Publications
146 results found
Belramman A, Bootun R, Lane TRA, et al., 2024, COmpressioN following endovenous TreatmenT of Incompetent varicose veins by sclerotherapy (CONFETTI), Journal of Vascular Surgery: Venous and Lymphatic Disorders, Vol: 12, ISSN: 2213-333X
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.
Smith S, Ravikumar R, Carvalho C, et al., 2024, Neuromuscular electrical stimulation for the treatment of diabetic sensorimotor polyneuropathy: A prospective, cohort, proof-of-concept study., Neurophysiol Clin, Vol: 54
OBJECTIVE: To assess a potential efficacy signal, safety and feasibility of neuromuscular electrical stimulation (NMES) therapy as an adjunct to standard care in patients with diabetic sensorimotor polyneuropathy (DSPN). METHODS: In this single-centre, prospective, cohort, proof-of-concept study, 25 patients with DSPN consented to at least one daily 30-minute NMES therapy session (Revitive® IX) for 10 weeks, with 20 patients completing the study. The primary outcome measure was nerve conductivity assessed using a nerve conduction study of the sural, superficial peroneal, common peroneal and tibial nerves at 10 weeks compared to baseline. Secondary outcomes included superficial femoral artery (SFA) haemodynamics during NMES therapy compared to rest and quality-of-life at 10 weeks compared to baseline. RESULTS: At 10 weeks, there were significant increases in sural sensory nerve action potential amplitude and conduction velocity (p < 0.001), superficial peroneal sensory nerve action potential amplitude (p = 0.001) and conduction velocity (p = 0.002), common peroneal nerve conduction velocity (p = 0.004) and tibial nerve compound muscle action potential amplitude (p = 0.002) compared to baseline. SFA volume flow and time-averaged mean velocity significantly increased (p ≤ 0.003) during NMES compared to rest. Patient-reported Michigan Neuropathy Screening Instrument scores significantly decreased (p = 0.028) at 10 weeks compared to baseline. Three unrelated adverse events occurred, and 15 participants adhered to treatment. CONCLUSIONS: NMES therapy as an adjunct to standard care for 10 weeks significantly increased lower limb nerve conductivity in patients with DSPN and may be beneficial in the treatment of DSPN.
Bergman H, Clay B, Lane T, 2024, Long-term outcomes of major and minor lower limb amputation: eight-year retrospective analysis from a single tertiary referral centre, Journal of Vascular Societies Great Britain & Ireland, Vol: 3, ISSN: 2754-0022
<jats:p>Objective: Lower limb amputation is increasingly common yet outcomes are historically poor, with high rates of short-term mortality, revisions and poor quality of life. This observational study evaluates outcomes from a high-volume tertiary vascular referral centre. Methods: Retrospective electronic case note review was performed to elicit all major and minor amputations performed between 03/11/2014 and 31/05/2022 for peripheral arterial disease and diabetic foot sepsis. Cases of amputation for trauma or chronic pain were not included. Results: A total of 1,566 amputations (865 major, 701 minor) were carried out in 1,237 patients during the study period. Mortality was significantly higher for patients undergoing major amputation compared with minor amputation at 30 days (7.9%, n=61/773 vs 1.0%, n=6/575; p<0.0001) and at 1 year post-procedure (23.7%, n=183/773 vs 13.6%, n=78/575, p<0.0001). Revision rates were significantly lower for major amputations than for minor amputations at 30 days (2.4%, n=19/799 vs 13.2%, n=91/691; p<0.0001) and at 1 year post-procedure (10.0%, n=68/677 vs 26.3%, n=163/619, p<0.0001). Of the patients with major amputation fitted with a prosthesis, there was no significant difference in the numbers of patients ambulating (p=0.19) or the mean ambulatory level (p=0.08) between above-knee and below-knee amputation at 6 months post-procedure. Conclusions: Both major and minor lower limb amputations are associated with a high risk of revision and mortality within 1 year which should be discussed explicitly as part of the informed consent process.</jats:p>
Burgess L, Babber A, Shalhoub J, et al., 2023, Neuromuscular electrical stimulation for intermittent claudication (NESIC): multicentre, randomised controlled trial, British Journal of Surgery, Vol: 110, Pages: 1785-1792, ISSN: 1365-2168
MethodsThis 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.ResultsOf 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.ConclusionSupervised 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.
