Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD

Inclusion criteria

Patients were eligible for enrollment into the study if they met the following criteria:

• Patients ≥ 18 years of age and ≤ 80 years of age
• Male or non-pregnant female (verified with a urine/blood pregnancy test, for women of reproductive potential)
• Life expectancy of at least one year, per the investigator's opinion
• Diagnosed with end-stage renal disease (ESRD) or chronic kidney disease requiring dialysis or anticipated start of dialysis within 6 months of enrollment
• Patients deemed medically eligible for upper extremity autogenous AV fistula creation, per institutional guidelines and/or clinical judgment
• Adequate quality vein based on pre-operative assessment

• Adjacent vein diameter of ≥ 2.0 mm at target anastomosis site
• Confirmed clinically significant outflow
• Adequate quality radial artery based on pre-operative assessment

a. Arterial lumen diameter of ≥ 2.0 mm at target anastomosis site

• Adequate collateral arterial perfusion

• Patent palmar arch
• Negative Allen's Test for ulnar artery insufficiency
• No clinical evidence of subclavian artery stenosis on the ipsilateral side.
• Radial artery-adjacent vein proximity ≤ 1.5 mm measured lumen edge-to-lumen edge as determined by pre-procedural ultrasound and confirmed pre-procedure
• Patient was able to provide written informed consent
• Able to travel to enrolling institution for follow-up examinations
• Able and willing to follow a daily aspirin and/or other anti-coagulation/antiplatelet regimen, not including warfarin (Coumadin, or comparable anti-coagulant, see exclusion criteria 15)

Exclusion criteria

Patients were excluded if any of the following was true:

• Documented or suspected central venous stenosis including upper extremity arterial stenosis (≥ 50%)
• a. Prior vascular surgery at or proximal (central) to the AVF target site b. Prior axillary dissection or mastectomy on the ipsilateral side as intended AV fistula site
• History of steal syndrome from a previous hemodialysis vascular access on the ipsilateral side which required intervention or abandonment
• Evidence of vascular disease at the radial artery/adjacent vein site on the ipsilateral side
• Pre-existing vascular disease that could confound the study results
• Systolic pressures < 100 mm Hg at the time of screening
• Suspected or confirmed skin disease at the skin entry site
• Immunocompromised patients (e.g. HIV positive)
• Edema of the upper extremity on the ipsilateral side
• Patients requiring immunosuppressant therapy such as sirolimus (Rapamune®) or Prednisone at a dose of > 10 mg per day
• Peripheral white blood cell count < 1.5 K/mm3 or platelet count < 75,000 cells/mm3
• Current diagnosis of carcinoma (defined as in remission < 1 year)
• Pregnant or currently breast feeding
• Known bleeding diathesis or coagulation disorder
• Receiving warfarin (Coumadin, or comparable anti-coagulant) therapy
• Patients with acute or active infection
• Scheduled kidney transplant within 6 months of enrollment
• Participation in another clinical investigation (excluding retrospective studies or studies not requiring a consent form)
• History of substance abuse or anticipated to be non-compliant with medical care or study requirements based on investigator judgment
• Patient required creation of an arteriovenous fistula distal to the wrist
• Patient required nerve block requiring immobilization of the arm