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Background Chronic limb-threatening ischaemia with ischaemic pain and/or tissue loss. Objective To examine the clinical and cost-effectiveness of a vein bypass-first compared to a best endovascular treatment-first revascularisation strategy in preventing major amputation or death. Design Superiority, open, pragmatic, multicentre, phase III randomised trial. Setting Thirty-nine vascular surgery units in the United Kingdom, and one each in Sweden and Denmark. Participants Patients with chronic limb-threatening ischaemia due to atherosclerotic peripheral arterial disease who required an infra-popliteal revascularisation, with or without an additional more proximal infra-inguinal revascularisation procedure, to restore limb perfusion. Interventions A vein bypass-first or a best endovascular treatment-first infra-popliteal, with or without an additional more proximal infra-inguinal revascularisation strategy. Main outcome measures The primary outcome was amputation-free survival. Secondary outcomes included overall survival, major amputation, further revascularisation interventions, major adverse limb event, health-related quality of life and serious adverse events. Methods Participants were randomised to a vein bypass-first or a best endovascular treatment-first revascularisation strategy. The original sample size of 600 participants (247 events) was based on a hazard ratio of 0.66 with amputation-free survival rates of 0.72, 0.62, 0.53, 0.47 and 0.35 in years 1–5 in the best endovascular treatment-first group with 90% power and alpha at p = 0.05. The sample size was revised to an event-based approach as a result of increased follow-up time due to slower than anticipated recruitment rates. Participants were followed up for a minimum of 2 years. A cost-effectiveness analysis was employed to estimate differences in total hospital costs and amputation-free survival between the groups. Additionally, a cost–utility analysis was carried out and the total cost and quality-adjusted life-years, 2 and 3 years after randomisation were used. Results Between 22 July 2014 and 30 November 2020, 345 participants were randomised, 172 to vein bypass-first and 173 to best endovascular treatment-first. Non-amputation-free survival occurred in 108 (63%) of 172 patients in the vein bypass-first group and 92 (53%) of 173 patients in the best endovascular treatment-first group [adjusted hazard ratio 1.35 (95% confidence interval 1.02 to 1.80); p = 0.037]. Ninety-one (53%) of 172 patients in the vein bypass-first group and 77 (45%) of 173 patients in the best endovascular treatment-first group died [adjusted hazard ratio 1.37 (95% confidence interval 1.00 to 1.87)]. Over follow-up, the economic evaluation discounted results showed that best endovascular treatment-first was associated with £1690 less hospital costs compared to vein bypass-first. The cost utility analysis showed that compared to vein bypass-first, best endovascular treatment-first was associated with £224 and £2233 less discounted hospital costs and 0.016 and 0.085 discounted quality-adjusted life-year gain after 2 and 3 years from randomisation. Limitations Recruiting patients to the Bypass versus Angioplasty in Severe Ischaemia of the Leg Trial-2 trial was difficult and the target number of events was not achieved. Conclusions A best endovascular treatment-first revascularisation strategy was associated with better amputation-free survival, which was largely driven by fewer deaths. Overall, the economic evaluation results suggest that best endovascular treatment-first dominates vein bypass-first in the cost-effectiveness analysis and cost–utility analysis as it was less costly and more effective than a vein bypass-first strategy. Future work The Bypass versus Angioplasty in Severe Ischaemia of the Leg Trial-2 investigators have a data sharing agreement with the BEst Surgical Therapy in patients with Chronic Limb threatening Ischaemia investigators. One output of this collaboration will be an individual patient data meta-analysis. Study registration Current Controlled Trials ISRCTN27728689. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 12/35/45) and is published in full in Health Technology Assessment; Vol. 28, No. 65. See the NIHR Funding and Awards website for further award information. Plain language summary Atherosclerosis, or narrowing of the arteries, can occur as a result of smoking, high blood pressure, diabetes, or high cholesterol in the blood. Atherosclerosis can affect any artery, including those supplying the legs, where the condition is called peripheral arterial disease. The most severe form of peripheral arterial disease is chronic limb-threatening ischaemia which can cause severe pain in the foot as well as ulcers and gangrene. Unless the blood supply to the leg and foot is improved, by a process called revascularisation, people with chronic limb-threatening ischaemia are at high risk of amputation and death. The blood supply can be improved by using a vein from the leg to bypass around the blockages (vein bypass) or by using a balloon (angioplasty) or small metal tubes (stents) to reopen the blocked arteries (best endovascular treatment). There is debate about which type of revascularisation is best in terms of preventing amputation and death, especially in people who need revascularisation of the arteries below the knee. Bypass versus Angioplasty in Severe Ischaemia of the Leg Trial-2 is the first randomised controlled trial to compare vein bypass-first and best endovascular treatment-first in this group of patients. Bypass versus Angioplasty in Severe Ischaemia of the Leg Trial-2 found that people randomised to a vein bypass-first revascularisation strategy were 35% more likely to require a major amputation or die than those randomised to a best endovascular treatment-first strategy. Most of this difference in favour of best endovascular treatment-first was due to a higher number of patients dying in the vein bypass-first group. Best endovascular treatment-first was also cheaper for the National Health Service. The results of this study suggest that in patients with chronic limb-threatening ischaemia due to peripheral arterial disease in the arteries below the knee, who are suitable for both vein bypass and best endovascular treatment and where there is uncertainty as to which is best, best endovascular treatment should be offered first rather than vein bypass. Scientific summary Background Chronic limb-threatening ischaemia (CLTI) is the severest manifestation of peripheral arterial disease (PAD) and presents with ischaemic pain at rest or tissue loss (ulceration, gangrene or both) or both. The researchers compared the effectiveness of a vein bypass (VB)-first with a best endovascular treatment (BET)-first revascularisation strategy in terms of preventing major amputation and death in patients with CLTI who required an infra-popliteal (IP) revascularisation, with or without an additional more proximal infra-inguinal revascularisation procedure, to restore limb perfusion. Objectives The primary objective of the study was to examine the effectiveness and cost-effectiveness of using a VB-first compared to a BET-first revascularisation strategy in terms of preventing major (above the ankle) amputation or death from any cause [amputation-free survival (AFS)] in patients with CLTI who required an IP, with or without an additional more proximal infra-inguinal revascularisation procedure, to restore limb perfusion. Design Superiority, open-label, pragmatic, multicentre, phase III