Fung KW, Szybka M, Lane T, et al., 2023, Spatio-temporal analysis of non-attendance for the National Abdominal Aortic Aneurysm Screening Program in Cambridgeshire, Peterborough and West Suffolk region between 2018 and 2022 and its link to socioeconomic deprivation, Journal of Vascular Societies Great Britain & Ireland, Vol: 3, Pages: 19-25, ISSN: 2754-0022
Objective: Non-attendance for National Abdominal Aortic Aneurysm Screening Program (NAAASP) screening scans results in a lost opportunity to improve public health and has financial implications for the healthcare system as a whole. This study aimed to assess the spatio-temporal distribution of the ‘did-not-attend’ (DNA) rate and identify high-risk geographical areas and associated risk factors for future policy making and allocation of healthcare resources.Methods: This was a retrospective spatio-temporal analysis of non-attendance to the NAAASP in Cambridgeshire, Peterborough and West Suffolk from 2018 to 2022. With the data from the national AAA screening system, Screening Management and Referral Tracking (SMaRT), the DNA rate was established for each postcode district and compared with the overall DNA rate. Using the number of ‘non-attenders’ in each postcode district, optimised hotspot analysis was performed to identify hotspots of non-attendance for each year between 2018 and 2022. Multiple logistic regression was used to investigate the association between degree of deprivation and non-attendance.Results: Overall, 6,364 of 23,957 people (26.6%) being called for screening did not attend from 2018 to 2022. Optimised hotspot analysis identified eight statistically significant hotspots of non-attendance. Postcode districts PE10 (n=8, 80%), PE1 (n=433, 44.5%), CB4 (n=331, 40.2%), CB3 (n=114, 36.7%) and CB1 (n=320, 35.8%) were identified as areas with statistically significantly higher DNA rates. PE1, CB1, CB3 and CB4 were high-risk areas with both high DNA rates and high numbers of non-attenders. A consistent spatial pattern of hotspots was observed while there was a significant drop in the DNA rate in 2020/21. While degree of deprivation was closely linked to non-attendance in Peterborough, the link was less obvious in Cambridge with little socioeconomic deprivation.Conclusion: PE1, CB1, CB3 and CB4 were identified as high-risk postcodes. T
Nimura M, Lane T, Rawashdeh M, et al., 2023, Study protocol for Neuromuscular Stimulation for Rehabilitation after general and vascular surgery - a pilot randomised clinical study, BMJ Open, Vol: 13, ISSN: 2044-6055
Objectives To investigate the acceptability and safety of neuromuscular stimulation (NMES) as an adjunct for rehabilitation after vascular and general surgery.Methods and analysis Prospective, single-centre, single-blind, parallel group, randomised controlled study. This study will be conducted in a single-centre, secondary care setting (National Healthcare Service Hospital) in the UK. All patients aged over 18 years undergoing vascular or general surgery with Rockwood Frailty Score of 3 or above on admission. Exclusion is inability or unwillingness to participate in trial, implanted electrical device, pregnancy and acute deep vein thrombosis. Target number of recruitment is 100. Participants will be randomly assigned to active NMES group (group A) or placebo NMES group (group B) prior to surgery. Participants will be blinded and asked to use the NMES device, 1–6 sessions daily (30 min per session) after surgery in addition to standard National Health Service rehabilitation care until discharge. The primary study outcomes are acceptability and safety of NMES assessed by the device satisfaction questionnaire on discharge and adverse events recorded during hospital stay. The secondary outcomes are the postoperative recovery and cost-effectiveness compared between two groups, assessed by various activity tests, mobility and independence measures and questionnaires.Ethics and dissemination Ethical approvals were provided by London-Harrow Research Ethics Committee (REC) and the Health Research Authority (HRA), Ref: 21/PR/0250. Findings will be published in a peer-reviewed journal and presented at national and international conferences.Trial registration number NCT04784962.
Judges D, Liu C, Onida S, et al., 2023, Left common iliac vein diameter in patients referred for lower limb venous duplex ultrasound, VASCULAR, ISSN: 1708-5381
Smith S, Normahani P, Lane T, et al., 2022, Prevention and management strategies for diabetic neuropathy, Life, Vol: 12, Pages: 1185-1185, ISSN: 2075-1729
Diabetic neuropathy (DN) is a common complication of diabetes that is becoming an increasing concern as the prevalence of diabetes rapidly rises. There are several types of DN, but the most prevalent and studied type is distal symmetrical polyneuropathy, which is the focus of this review and is simply referred to as DN. It can lead to a wide range of sensorimotor and psychosocial symptoms and is a major risk factor for diabetic foot ulceration and Charcot neuropathic osteoarthropathy, which are associated with high rates of lower limb amputation and mortality. The prevention and management of DN are thus critical, and clinical guidelines recommend several strategies for these based on the best available evidence. This article aims to provide a narrative review of DN prevention and management strategies by discussing these guidelines and the evidence that supports them. First, the epidemiology and diverse clinical manifestations of DN are summarized. Then, prevention strategies such as glycemic control, lifestyle modifications and footcare are discussed, as well as the importance of early diagnosis. Finally, neuropathic pain management strategies and promising novel therapies under investigation such as neuromodulation devices and nutraceuticals are reviewed.
