125 results found
Epstein D, Bootun R, Diop M, et al., 2021, Cost-effectiveness Analysis of Current Varicose Veins Treatments., J Vasc Surg Venous Lymphat Disord
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.
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.
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
Encarnacion S N, Onida S, Lane TR, et al., 2020, Do we need another modality for truncal vein ablation?, Phlebology, Vol: 35, Pages: 644-646, ISSN: 0268-3555
Benson RA, 2020, Global impact of the first coronavirus disease 2019 (COVID-19) pandemic wave on vascular services, British Journal of Surgery, Vol: 107, Pages: 1396-1400, ISSN: 0007-1323
This online structured survey has demonstrated the global impact of the COVID‐19 pandemic on vascular services. The majority of centres have documented marked reductions in operating and services provided to vascular patients. In the months during recovery from the resource restrictions imposed during the pandemic peaks, there will be a significant vascular disease burden awaiting surgeons.
Dattani N, Shalhoub J, Nandhra S, et al., 2020, Reducing the risk of venous thromboembolism following superficial endovenous treatment: a UK and Republic of Ireland consensus study, Phlebology, Vol: 35, Pages: 706-714, ISSN: 0268-3555
ObjectivesVenous thromboembolism is a potentially fatal complication of superficial endovenous treatment. Proper risk assessment and thromboprophylaxis could mitigate this hazard; however, there are currently no evidence-based or consensus guidelines. This study surveyed UK and Republic of Ireland vascular consultants to determine areas of consensus.MethodsA 32-item survey was sent to vascular consultants via the Vascular and Endovascular Research Network (phase 1). These results generated 10 consensus statements which were redistributed (phase 2). ‘Good’ and ‘very good’ consensus were defined as endorsement/rejection of statements by >67% and >85% of respondents, respectively.ResultsForty-two consultants completed phase 1. This generated seven statements regarding risk factors mandating peri-procedural pharmacoprophylaxis and three statements regarding specific pharmacoprophylaxis regimes. Forty-seven consultants completed phase 2. Regarding venous thromboembolism risk factors mandating pharmacoprophylaxis, ‘good’ and ‘very good’ consensus was achieved for 5/7 and 2/7 statements, respectively. Regarding specific regimens, ‘very good’ consensus was achieved for 3/3 statements.ConclusionsThe main findings from this study were that there was ‘good’ or ‘very good’ consensus that patients with any of the seven surveyed risk factors should be given pharmacoprophylaxis with low-molecular-weight heparin. High-risk patients should receive one to two weeks of pharmacoprophylaxis rather than a single dose.
Goodall R, Langridge B, Lane T, et al., 2020, A narrative review of the use of neuromuscular electrical stimulation in individuals with diabetic foot ulceration, International Journal of Lower Extremity Wounds, Vol: 19, Pages: 242-250, ISSN: 1534-7346
This review aims to summarise the evidence reported on the use of neuromuscular electrical stimulation (NMES) in individuals with diabetic foot ulceration (DFU).A systematic search of EMBASE and MEDLINE databases was performed in February 2019, using search terms relating to the domains DFU and NMES. All primary evidence assessing outcomes of NMES in DFU were included. Of 344 references obtained from database searching, seven met the inclusion criteria and included a total of 140 participants, 77 of whom had DFU. All included studies used prospective designs. Two studies demonstrated improvements in chronic ulcer healing with NMES use, however in each study, only three of the included participants had DFU and subgroup analyses based on ulcer aetiology was omitted. The remaining five studies were produced by the same research group and positive effects of NMES (in combination with heat therapy) on DFU healing were consistently demonstrated. They reported significantly better healing rates with NMES in DFU than in non-diabetic wounds of a similar grade (Healing rate: 70.0±32.3% in DFU vs. 38.4±22.3% in non diabetic ulcers (p<0.01)). These studies did not provide data assessing the isolated effects of NMES without concomitant heat exposure. Data on device tolerability and compliance were lacking. The existing data supports a potential role for NMES in individuals with DFU, however the identified studies inadequately controlled for confounding and were underpowered. Given the significant morbidity and mortality associated with DFU, higher quality evidence is needed to assess the adjunctive role for NMES in this group.
