Search

Venous stenosis and occlusion are a major cause of vascular access dysfunction and failure. The HeRO Graft bypasses occlusion and traverses stenosis with outflow directly into the central venous circulation. A randomized, multicenter study was conducted to evaluate the efficacy and safety of the HeRO Graft relative to conventional AV grafts. The design was to enroll 143 patients in a 2:1 randomization ratio between HeRO and conventional AV control groups. Data on 72 subjects (52 HeRO Graft and 20 AV graft controls) were obtained. The HeRO Graft and control cohorts were comparable in baseline characteristics. Adequacy of dialysis, bacteremia rates, and adverse events were consistent between groups. Twelve month Kaplan-Meier estimates for primary and secondary patency rates were 34.8% and 67.6% in the HeRO Graft cohort, and 30.6% and 58.4% in the control cohort. There was no statistical difference in terms of patency between groups. The rates of intervention were 2.2/year for HeRO Graft and 1.6/year for the control (p = 0.100). Median days to loss of secondary patency was 238 for HeRO Graft versus 102 for the control (p = 0.032). The HeRO Graft appears to provide similar patency, adequacy of dialysis, and bacteremia rates to those of conventional AV grafts.

Purpose: Vein collars and patches are used at the distal anastomoses of infrainguinal prosthetic grafts to improve graft patency. We initiated a randomized, prospective study to determine whether a Tyrell vein collar at the venous anastomosis of forearm loop arteriovenous grafts (AVGs) would improve patency. Methods: Patients who required new forearm AVGs were randomized to (1) a standard end-to-side graft-vein anastomosis (control group) or (2) a Tyrell vein collar between the graft and the vein (study group). End points were (1) graft thrombosis, (2) graft removal and ligation, or (3) inadequate graft function. Randomization of 75 subjects was planned. The study was terminated early for ethical reasons. Results: Seventeen patients (eight men, nine women) with a mean age of 52.8 years (range, 31-79 years) had 17 grafts placed (control group, n=10; study group, n=7). Comorbidities were not different between the groups ( P >.05). Six (86%) of seven study grafts failed by 9 months (mean, 4.6 months). Four (66%) failed study grafts had venous outflow tract stenosis from intimal hyperplasia. This was confirmed at surgery in three and by angiography in one. The 9-month primary patency was 80% for the control group versus 17% for the study group ( P =.015). Smaller outflow vein diameter in the study group ( P =.048) did not account for this inferior graft patency. Conclusion: A Tyrell vein collar at the venous anastomosis of a forearm AVG resulted in premature graft failure. The use of a Tyrell vein collar may accelerate venous anastomosis intimal hyperplasia. (J Vasc Surg 2000;32:1149-54.)