92 results found
Geoghegan L, Super J, Machin M, et al., 2021, Are venous thromboembolism risk assessment tools reliable in the stratification of microvascular risk following lower extremity reconstruction?, JPRAS Open, Vol: 29, Pages: 45-54, ISSN: 2352-5878
IntroductionThe incidence of flap failure is significantly higher in the lower extremity compared to free tissue transfer in the head, neck and breast. The most common cause of flap failure is venous thrombosis. The aim of this study was to assess the reliability of venous thromboembolism (VTE) risk assessment tools in this high-risk cohort and to assess the ability of such tools to identify patients at risk of developing microvascular venous thrombosis and venous thromboembolism following lower extremity free flap reconstruction.MethodsA single centre retrospective cohort study was conducted between August 2012-August 2019. Adult patients who had undergone free tissue transfer following open lower extremity fractures were eligible for inclusion. All patients were retrospectively risk assessed using the Department of Health (DoH), Modified Caprini and Padua VTE risk assessment tools.ResultsFifty-eight patients were included; all were at high risk of DVT according to the DoH (mean score ± SD, 3.7 ± 0.93), Caprini (10.2 ± 1.64) and Padua (5.4 ± 0.86) risk assessment tools. All patients received appropriate thromboprophylaxis; the incidence of symptomatic hospital acquired VTE was 3.5%. Micro-anastomotic venous thrombosis occurred in 4 patients resulting in one amputation. Partial flap necrosis occurred in 7 patients. There were no significant differences in scaled Caprini (median score, 10 vs 9, z = 1.289, p = 0.09), DoH (3 vs 3, z = 0.344, p = 0.36), and Padua (5 vs 5.5, z= -0.944, p = 0.17) scores between those with and without microvascular venous thrombosis.ConclusionThis data suggests that current VTE risk assessment tools do not predict risk of microvascular venous thrombosis following lower extremity reconstruction. Further prospective studies are required to optimise risk prediction models and thromboprophylaxis use in this cohort.
Geoghegan L, Onida S, Davies AH, 2021, The use of venous-specific preference based measures in health economic evaluation: Comparing apples and pears?, PHLEBOLOGY, ISSN: 0268-3555
Sutanto SA, Tan M, Onida S, et al., 2021, A systematic review on isolated coil embolization for pelvic venous reflux., J Vasc Surg Venous Lymphat Disord
OBJECTIVE: Pelvic venous reflux (PVR) can present with symptoms such as chronic pelvic pain, dysmenorrhea, and dyspareunia, resulting in a decreased quality of life among those affected. Percutaneous coil embolization (CE) is a common intervention for PVR; however, the efficacy and safety of its use in isolation has yet to be reviewed. METHODS: The MEDLINE and EMBASE databases were systematically searched from 1990 to July 20, 2020, for studies reporting on adult patients undergoing isolated CE for PVR. Articles not in English, case reports, studies reporting on pediatric patients, and studies not performing isolated CE were excluded. Search, review, and data extraction were performed by two independent reviewers (S.S. and M.T.). Changes in pain before and after CE was evaluated through a pooled analysis of visual analogue scale scores in seven studies. RESULTS: A total of 970 patients (range, 3-218, 100% female) undergoing isolated ovarian vein or mixed veins embolization from 20 studies were included. Pooled analysis revealed mean improvements of 5.47 points (95% CI, 4.77-6.16) on the visual analogue scale. Common symptoms such as urinary urgency and dyspareunia reported significant improvements of 78-100% and 60-89.5% respectively. Complications were rare, with coil migration (n = 19) being the most common. Recurrence rates differed based on the varying symptoms and studies, with recurrence in pain 1-2 years after CE ranging from 5.9-25%. Two randomized controlled trials revealed improved clinical outcomes with CE as compared with vascular plugs and hysterectomy. CONCLUSIONS: The current data suggests that isolated CE is technically effective and can result in clinical improvement among patients with PVR. However, further trials are required to ascertain its long-term effects.
