A Scoping Review of Decision Support Tools for Patients with Lower Extremity Arterial Disease: Toward Shared Decision-Making.

BACKGROUND: In recent years, decision support tools (DSTs) in various fields of medicine have emerged to aid clinicians and patients in the process of shared decision-making (SDM). This scoping review aims to identify the existing DSTs for selecting treatments in lower extremity arterial disease and to evaluate their effectiveness in facilitating SDM. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for scoping reviews were followed. A literature search was conducted across MEDLINE, EMBASE, and Cochrane databases, along with the Decision Aid Library Inventory, for studies published between January 2000 and June 2023. Articles reporting the development and/or clinical application of a DST specific to lower extremity arterial disease were included. A narrative synthesis of the results was performed and findings were presented in tabular formats. RESULTS: Five studies and 5 unique DSTs were included. Presenting formats included websites, booklets, brochures, and pocket cards. Overall, a high degree of heterogeneity was observed across all DSTs in their format, content, and delivery. A widespread acceptability and satisfaction were reported among patients and clinicians. However, their effect at improving SDM remains uncertain due to the lack of standardized outcome metrics. CONCLUSIONS: The development and implementation of DSTs for lower limb arterial disease treatment discussion remain in the early stages. This review lays the foundation for future studies to continue exploring optimal strategies for DST development and their role in supporting SDM.

A scoping review of scores or grading systems for pelvic venous disorders.

BACKGROUND: Pelvic venous disorders (PeVD) encompass a variety of conditions linked to chronic pelvic pain in women. However, PeVD remain underdiagnosed due to the absence of universally accepted diagnostic criteria. The complexity of PeVD classifications across specialties leads to delays in treatment. This scoping review aims to fill a gap in PeVD diagnosis and management by identifying all existing scoring or grading systems to lay the foundation for standardized clinical scoring tools for PeVD. METHODS: This scoping review was undertaken according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping reviews. Online databases were searched up to April 2023. Studies implementing a scoring or grading system for patients with confirmed or suspected PeVD were included. Scores or grading systems were classified into four main categories based on their use in the study: screening, diagnosis, measure of disease severity, and measure of response to treatment. RESULTS: Of the 2976 unique records identified, 82 were reviewed in full, and 20 were included in this study. The publication dates ranged from 1984 to 2023 (median, 2018; interquartile range, 2003-2022). A total of 21 scores and/or grading systems were identified. Of these 21 scores, 10 (47.6%) were clinical scores, and 10 (47.6%) were scores based on radiological findings; one study included a score that used both clinical and radiological findings. The identified scores were used in various settings. Of the 21 scores, 2 (9.52%) were used for screening in a tertiary care setting; 3 (14.3%) were used to establish the PeVD diagnosis; 8 (38.1%) were used to assess disease severity; and 8 (38.1%) were used as measures of response to treatment. Of the eight scores assessing disease severity, four (50.0%) assessed the degree of dilatation of pelvic veins and four (50%) assessed the severity of reflux. Only three of the scores were validated. CONCLUSIONS: This scoping review identified a range of scoring and grading systems for PeVD. We note a lack of a validated scoring system, both clinical and radiological, for screening and assessment of disease severity. This is an important first step in developing validated disease-specific scoring systems for patient screening, appropriate referral, assessment of symptom severity, and assessment of the response to treatment.

Identification of outcomes in clinical studies for pelvic venous disorders.

