Evaluating pharmacological THRomboprophylaxis in Individuals undergoing superficial endoVEnous treatment across NHS and private clinics in the UK: a multi-centre, assessor-blind, randomised controlled trial-THRIVE trial.

INTRODUCTION: Endovenous therapy is the first choice management for symptomatic varicose veins in NICE guidelines, with 56-70 000 procedures performed annually in the UK. Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a known complication of endovenous therapy, occurring at a rate of up to 3.4%. Despite 73% of UK practitioners administering pharmacological thromboprophylaxis to reduce VTE, no high-quality evidence supporting this practice exists. Pharmacological thromboprophylaxis may have clinical and cost benefit in preventing VTE; however, further evidence is needed. This study aims to establish whether when endovenous therapy is undertaken: a single dose or course of pharmacological thromboprophylaxis alters the risk of VTE; pharmacological thromboprophylaxis is associated with an increased rate of bleeding events; pharmacological prophylaxis is cost effective. METHODS AND ANALYSIS: A multi-centre, assessor-blind, randomised controlled trial (RCT) will recruit 6660 participants from 40 NHS and private sites across the UK. Participants will be randomised to intervention (single dose or extended course of pharmacological thromboprophylaxis plus compression) or control (compression alone). Participants will undergo a lower limb venous duplex ultrasound scan at 21-28 days post-procedure to identify asymptomatic DVT. The duplex scan will be conducted locally by blinded assessors. Participants will be contacted remotely for follow-up at 7 days and 90 days post-procedure. The primary outcome is imaging-confirmed lower limb DVT with or without symptoms or PE with symptoms within 90 days of treatment. The main analysis will be according to the intention-to-treat principle and will compare the rates of VTE at 90 days, using a repeated measures analysis of variance, adjusting for any pre-specified strongly prognostic baseline covariates using a mixed effects logistic regression. ETHICS AND DISSEMINATION: Ethical approval was granted by Brent Research Ethics Committee (22/LO/0261). Results will be disseminated in a peer-reviewed journal and presented at national and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN18501431.

Sarcopenia and Sarcopenic Obesity on Body Composition Analysis is a Significant Predictor of Mortality in Severe Acute Pancreatitis: A Longitudinal Observational Study.

BACKGROUND: The prevalence and impact of sarcopenia and sarcopenic obesity noted on body composition analysis in severe acute pancreatitis (SAP) is unknown. This study investigates the prevalence of sarcopenia at different timepoints and its effect on post-pancreatitis complications and mortality. METHODS: A prospective database of SAP admissions with organ failure at a single institution from 2015 to 2019 were analysed. Sarcopenia was determined by IMAGE J software on CT. Database was further queried for post-pancreatitis complications and mortality. RESULTS: 141 patients with a median age of 59 (range 18-88) and M:F ratio 1.52:1 of were analysed. Sarcopenia was present in 111/141 (79%) patients at admission, 78/79 (99%) at 3 months and 26/36 (72%) at 12 months. 67/111 patients with sarcopenia on admission had sarcopenic obesity. The mortality at 30 days, 3 months and 12 months was 16/141 (11%), 30/141 (21%) and 42/141 (30%) respectively. Mortality was significantly higher in sarcopenic patients at admission (35.14%) compared to the non-sarcopenic group (10%), P = 0.008). Mortality in the sarcopenic obesity group was significantly higher (45%) compared to the sarcopenic non-obese group (20%), P = 0.009) at admission. Multivariate logistic regression identified sarcopenic obesity (OR: 2.880), age (OR: 1.048) and number of organ failures (OR: 3.225) as significant predictors of mortality. CONCLUSIONS: Sarcopenia and Sarcopenic obesity are highly prevalent in SAP patients on admission and during follow up. Furthermore, sarcopenic obesity was shown to be a significant predictor of mortality at admission, suggesting that body composition analysis could be a potential predictive marker of mortality in SAP patients.

The Impact of Pre-Operative Anaemia on One Year Amputation Free Survival and Re-Admissions in Patients Undergoing Vascular Surgery for Peripheral Arterial Disease: a National Vascular Registry Study.

OBJECTIVE: Anaemia is common among patients undergoing surgery, but its association with post-operative outcomes in patients with peripheral arterial disease (PAD) is unclear. The aim of this observational population based study was to examine the association between pre-operative anaemia and one year outcomes after surgical revascularisation for PAD. METHODS: This study used data from the National Vascular Registry, linked with an administrative database (Hospital Episode Statistics), to identify patients who underwent open surgical lower limb revascularisation for PAD in English NHS hospitals between January 2016 and December 2019. The primary outcome was one year amputation free survival. Secondary outcomes were one year re-admission rate, 30 day re-intervention rate, 30 day ipsilateral major amputation rate and 30 day death. Flexible parametric survival analysis and generalised linear regression were performed to assess the effect of anaemia on one year outcomes. RESULTS: The analysis included 13 641 patients, 57.9% of whom had no anaemia, 23.8% mild, and 18.3% moderate or severe anaemia. At one year follow up, 80.6% of patients were alive and amputation free. The risk of one year amputation or death was elevated in patients with mild anaemia (adjusted HR 1.3; 95% CI 1.15 - 1.41) and moderate or severe anaemia (aHR 1.5; 1.33 - 1.67). Patients with moderate or severe anaemia experienced more re-admissions over one year (adjusted IRR 1.31; 1.26 - 1.37) and had higher odds of 30 day re-interventions (aOR 1.22; 1.04 - 1.45), 30 day ipsilateral major amputation (aOR 1.53; 1.17 - 2.01), and 30 day death (aOR 1.39; 1.03 - 1.88) compared with patients with no anaemia. CONCLUSION: Pre-operative anaemia is associated with lower one year amputation free survival and higher one year re-admission rates following surgical revascularisation in patients with PAD. Research is required to evaluate whether interventions to correct anaemia improve outcomes after lower limb revascularisation.

