Multicenter evaluation of the bovine mesenteric vein bioprostheses for hemodialysis access in patients with an earlier failed prosthetic graft.
(Clinical Trial;Journal Article;Multicenter Study)
BACKGROUND: The number of patients requiring hemodialysis increases each year, with a large cohort of patients still requiring prosthetic grafts for hemodialysis. All available prosthetic vascular access grafts have predictable failure rates, leading to a large group of patients with multiple failed access grafts. This report evaluates use of mesenteric vein bioprosthesis (MVB) as a conduit for patients who have failed at least one earlier synthetic vascular access graft. STUDY DESIGN: Two-hundred seventy-six access grafts were implanted in patients who had at least one earlier failed synthetic graft. Of these grafts, 183 were MVB and 93 were synthetic. Graft histories were obtained from 128 of the 183 patients who received the MVB, representing a nonrandomized historic data set of previously failed grafts as an internal control group (INT). Patency was determined by Kaplan-Meier analysis, and the Cox proportional hazards model was used for multivariate analysis of factors predictive of effect. RESULTS: Primary patency at 12 months was 35.6% MVB versus 28.4% synthetic grafts. At 24 months, secondary patency was 60.3% MVB, 42.9% synthetic, and 18.0% INT (p < 0.0001, log- rank). Complication rates, including dilation, seroma, infection, and thrombosis, were all notably lower for the MVB compared with synthetic grafts by Cox regression (p < 0.001). Intervention rate per patient year was lower in the MVB group (0.97 versus 1.37) compared with synthetic grafts (p = 0.003). CONCLUSIONS: MVB provided superior secondary graft patency compared with both historic graft data or newly implanted nonrandomized synthetic implants. A considerable reduction in thrombosis, infection, and interventions was observed with the MVB graft. These results suggest that MVB offers a safe alternative to patients who have a history of failing synthetic access grafts and may represent an option for extending vascular access to this patient population.
Katzman, HE; Glickman, MH; Schild, AF; Fujitani, RM; Lawson, JH
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