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NEW ORLEANS -- Patients with failing kidneys may soon be able to get an arteriovenous fistula for hemodialysis without surgery, a researcher reported here.
The Ellipsys Vascular Access System -- a single-catheter, image-guided vascular access system for hemodialysis -- met its primary efficacy endpoint of brachial artery flow volume ≥500 ml/min and vein diameter ≥4 mm in 86% (92 out of 107) of patients, exceeding the performance goal of 49% (P<0.0001).
Action Points
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
The prospective single-arm study also found zero device-related adverse events at 90 days, reported principal investigator Jeffrey E. Hull, MD, director of the Richmond Vascular Center in Virginia, at .
The investigational device, made by Avenu Medical, enters the body through a vein and is directed into an artery at the location of an anastomosis, Hull told ľֱ. The catheter then uses pressure and heat to fuse the artery and vein together and to cut an elliptical anastomosis. The anastomosis produces an arteriovenous fistula in the same way as a sutured anastomosis, he said. The total process takes about 23 minutes and can be performed in the office without going to the hospital.
"The ease and convenience of the procedure should improve the patient experience and improve the quality of care for patients with end-stage renal disease," Hull said during his presentation.
Kelly Hyndman, PhD, of the University of Alabama at Birmingham, who was not involved with the study, told ľֱ that "maturations and these surgeries are such a prevalent problem. If a little device goes in and then is out in 23 minutes and the patient has this really nice no-suture anastomosis ... if it's true, it's amazing."
Hull and colleagues enrolled 107 patients at five outpatient office-based labs throughout the country. Patients underwent ultrasound-guided anastomosis creation between the proximal radial artery and perforating vein with the Ellipsys Vascular Access System followed by separate maturation procedures.
The researchers created arteriovenous fistulas with fused anastomoses in 95% (N=102) of patients. Maturation procedures included anastomotic balloon dilation in 72% (77/107), brachial vein embolization in 32% (34/107), cubital vein ligation in 27% (29/107), and surgical transposition in 26% (28/107).
Hull reported that cumulative patency was 96.1%, 93.7%, and 91.% at 90, 180, and 360 days, respectively. Functional patency was 98.4%, 98.4%, and 92.3% at 90, 180, and 360 days.
The target dialysis vein was the cephalic, basilic, and brachial veins in 74% (73/99), 24% (24/99), and 2% (2/99), respectively, and two-needle dialysis was achieved in 88% (71/81) of patients on hemodialysis at an average of 113.1 days.
Hull noted that the process is similar to common procedures such as obtaining venous and arterial access with ultrasound and requires similar skills. Percutaneous creation of arteriovenous fistulas can also be completed by endovascular surgeons which will greatly increase the number of patients who receive this procedure, he added.
The device received a European CE Mark in 2016 and is currently under FDA review. "It is difficult to predict when FDA will grant market clearance," Hull told ľֱ.
Disclosures
The device is made by Avenu Medical Inc.
Hull disclosed relevant relationships with Avenu Medical.
Primary Source
ASN Kidney Week 2017
Hull JE, at al "The pivotal multicenter trial of ultrasound guided percutaneous arteriovenous fistulae for hemodialysis access" ASN 2017; Abstract SA-OR125.