Evaluation of the Argyle (Ritus) Fistula Cannula as an Alternative to Metal Needles for Hemodialysis: A Prospective Study

Background: Cannulation of arteriovenous fistula (AVF) for hemodialysis (HD) with metal needles is the standard of care in most countries. This practice is associated with a known risk of vessel injury, which can lead to several complications and eventual access loss. Metal needles also pose a risk of accidental puncture to the operator. Argyle (Ritus) Fistula Cannula (AFC) (Figure) offers an alternative that may reduce the risk of needle-related injury with additional benefits. Methods: This prospective, single-arm, interventional study was conducted in 3 U.S. HD centers. Fifteen trained operators used AFC for routine HD in adult end-stage renal disease patients. Patients were followed for 12 weeks. Safety and performance outcomes of AFC were compared to historical data from metal needle use in the same population. Results: Of 40 patients enrolled, 38 with mature AVF were included in the study and collectively underwent 1,148 attempted cannulations with AFC. AFC had high rates of successful cannulation (98.87%) and successful completion of HD session (98.61% with 2-needle cannulation). Cannulation-related adverse events were rare and did not require medical intervention (minor infiltration [3 events; 0.26%] and device dislodgement [2 events; 0.17%]). There were no reports of air embolism or significant blood loss. Dialysis adequacy was comparable between metal needles and AFC (spKt/V 1.54 and 1.49, respectively; mean difference 0.05, 95% CI -0.02 to 0.12) despite a slightly lower average blood flow rate with AFC (-2.6% difference). Patient satisfaction with AFC was high, citing freedom of movement and comfort during sessions. Overall patient-reported cannulation pain decreased from baseline (with metal needles) to the end of the study (-1.6 on Visual Analog Scale [0 to 10]). Feedback from the operators was positive with regard to the ease of use and safety features. No cases of needle stick injuries were reported. Conclusion: AFC provides a promising alternative to metal needles for AVF cannulation for HD. This study highlights the favorable safety profile of AFC and high satisfaction rates from both patients and operators without compromising dialysis quality. Funding: Commercial Support - Mozarc MedicalFigure