In:
Seminars in Dialysis, Wiley, Vol. 27, No. 3 ( 2014-05), p. 310-318
Abstract:
Venous stenosis and occlusion are a major cause of vascular access dysfunction and failure. The He RO 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 He RO Graft relative to conventional AV grafts. The design was to enroll 143 patients in a 2:1 randomization ratio between He RO and conventional AV control groups. Data on 72 subjects (52 He RO Graft and 20 AV graft controls) were obtained. The He RO 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 He RO 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 He RO Graft and 1.6/year for the control ( p = 0.100). Median days to loss of secondary patency was 238 for He RO Graft versus 102 for the control ( p = 0.032). The He RO Graft appears to provide similar patency, adequacy of dialysis, and bacteremia rates to those of conventional AV grafts.
Type of Medium:
Online Resource
ISSN:
0894-0959
,
1525-139X
DOI:
10.1111/sdi.2014.27.issue-3
Language:
English
Publisher:
Wiley
Publication Date:
2014
detail.hit.zdb_id:
2010756-0
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