randomised trial. Setting Thirty-nine vascular surgery units in the United Kingdom, and one each in Sweden and Denmark. Participants Those with CLTI due to atherosclerotic PAD and who required an IP revascularisation, with or without an additional more proximal infra-inguinal revascularisation procedure, to restore limb perfusion. Interventions A VB-first or a BET-first IP, with or without an additional more proximal infra-inguinal revascularisation strategy, to restore limb perfusion. Most VBs were constructed with great saphenous vein and originated from the common or superficial femoral arteries. Most endovascular interventions comprised plain balloon angioplasty with selective use of plain or drug-eluting stents. Outcome measures The primary outcome was AFS defined as time to first major (above the ankle) amputation or death from any cause. Secondary outcomes included: time to death from any cause (overall survival); time to major amputation of the trial leg; major adverse limb event (defined as major amputation of the trial leg, or any further major revascularisation intervention to the trial leg, following the first revascularisation intervention); major adverse cardiac event (defined as chronic limb-threatening ischaemia and/or major amputation affecting the non-trial leg, myocardial infarction, transient ischaemic attack or stroke); 30-day morbidity and mortality; relief of ischaemic pain as determined by visual analogue scale and opiate usage; health- related quality of life using generic [EuroQol-5 Dimensions, five-level version (EQ-5D-5L), Short Form questionnaire-12 items, ICEpop CAPability measure for Older people] and disease-specific (the Vascular Quality of Life Questionnaire) tools; further major revascularisation intervention to the trial leg (following the first revascularisation intervention); re-intervention and crossover intervention (where re-intervention is defined as the same, and a crossover procedure is defined as an alternative, revascularisation procedure to the first revascularisation procedure post-randomisation); healing of tissue loss (ulcers, gangrene) at or below the ankle presumed to be caused by PAD as assessed by the perfusion, extent, depth, infection and sensation score, the Wound Ischaemia and foot Infection tool; and haemodynamic measurements (ankle–brachial pressure index, and toe brachial pressure index). Serious adverse events were collected up to 30 days post first revascularisation. Economic evaluation analyses in the form of cost-effectiveness and cost–utility analysis (CUA) were conducted from the perspective of the UK NHS alongside the trial. The base case analyses considered only hospital costs and an additional scenario and subgroup analyses were carried out. Sample size The original sample size was based on a time-to-event analysis to be undertaken 2 years after completion of recruitment. It was anticipated that recruitment would take place over 3 years: 20% of patients recruited in year 1, 40% in year 2 and 40% in year 3. Based on the Bypass versus Angioplasty in Severe Ischaemia of the Leg Trial (BASIL-1) trial. AFS rates were assumed to be 0.72 in year 1, 0.62 in year 2, 0.53 in year 3, 0.47 in year 4 and 0.35 in year 5. Allowing for a 10% attrition rate and based on the survival estimates calculated using the BASIL-1 data, a population of 600 participants (247 primary outcome events) would have 90% power to detect a reduction in AFS of one-third [hazard ratio (HR) 0.66] at the 5% significance level. The initial assumptions made in this trial concerning recruitment rates were not achieved; therefore, recruitment continued beyond year 3. As a result, the median length of follow-up was longer than originally planned. Therefore, the number of randomised participants required to observe 247 events (as per the original sample size target) was reduced due to the increased exposure time. With support of the funder and independent oversight from the Data Monitoring Committee, recruitment rates, length of follow-up, and pooled event rates over time were modelled to predict the number of participants needed to reach 247 events, with 24 months minimum follow-up in each participant. The modelling was updated approximately every 6 months based on emerging data. Results Between 22 July 2014 and 30 November 2020, 345 participants were randomised, 172 to the VB-first group and 173 to the BET-first group. The baseline characteristics of the two groups were similar. Major amputation or death occurred in 108 (63%) of 172 patients in the VB-first group and 92 (53%) of 173 patients in the BET-first group {adjusted HR 1.35 [95% confidence interval (CI) 1.02 to 1.80]; p = 0.037}. Ninety-one (53%) of 172 patients in the VB-first group and 77 (45%) of 173 patients in the BET-first group died [adjusted HR 1.37 (95% CI 1.00 to 1.87)]. In both groups the commonest causes of morbidity and mortality, including those occurring within 30 days of their first revascularisation, were cardiovascular and respiratory events. Over follow-up, the economic evaluation results showed that BET-first was associated with £1690 less hospital costs compared to VB-first with additional survival without amputation. The cost utility analysis showed that compared to VB-first, BET-first was associated with £2524 and £2233 less hospital costs and 0.016 and 0.085 QALY gain after 2 and 3 years from randomisation. Conclusions In the BASIL-2 trial, a BET-first revascularisation strategy was associated with a better AFS, which was largely driven by fewer deaths in the BET-first group. In both the CUA and cost-effectiveness analysis (CEA) analyses and from a NHS and societal perspective BET-first dominated VB-first and is therefore a highly cost-effective intervention for the NHS. These data suggest a greater role for BET in the management of patients with CLTI who require an IP revascularisation to restore limb perfusion. In patients with CLTI who required an IP, with or without an additional more proximal infra-inguinal revascularisation procedure, to restore limb perfusion, a BET-first revascularisation strategy was associated with reduced hospital costs (£1690) and improved AFS (0.429 years), out to 7 years following randomisation. BET-first therefore dominated VB-first in the CEA. Similarly, in the health-related quality of life the CUA, BET-first was cost-saving with improved QALYs (£2524 and £2233 less hospital costs and 0.016 and 0.085 more QALYs at 2 and 3 years, respectively) and so dominated VB-first. This economic analysis therefore shows that BET-first is a cost-effective option from an NHS and societal perspective. The sensitivity analysis supported the base-case analysis and BET-first was found to be cost-effective at different willingness-to-pay thresholds. Similar findings were found in all other scenario analyses when considering costs of primary and other hospital healthcare services, taking a broader societal perspective, which includes out-of-pocket expenditure and the costs associated with productivity loss, patient’s adherence to study protocol, the impact of imputation by focusing on participants with complete hospital cost and EQ-5D-5L data only. However, these findings should be interpreted cautiously given the large number of imputed cost values and the substantial probability of a very small QALY difference. Study registration Current Controlled Trials ISRCTN27728689. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 12/35/45) and is published in full in Health Technology Assessment; Vol. 28, No. 65. See the NIHR Funding and Awards website for further award information.

