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Home > Vascular Annual Meeting^® > PP20. HeRO Device Experience in Vascular Access Challenged Patients

PP20. HeRO Device Experience in Vascular Access Challenged Patients

Howard E. Katzman
University of Miami Hospital, Miami, FL

OBJECTIVES: The purpose of this abstract is to report early commercialization experience with the HeRO™ Vascular Access Device, a new long-term dialysis access device approved by FDA for “access challenged” patients i.e., catheter-dependent or patients that are poor candidates for fistulas or grafts due to venous obstruction. The HeRO™ device is designed to provide a graft-like vascular access and lower bacteremia rates than a tunneled dialysis catheter.

METHODS: The HeRO™ device, a graft with central outflow designed to bypass peripheral stenosis, consists of an ePTFE upper arm graft fitted with a titanium connector that is surgically coupled to a subcutaneous nitinol reinforced silicone outflow catheter which exits into the right atrium via the internal jugular vein. Procedural data has been captured on 60 early commercialization patients implanted with the HeRO™ device including access and medical history and device-implant success.

RESULTS: To-date, data has been captured on 60 patients (mean age 58.9; 43.3% male; 55.0% diabetic) with a history of 4.1 years on dialysis, a mean 5.0 previous catheters, 2.2 previous grafts, and 1.5 previous fistulas and 3.6 mean previous bacteremias (range 1-17). The HeRO™ device was successfully implanted in all subjects using a variety of interventional techniques, although 60.0% percent had evidence of hemodynamically significant central venous stenosis.

CONCLUSIONS: This data demonstrates that access-challenged patients with challenging anatomy and central venous stenosis may be eligible for an alternative long-term vascular access device offering lower bacteremia rates compared to a tunneled dialysis catheter.

AUTHOR DISCLOSURES: H.E. Katzman, Participating in HeRO commercialization registry on behalf of Hemosphere, Inc and receiving nominal research grant to complete case report forms as investigator in registry.