Editor's Choice - Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL) Prospective Cohort Study and the Generalisability of the BASIL-2 Randomised Controlled Trial.

OBJECTIVE: The Bypass versus Angioplasty in Severe Ischaemia of the Leg-2 (BASIL-2) randomised controlled trial has shown that, for patients with chronic limb threatening ischaemia (CLTI) who require an infrapopliteal (IP) revascularisation a vein bypass (VB) first revascularisation strategy led to a 35% increased risk of major amputation or death when compared with a best endovascular treatment (BET) first revascularisation strategy. The study aims are to place the BASIL-2 trial within the context of the CLTI patient population as a whole and to investigate the generalisability of the BASIL-2 outcome data. METHODS: This was an observational, single centre prospective cohort study. Between 24 June 2014 and 31 July 2018, the BASIL Prospective Cohort Study (PCS) was performed which used BASIL-2 trial case record forms to document the characteristics, initial and subsequent management, and outcomes of 471 consecutive CLTI patients admitted to an academic vascular centre. Ethical approval was obtained, and all patients provided fully informed written consent. Follow up data were censored on 14 December 2022. RESULTS: Of the 238 patients who required an infrainguinal revascularisation, 75 (32%) had either IP bypass (39 patients) or IP BET (36 patients) outside BASIL-2. Seventeen patients were initially randomised to BASIL-2. A further three patients who did not have an IP revascularisation as their initial management were later randomised in BASIL-2. Therefore, 95/471 (20%) of patients had IP revascularisation (16% outside, 4% inside BASIL-2). Differences in amputation free survival, overall survival, and limb salvage between IP bypass and IP BET performed outside BASIL-2 were not subject to hypothesis testing due to the small sample size. Reasons for non-randomisation into the trial were numerous, but often due to anatomical and technical considerations. CONCLUSION: CLTI patients who required an IP revascularisation procedure and were subsequently randomised into BASIL-2 accounted for a small subset of the CLTI population as a whole. For a wide range of patient, limb, anatomical and operational reasons, most patients in this cohort were deemed unsuitable for randomisation in BASIL-2. The results of BASIL-2 should be interpreted in this context.

A vein bypass first versus a best endovascular treatment first revascularisation strategy for patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal revascularisation procedure to restore limb perfusion (BASIL-2): an open-label, randomised, multicentre, phase 3 trial.

BACKGROUND: Chronic limb-threatening ischaemia is the severest manifestation of peripheral arterial disease and presents with ischaemic pain at rest or tissue loss (ulceration, gangrene, or both), or both. We compared the effectiveness of a vein bypass first with a best endovascular treatment first revascularisation strategy in terms of preventing major amputation and death in patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion. METHODS: Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL)-2 was an open-label, pragmatic, multicentre, phase 3, randomised trial done at 41 vascular surgery units in the UK (n=39), Sweden (n=1), and Denmark (n=1). Eligible patients were those who presented to hospital-based vascular surgery units with chronic limb-threatening ischaemia due to atherosclerotic disease and who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion. Participants were randomly assigned (1:1) to receive either vein bypass (vein bypass group) or best endovascular treatment (best endovascular treatment group) as their first revascularisation procedure through a secure online randomisation system. Participants were excluded if they had ischaemic pain or tissue loss considered not to be primarily due to atherosclerotic peripheral artery disease. Most vein bypasses used the 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. Participants were followed up for a minimum of 2 years. Data were collected locally at participating centres. In England, Wales, and Sweden, centralised databases were used to collect information on amputations and deaths. Data were analysed centrally at the Birmingham Clinical Trials Unit. The primary outcome was amputation-free survival defined as time to first major (above the ankle) amputation or death from any cause measured in the intention-to-treat population. Safety was assessed by monitoring serious adverse events up to 30-days after first revascularisation. The trial is registered with the ISRCTN registry, ISRCTN27728689. FINDINGS: Between July 22, 2014, and Nov 30, 2020, 345 participants (65 [19%] women and 280 [81%] men; median age 72·5 years [62·7-79·3]) with chronic limb-threatening ischaemia were enrolled in the trial and randomly assigned: 172 (50%) to the vein bypass group and 173 (50%) to the best endovascular treatment group. Major amputation or death occurred in 108 (63%) of 172 patients in the vein bypass group and 92 (53%) of 173 patients in the best endovascular treatment group (adjusted hazard ratio [HR] 1·35 [95% CI 1·02-1·80]; p=0·037). 91 (53%) of 172 patients in the vein bypass group and 77 (45%) of 173 patients in the best endovascular treatment group died (adjusted HR 1·37 [95% CI 1·00-1·87]). In both groups the most common causes of morbidity and death, including that occurring within 30 days of their first revascularisation, were cardiovascular (61 deaths in the vein bypass group and 49 in the best endovascular treatment group) and respiratory events (25 deaths in the vein bypass group and 23 in the best endovascular treatment group; number of cardiovascular and respiratory deaths were not mutually exclusive). INTERPRETATION: In the BASIL-2 trial, a best endovascular treatment first revascularisation strategy was associated with a better amputation-free survival, which was largely driven by fewer deaths in the best endovascular treatment group. These data suggest that more patients with chronic limb-threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion should be considered for a best endovascular treatment first revascularisation strategy. FUNDING: UK National Institute of Health Research Health Technology Programme.

