"A Single-Center Experience of Percutaneous Arteriovenous Fistula Creation with the WavelinQ™ 4Fr EndoAVF System. A Retrospective Analysis of 30 Patients".

Abstract Purpose To retrospectively assess the safety and efficacy of percutaneous arteriovenous fistula (pAVF) creation with the WavelinQ™ 4Fr EndoAVF System. Materials and Methods From February 2018 to June 2020, 30 pAVF were created in 30 consecutive patients (30/30 male, age:55.3±13.6years). 21/30 patients (70%) were already on hemodialysis using a central venous catheter. Outcome measures were technical success, complications, and cannulation rate. Secondary outcome measures included the number of secondary procedures needed for cannulation, maintenance time to cannulation and pAVF survival. Results Technical success was 100%. Complication rate was 6.7% (2/30) including a pseudoaneurysm of the brachial artery that developed immediately after sheath removal and an aneurysm of the anastomosis 17 days post-procedure, which was isolated with a covered stent placed in the arterial side. Mean follow-up was 547±315.7days(range:14-1071). Cannulation rate was 86.7%(26/30). Mean time to cannulation was 61.3±32.5days(range:15-135). Mean follow-up after cannulation was 566.2±252.7days(range:35-1041days). Four pAVFs were thrombosed after cannulation with two of them successfully declotted. Sixteen interventions were needed to achieve cannulation after the index procedure in 15 patients (overall 0.53 procedures/patient). Seven maintenance endovascular interventions (following cannulation) were performed during the follow-up period in 6 patients (overall 0.27 procedures/patient, 0.17 procedures/patient-years). For the pAVF that were cannulated, survival was 96.1% at one year, and 82% at two and three years according to Kaplan Meier survival analysis. Conclusion This initial experience suggests that pAVF creation is safe, successfully performed with high maturation and long-term patency rates. Large-scale prospective studies are needed to validate results.