LAS VEGAS – Patients who had an arteriovenous fistula (AVF) created endovascularly using a new magnetic catheter system required fewer interventions and had fewer health care costs than patients whose AVF was created surgically, according to a late-breaking trial presented by Charmaine E. Lok, MD, at the 2016 Vascular Interventional Advances meeting.
The study compared AVF postcreation interventions between patients undergoing surgical (sAVF) creation and those whose fistula was created using a new endovascular AVF (endoAVF) system.
Medicare Standard Analytical Files were used to determine patient demographic and clinical characteristics and to identify and determine rates of sAVF postcreation interventions in patients with sAVF created from 2011 to 2013, according to Dr. Lok, a professor of medicine at the University of Toronto and senior scientist at the Toronto General Research Institute.
The rates of postcreation interventions per patient-year were determined based on patients’ outpatient and physician claims. Demographics and clinical information for patients with endoAVF were obtained from the single-arm Novel Endovascular Access Trial (NEAT) performed in Canada, Australia, and New Zealand.
The researchers determined the rates of postcreation interventions per patient-year from the trial based on patients’ outpatient and physician claims during specified follow-up.
Propensity score matching based on clinical and demographic factors was successful for comparing 60 Medicare patients who had surgical AVFs to NEAT patients. The matched surgical cohort had a significantly higher number of interventions than the endovascular cohort (3.4 vs. 0.6 per patient-year, respectively; P less than .0001). The associated average annual costs were $11,240 less for the endovascular patients, compared with the surgical patients.
In a breakdown of procedures, the endovascular cohort had lower event rates for angioplasty (0.04 vs. 0.93),respectively; thrombectomy (0.04 vs. 0.20); embolization/ligation of vein (0.13 vs. 0.1); revision (0.04 vs. 0.17); new AVF or transposition (0.11 vs. 0.30); catheter placement (0.11 vs. 0.43); vascular access–related infection (0.02 vs. 1.23), and arteriovenous graft placement (0.02 vs. 0.07), according to Dr. Lok.
The NEAT study assessed the FLEX system, which percutaneously creates a fistula in chronic kidney disease patients who require hemodialysis vascular access.
The FLEX system uses two catheters delivered percutaneously to an artery and a vein in proximity to each other in the arm. The catheters use magnets for alignment and a radio frequency system as an energy source. The catheters are magnetically aligned and an RF pulse creates an arteriovenous fistula endovascularly between the artery and vein and the catheters are then removed.
The technology used is not commercially available in the United States and is pending Food and Drug Administration review, according to Dr. Lok
The study was sponsored by TVA Medical. Dr. Lok has received honoraria from Maquet and W.L. Gore, and is a consultant for TVA Medical and W. L. Gore, and has received research funding from Maquet, Proteon, and TVA Medical.