Objectives: The aim of this study was to compare technical success, patency rates and clinical outcomes of vein bypass (VBP) with angioplasty and nitinol stents (NS) in femoropopliteal Trans-Atlantic Intersociety Consensus (TASC) II C and D lesions. Summary Background Data: Guidelines widely recommend an endovas-cular-first strategy for long femoropopliteal lesions without sufficient data comparing it with vein bypass surgery. Methods: A single-center prospective, randomized controlled trial (RCT) was performed, after approval of the local ethics committee, with technical success, primary and secondary patency as primary endpoints. Secondary endpoints were limb salvage, survival, complications, and clinical improvement. Results: Between 2016 and 2020, 218 limbs (109 per group) in 209 patients were included. Baseline and lesion characteristics were similar in both groups with a mean lesion length of 268 mm. The indication for treatment was chronic limb threatening ischemia in 53% of limbs in both groups. Technical success was feasible in 88% in the stent group. During a 4-year follow-up, primary patency, freedom from target lesion revascularizations, limb salvage, survival and complications showed no significant differences between the groups. At 48 months secondary patency for the bypass group was 73% versus 50% in the stent group (P = 0.021). Clinical improvement was significantly superior in the bypass group with 52% versus 19% reaching a Rutherford 0 category (P < 0.001). Conclusions: This is the largest RCT comparing angioplasty with NS and vein bypass in femoropopliteal TASC II C and D lesions and the first to report 4-year results. The data underline the feasibility of endovascular treatment in long lesions but also emphasize the advantages of VBP. [ABSTRACT FROM AUTHOR]

