A systematic review and meta-analysis of the use of the Omniflow II biosynthetic graft for aortic reconstruction

Abstract

Objective: Despite the improvements in xenogeneic grafts and surgical techniques, management of aortic graft infection has remained challenging. The optimal graft material has remained controversial, with high rates of reinfection using prosthetic grafts and a limited time for venous harvest in an emergent setting. Recent studies have highlighted an increase in the use of Omniflow II biosynthetic vascular grafts (LeMaitre Vascular, Burlington, MA) for aortic reconstruction. The primary aim of the present study was to review the key outcomes for the Omniflow II graft in terms of reinfection and complications.

Methods: The National Healthcare Service healthcare databases advanced search function was used to search nine databases for the search term "Omniflow." The present study complied with the PRISMA (preferred reporting items for systematic review and meta-analysis) statement. Eligible studies related to aortic graft infection or in situ aortic reconstruction were selected in accordance with prespecified eligibility criteria and included for review. Data on the surgical technique, comorbidities, graft reinfection, mortality, and complications were combined. The data were analyzed using Stata/MP, version 17 (StataCorp, College Station, TX), and the probabilities were pooled using a DerSimonian and Laird random effects model with Freeman-Tukey arcsine transformation.

Results: Six studies with 60 patients (44 men; age range, 29-89 years) were included. Of the 60 patients, 25 had undergone surgical reconstruction because of early graft infection (<4 months after the index procedure), 24 for late graft infection, and 3 because of mycotic aneurysms. Eight high-risk patients had undergone surgical reconstruction for prevention of an initial graft infection. Staphylococcus aureus, Escherichia coli, and S. epidermis were the most common organisms. Early mortality was 8.83% (95% confidence interval [CI], 1.12%-20.53%), and late mortality was 18.49% (95% CI, 5.51%-35.34%). Follow-up varied from 9 months to 2 years. No graft rupture or graft degeneration had occurred during follow-up. However, 6.2% (95% CI, 0.39%-15.81%) had experienced early graft occlusion, and 3.83% (95% CI, 0.00%-16.34%) had developed early graft stenosis. Two cases of postoperative reinfection were reported. The freedom from reinfection was 97.71% (95% CI, 87.94%-100.00%).

Conclusions: Use of the Omniflow II graft for aortic reconstruction is a feasible alternative with acceptable mortality and low reinfection rates. However, there is a risk of limb occlusion. Although these studies were of low quality, the Omniflow II graft shows promise in this difficult patient cohort, especially when bifurcated reconstruction is required.

Keywords: Aorta; Biosynthetic graft; Omniflow; Revascularization.