Frail patients having vascular surgery during the early COVID-19 pandemic experienced high rates of adverse perioperative events and amputation.

BACKGROUND: Frailty predicts adverse perioperative outcomes and increased mortality in patients having vascular surgery. Frailty assessment is a potential tool to inform resource allocation, and shared decision-making about vascular surgery in the resource constrained COVID-19 pandemic environment. This cohort study describes the prevalence of frailty in patients having vascular surgery and the association between frailty, mortality and perioperative outcomes. METHODS: The COVID-19 Vascular Service in Australia (COVER-AU) prospective cohort study evaluates 30-day and six-month outcomes for consecutive patients having vascular surgery in 11 Australian vascular units, March-July 2020. The primary outcome was mortality, with secondary outcomes procedure-related outcomes and hospital utilization. Frailty was assessed using the nine-point visual Clinical Frailty Score, scores of 5 or more considered frail. RESULTS: Of the 917 patients enrolled, 203 were frail (22.1%). The 30 day and 6 month mortality was 2.0% (n = 20) and 5.9% (n = 35) respectively with no significant difference between frail and non-frail patients (OR 1.68, 95%CI 0.79-3.54). However, frail patients stayed longer in hospital, had more perioperative complications, and were more likely to be readmitted or have a reoperation when compared to non-frail patients. At 6 months, frail patients had twice the odds of major amputation compared to non-frail patients, after adjustment (OR 2.01; 95% CI 1.17-3.78), driven by a high rate of amputation during the period of reduced surgical activity. CONCLUSION: Our findings highlight that older, frail patients, experience potentially preventable adverse outcomes and there is a need for targeted interventions to optimize care, especially in times of healthcare stress.

Evaluating the feasibility and acceptability of an exercise and behaviour change intervention in socioeconomically deprived patients with peripheral arterial disease: The textpad study protocol.

This pilot randomised controlled trial aims to assess the feasibility and acceptability of a 12-week home-based telehealth exercise and behavioural intervention delivered in socioeconomically deprived patients with peripheral artery disease (PAD). The study will also determine the preliminary effectiveness of the intervention for improving clinical and health outcomes. Sixty patients with PAD who meet the inclusion criteria will be recruited from outpatient clinic at the Freeman Hospital, United Kingdom. The intervention group will undergo telehealth behaviour intervention performed 3 times per week over 3 months. This program will comprise a home-based exercise (twice a week) and an individual lifestyle program (once per week). The control group will receive general health recommendations and advice to perform unsupervised walking training. The primary outcome will be feasibility and acceptability outcomes. The secondary outcomes will be objective and subjective function capacity, quality of life, dietary quality, physical activity levels, sleep pattern, alcohol and tobacco use, mental wellbeing, and patients' activation. This pilot study will provide preliminary evidence of the feasibility, acceptability and effectiveness of home-based telehealth exercise and behavioural intervention delivered in socioeconomically deprived patients with PAD. In addition, the variance of the key health outcomes of this pilot study will be used to inform the sample size calculation for a future fully powered, multicentre randomized clinical trial.

The PReliMinAry (Pain Relief in Major Amputation) Survey.

OBJECTIVES: Major Lower Limb Amputation (MLLA) is associated with significant peri- and post-operative pain and has been identified as a research priority by patient and healthcare groups. The PReliMinAry survey was designed to evaluate existing MLLA analgesia strategies; identifying areas of equipoise and informing future research. METHODS: A targeted multi-national, multi-disciplinary survey was conducted via SurveyMonkey® (October 5, 2020-November 3, 2020) and advertised via social media and society email lists. The 10-questions explored 'pain-team' services, pre-operative neuroleptic medication, pre-incision peripheral nerve blocks and catheters, surgically placed nerve catheters, post-operative adjunctive regimens, future research engagement and equipoise. RESULTS: Seventy-six responses were received from 60 hospitals worldwide. Twelve hospitals(20%) had a dedicated MLLA pain team, 7(12%) had none. Most pain teams (n = 52; 87%) assessed pain with a 0-10 numerical rating scale. Over half of respondents "never" preloaded patients with oral neuroleptic agents(n= 42/76; 55%). Forty-seven hospitals(78%) utilized patient controlled opioid analgesia. Most hospitals are able to provide pre-incision loco-regional peripheral nerve blocks, nerve catheters and surgical nerve catheters (95%, 77%, and 90% respectively), but use was variable. Ultrasound(US) guided peripheral nerve catheters were "infrequently" or "never" used in 57% of hospitals, whilst 23% "infrequently" or "never" utilize surgically placed nerve catheters. CONCLUSIONS: The survey revealed a preference towards 'single-shot' nerve blocks and surgical catheters. A difference between the use of US guided nerve catheters and those surgically placed likely reflects the difference of literature evaluating these techniques. Most respondents felt there was equipoise surrounding future trials evaluating nerve blocks/catheters, but less so for surgical catheters.

