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Updated: Sep 14, 2026
Full-root Aortic Valve Replacement by Stentless Aortic Xenografts in Patients with Small Aortic Roots
Published on: May 21, 2017
Long-Term Outcomes of Omniflow II and BioIntegral Xenografts for Open Aortic Reconstruction in Predominantly Infected
Tijmen W Kraai1, Eline I Reinders Folmer1, Barzi Gareb2
1Department of Surgery (Division of Vascular Surgery), University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Objective:
Evidence surrounding conduit selection for open in situ aortic reconstruction remains limited particularly for xenograft use in infected settings. We evaluated long-term outcomes after open aortic and aorto-iliac reconstruction using BioIntegral No-React bovine grafts and Omniflow II biosynthetic grafts in patients unsuitable for autologous vein reconstruction.
Methods:
This multicenter cohort study combined a retrospective Omniflow II cohort from six Dutch hospitals with a prospectively collected BioIntegral registry. Patients undergoing open aortic, aortoiliac, or aortofemoral reconstruction in infected and selected noninfected settings between 2014 and 2021 were included; peripheral bypasses and arteriovenous access procedures were excluded. The primary outcome was graft infection. Secondary outcomes included patency rates (primary, primary-assisted, and secondary), mortality, freedom from major amputation, and 30-day adverse events. Time-to-event outcomes were analyzed using Kaplan-Meier methods and univariate Cox regression.
Results:
Forty-four patients were included (BioIntegral n = 21, Omniflow II n = 23). Baseline characteristics were comparable except for a lower body mass index in the Omniflow group (26.8 vs. 23.9 kg/m2; p = 0.046). Thirty-day mortality was 19.0% for BioIntegral and 30.4% for Omniflow II. Infection from infection at 12, 24, and 60 months was 88.2%, 63.7%, and 43.7% for BioIntegral versus 87.1%, 79.1%, and 79.1% for Omniflow II (log-rank p = 0.13). Primary patency at 60 months was 49.9% versus 55.5% (p = 0.48) and secondary patency was 85.7% versus 72.4% (p = 0.24). Overall survival at 60 months was 25.0% versus 47.3% (p = 0.41). Freedom from major amputation at 60 months was 81.8% versus 88.8% (p = 0.59). Graft type was not associated with significant differences in univariate analyses.
Conclusions:
In open aortic reconstruction performed predominantly for vascular graft or endograft infection, BioIntegral and Omniflow II xenografts showed comparable long-term outcomes without statistically significant differences in patency, mortality or freedom from major amputation. Findings should be interpreted as descriptive given the small sample size and mixed indications. Late graft infections highlight the need for prolonged surveillance after reconstruction.
