Ellipsys, WavelinQ yield comparable primary outcomes for percutaneous fistula creation
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A meta-analysis revealed no significant difference in primary study outcomes using Ellipsys or WavelinQ to create arteriovenous fistulas in patients requiring access for dialysis.
“Chronic kidney disease is one of the leading causes of mortality in the United States with all patients eventually requiring hemodialysis when medical management fails. To facilitate the process of dialysis, arteriovenous fistulae (AVF) are created surgically for the management of patients with kidney failure at either the wrist or elbow,” Sanjay Misra, MD, a radiologist at the Mayo Clinic in Rochester, Minnesota, and colleagues wrote. “Currently, the two FDA-approved devices available in the market are the Ellipsys Vascular Access System and WavelinQ endoAVF system. The Ellipsys device operates using thermal anastomosis which allows the creation of an arteriovenous fistula, whereas the WavelinQ utilizes a dual catheter system containing magnets for appropriate alignment and creates an anastomosis between a deep artery and a vein using radiofrequency energy.”
In a systematic review and meta-analysis, researchers compared methods of AVF creation in patients requiring a permanent AVF for dialysis. The analysis included studies that used the Ellipsys device or WavelinQ with surgery since 2014. Using fixed-effects, researchers pooled the fixed sizes based on the level of heterogeneity.
Among 292 articles, four studies (three retrospective cohorts, two prospective cohorts) met criteria and underwent qualitative and quantitative analysis. There were 527 eligible patients reviewed.
Analyses revealed no statistically significant difference between surgical AVF and endoAVF primary outcomes. These outcomes included complications and procedural success. They also found no statistically significant differences for follow-up times, failure rate and time to two-needle cannulation. However, researchers reported differences between the two groups for procedural time, number of interventions needed to maintain patency and primary patency rate.
“Percutaneous fistula creation using Ellipsys or WavelinQ is a unique and safe alternative with outcomes comparable to surgery,” Misra and colleagues wrote. “Future studies are needed, including observational studies in current clinical practice, to evaluate the efficacy and outcomes of endovascular arteriovenous fistula creation in clinical populations.”
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