Anaemia: A risk factor for death and adverse outcomes following surgery for acute lower limb ischaemia.

INTRODUCTION: Acute limb ischaemia (ALI) forms a significant part of the vascular surgery workload and carries with it high rates of morbidity and mortality. Anaemia is also common amongst vascular surgical patients and has been linked with poor outcomes in some subgroups. We aimed to assess the frequency of anaemia in patients with ALI and its impact on survival and complications following revascularisation to help direct future efforts to optimise outcomes in this patient group. METHODS: A retrospective analysis of prospectively collected departmental data on patients undergoing surgical intervention for ALI between 2014 and 2018 was performed. Anaemia was defined as a pre-operative haemoglobin (Hb) of <120 g/L for women and <130 g/L for men. The primary outcome was overall survival, assessed with the Kaplan-Meier estimator, with application of Cox proportional hazard modelling to adjust for confounding covariates. RESULTS: There were 158 patients who underwent treatment for ALI: 89 (56.3%) of these were non-anaemic with a mean Hb of 146 (SD = 18.4), and 69 (43.7%) were anaemic with a mean Hb of 106 (SD = 13.4). Anaemic patients had a significantly higher risk of death than their non-anaemic counterparts on univariate analysis (HR = 2.11, 95% CIs, 1.28-3.5, p = 0.0036). There was ongoing divergence in survival up to around 6 months between anaemic and non-anaemic groups. Under the Cox model, anaemia was similarly significant as a predictor of death (HR = 2.15, 95% CIs, 1.17-3.95, p = 0.013), accounting for recorded comorbidities, medication use and blood transfusion. CONCLUSIONS: Anaemia is a significant and independent risk factor for death following revascularisation for ALI and can be potentially be modified. Vascular surgical centres should ensure they have robust pathways in place to identify and consider treating anaemia. There is scope for further work to assess how to best optimise a patient's levels of circulating haemoglobin.

Social Deprivation and the Association With Survival Following Fenestrated Endovascular Aneurysm Repair.

BACKGROUND: Social deprivation is associated with poor clinical outcomes. It is known to have an impact on length of stay and post-operative mortality across a number of other surgical specialties. This study evaluates the impact of social deprivation on outcomes following fenestrated endovascular aneurysm repair (FEVAR). METHODS: All elective FEVARs performed between 2010 and 2018 at a tertiary vascular center were analyzed. Deprivation (index of multiple deprivation [IMD]) data was sourced from the English indices of deprivation 2019, by postcode. Primary outcome was overall survival by Kaplan-Meier. Secondary outcomes included length of hospital stay (LOS) and complications. Cox-proportional hazard analyses were conducted. RESULTS: Some 132 FEVAR patients were followed-up for 3.7 (SD 2.2) years. Fifty-seven patients lived in areas with high levels of deprivation (IMD 1-3), 34 in areas with moderate deprivation (IMD 4-6) and 41 in areas with the lowest level (IMD 7-10) of deprivation. Groups were comparable for Age, BMI, AAA diameter and co-morbidity. A higher proportion of patients from deprived areas had renal failure (15% [26.3%] vs. 9% [11.8%] P = 0.019) but no overall difference in procedure time was observed (200 min [155-250] vs. 180 min [145-240] P = 0.412). Kaplan-Meier analysis demonstrated significantly poorer survival for patients living in areas with high levels of deprivation (IMD 1-3) (P = 0.03). Mortality was comparable for IMD 4-6 and 7-10 groups. Patients from the most deprived areas had longer hospital stay (6 days [4-9] vs. 5 [3-7] P = 0.005) and higher all-cause complication rates (21 [36.8%] vs. 14 [18.4%] P = 0.02). Decreasing IMD was associated with worse survival (HR -0.85 [0.75-0.97] [P = 0.02]). CONCLUSIONS: Social deprivation was associated with increased mortality, length of stay and all-cause complication rates in patients undergoing FEVAR for complex abdominal aortic aneurysm (AAA). These results may help direct preoptimization measures to improve outcomes in higher risk sub-groups.

Interventions for great saphenous vein incompetence.