Evaluation of the Global Limb Anatomic Staging System in patients with chronic limb-threatening ischemia undergoing endovascular intervention for femoropopliteal disease.

BACKGROUND: The Global Limb Anatomic Staging System (GLASS) is a new method of quantifying the anatomic severity of infrainguinal disease in patients with chronic limb-threatening ischemia. However, because GLASS has undergone limited validation, its value as an aid to shared decision-making regarding the choice of revascularization strategy remains incompletely defined. Here we report the relationship between GLASS and outcomes in a contemporary series comprising all 309 patients who underwent an attempt at femoropopliteal and/or infrapopiteal endovascular therapy for chronic limb-threatening ischemia in our unit between 2009 and 2014. METHODS: Baseline patient characteristics and outcome data including immediate technical success (ITS), amputation-free survival (AFS), overall survival, limb salvage, freedom from reintervention (FF-R), and freedom from major adverse limb events (FF-MALE) were obtained from hospital databases. GLASS grades and stage were obtained from pre-endovascular therapy angiographic imaging. Outcome data were censored on May 31, 2017. RESULTS: Baseline patient characteristics were similar across different GLASS femoropopliteal and IP grades and overall limb stages. Worsening GLASS stage was associated with a significant reduction in ITS (97.5% vs 91.5% vs 84.0%; P = .029). At 72 months FF-R (hazard ratio, 2.00; 95% confidence interval, 1.11-3.57; P = .020) and FF-MALE (hazard ratio, 1.76, 95% confidence interval, 1.10-2.81; P = .019) were significant worse in GLASS stage 3 than in stage 2 limbs. CONCLUSIONS: In our study, there were significant differences in ITS, FF-R and FF-MALE between limbs with GLASS stage 2 and 3 disease. However, further GLASS refinement seems likely to be required if its usefulness in everyday clinical practice as an aid to shared decision-making regarding the choice of revascularization strategy is to be maximized.

Procedural and 12-month in-hospital costs of primary infra-popliteal bypass surgery, infrapopliteal best endovascular treatment, and major lower limb amputation for chronic limb threatening ischemia.

OBJECTIVE: Chronic limb-threatening ischemia (CLTI) is a growing global problem due to the widespread use of tobacco and increasing prevalence of diabetes. Although the financial consequences are considerable, few studies have compared the relative cost-effectiveness of different CLTI management strategies. The Bypass vs Angioplasty in Severe Ischaemia of the Leg (BASIL)-2 trial is randomizing patients with CLTI to primary infrapopliteal (IP) vein bypass surgery (BS) or best endovascular treatment (BET) and includes a comprehensive within-trial cost-utility analysis. The aim of this study is to compare over a 12-month time horizon, the costs of primary IP BS, IP best endovascular treatment (BET), and major limb major amputation (MLLA) to inform the BASIL-2 cost-utility analysis. METHODS: We compared procedural human resource (HR) costs and total in-hospital costs for the index admission, and over the following 12-months, in 60 consecutive patients undergoing primary IP BS (n = 20), IP BET (n = 20), or MLLA (10 transfemoral and 10 transtibial) for CLTI within the BASIL prospective cohort study. RESULTS: Procedural HR costs were greatest for BS (BS £2551; 95% confidence interval [CI], £1934-£2807 vs MLLA £1130; 95% CI, £1046-£1297 vs BET £329; 95% CI, £242-£390; P < .001, Kruskal-Wallis) due to longer procedure duration and greater staff requirement. With regard to the index admission, MLLA was the most expensive due to longer hospital stay (MLLA £13,320; 95% CI, £8986-£18,616 vs BS £8714; 95% CI, £6097-£11,973 vs BET £4813; 95% CI, £3529-£6097; P < .001, Kruskal-Wallis). The total cost of the index admission and in-hospital care over the following 12 months remained least for BET (MLLA £26,327; 95% CI, £17,653-£30,458 vs BS £20,401; 95% CI, £12,071-£23,926 vs BET £12,298; 95% CI, £6961-£15,439; P < .001, Kruskal-Wallis). CONCLUSIONS: Over a 12-month time horizon, MLLA and IP BS are more expensive than IP BET in terms of procedural HR costs and total in-hospital costs. These economic data, together with quality of life data from BASIL-2, will inform the calculation of incremental cost-effectiveness ratios for different CLTI management strategies within the BASIL-2 cost-utility analysis.

