Omentin reduces venous neointimal hyperplasia in arteriovenous fistula through hypoxia-inducible factor-1 alpha inhibition.

Arteriovenous fistula (AVF) failure often involves venous neointimal hyperplasia (VNH) driven by elevated hypoxia-inducible factor-1 alpha (HIF-1α) in the venous wall. Omentin, known for its anti-inflammatory and anti-hyperplasia properties, has an uncertain role in early AVF failure. This study investigates omentin's impact on VNH using a chronic renal failure (CRF) rabbit model. The CRF rabbit model of AVF received omentin-expressing adenoviral vector or control ß-gal vector to assess omentin's effects on VNH. Human vascular smooth muscle cells (HVSMCs), stimulated with tumor necrosis factor-α (TNF-α), were exposed to recombinant human omentin (Rh-OMT) to study its influence on cell proliferation and migration. The AMP-activated protein kinase (AMPK) inhibitor compound C and the mammalian target of rapamycin (mTOR) activator MHY1485 were employed to explore omentin's mechanisms in VNH reduction through HIF-1α inhibition. Omentin treatment reduced VNH in CRF rabbits, concomitant with HIF-1α down-regulation and the suppression of downstream factors, including vascular endothelial growth factor and matrix metalloproteinases. Rh-OMT inhibited TNF-α-induced HVSMC proliferation and migration by modulating both cell cycle and cell adhesion proteins. Additionally, omentin reduced HIF-1α expression through the AMPK/mTOR pathway activation. Notably, the blockade of AMPK/mTOR signaling reversed omentin-mediated inhibition of VNH, cell proliferation, and migration, both in vivo and in vitro. In conclusion, omentin mitigates VNH post-AVF creation by restraining HIF-1α via AMPK/mTOR signaling. Strategies boosting circulating omentin levels may offer promise in averting AVF failure.

A Systematic Review and Meta-Analysis of Heparin-Bonded Expanded Polytetrafluoroethylene Grafts for Below-The-Knee Femoral Bypass Surgery.

BACKGROUND: Heparin-bonded expanded polytetrafluoroethylene (hb-ePTFE) synthetic grafts are an alternative to autologous vein grafts (AVG) for surgical bypass interventions in lower limb peripheral arterial disease (LLPAD). However, the clinical benefits of hb-ePTFE grafts have not been reviewed systematically for patients undergoing below-the-knee (BK) surgical bypass. This study aimed to meta-analyze available data on the utility of hb-ePTFE in patients undergoing BK surgical bypass. METHODS: Medline, Embase, and Cochrane databases were searched, restricted to material in English with no date restriction. In addition, proceedings from relevant congresses were screened going back 2 years. The search was performed in December 2021. Eligible studies included prospective or retrospective comparative studies or prospective single-arm cohorts with an hb-ePTFE arm. Methodological quality was assessed with the ROBINS-I criteria. Outcomes included primary patency, amputation/limb salvage, and overall survival. Clinical outcomes were expressed as event rates. Studies were compared using meta-analysis to generate a standardized mean event rate for each outcome, with its 95% confidence interval (95% CI), using a random-effects model. RESULTS: Following deduplication, 10,263 records were identified and 261 were assessed as full texts. No prospective comparative studies were identified. The level of evidence was uniformly low. Seventeen publications describing data from 9 individual patient cohorts met the inclusion criteria. These cohorts included a total of 1,452 patients undergoing BK surgical bypass with hb-ePTFE. The primary patency rate was 78.9% [95% CI: 72.2-85.7%] at 1 year, 68.2% [95% CI: 62.8-73.6%] at 2 years, decreasing to 48.0% [95% CI: 27.3-68.7%] at 5 years. The secondary patency rate was 84.8% [95% CI: 77.0-92.5%] at 1 year and 68.9% [95% CI: 43.0-94.9%] at 3 years; the 1-year limb salvage rate was 88.3% [95% CI: 79.6-97.1%] at 1 year and 79.0% [95% CI: 56.7-100%] at 3 years. CONCLUSIONS: In patients undergoing BK bypass surgery, hb-ePTFE synthetic grafts, compared to uncoated grafts, perform well for patency and limb salvage. However, the quality of the evidence is low, and well-performed randomized clinical trials are needed to inform clinical decision-making on the choice of synthetic graft.

