Abstract: SA-PO967
Interim Analysis of Randomized Trial Comparing VectorFlow and Palindrome Tunneled Dialysis Catheters
Session Information
- Dialysis: Vascular Access - II
October 27, 2018 | Location: Exhibit Hall, San Diego Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 704 Dialysis: Vascular Access
Authors
- Nadolski, Gregory, University of Pennsylvania, Philadelphia, Pennsylvania, United States
- Shin, Benjamin John, Hospital of University of Pennsylvania, Philadephia, Pennsylvania, United States
- Cohen, Raphael M., University of Pennsylvania, Philadelphia, Pennsylvania, United States
Background
Tunneled dialysis catheters (TDC) remain an important bridge to permanent hemodialysis (HD) access, a critical transition to new access creation when surgical access fails, and the only source of HD access when venous anatomy is exhausted for surgical access. Selection of an HD catheter capable of providing efficient HD with high primary patency is of utmost importance to improving outcomes in ESRD patients. The purpose of this trial is to compare a widely used symmetrical tip TDC, Palindrome (P), to a recently FDA-approved symmetrical design with helical flow at the tip to reduce blood cell shear stress, VectorFlow (VF).
Methods
The target recruitment of the study was 100 subjects enrolled at two centers with 1:1 randomization. Exclusion criteria included uncorrectable coagulopathy or thrombocytopenia; neutropenia, bacteremia, or infected surgical HD access within 7 days prior to enrollment; central venous stenosis or occlusion preventing jugular catheter insertion. The primary endpoint was primary patency at 90 days. Secondary endpoints include dialysis adequacy with Kt/V and URR monthly for 3 months, catheter flow (Qb) and lumen pressures at initial HD and monthly for 3 months.
Results
At present, the trial has enrolled 78 subjects and is anticipated to complete enrollment by the fall of 2018. Interim analysis showed 90-day primary patency of 74% in the VF group compared to 71% in the Palindrome group (P=0.81). Mean Kt/V at 30, 60 and 90 days was higher with the VF than P (30 d ay, 1.48 vs. 1.40; 60 days, 1.48 vs. 1.37; 90 days, 1.51 vs. 1.35); mean Kt/V averaged across all time points was significantly higher among subjects receiving the VF catheter compared to P (1.48 vs. 1.38, P=0.020). No significant differences were seen with URR (69 vs. 69) or Qb. Additional study data are pending final subject enrollment.
Conclusion
The ongoing trial comparing VectorFlow tunneled dialysis catheter to Palindrome tunneled dialysis catheter is the first US randomized trial comparing different HD catheter tip designs in nearly two decades, and the first to address dialysis adequacy. The results of this trial may elucidate which catheter design provides optimal HD adequacy and catheter patency.
Funding
- Commercial Support –