Comparison of femoropopliteal plain balloon angioplasty for chronic limb-threatening ischemia in the BASIL trial and in a UK contemporary series.

BACKGROUND: Since the turn of the millennium, there has been a worldwide trend towards an endovascular-first strategy where possible revascularization strategy for chronic limb-threatening ischemia. There is concern that this may be inappropriate and can result in net patient harm. The aim of this study, therefore, is to compare important clinical outcomes following femoropopliteal plain balloon angioplasty (FP-PBA), with selective use of bare metal stents (BMSs), in a contemporary series (CS) of patients treated in our unit between 2009 and 2014 with those observed following FP-PBA ± BMS in the United Kingdom National Institute of Health Research Health Technology Assessment-funded Bypass vs Angioplasty in Severe Ischaemia of the Leg (BASIL-1 [B1]) trial (treated 1999-2004). METHODS: Baseline and clinical outcome data (amputation-free survival [AFS], overall survival [OS], limb salvage, freedom from reintervention, and freedom from major adverse limb events) were obtained from prospectively gathered hospital data and B1 trial case record forms. RESULTS: There were 237 CS and 218 B1 patients. CS patients were older (77 vs 73 years; P = .0002). B1 patients were more likely to be current smokers, less likely to be on best medical therapy, and underwent more extensive endovascular interventions. CS had more hospital admissions (4 vs 2; P < .0001) before they reached their primary endpoint (AFS). Immediate technical success was nonsignificantly higher in the CS patients (87% vs 83%; P = .2). BMS were used in 20 CS (8%) and 2 B1 (1%) patients (P = .0002). AFS (hazard ratio, 0.64; 95% confidence interval, 0.49-0.82; P = .0005) and OS (hazard ratio, 0.58; 95% confidence interval, 0.44-0.76; P = .0001) were significantly worse in the CS cohort. There was no significant difference in limb salvage, freedom from reintervention, or freedom from major adverse limb events. CONCLUSIONS: Patients with chronic limb-threatening ischemia managed in our unit (2009-2014) by means of a FP-PBA ± BMS first (where possible) revascularization strategy experienced significantly worse AFS and OS than patients treated with FP-PBA ± BMS in the B1 trial 10 years earlier (1999-2004).

A Comparison of Contemporary Clinical Outcomes Following Femoro-Popliteal Plain Balloon Angioplasty and Bypass Surgery for Chronic Limb Threatening Ischemia.