Langridge BJ, Onida S, Weir J, et al., 2020, Cyanoacrylate glue embolisation for varicose veins - A novel complication, Phlebology, Vol: 35, Pages: 520-523, ISSN: 0268-3555
BackgroundNon-thermal non-tumescent methods for varicose vein treatment have rapidly gained popularity in recent years due to clinical efficacy comparable to other endovenous methods, but with a superior safety and tolerability profile. Cyanoacrylate is an adhesive that rapidly polymerises during endovenous treatment to cause rapid occlusion of veins and initiate vein fibrosis.MethodCyanoacrylate glue treatment is known to cause complications such as phlebitis, cellulitis and deep vein thrombosis in rare instances. We present the first reported case of cyanoacrylate extravasation with chronic foreign body reaction in a patient nine months after initial treatment.ResultsWe discuss the aetiology of this complication, its treatment, patient outcome and its significance to both clinicians and patients.ConclusionCyanoacrylate glue embolisation can, in rare instances, lead to extravasation and chronic foreign body reaction, necessitating surgical intervention. The relative novelty of cyanoacrylate glue embolisation in the treatment of varicose veins requires clinicians to monitor for rare complications during its use in clinical practice. Patients should be aware of the rare risk of glue extravasation and foreign body reaction for fully informed consent prior to treatment.
Dattani N, Shalhoub J, Nandhra S, et al., 2020, Corrigendum to Reducing the risk of venous thromboembolism following superficial endovenous treatment: A UK and Republic of Ireland consensus study, Phlebology, Vol: 35, Pages: 844-844, ISSN: 0268-3555
BACKGROUND: Median arcuate ligament syndrome (MALS) describes the clinical presentation associated with direct compression of the celiac artery by the median arcuate ligament. The poorly understood pathophysiologic mechanism, variable symptom severity, and unpredictable response to treatment make MALS a controversial diagnosis. METHODS: This review summarizes the literature pertaining to the pathophysiologic mechanism, presentation, diagnosis, and management of MALS. A suggested diagnostic workup and treatment algorithm are presented. RESULTS: Individuals with MALS present with signs and symptoms of foregut ischemia, including exercise-induced or postprandial epigastric pain, nausea, vomiting, and weight loss. Consideration of MALS in patients' diagnostic workup is typically delayed. Currently, no group consensus agreement as to the diagnostic criteria for MALS exists; duplex ultrasound, angiography, and gastric exercise tonometry are used in different combinations and with varying diagnostic values throughout the literature. Surgical management involves decompression of the median arcuate ligament's constriction of the celiac artery; robotic, laparoscopic, endoscopic retroperitoneal, and open surgical intervention can provide effective symptom relief, but long-term follow-up data (>5 years) are lacking. Patients treated nonoperatively appear to have worse outcomes. CONCLUSIONS: MALS is an important clinical entity with significant impact on affected individuals. Presenting symptoms, patient demographics, and radiologic signs are generally consistent, as is the short-to medium-term (<5 years) response to surgical intervention. Future prospective studies should directly compare long-term symptomatic and quality of life outcomes after nonoperative management with outcomes after open, laparoscopic, endoscopic retroperitoneal, and robotic celiac artery decompression to enable the development of evidence-based guidelines for the management of MALS.
