ASN's Mission

ASN leads the fight to prevent, treat, and cure kidney diseases throughout the world by educating health professionals and scientists, advancing research and innovation, communicating new knowledge, and advocating for the highest quality care for patients.

learn more

Contact ASN

1401 H St, NW, Ste 900, Washington, DC 20005

email@asn-online.org

202-640-4660

The Latest on Twitter

Kidney Week

Abstract: SA-PO967

Interim Analysis of Randomized Trial Comparing VectorFlow and Palindrome Tunneled Dialysis Catheters

Session Information

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