Smith S, Normahani P, Lane T, et al., 2022, Pathogenesis of distal symmetrical polyneuropathy in diabetes, Life, Vol: 12, Pages: 1-16, ISSN: 2075-1729
Distal symmetrical polyneuropathy (DSPN) is a serious complication of diabetes associated with significant disability and mortality. Although more than 50% of people with diabetes develop DSPN, its pathogenesis is still relatively unknown. This lack of understanding has limited the development of novel disease-modifying therapies and left the reasons for failed therapies uncertain, which is critical given that current management strategies often fail to achieve long-term efficacy. In this article, the pathogenesis of DSPN is reviewed, covering pathogenic changes in the peripheral nervous system, microvasculature and central nervous system (CNS). Furthermore, the successes and limitations of current therapies are discussed, and potential therapeutic targets are proposed. Recent findings on its pathogenesis have called the definition of DSPN into question and transformed the disease model, paving the way for new research prospects.
Bootun R, Onida S, Lane T, et al., 2022, Varicose veins, Surgery (Oxford), Vol: 40, Pages: 411-419, ISSN: 0263-9319
Varicose veins are common and have a negative impact on people's quality of life. Treatment has been shown to improve the quality of life in those affected and is endorsed by international clinical practice guidelines. In the UK, traditional techniques of saphenofemoral and saphenopopliteal junctional ligation with or without stripping have been largely superseded by minimally invasive day surgery techniques under local anaesthesia. The most performed procedures include radiofrequency ablation and endovenous laser ablation, both of which may be associated with procedural discomfort and complications relating to the use of thermal energy. More recently, novel techniques, including mechanochemical ablation and cyanoacrylate glue, have entered the clinical arena with promising results. However, newer complications are also emerging (especially for cyanoacrylate). Saphenous sparing techniques also exist, selectively disconnecting refluxing points between the superficial and deep venous systems (CHIVA) or by removing incompetent tributaries via selective phlebectomy (ASVAL). This article discusses the epidemiology, diagnosis, and management of varicose veins, including the latest endovascular and targeted open surgical techniques.
Belramman A, Bootun R, Tang TY, et al., 2022, Pain outcomes in a multicentre randomised clinical trial comparing MechanOChemical ablation versus CyanoAcrylate Adhesive for the treatment of primary truncal saphenous veins incompetence, JAMA Surgery, Vol: 157, Pages: 395-404, ISSN: 2168-6262
Importance Endovenous thermal ablations (ETAs) are recommended as first-line treatment for truncal vein reflux, have a short recovery time, and are cost-effective. However, ETAs are associated with discomfort during tumescent anesthesia infiltration. To minimize discomfort, nonthermal, nontumescent ablation techniques had emerged in the form of mechanochemical ablation (MOCA) and cyanoacrylate adhesive injection (CAE).Objective To assess pain scores immediately after truncal ablation using a 100-mm visual analog scale and 10-point number scale to compare pain-related outcomes following mechanochemical ablation vs cyanoacrylate adhesive treatment.Design, Setting, and Participants The Multicenter Randomized II Clinical Trial Comparing Mechanochemical Ablation vs Cyanoacrylate Adhesive for the Treatment of Primary Truncal Saphenous Veins Incompetence study was a prospective multicenter randomized clinical trial conducted at 3 sites between November 2017 and January 2020. Inclusion criteria were primary great or small saphenous varicose veins; exclusion criteria included recurrent varicose veins, current deep venous thrombosis, or serious arterial disease. There were 392 participants screened, 225 were excluded, and 167 participants underwent randomization. Four participants did not receive allocated intervention and were included in the intention-to-treat analysis. Follow-up took place at 2 weeks, and 3, 6, and 12 months.Interventions Patients with primary truncal vein incompetence were randomized to receive either MOCA or CAE.Main Outcomes and Measures The primary outcome measure was pain score immediately after completing truncal ablation using a 100-mm visual analog scale (VAS) and a 10-point number scale. Secondary outcome measures included degree of ecchymosis, occlusion rates, clinical severity, and generic and disease-specific quality of life (QoL) scores.Results Of 167 study participants, 99 (59.3%) were women, and the mean (SD) age was 56 (15.8) years. O
Bickerton S, Awopetu A, Abood A, et al., 2022, Atraumatic Clostridium septicum myonecrosis presenting as upper limb ischaemia in a patient with undiagnosed bowel cancer., Ann R Coll Surg Engl, Vol: 104, Pages: e95-e97
Necrotising infections remain challenging to surgeons, both in diagnosis and management. Timely recognition and treatment remain vital. We report a presentation of limb ischaemia with no apparent precipitating factors, in a systemically stable patient, due to atraumatic Clostridium septicum myonecrosis. This article demonstrates the use of rapid cross-sectional imaging in finding an undiagnosed bowel cancer as a basis for this type of infection. Rapid cross-sectional imaging may be utilised where there is doubt about the underlying pathology of upper limb ischaemia. Patients whose cultures grow Clostridium septicum must be investigated for malignancy.
