Abstract：
OBJECTIVE: To investigate the role of the Omniflow II prosthesis in the prevention of VGI in patients with peripheral arterial disease and to report on short-and mid-term graft-related morbidity.
METHODS: Patients were included in prospective registry between October 2019 and March 2023. The primary endpoint was to report infection related problems, operation related wound problems and short- and mid-term graft-related morbidity. Secondary endpoint was to report the bypass patency rates and limb salvage rates.
RESULTS: A total of 146 Omniflow II grafts were implanted in 125 patients. Sixty-seven patients (45.9%) received a femoral interposition graft and 77 patients (52.7%) underwent ipsilateral bypass surgery (femoropopliteal/femorocrural). Forty-one patients (28.1%) underwent crural bypass surgery. Seventy-six patients (52.1%) had previous vascular operation in the groin. Mean Follow-up time was 352 days (range 0-1108 days). 3.4% of the patients suffered a wound infection limited to the dermis and in 8.2% the subcutaneous tissue was involved. Five early VGI (3.4%) and one late VGI (0.7%) occurred. One year primary patency rate of above the knee bypass was significantly better compared to the bypass below the knee (74.5% ± 0.131 versus 54% ± 0.126 (p=0.049)). This difference was not significantly different when below the knee bypass surgery was compared to crural bypass surgery (54% ± 0.126 versus 23.8% ± 0.080 (p=0.098)).
CONCLUSIONS: The performance of the Omniflow II prosthesis in the preventive setting is highly influenced by the anatomic location of the distal anastomosis. No influence on the incidence of postoperative wound problems could be observed. The rate of Omniflow II VGI in a high risk population is similar to reported outcomes in other prosthetic grafts.
METHODS: Patients were included in prospective registry between October 2019 and March 2023. The primary endpoint was to report infection related problems, operation related wound problems and short- and mid-term graft-related morbidity. Secondary endpoint was to report the bypass patency rates and limb salvage rates.
RESULTS: A total of 146 Omniflow II grafts were implanted in 125 patients. Sixty-seven patients (45.9%) received a femoral interposition graft and 77 patients (52.7%) underwent ipsilateral bypass surgery (femoropopliteal/femorocrural). Forty-one patients (28.1%) underwent crural bypass surgery. Seventy-six patients (52.1%) had previous vascular operation in the groin. Mean Follow-up time was 352 days (range 0-1108 days). 3.4% of the patients suffered a wound infection limited to the dermis and in 8.2% the subcutaneous tissue was involved. Five early VGI (3.4%) and one late VGI (0.7%) occurred. One year primary patency rate of above the knee bypass was significantly better compared to the bypass below the knee (74.5% ± 0.131 versus 54% ± 0.126 (p=0.049)). This difference was not significantly different when below the knee bypass surgery was compared to crural bypass surgery (54% ± 0.126 versus 23.8% ± 0.080 (p=0.098)).
CONCLUSIONS: The performance of the Omniflow II prosthesis in the preventive setting is highly influenced by the anatomic location of the distal anastomosis. No influence on the incidence of postoperative wound problems could be observed. The rate of Omniflow II VGI in a high risk population is similar to reported outcomes in other prosthetic grafts.
摘要：
目的：研究OmniflowII型假体在预防外周动脉疾病患者VGI中的作用，并报告短期和中期移植物相关发病率。
方法：患者在2019年10月至2023年3月期间纳入前瞻性登记。主要终点是报告感染相关问题，手术相关的伤口问题和短期和中期移植物相关的发病率。次要终点是报告旁路通畅率和肢体抢救率。
结果：125例患者共植入了146枚OmniflowII移植物。67例患者（45.9％）接受了股骨插入移植物，77例患者（52.7％）接受了同侧旁路手术（股pop/股骨干）。41例患者（28.1％）接受了小腿搭桥手术。76例患者（52.1％）曾在腹股沟进行过血管手术。平均随访时间为352天（范围0-1108天）。3.4％的患者遭受仅限于真皮的伤口感染，而8.2％的患者则涉及皮下组织。发生了五次早期VGI（3.4％）和一次晚期VGI（0.7％）。与膝盖下方的旁路相比，膝盖上方旁路的一年主要通畅率显着更好（74.5％±0.131对54％±0.126（p=0.049））。当膝盖以下搭桥手术与小腿搭桥手术相比时，这种差异没有显着差异（54％±0.126对23.8％±0.080（p=0.098））。
结论：OmniflowII型假体在预防性环境中的性能受到远端吻合的解剖位置的高度影响。未观察到对术后伤口问题发生率的影响。高危人群中OmniflowIIVGI的发生率与其他假体移植物的报告结果相似。
方法：患者在2019年10月至2023年3月期间纳入前瞻性登记。主要终点是报告感染相关问题，手术相关的伤口问题和短期和中期移植物相关的发病率。次要终点是报告旁路通畅率和肢体抢救率。
结果：125例患者共植入了146枚OmniflowII移植物。67例患者（45.9％）接受了股骨插入移植物，77例患者（52.7％）接受了同侧旁路手术（股pop/股骨干）。41例患者（28.1％）接受了小腿搭桥手术。76例患者（52.1％）曾在腹股沟进行过血管手术。平均随访时间为352天（范围0-1108天）。3.4％的患者遭受仅限于真皮的伤口感染，而8.2％的患者则涉及皮下组织。发生了五次早期VGI（3.4％）和一次晚期VGI（0.7％）。与膝盖下方的旁路相比，膝盖上方旁路的一年主要通畅率显着更好（74.5％±0.131对54％±0.126（p=0.049））。当膝盖以下搭桥手术与小腿搭桥手术相比时，这种差异没有显着差异（54％±0.126对23.8％±0.080（p=0.098））。
结论：OmniflowII型假体在预防性环境中的性能受到远端吻合的解剖位置的高度影响。未观察到对术后伤口问题发生率的影响。高危人群中OmniflowIIVGI的发生率与其他假体移植物的报告结果相似。