Cruddas L, Onida S, Davies AH, 2021, Venous aneurysms: When should we intervene?, PHLEBOLOGY, ISSN: 0268-3555
Guni A, Machin M, Onida S, et al., 2021, Acute iliofemoral DVT – what evidence is required to justify catheter-directed thrombolysis?, Phlebology, Vol: 36, Pages: 339-341, ISSN: 0268-3555
Bergner R, Onida S, Velineni R, et al., 2021, Metabolic profiling reveals changes in serum predictive of venous ulcer healing, Annals of Surgery, ISSN: 0003-4932
Objective: The aim of this study was to identify potential biomarkers predictive of healing or failure to heal in a population with venous leg ulceration.Summary Background Data: Venous leg ulceration presents important physical, psychological, social and financial burdens. Compression therapy is the main treatment, but it can be painful and time-consuming, with significant recurrence rates. The identification of a reliable biochemical signature with the ability to identify nonhealing ulcers has important translational applications for disease prognostication, personalized health care and the development of novel therapies.Methods: Twenty-eight patients were assessed at baseline and at 20 weeks. Untargeted metabolic profiling was performed on urine, serum, and ulcer fluid, using mass spectrometry and nuclear magnetic resonance spectroscopy.Results: A differential metabolic phenotype was identified in healing (n = 15) compared to nonhealing (n = 13) venous leg ulcer patients. Analysis of the assigned metabolites found ceramide and carnitine metabolism to be relevant pathways. In this pilot study, only serum biofluids could differentiate between healing and nonhealing patients. The ratio of carnitine to ceramide was able to differentiate between healing phenotypes with 100% sensitivity, 79% specificity, and 91% accuracy.Conclusions: This study reports a metabolic signature predictive of healing in venous leg ulceration and presents potential translational applications for disease prognostication and development of targeted therapies.
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.
Salim S, Tan M, Geoghegan L, et al., 2021, A systematic review assessing the quality of clinical practice guidelines in chronic venous disease, JOURNAL OF VASCULAR SURGERY-VENOUS AND LYMPHATIC DISORDERS, Vol: 9, Pages: 787-+, ISSN: 2213-333X
Cruddas L, Onida S, Davies AH, 2021, What, if anything, should replace the Villalta score for post thrombotic syndrome?, PHLEBOLOGY, ISSN: 0268-3555
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.
Salim S, Heatley F, Bolton L, et al., 2021, The management of venous leg ulceration post the EVRA (early venous reflux ablation) ulcer trial: Management of venous ulceration post EVRA, Phlebology, Vol: 36, Pages: 203-208, ISSN: 0268-3555
ObjectivesThis survey study evaluates current management strategies for venous ulceration and the impacts of the EVRA trial results.MethodsAn online survey was disseminated to approximately 15000 clinicians, through 12 vascular societies in 2018. Survey themes included: referral times, treatment times and strategies, knowledge of the EVRA trial and service barriers to managing venous ulceration. Data analysis was performed using Microsoft Excel and SPSS.Results664 responses were received from 78 countries. Respondents were predominantly European (55%) and North American (23%) vascular surgeons (74%). Responses varied between different countries. The median vascular clinic referral time was 6 weeks and time to be seen in clinic was 2 weeks. This was significantly higher in the UK (p ≤ 0.02). 77% of respondents performed surgical/endovenous interventions prior to ulcer healing, the median time to intervention was 4 weeks. 31% of participants changed their practice following EVRA. Frequently encountered barriers to implementing change were a lack of operating space/time (18%).ConclusionVenous ulcers are not managed as quickly as they should be. An evaluation of local resource requirements should be performed to improve service provision for venous ulceration. When interpreting the results of this survey consideration should be given to the response rate.
Gwilym B, Dovell G, Dattani N, et al., 2021, Systematic review and meta-analysis of wound adjuncts for the prevention of groin wound surgical site infection in arterial surgery, European Journal of Vascular and Endovascular Surgery, Vol: 61, Pages: 636-646, ISSN: 1078-5884
Review methodsThis review was undertaken according to established international reporting guidelines and was registered prospectively with the International prospective register of systematic reviews (CRD42020185170). The MEDLINE, EMBASE, and CENTRAL databases were searched using pre-defined search terms without date restriction. Randomised controlled trials (RCTs) and observational studies recruiting patients with non-infected groin incisions for arterial exposure were included; SSI rates and other outcomes were captured. Interventions reported in two or more studies were subjected to meta-analysis.ResultsThe search identified 1 532 articles. Seventeen RCTs and seven observational studies, reporting on 3 747 patients undergoing 4 130 groin incisions were included. A total of seven interventions and nine outcomes were reported upon. Prophylactic closed incision negative pressure wound therapy (ciNPWT) reduced groin SSIs compared with standard dressings (odds ratio [OR] 0.34, 95% CI 0.23 – 0.51; p < .001, GRADE strength of evidence: moderate). Local antibiotics did not reduce groin SSIs (OR 0.60 95% CI 0.30 – 1.21 p = .15, GRADE strength: low). Subcuticular sutures (vs. transdermal sutures or clips) reduced groin SSI rates (OR 0.33, 95% CI 0.17 – 0.65, p = .001, GRADE strength: low). Wound drains, platelet rich plasma, fibrin glue, and silver alginate dressings did not show any significant effect on SSI rates.ConclusionThere is evidence that ciNPWT and subcuticular sutures reduce groin SSI in patients undergoing arterial vascular interventions involving a groin incision. Local antibiotics did not reduce groin wound SSI, although the strength of this evidence is lower. No other interventions demonstrated a significant effect.