BACKGROUND: Great saphenous vein (GSV) incompetence, causing varicose veins and venous insufficiency, makes up the majority of lower-limb superficial venous diseases. Treatment options for GSV incompetence include surgery (also known as high ligation and stripping), laser and radiofrequency ablation, and ultrasound-guided foam sclerotherapy. Newer treatments include cyanoacrylate glue, mechanochemical ablation, and endovenous steam ablation. These techniques avoid the need for a general anaesthetic, and may result in fewer complications and improved quality of life (QoL). These treatments should be compared to inform decisions on treatment for varicosities in the GSV. This is an update of a Cochrane Review first published in 2011. OBJECTIVES: To assess the effects of endovenous laser ablation (EVLA), radiofrequency ablation (RFA), endovenous steam ablation (EVSA), ultrasound-guided foam sclerotherapy (UGFS), cyanoacrylate glue, mechanochemical ablation (MOCA) and high ligation and stripping (HL/S) for the treatment of varicosities of the great saphenous vein (GSV). SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, and AMED databases, and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 2 November 2020. We undertook reference checking to identify additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) treating participants for varicosities of the GSV using EVLA, RFA, EVSA, UGFS, cyanoacrylate glue, MOCA or HL/S. Key outcomes of interest are technical success, recurrence, complications and QoL. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials, applied Cochrane's risk of bias tool, and extracted data. We calculated odds ratios (ORs) with 95% confidence intervals (CIs) and assessed the certainty of evidence using GRADE. MAIN RESULTS: We identified 11 new RCTs for this update. Therefore, we included 24 RCTs with 5135 participants. Duration of follow-up ranged from five weeks to eight years. Five comparisons included single trials. For comparisons with more than one trial, we could only pool data for 'technical success' and 'recurrence' due to heterogeneity in outcome definitions and time points reported. All trials had some risk of bias concerns. Here we report the clinically most relevant comparisons. EVLA versus RFA Technical success was comparable up to five years (OR 0.98, 95% CI 0.41 to 2.38; 5 studies, 780 participants; moderate-certainty evidence); over five years, there was no evidence of a difference (OR 0.85, 95% CI 0.30 to 2.41; 1 study, 291 participants; low-certainty evidence). One study reported recurrence, showing no clear difference at three years (OR 1.53, 95% CI 0.78 to 2.99; 291 participants; low-certainty evidence), but a benefit for RFA may be seen at five years (OR 2.77, 95% CI 1.52 to 5.06; 291 participants; low-certainty evidence). EVLA versus UGFS Technical success may be better in EVLA participants up to five years (OR 6.13, 95% CI 0.98 to 38.27; 3 studies, 588 participants; low-certainty evidence), and over five years (OR 6.47, 95% CI 2.60 to 16.10; 3 studies, 534 participants; low-certainty evidence). There was no clear difference in recurrence up to three years and at five years (OR 0.68, 95% CI 0.20 to 2.36; 2 studies, 443 participants; and OR 1.08, 95% CI 0.40 to 2.87; 2 studies, 418 participants; very low-certainty evidence, respectively). EVLA versus HL/S Technical success may be better in EVLA participants up to five years (OR 2.31, 95% CI 1.27 to 4.23; 6 studies, 1051 participants; low-certainty evidence). No clear difference in technical success was seen at five years and beyond (OR 0.93, 95% CI 0.57 to 1.50; 5 studies, 874 participants; low-certainty evidence). Recurrence was comparable within three years and at 5 years (OR 0.78, 95% CI 0.47 to 1.29; 7 studies, 1459 participants; and OR 1.09, 95% CI 0.68 to 1.76; 7 studies, 1267 participants; moderate-certainty evidence, respectively). RFA versus MOCA There was no clear difference in technical success (OR 1.76, 95% CI 0.06 to 54.15; 3 studies, 435 participants; low-certainty evidence), or recurrence (OR 1.00, 95% CI 0.21 to 4.81; 3 studies, 389 participants; low-certainty evidence). Long-term data are not available. RFA versus HL/S No clear difference in technical success was detected up to five years (OR 5.71, 95% CI 0.64 to 50.81; 2 studies, 318 participants; low-certainty evidence); over five years, there was no evidence of a difference (OR 0.88, 95% CI 0.29 to 2.69; 1 study, 289 participants; low-certainty evidence). No clear difference in recurrence was detected up to three years (OR 0.93, 95% CI 0.58 to 1.51; 4 studies, 546 participants; moderate-certainty evidence); but a possible long-term benefit for RFA was seen (OR 0.41, 95% CI 0.22 to 0.75; 1 study, 289 participants; low-certainty evidence). UGFS versus HL/S Meta-analysis showed a possible benefit for HL/S compared with UGFS in technical success up to five years (OR 0.32, 95% CI 0.11 to 0.94; 4 studies, 954 participants; low-certainty evidence), and over five years (OR 0.09, 95% CI 0.03 to 0.30; 3 studies, 525 participants; moderate-certainty evidence). No clear difference was detected in recurrence up to three years (OR 1.81, 95% CI 0.87 to 3.77; 3 studies, 822 participants; low-certainty evidence), and after five years (OR 1.24, 95% CI 0.57 to 2.71; 3 studies, 639 participants; low-certainty evidence). Complications were generally low for all interventions, but due to different definitions and time points, we were unable to draw conclusions (very-low certainty evidence). Similarly, most studies evaluated QoL but used different questionnaires at variable time points. Rates of QoL improvement were comparable between interventions at follow-up (moderate-certainty evidence). AUTHORS' CONCLUSIONS: Our conclusions are limited due to the relatively small number of studies for each comparison and differences in outcome definitions and time points reported. Technical success was comparable between most modalities. EVLA may offer improved technical success compared to UGFS or HL/S. HL/S may have improved technical success compared to UGFS. No evidence of a difference was detected in recurrence, except for a possible long-term benefit for RFA compared to EVLA or HL/S. Studies which provide more evidence on the breadth of treatments are needed. Future trials should seek to standardise clinical terminology of outcome measures and the time points at which they are measured.

