Maxence Aubertin, Paolo Perini, Salomé Kuntz, Nabil Chakfe, Anne Lejay
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Secondary outcomes were 30 day all cause mortality, survival, primary and secondary patency, freedom from amputation, and aneurysmal degeneration. Statistical analysis was conducted using Prometa 3.0 and OpenMeta software. Evidence certainty for key outcomes was assessed using GRADE.</p><p><strong>Results: </strong>Six studies (116 patients) were included in the quantitative synthesis. Overall risk of bias was low in four studies and high in two studies. Freedom from re-infection was 90% (95% confidence interval [CI] 82 - 95%) at one year and 76% (95% CI 47 - 92%) at three years. All cause 30 day mortality was 4% (95% CI 0 - 10%). Survival was 93% (95% CI 86 - 97%) at one year and 87% (95% CI 73 - 95%) at three years. Primary patency was 76% (95% CI 66 - 83%) at one year and 68% (95% CI 56 - 77%) at three years. Secondary patency was 83% (95% CI 74 - 89%) at one year and 77% (95% CI 65 - 86%) at three years. Freedom from amputation was 89% (95% CI 82 - 94%) at one year and 88% (95% CI 77 - 94%) at three years. No aneurysmal degeneration was reported. GRADE certainty was low or very low for all outcomes.</p><p><strong>Conclusion: </strong>The Omniflow II graft offers an off the shelf solution for infra-inguinal reconstructions in infected fields when there is no option for autologous vein. Larger prospective cohorts are needed to further validate its effectiveness.</p>","PeriodicalId":55160,"journal":{"name":"European Journal of Vascular and Endovascular Surgery","volume":" ","pages":""},"PeriodicalIF":5.7000,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Omniflow II Biosynthetic Graft for Infra-inguinal Arterial Reconstruction in Infected Fields: A Systematic Review.\",\"authors\":\"Maxence Aubertin, Paolo Perini, Salomé Kuntz, Nabil Chakfe, Anne Lejay\",\"doi\":\"10.1016/j.ejvs.2025.05.040\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>This review aimed to evaluate the use of Omniflow II biosynthetic grafts for infra-inguinal vascular reconstruction in infected fields.</p><p><strong>Data sources: </strong>A systematic literature search (Pubmed, Embase, Cochrane Library) following PRISMA guidelines was performed (Prospero registration number CRD420251000785).</p><p><strong>Review methods: </strong>All English full text studies from 1989 - 2024 reporting on infra-inguinal vascular reconstruction using an Omniflow II in an infected field were included. Cases series and cohorts with fewer than five patients were excluded from the pooled analysis. The primary outcome was freedom from re-infection at one year and three years. Secondary outcomes were 30 day all cause mortality, survival, primary and secondary patency, freedom from amputation, and aneurysmal degeneration. Statistical analysis was conducted using Prometa 3.0 and OpenMeta software. Evidence certainty for key outcomes was assessed using GRADE.</p><p><strong>Results: </strong>Six studies (116 patients) were included in the quantitative synthesis. Overall risk of bias was low in four studies and high in two studies. Freedom from re-infection was 90% (95% confidence interval [CI] 82 - 95%) at one year and 76% (95% CI 47 - 92%) at three years. All cause 30 day mortality was 4% (95% CI 0 - 10%). Survival was 93% (95% CI 86 - 97%) at one year and 87% (95% CI 73 - 95%) at three years. Primary patency was 76% (95% CI 66 - 83%) at one year and 68% (95% CI 56 - 77%) at three years. Secondary patency was 83% (95% CI 74 - 89%) at one year and 77% (95% CI 65 - 86%) at three years. Freedom from amputation was 89% (95% CI 82 - 94%) at one year and 88% (95% CI 77 - 94%) at three years. No aneurysmal degeneration was reported. GRADE certainty was low or very low for all outcomes.</p><p><strong>Conclusion: </strong>The Omniflow II graft offers an off the shelf solution for infra-inguinal reconstructions in infected fields when there is no option for autologous vein. 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引用次数: 0
