Clinical trials of the T-fluted (Ash Advantage) peritoneal dialysis catheter

The Ash Advantage is a T-shaped peritoneal catheter with a single transabdominal tube joining to a tube lying against the parietal peritoneum. Segments with long flutes (grooves) serve as fluid ports rather than 1-mm diameter holes. The folded catheter is placed through the expandable Y-TEC Quill positioned peritoneoscopically, similar to the procedure for a conventional Tenckhoff catheter. In a clinical study, we placed 18 Ash Advantage ("Advantage") catheters, 8 in patients with prior hydraulic or infectious complications of Tenckhoff catheters and 10 in patients initiating peritoneal dialysis. Mean follow-up has been 8.4 months. Outflow rate for the Advantage catheters is uniformly higher than for Tenckhoff catheters at 220 +/- 100 mL/min for the first 5 minutes and 145 +/- 72 mL/min for the next 5 minutes, with outflow completed in 6 to 15 minutes. Variation of outflow volumes for similar exchanges in the same patient is +/- 3% to 5%, much less than with Tenckhoff catheters. Four catheters failed after placement, each for a different reason including outflow failure because of preexisting intraperitoneal adhesions, preexisting peritonitis failing to clear, tubing kink during placement, and catheter break after a freak accident. Life-table analysis of the production version of the catheter in study patients and 12 additional unselected patients indicates a 90% survival at 12 months. In long-term use, the fixed position of the cuffs of this catheter may avoid catheter extrusion, pericatheter hernias, and pericatheter leaks. Multiple fluted ports appear to diminish omental attachment. The catheter may be a useful alternative to conventional Tenckhoff catheters in patients at high risk of catheter failure or in standard peritoneal dialysis patients.