Glycemic Variability as a Predictor of Graft Failure Following Infrainguinal Bypass for Peripheral Arterial Disease: A Retrospective Cohort Study.

BACKGROUND: Glycemic variability (GV), measured as the change in visit-to-visit glycated hemoglobin (HbA1c), increases the risk of multiple adverse outcomes. However, the impact of GV on graft patency following infrainguinal bypass (IIB) is unknown. A retrospective cohort study was undertaken to assess the impact of GV on graft patency. METHODS: A 3-year single-center retrospective case notes analysis of all people undergoing IIB between 2017 and 2019. Rutherford stage, graft conduit, level of bypass, procedure details, baseline demographics, comorbidities, and GV were assessed. Time to reintervention, ipsilateral amputation, or death was recorded to determine primary patency (PP). RESULTS: One hundred six IIB outcomes were analyzed: mean (± standard deviation) age 68.0 (9.2) years; 69 (65.1%) male, 37 (33.9%), 75 (70.8%) had diabetes mellitus; and 46 (43.4%) underwent elective procedures. GV > 9.1% was associated with significantly lower median PP than GV < 9.1%, 198 (97-753.5) vs. 713 (166.5-1,044.5) days (P = 0.045). On univariate analysis, GV > 9.1% vs. < 9.1% was significantly associated with PP (hazard ratio [HR] 1.85 [confidence interval {CI} 1.091-3.136], P = 0.022). Bypass level was also a univariate predictor, with below knee bypasses (HR 2.31 [CI 1.164-4.564], P = 0.017), and tibial (HR 2.00 [CI 1.022-3.090], P < 0.043) having lower PP than above knee bypasses. On multivariate adjustment, GV > 9.1% and level of bypass remained independent predictors of PP, HR 1.96 (95% CI: 1.12-3.42, P = 0.018) and HR 2.54 (95% CI: 1.24-5.22, P = 0.011), respectively. CONCLUSIONS: GV is an independent predictor of PP following infrainguinal bypass, thus optimizing GV should be a therapeutic target.

Rejoining Veins for Forced Maturation of Small-Caliber Arteriovenous Fistula.

BACKGROUND: To evaluate the efficacy of rejoining mainstream and accessory veins for forced maturation of autogenous arteriovenous fistula (AVF). METHODS: Twenty-three patients who underwent forced maturation through vein rejoining between January 2018 and September 2022 were included. In cases where AVF maturation failure due to the presence of accessory veins, rejoining was primarily considered when distinguishing the main branch becomes challenging. This difficulty typically occurs when the sizes of the 2 vessels are nearly equal and the combined diameters of these veins exceed 6 mm. RESULTS: The mean age and follow-up duration were 57.39 ± 16.22 years and 965.65 ± 573.42 days, respectively. Rejoining of both arterial and venous cannulation sites was performed in 11 patients (47.8%), and rejoining of only the venous cannulation site or only the arterial cannulation site was performed in 11 patients (47.8%) and 1 patient (4.3%), respectively. The mean vein size was 0.35 ± 0.06 cm before rejoining and 0.69 ± 0.07 cm after surgery, indicating a significant increase in size (P < 0.01), whereas the flow did not change significantly following rejoining surgery. Maturation and cannulation success was 100%. The 1-year primary patency rate after surgery was 82.0%. During the follow-up period, 34.8% of the patients required additional percutaneous transluminal angioplasty to maintain patency, and 2 patients (11.8%) had stenosis in the rejoined section. CONCLUSIONS: Rejoining surgery is an effective method for achieving AVF maturation in patients with accessory veins when identification of the mainstream vein is difficult, and this method may be considered when achieving maturation by sacrificing 1 vein is expected to be challenging.

Hemodynamics and Wall Mechanics of Vascular Graft Failure.