Background and aim Owing to the increased risk of morbidity and mortality, the treatment of acute limb ischemia (ALI) is challenging. The authors aimed to investigate the outcomes of thrombolysis in the treatment of ALI and limb salvage. Patients and methods A retrospective observational study was conducted to revise the data of 49 patients who underwent catheter-direct thrombolysis for ALI. A total of 33 cases were at lower limb and 16 cases were at upper limb. The assessed outcomes were primary and secondary patency, survival, amputation-free survival, and conversion to surgery. Results The patients were classified according to the Rutherford classification into class I (52%), class IIa (38%), class IIb (8%), and class III (2%). The primary patency was present in 34% of the patients after the first year and 22% after the second year. On the contrary, 28% of the patients were subjected to conversion to open surgery, 8% were subjected to reintervention, and 6% were subjected to amputation within the first month. The mortality rate within 1 month was 6%. The worst primary and secondary patency rates were seen in the prosthetic grafts in addition to vein bypasses, whereas the native artery was the most successful one regarding the primary patency, secondary patency, and amputation-free survival (P

Background: Chronic limb-threatening ischaemia with ischaemic pain and/or tissue loss., Objective: To examine the clinical and cost-effectiveness of a vein bypass-first compared to a best endovascular treatment-first revascularisation strategy in preventing major amputation or death., Design: Superiority, open, pragmatic, multicentre, phase III randomised trial., Setting: Thirty-nine vascular surgery units in the United Kingdom, and one each in Sweden and Denmark., Participants: Patients with chronic limb-threatening ischaemia due to atherosclerotic peripheral arterial disease who required an infra-popliteal revascularisation, with or without an additional more proximal infra-inguinal revascularisation procedure, to restore limb perfusion., Interventions: A vein bypass-first or a best endovascular treatment-first infra-popliteal, with or without an additional more proximal infra-inguinal revascularisation strategy., Main Outcome Measures: The primary outcome was amputation-free survival. Secondary outcomes included overall survival, major amputation, further revascularisation interventions, major adverse limb event, health-related quality of life and serious adverse events., Methods: Participants were randomised to a vein bypass-first or a best endovascular treatment-first revascularisation strategy. The original sample size of 600 participants (247 events) was based on a hazard ratio of 0.66 with amputation-free survival rates of 0.72, 0.62, 0.53, 0.47 and 0.35 in years 1-5 in the best endovascular treatment-first group with 90% power and alpha at p  = 0.05. The sample size was revised to an event-based approach as a result of increased follow-up time due to slower than anticipated recruitment rates. Participants were followed up for a minimum of 2 years. A cost-effectiveness analysis was employed to estimate differences in total hospital costs and amputation-free survival between the groups. Additionally, a cost-utility analysis was carried out and the total cost and quality-adjusted life-years, 2 and 3 years after randomisation were used., Results: Between 22 July 2014 and 30 November 2020, 345 participants were randomised, 172 to vein bypass-first and 173 to best endovascular treatment-first. Non-amputation-free survival occurred in 108 (63%) of 172 patients in the vein bypass-first group and 92 (53%) of 173 patients in the best endovascular treatment-first group [adjusted hazard ratio 1.35 (95% confidence interval 1.02 to 1.80); p  = 0.037]. Ninety-one (53%) of 172 patients in the vein bypass-first group and 77 (45%) of 173 patients in the best endovascular treatment-first group died [adjusted hazard ratio 1.37 (95% confidence interval 1.00 to 1.87)]. Over follow-up, the economic evaluation discounted results showed that best endovascular treatment-first was associated with £1690 less hospital costs compared to vein bypass-first. The cost utility analysis showed that compared to vein bypass-first, best endovascular treatment-first was associated with £224 and £2233 less discounted hospital costs and 0.016 and 0.085 discounted quality-adjusted life-year gain after 2 and 3 years from randomisation., Limitations: Recruiting patients to the Bypass versus Angioplasty in Severe Ischaemia of the Leg Trial-2 trial was difficult and the target number of events was not achieved., Conclusions: A best endovascular treatment-first revascularisation strategy was associated with better amputation-free survival, which was largely driven by fewer deaths. Overall, the economic evaluation results suggest that best endovascular treatment-first dominates vein bypass-first in the cost-effectiveness analysis and cost-utility analysis as it was less costly and more effective than a vein bypass-first strategy., Future Work: The Bypass versus Angioplasty in Severe Ischaemia of the Leg Trial-2 investigators have a data sharing agreement with the BEst Surgical Therapy in patients with Chronic Limb threatening Ischaemia investigators. One output of this collaboration will be an individual patient data meta-analysis., Study Registration: Current Controlled Trials ISRCTN27728689., Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 12/35/45) and is published in full in Health Technology Assessment ; Vol. 28, No. 65. See the NIHR Funding and Awards website for further award information.