OBJECTIVE: There is increasing recognition that health systems need to measure and improve the value of patient care by measuring outcomes. Chronic pelvic pain secondary to pelvic venous insufficiency can have a significant impact on the quality of life (QOL) of women affected. Despite growing recognition, pelvic venous disorders (PeVDs), an important cause of chronic pelvic pain, remain underdiagnosed. Developing a core outcome set (COS) for benchmarking care delivery enhances the standardization of care. However, there is no consensus regarding a standardized minimum set of outcomes for PeVD. We aimed to generate a list of outcomes reported in previous PeVD treatment studies to lay the foundation for developing a COS for PeVD. METHODS: This scoping review was undertaken according to the PRISMA-ScR guidelines. Initially, screening, full-text review and extraction was conducted on studies published between 2018 and 2023. Subsequently, the search was expanded using 1-year intervals, until, over a 1-year interval, no new outcomes were recorded. Closely related outcomes were classified into domains, and domains into three core areas: disease-specific, treatment-related, and QOL-related outcomes. RESULTS: Of the 1579 records identified, 51 publications were included. From these studies, 108 different outcomes were identified. The median number of outcomes per study was 8 (interquartile range, 6-13). Closely related outcomes were organized into 42 outcome domains, which were then categorized into 3 core outcome areas; 47.6% (20/42) were disease specific, 35.7% (15/42) treatment related, and 16.7% (7/42) were QOL related. Of the 51 included studies, disease-specific outcomes were identified in 96.1% of the studies (49/51), treatment-related outcomes in 94.1% (48/51), and QOL outcomes in only 13.7% (7/51). CONCLUSIONS: There was significant heterogeneity in outcomes reported in PeVD studies. Most PeVD treatment studies evaluated disease-specific and treatment-related outcomes of PeVD, but few reported outcomes that measured the impact on QOL. These findings will inform the next steps in developing a COS for PeVD.

Randomized controlled trials of interventions for acute iliofemoral deep venous thrombosis.

Venous thromboembolism (VTE), notably deep venous thrombosis (DVT), represents a significant cardiovascular disease with high morbidity from post-thrombotic syndrome (PTS). Recent advancements in early thrombus removal technologies have prompted randomized controlled trials (RCT) to assess their efficacy and safety, particularly for iliofemoral DVT (IF-DVT), which carries the greatest risk of developing PTS. This narrative review summarizes these trials and introduces upcoming innovations to evaluate acute intervention for IF-DVT. Specific technologies discussed include catheter-directed thrombolysis, pharmacomechanical catheter-directed thrombolysis, ultrasound-accelerated catheter-directed thrombolysis, and non-lytic mechanical thrombectomy. This review underscores the importance of patient selection, with those presenting with extensive, symptomatic IF-DVT likely to benefit most.

Systematic review and meta-analysis of outcomes after semi-conversion with graft preservation for failed endovascular aneurysm repair.

OBJECTIVE: The aim of this study was to evaluate the outcomes after semi-conversion (open conversion with graft preservation) after failed endovascular aneurysm repair (EVAR). The primary outcomes were 30-day mortality and semi-conversion failure. Secondary outcomes were 30-day major systemic complications, endoleak recurrence, reinterventions, and overall survival. METHODS: The review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The protocol was prospectively registered on PROSPERO (CRD42023421153). All studies reporting the outcomes of semi-conversions for failed EVAR were eligible for inclusion. Quality assessment was performed using the Methodological Index for Non-Randomized Studies (MINORS) tool. A random effects meta-regression of proportions was conducted using the double arcsine-Tukey transformation, given the frequent zero event rate in the primary outcome. Heterogeneity was assessed with the I2 statistic. RESULTS: Eight studies were included in the review after full text screening. A total of 196 patients underwent semi-conversion at a mean time from EVAR of 47.4 months, 68.9% in an elective setting. Mean age at conversion was 78.1 years, and the main indication was isolated endoleak type II (70.1% of cases). Aortic clamping was not necessary in 92.3% of semi-conversions; the aortic sac was opened in 96.1% of cases; in 93.3% of cases, ligation/suture of one or more culprit arteries were performed; and aortic neck banding was executed in 29.2%. At 30 days from surgery, the pooled mortality and the major systemic complications rates were 5.3% (I2 = 24.9%) and 13.4% (I2 = 54.3%), respectively. At follow-up, endoleak recurred after 12.6% semi-conversions (I2 = 83.2%), and the rate of reinterventions was 7% (I2 = 50.1%); the semi-conversion failure rate was 5.5% (I2 = 54.1%), and the overall survival was 84.6% (I2 = 33.3%). CONCLUSIONS: Semi-conversions have acceptable 30-day mortality rates, but the early and mid-term risks of complications, reinterventions, ruptures, and infections are not negligible. This procedure might be an alternative to complete or partial graft explant in patients whom aortic cross-clamping is not ideal.