Blood vessels are subjected to complex biomechanical loads, primarily from pressure-driven blood flow. Abnormal loading associated with vascular grafts, arising from altered hemodynamics or wall mechanics, can cause acute and progressive vascular failure and end-organ dysfunction. Perturbations to mechanobiological stimuli experienced by vascular cells contribute to remodeling of the vascular wall via activation of mechanosensitive signaling pathways and subsequent changes in gene expression and associated turnover of cells and extracellular matrix. In this review, we outline experimental and computational tools used to quantify metrics of biomechanical loading in vascular grafts and highlight those that show potential in predicting graft failure for diverse disease contexts. We include metrics derived from both fluid and solid mechanics that drive feedback loops between mechanobiological processes and changes in the biomechanical state that govern the natural history of vascular grafts. As illustrative examples, we consider application-specific coronary artery bypass grafts, peripheral vascular grafts, and tissue-engineered vascular grafts for congenital heart surgery as each of these involves unique circulatory environments, loading magnitudes, and graft materials.

Autologous Alternative Vein Grafts for Infrainguinal Bypass in the Absence of Single-Segment Great Saphenous Vein: A Single-Center Study.

BACKGROUND: Alternative autologous veins can be used as a conduit when adequate great saphenous vein is unavailable. We analyzed the results of our infrainguinal bypasses after adopting upper extremity veins in our practice. METHODS: This is a single-center observational study involving all patients whose infrainguinal bypass involved the use of upper extremity veins between April 2019, when we began using arm veins, and February 2023. RESULTS: During the study period, 49 bypasses were done in 48 patients; mean age 68.1 ± 9.8; men 32 (66.7%); body mass index 28.0 ± 4.8; indications for surgery: chronic limb threatening ischemia 41 (83.7%); acute limb ischemia 3 (6.1%); complications of previous prosthetic 3 (6.1%), or autologous 2 (4.1%) bypass grafts. Vein splicing was used in 43 (87.8%) bypasses with 3-segment grafts being the most common (26; 53.1%). There were 24 (49.0%) femorotibial, 11 (22.4%) femoropopliteal, 9 (18.4%) femoropedal, and 5 (10.2%) extension jump bypass procedures. Eighteen (36.7%) operations were redo surgeries. Twenty-one (42.9%) bypasses were formed using only arm veins. The median follow-up was 12.9 months (4.5-24.2). Two bypasses occluded during the first 30 postoperative days (2/49; 4.1%). Overall 30-day, 1-year, and 2-year primary patency rates were 93.7% ± 3.5%, 84.8% ± 5.9%, and 80.6% ± 6.9%, and secondary patency (SP) rates were 95.8% ± 2.9%, 89.2% ± 5.3%, and 89.2% ± 5.3%. One-segment grafts had better patencies than 2-, 3-, and 4-segment grafts (1-year SP 100% ± 0% vs 87.6% ± 6.0%). Two-year amputation-free survival was 86.8% ± 6.5%; 2-year overall survival was 88.2% ± 6.6%. CONCLUSIONS: Integration of arm vein grafts in infrainguinal bypass practice can be done safely with low incidences of perioperative graft failure. One-segment grafts had better patencies than spliced vein grafts. The achieved early patency and amputation-free survival rates strongly encourage their use. In the absence of a single-segment great saphenous vein, upper extremity vein grafts should be the preferred conduit choice.

Comparison of Clinical Effectiveness and Safety of Drug-Coated Balloons versus Percutaneous Transluminal Angioplasty in Arteriovenous Fistulae: A Review of Systematic Reviews and Updated Meta-Analysis.

