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A Prospective Clinical Study of a Percutaneous Vascular Access System for Hemodialysis Catheters

  • Clinical Investigation
  • Venous Interventions
  • Published:
CardioVascular and Interventional Radiology Aims and scope Submit manuscript

Abstract

Introduction

Dysfunctional or infected hemodialysis polyester-cuffed catheters often require removal and are dissected out. The DermaPort™, percutaneous vascular access system (PVAS) permanently integrates a titanium mesh with the skin forming a stable, sterile barrier that allows for catheter placement, adjustment, or catheter exchange. This study aimed to describe the use and clinical outcomes of the DermaPort PVAS.

Methods

Thirty-eight patients who were receiving hemodialysis via a tunneled catheter were enrolled in this prospective open-label study. Assessments were performed biweekly for the first month and monthly thereafter, which included physical examination of the site of implantation for infection, catheter blood flow, and need for interventions to maintain catheter patency. Patient satisfaction was assessed with a visual analog score.

Results

Implantation of technical success was 100% with the implantation site demonstrating early tissue incorporation after 2 weeks and full incorporation within 4 weeks. The DermaPort™ successfully enabled 31 catheter exchanges and 10 repositions thru the port without dissection in 18 patients with nine repositions (90%) performed at bedside. The mean primary patency of the DermaPort™ was 172 ± 150 days, and mean secondary patency was 430 ± 203 days. There were no reportable serious adverse events in 12,100 catheter days of use and zero explantations of the device attributed to infection. The observed catheter infection rate was 0.33/1000 days.

Conclusions

The DermaPort™ system can be effectively implanted and facilitates catheter interventions in hemodialysis patients requiring long-term catheter use and has a lower infection rate than historical catheter infection rates.

Clinical Trial Protocol Number DermaPort-001 (no clinicaltrials.gov number as study was performed 9 years ago).

Health Canada Reference Application Number: 118393.

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Abbreviations

CRI:

Catheter-related infection

PVAS:

Percutaneous vascular access system

SD:

Standard deviation

SQ:

Subcutaneous

QB:

Blood flow rate

TDC:

Tunneled dialysis catheters

VAS:

Visual analog scales

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Acknowledgements

The authors acknowledge the following people for their help in this study: Anna-Marie Sutherland (Former Clinical Coordinator, Lakeridge Health); Abe Janis (Former Technical Liaison for Scientific Development, DermaPort, Inc.). We thank Richard Holcomb for statistical support of this work.

Author information

Authors and Affiliations

  1. Division of Vascular Interventional Radiology, Department of Medical Imaging, University Health Network, University of Toronto, 585 University Avenue, 1-PMB-287, Toronto, ON, M5G 2N2, Canada

    Dheeraj K. Rajan

  2. Former President DermaPort Inc., President Moran Medical Device Consulting, Santa Barbara, CA, USA

    Buzz Moran

  3. Alfred Mann Institute at University of Southern California, Los Angeles, CA, USA

    Thomas J. Lobl

  4. Department of Interventional Radiology, Lakeridge Health, Oshawa, ON, Canada

    Murray R. Asch

  5. Medical Director and Section Chief of Nephrology and Diabetes, Lakeridge Health, Oshawa, ON, Canada

    Andrew W. Steele

  6. Medical Director of Chronic Kidney Diseases and Hemodialysis Vascular Access Programs, Toronto General Hospital, Toronto, ON, Canada

    Charmaine E. Lok

Authors
  1. Dheeraj K. Rajan
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  2. Buzz Moran
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  3. Thomas J. Lobl
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  4. Murray R. Asch
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  5. Andrew W. Steele
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  6. Charmaine E. Lok
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Corresponding author

Correspondence to Dheeraj K. Rajan.

Ethics declarations

Conflicts of interest

All authors declare that they have no conflict of interest.

Ethical Standards

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committees and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Financial Support

We acknowledge DermaPort, Inc. for funding this clinical trial. We also thank the Alfred Mann Institute for Biomedical Research at the University of Southern California for support of this paper. Dheeraj K. Rajan, Murray Asch, and Andrew Steele were paid consultants to DermaPort, Inc.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

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Rajan, D.K., Moran, B., Lobl, T.J. et al. A Prospective Clinical Study of a Percutaneous Vascular Access System for Hemodialysis Catheters. Cardiovasc Intervent Radiol 41, 1513–1519 (2018). https://doi.org/10.1007/s00270-018-2031-z

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  • DOI: https://doi.org/10.1007/s00270-018-2031-z

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