NEW YORK (Reuters Health) – Both a Gracz-type surgical arteriovenous fistula (AVF) and an Ellipsys percutaneous AVF show high technical success and secondary patency rates at the proximal forearm in patients needing hemodialysis access, according to a new German study.
However, the percutaneous AVFs using the Ellipsys device (Avenu Medical Inc., San Juan Capistrano, California) required “dramatically shorter procedure times,” researchers report. The rate of required interventions was similar between the two procedures.
Creation of the Ellipsys percutaneous AVF avoids some issues with surgical AVFs “that result from a skin incision, inflammation associated with vessel dissection and manipulation, and a high rate of primary failure reported in many studies,” the researchers note in the American Journal of Kidney Diseases.
“In addition,” they say, “the procedure is minimally invasive, does not leave a surgical scar, involves less post-operative pain, and can be performed as an office-based procedure.”
Lea author Dr. Robert Shahverdyan of the Vascular Access Center, Asklepios Clinic Barmbek, in Hamburg, said that in choosing one approach over the other, “the criteria are similar for both, except that for Ellipsys the distance between the perforating vein and proximal radial artery, where the anastomosis is created, should be less than 1.5 mm.”
Otherwise, he told Reuters Health by email, both procedures require a healthy inflow artery, a radial artery larger than 2 mm, a perforating vein larger than 2 mm and at least one outflow vein on the upper arm larger than 2 mm using a tourniquet.
In the new study, Dr. Shahverdyan and his colleagues looked at prospectively collected clinical data on 158 patients at a single university-affiliated surgical center. The center had developed an algorithm that prioritizes vascular access using (most preferred) a distal radial-cephalic AVF, followed by percutaneous AVF options, a Gracz-type surgical AVF, upper-arm AVF, brachial vein AVF and AV graft.
Dr. Shahverdyan explained that a more distal fistula is preferable for several reasons, including smaller vessels posing a lower risk of malperfusion of the hand, a lower risk of heart overload because of higher flow, and the potential to create a more proximal access in the future should the distal fistula fail.
The patients had a mean age of 67 and a BMI of 26.6, and two-thirds had diabetes. Between September 2017 and July 2020, 89 participants underwent a percutaneous AVF and 69 underwent a surgical AVF. Dr. Shahverdyan performed all of the procedures.
There were no significant differences in age, BMI, gender ratio or presence of chronic kidney disease between the two groups.
Mean completion times were 14 minutes for the Ellipsys percutaneous procedure and 74 minutes for the surgical. Both procedures had a 100% technical success rate.
Time to AVF physiological maturity did not differ significantly between the two groups. Surgical or endovascular interventions (most commonly inflow angioplasty) were required in both groups, but the frequency of these was not significantly different.
Overall, primary patency showed a nonsignificant tendency to favor the surgical approach.
However, in the subgroup in which inflow was provided only by the proximal radial artery (all percutaneous cases and 30% of surgical), primary and cumulative patency were higher in the percutaneous group.
The researchers note that creating a Gracz-type surgical AVF is possible following a failed Ellipsys percutaneous AVF.
When a distal radial artery AVF is not feasible, the authors conclude, an Ellipsys percutaneous AVF “might be an appropriate and logical next-step procedure for creating a safe and functional access while maintaining future proximal forearm (surgical AVF) creation options.”
Dr. Pietro Ravani of the Cumming School of Medicine at the University of Calgary, in Canada, who studies hemodialysis access, told Reuters Health by email that “evidence supporting vascular access choice and use is very poor and almost entirely based on low-quality observational studies.”
Until large trials can show that the benefits and harms of the two procedures are the same, he continued, “we can speculate that less-invasive procedures may be preferred by patients and healthcare providers” and might cause fewer complications down the road.
However, Dr. Ravani, who was not involved in the new research, cautioned that technical issues such as small vessels could make the percutaneous procedures more difficult.
The authors reported no specific funding for the study.
Dr. Shahverdyan serves as a speaker/consultant for Avenu Medical and other companies. Two others of the seven authors also reported ties to Avenu Medical.
SOURCE: https://bit.ly/39qtcLg American Journal of Kidney Diseases, online February 28, 2021.
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