INTRODUCTION: Despite the BASIL-1 trial concluding that bypass surgery (BS) was superior to plain balloon angioplasty (PBA) in terms of longer-term amputation free (AFS) and overall survival (OS), CLTI patients are increasingly offered an endovascular-first revascularization strategy. This study investigates whether the results of BASIL-1 are still relevant to current practice by comparing femoro-popliteal (FP) BS with PBA in a series of CLTI patients treated in our unit 10 years after BASIL-1 (1999-2004). METHODS: We retrospectively analyzed prospectively gathered hospital data pertaining to 279 patients undergoing primary FP BS or PBA for CLTI in the period 2009 to 2014. We report baseline characteristics, 30-day morbidity and mortality, major adverse cardiovascular events (MACE) and long-term AFS, limb salvage (LS), OS, major adverse limb events (MALE), and freedom from re-intervention (FFR). RESULTS: 234 (84%) and 45 (16%) patients underwent PBA and BS respectively. PBA patients were significantly older (77 vs 71 years, P = 0.001) and more likely to be female (45% vs 28%, P = 0.026). Bollinger and GLASS anatomic scores were significantly more severe in the BS group. Technical success was better for BS (100% vs 87%, P = 0.007). Index hospital stay was shorter for PBA (9.1 vs 15.6 days, P = 0.035) but there was no difference in hospital days or admissions over the next 12 months. AFS (HR 1.00), LS (HR 1.44), OS (HR 0.81), MALE (HR 1.25) and FFR (HR = 1.00) were not significantly different between PBA and BS. CONCLUSION: Important clinical outcomes following FP BS and PBA for CLTI have not changed significantly in our unit in the 10 years following the BASIL-1 trial. BASIL-1 therefore remains relevant to our current practice and should inform our approach to the management of CLTI going forward.

Outcomes in Men From the NHS Abdominal Aortic Aneurysm Screening Programme With a Large Aneurysm Referred for Intervention.

OBJECTIVE: The NHS Abdominal Aortic Aneurysm Screening Programme (NAAASP) has been implemented since 2013. Men with a large aneurysm >54 mm, either at first screen or during surveillance, are referred for intervention. The aim of the present study was to explore outcomes in these men and to see whether there was any regional variation in treatment rates and type of repair. METHODS: The study cohort included all men referred to a vascular network with a large abdominal aortic aneurysm (AAA). Basic demographic information, nurse assessment details, as well as outcome data were extracted from the national NAAASP IT system, AAA SMaRT, for analysis. RESULTS: Some 3 026 men were referred for possible intervention (48% first screen, 52% surveillance). Some 448 men (13.3%) either declined (63, 2.1%), or were turned down for early intervention for various reasons (385, 12.7%). Some 8% were declined for medical reasons (true turn down rate). Men referred from surveillance were older, and more likely not to have had elective surgery within three months (16.0 vs. 11.2%; HR 1.37, 95% CI 1.07-1.75, p = .011). Turn down rates did not vary among local programmes, when surveillance men were taken into account. Some 2 624 (87%) men had planned AAA repair, with a peri-operative mortality of 1.3%. Thirty day surgical mortality was lower after EVAR: 0.4% compared with 2.1% after open repair. The method of repair remained consistent year on year, with roughly equal numbers undergoing endovascular (50%) and open surgical repair (48%); 2% unknown. There was regional variation in the proportion treated by endovascular repair: from 20% to 97%. CONCLUSION: The turn down rate after referral for treatment with a screen detected AAA was low, but there remains considerable regional variation in the proportion undergoing endovascular repair. Procedures were undertaken with low peri-operative mortality.

Comparison of Clinical Outcomes in Patients Selected for Infra-Popliteal Bypass or Plain Balloon Angioplasty for Chronic Limb Threatening Ischemia Between 2009 and 2013.

INTRODUCTION: A published subgroup analysis of the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-1 trial suggests that, in patients with chronic limb threatening ischemia (CLTI) due to infra-popliteal (IP) disease, clinical outcomes are better following vein bypass surgery (BS) than after plain balloon angioplasty (PBA). The aim of the present study is to determine if clinical outcomes following IP revascularization in our unit are concordant with those found in BASIL-1. METHODS: We analyzed prospectively gathered data pertaining to 137 consecutive CLTI patients undergoing IP PBA or BS between 2009 and 2013. We compared 30-day morbidity and mortality, days in hospital (index admission and out to 12-months), amputation free survival (AFS), overall survival (OS), limb salvage (LS), and freedom from arterial re-intervention (FFR). Patient outcomes were censored on 1 February 2017, providing a minimum 3 years follow-up. RESULTS: Patients undergoing BS (73/137, 47%) tended to be younger, have less comorbidity, and were more likely to be on best medical therapy (BMT). BS patients spent more days in hospital during the index admission (median 9 vs 5, p = .003), but not out to 12 months (median 15 vs 13, NS). BS patients suffered more 30-day morbidity (36% vs 10%, p < .001), mainly due to infective complications, but not mortality (3.1% vs 6.8%, NS). AFS (p = .001) and OS (p < .001), but not LS or FFR, were better after BS. CONCLUSIONS: CLTI patients selected for revascularization by means of IP BS had better long-term outcomes in terms of AFS and OS, but not FFR or LS. Although we await the results of the BASIL-2 trial, current data support the BASIL-1 sub-group analysis which suggests that patients requiring revascularization for IP disease should have BS where possible and that PBA should usually be reserved for patients who are not suitable for BS.

