Omniflow® II biosynthetic graft offers acceptable early and mid-term outcomes in redo surgery in patients with critical limb-threatening ischemia with no available autologous vein material.

BACKGROUND: In this study, the early and mid-term outcomes of Omniflow® II (LeMaitre Vascular, Inc., Burlington, MA, USA) biosynthetic graft in redo surgery in patients with critical limb-threatening ischemia (CLTI) with no available autologous vein material were investigated with the aim to compare the outcomes obtained in "de novo" surgery versus redo surgery. METHODS: From January 2018 until December 2022, data of CLTI patients from 18 centers in Italy with no autologous vein material underwent infrainguinal bypass with Omniflow® II biosynthetic graft were collected. Thirty-day outcome measures including intraoperative technical success, major morbidity, mortality, and graft patency were assessed and compared. At two-year follow-up, estimated outcomes of survival, primary patency, primary assisted patency, secondary patency, freedom from reintervention, and amputation-free survival were analyzed using Kaplan-Meier curves and compared between groups using the log-rank test. RESULTS: In the study period 119 CLTI patients had an infrainguinal bypass with Omniflow® II biosynthetic graft. Seventy-seven patients (64.7%) underwent bypass as "de novo" treatment (group de novo), whilst in the remaining 42 patients (35.3%) the procedure was performed as redo surgery due to occlusion and/or infection of a previous bypass graft (group redo). Two groups were homogeneous in terms of demographic, clinical, and morphological data. In group redo explantation of an infected prosthetic graft was needed in 4 cases (9.5%). Intraoperative technical success was achieved in all cases in both groups. At 30 days, the overall patency rate did not differ between the two groups (69/77, 89.6%, group de novo vs. 35/42, 83.3%, group redo; P=0.24), whilst in group redo limb loss was higher with a statistically significant different 30-day major amputation rate between the two groups (11.9% group redo vs. 1.3% group de novo; P<0.001). Overall median duration of follow-up was eight months (IQR 6-13). At two-year follow-up there were no differences between the two groups in terms of survival (67.7% group de novo vs. 55.8% group redo, P=0.53), primary patency (34.4% group de novo vs. 26.8% group redo, P=0.25), primary assisted patency (43.6% group de novo vs. 28.8% group redo, P=0.12), freedom from reintervention (64.1% group de novo vs. 68.8% group redo, P=0.98), and amputation-free survival (67.8% group de novo vs. 60% group redo, P=0.12). Secondary patency was significantly higher in group de novo (53.7% vs. 32.3%, P=0.05). During the follow-up, the overall rates of graft infection and aneurysmal degeneration were 3.4%, and 0.8%, respectively. CONCLUSIONS: Nevertheless, poorer early outcomes in terms of limb salvage, Omniflow® II biosynthetic graft offers acceptable ywo-year outcomes in redo surgery in CLTI patients with no available autologous vein material. Further studies with larger population sizes are needed to validate these outcomes.

Outcomes of biosynthetic vascular graft for infrainguinal femoro-popliteal and femoro-distal revascularization.

BACKGROUND: The aim of this study was to retrospectively analyze early and late outcomes of infrainguinal revascularization performed with the Omniflow-II® (LeMaitre Vascular, Inc., Burlington, MA, USA) biosynthetic vascular graft (BVG) for complex femoro-popliteal obstructive disease. METHODS: Over a 10-year period, this BVG was used in 110 patients who underwent infrainguinal femoro-popliteal or femoro-distal bypass. Early (intraoperative and <30 days) results were analyzed in terms of death, thrombosis, amputations and reinterventions. Follow-up results were analyzed in terms of primary and secondary graft patency, and amputation-free survival. RESULTS: We performed 87 (79.1%) above-the-knee bypass, 20 (18.2%) below-the-knee bypass, and 3 (2.7%) tibial artery bypass. In-hospital mortality was not observed. Mean follow-up was 66±37 months (range, 3-150). Estimated primary patency rate at 1, 2 and 5-years of follow-up was 77%±4 (95%CI: 68-84), 73%±5 (95%CI: 63.5-83), and 59%±6 (95%CI: 47-70.5) respectively. Predictors of primary patency loss were the presence of critical limb ischemia (P=0.048; HR: 2.1; 95%CI: 1.01-4.28), and the necessity of below-the-knee bypass (P=0.012; HR: 2.4; 95%CI: 1.22-4.75). Aneurysmal degeneration of the BVG was detected in 4 (3.6%) patients, an infected BVG occurred in 3 (2.7%) patients. The amputation-free survival was 96%±2 (95%CI: 91-99), 93%±3 (95%CI: 86-96), and 76%±5 (95%CI: 66-84) at 1, 2 and 5-years respectively. CONCLUSIONS: In our experience, Omniflow-II® is a valid first-line alternative for infrainguinal revascularization when the ipsilateral autologous saphenous vein is not available. Aneurysmal degeneration was lower than previously reported with alternative BVGs, and the incidence of BVG infection was acceptably low.

Vascular Surgery During COVID-19 Emergency in Hub Hospitals of Lombardy: Experience on 305 Patients.

OBJECTIVE: During the most aggressive phase of the COVID-19 outbreak in Italy, the Regional Authority of Lombardy identified a number of hospitals, named Hubs, chosen to serve the whole region for highly specialised cases, including vascular surgery. This study reports the experience of the four Hubs for Vascular Surgery in Lombardy and provides a comparison of in hospital mortality and major adverse events (MAEs) according to COVID-19 testing. METHODS: Data from all patients who were referred to the Vascular Surgery Department of Hubs from 9 March to 28 April 2020 were collected prospectively and analysed. A positive COVID-19 polymerase chain reaction swab test, or symptoms (fever > 37.5 °C, upper respiratory tract symptoms, chest pain, and contact/travel history) associated with interstitial pneumonia on chest computed tomography scan were considered diagnostic of COVID-19 disease. Patient characteristics, operative variables, and in hospital outcomes were compared according to COVID-19 testing. A multivariable model was used to identify independent predictors of in hospital death and MAEs. RESULTS: Among 305 included patients, 64 (21%) tested positive for COVID-19 (COVID group) and 241 (79%) did not (non-COVID group). COVID patients presented more frequently with acute limb ischaemia than non-COVID patients (64% vs. 23%; p < .001) and had a significantly higher in hospital mortality (25% vs. 6%; p < .001). Clinical success, MAEs, re-interventions, and pulmonary and renal complications were significantly worse in COVID patients. Independent risk factors for in hospital death were COVID (OR 4.1), medical treatment (OR 7.2), and emergency setting (OR 13.6). COVID (OR 3.4), obesity class V (OR 13.5), and emergency setting (OR 4.0) were independent risk factors for development of MAEs. CONCLUSION: During the COVID-19 pandemic in Lombardy, acute limb ischaemia was the most frequent vascular disease requiring surgical treatment. COVID-19 was associated with a fourfold increased risk of death and a threefold increased risk of major adverse events.