Todd Berland, Jason Clement, Nicholas Inston, Paul Kreienberg, Kenneth Ouriel, Saravanan Bala, Urs Benck, Todd L. Berland, Jan Brunkwall, Tze Chan, Frank Dellanna, Adrian Ebner, James Gilbert, Joseph Griffin, Patrick Haage, Mercedeh Kiaii, Michael Lichtenberg, Eric K. Peden, Dierk Scheinert, Thomas Schmitz-Rixen, Alexander Rosenkranz, Arne Schwindt, Afshin Tavakoli, Jan Tordoir, Ashar Wadoodi, Norbert Weiss, and Gregory G. Westin
BACKGROUND Percutaneous devices for creation of native arteriovenous fistulae offer an alternative to traditional open surgical techniques. The 4 Fr WavelinQ EndoAVF System was developed as a lower profile alternative to facilitate access through smaller vessels and minimize access site complications; The current report is the original first experience of this device, assessing outcome in 120 patients followed for 6 months. METHODS The use of the 4 Fr WavelinQ system in three studies, EASE (32 patients), EASE-2 (24 patients), and the EU post-market clinical follow-up study (64 patients) was aggregated and analyzed. Patients were followed with duplex ultrasound at discharge and follow-up visits at 1, 3, and 6 months. Primary, assisted primary, and secondary patency rates were evaluated as Kaplan-Meier (KM) estimates and standard errors. Time to maturity and time to successful cannulation were defined as the mean ± SD days from the procedure in patients enrolled on dialysis. RESULTS Procedural success was achieved in 116 patients (96.7%). Primary, assisted-primary, and secondary 6-month patency rates were 71.9%±4.5%, 80.7%±4.1%, and 87.8%±3.3%, respectively. Time to maturity averaged 41±17 days. Time to successful cannulation averaged 68±51 days. Device-related serious adverse events were reported in 3/120 patients (2.5%) and procedure-related serious adverse events occurred in 7/120 patients (5.8%). Arterial or venous access complications were not reported in any of the patients. Access circuit reinterventions were performed in 23 patients (19.2%), split between those performed for EndoAVF maturation (13/120, 10.8%) and maintenance (11/120. 9.2%). CONCLUSIONS Percutaneous creation of native dialysis fistulae with the 4 Fr WavelinQ EndoAVF System is safe and effective, with favorable durability and a low rate of serious complications and reinterventions through 6-month follow-up. Utilization of the 4F device allows for percutaneous fistula creation between the radial artery and radial vein or the ulnar artery and ulnar vein. These findings suggest that the 4 Fr device is a useful percutaneous alternative to open surgical AVF or endovascular AVF with larger-bore devices.