysis on a catheter continue to rely on a catheter 6 months later9

 

2
catheter-based bloodstream infections per catheter per year result in hospitalization10

 

$23k
average cost per hospitalization
from bloodstream infections10, 11, 12

 

$160
incremental cost per
catheter per day
compared to patients
with an AVF10, 13, 14, 15

 

2-3x-greater-mortality2-3x
greater mortality for patients
with a catheter vs patients
with an AVF16, 17, 18, 19, 20, 21

 

 

Minimizing catheter days for dialysis patients
is a high priority for the AV access care team.

 

Every day counts.

 

Ultrasound Accurately Assesses Maturation,
But Is Not Available in the Dialysis Clinic

 

Ultrasound Drastically Improves Maturation Assessments

physical exam vs ultrasound

“Ultrasound should be the first technique of choice in the
evaluation of maturation, regardless of physical examination.” 24

 

Ultrasound Criteria Established to Assess Maturation

Flow Diameter Depth

Ultrasound parameters offer predictive value starting at 2-weeks post-op.25

 

Dialysis Patients Do Not Have Routine Access to Ultrasound

dollar sign

conventional ultrasound requires
expensive equipment, highly
trained personnel and a separate
visit to a vascular lab

 

12-33%
for a variety of reasons,
patient compliance is only 12-33%
for visits outside of routine
dialysis sessions26

 

The Sonavex System Fills the Gap and Meets the Patient Where They Are:
In the Dialysis Clinic


QUANTIFY
volumetric flow rate, depth and diameter


VISUALIZE
diameter and depth
along fistula


TRACK
flow values
over time

 

 

EchoMark LP

Bioresorbable implant

EchoSure

Custom automated 3D ultrasound

 

EchoSure screen

Sonavex’s Patented EchoMark and EchoSure Technology Is Designed to Enable Any Member of the Care Team to Collect Arteriovenous Fistula Volumetric Flow Rate, Diameter and Depth Information in the Dialysis Clinic to Support Maturation Assessment.

REFERENCES:

  1. Shenoy S, et al. Clinical Trial End Points for Hemodialysis Vascular Access. CJASN March 2018, 13 (3) 490-494
  2. 2019 USRDS Annual Data Report
  3. Fresenius 2011 Annual Report
  4. Fresenius 2018 Annual Report
  5. Fresenius 2019 Annual Report
  6. Sheth RA, et al. Nonmaturing Fistulae: Epidemiology, Possible Interventions, and Outcomes. Techniques in Vascular and Interventional radiology. 2017;20(1):31-7
  7. Lee T, et al. Long-Term Outcomes of Arteriovenous With Unassisted Versus Assisted Maturation: A Retrospective National Hemodialysis Cohort Study. J Am Soc Nephrol 2019, 30(11):2209-2218
  8. Thamer M, et al. Medicare Costs Associated With Arteriovenous Fistulas Among US Hemodialysis Patients. Am J Kidney Dis. 2018 Jul;72(1):10-18
  9. 2021 USRDS Annual Data Report
  10. Al-Balas A, et al. The Clinical and Economic Effect of Vascular Access Selection in Patients Initiating Hemodialysis with a Catheter. JASN.  Dec 2017, 28(12)
  11. Hall RK, et al.  Choice of Hemodialysis Accesss in Older Adults: A Cost-Effectiveness Analysis.  Clin J Am Soc Nephrol  June 2017, 12(6) 947-954
  12. Landry D, Braden G. Editorial: Reducing Catheter-Related Infections in Hemodialysis Patients. Clin J Am Soc Nephrol July 2014, 9: 1156-1159
  13. Note: A comprehensive list of several supporting publications is available as a separate document entitled “Costs Associated with Central Venous Catheters” – available upon request.
  14. Wang K, et al. Epidemiology of haemodialysis catheter complications. BMJ Open 2015;5
  15. CMS OPPS Fee Schedule 2019, CMS Physician Fee Schedule for CPT 36581
  16. Dhingra RK, et al. Type of vascular access and mortality in U.S. hemodialysis patients. Kidney Int. 2001;60(4):1443-1451
  17. Xue JL, et al. The association of initial hemodialysis access type with mortality outcomes in elderly Medicare ESRD patients. Am J Kidney Dis. 2003;42(5):1013-1019
  18. Riella MC, Roy-Chaudhury P. Vascular access in haemodialysis: strengthening the Achilles’ heel. Nat Rev Nephrol. 2013;9(6):348-357
  19. Allon M, et al. Effect of change in vascular access on patient mortality in hemodialysis patients. Am J Kidney Dis. 2006;47(3):469-477
  20. Lok CE, Foley R. Vascular access morbidity and mortality: trends of the last decade. Clin J Am Soc Nephrol. 2013;8(7):1213-1219
  21. Yeh LM, Chiu SY, Lai PC. The Impact of Vascular Access Types on Hemodialysis Patient Long-term Survival. Sci Rep. 2019;9(1):10708
  22. Ferring M, et al. Accuracy of early postoperative clinical and ultrasound examination of arteriovenous fistulae to predict dialysis use J Vasc Access 2014;15 (4): 291-297
  23. Zhu YL, et al. Predicting the maturity of haemodialysis arteriovenous fistulas with colour Doppler ultrasound: a single-centre study from China. Clin Radiol. 2016;71(6):576-582
  24. Malik, et al. The Role of Doppler Ultrasonography in Vascular Access Surveillance- Controversies Continue. J VascularAccess 2021;22 (1S):63-70
  25. Robbin ML, et al and Hemodialysis Fistula Maturation Study Group. Prediction of Arteriovenous Fistula Clinical Maturation from Postoperative Ultrasound Measurements: Findings from the Hemodialysis Fistula Maturation Study. Am Soc Nephrol 2018. 29:2735-2744
  26. Lynch SK, et al. Patient Compliance Limits the Efforts of Quality Improvement Initiatives on Arteriovenous Fistula Maturation. Journal of Vascular Surgery 2015;61:184-91