Epstein D, Bootun R, Diop M, et al., 2022, Cost-effectiveness analysis of current varicose veins treatments, Journal of vascular surgery. Venous and lymphatic disorders, Vol: 10, Pages: 504-513.e7, ISSN: 2213-3348
OBJECTIVE: To analyze the effectiveness and cost-effectiveness of technologies for treatment of varicose veins over 5 years - conservative care (CONS), surgery (HL/S), ultrasound guided foam sclerotherapy (UGFS), endovenous laser ablation (EVLA), and radiofrequency ablation (RFA), mechanochemical ablation (MOCA) and cyanoacrylate glue occlusion (CAE). METHODS: A systematic review was updated and used to construct a Markov decision model. Outcomes were re-intervention on the truncal vein, re-treatment of residual varicosities and quality-adjusted life years (QALY) and costs over five years. RESULTS: UGFS has a significantly greater re-intervention rate than other procedures, while there is no significant difference between the other procedures. The cost per QALY of EVLA versus UGFS in our base-case model is £16966 ($23700) per QALY, which is considered cost-effective in the UK. RFA, MOCA and CAE have greater procedure costs than EVLA with no evidence of greater benefit for patients. CONCLUSIONS: EVLA is the most cost-effective therapeutic option, with RFA a close second, in adult patients requiring treatment in the upper leg for incompetence of the GSV. MOCA, UGFS, CAE, CONS and HL/S are not cost-effective at current prices in the UK National Health Service. MOCA and CAE appear promising but further evidence on effectiveness, re-interventions and health-related quality of life is needed, as well as how cost-effectiveness may vary across settings and reimbursement systems.
Tan K, Salim S, Machin M, et al., 2022, Abdominal aortic aneurysm clinical practice guidelines: a methodological assessment using the AGREE II instrument, BMJ Open, Vol: 12, Pages: 1-9, ISSN: 2044-6055
Objectives: Abdominal aortic aneurysm (AAA) clinical practice guidelines (CPGs) provide evidence-based information on patient management; however, methodological differences exist in the development of CPGs. This study examines the methodological quality of AAA CPGs using a validated assessment tool. Design: Medline, EMBASE and online CPG databases were searched from 1946 to 31st October 2021. Full-text, English language, evidence-based AAA CPGs were included. Consensus-based CPGs, summaries of CPGs or CPGs which were only available upon purchase were excluded. Five reviewers assessed their quality using the Appraisal of Guidelines for Research and Evaluation II instrument. An overall guideline assessment scaled score of ≥80% was considered as the threshold to recommend CPG use in clinical practice.Results: Seven CPGs were identified. Scores showed good inter-reviewer reliability (ICC 0.943, 95% CI 0.915-0.964). On average, CPGs performed adequately with mean scaled scores of over 50% in all domains. However, between CPGs, significant methodological heterogeneity was observed in all domains. Four CPGs scored ≥80% (European Society of Cardiology, the Society of Vascular Surgery, the European Society of Vascular Surgery, and the National Institute of Health and Care Excellence), supporting their use in clinical practice.Conclusions: Four CPGs were considered of adequate methodological quality to recommend their use in clinical practice; nonetheless, these still showed areas for improvement, potentially through performing economic analysis and trial application of recommendations. A structured approach employing validated CPG creation tools should be used to improve rigour of AAA CPGs. Future work should also evaluate recommendation accuracy using validated appraisal tools.
