Comparison of Outcomes of Percutaneous Arteriovenous Fistulae Creation by Ellipsys and WavelinQ Devices

Abstract

The purpose of this study was to compare the clinical outcomes of Ellipsys with those of WavelinQ-4F percutaneous arteriovenous fistulae (pAVF) devices in a single center by a single operator. Materials and Methods: A retrospective review was conducted in 100 patients who underwent pAVFs procedures (65 Ellipsys and 35 WavelinQ patients) and created between December 2017 and December 2019. A total of 69% were male and 37% were diabetic. Median age was 64.1 years (range: 28-86), and median body mass index was 27.2 (range: 15-45.1) kg/m 2. A procedure sequence algorithm was followed for selecting all vascular accesses created. Results: Ellipsys outcomes were compared to WavelinQ outcomes. Technical success was 100% versus 97%, respectively, and median procedure times were 14 versus 63 minutes, respectively (P < .001), with 183 (1-487) versus 185 (0-760) days follow-up, respectively. Maturation at 4 weeks was 68.3% versus 54.3%, respectively, and median times to cannulation were 60 (1-164) versus 90 (1-180) days, respectively. Successful pAVF dialysis was established in 31 of 39 patients (79.5%) versus 14 of 24 patients (58%), respectively (P ¼ .071), dialysis patients with access-related adverse events observed in 4 individuals (1 Ellipsys versus 3 WavelinQ). Six patients (5 versus 1) with matured outflow from previous AVFs underwent first-day cannulations. Interventions were performed in 27.7% (33 Ellipsys) and 26.5% (15 WavelinQ) patients, and the number of interventions per patient-years was 0.96 versus 0.46, respectively. pAVF failure was seen in 15.4% versus 37.1% patients, respectively (P ¼ .0137). Secondary patency at 12 months was significantly higher among patients who had an Ellipsys procedure (82%) than among those who underwent the WavelinQ procedure (60%). Conclusions: pAVFs were created with high technical success and low complications with both devices. Ellipsys pAVFs demonstrated significantly shorter procedure times without a need for radiation exposure and with superior secondary patency. ABBREVIATIONS DCV ¼ deep communicating vein, pAVF ¼ percutaneous arteriovenous fistulae, PRA ¼ proximal radial artery, sAVF ¼ surgically created arteriovenous fistulae Early results with newly approved devices to create percutaneous arteriovenous fistulae (pAVF) suggest that they may offer improved outcomes compared to open surgical AFV (sAVF) access without compromising conventional surgical sites for future dialysis access creation (1-6). Two such devices have been certified by Conformit e Europ eenne and approved by US Food and Drug Administration, the WavelinQ-4F system (Beckton Dickinson, Franklin Lakes,

Comparison of Ellipsys Percutaneous and Proximal Forearm Gracz-Type Surgical Arteriovenous Fistulas

“…Screening of 251 patients in whom a VA was planned, found 60.6% (152) were eligible for the Ellipsys-pAVF. The access sequence algorithm used during the study period for VA site selection and planning 16 resulted in a RCAVF created in 62 patients. As the second option when adequate vessels were present, an Ellipsys-pAVF was created in 90 cases (20.9% of total VA cases).…”

“…The procedure has been previously described in detail 16,27,28 . Venous outflow utilized the cephalic, median cubital or both veins, with both left undisturbed when available for outflow.…”

“…It is recommended that consideration for access creation starts distally at the wrist and progress proximally to the upper arm 14,15 . At our center, a standardized anatomical succession algorithm has been previously described 16 and was used in site selection and planning of VA for these patients throughout the study period. This autogenous access succession sequence included, in order of preference: a distal radial-cephalic AVF (RCAVF) (including snuffbox-fistula), pAVF options, a Gracz-type surgical AVF (sAVF), upper arm AVF (brachial-cephalic/brachial-basilic), brachial vein AVF and AVgraft (AVG).…”

“…The protocol for AVF planning and creation has been previously described 16 . Briefly, the first choice for access placement was a distal forearm sAVF.…”

“…Based on our successful experience, we propose that the pAVF be incorporated into this strategy 16 . The comparison between the pAVF and sAVF-groups in this study confirmed equipoise on the major outcomes' domains of creation, maturation, initial and sustained clinical use and dysfunction, and that this inclusion is both logical and appropriate.…”