PURPOSE: To evaluate the clinical effectiveness and safety of drug-coated balloons (DCBs) compared with those of percutaneous transluminal angioplasty (PTA) for arteriovenous fistula (AVF) stenosis via a review of systematic reviews (SRs) and an update of the current meta-analysis. MATERIALS AND METHODS: Literature was searched to retrieve SRs comparing DCBs and PTA for AVFs. A narrative review of SRs and pooled analysis were performed. RESULTS: Eleven SRs were included. DCBs demonstrated favorable outcomes at 6 and 12 months compared with PTA, with improved patency in 7 SRs and a trend toward favorable outcomes without statistical significance in 3 SRs. Target lesion revascularization (TLR) was reported in 3 SRs; 2 reviews reported a significantly lower incidence in the DCB group than in the PTA group, whereas 1 review reported no significant differences at 12 months. Four studies reporting all-cause mortality revealed no significant difference between the 2 treatments. In the updated meta-analysis including 23 studies, DCBs demonstrated improved primary patency at 6 months (risk ratio [RR], 1.27; 95% CI, 1.07-1.50) and 12 months (RR, 1.36; 95% CI, 1.19-1.55) and were associated with a lower incidence of TLR at 6 months (RR, 0.54; 95% CI, 0.41-0.73) and 12 months (RR, 0.78; 95% CI, 0.62-0.99). There was no difference in mortality between the 2 groups for 24 months. CONCLUSIONS: A review of SRs and meta-analysis update revealed the consistent benefits of DCBs over PTA in treating AVFs in terms of primary patency and TLR. Compared with PTA, DCBs do not increase mortality risk.

Comparison between the 0- and 30-s balloon dilation time in percutaneous transluminal angioplasty for restenosed arteriovenous fistula among hemodialysis patients: a multicenter, prospective, randomized trial (CARP study).

BACKGROUND: This study aims to compare patency rates of the 0- and 30-s (sec) balloon dilation time in hemodialysis (HD) patients with restenosis after percutaneous transluminal angioplasty (PTA). METHODS: The patients who underwent PTA within 6 months for failed arteriovenous fistula at the forearm were randomly assigned the 0-s or 30-s dilation time group. Effect of dilation time on the 3- and 6-month patency rates after PTA was examined. RESULTS: Fifty patients were enrolled in this study. The 3-month patency rate in the 30-s dilation group was better than that in the 0-s dilation group (P = 0.0050), while the 6-month patency rates did not show a significant difference between the two groups (P = 0.28). Cox's proportional hazard model revealed that 30-s of inflation time (hazard ratio 0.027; P = 0.0072), diameter of the proximal (hazard ratio 0.32; P = 0.031), and dilation pressure (hazard ratio 0.63; P = 0.014) were associated with better 3-month patency. Dilation pressure between previous and present PTA did not differ in the 0-s (P = 0.15) and 30-s dilation groups (P = 0.16). The 6-month patency rate of the present PTA in the 30-s dilation group was higher than that of the previous PTA (P = 0.015). The visual analog scale did not differ between the two groups (P = 0.51). CONCLUSION: The presenting data suggest that 30-s dilation potentially results in a better 3-month patency rate than 0-s dilation in HD patients with restenosis after PTA.

Arteriovenous Fistula Maturation in Patients with Ipsilateral Versus Contralateral Tunneled Dialysis Catheter: A Systematic Review and Meta-analysis.

BACKGROUND: Although it is evident that a prior history of tunneled dialysis catheter (TDC) affects arteriovenous fistula (AVF) function, it is unclear whether its location (contralateral versus ipsilateral to AVF) has any effect on AVF maturation and failure rates. We aimed to document this possible effect. METHODS: This systematic review and meta-analysis were performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies comparing outcomes between patients with contralateral TDC (CONTRA group) and those with ipsilateral one (IPSI group) were examined for inclusion. A random effects model meta-analysis of the odds ratio (OR) was conducted. Primary outcomes were AVF functional maturation, assisted maturation, and failure rates. RESULTS: Four eligible studies comprising 763 patients were included in the meta-analysis. There were no significant differences in terms of AVF functional maturation (OR: 1.49; 95% confidence interval [CI]: 0.64-3.47; I2 = 83.4%), assisted maturation (OR: 0.59; 95% CI: 0.29-1.19; I2 = 61.4%), and failure rates (OR: 0.67; 95% CI: 0.29-1.58; I2 = 83.3%) between the 2 study groups. CONCLUSIONS: TDC laterality seems not to affect fistula maturation rate in patients requiring TDC placement and concurrent AVF creation, but rather, vein- and patient-related characteristics might play a more important role in choosing TDC access site. Further studies are needed to validate these results.