Belramman A, Bootun R, Tang TY, et al., 2022, Pain outcomes in a multicentre randomised clinical trial comparing MechanOChemical ablation versus CyanoAcrylate Adhesive for the treatment of primary truncal saphenous veins incompetence A Randomised Clinical Trial, JAMA Surgery, ISSN: 2168-6254
Importance Endovenous thermal ablations (ETAs) are recommended as first-line treatment of truncal vein reflux and have a short recovery time and are cost-effective. However, ETAs are associated with discomfort during tumescent anesthesia infiltration. To minimise discomfort, non-thermal, non tumescent ablation techniques, in the form of mechanochemical ablation (MOCA) and cyanoacrylate adhesive injection (CAE), have emerged. ObjectiveTo assess pain score immediately after truncal ablation using 100-mm Visual Analogue Scale and 10-point number scale. Design, Setting, and Participants The MOCCA study was a prospective, multicentre, randomised clinical trial, conducted at three sites between November 2017 and January 2020. There were 392 participants screened, 225 were excluded, and 167 participants underwent randomisation. Four participants did not receive allocated intervention and were included in the intention to treat analysis. Patients were reviewed at 2 weeks, and at 3, 6, and 12 months. Interventions Patients with primary truncal vein incompetence were randomised to receive either MOCA or CAE Main Outcomes and Measures Primary outcome measure was pain score immediately after completing truncal ablation using 100- mm Visual Analogue Scale (VAS) and 10-point number scale. Secondary outcome measures included degree of ecchymosis; occlusion rates, clinical severity, generic and disease specific quality of life (QoL) scores. Results 60% were women with mean age 56 years. 92.8% of truncal veins treated were GSV. Demographic data and baseline status was comparable. 47% underwent adjunctive treatment ofvaricosities. Overall median maximum pain score after truncal treatment was 23mm on VAS and 3 5 on number scale. There was no difference in pain measured by VAS (MOCA 24mm vs CAE 20mm, p = .230) or number scale (MOCA 4, vs CAE 3, p = .179). Both groups demonstrated significant and comparable improvement in clinical severity, generic and disease specific QoL scores, and c
Belramman A, Bootun R, Tjun Yip T, et al., 2022, Pain outcomes in a multicentre randomised clinical trial comparing MechanOChemical ablation versus CyanoAcrylate Adhesive for the treatment of primary truncal saphenous veins incompetence A Randomised Clinical Trial, JAMA Surgery, ISSN: 2168-6254
Benson RA, 2022, Documenting the recovery of vascular services in European centres following the initial COVID-19 pandemic peak: results from a multicentre collaborative study, EJVES Vascular Forum, Vol: 57, Pages: 28-34, ISSN: 2666-688X
ObjectiveTo document the recovery of vascular services in Europe following the first COVID-19 pandemic peak.MethodsAn online structured vascular service survey with repeated data entry between 23 March and 9 August 2020 was carried out. Unit level data were collected using repeated questionnaires addressing modifications to vascular services during the first peak (March – May 2020, “period 1”), and then again between May and June (“period 2”) and June and July 2020 (“period 3”). The duration of each period was similar. From 2 June, as reductions in cases began to be reported, centres were first asked if they were in a region still affected by rising cases, or if they had passed the peak of the first wave. These centres were asked additional questions about adaptations made to their standard pathways to permit elective surgery to resume.ResultsThe impact of the pandemic continued to be felt well after countries’ first peak was thought to have passed in 2020. Aneurysm screening had not returned to normal in 21.7% of centres. Carotid surgery was still offered on a case by case basis in 33.8% of centres, and only 52.9% of centres had returned to their normal aneurysm threshold for surgery. Half of centres (49.4%) believed their management of lower limb ischaemia continued to be negatively affected by the pandemic. Reduced operating theatre capacity continued in 45.5% of centres. Twenty per cent of responding centres documented a backlog of at least 20 aortic repairs. At least one negative swab and 14 days of isolation were the most common strategies used for permitting safe elective surgery to recommence.ConclusionCentres reported a broad return of services approaching pre-pandemic “normal” by July 2020. Many introduced protocols to manage peri-operative COVID-19 risk. Backlogs in cases were reported for all major vascular surgeries.