Objective: In peripheral arterial disease, patency, limb salvage, and survival rates are mostly reported using Kaplan-Meier analyses. When comparing different revascularisation techniques, these methods have limitations in analysing complex patient flows over time. This study aimed to present, illustrate, and discuss new concepts based on multistate models of analysing outcome parameters in peripheral arterial disease., Methods: Previously published data from a single centre, randomised controlled trial (RCT) with 218 cases that underwent either vein bypass surgery (bypass group, n = 109) or nitinol stent angioplasty (stent group, n = 109) of long femoropopliteal lesions were re-analysed using non-homogeneous Markov models. A step by step description of the concepts of states, state space, definitions, and illustration of transition probability curves as well as the benefits of multistate models is given. The RCT was registered at ISRCTN.com (ISRCTN18315574)., Results: Transition probability curves over time showed similar patterns in the bypass and stent groups. Significant differences in the transition probabilities were found for transitions from primary patency as well as secondary patency to end of patency. The transition probability for patients with preserved primary patency at 24 months who moved to end of patency at 48 months was 19.9% in the stent group vs. 6.4% in the bypass group (p < .001)., Conclusion: The proposed method can answer important questions, such as: Did patients after femoropopliteal stenting with preserved primary patency at two years lose their patency more quickly within the following years compared with bypass surgery? and Did stent patients after a re-intervention to maintain patency at one year lose their patency more quickly compared with bypass surgery within the following years? Completely new research questions can now be raised and answered to optimise treatment and follow up strategies; this might lead to better identification of subgroups at higher risk of clinical deterioration following revascularisation procedures., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

BackgroundDue to an increasing life expectancy, more and more patients experience the failure of peripheral arterial revascularization. This study aims to investigate patients treated for the failure of infra-inguinal bypass grafts, and to investigate the interaction of different bypass materials [great saphenous vein (GSV) and polytetrafluoroethylene (PTFE)] and the further outcome.MethodsRetrospective single-center analysis of consecutive patients treated for acute or chronic occlusion of infra-inguinal bypasses at a university hospital was conducted. Hospitalizations from 1st January 2010 through 31st December 2019 were included. Perioperative parameters from the index operation including graft material (prosthetic vs. autologous) were assessed. After bypass occlusion, the grade of ischemia, as well as the distal landing zone of the redo bypass compared with the primary bypass was investigated.ResultsIn this study, 158 (65% men and 35% women with a m mean age of 70.5 years) eligible patients were included (57% vein and 42% prosthetic bypass grafts). After graft occlusion, 47% of the patients presented with symptoms of acute limb-threatening ischemia, 53% with symptoms of chronic leg ischemia. The rate of acute limb-threatening ischemia was significantly higher when prosthetic graft material was used during the index operation (p =0.016). Additionally, in case of reoperation, the landing zone of the redo bypass was significantly more distally located after occlusion of prosthetic bypass graft (p = 0.014)ConclusionOcclusions of prosthetic bypass grafts were associated with significantly higher rates of acute symptoms compared with vein grafts. Additionally, a shift to a more distal landing zone was recognized after the failure of a prosthetic bypass graft during the redo bypass operation.