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.

Two-Year Cumulative and Functional Patency after Creation of Endovascular Arteriovenous Hemodialysis Fistulae.

PURPOSE: To assess 2-year cumulative and functional patency of endovascular arteriovenous fistulae (endoAVF) created with the WavelinQ device. MATERIALS AND METHODS: Patients who had fistulae created at a single center from December 2019 to December 2020 were included in this retrospective study. Forty-three patients underwent endoAVF creation (22 females, 21 males). Data collected included patient demographics, location of fistula creation, interventions performed, and brachial artery flow before and after creation. Two-year cumulative and functional patency rates were assessed with Kaplan-Meier method, and variables that affected patency and maturation were examined using Cox proportional hazards model. RESULTS: Technical success was 95% (41/43), and in 4 patients, the fistula did not mature for dialysis use (9.7%). For the remaining 37 patients with endoAVF maturation, 25 had ulnar-ulnar fistulae, 10 had radial-radial fistulae, and 2 had interosseous artery-vein fistulae. Mean maturity time was 73 days, and brachial artery flow of >886 mL/min was predictive of maturation. Mean tunneled dialysis catheter removal time was 133 days. Number of interventions per patient-year was 0.38, where 8 were maturation procedures (5 vein elevations/transpositions and 3 coil embolizations) and 21 were maintenance angioplasties. Two-year cumulative/secondary and functional patency rates were 89.4% and 92.1%, respectively, with a mean follow-up of 665.7 days. Examined variables did not impact cumulative or functional patency. One adverse event was migration of coil to the heart, which was successfully retrieved at time of procedure. CONCLUSIONS: Two-year patency of 89.4% and functional patency of 92.1% were observed after endoAVF creation with WavelinQ device.

Influence of lipoproteins and antiplatelet agents on vein graft patency 1 year after coronary artery bypass grafting.

OBJECTIVE: It remains unclear whether aggressive low-density lipoprotein cholesterol (LDL-C) management (<1.8 mmol/L) can slow the process of vein graft stenosis. This study aimed to explore the impact of baseline LDL-C levels on vein graft patency in patients on ticagrelor with or without aspirin 1 year after coronary artery bypass grafting (CABG). METHODS: This was a post hoc analysis of the DACAB (Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery) trial (NCT02201771), a randomized controlled trial (ticagrelor + aspirin or ticagrelor vs aspirin) of patients undergoing CABG in China. The study subjects were stratified as LDL-low (baseline LDL-C <1.8 mmol/L, 148 patients with 430 vein grafts) versus LDL-high (baseline LDL-C ≥1.8 mmol/L, 352 patients with 1030 vein grafts). The primary outcome was the 1-year vein graft patency (Fitzgibbon grade A) assessed by coronary computed tomographic angiography or coronary angiography. RESULTS: Baseline/1-year LDL-C were 1.4/1.6 and 2.6/2.4 mmol/L in the LDL-low and LDL-high subgroups, respectively. Regardless of antiplatelet regimen, no significant inter-subgroup difference was observed for 1-year graft patency (LDL-low: 83.8% [359/430 grafts]; LDL-high: 82.3% [848/1030 grafts]; adjusted OR for non-patency [ORadj], 0.96; 95% confidence interval [CI], 0.62-1.50, P = .857). For both subgroups, the 1-year graft patency rates were greater with ticagrelor + aspirin versus aspirin (LDL-low: ORadj, 0.41; 95% CI, 0.17-0.97; LDL-high: ORadj, 0.38; 95% CI, 0.20-0.71; inter P = .679). CONCLUSIONS: In general, baseline LDL-C is not associated with 1-year vein graft patency after CABG. Regardless of the baseline LDL-C levels, ticagrelor + aspirin was superior to aspirin alone in maintaining vein graft patency. The primary factor causing early vein graft disease might not be atherosclerosis but thrombosis.

The predictive value of microperfusion assessments for the follow-up of tibial bypass grafts.

