Maintenance of blood flow rate on dialysis with self‐centering CentrosFLO catheter: A multicenter prospective study

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. KaplanMeier 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.

Clinical and Regulatory Considerations for Central Venous Catheters for Hemodialysis

“…The self-centering catheter is designed to prolong CVC survival by preventing the end holes from coming into direct contact with the vessel wall, which can lead to fibrin sheath formation and encasement of the end holes and vascular injury. Several prospective clinical trials have indicated a high patency of the self-centering catheter, with approximately 90% patency after 3 months of use (20,31,32). This patency compares favorably to numerous studies of other catheters (32).…”

“…Several prospective clinical trials have indicated a high patency of the self-centering catheter, with approximately 90% patency after 3 months of use (20,31,32). This patency compares favorably to numerous studies of other catheters (32). Although one of these trials was multicenter, none were prospectively controlled.…”

Hemodialysis Catheters: Update on Types, Outcomes, Designs and Complications

“…39 In a continuous effort to improve catheter patency rate and reduce complications, the self-centering CentrosFLO catheter was developed. 40 This catheter is an iteration of the split-tip prototype in which both the arterial and venous limbs of the catheter are curved, forming an oval shaped configuration. The side ports are directed inward to prevent contact with the vessel wall, a merit that hinders fibrin sheath formation and encasement of the side ports (►Fig.…”

The Ash Split Cath(TM): The best inventions are simple

“…A casualty of this dispute with Medcomp was the relationship we had developed between our two companies. Some years later I designed a split‐tip catheter with two tips bending inward (CentrosFLO™) to avoid fibrous sheathing of the tips 9 . This catheter was licensed to another company, not Medcomp.…”

“…Some years later I designed a split-tip catheter with two tips bending inward (CentrosFLO™) to avoid fibrous sheathing of the tips. 9 This catheter was licensed to another company, not Medcomp.…”