Long J, Atkin L, Gronlund T, et al., 2022, Research priorities for venous conditions: results of the UK Vascular James Lind Alliance Priority Setting Process, Journal of Vascular Societies Great Britain & Ireland, Vol: 22, ISSN: 2754-0022
<jats:p>Introduction: Venous disease comprises a range of conditions of varying severity, which can result in pain and discomfort and a reduced quality of life. The annual costs for the treatment and management of venous disease in the UK is in the order of billions of pounds. It is vitally important to direct finite National Health Service (NHS) funding into areas that will maximise health outcomes and reduce the burden on the NHS. To address the issue of where best to target resources and research, the Vascular Society of Great Britain and Ireland (VSGBI) in association with the James Lind Alliance (JLA) undertook a national Priority Setting Process (PSP) for vascular conditions. This paper presents the results of this process, with a focus on the topic of ‘venous conditions’. Methods: A modified JLA Priority Setting Partnership was developed to gather clinician, patient and carer research priorities for vascular conditions. Consensus workshops were held to discuss clinician and patient priorities and agree a list of joint research priorities. Consensus was achieved using the nominal group technique and a ranked ‘top 10’ list of research priorities for venous conditions was established. Results: In the first phase (clinician-led survey), 481 clinicians submitted 1,231 research questions related to vascular conditions in general. Of these, 130 venous-specific research priorities were reduced to 13 overarching summary priorities recirculated for interim scoring. In the second phase (patient and carer-led survey), 373 patients and carers submitted 582 research priorities. Of these, 101 venous-specific priorities were reduced to 22 overarching summary priorities and recirculated for interim scoring. In the third phase (consensus workshop), clinician and patient priorities were amalgamated into 14 priorities for discussion. The final ‘top 10’ list of venous condition research priorities relate to: access to specialist venous
Bootun R, Belramman A, Bolton-Saghdaoui L, et al., 2021, Randomized controlled trial of compression after endovenous thermal ablation of varicose veins (COMETA Trial), Journal of Vascular Surgery, Vol: 9, Pages: 103-104, ISSN: 0741-5214
Gwilym B, Maheswaran R, Edwards A, et al., 2021, Income deprivation and groin wound surgical site infection: cross-sectional analysis from the Groin wound Infection after Vascular Exposure (GIVE) multicentre cohort study, Surgical Infections, ISSN: 1096-2964
Gwilym BL, Ambler GK, Saratzis A, et al., 2021, Groin Wound Infection after Vascular Exposure (GIVE) Risk Prediction Models: Development, Internal Validation, and Comparison with Existing Risk Prediction Models Identified in a Systematic Literature Review, European Journal of Vascular and Endovascular Surgery, ISSN: 1078-5884
Ravikumar R, Lane TRA, Babber A, et al., 2021, A randomised controlled trial of neuromuscular stimulation in non-operative venous disease improves clinical and symptomatic status, Phlebology, Vol: 36, Pages: 290-302, ISSN: 0268-3555
BackgroundThis randomised controlled trial investigates the dosing effect of neuromuscular electrical stimulation (NMES) in patients with chronic venous disease (CVD).MethodsSeventy-six patients with CEAP C3-C5 were randomised to Group A (no NMES), B (30 minutes of NMES daily) or C (60 minutes of NMES daily). Primary outcome was percentage change in Femoral Vein Time Averaged Mean Velocity (TAMV) at 6 weeks. Clinical severity scores, disease-specific and generic quality of life (QoL) were assessed.ResultsSeventy-six patients were recruited - mean age 60.8 (SD14.4) and 47:29 male. Six patients lost to follow-up. Percentage change in TAMV (p<0.001) was significantly increased in Groups B and C. Aberdeen Varicose Veins Questionnaire Score (-6.9, p=0.029) and Venous Clinical Severity Score (-4, p-0.003) improved in Group C, and worsened in Group A (+1, p=0.025).ConclusionsDaily NMES usage increases flow parameters, with twice daily usage improving QoL and clinical severity at 6 weeks in CVD patients.