Lane T, Onida S, Davies A, 2020, Comment on: Strength of public preferences for endovascular or open aortic aneurysm repair, BRITISH JOURNAL OF SURGERY, Vol: 107, Pages: 613-613, ISSN: 0007-1323
Babber A, Ravikumar R, Onida S, et al., 2020, Effect of footplate neuromuscular electrical stimulation on functional and quality‐of‐life parameters in patients with peripheral artery disease: pilot, and subsequent randomized clinical trial, British Journal of Surgery, Vol: 107, Pages: 355-363, ISSN: 0007-1323
BackgroundSupervised exercise programmes for intermittent claudication have poor access and limited compliance. Neuromuscular electrical stimulation (NMES) may be an effective alternative. A proof‐of‐concept study and RCT were conducted.MethodsIn study 1, eligible patients underwent baseline assessment; treadmill testing for initial (ICD) and maximum (MCD) claudication distance; EuroQoL Five Dimensions five‐level instrument (EQ‐5D‐5L™) and Intermittent Claudication Questionnaire (ICQ) assessment; and measurement of ultrasound haemodynamics of the superficial femoral artery. After familiarization with the NMES device, participants underwent a 30‐min session of stimulation with concomitant recording of haemodynamic measures at 15 min, and after device cessation. Measurements were repeated after 6 weeks of daily use of NMES. In study 2, consecutive patients underwent baseline assessment before online randomization to a supervised exercise programme only, or adjunctive NMES treatment for 6 weeks, followed by repeat measurements.ResultsStudy 1 (20 patients) showed a significant improvement in MCD (46 per cent; P < 0·001) and ICD (71 per cent; P < 0·001). The RCT (42 patients) showed a significant adjunctive benefit of NMES in ICD (46 per cent; P = 0·014). Improvements were seen in the ICQ (9 points; P = 0·009) and EQ‐5D‐5L™ (P = 0·007) in study 1, and there was a significant adjunctive benefit of NMES on the ICQ score in patients who did supervised exercise (11·2 points; P = 0·031). Blood volume flow and time‐adjusted mean velocity increased significantly with the device on (P < 0·050). Overall, NMES compliance exceeded 95 per cent.ConclusionFootplate NMES significantly improved walking distance in patients with intermittent claudication when used independently and also as an ad
Saratzis A, Joshi S, Benson RA, et al., 2019, Acute Kidney Injury (AKI) in Aortic Intervention: Findings From the Midlands Aortic Renal Injury (MARI) Cohort Study, European Journal of Vascular and Endovascular Surgery, ISSN: 1078-5884
Belramman A, Bootun R, Onida S, et al., 2019, ClariVein®, mechanochemical endovenous ablation: patient selection and perspective, Journal of Vascular Diagnostics and Interventions, Vol: 7, Pages: 1-8, ISSN: 2463-5618
The American Venous Forum and the National Institute for Health and Care Excellence recommend endothermal ablation (ETA) techniques as the first line treatment for superficial venous incompetence. However, these techniques require the use of tumescent anaesthesia prior to energy delivery, which may be a source of discomfort for the patient and can prolong procedure time. Recently, nonthermal, nontumescent (NTNTs) techniques such as mechanochemical ablation (MOCA) have been developed to address some of the negative aspects associated with ETA. This article reviews this technique from a patient selection and perspective point view.
Goodall R, Langridge B, Lane T, et al., 2019, A systematic review of the use of neuromuscular electrical stimulation in individuals with diabetic foot disease, International Surgical Congress of the Association-of-Surgeons-of-Great-Britain-and-Ireland (ASGBI), Publisher: Wiley, Pages: 44-44, ISSN: 0007-1323
Saratzis A, Jaspers NEM, Gwilym B, et al., 2019, Observational study of the medical management of patients with peripheral artery disease, British Journal of Surgery, Vol: 106, Pages: 1168-1177, ISSN: 0007-1323
BackgroundPrevious research has suggested that patients with peripheral artery disease (PAD) are not offered adequate risk factor modification, despite their high cardiovascular risk. The aim of this study was to assess the cardiovascular profiles of patients with PAD and quantify the survival benefits of target‐based risk factor modification.MethodsThe Vascular and Endovascular Research Network (VERN) prospectively collected cardiovascular profiles of patients with PAD from ten UK vascular centres (April to June 2018) to assess practice against UK and European goal‐directed best medical therapy guidelines. Risk and benefits of risk factor control were estimated using the SMART‐REACH model, a validated cardiovascular prediction tool for patients with PAD.ResultsSome 440 patients (mean(s.d.) age 70(11) years, 24·8 per cent women) were included in the study. Mean(s.d.) cholesterol (4·3(1·2) mmol/l) and LDL‐cholesterol (2·7(1·1) mmol/l) levels were above recommended targets; 319 patients (72·5 per cent) were hypertensive and 343 (78·0 per cent) were active smokers. Only 11·1 per cent of patients were prescribed high‐dose statin therapy and 39·1 per cent an antithrombotic agent. The median calculated risk of a major cardiovascular event over 10 years was 53 (i.q.r. 44–62) per cent. Controlling all modifiable cardiovascular risk factors based on UK and European guidance targets (LDL‐cholesterol less than 2 mmol/l, systolic BP under 140 mmHg, smoking cessation, antiplatelet therapy) would lead to an absolute risk reduction of the median 10‐year cardiovascular risk by 29 (20–38) per cent with 6·3 (4·0–9·3) cardiovascular disease‐free years gained.ConclusionThe medical management of patients with PAD in this secondary care cohort was suboptimal. Controlling modifiable risk factors to guideline‐based targets would confer significant patient benefit.