摘要
目的：评价Omniflow II型生物合成移植物在感染区腹股沟下血管重建中的应用。数据来源：按照PRISMA指南进行系统文献检索（Pubmed, Embase, Cochrane Library） （Prospero注册号CRD420251000785）。回顾方法：纳入1989 - 2024年所有报道在感染区使用Omniflow II进行腹股沟下血管重建的英文全文研究。少于5例患者的病例系列和队列被排除在合并分析之外。主要结局是1年和3年无再感染。次要结局是30天的全因死亡率、生存率、原发性和继发性通畅、免于截肢和动脉瘤变性。采用Prometa 3.0和OpenMeta软件进行统计分析。使用GRADE评估关键结果的证据确定性。结果：6项研究（116例）纳入定量综合。4项研究的总体偏倚风险较低，2项研究偏倚风险较高。一年后再感染率为90%(95%可信区间[CI] 82 - 95%)，三年后为76%（95%可信区间[CI] 47 - 92%）。全因30天死亡率为4% （95% CI 0 - 10%）。1年生存率为93% (95% CI 86 - 97%)， 3年生存率为87% （95% CI 73 - 95%）。一期通畅率为76% (95% CI 66 - 83%)，三年通畅率为68% （95% CI 56 - 77%）。1年继发通畅率为83% (95% CI 74 - 89%)， 3年继发通畅率为77% （95% CI 65 - 86%）。1年截肢自由为89% (95% CI 82 - 94%)， 3年截肢自由为88% （95% CI 77 - 94%）。未见动脉瘤变性的报道。所有结果的GRADE确定性都很低或非常低。结论：Omniflow II型移植物为腹股沟下感染区无自体静脉重建提供了一种现成的解决方案。需要更大的前瞻性队列来进一步验证其有效性。
Omniflow II Biosynthetic Graft for Infra-inguinal Arterial Reconstruction in Infected Fields: A Systematic Review.
Objective: This review aimed to evaluate the use of Omniflow II biosynthetic grafts for infra-inguinal vascular reconstruction in infected fields.
Data sources: A systematic literature search (Pubmed, Embase, Cochrane Library) following PRISMA guidelines was performed (Prospero registration number CRD420251000785).
Review methods: All English full text studies from 1989 - 2024 reporting on infra-inguinal vascular reconstruction using an Omniflow II in an infected field were included. Cases series and cohorts with fewer than five patients were excluded from the pooled analysis. The primary outcome was freedom from re-infection at one year and three years. Secondary outcomes were 30 day all cause mortality, survival, primary and secondary patency, freedom from amputation, and aneurysmal degeneration. Statistical analysis was conducted using Prometa 3.0 and OpenMeta software. Evidence certainty for key outcomes was assessed using GRADE.
Results: Six studies (116 patients) were included in the quantitative synthesis. Overall risk of bias was low in four studies and high in two studies. Freedom from re-infection was 90% (95% confidence interval [CI] 82 - 95%) at one year and 76% (95% CI 47 - 92%) at three years. All cause 30 day mortality was 4% (95% CI 0 - 10%). Survival was 93% (95% CI 86 - 97%) at one year and 87% (95% CI 73 - 95%) at three years. Primary patency was 76% (95% CI 66 - 83%) at one year and 68% (95% CI 56 - 77%) at three years. Secondary patency was 83% (95% CI 74 - 89%) at one year and 77% (95% CI 65 - 86%) at three years. Freedom from amputation was 89% (95% CI 82 - 94%) at one year and 88% (95% CI 77 - 94%) at three years. No aneurysmal degeneration was reported. GRADE certainty was low or very low for all outcomes.
Conclusion: The Omniflow II graft offers an off the shelf solution for infra-inguinal reconstructions in infected fields when there is no option for autologous vein. Larger prospective cohorts are needed to further validate its effectiveness.
期刊介绍：
The European Journal of Vascular and Endovascular Surgery is aimed primarily at vascular surgeons dealing with patients with arterial, venous and lymphatic diseases. Contributions are included on the diagnosis, investigation and management of these vascular disorders. Papers that consider the technical aspects of vascular surgery are encouraged, and the journal includes invited state-of-the-art articles.
Reflecting the increasing importance of endovascular techniques in the management of vascular diseases and the value of closer collaboration between the vascular surgeon and the vascular radiologist, the journal has now extended its scope to encompass the growing number of contributions from this exciting field. Articles describing endovascular method and their critical evaluation are included, as well as reports on the emerging technology associated with this field.
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