Abstract
The purpose of this article is to assess the performance and safety of a novel, symmetric, side-hole-free tunneled cuffed catheter hypothesized to sustain adequate flow without the need for side holes. Between November 2016 and January 2019, Pristine hemodialysis catheters were placed de novo in 45 end-stage renal disease patients (27 males and 18 females) at a single investigational site. Forty-one catheters were placed in the right and four in the left internal jugular vein. There were no incidents of insertion failure. Patients had dialysis three times per week and were followed at four investigational sites. Nominal catheter flows, incidence of poor flow, and catheter-related infections were recorded at each dialysis session and analyzed. The average follow-up time was 161.69 days for a total of 7116 catheter days. Nine patients died from reasons unrelated to the catheter and one patient switched to fistula. Four patients had poor flows necessitating catheter replacement. Four patients had catheter-related bloodstream infections which resolved with antibiotics. These equate to 0.56 events per 1000 catheter days. Catheter survival was 100%, 97.6%, and 89.7% at 30, 90, and 180 days, respectively. The initial clinical assessment of the symmetric Pristine hemodialysis catheter featuring a Y-tip devoid of side holes revealed good catheter performance and survival and a low complication rate.