COmpressioN following endovenous TreatmenT of Incompetent varicose veins by sclerotherapy (CONFETTI).

OBJECTIVE: The evidence for post-foam sclerotherapy compression stockings for varicose veins is limited. Thus, we examined the effects of post-procedural compression stockings on varicose vein patients undergoing foam sclerotherapy. METHODS: The CONFETTI study was a prospective, single-center, randomized controlled trial. Patients with foam sclerotherapy-suitable varicose veins were randomly assigned to the compression group (CG) or the no compression stockings group (NCG) for 7 days. The primary outcome was post-procedural pain measured on a 100-mm visual analog scale for 10 days. Secondary outcomes included clinical severity, generic and disease-specific quality of life scores, return to normal activities and/or work, occlusion rates, degree of ecchymosis, CG compliance, and complications. Patients were reviewed at 2 weeks and 6 months. RESULTS: A total of 139 patients were consented to and randomly assigned. The intention-to-treat analysis included 15 patients who did not receive the allocated intervention. Both groups had similar baseline characteristics. Of the patients, 63.3% and 55.4% returned for follow-up at 2 weeks and 6 months, respectively. Most of the veins treated were tributaries. The CG experienced significantly lower pain scores than the NCG, with median scores of 7 mm and 19 mm, respectively (Mann-Whitney U-test; P = .001). At 2 weeks, no differences were observed in ecchymosis or the time to return to normal activities or work. Both groups showed improvements in clinical severity and quality of life, and occlusion rates were comparable. The NCG experienced one deep venous thrombosis and superficial thrombophlebitis, whereas the CG experienced two superficial thrombophlebitis. CONCLUSIONS: The CONFETTI study suggests that short-term post-procedural compression stockings are beneficial for reducing post-procedure pain.

An international, multispecialty, expert-based Delphi Consensus document on controversial issues in the management of patients with asymptomatic and symptomatic carotid stenosis.

OBJECTIVE: Despite the publication of various national/international guidelines, several questions concerning the management of patients with asymptomatic (AsxCS) and symptomatic (SxCS) carotid stenosis remain unanswered. The aim of this international, multi-specialty, expert-based Delphi Consensus document was to address these issues to help clinicians make decisions when guidelines are unclear. METHODS: Fourteen controversial topics were identified. A three-round Delphi Consensus process was performed including 61 experts. The aim of Round 1 was to investigate the differing views and opinions regarding these unresolved topics. In Round 2, clarifications were asked from each participant. In Round 3, the questionnaire was resent to all participants for their final vote. Consensus was reached when ≥75% of experts agreed on a specific response. RESULTS: Most experts agreed that: (1) the current periprocedural/in-hospital stroke/death thresholds for performing a carotid intervention should be lowered from 6% to 4% in patients with SxCS and from 3% to 2% in patients with AsxCS; (2) the time threshold for a patient being considered "recently symptomatic" should be reduced from the current definition of "6 months" to 3 months or less; (3) 80% to 99% AsxCS carries a higher risk of stroke compared with 60% to 79% AsxCS; (4) factors beyond the grade of stenosis and symptoms should be added to the indications for revascularization in AsxCS patients (eg, plaque features of vulnerability and silent infarctions on brain computed tomography scans); and (5) shunting should be used selectively, rather than always or never. Consensus could not be reached on the remaining topics due to conflicting, inadequate, or controversial evidence. CONCLUSIONS: The present international, multi-specialty expert-based Delphi Consensus document attempted to provide responses to several unanswered/unresolved issues. However, consensus could not be achieved on some topics, highlighting areas requiring future research.

Patient perspectives of quality of life in chronic limb-threatening ischemia: a qualitative study.