Staniszewska A, Gimzewska M, Onida S, et al., 2021, Lower extremity arterial interventions in England, ANNALS OF THE ROYAL COLLEGE OF SURGEONS OF ENGLAND, Vol: 103, Pages: 360-366, ISSN: 0035-8843
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Onida S, Heatley F, Peerbux S, et al., 2021, Study protocol for a multicentre, randomised controlled trial to compare the use of the decellularised dermis allograft in addition to standard care versus standard care alone for the treatment of venous leg ulceration: DAVE trial, BMJ Open, Vol: 11, ISSN: 2044-6055
Introduction Venous leg ulceration (VLU), the most common type of chronic ulcer, can be difficult to heal and is a major cause of morbidity and reduced quality of life. Although compression bandaging is the principal treatment, it is time-consuming and bandage application requires specific training. There is evidence that intervention on superficial venous incompetence can help ulcer healing and recurrence, but this is not accessible to all patients. Hence, new treatments are required to address these chronic wounds. One possible adjuvant treatment for VLU is human decellularised dermis (DCD), a type of skin graft derived from skin from deceased tissue donors. Although DCD has the potential to promote ulcer healing, there is a paucity of data for its use in patients with VLU.Methods and analysis This is a multicentre, parallel group, pragmatic randomised controlled trial. One hundred and ninety-six patients with VLU will be randomly assigned to receive either the DCD allograft in addition to standard care or standard care alone. The primary outcome is the proportion of participants with a healed index ulcer at 12 weeks post-randomisation in each treatment arm. Secondary outcomes include the time to index ulcer healing and the proportion of participants with a healed index ulcer at 12 months. Changes in quality of life scores and cost-effectiveness will also be assessed. All analyses will be carried out on an intention-to-treat (ITT) basis. A mixed-effects, logistic regression on the outcome of the proportion of those with the index ulcer healed at 12 weeks will be performed. Secondary outcomes will be assessed using various statistical models appropriate to the distribution and nature of these outcomes.Ethics and dissemination Ethical approval was granted by the Bloomsbury Research Ethics Committee (19/LO/1271). Findings will be published in a peer-reviewed journal and presented at national and international conferences.
Groin wound Infection after Vascular Exposure Study Group, Shalhoub J, 2021, Groin wound infection after vascular exposure (GIVE) multicentre cohort study, International Wound Journal, Vol: 18, Pages: 164-175, ISSN: 1742-4801
Background: Surgical site infections (SSIs) of groin wounds are a common and potentially preventable cause of morbidity, mortality and healthcare costs in vascular surgery. Our aim was to define the contemporaneous rate of groin SSIs, determine clinical sequelae, and identify risk factors for SSI.Method:An international multicentre prospective observational cohort study of consecutive patients undergoing groin incision for femoral vessel access in vascular surgery was undertaken over 3 months, follow up was 90 days. The primary outcome was incidence of groin wound SSI.Results:1337 groin incisions (1039 patients) from 37 centres were included. 115 groin incisions (8.6%) developed SSI, of which 62 (4.6%) were superficial. Patients who developed an SSI had a significantly longer length of hospital stay (6 vs 5 days, p=0.005), a significantly higher rate of post-operative acute kidney injury (19.6% vs 11.7%, p=0.018), with no significant difference in 90-day mortality. Female sex, Body Mass Index≥30kg/m2, ischaemic heart disease, aqueous betadine skin preparation, bypass/patch use (vein, xenograft or prosthetic) and increased operative time were independent predictors of SSI. Conclusion:Groin infections which are clinically apparent to the treating vascular unit are frequent and their development carries significant clinical sequelae. Risk factors include modifiable and non-modifiable variables.
Bootun R, Belramman A, Bolton-Saghdaoui L, et al., 2021, Randomized controlled trial of compression after endovenous thermal ablation of varicose veins (COMETA Trial), Annals of Surgery, Vol: 273, Pages: 232-239, ISSN: 0003-4932
Background: The 21st century has witnessed a rise in the use of endovenousthermal ablation. Being highly clinically and cost-effective and improving thequality of life of patients, they are now considered to be the ‘‘gold-standard’’treatment for varicose veins. Post-intervention management, especially interms of postoperative compression, however, remains unclear. As a result, arandomized study was undertaken to investigate the effects of wearingcompression stockings after varicose vein treatment.Method: Patients with saphenous vein reflux undergoing treatment withendothermal ablation (with or without concurrent phlebectomies) wererandomized to receive either 7 days of compression stockings or no stockings.The primary outcome measure for this study was the pain score over the first10 postoperative days. The pain scores, clinical score, time to return to normalactivities, and ecchymosis were assessed. Patients were followed-up at2 weeks and 6 months post-ablation.Results: In total, 206 patients were randomized, 49% of them to thecompression group. The mean age was 49.7 (16) years and