OBJECTIVE: We conducted a prospective evaluation of microperfusion parameters after tibial bypass surgery was performed. Differences between grafts with occlusions during follow-up and patent grafts were analyzed in relation to the pedal arch quality. METHODS: Patients receiving tibial bypass grafts for chronic limb-threatening ischemia from 2019 to 2020 were included. Assessment of microcirculation (parameters: hemoglobin oxygen saturation [sO2] and flow) was done by laser Doppler flowmetry and white light spectrometry (oxygen-to-see), supine and in elevation, whereas the macrocirculation was evaluated by the ankle-brachial index and duplex ultrasound examination. The quality of run-off was graded for each patient. Measurements were performed preoperatively, 1 day postoperatively, and after 6 months. Patients with graft occlusions during follow-up (OCCLUDED) and patients without occlusions (OPEN) were compared. RESULTS: We included 42 patients (13 women, 29 men; mean age, 76.1 years; range, 60-89 years) were included. The patency of all grafts 1 day after the operation was confirmed by ultrasound examination. The overall analysis of the microcirculation showed significant changes in both the supine and elevated leg position between measurements taken preoperatively, 1 day after the operation, and after 6 months for the parameters sO2 and FLOW (sO2 supine, P = .001; sO2 elevated, P < .001; FLOW supine, P < .001; FLOW elevated, P < .001). The comparison of the values 1 day after the operation yielded significantly decreased microperfusion parameters (both O2 and FLOW) in the group that developed bypass occlusion in the later follow-up period (sO2 supine: OCCLUDED, 35.7% [7.3-65.0] and OPEN, 48.7% [25.0-72.3] P = .011; FLOW supine: OCCLUDED, 27.7 A.U. [12.7-52.7] and OPEN, 57.3 A.U. [16.0-106.7], P = .008). No significant differences in the severity of the arch impairment was found between the OPEN and OCCLUDED groups (P = .651). Absolute values of the parameters sO2 and flow showed no correlation with the pedal arch classification. CONCLUSIONS: Significantly poorer microperfusion was detected postoperatively in patients with later occurrence of graft occlusions despite patent grafts on the first postoperative day. Microperfusion measurements might be a possible tool for the prediction of graft failure.

Early Graft, Limb and Mortality Outcomes from the Omniflow II Bio-Synthetic Graft.

BACKGROUND: Omniflow II biosynthetic grafts are a commonly used alternative to autologous grafts in vascular bypass procedures. They are chosen for their purported resilience to infection, often in instances of existing graft failure or infection. We examined the short term, 1-3 year outcomes of Omniflow grafts in terms of patency, limb survival and mortality in a sample of 24 individuals. METHODS: This is a single centred retrospective study of Omniflow II grafts implanted between September 23, 2015 and April 05, 2018 in our department. It includes grafts in all anatomical locations. Primary outcome measures were overall patient survival and time to this, primary graft patency (patency with no intervention) and then limb survival at 1 and 3 years. Kaplan-Meier survival analysis was plotted for the 3 primary outcome measures. RESULTS: A total of 24 grafts from 24 individuals were included with mean age 71.4 ± 11.7. We included 5 female and 19 male patients. The commonest indication was rest pain/claudication (N = 8) followed by graft occlusion (N = 6). Femoro-popliteal bypass (N = 13) and Femoro-distal bypass (N = 5) were the commonest procedures. Kaplan-Meier survival analysis demonstrated that 1 and 3-year primary patency rates were 54.2% and 37.5% respectively with Limb survival probability of 75% at 1 year and 70.8% at 3 years. These rates were all considerably lower than those found in previous comparative studies. Mortality however, compared favourably with 1 and 3-year survival probability 91.7% and 87.5% on average 296 days (range 95-451 days) after graft implantation. CONCLUSIONS: We found that rates of primary patency and limb salvage for this graft type were markedly lower than in comparable studies. Further work in the form of a RCT is indicated.

Evaluation of Long-Term Outcomes of Femoropopliteal Bypass Surgery in Patients With Chronic Limb-Threatening Ischemia in an Endovascular Era.