BACKGROUND: Quality of life (QOL) is an outcome that matters to patients with chronic limb-threatening ischemia (CLTI). However, we identified the lack of and need for a CLTI-specific QOL instrument. Our group is developing this instrument which requires a deep understanding of patient perspectives of QOL in CLTI. METHODS: Qualitative inquiry with patient and public involvement was performed in accordance with the Standards for Reporting Qualitative Research. Reflexive thematic analysis of semi-structured interviews was conducted within a constructivist-interpretivist research paradigm. Data were organized and managed in NVivo. Techniques to enhance trustworthiness included maintaining an audit trail, member checking, mentoring, and peer-debriefing. Patient and the public were consulted for feedback on codes, themes, and thematic maps. RESULTS: Thirteen participants (median age: 74 years, range: 43-90 years) with a variety of patient demographics were interviewed. Four themes were developed on QOL in CLTI: (i) 'independence as key to life satisfaction', (ii) 'change in identity when continuity is needed', (iii) 'coping with intractable disease', and (iv) 'not wanting to be alone'. Member checking with patient and public involvement confirmed the relevance and centrality of these themes to the lived experiences of patients with CLTI. CONCLUSIONS: The thematic outputs contribute important insights into what QOL truly means to patients with CLTI and what matters for their QOL. The content validity of the new CLTI-specific QOL instrument is improved by giving patients voice. This study highlights the value of qualitative inquiry and patient and public involvement in vascular surgical research.

An Updated Systematic Review and Meta-analysis of the Impact of Graduated Compression Stockings in Addition to Pharmacological Thromboprophylaxis for Prevention of Venous Thromboembolism in Surgical Inpatients.

OBJECTIVE: To compare the rate of venous thromboembolism (VTE) in surgical inpatients with pharmacological thromboprophylaxis and additional graduated compression stockings (GCSs) versus pharmacological thromboprophylaxis alone. BACKGROUND: Surgical inpatients have elevated VTE risk; recent studies cast doubt on whether GCS confers additional protection against VTE, compared with pharmacological thromboprophylaxis alone. METHODS: The review followed "Preferred Reporting Items for Systematic Reviews and Meta-analyses" guidelines using a registered protocol (CRD42017062655). The MEDLINE and Embase databases were searched up to November 2022. Randomized trials reporting VTE rate after surgical procedures, utilizing pharmacological thromboprophylaxis, with or without GCS, were included. The rates of deep venous thrombosis (DVT), pulmonary embolism, and VTE-related mortality were pooled through fixed and random effects. RESULTS: In a head-to-head meta-analysis, the risk of DVT for GCS and pharmacological thromboprophylaxis was 0.85 (95% CI: 0.54-1.36) versus for pharmacological thromboprophylaxis alone (2 studies, 70 events, 2653 participants). The risk of DVT in pooled trial arms for GCS and pharmacological thromboprophylaxis was 0.54 (95% CI: 0.23-1.25) versus pharmacological thromboprophylaxis alone (33 trial arms, 1228 events, 14,108 participants). The risk of pulmonary embolism for GCS and pharmacological prophylaxis versus pharmacological prophylaxis alone was 0.71 (95% CI: 0.0-30.0) (27 trial arms, 32 events, 11,472 participants). There were no between-group differences in VTE-related mortality (27 trial arms, 3 events, 12,982 participants). CONCLUSIONS: Evidence from head-to-head meta-analysis and pooled trial arms demonstrates no additional benefit for GCS in preventing VTE and VTE-related mortality. GCS confer a risk of skin complications and an economic burden; current evidence does not support their use for surgical inpatients.

Systematic Review and Meta-Analysis of Elective Open Conversion versus Fenestrated and Branched Endovascular Repair for Previous Non-Infected Failed Endovascular Aneurysm Repair.

