HeRO Vascular Access Device Bacteremia Study

Inclusion criteria

• 21 years of age or older.
• Male or non-pregnant female.
• Life expectancy less than 1 year.
• ESRD on hemodialysis with poor remaining venous access sites for creation of an AV fistula or placement of a graft in the upper extremities.
• Implant side central venous system that surgeon believes can be accessed with interventional devices and can accommodate the 19 Fr GVAS device.
• Potential GVAS target brachial artery ≥ 3 mm in diameter determined by any suitable measure.
• Ability to understand and provide written informed consent.
• Willing and able to cooperate with follow-up examinations.

Exclusion criteria

• Documented history of drug abuse within six months prior to enrollment.
• "Planned" concomitant surgical procedure or previous major surgery within 30 days, excluding vascular access related procedures.
• Currently being treated with another investigational device or drug.
• Known bleeding diathesis or hypercoaguable state.
• Peripheral white blood cell count 1.5 K/mm3 or platelet count 50 K/mm3.
• Degenerative connective tissue disease, e.g., Marfan's and Ehlers Danlos Syndrome. Subjects with Lupus Erythematosus may be enrolled if receiving no immunosuppressants or low dose prednisone only (< 10 mg/day orally).
• Subjects with known or suspected concomitant active bacterial, fungal, viral, or parasitic infection. Subjects with Hepatitis B and/or Hepatitis C may be enrolled. Subjects who are HIV + with CD4 count of < 200 are excluded. Subjects with bacteremia within the past six (6) weeks must have negative blood cultures one week after completing appropriate antibiotic therapy prior to enrollment.
• Severe underlying co-morbidity or immediate life-threatening condition.
• Subjects with any condition which, in the opinion of the investigator, could preclude evaluation of response or completion of follow-up or affect subject safety.
• Subjects with significant arterial occlusive disease which would preclude safe placement of an upper extremity hemodialysis access.
• Subjects with history or findings on physical examination suggesting significant arterial insufficiency that could affect patient safety and/or device performance in the extremity planned for use with GVAS (i.e., steal syndrome, hand ischemia, peripheral arterial vascular disease, etc.).
• Subjects with scheduled kidney transplant within the next 12 months.
• Subjects with history of superior vena cava syndrome are excluded unless it was induced by previous access (these subjects can be enrolled).
• Subjects with history of decreased cardiac output with ejection fraction < 20% and/or NYHA class III or IV. NYHA definitions: Class III - Subjects with marked limitation of activity; they are comfortable only at rest; Class IV - Subjects who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest.
• Subjects with history of uncorrected hypotension with systolic blood pressures routinely < 100 mg Hg.
• Subjects who currently have a pacemaker or ICD in their central venous system on the same side where the GVAS device would be implanted.