Objective: The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-2 trial enrolled participants with chronic limb threatening ischaemia who required an infrapopliteal, with or without a femoropopliteal, revascularisation procedure to restore limb perfusion. Participants randomised to a vein bypass (VB) first revascularisation strategy were over one third more likely than those randomised to a best endovascular treatment (BET) first revascularisation strategy to die from any cause during a median follow up of 40.0 (interquartile range 20.9, 60.6) months. The aim of the present study was to describe the timing and causes of death in BASIL-2 as a first step towards trying to better understand why randomisation to a VB first revascularisation strategy was associated with this excess mortality., Methods: A 10 person international panel comprising vascular and endovascular surgeons as well as vascular interventional radiologists, who had all been principal investigators in BASIL-2, took part in a modified Delphi consensus exercise to adjudicate the primary cause of death and, in particular, whether the cause was primarily cardiac or non-cardiac., Results: In 151 of 168 deaths (89.9%), the Delphi panel achieved a consensus regarding the cause of death being probably cardiac or non-cardiac. In the BET group, 16 of 77 deaths (21%) were classified as probably cardiac compared with 32 of 91 (35%) in the VB group (unadjusted subdistribution hazard ratio 2.16, 95% confidence interval [CI] 1.20 - 3.87; unadjusted cause specific hazard ratio 2.15, 95% CI 1.19 - 3.90). At the point of randomisation, 64 of 344 (18.6%), 40 of 342 (11.7%), and 37 of 344 (10.8%) participants had a previous myocardial infarction (MI), percutaneous coronary intervention (PCI), and coronary artery bypass graft (CABG), respectively. There was no evidence of varying treatment effects for cause of death in subgroup analyses of previous PCI, CABG, or MI., Conclusion: The excess mortality observed in the VB first revascularisation strategy group in BASIL-2 was largely due to deaths that were adjudicated by the Delphi panel as probably primarily cardiac. These excess cardiac deaths were observed throughout follow up and there was no evidence of non-proportional hazards. Further work is ongoing to try to better understand the reasons for these findings., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

There is no consensus on the optimal anticoagulant regimen following lower extremity bypass. Historically, warfarin has been utilized for prosthetic or compromised vein bypasses. Direct-acting oral anticoagulants (DOACs) are increasingly replacing warfarin in this context, but their efficacy in bypass preservation has not been well-studied. Recent studies have shown that DOACs may improve outcomes following bypasses; however, it is unclear if this is dependent upon type of bypass conduit. The goal of this study was to evaluate whether a difference exists between vein and prosthetic infra-geniculate bypasses outcomes based on the anticoagulant utilized on discharge, warfarin or DOAC. The Vascular Quality Initiative infra-inguinal bypass database was queried for all patients who underwent an infra-geniculate bypass and were anticoagulation-naive at baseline but were discharged on either warfarin or DOACs. A survival analysis was performed for patients up to 1 year to determine whether the choice of discharge anticoagulation was associated with differences between those with vein vs prosthetic conduits in overall survival, primary patency, risk of amputation, or risk of major adverse limb events (MALE). A multivariable Cox proportional hazards analysis was performed to control for differences in baseline demographic factors between the groups. During the study period (2003-2020), 57,887 patients underwent infra-geniculate bypass. Of these, 3230 (5.5%) were anticoagulated on discharge. There was a similar distribution of anticoagulation between vein (n = 1659; 51.4%) and prosthetic conduits (n = 1571; 48.6%). Thirty-two percent were discharged on DOACs, and 68.0% were discharged on warfarin. For prosthetic conduits, being discharged on a DOAC was associated with improved outcomes on univariate and multivariable analyses revealing lower risk of overall mortality (hazard ratio [HR], 0.61; 95% confidence interval [CI], 0.41-0.93; P =.021), loss of primary patency (HR, 0.70; 95% CI, 0.55-0.89; P =.003), risk of amputation (HR, 0.71; 95% CI, 0.54-0.93; P =.013), and risk of MALE (HR, 0.80; 95% CI, 0.64-1.00; P =.048). Patients with a vein bypass had improved univariate outcomes for survival and primary patency; however, with multivariable analysis, there were no significant differences in outcomes between DOAC and warfarin. Anticoagulation-naive patients who underwent an infra-geniculate prosthetic bypass had higher rates of overall survival, bypass patency, amputation-free survival, and freedom from MALE when discharged on a DOAC compared with warfarin. Those with vein bypasses had similar outcomes regardless of the choice of anticoagulation. [ABSTRACT FROM AUTHOR]