OBJECTIVE: To evaluate outcomes of patients electively undergoing fenestrated and branched endovascular repair (F/B-EVAR) or open conversion for failed previous non-infected endovascular aneurysm repair (EVAR). DATA SOURCES: Embase, MEDLINE, Cochrane Library. REVIEW METHOD: The protocol was prospectively registered on PROSPERO (CRD42023404091). The review followed the PRISMA guidelines; certainty was assessed through the GRADE and quality through MINORS tools. Outcomes data were pooled separately for F/B-EVAR and open conversion. A random effects meta-analysis of proportions was conducted; heterogeneity was assessed with the I2 statistic. RESULTS: Thirty eight studies were included, for a total of 1 645 patients of whom 1 001 (60.9%) underwent an open conversion and 644 (39.1%) a F/B-EVAR. The quality of evidence was generally limited. GRADE certainty was judged low for 30 day death (in both groups) and F/B-EVAR technical success, and very low for the other outcomes. Pooled 30 day death was 2.3% (I2 33%) in the open conversion group and 2.4% (I2 0%) in the F/B-EVAR conversion group (p = .36). Technical success for F/B-EVAR was 94.1% (I2 23%). The pooled 30 day major systemic complications rate was higher in the open conversion (21.3%; I2 74%) than in the F/B-EVAR (15.7%; I2 78%) group (p = .52). At 18 months follow up, the pooled re-intervention rate was 4.5% (I2 58%) in the open conversion and 26% (I2 0%) in the F/B-EVAR group (p < .001), and overall survival was 92.5% (I2 59%) and 81.6% (I2 68%), respectively (p = .005). CONCLUSION: In the elective setting, and excluding infections, the early results of both open conversion and F/B-EVAR after failed EVAR appear satisfactory. Although open conversion presented with higher complication rates in the first 30 days after surgery, at follow up it seemed to be associated with fewer re-interventions and better survival compared with F/B-EVAR.

A Systematic Review of the Quality of Clinical Practice Guidelines for Chronic Limb-Threatening Ischemia.

BACKGROUND: To assess the quality of clinical practice guidelines (CPGs) for chronic limb-threatening ischemia (CLTI) using the Appraisal of Guidelines for Research and Evaluation II instrument. METHODS: A systematic review of Medline, Embase, and online CPG databases was carried out. Four CPGs on CLTI were identified: Global Vascular Guidelines (GVG), European Society of Cardiology (ESC), American College of Cardiology, and National Institute for Health and Care Excellence guidelines on lower limb peripheral arterial disease. Two independent appraisers analyzed the 4 CPGs using the Appraisal of Guidelines for Research and Evaluation II instrument. CPGs were ranked across 6 domains with 23 items that ranged from 1 (strongly disagree) to 7 (strongly agree). A scaled domain score was calculated as a percentage of the maximum possible score achievable. A domain score of ≥50% and an overall average domain score of ≥80% reflected a CPG of adequate quality recommended for use. RESULTS: GVG had the highest overall score (82.9%), as an average of all domains, and ESC had the lowest score (50.2%). GVG and National Institute for Health and Care Excellence guidelines had all domains scoring >50%, while American College of Cardiology had 5 and ESC had 3. Two domains, rigor of development and applicability, scored the lowest among the CPGs. There was a lack of detail in describing systematic methods used in the literature review, how guidelines were formulated with minimal bias, and the planned procedure for updating the guidelines. Implications of guideline application and monitoring of outcomes after implementations were not explicitly discussed. CONCLUSIONS: The GVG guideline published in 2019 discussing CLTI is assessed to be of high quality and recommended for use. This review helps to improve clinical decision-making and quality of future CPGs for CLTI.

Atypical case of coexistent vascular compression syndromes: median arcuate ligament syndrome and nutcracker syndrome.

Vascular compression syndromes, including median arcuate ligament syndrome (MALS) and nutcracker syndrome (NCS), are poorly understood and frequently delayed diagnoses. This case describes a young adult female presenting with chronic vomiting, abdominal pain and weight loss, with dependence on nasogastric feeding. Subsequent to her gastrointestinal symptoms, she developed haematuria and orthostatic intolerance. Investigations confirmed NCS and possible MALS, with superadded gastroparesis and bradygastria. Under the joint care of general and vascular surgeons, she underwent a gastrojejunostomy and panelled renocaval bypass which led to partial resolution of her symptoms. It is hypothesised that gastroparesis may have been caused by MALS via a neurogenic mechanism, or coexistent compression of the duodenum by the superior mesenteric artery. This case highlights the difficulty in diagnosis of vascular compression syndromes, the overlap between the conditions and the potential for multiple coexistent conditions which complicate diagnosis and lead to increased lead-time and morbidity for patients.

