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Maintenance of blood flow rate on dialysis with self-centering CentrosFLO catheter: A multicenter prospective study
Anil K Agarwal1, Stephen R Ash2, 3
1Professor of Medicine, Chief, Section of Nephrology at University Hospiital East, Director, Interventional Nephrology, Director of Clinical Scholarship for FAME, The Ohio State University Wexner Medical Center, Columbus, Ohio, 43210, USA.
Insights
The CentrosFLO central venous catheter (CVC) maintained high blood flow rates over 26 weeks in dialysis patients. This novel catheter design significantly reduces fibrous sheathing, improving long-term dialysis CVC patency.
Area of Science:
- Nephrology
- Vascular Access
- Medical Device Engineering
Background:
- Chronic central venous catheters (CVCs) used for dialysis often experience reduced patency and blood flow due to fibrous sheathing at the lumen tips.
- This degradation impacts the efficacy and longevity of dialysis vascular access.
Purpose of the Study:
- To evaluate the long-term patency and blood flow performance of the novel CentrosFLO central venous catheter in dialysis patients.
- To assess if the unique catheter tip design mitigates fibrous sheathing and maintains hydraulic resistance.
Main Methods:
- A prospective, multicenter, observational study involving 75 dialysis patients using the CentrosFLO catheter via internal jugular veins.
- Data on blood flow rate and pressures were collected for up to 26 weeks.
- Kaplan-Meier analysis was used to assess patency and flow rates.
Main Results:
- 87% of patients maintained a blood flow rate above 300 mL/min for the entire 26-week follow-up period.
- No decline in average dialysis blood flow rate was observed.
- Hydraulic resistance of the catheter lumens remained stable, indicating no significant fibrous sheathing.
Conclusions:
- The CentrosFLO catheter demonstrates sustained long-term patency and effective blood flow rates in dialysis patients.
- The catheter's design appears to successfully prevent fibrous sheathing, offering a significant clinical improvement over existing CVCs.
Abstract:
Introduction Chronic central venous catheters (CVC) for dialysis lose patency and deliver lower blood flow over time, often due to fibrous sheathing that covers the lumen tips. The CentrosFLO central venous catheter has a shape that directs the arterial and venous tips away from the walls of the vena cava and right atrium, making sheathing of the tips less likely. Methods A prospective, multicenter, single arm, non-controlled, observational study was conducted at eight sites in the United States. All consenting dialysis patients receiving CentrosFLO catheters through the right or left internal jugular veins were accepted in the study, as long as the catheter was expected to be used for 45 days and was not an over-the-wire replacement for a previous CVC. Data were automatically collected on initial and average dialysis blood flow rate and initial arterial and venous pressures, for up to 26 weeks of dialysis therapy. Findings 75 patients were enrolled. Kaplan-Meier analysis indicated that 87% of patients maintained blood flow rate over 300 mL/min throughout 26 weeks of follow-up. There was no decline in average dialysis blood flow rate and no significant change in hydraulic resistance of the arterial or venous lumens of the catheters during the study. Discussion The CentrosFLO catheter demonstrates long term patency with good flow rates on dialysis, which, by comparison with previous studies, shows a clinically significant improvement in blood flow rate vs. other catheters. Stable hydraulic resistance of the catheter lumens showed no evidence of tip encroachment by fibrous sheaths.
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