The HeRO Vascular Access Device: A New Long-Term Dialysis Access Option for Access Challenged Patients

OBJECTIVE
The purpose of the study was to assess HeRO bacteremia and patency rates, adequacy of dialysis, and adverse events in graft-eligible and in “access challenged” subjects i.e., catheter dependent /poor-venous outflow subjects.

METHODS
The HeRO device consists of a 6 mm inner diameter (ID) ePTFE upper arm graft fitted with a titanium connector that is surgically coupled to a subcutaneous 5 mm ID nitinol reinforced silicone outflow catheter designed to bypass peripheral stenosis and exit into the right atrium via the IJ vein. Ninety HeRO subjects were enrolled in two study arms - access challenged (catheter arm) and graft-eligible (graft arm) subjects. Study endpoints included bacteremia and patency rates, adequacy of dialysis and adverse events. All results were compared to literature.

RESULTS
The data shows a marked decrease in the HeRO-related bacteremia rate in both study arms. The catheter arm HeRO-related bacteremia rate was 0.12/1,000 days versus IJ tunneled dialysis catheter (TDC) literature rate of 2.3/1,000 days. The graft arm HeRO-related bacteremia rate was 0.06/1,000 days versus graft literature rate of 0.11/1,000 days. HeRO patency rates (primary, primary-assisted, secondary and functional) in both study arms were better than TDC literature and equivalent to graft literature. HeRO adequacy of dialysis data (Kt/V 1.6-1.7) surpasses TDC literature (Kt/V 1.29-1.46) and was comparable to graft literature (Kt/V 1.37-1.67). Serious device/procedure-related adverse events were comparable to both TDC and graft literature.

CONCLUSIONS
The HeRO device may be the best long-term access alternative for access challenged patients including those that are catheter dependent, are failing fistulas and grafts due to venous obstructions, have poor anatomy for a fistula or graft, or are receiving inadequate dialysis via a TDC.