Llwyd Gwilym B, Saratzis A, Benson R, et al., 2019, Study protocol for the Groin wound Infection after Vascular Exposure (GIVE) audit and multicentre cohort study, International Journal of Surgery Protocols, Vol: 16, Pages: 9-13, ISSN: 2468-3574
IntroductionSurgical site infections (SSI) following groin incision for arterial exposure are commonplace and a significant cause of morbidity and mortality following major arterial surgery. Published incidence varies considerably. The primary aim of GIVE will be to compare individual units’ practice with established guidelines from The National Institute for Health and Care Excellence (NICE). Secondary aims will be to describe the contemporary rate of SSI in patients undergoing groin incision for arterial exposure, to identify risk factors for groin wound infection, to examine the value of published tools in the prediction of SSI, to identify areas of equipoise which could be examined in future efficacy/effectiveness trials and to compare UK SSI rates with international centres.Methodsand analysisThis international, multicentre, prospective observational study will be delivered via the Vascular and Endovascular Research Network (VERN). Participating centres will identify all patients undergoing clean emergency or elective groin incision(s) for arterial intervention during a consecutive 3-month period. Follow up data will be captured at 90 days after surgery. SSIs will be defined according as per the Centres for Disease Control and Prevention (CDC) criteria. Data will be gathered centrally using an anonymised electronic data collection tool or secure email transfer.Ethics and disseminationThis study will be registered as a clinical audit at all participating UK centres; research ethics approval is not required. National leads will oversee the appropriate registration and approvals in countries outside the UK as required. Site specific reports of SSI rates will be provided to each participating centre. Study results will be disseminated locally at each site, publicised on social media and submitted for peer-reviewed publication.
Belramman A, Bootun R, Lane TRA, et al., 2019, Foam sclerotherapy versus ambulatory phlebectomy for the treatment of varicose vein tributaries: study protocol for a randomised controlled trial, Trials, Vol: 20, ISSN: 1745-6215
BackgroundAmbulatory phlebectomies and foam sclerotherapy are two of the most common treatments for varicose vein tributaries. Many studies have been published on these treatments, but few comparative studies have attempted to determine their relative effectiveness.Methods/designThis is a prospective single-centre randomised clinical trial. Patients with primary truncal vein incompetence and varicose vein tributaries requiring treatment will be assigned randomly to either ambulatory phlebectomies or foam sclerotherapy. The primary outcome measure is the re-intervention rate for the varicose vein tributaries during the study period. The secondary outcomes include the degree of pain during the first two post-operative weeks and the time to return to usual activities or work. Improvements in clinical scores, quality of life scores, occlusion rates and cost-effectiveness for each intervention are other secondary outcomes. The re-intervention rate will be considered from the third month.DiscussionThis study compares ambulatory phlebectomies and foam sclerotherapy in the treatment of varicose vein tributaries. The re-intervention rates, safety, patient experience and the cost-effectiveness of each intervention will be assessed. This study aims to recruit 160 patients and is expected to be completed by the end of 2019.Trial registrationClinicalTrials.gov, NCT03416413. Registered on 31 January 2018.
Taha MA, Lane T, Shalhoub J, et al., 2019, Endovenous stenting in chronic venous disease secondary to iliac vein obstruction, Italian Journal of Vascular and Endovascular Surgery, Vol: 26, Pages: 89-99, ISSN: 1824-4777
Endovenous stenting has become the treatment of choice for chronic (thrombotic or non-thrombotic) venous obstructive iliac disease. This review aims to focus on the role of venous stents in the management of chronic conditions affecting the deep venous systems of the lower limbs. In addition, the review provides an overview on chronic venous outflow obstructive diseases.
