Journal of Vascular Surgery
Volume 50, Issue 3 , Pages 600-607.e1, September 2009

Initial experience and outcome of a new hemodialysis access device for catheter-dependent patients

  • Howard E. Katzman, MD

      Affiliations

    • Department of Surgery, University of Miami Hospital, Miami, Fla
    • Corresponding Author InformationReprint requests: Howard E. Katzman, MD, University of Miami Hospital, 1321 NW 14th St, Ste 306, Miami, FL 33125
    • ,
  • Robert B. McLafferty, MD

      Affiliations

    • Department of Surgery, Southern Illinois University, Springfield, Ill
    • ,
  • John R. Ross, MD

      Affiliations

    • Department of Surgery, Bamberg County Hospital, Bamberg, SC
    • ,
  • Marc H. Glickman, MD

      Affiliations

    • Department of Surgery, Sentara Heart Hospital, Norfolk, Va
    • ,
  • Eric K. Peden, MD

      Affiliations

    • Department of Surgery, The Methodist Hospital, Houston, Tex
    • ,
  • Jeffery H. Lawson, MD, PhD

      Affiliations

    • Department of Surgery, Duke Medical Center, Durham, NC

Received 15 November 2008; accepted 6 April 2009. published online 23 July 2009.

Objective

The effects of a new long-term subcutaneous vascular access device were studied in access-challenged patients who were poor candidates for fistulas or grafts due to venous obstruction. Bacteremia rates, patency, and function of the Hemodialysis Reliable Outflow (HeRO) Vascular Access Device (Hemosphere Inc, Minneapolis, Minn) were evaluated.

Methods

The HeRO device consists of a 6-mm expanded polytetrafluoroethylene graft attached to a 5-mm nitinol-reinforced silicone outflow component designed to bypass venous stenoses and enter the internal jugular vein directly, providing continuous arterial blood flow into the right atrium. The HeRO device was studied in a multicenter clinical trial to test the hypothesis that access-challenged patients would experience a statistically significant reduction in bacteremia rates compared with a tunneled dialysis catheter (TDC) literature control of 2.3/1000 days. HeRO-related bacteremia rates, adequacy of dialysis, patency, and adverse events were analyzed.

Results

The HeRO device was implanted in 36 access-challenged patients who were followed for a mean 8.6 months (9931 HeRO days). The HeRO-related bacteremia rate was 0.70/1000 days. All HeRO-related bacteremias occurred during the bridging period when a TDC was still implanted before HeRO graft incorporation. HeRO adequacy of dialysis (mean Kt/V) was 1.7. HeRO primary patency was 38.9%, and secondary patency was 72.2%.

Conclusions

In access-challenged patients, a statistically significant reduction in HeRO-related bacteremia was noted compared with TDC literature. The device had similar function and patency compared with conventional arteriovenous graft literature.

 

 This study was sponsored by Hemosphere Inc, to collect safety and efficacy data in support of a 510(k) submission to the Food and Drug Administration seeking market clearance for the HeRO Vascular Access Device. All of the authors' institutions were compensated by Hemosphere for conducting the study.

 Competition of interest: Marc H. Glickman, MD, and John R. Ross, were paid consulting fees during the product development period, which have since ceased as of 2007.

 Additional material for this article may be found online at www.jvascsurg.org.

PII: S0741-5214(09)00847-7

doi:10.1016/j.jvs.2009.04.014

Journal of Vascular Surgery
Volume 50, Issue 3 , Pages 600-607.e1, September 2009

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