Patients with end-stage kidney disease (ESKD) who use hemodialysis to filter their blood require vascular access for the dialysis machine; the most common type of vascular access is called an arteriovenous fistula (AVF). The AVF is a direct connect between an artery and vein.
Until recently, AVFs were only created through surgery that requires general anesthesia and opening up the skin. Now there are 2 FDA-approved devices designed to create AVFs using endovascular techniques (endoAVF), which means a device that goes through the skin instead of opening the skin up. Also patients are not required to be under general anesthesia, they can receive local anesthesia instead. Due to the relatively new approval of these devices, there is not a randomized study to compare the results of endoAVF versus surgAVF.
This study is a pilot study for an eventually larger scale study to compare the results of endoAVF versus surgAVF. The study aims to determine what the proportion of patients seeking hemodialysis access could qualify for receiving either an endoAVF , surgAVF, or both. Patients who are screened for hemodialysis access must undergo a duplex ultrasound of the blood vessels in the arm to confirm correct sizing. If participants qualify for both procedures they will be randomized to either endoAVF or surgAVF and will track the clinical and patient-reported outcomes of each procedure. Our pilot study hopes to enroll 90 participants. Those outcomes will inform a larger scale study. If the potential participant chooses to abstain from participation in the randomized trial, preferring to decide the method of AVF creation, we will offer to them a chance to join an endoAVF/surgAVF registry that will track the clinical outcomes of the procedure via medical record monitoring.
ESKD patients aged ≥ 18 who have chosen hemodialysis as their renal replacement option.
Ability to give consent to participate in a research study.
Upper arm vein diameter of ≥ 2.0 mm.
Confirmed radial artery-adjacent vein proximity ≤ 1.5 mm measured lumen edge-to-lumen edge as determined by preprocedural ultrasound and confirmed pre-procedurally.
People under the age of 18.
Inability to understand the consent process and/or give consent.
Upper arm vein diameter less than 2.0 mm making them unsuitable to receive an surgAVF AND endoAVF.
Patients who are deemed by the surgeon to be anatomic candidates for a forearm vascular access, and the surgeon and the patient determine that a forearm access is the optimal access for the patient, in order to preserve more proximal anatomic sites for future accesses.
Parallel
endoAVF
DeviceThe device will be used according to manufactures instructions and medical facilities standard of care. EndoAVF has a high likelihood of requiring additional procedures that would not have been required if they had undergone surgAVF.
surgAVF
Procedure/SurgeryThe surgAAVF procedure will be done according to the medical facilities standard of care. SurgAVF can also require additional procedures to help with the fistula being useable.
Physiologically mature fistula
flow ≥ 500 ml/min and internal diameter \>0.5 cm
clinically mature
cannulate with 2 dialysis needles for 75% of dialysis sessions within a 4-week period and achieve the prescribed dialysis
primary patency
Interval from time of access creation until any intervention to maintain or reestablish patency, access thrombosis, or end of study period, whichever comes first
secondary patency
Interval from the time of access creation until access abandonment, including intervening interventions
functional patency
Interval from time of access first use and access abandonment, including intervening interventions
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University of California, Los Angeles
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