Editor's Choice - Relationship Between Global Limb Anatomic Staging System (GLASS) and Clinical Outcomes Following Revascularisation for Chronic Limb Threatening Ischaemia in the Bypass Versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-1 Trial.

OBJECTIVE: The Global Vascular Guideline on chronic limb threatening ischaemia (CLTI) has introduced the Global Limb Anatomic Staging System (GLASS) as a new angiographic scoring system. However, the relationship between GLASS and outcomes following revascularisation has not previously been studied. METHODS: Using pre-intervention angiograms the relationship between GLASS and immediate technical failure (ITF), amputation free survival (AFS), limb salvage (LS), overall survival (OS), and freedom from major adverse limb events (FF-MALE) was examined in 377 patients undergoing endovascular therapy (EVT, n = 213) or bypass surgery (BS, n = 164) in the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-1 trial (randomised 1999-2004). RESULTS: There was no significant difference in GLASS between cohorts. There was a significant relationship between ITF and GLASS in EVT (I 14%, II 15%, III 28%, p = .049). GLASS was significantly related to AFS (hazard ratio [HR], 1.37; 95% CI 1.01-1.85; p = .042), LS (HR 1.96; 95 % CI 1.12-3.43; p = .018), and FF-MALE (HR 1.49; 95% CI 1.04-1.87; p = .028) in the EVT cohort. In BS patients, there was no relationship between GLASS and these outcomes. FF-MALE was significantly worse after EVT than BS in GLASS II (p = .038) and III (p = .001). Among the subgroup of patients with femoropopliteal (FP) disease (BS, n = 109 or EVT, n = 159), FF-MALE was significantly higher after BS than EVT (p < .001). The superiority of BS over EVT with increasing GLASS FP grade was greater in the analysis of patients using vein grafts. CONCLUSION: In the BASIL-1 cohort, GLASS is associated with outcomes following EVT but not BS. Although further validation in contemporary CLTI cohorts is required, GLASS seems likely be useful in shared decision making and for stratifying patients in future trials.

Comparison of Immediate and Long-term Outcomes in Men and Women Undergoing Revascularisation for Chronic Limb Threatening Ischaemia in the Bypass vs. Angioplasty in Severe Ischaemia of the Leg (BASIL-1) Trial.

BACKGROUND: The reports from cohort studies comparing outcomes after revascularisation for chronic limb threatening ischaemia (CLTI) between men and women remain controversial. Anatomical and clinical disease severity is often heterogeneous, and treatment choice influenced by a variety of clinician and patient factors. The aim was to compare outcomes in men and women entered into the only randomised study comparing bypass and angioplasty for infra-inguinal disease causing severe limb ischaemia. METHODS: Data were obtained from BASIL-1 trial case record forms. Baseline demographics were compared, and Cox proportional hazard models were used to examine the relationship between sex and amputation free survival (AFS), overall survival (OS), and freedom from major adverse limb events (FF-MALE) using a per-protocol analysis. Data were analysed using a per-protocol analysis. RESULTS: A total of 452 patients were randomised into the BASIL-1 trial from 1999 to 2004. At randomisation, women were older and less likely to be smokers, to have diabetes, or to be on recommended best medical therapy. Men were more likely to present with gangrene. Ankle brachial pressure index (ABPI), post-revascularisation length of hospital stay, and 30 day morbidity and mortality were similar for men and women. At three years, female sex was associated with significantly better AFS (HR 0.65, 95% CI 0.47-0.89, p < .01), OS (HR 0.66 95% CI 0.46-0.95, p = .02) and FF-MALE (HR 0.74, 95% CI 0.57-0.96, p = .02). CONCLUSION: In the BASIL-1 trial, women had similar short term but better long term outcomes after revascularisation. Sex is an important consideration when developing early, evidence based treatment pathway and revascularisation strategies for CLTI, and is an independent risk factor for outcomes following revascularisation as well as development of symptomatic PAD.

