Purpose: The purpose of this study was to perform bench and clinical testing of a catheter-based intravascular system capable of measuring blood flow in hemodialysis vascular accesses during endovascular procedures.
Methods: We tested the Transonic ReoCath Flow Catheter System which uses the thermodilution method. A simulated vascular access model was constructed for the bench test. In total, 1960 measurements were conducted and the results were used to determine the accuracy and precision of the catheters, the effects of external factors (e.g., catheter placement, injection duration), and to test for systematic bias. In the clinical study, two interventional radiologists conducted a total of 250 measurements in 14 patients with arteriovenous fistulas to determine clinical precision and enable testing for bias between measurers.
Results: Accuracy was excellent for both catheters with a high level of agreement between results from the ReoCath Flow Catheter System and the reference flowmeter. Clinical precision, expressed as the mean coefficient of variation, was 5.9% and 4.7% for the antegrade and retrograde catheters, respectively. Flow measurements were significantly affected by the distance between a stenosis and the tip of a retrograde catheter with the effect being proportional to the degree of stenosis. There was no systematic bias between measurers.
Conclusions: The Reocath Flow Catheter System was found to be accurate and precise. Reliable results require careful attention to catheter placement. Blood flow measurements provide unique information on the hemodynamic status of a vascular access and have the potential to optimize results of interventions.