Initial experience and outcome of a new hemodialysis access device for catheter-dependent patients.
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.
Katzman
Howard E
HE
Department of Surgery, University of Miami Hospital, Miami, FL 33125, USA. hkatzman4@comcast.net
McLafferty
Robert B
RB
Ross
John R
JR
Glickman
Marc H
MH
Peden
Eric K
EK
Lawson
Jeffery H
JH
D000497:Alloys; D001132:Arm / Q000098:blood supply*; D001807:Blood Vessel Prosthesis / Q000009:adverse effects; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D055499:Catheter-Related Infections / Q000382:microbiology; D002405:Catheterization, Central Venous / Q000009:adverse effects / Q000295:instrumentation*; D002408:Catheters, Indwelling; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011138:Polytetrafluoroethylene; D011446:Prospective Studies; D011474:Prosthesis Design; D016459:Prosthesis-Related Infections / Q000382:microbiology; D006435:Renal Dialysis; D012828:Silicones; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014654:Vascular Patency
D000497:Alloys; D012828:Silicones; C013616:nitinol; D011138:Polytetrafluoroethylene