Department of Vascular Surgery, 1170Meander Medical Center, The Netherlands.
Vascular. 2022 Aug;30(4):749-758. doi: 10.1177/17085381211029815. Epub 2021 Jul 1.
The aim of this study is to evaluate the outcome of Omniflow II biosynthetic vascular grafts as compared to synthetic expanded polytetrafluoroethylene (ePTFE) grafts in infrainguinal bypass surgery.
A single-center, retrospective, observational study was performed reviewing patients with critical limb ischemia who underwent infrainguinal bypass surgery between 2014 and 2018. Patients characteristics, graft characteristics, and treatment outcomes were collected. Patency rates were compared using Kaplan-Meier estimates.
Sixty bypasses were performed in 57 patients. For above-knee surgery, six were Omniflow and 13 were synthetic. For below-knee surgery, 19 were Omniflow and 22 were synthetic. Patient characteristics between groups were similar. However, American Society of Anesthesiologists (ASA) classification scores were higher in the Omniflow group as compared to ePTFE (88% was ASA 3 or higher versus 60%; = 0.018). Furthermore, wound, ischemia, and foot infection (WIfI) composite scores were higher in the Omniflow group ( = 0.0001). There was a trend toward more active infection at time of surgery in the Omniflow group (40 vs 22.9%, = 0.15). At 1 year, primary patency rates were 60.0% versus 46.9% for above-knee Omniflow versus ePTFE grafts, respectively ( = 0.72). Secondary patency rates were 80.0% versus 82.5% ( = 0.89), and limb salvage rates were 83.3% versus 100% ( = 0.14). For below-knee surgery, 1- and 2-year primary patency rates in Omniflow versus ePTFE grafts were 36.0% versus 41.8% ( = 0.60) and 36.0% versus 31.1% ( = 0.87). Secondary patency rates were 66.8% versus 75.2% at 1 year ( = 0.53) and 58.8% versus 48.3% ( = 0.77) at 2 years. Below-knee limb salvage rates for Omniflow versus ePTFE after 2 years were 88.0% versus 68.3% ( = 0.28), respectively. Aneurysmal degeneration occurred in 2/25 (8%) in the Omniflow group and 0/35 (0%) in the ePTFE group. Bypass infections occurred in 2/25 (8%) in the Omniflow group and 0/35 (0%) in the ePTFE group ( = 0.09).
Omniflow bypasses were more commonly implanted in patients with higher limb infection rate as confirmed with a higher adapted WIfI score. A trend toward a higher infection rate of Omniflow grafts was observed but not statistically significant. Graft infection rates were relatively low and treatable with antibiotics. No significant difference in graft performance was observed. The choice between the two studied grafts remains based on surgeon's preference.
本研究旨在评估 Omniflow II 生物合成血管移植物与合成膨体聚四氟乙烯（ePTFE）移植物在下肢旁路手术中的结果。
进行了一项单中心、回顾性、观察性研究，对 2014 年至 2018 年期间接受下肢旁路手术的患有严重肢体缺血的患者进行了回顾。收集了患者特征、移植物特征和治疗结果。使用 Kaplan-Meier 估计比较通畅率。
57 例患者共进行了 60 次旁路手术。对于膝上手术，有 6 例为 Omniflow，13 例为合成。对于膝下手术，有 19 例为 Omniflow，22 例为合成。两组患者的特征相似。然而，与 ePTFE 相比，Omniflow 组的美国麻醉医师协会（ASA）分级评分更高（88%为 ASA 3 或更高，而 ePTFE 为 60%；=0.018）。此外，Omniflow 组的伤口、缺血和足部感染（WIfI）综合评分更高（=0.0001）。Omniflow 组在手术时更倾向于有活动性感染（40%比 22.9%；=0.15）。在 1 年时，膝上 Omniflow 与 ePTFE 移植物的主要通畅率分别为 60.0%和 46.9%（=0.72）。次要通畅率分别为 80.0%和 82.5%（=0.89），肢体挽救率分别为 83.3%和 100%（=0.14）。对于膝下手术，Omniflow 与 ePTFE 移植物在 1 年和 2 年时的主要通畅率分别为 36.0%和 41.8%（=0.60）和 36.0%和 31.1%（=0.87）。次要通畅率在 1 年时分别为 66.8%和 75.2%（=0.53），在 2 年时分别为 58.8%和 48.3%（=0.77）。在 2 年后，Omniflow 与 ePTFE 的膝下肢体挽救率分别为 88.0%和 68.3%（=0.28）。在 Omniflow 组中有 2/25（8%）发生动脉瘤样变性，而在 ePTFE 组中没有发生（0%）（=0.09）。在 Omniflow 组中有 2/25（8%）发生旁路感染，而在 ePTFE 组中没有发生（0%）（=0.09）。
Omniflow 旁路更常见于下肢感染率较高的患者，这与适应性 WIfI 评分较高有关。观察到 Omniflow 移植物的感染率有升高的趋势，但没有统计学意义。感染率相对较低，可通过抗生素治疗。两种研究移植物的性能没有显著差异。两种移植物的选择仍取决于外科医生的偏好。
