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Contemporary Results with the Biosynthetic Glutaraldehyde Denatured Ovine Collagen Graft (Omniflow II) in Lower Extremity Arterial Revascularization in a Septic Context

Published:April 20, 2022DOI:https://doi.org/10.1016/j.avsg.2022.04.011

      Highlights

      • This multi-center study is the largest series on the use of the biosynthetic glutaraldehyde denatured ovine collagen graft (Omniflow II®) in an infected environment.
      • It confirms the plausibility of using the Omniflow II® bioprosthetic graft in a septic field, with excellent procedural success rates and encouraging freedom from major amputation, reinfection and secondary patency rates given the disease severity of these patients.
      • As such, the Omniflow II represents an acceptable vascular substitute in the absence of an autologous vein.

      Background

      Peripheral vascular graft infections are poorly-evaluated, despite high mortality and amputation rates. The vascular substitute of choice remains controversial when veins are unavailable. This study aims to evaluate the results of a biosynthetic collagen graft (Omniflow II®) in an infected field when autologous veins are unavailable.

      Methods

      This retrospective, multicentric study included all consecutive patients in whom an Omniflow II graft was used for infra-inguinal revascularization in a septic context from January 2015 to January 2020. The primary end-point was freedom from major amputation; secondary end-points were 30-day mortality, survival, patency, and freedom from reinfection estimated using the Kaplan-Meier method.

      Results

      Twenty-nine patients (27 men, median age of 69 years interquartile range IQR:60; 76) were included. Fever was present in 58.6%, a septic rupture in 17.9%, a pseudo-aneurysm in 25.0%. The 30-day mortality rate was 3.4%. Median follow-up reached 49 months. At 1 and 3 years, estimated freedom from major amputation was 88.4% and 83.9%, survival: 96%, primary patency: 74.6% and 65.8%, and reinfection free-survival: 85.6%. There were 7 occlusions (1 iliofemoral, 1 below-knee, and 5 above-knee bypasses), 3 explantations for persistent sepsis, 4 reinfections (all within 6 months which led to 1 death and 3 out of 4 major amputations). The risk of major amputation increased with bypass reinfection (P = 0.004), occlusion (P = 0.005), and polymicrobial infection (P = 0.05).

      Conclusions

      In a septic context, the Omniflow II graft shows acceptable freedom from major amputation and reinfection. This usage remains outside the instructions of use, it is, therefore, is essential to pursue longer-term studies in larger cohorts.
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      References