Dissecting the Management and Outcomes of Thoracic Aortovascular Disease During the COVID-19 Pandemic.

OBJECTIVE: The COVID-19 pandemic has forced the cancellation of planned surgery and led to significant surgical service reductions. Early intervention in aortovascular disease is often critical and cannot be deferred despite these reductions. There is urgent need to evaluate the provision and outcomes of thoracic aortovascular intervention during the peak of the pandemic. METHODS: Prospective data was collected for patients receiving open and endovascular thoracic aortovascular intervention over two-time points; January-May 2020 and January-May 2019 at three tertiary cardiovascular centres. Baseline demographics, cardiovascular risk and COVID-19 screening results were noted. Primary outcomes were median length of intensive care unit and hospital stay, intra-operative mortality, 30-day mortality, post-operative stroke, and spinal cord injury. RESULTS: Patients operated in 2020 (41) had significantly higher median EuroSCORE II than 2019 (53) (7.44 vs. 5.86, P = 0.032) and rates of previous cardiac (19.5% vs. 3.8%, P = 0.019), aortic (14.6% vs. 1.9%, P = 0.041), and endovascular (22.0% vs. 3.8%, P = 0.009) intervention. There was an increase in proportion of urgent cases in 2020 (31.7% vs. 18.9%). There were no intra-operative deaths in 2020 and 1 in 2019 (P = 1.00). There were no significant differences (P ≥ 0.05) in 30-day mortality (4.9% vs. 13.2%), median intensive care unit length of stay (72 vs. 70 hr), median hospital length of stay (8 vs. 9 days), post-operative stroke (3 vs. 6), or spinal cord injury (2 vs. 1) between 2020 and 2019 respectively. CONCLUSIONS: Despite the increased mortality risk of patients and urgency of cases during COVID-19, complicated by the introduction of cohorting and screening regimens, thoracic aortovascular intervention remained safe with comparable in outcomes to pre-COVID-19.

Sarcopenia in Patients Undergoing Lower Limb Bypass Surgery is Associated with Higher Mortality and Major Amputation Rates.

BACKGROUND: Sarcopenia is adversely associated with survival in several diseases. Vasculopathy is often associated with multimorbidity and consequent deconditioning with poor long-term outcomes. This study examined the impact of sarcopenia on clinical outcome in patients with and without critical limb-threatening ischaemia who underwent infrainguinal bypass surgery. METHODS: All patients undergoing infra-inguinal surgical revascularisation in 2016-2018 were retrospectively reviewed. Sarcopenia was defined as a skeletal muscle area at the L3 vertebral level (defined as L3 muscle area < 114cm2 for men or <89.8cm2 for women) on CT angiography. The primary outcome was overall survival by analysed by time to event analysis. Secondary outcomes included ipsilateral major lower-limb amputation, length of hospital stay, myocardial infarction and surgical-site infection. RESULTS: A total of 116 patients with a mean age of 66.9 years were included, with a mean follow-up of 21 months. 14 (12%) of patients were sarcopenic; there were more patients with diabetes (40% vs 7%) in the sarcopenic group, p=0.018. Age, gender, Rutherford grade at presentation, other co-morbidities, other laboratory tests, conduit material and Rutherford grade at presentation were similar in those with and without sarcopenia and were statistically insignificant upon testing. Overall survival was worse for sarcopenic patients (Log Rank P=0.001) and Hazard Ratio for death 5.8; 95%CI 1.8-19.1; P=0.001. Major lower-limb amputation occurred more frequently in patients with sarcopenia (7/14 [50%] vs 23/102 [23%]; P=0.046). There was no difference in other secondary outcomes including rates of graft occlusion, myocardial infarction, surgical site infection and length of stay. Adding SMA measurement to a multivariate generalised linear model including age, sex, diabetes, and haemoglobin improved the AUROC from 0.75-0.85. CONCLUSION: In this cohort of patients undergoing vascular surgery, sarcopenia defined using L3 muscle area was significantly associated with overall mortality and major lower-limb amputation.

Editor's Choice - Systematic Review and Meta-Analysis of Wound Adjuncts for the Prevention of Groin Wound Surgical Site Infection in Arterial Surgery.