Contemporary (2009-2014) clinical outcomes after femoropopliteal bypass surgery for chronic limb threatening ischemia are inferior to those reported in the UK Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL) trial (1999-2004).

BACKGROUND: Bypass surgery (BS) remains the gold standard revascularization strategy in patients with chronic limb-threatening ischemia (CLTI) owing to infrainguinal disease. The Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL)-1 trial showed that, in patients with CLTI who survived for 2 years or more, BS resulted in better clinical outcomes. Despite this finding, there has been an increasing trend toward an endovascular-first approach to infrainguinal CLTI. Our aim was to investigate whether changes in practice have impacted the clinical outcomes of BS in our unit 10 years after BASIL-1. METHODS: Data for patients who underwent femoropopliteal (FP) BS in BASIL-1 (1999-2004) were retrieved from trial case record forms. The comparator contemporary series (CS) comprised all patients undergoing FP BS for CLTI in our unit between 2009 and 2014. Demographic and clinical outcome data on patients in the CS were collected from the prospectively collected hospital electronic notes. Anatomic patterns of disease in the BASIL-1 and CS cohorts were scored using the Bollinger and GLASS criteria. Statistical analysis was performed in SAS v9.4. RESULTS: There were 128 patients from BASIL-1 and 50 patients in the CS. Baseline age, gender, affected limb, and diabetes prevalence were similar, as were days spent in hospital out to 12 months and length of follow-up. BASIL-1 patients were more likely to be current smokers (P = .000) and had a higher creatinine (P = .04). The 30-day morbidity and mortality were higher in BASIL-1 (45.3% vs 22%; P = .004). There was no significant difference between BASIL-1 and CS with regard to run-off Bollinger (37.7 vs 32.1; P = .167) and IP GLASS (0 vs 0; P = .390) scores, with both groups having a median of two runoff vessels. Amputation-free survival (62% vs 28%; hazard ratio [HR], 1.86; 95% confidence interval [CI], 1.18-2.93; P = .007), limb salvage (85% vs 69%; HR, 2.31; 95% CI, 1.14-4.68; P = .02), overall survival (69% vs 35%; HR, 1.66; 95% CI, 1.00-2.74; P = .05) and major adverse limb events (67% vs 47%; HR, 1.93; 95% CI, 1.15-3.22; P = .01) were all significantly better in BASIL-1. CONCLUSIONS: Although 30-day mortality and morbidity were significantly lower, all of the examined longer term clinical outcomes after FP BS were significantly worse in the CS group a decade on from BASIL-1. Further research in the form of prospective cohort studies and randomized controlled trials is urgently required to determine if the CS data reported herein are generalizable to current vascular surgical practice and, if so, to determine the reasons for these unexpected outcomes.

A Comparison of Clinical Outcomes Following Femoropopliteal Bypass or Plain Balloon Angioplasty with Selective Bare Metal Stenting in the Bypass Versus Angioplasty in Severe Ischaemia of the Limb (BASIL) Trial.

OBJECTIVE: To compare outcomes in patients with chronic limb threatening ischaemia (CLTI) due to femoropopliteal (FP), with or without infrapopliteal (IP), disease who underwent FP (vein or synthetic) open surgical bypass (OSB), or plain balloon angioplasty (PBA), with or without bare metal stenting (BMS), in the Bypass versus Angioplasty in Severe Ischaemia of the Limb (BASIL-1) trial. METHODS: Data were extracted from BASIL-1 case record forms. Outcomes reported include immediate technical success, freedom from major adverse limb events (FF-MALE) and further re-intervention (FF-R), amputation free survival (AFS), overall survival (OS), and limb salvage (LS). RESULTS: Patients underwent primary OSB (n = 128; 89 vein, 39 synthetic) or primary PBA (n = 183; six had BMS). Mean follow up was 46.2 and 43.6 months respectively. Patients were well matched at baseline except that PBA ± BMS patients were significantly more likely to be current smokers. There was no difference in overall or IP (runoff) Bollinger angiogram scores between groups. Immediate technical success was significantly higher for OSB (98% vs. 81%; p < .001). OSB was associated with a longer mean index hospital admission (p = .001), but there was no difference in hospital days at 12 months. FF-MALE (hazard ratio [HR] 1.51; p = .04) and FF-R (HR 1.68; p = .02) but not AFS (HR 1.18; p = .4), OS (HR 1.14; p = .5), and LS (HR 1.09; p = .8) were significantly better after OSB. CONCLUSION: Although AFS, OS, and LS were similar in the two groups, OSB was associated with significantly fewer MALE and re-interventions. So, while PBA ± BMS may be a less resource intensive (expensive) and morbid option in the short term, this appears unlikely to be the case in the longer term. Present data add further weight to the argument that, where possible, patients presenting with CLTI due to FP disease should be offered OSB as their primary revascularisation procedure.

