Back to Search
Start Over
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.
- Source :
-
International angiology : a journal of the International Union of Angiology [Int Angiol] 2024 Apr; Vol. 43 (2), pp. 255-261. Date of Electronic Publication: 2024 Feb 12. - Publication Year :
- 2024
-
Abstract
- Background: In this study, the early and mid-term outcomes of Omniflow <superscript>®</superscript> 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.<br />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 <superscript>®</superscript> 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.<br />Results: In the study period 119 CLTI patients had an infrainguinal bypass with Omniflow <superscript>®</superscript> 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.<br />Conclusions: Nevertheless, poorer early outcomes in terms of limb salvage, Omniflow <superscript>®</superscript> 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.
- Subjects :
- Humans
Male
Female
Aged
Retrospective Studies
Italy
Middle Aged
Aged, 80 and over
Time Factors
Treatment Outcome
Peripheral Arterial Disease surgery
Peripheral Arterial Disease physiopathology
Graft Occlusion, Vascular surgery
Graft Occlusion, Vascular etiology
Graft Occlusion, Vascular physiopathology
Veins transplantation
Veins surgery
Critical Illness
Risk Factors
Prosthesis Design
Reoperation
Ischemia surgery
Ischemia physiopathology
Vascular Patency
Blood Vessel Prosthesis adverse effects
Blood Vessel Prosthesis Implantation adverse effects
Blood Vessel Prosthesis Implantation instrumentation
Limb Salvage
Amputation, Surgical
Subjects
Details
- Language :
- English
- ISSN :
- 1827-1839
- Volume :
- 43
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- International angiology : a journal of the International Union of Angiology
- Publication Type :
- Academic Journal
- Accession number :
- 38345547
- Full Text :
- https://doi.org/10.23736/S0392-9590.24.05152-6