LAS VEGAS — A catheter-based approach to create an endovascular autogenous fistula in patients with chronic kidney disease appears to be safe, according to data presented at VIVA 15.
Charmaine E. Lok, MD, MSc, FRCPC and colleagues enrolled 80 patients (mean age, 60.1 years; 68% men) with stage 5 chronic kidney disease in the Novel Endovascular Access Trial (NEAT) to determine periprocedural and early postprocedural safety of a device (everlinQ endoAVF system, TVA Medical) that uses radiofrequency energy in a minimally invasive method of endovascular fistula creation.
Charmaine E. Lok
Patients with late-stage kidney disease who need hemodialysis access can benefit from creation and use of an arteriovenous fistula, but they are not used as widely as they should be because some patients are unwilling to undergo open surgery and because of complications such as fistula failure and thrombosis, Lok, from University Health Network˗Toronto General Hospital, said during a presentation.
“With these challenges, there can be a lot of cost to both the patient and the health care system,” she said. “We need to find another option for creating that arteriovenous fistula.”
The endovascular system for arteriovenous fistula creation consists of two 6F catheters aligned by rare-earth magnets, Lok said, noting that the venous catheter has a radiofrequency electrode and the arterial catheter has a ceramic backstop. “So what happens is that these catheters go into their respective vessels, the magnets bring the vessels together, they align so [the electrode and the backstop] are in alignment, the electrode is depressed, and radiofrequency energy is given to create a fistula,” she said. “The catheters are removed, and there is nothing left in the body.”
The system had a 99% procedural success rate, with only one failure, which was due to nonoptimal device positioning before the delivery of radiofrequency, Lok said..
At 4 weeks, only 3.75% of patients experienced thrombosis, she added. At 1 month, there were seven serious adverse events related to the procedure and two related to the device, she said.
At 1 month, brachial artery flow, an indicator of fistula maturation, increased from 80 mL/min at baseline to 876 mL/min on average (P < .0001), according to Lok, who noted that most patients experienced an increase in vein diameters beyond 4 mm (P < .0001).
“The technique is safe, reproducible, and has a low thrombosis rate,” she concluded. “Early ultrasound results suggest that the endofistula may be physiologically suitable for dialysis, and the long-term follow-up will reveal the functional patency and clinical utility of the endofistula.”
The system is not yet approved for use in the United States. – by Erik Swain
Lok CE, et al. Late-Breaking Clinical Trials. Presented at: VIVA 15; Nov. 2-5, 2015; Las Vegas.
Disclosure: Lok reports NEAT was funded by TVA Medical.
Editor’s Note: On Dec. 4, the article was updated to clarify some data.