        • Exton R.J.
        • Galland R.B.
        Major groin complications following the use of synthetic grafts.
        Eur J Vasc Endovasc Surg. 2007; 34: 188-190https://doi.org/10.1016/j.ejvs.2007.03.012
        • Revest M.
        • Camou F.
        • Senneville E.
        • et al.
        Medical treatment of prosthetic vascular graft infections: review of the literature and proposals of a Working Group.
        Int J Antimicrob Agents. 2015; 46: 254-265https://doi.org/10.1016/j.ijantimicag.2015.04.014
        • FitzGerald S.F.
        • Kelly C.
        • Humphreys H.
        Diagnosis and treatment of prosthetic aortic graft infections: confusion and inconsistency in the absence of evidence or consensus.
        J Antimicrob Chemother. 2005; 56: 996-999https://doi.org/10.1093/jac/dki382
        • Chambers S.T.
        Diagnosis and management of staphylococcal infections of vascular grafts and stents.
        Intern Med J. 2005; 35: S72-S78https://doi.org/10.1111/j.1444-0903.2005.00981.x
        • Chakfé N.
        • Diener H.
        • Lejay A.
        • et al.
        Editor’s choice – European society for vascular surgery (ESVS) 2020 clinical practice guidelines on the management of vascular graft and endograft infections.
        Eur J Vasc Endovasc Surg. 2020; 59: 339-384https://doi.org/10.1016/j.ejvs.2019.10.016
        • Saleem B.R.
        • Meerwaldt R.
        • Tielliu I.F.J.
        • et al.
        Conservative treatment of vascular prosthetic graft infection is associated with high mortality.
        Am J Surg. 2010; 200: 47-52https://doi.org/10.1016/j.amjsurg.2009.05.018
        • Legout L.
        • D’Elia P.V.
        • Sarraz-Bournet B.
        • et al.
        Diagnosis and management of prosthetic vascular graft infections.
        Med Mal Infect. 2012; 42: 102-109https://doi.org/10.1016/j.medmal.2012.01.003
        • Ehsan O.
        • Gibbons C.P.
        A 10-year experience of using femoro-popliteal vein for re-vascularisation in graft and arterial infections.
        Eur J Vasc Endovasc Surg. 2009; 38: 172-179https://doi.org/10.1016/j.ejvs.2009.03.009
        • Chew D.K.W.
        • Owens C.D.
        • Belkin M.
        • et al.
        Bypass in the absence of ipsilateral greater saphenous vein: safety and superiority of the contralateral greater saphenous vein.
        J Vasc Surg. 2002; 35: 1085-1092
        • Lejay A.
        • Delay C.
        • Girsowicz E.
        • et al.
        Cryopreserved cadaveric arterial allograft for arterial reconstruction in patients with prosthetic infection.
        Eur J Vasc Endovasc Surg. 2017; 54: 636-644https://doi.org/10.1016/j.ejvs.2017.07.016
        • O’Banion L.A.
        • Wu B.
        • Eichler C.M.
        • et al.
        Cryopreserved saphenous vein as a last-ditch conduit for limb salvage.
        J Vasc Surg. 2017; 66: 844-849https://doi.org/10.1016/j.jvs.2017.03.415
        • Ziza V.
        • Canaud L.
        • Gandet T.
        • et al.
        Outcomes of cold-stored venous allograft for below-knee bypasses in patients with critical limb ischemia.
        J Vasc Surg. 2015; 62: 974-983https://doi.org/10.1016/j.jvs.2015.04.437
        • Töpel I.
        • Audebert F.
        • Betz T.
        • et al.
        Microbial spectrum and primary resistance to rifampicin in infectious complications in vascular surgery: limits to the use of rifampicin-bonded prosthetic grafts.
        Angiology. 2010; 61: 423-426https://doi.org/10.1177/0003319709360029
        • Matic P.
        • Tanaskovic S.
        • Babic S.
        • et al.
        In situ revascularisation for femoropopliteal graft infection: ten years of experience with silver grafts.
        Vascular. 2014; 22: 323-327https://doi.org/10.1177/1708538113504399
        • Ketharnathan V.
        • Christie B.A.
        Glutaraldehyde-tanned ovine collagen conduits as vascular xenografts in dogs: a preliminary report.
        Arch Surg. 1980; 115: 967-969https://doi.org/10.1001/archsurg.1980.01380080057011
        • Werkmeister J.A.
        • Glattauer V.
        • Tebb T.A.
        • et al.
        Structural stability of long-term implants of a collagen-based vascular prosthesis.
        J Long Term Eff Med Implants. 1991; 1: 107-119
        • Koch G.
        • Gutschi S.
        • Pascher O.
        • et al.
        Analysis of 274 Omniflow vascular prostheses implanted over an eight-year period.
        Aust N Z J Surg. 1997; 67: 637-639
        • Töpel I.
        • Stigler T.
        • Ayx I.
        • et al.
        Biosynthetic grafts to replace infected prosthetic vascular bypasses: a single-center experience.
        Surg Infect (Larchmt). 2017; 18: 202-205https://doi.org/10.1089/sur.2016.203
        • Dünschede F.
        • Stabrauskaite J.
        • Weisser G.
        • et al.
        Crural bypass for critical lower limb ischemia with Omniflow II prosthesis.
        Thorac Cardiovasc Surg. 2016; 64: 311-315https://doi.org/10.1055/s-0035-1560039
        • Wiltberger G.
        • Matia I.
        • Schmelzle M.
        • et al.
        Mid- and long-term results after replacement of infected peripheral vascular prosthetic grafts with biosynthetic collagen prosthesis.
        J Cardiovasc Surg (Torino). 2014; 55: 693-698
        • Lyons O.T.A.
        • Baguneid M.
        • Barwick T.D.
        • et al.
        Diagnosis of aortic graft infection: a case definition by the management of aortic graft infection collaboration (MAGIC).
        Eur J Vasc Endovasc Surg. 2016; 52: 758-763https://doi.org/10.1016/j.ejvs.2016.09.007
        • Puges M.
        • Bérard X.
        • Ruiz J.-B.
        • et al.
        Retrospective study comparing WBC scan and 18F-FDG PET/CT in patients with suspected prosthetic vascular graft infection.
        Eur J Vasc Endovasc Surg. 2019; 57: 876-884
        • Thermann F.
        • Wollert U.
        Continuous irrigation as a therapeutic option for graft infections of the groin.
        World J Surg. 2014; 38: 2589-2596https://doi.org/10.1007/s00268-014-2650-8
        • Krasznai A.G.
        • Snoeijs M.
        • Siroen M.P.
        • et al.
        Treatment of aortic graft infection by in situ reconstruction with Omniflow II biosynthetic prosthesis.
        Vascular. 2016; 24: 561-566https://doi.org/10.1177/1708538115621195
        • Castier Y.
        • Paraskevas N.
        • Maury J.-M.
        • et al.
        Cryopreserved arterial allograft reconstruction for infected peripheral bypass.
        Ann Vasc Surg. 2010; 24: 994-999https://doi.org/10.1016/j.avsg.2010.01.017
        • Fellmer P.T.
        • Wiltberger G.
        • Tautenhahn H.-M.
        • et al.
        Early results after peripheral vascular replacement with biosynthetic collagen prosthesis in cases of graft infection.
        Zentralbl Chir. 2014; 139: 546-551https://doi.org/10.1055/s-0032-1327968
        • Brown K.E.
        • Heyer K.
        • Rodriguez H.
        • et al.
        Arterial reconstruction with cryopreserved human allografts in the setting of infection: a single-center experience with midterm follow-up.
        J Vasc Surg. 2009; 49: 660-666https://doi.org/10.1016/j.jvs.2008.10.026
        • Bozoglan O.
        • Mese B.
        • Eroglu E.
        • et al.
        Which prosthesis is more resistant to vascular graft infection: polytetrafluoroethylene or Omniflow II biosynthetic grafts?.
        Surg Today. 2016; 46: 363-370https://doi.org/10.1007/s00595-015-1141-3
        • Woźniak W.
        • Kozińska A.
        • Ciostek P.
        • et al.
        Susceptibility of vascular implants to colonization in vitro by Staphylococcus aureus, Staphylococcus epidermidis, Enterococcus faecalis and Pseudomonas aeruginosa.
        Pol J Microbiol. 2017; 66: 125-129https://doi.org/10.5604/17331331.1235001
        • Menger M.D.
        • Hammersen F.
        • Messmer K.
        In vivo assessment of neovascularization and incorporation of prosthetic vascular biografts.
        Thorac Cardiovasc Surg. 1992; 40: 19-25https://doi.org/10.1055/s-2007-1020105