We reviewed our initial experience creating a percutaneous arteriovenous fistula (pAVF) using a thermal resistance anastomosis device with proximal radial artery inflow. A retrospective review was conducted of all patients who underwent a pAVF creation procedure between May 2017 and October 2017. Primary end points of the study were technical success, patency by Doppler ultrasound examination or angiography, flow levels achieved, time to first use, and pAVF-related complications. A pAVF was attempted in 34 patients with technical success in 33 individuals (97%). Patency of the pAVF was 94%. Mean access flow was 946 mL/min (brachial artery measurement) at the latest follow-up visit (53-229 days; average, 141 days). At 6 weeks, all fistulas have been used or were ready for dialysis by clinical examination or ultrasound examination. Only one patient required superficialization of the upper arm cephalic vein by lipectomy. There were no adverse events related to the pAVF creation or use, nor was there need for further interventions. Successful pAVFs with proximal radial artery inflow were created with excellent initial results regarding technical success, patency, and safety. Advantages include avoidance of a surgical incision, short procedure times, good acceptance by patients, prompt access maturation, moderate flow, and low-pressure access, with possible reduction of risk for ischemic complications. Avoidance of vessel manipulation and side branch ligation might reduce risk of thrombosis and improve long-term patency and reduce need for further interventions. These early findings need to be confirmed in larger and longer follow-up studies.

The aim of this study is to report our mid-term results of percutaneous arteriovenous fistula (pAVF) creation using the Ellipsys device and present technical recommendations and our algorithm of pAVF maintenance. A single center comprehensive database of all consecutive pre-dialysis and end-stage renal disease patients that had a pAVF creation with the Ellipsys® device was reviewed retrospectively. Study endpoints included technical success, maturation, functional patency and required interventions. Between May 2017 and July 2019, 234 patients (mean age 64, 148 males - 63%) had a pAVF created. Technical success was achieved in 232 individuals (99%) and average duration of the procedure was 15 minutes (7-35minutes). Average follow up was 252 days (range 83-696). One year, primary, primary assisted and secondary patency were 54%, 85% and 96%, respectively. Average pAVF flow was 923ml/min (range 425-1440). There were no significant adverse events related to the procedure. Only 3 patients (1%) required a later conversion of the pAVF anastomosis to a surgical fistula. Twenty-four (10%) patients required superficialization of deep outflow veins due to difficult cannulation. Average maturation time was 4 weeks (range 1-12 weeks). Fourteen patients (6%) had early (< 2 weeks after creation) cannulation of their pAVF. The Ellipsys® pAVF device allows for the rapid and safe creation of a reliable autogenous access. Rates of technical success, patency and maturation were excellent. For patients unsuited for a distal radio-cephalic arteriovenous fistula, it should be considered the next preferred access option.

The aim of the present study was to compare the results between percutaneous arteriovenous fistulas (p-AVFs) created with the Ellipsys device (Ellipsys Vascular Access System; Avenu Medical, San Juan Capistrano, Calif) and surgical arteriovenous fistulas (s-AVFs). A single-center retrospective comparative study of the first 107 patients who had undergone p-AVF creation with the Ellipsys system from May 2017 to May 2018 with an equal number of consecutive patients who had undergone s-AVF creation in our center during the same period. The primary endpoints included the maturation and patency rates. The secondary endpoints were reintervention, risk of infection, and the incidence of steal syndrome and aneurysm formation. The demographic, hypertension, and diabetes data were similar for both groups. The only difference between the two groups was that more p-AVF patients had already been receiving hemodialysis (61% vs 47%; P < .05). The p-AVFs showed superior maturation rates at 6 weeks (65% vs 50%; P = .01). The primary patency rates were greater for the s-AVFs at 12 months (86% vs 61%; P < .01). However, primary patency was comparable between the two groups at 24 months (52% vs 55%; P = .48). No significant difference was found in the secondary patency rates at 12 (90% vs 91%) and 24 (88% vs 91%) months. At the 2-year follow-up point, the rate of percutaneous reintervention was similar; however, the s-AVFs had required more frequent surgical revision (36% vs 17%; P = .01). Issues with wound healing and infection were also more frequent with s-AVFs (9% vs 0.9%; P < .01). Fistulas created percutaneously with the Ellipsys system showed superior maturation rates and similar patency with s-AVFs created in an experienced high-volume vascular surgery practice. p-AVFs had a lower risk of wound healing issues, infection, and surgical revision. Larger, prospective, randomized multicenter studies are needed to confirm these findings.

Timely creation and maintenance of a safe and reliable vascular access is essential for hemodialysis patients with end-stage renal disease. Hemodialysis access–induced distal ischemia (HAIDI) is a recognized complication of arteriovenous fistulas and grafts that may result in serious or even devastating consequences. Avoiding such complications is clearly preferred over treatment of HAIDI once established. Proper recognition of patients at increased risk of HAIDI includes careful pre-operative evaluation of the patient’s medical and surgical history along with physical examination and imaging to determine a plan for creating a functional permanent access while minimizing the risk of distal ischemia. Our aim is to review identifying characteristics of individuals at risk of HAIDI and provide recommendations regarding pre-operative assessment. Vascular access options and techniques are suggested for establishing a functional vascular access without distal ischemia for such patients.

Objective: To investigate the feasibility of percutaneous arteriovenous fistula creation in consecutive patients screened for first access creation. Methods: Prospective study of ultrasound mapping based on the following minimal anatomic requirements: a patent proximal radial artery and adjacent elbow perforating vein with straight trajectory, each greater than or equal to 2 mm in diameter and within 1.5 mm of each other. In addition, the same population was evaluated for feasibility of a distal radiocephalic fistula established. Results: One hundred consecutive patients were examined between November 2018 and January 2019. Sixty-seven were male (67%) and mean age was 61 years. Sixty-three patients (63%) and a total of 100 limbs (50%) were found to be eligible for a percutaneous fistula creation with Ellipsys^®. Thirty-seven percent of patients were ineligible because of the absence of both median cephalic and median cubital veins (15%), absence or inadequate elbow perforating vein and/or smaller than 2 mm proximal radial artery (14%), and/or distance greater than 1.5 mm (8%). We found suitable vessels for a surgical distal fistula creation in 91 extremities (45%), but this percentage dropped to 17% in patients over 70 years old. Among the 100 limbs eligible for percutaneous arteriovenous fistula, only 30 (30%) were eligible for radiocephalic arteriovenous fistula. Conclusion: More than 60% of patients were eligible for Ellipsys. The absence of veins at the elbow and a large distance between vessels were the most common limiting factors. Less than one half of the patients were candidates for surgical fistula and this percentage dropped significantly for older individuals.