Neuromuscular Electrical Stimulation for Intermittent Claudication (NESIC): multicentre, randomized controlled trial.

METHODS: This was an open, multicentre, randomized controlled trial. Patients with intermittent claudication attending vascular surgery outpatient clinics were randomized (1:1) to receive either neuromuscular electrical stimulation (NMES) or not in addition to local standard care available at study centres (best medical therapy alone or plus supervised exercise therapy (SET)). The objective of this trial was to investigate the clinical efficacy of an NMES device in addition to local standard care in improving walking distances in patients with claudication. The primary outcome was change in absolute walking distance, measured by a standardized treadmill test at 3 months. Secondary outcomes included intermittent claudication (IC) distance, adherence, quality of life, and haemodynamic changes. RESULTS: Of 200 participants randomized, 160 were included in the primary analysis (intention to treat, Tobit regression model). The square root of absolute walking distance was analysed (due to a right-skewed distribution) and, although adjunctive NMES improved it at 3 months, no statistically significant effect was observed. SET as local standard care seemed to improve distance compared to best medical therapy at 3 months (3.29 units; 95 per cent c.i., 1.77 to 4.82; P < 0.001). Adjunctive NMES improved distance in mild claudication (2.88 units; 95 per cent c.i., 0.51 to 5.25; P = 0.02) compared to local standard care at 3 months. No serious adverse events relating to the device were reported. CONCLUSION: Supervised exercise therapy is effective and NMES may provide further benefit in mild IC.This trial was supported by a grant from the Efficacy and Mechanism Evaluation Program, a Medical Research Council and National Institute for Health and Care Research partnership. Trial registration: ISRCTN18242823.

Patients with intermittent claudication experience pain in their legs during walking or exercise which ends with rest. This severely impairs physical activity and quality of life. Treatment for such patients typically involves best medical therapy, which includes exercise advice. This study aimed to determine whether a neuromuscular electrical stimulation device improved the walking distance of patients with intermittent claudication compared to local standard care available (which may include supervised exercise therapy) in a trial. Supervised exercise improved walking distances but there was no difference in those that received a device in this patient group.

Meta-analysis of lytic catheter-based intervention for acute proximal deep vein thrombosis in the reduction of post-thrombotic syndrome.

OBJECTIVE: Post-thrombotic syndrome (PTS) is a common complication of deep vein thrombosis (DVT) that can result in significant morbidity for the patient with detrimental impact on their quality of life. Evidence supporting lytic catheter-based interventions (LCBI) undertaken for early thrombus reduction in acute proximal DVT for the prevention of PTS is conflicting. Despite this, rates of LCBIs are increasing. To summaries the existing evidence and pool treatment effects, a meta-analysis of randomized controlled trials assessing the efficacy of LCBIs in proximal acute DVT for the prevention of PTS was undertaken. METHODS: This meta-analysis was undertaken aligning with PRISMA guidelines following a protocol pre-registered on PROSPERO. Online searches of Medline and Embase databases, as well as the gray literature, were performed up to December 2022. Included articles were randomized controlled trials that studied the use of LCBIs with additional anticoagulation vs anticoagulation alone and had determined follow-up periods. Outcomes of interest were PTS development, moderate to severe PTS, major bleeding episodes, and quality-of-life measures. Subgroup analyses were performed for DVTs involving the iliac vein and/r common femoral vein. Meta-analysis was performed using a fixed effects model. Quality assessment was performed using the Cochrane Risk of Bias and GRADE assessment tools. RESULTS: Three trials were included in the final meta-analysis, the Post-thrombotic Syndrome after Catheter-directed Thrombolysis for Deep Vein Thrombosis (CaVenT), Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT), and Ultrasound-accelerated Catheter-directed Thrombolysis Versus Anticoagulation for the Prevention of Post-thrombotic Syndrome (CAVA) trials, comprising 987 patients. Patients undergoing LCBIs had a reduced risk of PTS (relative risk [RR], 0.84; 95% confidence interval [CI], 0.74-0.95; P = .006) and a lower risk of developing moderate to severe PTS (RR, 0.75; 95% CI, 0.58-0.97; P = .03). LBCIs increased the risk of having a major bleed (RR, 2.03; 95% CI, 1.08-3.82; P = .03). In the iliofemoral DVT subgroup analysis, there was a trend toward decreasing the risk of developing PTS and moderate to severe PTS (P = .12 and P = .05, respectively). There was no significant difference in quality-of-life score (as measured by the Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms) between the two groups (P = .51). CONCLUSIONS: Pooling of current best evidence suggests that LCBIs in acute proximal DVT decreases the rate of PTS and moderate to severe PTS with a number needed to treat of 12 and 18, respectively. However, this is complicated by a significantly higher rate of major bleeding with a number needed to treat of 37. This evidence supports the use of LCBIs in selected patients, including those who are at low risk of major bleeding.