Machin M, Younan H-C, Guéroult A, et al., 2021, Systematic review of inframalleolar endovascular interventions and rates of limb salvage, wound healing, restenosis, rest pain, reintervention and complications, Vascular, ISSN: 0967-2109
ObjectivesPeripheral artery disease is estimated to affect 237 million individuals worldwide. Critical limb ischaemia, also known as chronic limb threatening ischaemia is a consequence of the progression of peripheral artery disease which occurs in ∼21% of patients over a five-year period. The aim of this systematic review is to assess the use of additional below-the-ankle angioplasty in comparison to the use of above-the-ankle angioplasty alone, and the subsequent rates of amputation, wound healing, restenosis, rest pain, reintervention and complications.MethodsThis systematic review was undertaken in accordance with PRISMA guidelines following a registered protocol (CRD42019154893). Online databases were searched using a search strategy of 20 keywords. Included articles reported the outcome for inframalleolar (pedal artery, pedal arch, plantar arteries) angioplasty with additional proximal angioplasty in comparison to proximal angioplasty alone. GRADE assessment was applied to assess the quality of the evidence.ResultsAfter screening 1089 articles, 10 articles met the inclusion criteria. Comparative performance assessment of below-the-ankle with above-the-ankle versus above-the-ankle angioplasty alone was undertaken in 3 articles, with the remaining 7 articles reporting outcomes of below-the-ankle with above-the-ankle angioplasty with no distinct comparator group. Significant decrease in major lower limb amputation at the last follow-up in the below-the-ankle group when compared with the above-the-ankle angioplasty alone group was observed in a single study (3.45% vs. 14.9%, p < 0.05). Improved wound healing rate at follow-up in the below-the-ankle group versus above-the-ankle angioplasty alone group was also reported in a single study (59.3% vs. 38.1%, p < 0.05). Subsequent rate of amputation after below-the-ankle angioplasty has been estimated as 23.5%.ConclusionTo date, there is a lack of studies assessing inframalleolar in
Richards T, Anwar M, Beshr M, et al., 2021, Systematic review of ambulatory selective variceal ablation under local anesthetic technique for the treatment of symptomatic varicose veins, JOURNAL OF VASCULAR SURGERY-VENOUS AND LYMPHATIC DISORDERS, Vol: 9, Pages: 525-535, ISSN: 2213-333X
Machin M, Salim S, Tan M, et al., 2021, Surgical and non-surgical approaches in the management of lower limb post-thrombotic syndrome, Expert Review of Cardiovascular Therapy, Vol: 19, Pages: 191-200, ISSN: 1477-9072
Introduction: Post-thrombotic syndrome (PTS) is a common lifelong condition affecting up to 50% of those suffering from deep vein thrombosis (DVT). PTS compromises function and quality of life with subsequent venous ulceration in up to 29% of those affected.Areas covered: A literature review of surgical and non-surgical approaches in the prevention and treatment of PTS was undertaken. Notable areas include the use of percutaneous endovenous interventions and the use of graduated compression stockings (GCS) after acute proximal DVT.Expert opinion: In patients with acute iliofemoral DVT, we think it is important to have a frank conversation with the patient about catheter-directed thrombolysis, aiming to reduce the severity of PTS experienced. We advocate ultrasound-accelerated thrombolysis with adjunctive procedures, such as deep venous stenting for proximal iliofemoral DVT. For patients with isolated femoral DVT, we believe that anticoagulation and GCS should be recommended. In patients with established PTS, we recommend GCS for symptomatic relief. We recommend that patients engage in regular exercise where possible with the prospect of gaining symptomatic relief. For those with severe PTS that has a significant effect on quality of life, we discuss the patient’s case at a multi-disciplinary team meeting to plan for endovenous intervention.