Objective The aim was to compare outcomes in a subgroup of patients with infrapopliteal (IP) disease randomised to infrapopliteal vein bypass (VB) or plain balloon angioplasty (PBA) in the original BASIL trial. Methods A comparison of outcomes from patients randomised to VB or PBA undergoing revascularisation for severe limb ischaemia (SLI) because of IP disease with or without femoropopliteal disease. Data were extracted from case report forms from the BASIL trial. The primary outcome was amputation free survival (AFS); secondary outcomes included overall survival (OS), 30 day mortality and morbidity, freedom from arterial re-intervention, immediate technical success, repeat and crossover interventions, length of hospital stay, and quality of revascularisation. Results A total of 104 patients were identified in the BASIL study with IP disease, 56 randomised to IP VB, and 48 to IP PBA. Groups were similar at baseline except for more chronic kidney disease and non-steroidal anti-inflammatory drug use in the VB group, and more previous surgical arterial intervention and antihypertensive use in the PBA group. There were no statistically significant differences in AFS or OS; however, clinically important trends were apparent in favour of a VB first strategy. Patients allocated to VB demonstrated significantly quicker relief of rest pain when compared with PBA ( p = .005), but no significant differences in improved tissue healing. Median length of index hospital admission was significantly greater in the VB than in the PBA group (18 vs. 10 days, p < .0001) but there was no difference between the two groups in median total hospital stay between randomisation and the primary endpoint (VB 43.5 vs. PBA 42 days). Conclusions Further randomised trials, like BASIL-2 and BEST-CLI, are required to determine whether patients with severe limb ischaemia who require IP revascularisation and who are suitable for VB should have bypass or endovascular intervention as their primary revascularisation procedure. [ABSTRACT FROM AUTHOR]

Clinical vignette Despite being the most common antithrombotic strategy in trials comparing venous with prosthetic grafts, the use of vitamin K antagonists (VKAs) to improve the outcome of venous bypass remains the subject of debate. In this systematic review, evidence supporting the use of VKAs for improving venous patency following infrainguinal venous bypass is provided. Clinical question A 67 year old man with lifestyle limiting claudication underwent a successful infrainguinal venous bypass. Can VKAs help preserve patency after venous bypass surgery? Methods A systematic review of electronic databases, including MEDLINE and Embase, was conducted. Only randomized controlled studies comparing VKAs with aspirin (ASA) were included. The main outcome was bypass patency. Results Four studies using different intensities of anticoagulation ± ASA were identified. All but one showed a benefit of VKAs over ASA with respect to primary patency. However, this benefit was also accompanied by an increased risk of bleeding. The Dutch Bypass Oral Anticoagulants, or ASA, study was the largest included and showed that VKAs (without concomitant ASA) were superior to ASA alone for the prevention of graft occlusion (hazard ratio 0.69, 95% confidence interval 0.54–0.88). Conclusion Current evidence suggests that VKAs are superior to ASA for the prevention of infrainguinal autologous venous graft thrombosis. [ABSTRACT FROM AUTHOR]

Aim: Hybrid vascular interventions performed in patients with chronic limb ischemia are considered minimally invasive techniques for treating complex multilevel arterial occlusive disease.Methods: We report the case of a 42-year-old woman with a critical upper limb ischemia, who underwent angioplasty and secondary stenting of the distal-third of the axillary artery followed by a brachial-brachial bypass using an autologous graft.Results: The patient had an uneventful recovery. To our knowledge, this is the first case reported in the literature of hybrid vascular reconstruction in the upper limb due to atherosclerosis.Conclusion: Hybrid revascularization procedure in the upper limb is technically feasible, safe for the patient, and should become a part of the armamentarium of the modern vascular surgeon. [ABSTRACT FROM AUTHOR]