OBJECTIVE: Groin incision surgical site infections (SSIs) following arterial surgery are common and are a source of considerable morbidity. This review evaluates interventions and adjuncts delivered immediately before, during, or after skin closure, to prevent SSIs in patients undergoing arterial interventions involving a groin incision. DATA SOURCES: MEDLINE, EMBASE, and CENTRAL databases were searched. REVIEW METHODS: This review was undertaken according to established international reporting guidelines and was registered prospectively with the International prospective register of systematic reviews (CRD42020185170). The MEDLINE, EMBASE, and CENTRAL databases were searched using pre-defined search terms without date restriction. Randomised controlled trials (RCTs) and observational studies recruiting patients with non-infected groin incisions for arterial exposure were included; SSI rates and other outcomes were captured. Interventions reported in two or more studies were subjected to meta-analysis. RESULTS: The search identified 1 532 articles. Seventeen RCTs and seven observational studies, reporting on 3 747 patients undergoing 4 130 groin incisions were included. A total of seven interventions and nine outcomes were reported upon. Prophylactic closed incision negative pressure wound therapy (ciNPWT) reduced groin SSIs compared with standard dressings (odds ratio [OR] 0.34, 95% CI 0.23 - 0.51; p < .001, GRADE strength of evidence: moderate). Local antibiotics did not reduce groin SSIs (OR 0.60 95% CI 0.30 - 1.21 p = .15, GRADE strength: low). Subcuticular sutures (vs. transdermal sutures or clips) reduced groin SSI rates (OR 0.33, 95% CI 0.17 - 0.65, p = .001, GRADE strength: low). Wound drains, platelet rich plasma, fibrin glue, and silver alginate dressings did not show any significant effect on SSI rates. CONCLUSION: There is evidence that ciNPWT and subcuticular sutures reduce groin SSI in patients undergoing arterial vascular interventions involving a groin incision. Local antibiotics did not reduce groin wound SSI, although the strength of this evidence is lower. No other interventions demonstrated a significant effect.

Outcomes of Vascular and Endovascular Interventions Performed During the Coronavirus Disease 2019 (COVID-19) Pandemic.

OBJECTIVE: The aim of the COVER Study is to identify global outcomes and decision making for vascular procedures during the pandemic. BACKGROUND DATA: During its initial peak, there were many reports of delays to vital surgery and the release of several guidelines advising later thresholds for vascular surgical intervention for key conditions. METHODS: An international multi-center observational study of outcomes after open and endovascular interventions. RESULTS: In an analysis of 1103 vascular intervention (57 centers in 19 countries), 71.6% were elective or scheduled procedures. Mean age was 67 ±â€Š14 years (75.6% male). Suspected or confirmed COVID-19 infection was documented in 4.0%. Overall, in-hospital mortality was 11.0% [aortic interventions mortality 15.2% (23/151), amputations 12.1% (28/232), carotid interventions 10.7% (11/103), lower limb revascularisations 9.8% (51/521)]. Chronic obstructive pulmonary disease [odds ratio (OR) 2.02, 95% confidence interval (CI) 1.30-3.15] and active lower respiratory tract infection due to any cause (OR 24.94, 95% CI 12.57-241.70) ware associated with mortality, whereas elective or scheduled cases were lower risk (OR 0.4, 95% CI 0.22-0.73 and 0.60, 95% CI 0.45-0.98, respectively. After adjustment, antiplatelet (OR 0.503, 95% CI: 0.273-0.928) and oral anticoagulation (OR 0.411, 95% CI: 0.205-0.824) were linked to reduced risk of in-hospital mortality. CONCLUSIONS: Mortality after vascular interventions during this period was unexpectedly high. Suspected or confirmed COVID-19 cases were uncommon. Therefore an alternative cause, for example, recommendations for delayed surgery, should be considered. The vascular community must anticipate longer term implications for survival.

Study protocol for COvid-19 Vascular sERvice (COVER) study: The impact of the COVID-19 pandemic on the provision, practice and outcomes of vascular surgery.

BACKGROUND: The novel Coronavirus Disease 2019 (COVID-19) pandemic is having a profound impact on global healthcare. Shortages in staff, operating theatre space and intensive care beds has led to a significant reduction in the provision of surgical care. Even vascular surgery, often insulated from resource scarcity due to its status as an urgent specialty, has limited capacity due to the pandemic. Furthermore, many vascular surgical patients are elderly with multiple comorbidities putting them at increased risk of COVID-19 and its complications. There is an urgent need to investigate the impact on patients presenting to vascular surgeons during the COVID-19 pandemic. METHODS AND ANALYSIS: The COvid-19 Vascular sERvice (COVER) study has been designed to investigate the worldwide impact of the COVID-19 pandemic on vascular surgery, at both service provision and individual patient level. COVER is running as a collaborative study through the Vascular and Endovascular Research Network (VERN), an independent, international vascular research collaborative with the support of numerous national and international organisations). The study has 3 'Tiers': Tier 1 is a survey of vascular surgeons to capture longitudinal changes to the provision of vascular services within their hospital; Tier 2 captures data on vascular and endovascular procedures performed during the pandemic; and Tier 3 will capture any deviations to patient management strategies from pre-pandemic best practice. Data submission and collection will be electronic using online survey tools (Tier 1: SurveyMonkey® for service provision data) and encrypted data capture forms (Tiers 2 and 3: REDCap® for patient level data). Tier 1 data will undergo real-time serial analysis to determine longitudinal changes in practice, with country-specific analyses also performed. The analysis of Tier 2 and Tier 3 data will occur on completion of the study as per the pre-specified statistical analysis plan.

The Influence of Preoperative Anemia on Clinical Outcomes After Infrainguinal Bypass Surgery.