Tan MKH, Salim S, Onida S, et al., 2021, Postsclerotherapy compression: A systematic review, JOURNAL OF VASCULAR SURGERY-VENOUS AND LYMPHATIC DISORDERS, Vol: 9, Pages: 264-274, ISSN: 2213-333X
Heatley F, Saghdaoui LB, Salim S, et al., 2020, Primary care survey of venous leg ulceration management and referral pre-EVRA trial., Br J Community Nurs, Vol: 25, Pages: S6-S10, ISSN: 1462-4753
Venous leg ulceration (VLU) is a public health concern that is largely managed in community settings. The present study aimed to survey current VLU management in the community. A 14-question survey was distributed to primary care professionals, and 90 responses were received. Some 54% of respondents stated that they would assess ankle brachial pressure indices (ABPI) for those with VLU, while 25% reported that they would not. Additionally, 62% reported not organising duplex ultrasound scanning. Compression therapy was offered by 82% of respondents. When asked whether VLU patients were referred to specialist services in secondary or tertiary care, some 32% reported that they would. However, 57% reported that, if a study suggested that referral to specialist services was beneficial, they would change their practice. On the basis of the findings, the authors concluded that there is diversity in VLU diagnostic and treatment pathways. New, high-quality evidence may improve practice, but care delivery is influenced by local factors including time and resource distribution.
Salim S, Machin M, Patterson BO, et al., 2020, Global Epidemiology of Chronic Venous Disease: A Systematic Review with Pooled Prevalence Analysis., Ann Surg
OBJECTIVE: To provide an updated estimate of the global prevalence of CVD and to comprehensively evaluate risk factors associated with this condition. BACKGROUND: Chronic Venous Disease (CVD) is an important cause of morbidity internationally, but the global burden of this condition is poorly characterised. The burden of CVD must be better characterised to optimise service provision and permit workforce planning to care for patients with different stages of CVD. METHODS: A systematic search in Ovid MEDLINE and Embase (1946 - 2019) identified 1271 articles. Full-text, English language articles reporting on the epidemiology of CVD in a general adult population were included. Data extraction was performed by two independent reviewers, in accordance with a pre-registered protocol (PROSPERO: CRD42019153656). STATA and Review Manager were used for quantitative analysis. A crude, unadjusted pooled prevalence was calculated for each Clinical (C) stage in the Clinical, Etiologic, Anatomic, Pathophysiologic (CEAP) classification and across different geographical regions. Qualitative analysis was performed to evaluate associated risk factors in CVD. RESULTS: 32 articles across 6 continents were identified. 19 studies were included in the overall pooled prevalence for each Clinical (C) stage; pooled estimates were: C0 s: 9%, C1: 26%, C2: 19%, C3: 8%, C4: 4%, C5: 1%, C6: 0·42%. The prevalence of C2 disease was highest in Western Europe and lowest in the Middle East and Africa. Commonly reported risk factors for CVD included: female gender (OR 2·26, 95% CI 2·16-2·36, p < 0.001), increasing age, obesity, prolonged standing, positive family history, parity and Caucasian ethnicity. There was significant heterogeneity across the included studies. CONCLUSIONS: CVD affects a significant proportion of the population globally however there is significant heterogeneity in existing epidemiological studies.
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
Ding A, Machin M, Onida S, et al., 2020, A systematic review of fasciotomy in chronic exertional compartment syndrome, Journal of Vascular Surgery, Vol: 72, Pages: 1802-1812, ISSN: 0741-5214
BackgroundChronic exertional compartment syndrome (CECS) is an overuse injury typically seen in young and athletic patients. The five cardinal symptoms are pain, tightness, cramping, weakness and paraesthesia. These classically occur during exertion and disappear with cessation of the activity, with no permanent damage to tissues within the compartment; nonetheless, CECS presents a significant functional impairment to those affected. Regulating exercise has been shown to alleviate symptoms but this may not be acceptable to some patients e.g. professional athletes. For patients that fail to respond to conservative management or where exercise reduction is unrealistic, fasciotomy can be considered. There are no established guidelines on the management of CECS, and it remains underdiagnosed. The aim of this systematic review is to compare the outcomes in patients suffering from CECS managed with either fasciotomy or non-operative means by examining functional outcomes and resolution of symptoms.MethodsMEDLINE, Embase databases and clinical trial registries were searched comprehensively. 219 articles were identified and 14 articles were included in the systematic review. Given the heterogeneity between the studies in terms of outcomes reported, a qualitative synthesis was performed.ResultsThe majority of included studies were retrospective cohort studies, with a single prospective cohort study. Studies included fasciotomies performed in the upper and lower limbs. Patient population included military servicemen, motocross racers and unselected patients. There is insufficient evidence in the literature to support conservative or surgical management over the other in the management of CECS. However, fasciotomy appears to be a safe approach with satisfaction rates of 48-94%. Complications related to the fasciotomy included haematomas (2.7- 22.5%), nerve injuries (2.0 -18.6%), DVT (2.7%) and symptom recurrence (0.65- 8.4%). Up to 10.4% patients required revision fasciotomy.C
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
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.