Left common iliac vein diameter in patients referred for lower limb venous duplex ultrasound.

INTRODUCTION: Evidence regarding ultrasound assessment of left common iliac vein diameter (LCIV) is limited. Extensive work is currently being undertaken worldwide on non-thrombotic iliac vein lesions to identify patients who may benefit from intervention to alleviate symptoms of chronic venous obstruction. Interventions include long-term stent implantation to improve vein diameter stenosis. This study aimed to assess a cohort of symptomatic venous patients and the diameter of the LCIV in these patients. METHODS: : Retrospective medical records review of all patients attending a tertiary vascular surgery centre who underwent a venous duplex ultrasound assessment between April 2017 and February 2018 were analysed for assessment of LCIV. Medical records of those patients with documented LCIV diameter were assessed over 18 months of follow-up. RESULTS: : A total of 672 (271 males, 401 females) LCIV diameter measurements were collected. The age of the patients ranged from 21 to 95 years (mean = 56.38). Median LCIV diameter overall was 7.64 mm (IQR 5.80mm-9.00 mm). 40 patients (6%) were reported to have a LCIV diameter measurement of < 4 mm, 8 (20%) male and 32 female (80%). 17 of these 40 patients (47.5%) were treated conservatively. Median LCIV diameter was 3.4 mm (IQR 2.5-3.7). 21 of these 40 patients (52.5%) underwent superficial venous intervention only, with a median LCIV diameter of 3.5 mm (IQR 3.2-3.7) and 2 out of these 40 patients (5%) underwent deep venous stenting (2/2 female - 100%), with a median LCIV diameter of 2.9 (IQR 2.9-2.9). No patients underwent both superficial and deep venous treatment in this 40 patient cohort. In those undergoing superficial venous intervention, 4 (19%) underwent repeat treatment. The two deep venous stenting patients underwent magnetic resonance venogram and venogram with intravascular ultrasound to allow stent placement, which confirmed a narrowed left common iliac vein. Primary stent patency at 18 months was 100%. CONCLUSION: In this large study cohort of venous duplex assessments the median vein diameter was 7.64 mm and 40 patients out of 672 had a vein diameter smaller than 4 mm. 2 patients underwent deep venous stenting with primary patency of 100%.

Examining the benefit of graduated compression stockings in the prevention of hospital-associated venous thromboembolism in low-risk surgical patients: a multicentre cluster randomised controlled trial (PETS trial).

