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.

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 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.

Comparison of Outcomes Following Infrapopliteal Plain Balloon Angioplasty in the BASIL Trial (1999-2004) and in a Contemporary Series (2009-2013).

OBJECTIVES: To compare outcomes in patients randomized to infrapopliteal (IP) plain balloon angioplasty (PBA) for chronic limb-threatening ischemia within the Bypass versus Angioplasty in Severe Ischemia of the Leg (BASIL)-1 trial between 1999 and 2004 with outcomes in consecutive patients undergoing IP PBA at an academic vascular unit a decade later (2009-2013, Contemporary series [CS]). METHODS: Individual patient data were obtained from prospective BASIL-1 (48 patients) and CS databases (73 patients). All had a minimum of 3-years of follow-up. Outcomes studied were amputation-free survival (AFS), overall survival (OS), major (above ankle) limb amputation, arterial reintervention, immediate technical success, and length of hospital stay for the index procedure and during the following 12-month period. Statistical analysis was performed using SAS version 9.4. RESULTS: The BASIL and CS cohorts were well matched for gender, age, diabetes, previous stroke, myocardial infarction and arterial intervention, and presence of tissue loss. More patients in BASIL-1 underwent concomitant treatment of the superficial femoral (60% vs 37%, P = .01) and above knee popliteal (60% vs 34%, P = .005) arteries. Immediate technical success increased from 73% in BASIL-1 to 90% in the CS (P = .01). Between the two cohorts, there were no differences in AFS (hazard ratio [HR] = 1.00, 95% confidence interval [CI]: 0.65-1.54, P = 1.0), OS (HR = 1.04, 95% CI: 0.66-1.62, P = .9), major amputation (HR = 0.86, 95% CI: 0.37-1.97, P = .7), or reintervention (HR = 0.61, 95% CI: 0.29-1.27, P = .2). Contemporary series patients spent significantly fewer days in hospital following the index procedure (P = .02) and also over the following 12 months (P = .002). CONCLUSIONS: Despite improvements in the immediate technical angiographic success of IP PBA between BASIL and the CS, there were no significant improvements in survival outcomes. Results from BASIL-2 and BEST-CLI are required in order to properly define the clinical and cost-effectiveness of endovascular treatment in such patients.

Analysis of Effect of National Institute for Health and Care Excellence Clinical Guideline CG168 on Management of Varicose Veins in Primary Care Using the Health Improvement Network Database.

OBJECTIVE/BACKGROUND: In July 2013, new UK guidelines recommended that all patients with symptomatic varicose veins (VV) be referred to a specialist vascular service for consideration of superficial venous intervention (SVI). In the UK, general practitioners (GPs) in primary care control access to publicly funded vascular services provided through the National Health Service. GP awareness and concordance with Clinical Guideline (CG)168 recommendations is vital if patients with VV are to receive evidence-based treatment in line with national recommendations. The aim was to assess the UK-wide impact of new guidelines on GP management of VV using a large database of electronic GP records. METHODS: An eligible population of patients aged ≥ 18 years was analysed over two 18-month periods, before and after guideline publication. Those with a new diagnosis of VV in each time period were analysed in terms of demographics, specialist referral, compression hosiery prescriptions, and recorded SVI. RESULTS: Analysis included approximately two million patients from 285 GP practices. Before and after CG168 cohorts were well matched. Study populations included 13,014 patients before and 12,466 patients after guideline publication. There was an increase in specialist referrals from 24% (n = 3173) to 28% (n = 3457) (Cox hazard ratio [HR] 1.15, 95% confidence interval [CI] 1.09-1.20; p < .001). Median time to referral was 1.5 days. Prescribed compression hosiery declined from 20% (n = 2558) before the new guidelines to 18% (n = 2292) after the new guidelines (HR 0.93, 95% CI 0.88-0.98; p = .008). There were similar increases in proportions recorded as having SVI, from 3.6% (n = 469) before the new guidelines to 4.2% (n = 526) after the new guidelines (HR 1.16, 95% CI 1.02-1.31; p = .023). There was a statistically significant increase in endothermal ablation after CG168. In Cox models, age, sex, Townsend quintile, and body mass index were significantly related to the chance of referral and SVI. CONCLUSION: Encouragingly, following publication of National Institute for Health and Care Excellence CG168, there has been a statistically significant improvement in the management of VV in primary care in line with the CG recommendations.

Peritoneal fluid culture in appendicitis: review in changing times.

Appendicectomy is one of the commoner operations with a lifetime risk as high as 12% or 23% in males or females, respectively. Since the 1940s intra-operative intra-peritoneal swabs have commonly been taken from the appendix site, the spectrum of infecting organisms and their antibiotic sensitivity may be gauged from the culture results. This approach remains common but in recent years, studies have claimed that intra-peritoneal swabs are unnecessary; however, they relied upon retrospective patient groups predating wider use of laparoscopic appendicectomy, increasing numbers of immunocompromised people at risk of appendicitis and the clinical/medicolegal significance of increasing risk of antibiotic-associated Clostridium difficile colitis. Therefore, a key-word literature research was done to identify relevant publications from 1930 to June 2009. Newer features relating to intra-peritoneal swabs in appendicectomy have been discussed against this background information for periabdominal appendicectomy with or without appendicular perforation, laparoscopic appendicectomy and appendicectomy in the growing numbers of immunocompromised patients. All studies questioning the use of intra-peritoneal swabs were open, non-randomised, and retrospective with incompletely matched control groups, non-standardised swab collection techniques, and consequently lacked power to inform surgical practice. They concluded that an appropriately powered randomised, blinded, prospective, controlled clinical trial is needed to test for absolute efficacy in the use of peritoneal swabs in patient management. Until controlled trial data becomes available, it may be wise to continue peritoneal swabs at least in high-risk patients to decrease clinical and medicolegal risk.