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.