INTRODUCTION: Hospital-acquired thrombosis (HAT) is defined as any venous thromboembolism (VTE)-related event during a hospital admission or occurring up to 90 days post discharge, and is associated with significant morbidity, mortality and healthcare-associated costs. Although surgery is an established risk factor for VTE, operations with a short hospital stay (<48 hours) and that permit early ambulation are associated with a low risk of VTE. Many patients undergoing short-stay surgical procedures and who are at low risk of VTE are treated with graduated compression stockings (GCS). However, evidence for the use of GCS in VTE prevention for this cohort is poor. METHODS AND ANALYSIS: A multicentre, cluster randomised controlled trial which aims to determine whether GCS are superior in comparison to no GCS in the prevention of VTE for surgical patients undergoing short-stay procedures assessed to be at low risk of VTE. A total of 50 sites (21 472 participants) will be randomised to either intervention (GCS) or control (no GCS). Adult participants (18-59 years) who undergo short-stay surgical procedures and are assessed as low risk of VTE will be included in the study. Participants will provide consent to be contacted for follow-up at 7-days and 90-days postsurgical procedure. The primary outcome is the rate of symptomatic VTE, that is, deep vein thrombosis or pulmonary embolism during admission or within 90 days. Secondary outcomes include healthcare costs and changes in quality of life. The main analysis will be according to the intention-to-treat principle and will compare the rates of VTE at 90 days, measured at an individual level, using hierarchical (multilevel) logistic regression. ETHICS AND DISSEMINATION: Ethical approval was granted by the Camden and Kings Cross Research Ethics Committee (22/LO/0390). Findings will be published in a peer-reviewed journal and presented at national and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN13908683.

Cost-effectiveness of Diagnostic Tools to Establish the Presence of Peripheral Arterial Disease in People With Diabetes.

OBJECTIVE: To evaluate the cost-effectiveness of point-of-care duplex ultrasound (PAD-scan) and other bedside tests for the diagnosis of peripheral arterial disease (PAD) in people with diabetes. BACKGROUND: PAD is a risk factor for cardiovascular disease, diabetic foot ulceration (DFU), and amputation in diabetic patients. Diagnosis enables optimization of therapies to manage these risks. PAD-scan can be performed by frontline staff and has been shown to be the most accurate bedside test. However, its cost-effectiveness has not been investigated. METHODS: A Markov model was constructed to estimate the health outcomes and costs over 5 years of different testing strategies applied to a cohort of diabetic patients. Bedside tests investigated were PAD-scan, ankle-brachial pressure index, toe-brachial pressure index, audible and visual Doppler, transcutaneous pressure of oxygen, and pulse palpation. Health outcomes were incidence of new DFU, major cardiovascular events, amputation, death, and DFU healing rates. Sensitivity analyses were performed. RESULTS: PAD-scan was the most cost-effective bedside test with an incremental cost-effectiveness ratio of £11,391/quality-adjusted life years. PADscan had the highest probability (78.7%) of having the greatest net benefit at a willingness to pay threshold of £20,000 per quality-adjusted life years. It reduced the number of amputations by 24% and the number of cardiovascular deaths by 10% over 5 years, compared to toe-brachial pressure index (next best alternative). PAD-scans superiority in incremental cost-effectiveness ratio occurred at a PAD prevalence threshold of 0.24. DISCUSSION: PAD-scan is a cost-effective test for the detection of PAD in patients with diabetes.

Cost-effectiveness of carotid endarterectomy in symptomatic patients.

BACKGROUND: Medical therapy for stroke prevention has improved significantly over the past 30 years. Recent analyses of medically treated cohorts have suggested that early rates of stroke may have reduced, and reports of the safety of carotid surgery have also shown improvements. Since the effectiveness of carotid surgery versus medical therapy was established in the 1990s, there is an urgent need to evaluate whether surgery remains cost-effective in the UK. METHODS: A decision model was developed to estimate the lifetime costs and utilities of modern medical therapy with and without carotid endarterectomy in patients with symptomatic stenosis from the perspective of the UK National Health Service. The base-case population consisted of adults aged 70 years with 70-99 per cent stenosis. Model data were obtained from clinical studies and wider literature. Univariate and probabilistic sensitivity analyses were carried out. RESULTS: In the base-case scenario, the 5-year absolute risk reduction with carotid endarterectomy was 5 per cent, and the incremental cost-effectiveness ratio was €12 021 (exchange rate £1 GBP = €1.1125 (Tuesday 1 January 2019)) per quality-adjusted life-year. Surgery was more cost-effective if performed rapidly after presentation. In patients with 50-69 per cent carotid stenosis, surgery appeared less clinically effective. However, there was considerable uncertainty. CONCLUSION: Surgery may not now be clinically effective and cost-effective in those with moderate carotid stenosis. However, these results are uncertain because of the limited data on modern medical therapy and an RCT may be justified.