approximately51% of the population was male. The median pain score in the compressiongroup using a visual analog scale was significantly lower on days 2–5,compared to the no compression group. Those having concurrent phlebectomies and compression stockings also had significantly better pain scores ondays 1–3, day 5, and day 7. Improvement in the median venous clinicalseverity score was noted at 6-month follow-up, but this was not significant. Nodifference in the generic- or disease-specific quality of life was observed andthe time to return to activities was similar. There were no differences in thedegree of ecchymosis between the 2 groups and both groups had similarocclusion rates.Conclusions: These results indicate that wearing compression stockings afterendothermal ablation is advantageous in the first few days after treatment andis especially benef
Tan K, Salim S, Beshr M, et al., 2020, A methodological assessment of lymphoedema clinical practice guidelines, Journal of vascular surgery. Venous and lymphatic disorders, Vol: 8, Pages: 1111-1118.e3, ISSN: 2213-3348
ObjectivesTo determine the methodological quality of current lymphoedema clinical practice guidelines (CPGs) to assist healthcare professionals in selecting accessible, high-quality guidance and to identify areas for improvement in future CPGs.MethodsMedline, EMBASE, online CPG databases and reference lists of included guidelines were searched up to 31st January 2020. Full-text CPGs reporting on evidence-based recommendations in lymphoedema diagnosis and/or management in English were included. CPGs based on expert consensus, CPG summaries or CPGs that were not freely available were excluded. Two reviewers identified eligible CPGs, extracted data and assessed their quality independently using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument. Significant scoring discrepancies were discussed with a third reviewer. An overall scaled quality score of ≥80% was the threshold to recommend guideline use.ResultsSix relevant CPGs were identified. One was subsequently excluded as its full-text could not be obtained. Overall, there was very good inter-reviewer reliability of scores with ICC of 0.952 (95% CI, 0.921-0.974). No single CPG scored highest in all domains, with methodological heterogeneity observed. Poor performance was noted in domains 5 (mean scaled score 23.8±17.1%) and 6 (22.9±26.7%). No CPG achieved an overall scaled quality score of ≥80%, with the top CPG scoring 79.2%.ConclusionsAccording to the defined threshold, no lymphoedema CPG was considered adequate for use in clinical practice. All current lymphoedema CPGs have areas for improvement with elements of methodological quality lacking, particularly with respect to rigour of development. A structured approach, guided by the use of CPG creation tools and checklists such as the AGREE II instrument, should help CPG development groups in improving the quality of future CPGs; this is of particular importance in a complex, multidisciplinary condition such as lympho
Staniszewska A, Onida S, Lane T, et al., 2020, The good, bad and the ugly of the acute venous thrombosis: thrombus removal with adjunctive catheter-directed thrombolysis trial from the viewpoint of clinicians, Journal of vascular surgery. Venous and lymphatic disorders, Vol: 8, Pages: 912-918, ISSN: 2213-3348
OBJECTIVE: Acute deep venous thrombosis (DVT) can be complicated by post-thrombotic syndrome, which is associated with significant morbidity and healthcare costs. The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) was the largest and most controversial randomized controlled trial evaluating the use of pharmacomechanical catheter-directed thrombolysis (CDT) for the prevention of post-thrombotic syndrome after acute DVT. This study aimed to evaluate clinicians' opinion on the ATTRACT trial and its impact on clinical practice. METHODS: An online survey consisting of 10 core multiple choice items and a maximum of five follow-up open-ended questions was delivered to vascular surgeons, interventional radiologists, hematologists, and interventional cardiologists affiliated with 10 international societies between April 23 and July 1, 2019. Clinicians' views on the main limitations of the ATTRACT trial, its impact on patient selection for thrombolysis and the need for a new trial were evaluated. RESULTS: Out of 15,650 contacted clinicians, 451 (3%) completed the survey, with 74% vascular surgeons, 24% interventional radiologists, 2% hematologists, and 0.2% interventional cardiologists. The majority of respondents (79%) were aware of the results of the ATTRACT trial before completing the survey and routinely performed pharmacomechanical CDT (PCDT) in their centers (70%). Only 20% of clinicians considered ATTRACT to be a well-designed and well-performed trial. The inclusion of femoropopliteal DVT was reported as the main limitation of the trial by 55% of respondents. Despite half of the participating clinicians reporting no change in their clinical practice, equal number of clinicians (14%) were encouraged and discouraged from treating iliofemoral DVT. More than one-half of the respondents thought that the use of PCDT would be defensible in a court of law despite the increased risk of bleeding reported in the study. Nearly tw
Lane TRA, Davies AH, 2020, Diagnosis and management of abdominal aortic aneurysm, Practitioner, Vol: 264, Pages: 11-14, ISSN: 0032-6518
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