Ultrasound screening for abdominal aortic aneurysm: current practice, challenges and controversies.

The UK screening programme began in 2009, and has now been expanded around the UK. Long-term follow-up of the original cohorts continues to demonstrate significant benefits for abdominal aortic aneurysm (AAA)-related and all-cause mortality , and results from the first 5 years of the formal screening programme have demonstrated similar success. Ultrasound scanning is an effective and safe screening tool for the detection of AAA, although a variety of measurement protocols are employed internationally. Key challenges for the future of the programme relate to declining incidence of screen detected aneurysms.  Recent publications have demonstrated a UK incidence of only 1.34%, compared to 4.9-7.2% of men invited for screening in the original trials. Work into increasing engagement amongst the target group, and expanding screening to siblings and women is underway to address this issue. This review describes the evidence behind the screening programme, its justification in addressing AAA as a significant health problem and discusses some of the potential developments in the future.

Editor's Choice - A Comparison of Clinical Outcomes Between Primary Bypass and Secondary Bypass After Failed Plain Balloon Angioplasty in the Bypass versus Angioplasty for Severe Ischaemia of the Limb (BASIL) Trial.

OBJECTIVE: Chronic limb threatening ischaemia (CLTI) is a growing global health problem. The UK NIHR HTA funded BASIL trial is still the only randomised controlled trial to have compared a "bypass surgery first" with a "plain balloon angioplasty (PBA) first" strategy for the management of CLTI. In patients who were likely to survive for 2 years and had a suitable vein, primary bypass (PB) was associated with better clinical outcomes. Furthermore, PBA was associated with a high technical and clinical failure rate and many went on to have secondary bypass (SB). This study aimed at comparing clinical outcomes following PB and SB in the BASIL trial. METHODS: Demographic, procedural, and outcome data were obtained from the BASIL case report forms. Outcomes were amputation free survival (AFS), limb salvage (LS), overall survival (OS), and freedom from revascularisation (FFR). The SB cohort comprises patients whose first trial intervention was PBA and who subsequently underwent bypass during follow up. The PB cohort comprises those patients whose first trial intervention was bypass. RESULTS: The 190 PB and 49 SB patients were well matched except that the SB patients were more likely to be current smokers. At a median of 7 years, PB was associated with better AFS (PB 60% vs. SB 40%; HR 1.58, p = .04), LS (PB 85% vs. SB 73%, p = .06), and OS (PB 68% vs. 51%, p = .06). FFR was equivalent (PB 53% vs. 53%, p = .3). CONCLUSION: In the BASIL trial, clinical outcomes following PB were significantly better than in patients undergoing SB after failed PBA. Prior to treating patients with CLTI with primary PBA, clinicians should consider that if this should fail, the outcome of attempted subsequent bypass is likely to be significantly worse than if PB were attempted.

Prior Radiological Investigations in 65-Year-Old Men Screened for AAA.