Belramman A, Bootun R, Lang TY, et al., 2019, EARLY RESULTS OF A RANDOMISED CLINICAL TRIAL OF MECHANOCHEMICAL ABLATION VERSUS CYANOACRYLATE ADHESIVE FOR THE TREATMENT OF VARICOSE VEINS (MOCCA), Joint Meeting of the Royal-Society-of-Medicine / Annual Meeting of the Society-of-Academic-and-Research-Surgery, Publisher: WILEY, Pages: 25-25, ISSN: 0007-1323
Epstein DM, Gohel MS, Heatley F, et al., 2019, Cost-effectiveness analysis of a randomized clinical trial of early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration, British Journal of Surgery, Vol: 106, Pages: 555-562, ISSN: 0007-1323
BackgroundTreatment of superficial venous reflux in addition to compression therapy accelerates venous leg ulcer healing and reduces ulcer recurrence. The aim of this study was to evaluate the costs and cost‐effectiveness of early versus delayed endovenous treatment of patients with venous leg ulcers.MethodsThis was a within‐trial cost‐utility analysis with a 1‐year time horizon using data from the EVRA (Early Venous Reflux Ablation) trial. The study compared early versus deferred endovenous ablation for superficial venous truncal reflux in patients with a venous leg ulcer. The outcome measure was the cost per quality‐adjusted life‐year (QALY) over 1 year. Sensitivity analyses were conducted with alternative methods of handling missing data, alternative preference weights for health‐related quality of life, and per protocol.ResultsAfter early intervention, the mean(s.e.m.) cost was higher (difference in cost per patient £163(318) (€184(358))) and early intervention was associated with more QALYs at 1 year (mean(s.e.m.) difference 0·041(0·017)). The incremental cost‐effectiveness ratio (ICER) was £3976 (€4482) per QALY. There was an 89 per cent probability that early venous intervention is cost‐effective at a threshold of £20 000 (€22 546)/QALY. Sensitivity analyses produced similar results, confirming that early treatment of superficial reflux is highly likely to be cost‐effective.ConclusionEarly treatment of superficial reflux is highly likely to be cost‐effective in patients with venous leg ulcers over 1 year. Registration number: ISRCTN02335796 (http://www.isrctn.com).
Saratzis A, Jaspers N, Gwilym B, et al., 2019, Current medical management of patients with peripheral arterial disease and potential benefits of risk-factor optimization: findings from a prospective national cohort by the Vascular and Endovascular Research Network (VERN) collaboration, British Journal of Surgery, ISSN: 1365-2168
Background: Previous research suggests patients with Peripheral Arterial Disease (PAD) are not offered adequate risk-factor modification, despite their high cardiovascular risk. We aimed to assess the cardiovascular profiles of patients with PAD in the UK and quantify the survival benefits of target-based risk-factor modification. Methods: The Vascular and Endovascular Research Network (VERN) prospectively collected cardiovascular profiles of patients with PAD from ten UK vascular centres (April - June 2018) to assess practice against UK and European goal-directed BMT guidelines. Risk and benefits of risk-factor control were estimated using the SMART-REACH model, a validated cardiovascular prediction tool for patients with PAD. Results: Overall, 440 patients (mean age: 70±11 years, 24% female) were included. Mean cholesterol (4.3±1.2 mmol/L) and LDL (2.7±1.1 mmol/L) levels were above recommended levels; 319 (73%) patients were hypertensive and 343 (78%) were smokers. Only 12% of patients were prescribed high-dose statin therapy and 39% an antithrombotic agent. The median risk of a major cardiovascular event over 10-years was 53% [Interquartile Range (IQR): 44-62%]. Controlling all modifiable cardiovascular risk-factors based on UK and European guidance targets (LDL<2mmol/L, SBP<140mmHg, smoking cessation, antiplatelet therapy) would lead to an absolute risk reduction of the median 10-year cardiovascular risk by 29% (range: 20-38%) with 6.3 cardiovascular disease-free years gained (range: 4.0-9.3 years).Conclusion: The medical management of patients with PAD is suboptimal. Controlling modifiable risk-factors to guideline-based targets confers a large therapy-benefit from both a 10-year and a lifetime perspective.
Varicose veins are common and affect a significant proportion of the UK population. They negatively impact on patients’ quality of life and are an important cause of morbidity. 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 commonly performed include radiofrequency ablation and endovenous laser ablation, both endothermal techniques 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. 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.
Bootun R, Lane TRA, Davies AH, 2018, One-stop vein clinic: The ideal option, Venous Disorders: Current Concepts, Pages: 225-233, ISBN: 9789811311079
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