Abstract: Although brain bypass surgery has often been selected to treat internal carotid arteries (ICA) which are restricted by aneurysm or artery stenosis, its effectiveness has not been quantitatively evaluated. The purpose of this study is to propose an innovative approach for the evaluation of brain extracranial-to-intracranial (EC–IC) vein bypass surgery, based on the analysis of flow resistance in vein bypasses and within their contralateral carotid arteries through the use of computational fluid dynamics (CFD). Seven patients who underwent vein bypass surgery were examined with the use of high-resolution; computed tomography angiogram (CTA). The reconstructed three-dimensional (3D) geometries were segmented to create CFD calculation domains. Colour Doppler ultrasound (CDU) was used to measure blood flow velocities at the common carotid arteries (CCA), in order to determine inflow conditions. Based on the pipe flow theory, pressure drop was expressed as where A and B represent flow resistance coefficients and represents blood mass flow rate. The CFD results revealed that for a healthy ICA, the average values of A and B were 0.013088Pa/(ml/min)2 and 3.105Pa/(ml/min), respectively. For the vein bypass, an average value of A was 0.0143Pa/(ml/min)2 and B 3.402Pa/(ml/min), which was approximately that of a healthy ICA. However, in the case of a bypass utilising a venous conduit possessing a large-sized valve or existing size alteration, the flow resistance in that bypass would be higher than those found in the healthy ICA. An imbalance of flow resistances may impose conditions that could predispose hemodynamic failure or distal aneurysm development. [Copyright &y& Elsevier]

The article presents a study on the effects of periadventitial rapamycin release on pig vein grafts. It states that the known conduit for coronary artery bypass is the saphenous vein due to its predictable handling qualities and easy access. It discusses vein grafts and coronary artery bypass in relation to neointima formation, plaque rupture, peripheral bypass grafts, rapamycin-eluting polyvinyl alcohol (PVA), and proliferating cell nuclear antigen (PCNA) immunocytochemistry (ICC).

Copyright of Gefaesschirurgie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Gefaesschirurgie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Medizinische Klinik (Urban & Vogel) is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Gefaesschirurgie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

This case panel discussion addresses some of the problems and judgment decisions required in a patient with extensive forefoot gangrene, a stenosis of the superficial femoral artery (SFA), and occlusions of all three leg arteries in the mid and upper leg. With extensive foot debridement to the trans-metatarsal level, balloon angioplasty of the SFA, and a vein bypass to the distal anterior tibial artery, a functional foot remnant was saved. The timing of the various procedures, technical details regarding them, and other issues are discussed. [ABSTRACT FROM PUBLISHER]

Background: Due to an increasing life expectancy, more and more patients experience the failure of peripheral arterial revascularization. This study aims to investigate patients treated for the failure of infra-inguinal bypass grafts, and to investigate the interaction of different bypass materials [great saphenous vein (GSV) and polytetrafluoroethylene (PTFE)] and the further outcome., Methods: Retrospective single-center analysis of consecutive patients treated for acute or chronic occlusion of infra-inguinal bypasses at a university hospital was conducted. Hospitalizations from 1st January 2010 through 31st December 2019 were included. Perioperative parameters from the index operation including graft material (prosthetic vs. autologous) were assessed. After bypass occlusion, the grade of ischemia, as well as the distal landing zone of the redo bypass compared with the primary bypass was investigated., Results: In this study, 158 (65% men and 35% women with a m mean age of 70.5 years) eligible patients were included (57% vein and 42% prosthetic bypass grafts). After graft occlusion, 47% of the patients presented with symptoms of acute limb-threatening ischemia, 53% with symptoms of chronic leg ischemia. The rate of acute limb-threatening ischemia was significantly higher when prosthetic graft material was used during the index operation ( p =0.016). Additionally, in case of reoperation, the landing zone of the redo bypass was significantly more distally located after occlusion of prosthetic bypass graft ( p = 0.014)., Conclusion: Occlusions of prosthetic bypass grafts were associated with significantly higher rates of acute symptoms compared with vein grafts. Additionally, a shift to a more distal landing zone was recognized after the failure of a prosthetic bypass graft during the redo bypass operation., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Rother, Gruber, Behrendt, Günther, Lang and Meyer.)