BACKGROUND: To investigate the long-term outcomes of femoropopliteal bypass surgery in patients with chronic limb-threatening ischemia (CLTI) and TransAtlantic Inter-Society Consensus II (TASC II), type D (TASC D) femoropopliteal disease. METHODS: A retrospective analysis was performed for all consecutive patients undergoing above-knee (AK) femoropopliteal bypass surgery at an academic vascular centre between January 2007 and March 2019. Patients with claudication (IC) and patients with CLTI were included. Patency rates and freedom from major adverse limb events (MALE) after 5 years were analysed. RESULTS: In total, 432 femoropopliteal grafts were performed. Indications for surgery were claudication and CLTI in 232 (53.7%) and 200 (46.3%) patients, respectively. Graft material was autologous vein in 186 patients (43.1%), polytetrafluoroethylene (PTFE) in 128 patients (29.6%), and heparin-bonded expanded polytetrafluoroethylene (HePTFE) in 118 patients (27.3%). At the 5-year follow-up, the primary patency rate was 58.1% and 58.3% in patients with CLTI and claudication, respectively. Secondary patency rates were 74.1% and 68.6%, respectively. Freedom from MALE was 64.5% and 61.9%, respectively. Analyses of graft material in the CLTI group showed that, at 5 years, autologous vein grafts had better long-term patency rates than PTFE and HePTFE grafts. At 5 years, the primary and secondary patency rate for autologous vein grafts were 63.2% (P= 0.324) and 83.2% (P = 0.020), respectively. Freedom from MALE was 72.0% with the use of autologous vein grafts, 47.9% using PTFE and, 52.9% using HePTFE, respectively (P= 0.021). CONCLUSIONS: Our study shows that femoropopliteal bypass surgery in patients with TASC D lesions is safe and effective in the long term. Autologous vein grafts remain the first choice for patients with CLTI, also for bypasses in AK position. However, prosthetic grafts in AK the position are an acceptable alternative for revascularisation when the saphenous vein is not available.

Medical Adjuvant Therapy in Reducing Thrombosis With Arteriovenous Grafts and Fistulae Use: A Meta-Analysis of Randomized Controlled Trials.

Hemodialysis is required for patients with end-stage renal disease (ESRD) that require arteriovenous (AV) grafts or fistulas for vascular access. These access points are prone to thrombosis. To determine the effect of medical adjuvant therapy on AV graft/fistula patency among patients with ESRD on hemodialysis. Adhering to the PRISMA 2020 statement, a systematic search was conducted until August 20, 2021, with keywords including arteriovenous graft, fistula, patency, thrombosis, hemodialysis, adjuvant treatment. The following databases were searched: PubMed, Scopus, Web of Science, CINAHL Plus, and Cochrane. A random-effects model was employed using Review Manager 5.4 for data analysis. The meta-analysis pooled in 1985 participants with 1000 (50.4%) in the medical adjuvant treatment group. At a snapshot, medical adjuvant therapy reduced the risk for graft thrombosis (RR = 0.64, P = .02). Notable medications included aspirin for graft thrombosis (RR = 0.36, P = .006) and ticlopidine for fistula thrombosis (RR = 0.53, P = .01). Certain antiplatelet therapies (aspirin and ticlopidine) reduced the number of patients with AV fistula/graft thrombosis among patients with high heterogeneity among the trials. Other therapies (fish oil, sulfinpyrazone, clopidogrel, and aspirin/dipyridamole) did not demonstrate significant improvement but may be promising once concrete evidence is available. Potential benefits of anti-platelet therapies may be explored to maintain the potency of AV grafts/fistulas through well-designed placebo-controlled trials and long-term follow-up.

Drug Coated Balloons for Dysfunctional Haemodialysis Venous Access: A Patient Level Meta-Analysis of Randomised Controlled Trials.

