The VWING was safe and effective in facilitating AVF cannulation for patients with an otherwise mature but noncannulatable fistula. Successful AVF access was achieved using the VWING in 49 (96%) of the 51 patients evaluated. The AVF survival rate at 6 months was 100%.
Purpose
To explore the safety and efficacy of PRT-201 applied to the outflow vein of a newly created arteriovenous graft (AVG).
Methods
Randomized, double-blind, placebo-controlled, single-dose escalation study of PRT-201 (0.01 to 9 mg) applied to the graft-vein anastomosis and adjacent outflow vein immediately after AVG placement. The primary outcome measure was safety. The efficacy measures were intraoperative increases in outflow vein diameter and blood flow rate, primary unassisted patency, and secondary patency by dose groups (placebo, low, medium, high and All PRT-201).
Results
A total of 89 patients were treated (28 placebo and 61 PRT-201). There were no significant differences in the proportion of placebo and PRT-201 patients reporting adverse events. Intraoperative outflow vein diameter increased 5% (p=0.14) in the placebo group compared with 13% (p=0.01), 15% (p=0.07) and 12% (p<0.001), in the low, medium and high groups, respectively. The comparison between the high and placebo groups was marginally statistically significant (p=0.06). The intraoperative blood flow did not change in the placebo group, and increased in the low, medium and high groups by 19% (p=0.34), 36% (p=0.09) and 46% (p=0.02), respectively. The low group had the longest primary unassisted and secondary patency and the fewest procedures to restore or maintain patency; however, the differences between groups were not statistically significant.
Conclusions
PRT-201 was well tolerated and increased AVG intraoperative outflow vein diameter and blood flow. Low dose tended to increase secondary patency and decrease the rate of procedures to restore or maintain patency. Larger studies with these doses will be necessary to confirm these results.
Most subjects had prompt, uncomplicated cannulation but a few had wound necrosis, large hematomas and prolonged time until cannulation. Liposuction is effective in enabling cannulation of deep vein fistulas but because of the substantial risk of serious surgical site complications, it may not be the ideal method.
Flow rate at the 1-week postoperative visit was the most important predictor of RCAVF patency. Thus, it should be possible to identify patients who would benefit from early intervention or closer follow-up as soon as the first postoperative visit. This should help reduce the use of bridging hemodialysis catheters and minimize the risks of catheter dependency.
HeRO patients had lower primary and secondary patency rates versus thigh fistula patients and HeRO grafts required five-fold more interventions to maintain secondary patency. However, patients with thigh fistulas had significantly more wound healing problems. Thus, the SFA-tFV has become our access of choice for patients with bilateral central venous stenosis.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.