BACKGROUND: Anemia is associated with greater mortality and complications in cardiovascular surgery. Within chronic limb-threatening ischemia, the effect of anemia is becoming apparent. This study aimed to further understand the influence of anemia in patients undergoing surgical revascularization for lower limb ischemia. METHODS: A retrospective review of all patients undergoing infrainguinal surgical revascularization between 2016 and 2018 at a tertiary center was performed. Anemia was defined as an hemoglobin (Hb) level of less than 120 g/L. The primary outcome was overall survival by the Kaplan-Meier analysis. Secondary outcomes included length of hospital stay, blood transfusion requirements, wound infection, myocardial infarction, and limb-loss and all-cause mortality. The Cox proportional-hazard analysis and receiver operating characteristics (ROC) were performed. RESULTS: A total of 124 patients were followed-up for a mean of 23(8) months. Forty-five patients were anemic. There were comparable baseline demographics, comorbidity, and severity of symptoms. Overall survival was significantly worse (logrank P < 0.01) in the anemic group as was the duration of stay, 27 (23) days vs. 14 (16) days (P = 0.001). Patients with anemia received more blood transfusions, 19 (42%) compared with 13 (16.5%) (P = 0.001), and had more cardiac complications (11.1% vs. 3.8%) (P = 0.02). Surgical site infection rates were also higher (20% vs. 6.3%; P = 0.036). There was no difference in graft patency or subsequent ipsilateral major lower extremity amputation. Thirty-day mortality was comparable between the anemic versus the nonanaemic groups, 3 (6.7%) vs. 1 (1.3%) (P = 0.132). At 1 year, there was a higher mortality rate in the anemic group of 8 (18%) vs. 4 (5%) in the nonanaemic group (P = 0.037), which persisted to the long term. Anemia was independently associated with mortality; hazard ratio 4.0 (1.14-12.1). A 'cut-off' Hb level of 112 g/L was identified by ROC analysis. CONCLUSIONS: Preoperative anemia in infrainguinal bypass surgery has a significant association with mortality and morbidity. Preoperative anemia should prompt the vascular team to consider these patients as high risk and consider optimization of Hb.

A randomised controlled trial of perivenous tumescent anaesthesia in addition to general anaesthesia for surgical ligation and stripping of the great saphenous vein.

INTRODUCTION: Open surgical ligation and stripping of the great saphenous vein is a highly cost-effective treatment when compared with conservative management and foam sclerotherapy but has limitations including post-operative morbidity and pain. This study aims to identify if the addition of tumescent anaesthesia could improve patient outcomes following treatment. METHODS: Patients with primary superficial venous incompetence undergoing open surgical ligation and stripping of the great saphenous vein were randomised to either General Anaesthesia (GA) alone (GA) procedure or the addition of tumescent (G + T). The primary outcome was bodily pain (within SF-36) at one week. Additional outcomes included post-procedural pain score (100 mm visual analogue scale), complications and quality of life. RESULTS: A total of 90 patients were randomised for inclusion. There was no significant difference in primary outcome; bodily pain at one week. Secondary outcome of 4-h post-procedural scores were significantly lower in the G + T group (32 (20-54) mm vs. (GA alone) 56 (24-70) mm (P = 0.016)). Complications were minor and equivalent. Both groups saw a significant increase (worsening) in Aberdeen Varicose Vein Questionnaire scores at week 1 with the G + T group faring worse at six weeks (10.0 (Interquartile Range [IQR] 5.6-17.9) vs. 4.3 (IQR 2.7-7.9) P = 0.004). CONCLUSION: The G + T group did not demonstrate a significant difference in the one-week bodily pain domain. The addition of tumescent anaesthesia does improve immediate post-operative pain but appears to negatively impact on six-week quality of life. EudraCT Number: 2011-005574-39.

A Randomised Clinical Trial of Buffered Tumescent Local Anaesthesia During Endothermal Ablation for Superficial Venous Incompetence.

OBJECTIVE/BACKGROUND: Endovenous thermal ablation (EVTA) is the recommended first line intervention for superficial venous incompetence (SVI). While the infiltration of perivenous tumescent local anaesthesia (TLA) is key to procedural success, it is paradoxically the predominant source of patient reported discomfort. This randomised controlled trial investigates the potential to reduce peri-procedural pain and improve patient reported outcome measures (PROMs), including quality of life (QoL) using TLA buffered to physiological pH. METHODS: Patients undergoing great saphenous vein EVTA with concomitant phlebectomies were randomised to either standard (ST) or buffered (BT) TLA. Follow up assessments were performed at weeks 1, 6, and 12. The primary outcome was patient reported peri-procedural pain on a 100 mm visual analogue scale (VAS). Secondary outcomes were one week post-procedural pain VAS and analgesia use, QoL (disease specific: Aberdeen Varicose Vein Questionnaire [AVVQ]; generic: Short Form-36 [SF-36] and EuroQol 5 Dimensions Questionnaire [EQ-5D]), patient satisfaction VAS, technical success on duplex ultrasound (DUS) examination, and complications. RESULTS: Ninety-seven patients were randomised: 50 to ST and 47 to BT. The groups had comparable baseline demographics, Clinical Etiologic Anatomic Pathological, Venous Clinical Severity Score, QoL, and DUS parameters. Equally, intra-procedural parameters (volume of TLA, length of ablation, and linear energy delivered) were also comparable. Peri-procedural pain scores were significantly lower in the BT group with a mean ± SD score of 2.86 ± 3.57 versus 4.44 ± 2.94 (p = .001). Pain scores and analgesia use over the subsequent week were equivalent. SF-36 Bodily Pain domain scores were significantly better in the BT group at week 1 (77 vs. 62; p = .008). AVVQ, SF-36, and EQ-5D scores were otherwise similar between the groups throughout follow up, significantly improving over baseline. Technical success was high in both groups, with no major complications and few minor complications. CONCLUSION: Buffered TLA offers a significantly lower peri-procedural pain experience for patients undergoing EVTA and should replace current tumescent formulae.