Machin M, Salim S, Onida S, et al., 2020, The less invasive paradox, why carotid artery stenting is not suitable for the high-risk patient, ANNALS OF TRANSLATIONAL MEDICINE, Vol: 8, ISSN: 2305-5839
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
Saghdaoui LB, Onida S, Davies AH, et al., 2020, Why nurses in primary care need to be research active: the case of venous leg ulceration., Br J Community Nurs, Vol: 25, Pages: 422-428, ISSN: 1462-4753
Venous leg ulceration (VLU) is predominantly managed in primary care by district nurses, however much of the research takes place in secondary care. This study aimed to identify to what extent nurses are involved in publishing VLU research and to ascertain how much VLU research is conducted in primary care. Three searches of literature published between 2015 and 2020 were undertaken, reviewing VLU publications on interventions, quality of life and qualitative research. Some 37% of intervention studies had one or more nurse authors, compared with 65% of quality of life studies and 86% of qualitative research publications. Of papers that providing details of recruitment, 39% of intervention and quality of life studies included primary care as a recruitment setting. Qualitative studies were more likely to recruit from primary as well as secondary care (50%). Nurses are involved in leading VLU research but are more likely to publish quality of life and qualitative research than intervention studies. The majority of nurse authors in this field are based in academic institutions. A minority of studies utilise primary care as a recruitment setting for VLU research. More must be done to enable VLU research in community settings and to promote the involvement of clinical nurses in research.
Heatley F, Onida S, Davies AH, 2020, The global management of leg ulceration: Pre early venous reflux ablation trial, Phlebology, Vol: 35, Pages: 576-582, ISSN: 0268-3555
BackgroundVarious guidelines exist worldwide for the diagnosis and management of venous leg ulcers; however, these are difficult to implement resulting in disparate treatment of patients globally.MethodAn online, 26-question survey was designed to evaluate the current global management of venous leg ulceration and was emailed globally to approximately 15,000 participants (November 2017–February 2018).ResultsOverall, 799 responses were received from 86 countries, with a 5% response rate. The respondent physicians saw a median of 10 (interquartile range 5–20) patients per month, with a median time to referral from primary to secondary care of six weeks. Of the respondents, 61% arranged an ankle brachial pressure index on first visit and 84% performed a venous duplex, with 95% prescribing compression for those in whom it was not contraindicated. Fifty-nine percent performed endovenous intervention or surgery prior to ulcer healing.ConclusionsThe survey showed a diversity of treatment pathways. The need to develop a robust, clear pathway for patients with leg ulceration is clearly required.
Goodall R, Ellauzi J, Tan K, et al., 2020, A systematic review of the impact of foot-care education on self-efficacy and self-care in patients with diabetes, European Journal of Vascular and Endovascular Surgery, Vol: 60, Pages: 282-292, ISSN: 1078-5884
Objectives: Assess the evidence supporting the impact of patient foot-care education on self-efficacy, self-care behaviour and self-care knowledge in individuals with diabetes.Design: Systematic review registered prospectively on the PROSPERO database (CRD42019106171).Materials and Methods: Ovid EMBASE and MEDLINE databases were searched from 1946 to end of March 2019, using search terms related to the domains diabetic foot, patient education, self-efficacy, self-care behaviour and self-care knowledge. All included studies were prospective, randomised controlled trials that assessed foot-care education interventions in individuals with diabetes and recorded an outcome related to self-efficacy, self-care behaviour and/or self-care knowledge.Results: 13 randomised controlled trials were included, reporting on a total of 3,948 individuals. The risk of bias was high or unclear in 11 of the 13 included studies, and low in 2 studies. Both the education-interventions delivered, and the outcome assessment tools used were heterogenous across included studies: meta-analysis was therefore not performed. Eight of 11 studies identified significantly better foot self-care behaviour scores in individuals randomised to education compared with controls. Self-efficacy scores were significantly better in education groups in four of five studies reporting this primary outcome. Foot-care knowledge was significantly better in intervention versus control in three of seven studies. In general, studies assessing secondary end-points including quality of life and ulcer/amputation incidence tended not to identify significant clinical improvements.Conclusion: The available evidence is of inadequate quality to reliably conclude that foot-care education has a positive impact on foot self-care behaviour and self-efficacy in individuals with diabetes. Quality data supporting accompanying benefits on quality of life or ulcer/amputation incidence are also lacking and should be considered as an impor
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.
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