Clinical outcomes associated with the use of the NexSite hemodialysis catheter with new exit barrier technology: Results from a prospective, observational multi-center registry study

PLoS One. 2019 Oct 7;14(10):e0223285. doi: 10.1371/journal.pone.0223285. eCollection 2019.

Abstract

Purpose: Decreasing the risk of catheter related bloodstream infections (CRBSIs) remains a key focus for improving outcomes and reducing cost of care for hemodialysis (HD) patients. Recent studies demonstrate CRBSI rates can be improved by managing bacterial colonization at the catheter exit site. Herein we present the results of a study documenting the clinical performance of the NexSite HD catheter, a new tunneled central venous catheter which incorporates Exit Site Management (ESM) technology.

Methods: We conducted an observational study using a prospective, multi-center registry of HD patients implanted with the NexSite HD catheter. The primary endpoint for the study was CRBSI rate for a period up to 180-days following catheter placement. Secondary endpoints included device placement success rate, exit site healing, development of an exit site or tunnel infection, and early or late non-infectious catheter-related complications. All reasons for early non-elective catheter removal were recorded.

Results: A total of 115 HD patients at 6 sites were included in the final analysis. Cumulative catheter use was 10,924 days with a mean duration of 95 days. Seven patients experienced CRBSIs during the study period resulting in a CRBSI rate of 0.64 per 1,000 catheter-days. Seventy-four patients (64.3%) had either elective catheter removal (n = 56) or utilized the catheter for the entire 180-day observation period (n = 18). Thirty-five patients (30%) underwent non-elective device removal either due to CRBSI (n = 5), low flow (n = 16), exit site issues (n = 7), or for other causes (n = 7). Six patients died during the observation period with 1 death due to CRBSI-associated complications and the remaining 5 deaths attributed to non-device related causes.

Conclusion: Our findings demonstrate that the NexSite HD catheter equipped with ESM technology can achieve a CRBSI rate in compliance with the NKF KDOQI (National Kidney Foundation Kidney Disease Outcome Quality Initiatives) Clinical Performance Guidelines stated goal of less than 1.0/1,000 catheter-days when used in hemodialysis patients using current standard of care nursing protocols.

Publication types

  • Multicenter Study
  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Catheter-Related Infections / epidemiology
  • Catheter-Related Infections / etiology
  • Catheter-Related Infections / prevention & control*
  • Catheterization, Central Venous / adverse effects
  • Catheterization, Central Venous / instrumentation
  • Catheterization, Central Venous / methods*
  • Central Venous Catheters / adverse effects*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Renal Dialysis / adverse effects
  • Renal Dialysis / instrumentation
  • Renal Dialysis / methods*

Associated data

  • Dryad/10.5061/dryad.4t8v4jf

Grants and funding

This study was funded by a research grant from Marvao Medical Limited, Galway, Ireland who participated in the study design. JGH, RDB, MM, MAM, JN, PEP, NS, and CJW received compensation in the form of research grants to their centers for participation in this study. JRR, LAM, and ADB received compensation from Marvao Medical for their roles as a part of the study’s Clinical Events Committee. JGH receives financial compensation from Capital Nephrology Associates. PA, RDB, MM, NS, and JN receive financial compensation from Eastern Nephrology Associates PLLC, MAM receives financial compensation from SC Clinical Research LLC, PEP receives financial compensation from Renal Associates PA, CJW received financial compensation from the Kidney & Blood Pressure Clinic of Lubbock PA, and JRR receives financial compensation from Access Connections LLC. Other than Marvao Medical's role in study design, they had no additional role in the decision to publish, or preparation of the manuscript.