Laparoscopic surgery for elective abdominal aortic aneurysm repair.

BACKGROUND: Abdominal aortic aneurysm (AAA) is an abnormal dilatation of the infradiaphragmatic aorta that is equal to or greater than 30 mm or a local dilatation of equal to or greater than 50% compared to the expected normal diameter of the artery. AAAs rarely occur in individuals under 50 years of age, but thereafter the prevalence dramatically increases with age, with men at a six-fold greater risk of developing an AAA than women. Prevalence of AAA has been reported to range from 1.3% in women aged 65 to 80 years to between 4% and 7.7% in men aged 65 to 80 years.There is evidence that the risk of rupture increases as the aneurysm diameter increases from 50 mm to 60 mm. People with AAAs over 55 mm in diameter are therefore generally referred for consideration of repair, as the risk of rupture exceeds the risk of repair. The traditional treatment for AAA is open surgical repair (OSR) which involves a large abdominal incision and is associated with a significant risk of complications. Two less invasive procedures have recently become more widely used: endovascular aneurysm repair (EVAR) and laparoscopic repair. EVAR is carried out through sheaths inserted in the femoral artery in the groin: thereafter, a stent graft is placed within the aneurysm sac under radiological image guidance and anchored in place to form a new channel for blood flow. Laparoscopic repair involves the use of a laparoscope which is inserted through small cuts in the abdomen and the synthetic graft is sewn in place to replace the weakened area of the aorta. Laparoscopic AAA repair falls into two categories: hand-assisted laparoscopic surgery (HALS), where an incision is made to allow the surgeon's hand to assist in the repair; and total laparoscopic surgery (TLS). Both EVAR and laparoscopic repair are favourable over OSR as they are minimally invasive, less painful, associated with fewer complications and lower mortality rate and have a shorter duration of hospital stay.Current evidence suggests that elective laparoscopic AAA repair has a favourable safety profile comparable with that of EVAR, with low conversion rates as well as similar mortality and morbidity rates. As a result, it has been suggested that elective laparoscopic AAA repair may have a role in treating those patients for whom EVAR is unsuitable. OBJECTIVES: To assess the effects of laparoscopic surgery for elective abdominal aortic aneurysm repair.The primary objective of this review was to assess the perioperative mortality and operative time of laparoscopic (total and hand-assisted) surgical repair of abdominal aortic aneurysms (AAA) compared to traditional open surgical repair or EVAR. The secondary objective was to assess complication rates, all-cause mortality (> 30 days), hospital and intensive care unit (ICU) length of stay, conversion and re-intervention rates, and quality of life associated with laparoscopic (total and hand-assisted) surgical repair compared to traditional open surgical repair or EVAR. SEARCH METHODS: The Cochrane Vascular Information Specialist (CIS) searched the Specialised Register (last searched August 2016) and CENTRAL (2016, Issue 7). In addition the CIS searched trials registries for details of ongoing or unpublished studies. We searched the reference lists of relevant articles retrieved by electronic searches for additional citations. SELECTION CRITERIA: Randomised controlled trials and controlled clinical trials in which patients with an AAA underwent elective laparoscopic repair (total laparoscopic repair or hand-assisted laparoscopic repair) compared with either open surgical repair or EVAR. DATA COLLECTION AND ANALYSIS: Studies identified for potential inclusion were independently assessed for inclusion by at least two review authors. MAIN RESULTS: One randomised controlled trial with a total of 100 male participants was included in the review. The trial compared hand-assisted laparoscopic repair with EVAR and provided results for in-hospital mortality, operative time, length of hospital stay and lower limb ischaemia. The included study did not report on the other pre-planned outcomes of this review. No in-hospital deaths occurred in the study. Hand-associated laparoscopic repair was associated with a longer operative time (MD 53.00 minutes, 95% CI 36.49 to 69.51) than EVAR. The incidence of lower limb ischaemia was similar between the two treatment groups (risk ratio (RR) 0.50, 95% confidence interval (CI) 0.05 to 5.34). The mean length of hospital stay was 4.2 days and 3.4 days in the hand-assisted laparoscopic repair and EVAR groups respectively but standard deviations were not reported and therefore it was not possible to independently test the statistical significance of this result. The quality of evidence was downgraded for imprecision due to the inclusion of one small study; and wide confidence intervals and indirectness due to the study including male participants only. No study compared laparoscopic repair (total or hand-assisted) with open surgical repair or total laparoscopic surgical repair with EVAR. AUTHORS' CONCLUSIONS: There is insufficient evidence to draw any conclusions about effectiveness and safety of laparoscopic (total and hand-assisted) surgical repair of AAA versus open surgical repair or EVAR, because only one small randomised trial was eligible for inclusion in this review. High-quality randomised controlled trials are needed.