OBJECTIVE: To perform an individual patient data level meta-analysis of randomised controlled trials comparing drug coated balloon angioplasty (DCB) against conventional percutaneous transluminal angioplasty (PTA) in the treatment of dysfunctional haemodialysis venous access. METHODS: A search was conducted from inception to 13 November 2020. Kaplan-Meier curves comparing DCB with PTA by target lesion primary patency (TLPP) and access circuit primary patency (ACPP) were graphically reconstructed to retrieve patient level data. One stage meta-analyses with Cox models with random effects shared frailties were conducted to determine hazard ratios (HRs). Dynamic restricted mean survival times (RMST) were conducted in view of violation of the proportional hazards assumption. Conventional two stage meta-analyses and network meta-analyses under random effects Frequentist models were conducted to determine overall and comparative outcomes of paclitaxel concentrations used. Where outliers were consistently detected through outlier and influence analyses, sensitivity analyses excluding those studies were conducted. RESULTS: Among 10 RCTs (1 207 patients), HRs across all models favoured DCB (one stage shared frailty HR 0.62, 95% CI 0.53 - 0.73, p < .001; two stage random effects HR 0.60, 95% CI 0.42 - 0.86, p = .018, I2 = 65%) for TLPP. Evidence of time varying effects (p = .005) was found. TLPP RMST was + 3.54 months (25.0%) longer in DCB treated patients compared with PTA (p = .001) at three years. TLPP at six months, one year, and two years was 75.3% vs. 58.1%, 51.1% vs. 37.1%, and 31.4% vs. 26.0% for DCB and PTA, respectively. The P-Scores within the Frequentist network meta-analysis suggest that higher concentrations of paclitaxel were associated with better TLPP and ACPP. Among six RCTs (854 patients), the one stage model favoured DCB (shared frailty HR 0.72, 95% CI 0.60 - 0.87, p < .001) for ACPP. Conversely, the two stage random effects model demonstrated no significant difference (HR 0.76, 95% CI 0.35 - 1.67, p = .41, I2 = 81%). Sensitivity analysis excluding outliers significantly favoured DCB (HR 0.61, 95% CI 0.41 - 0.91, p = .027, I2 = 62%). CONCLUSION: Overall evidence suggests that DCB is favoured over PTA in TLPP and ACPP.

Editor's Choice - Paclitaxel Coated Balloon Angioplasty vs. Plain Balloon Angioplasty for Haemodialysis Arteriovenous Access Stenosis: A Systematic Review and a Time to Event Meta-Analysis of Randomised Controlled Trials.

OBJECTIVE: A systematic review and meta-analysis of randomised controlled trials (RCTs) was performed to determine the effectiveness and safety of drug coated balloon (DCB) angioplasty compared with uncoated plain balloon (PB) angioplasty in treating arteriovenous access stenosis. METHODS: MEDLINE, Embase, Scopus, and the Cochrane Central Register of Controlled Trials were searched for RCTs comparing paclitaxel coated DCB and PB angioplasty for arteriovenous access stenosis. The last date of the literature search was 31 December 2020. Risk of bias of the retrieved studies was assessed with the Cochrane Collaboration tool for assessing risk of bias (RoB 2.0). The random effects model was used to estimate the risk of loss of target lesion patency (six and 12 months) and circuit patency (six and 12 months). Procedure related adverse events and mortality rate were also compared. Patency results were pooled using the time to event meta-analytical method and the quality of evidence was assessed according to the GRADE approach. RESULTS: Sixteen eligible trials, including 1 682 lesions, were included in the quantitative analysis for the efficacy and safety of paclitaxel coated DCBs. DCBs were associated with a lower risk of loss of target lesion patency at six months (HR 0.53, 95% CI 0.42 - 0.66) and 12 months (HR 0.60, 95% CI 0.47 - 0.76), and were also associated with improved six and 12 month circuit patency. Overall quality of evidence was moderate to low. Procedural complications were rare, and the risk of death up to 12 months was similar between the two groups (OR 1.03, 95% CI 0.68 - 1.56). CONCLUSION: Paclitaxel coated DCBs reduced the risk of loss of target lesion patency and circuit patency in arteriovenous access stenosis compared with PBs. Considering the heterogeneity of the included trials, there is a need to investigate optimal treatment regimens regarding drug dose and agent of the DCB and the treatment procedure.