Arteriovenous fistula creation using the Optiflow™ vascular anastomotic connector: the OPEN (Optiflow PatEncy and MaturatioN) study

Purpose: Arteriovenous fistulas (AVFs) are the preferred form of vascular access for hemodialysis. However, non-maturation and patency are major clinical problems. The Optiflow (TM) device is an implantable anastomotic connector used to standardize the creation of an AVF. Studies have suggested that the geometry of the anastomosis and experience of the surgeon impact patency and maturation rates. The Optiflow serves as a surgical template whereby the geometry and flow path of the anastomosis are predetermined. This prospective study was intended to evaluate maturation, patency and safety of the Optiflow. Methods: Forty-one upper arm AVFs were created in 41 end-stage renal disease patients using the Optiflow device at two investigational sites. Patients were followed for 90 days with serial Doppler ultrasounds performed at approximately 14, 42 and 90 days to determine AVF maturation. The primary performance endpoint was unassisted maturation, defined as an outflow vein that was equal to or greater than 5 mm in diameter, and with flow equal to or greater than 500 mL/min without the need for any intervention intended to promote or maintain maturation. The primary safety endpoint was the rate of device-related serious adverse events. Results: Unassisted maturation rates were 76%, 72% and 68% and unassisted patency rates were 93%, 88% and 78%, at 14, 42 and 90 days, respectively. There were no device-related serious adverse events. Conclusions: The results suggest that the Optiflow is safe for its intended use and could play an important role in enhancing AVF maturation while standardizing the anastomotic technique.