BACKGROUND: The National Health Service abdominal aortic aneurysm screening programme (NAAASP) is now fully operational. Those who have previously been formally investigated for abdominal aortic aneurysm (AAA) are excluded; however, many patients undergo radiological investigation of the abdomen for other reasons. Such practices may find incidental AAA which may be eroding the performance of the NAAASP. We investigated the rates of preinvestigation before invitation to screening in our local AAA screening programme. METHODS: Electronic patient records were retrospectively reviewed for all patients called between March 2013 and February 2016 in 1 local AAA screening programme. Their records were interrogated to identify any abdominal imaging within 5 years of their invitation to screening. RESULTS: Two thousand six hundred thirty-eight men were invited for screening; of these, 563 (21.3%) had been "prescreened". Median time between prescreening and screening was 19 months (0-60 months). Ultrasound abdomen was the most prevalent at 248 (44.0%). Two thousand two hundred forty-three (85.0%) men attended screening, and 6 (0.27%) were excluded for known AAA. Prevalence of AAA was 1.8% (n = 41). Of these, 15 (36.6%) had prior investigation with 6 (40.0%) having AAA diagnosed. Therefore, 9 (22.0%) had potential missed AAA on "prescreening" (mean diameter 35 mm [30-45], mean time lapse between investigation and screening 21.1 months [1-49]). Incidence of missed aneurysm in the "prescreened" cohort was 1.6% (9/563). CONCLUSIONS: Large numbers of men invited for AAA screening have undergone preinvestigation of their abdominal aorta, with 60% of the present AAA being missed. Reliance on incidental detection of AAA would leave many patients undiagnosed in the community-at risk of future rupture.

Outcome after Turndown for Elective Abdominal Aortic Aneurysm Surgery.

OBJECTIVES: The aim was to assess the survival of patients who had been turned down for repair of an abdominal aortic aneurysm (AAA) and to examine the factors influencing this. METHODS: This was a retrospective observational study of a prospectively maintained database of all patients turned down for AAA intervention by the Black Country Vascular Network multidisciplinary team (MDT) from January 2013 to December 2015. Data on AAA size, cardiopulmonary exercise testing (CPET) and cause of death were recorded. RESULTS: There were 112 patients. The median age at turndown was 83.9 years (IQR 10.2 years). The median AAA size at turndown was 63 mm (IQR 16.7 mm). The median follow-up time after turndown was 324 days (IQR 537.5 days). Sixty-four patients (57.1%) were deceased after 2 years, with a median survival time of 462 days (IQR 579 days). Patients who died had a significantly larger AAA dimension (median 65 mm, IQR 18.5 mm) than those surviving to date (median 59 mm, IQR 10 mm, p = .004). Using Cox regression analysis, the probability of 1 year survival in the whole population was 0.614. The probability of 2 year survival was 0.388. When accounting for age, gender, AAA dimension, and British Aneurysm Repair risk score, no factors had significant influence over survival. Of the 64 deceased patients, 30 had an accessible cause of death: 36.7% of these were due to ruptured AAAs. There was no significant difference in AAA size between those dying of ruptures and those dying of other causes (p = .225, mean 74 mm and 67 mm respectively). CONCLUSIONS: Being turned down for AAA repair carries a significant short-term risk of mortality. Those turned down for repair carried significant levels of comorbid disease but no factors considered were found to be independently predictive of the length of survival.

Simultaneous Iliac Vein Bovine Pericardial Patch Venoplasty and Creation of PTFE Lower Limb Arteriovenous Fistula Graft for Rescue Vascular Access.

BACKGROUND: We present a case of external iliac vein patch venoplasty to accommodate rescue vascular access via a polytetrafluoroethylene loop arteriovenous fistula graft (AVG) for a patient with multiple central venous stenoses. METHODS: A 35-year-old female with anti-glomerular basement membrane antibody disease required rescue vascular access for hemodialysis. Repeated occlusion and/or thrombosis of long-term central venous access cannulae, to facilitate dialysis, had caused stenosis of brachiocephalic veins: right external iliac vein and occlusion of the left common iliac vein. A previous right brachiobasilic fistula had occluded within 1 year. No other upper limb options for arteriovenous fistula (AVF) were available. A right external iliac vein bovine patch angioplasty concurrently with a polytetrafluoroethylene AV graft between common femoral artery and common femoral vein was performed to restore venous patency and allow rescue dialysis access. RESULTS: At 3-year follow-up, the fistula remains widely patent with 2 L/min flow rates and no recurrent stenosis to the treated iliac vein. She has not required any further surgical or interventional radiological procedures to maintain fistula or central venous patency. Central venous stenosis or occlusion is common for patients requiring dialysis, especially those with multiple previous long-term central venous cannulations. If restriction of outflow is present, AVF may fail. Venous patch angioplasty in these cases is a successful technique, allowing AVF formation and long-term patency. CONCLUSION: Central venous stenosis can be treated successfully with patch venoplasty to accommodate AVF/AVG formation for rescue vascular access; this is a potentially lifesaving intervention for patients requiring dialysis.