Publications
867 results found
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
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
Lane TRA, Davies AH, 2020, Diagnosis and management of abdominal aortic aneurysm, Pages: 11-14, ISSN: 0032-6518
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.
Hughes W, Goodall R, Salciccioli J, et al., 2020, Trends in lower limb amputation incidence in European Union 15+ Countries 1990-2017, European Journal of Vascular and Endovascular Surgery, Vol: 60, Pages: 602-612, ISSN: 1078-5884
Objective: Lower extremity amputation (LEA) carries significant mortality, morbidity and health economic burden. In the Westernworld,it most commonly results from complications of peripheral arterial occlusive disease (PAOD) or diabetic foot disease. Incidence of PAOD has declined in Europe,the United States and parts of Australasia.We aimed to assess trends in LEA incidence in European Union (EU15+) countries for the years 1990 to 2017. Design: Observational study using data obtained from the 2017 Global Burden of Disease (GBD) study. Materials: GBD Results Tool: http://ghdx.healthdata.org/gbd-results-too. Methods: Age-standardised incidence rates (ASIRs) for LEA (stratified into toe amputation,and LEA proximal to toes) were extracted from the GBD Results Tool for EU15+ countries foreach ofthe years 1990-2017.Trends were analysed using Join point regression analysis. Results: Between 1990 and 2017, variable trends in the incidence of LEA were observedin EU15+ countries. For LEAs proximal to toes, increasing trends were observed in 6 of 19 countries anddecreasing trends in 9 of 19 countries, with 4 countries showing varying trendsbetween sexes. For toe amputation, increasing trends were observed in 8 of 19 countries and decreasing trends in 8 of 19 countries for both sexes, with 3 countries showing varying trendsbetween sexes. Australia hadthe highest ASIRs for both sexes in all LEAs at all time 6 points, with steadily increasing trends. The USA observed the greatest reduction all LEAsin both sexes over the time periodanalysed (LEAs proximal to toes: females -22.93%, males -29.76%; toe amputation: females -29.93%, males -32.67%). The greatest overall increase in incidence was observed in Australia. Conclusions: Variable trends in LEA incidence were observed across EU15+ countries. These trends do not reflect previously observed reductions in incidence of PAO Dover the same t
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
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
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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, 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.
Parsi K, van Rij AM, Meissner MH, et al., 2020, Triage of patients with venous and lymphatic diseases during the COVID-19 pandemic - The Venous and Lymphatic Triage and Acuity Scale (VELTAS) A consensus document of the International Union of Phlebology (UIP), Australasian College of Phlebology (ACP), American Vein and Lymphatic Society (AVLS), American Venous Forum (AVF), European College of Phlebology (ECoP), European Venous Forum (EVF), Interventional Radiology Society of Australasia (IRSA), Latin American Venous Forum, Pan-American Society of Phlebology and Lymphology and the Venous Association of India (VAI), PHLEBOLOGY, Vol: 35, Pages: 550-555, ISSN: 0268-3555
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Parsi K, van Rij AM, Meissner MH, et al., 2020, Triage of patients with venous and lymphatic diseases during the COVID-19 pandemic - The Venous and Lymphatic Triage and Acuity Scale (VELTAS): A consensus document of the International Union of Phlebology (UIP), Australasian College of Phlebology (ACP), American Vein and Lymphatic Society (AVLS), American Venous Forum (AVF), European College of Phlebology (ECoP), European Venous Forum (EVF), Interventional Radiology Society of Australasia (IRSA), Latin American Venous Forum, Pan-American Society of Phlebology and Lymphology and the Venous Association of India (VAI), JOURNAL OF VASCULAR SURGERY-VENOUS AND LYMPHATIC DISORDERS, Vol: 8, Pages: 706-710, ISSN: 2213-333X
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Tiwari A, Walsh SR, Davies AH, et al., 2020, A need for evidence to guide treatment recommendation for women with chronic venous disease during childbearing years, PHLEBOLOGY, Vol: 35, Pages: 548-549, ISSN: 0268-3555
Gohel M, Mora J, Szigeti M, et al., 2020, Long-term clinical and cost-effectiveness of early endovenous ablation in venous ulceration (The EVRA randomized clinical trial), JAMA: Journal of the American Medical Association, ISSN: 0098-7484
ImportanceOne-year outcomes from the Early Venous Reflux Ablation (EVRA) randomized trial showed accelerated venous leg ulcer healing and greater ulcer free time for participants treated with early endovenous ablation of lower extremity superficial reflux. Outcomes up to 5 years are presented here.ObjectiveTo evaluate the clinical and cost-effectiveness of early endovenous ablation of superficial venous reflux in patients with venous leg ulceration.DesignRandomized clinical trial.SettingVascular surgery departments in twenty United Kingdom hospitalsParticipantsBetween October 2013 and September 2016, 450 participants (450 legs) with venous leg ulceration of <6 months and superficial venous reflux were enrolled. InterventionsPatients were randomly assigned to receive compression therapy with early endovenous ablation within 2 weeks of randomization (early intervention, n=224) or compression with deferred endovenous treatment of superficial venous reflux (deferred intervention, n=226). Endovenous modality and strategy were left to the preference of the treating clinical team. Main outcomes and measuresThe primary outcome for the extended phase was time to first ulcer recurrence. Secondary outcomes included ulcer recurrence rate and cost effectiveness.ResultsOf 426 participants whose leg ulcer had healed, 121 (28.4%) experienced at least one recurrence during follow-up. There was no clear difference in time to first ulcer recurrence between the two groups (hazard ratio 0.82; 95% confidence interval [CI] 0.57 to 1.17; P=0.278). Ulcers recurred at a lower rate of 0.107 per person year (PY) in the early-intervention group compared to 0.162 per PY in the deferred-intervention group (incidence rate ratio 0.658; 95% CI: 0.480 to 0.898, p=0.003). Time to ulcer healing was shorter in the early-intervention group for primary ulcers (hazard ratio 1.36; 95% CI 1.12 to 1.64, p=0.002). At three years, early intervention is 91.6% likely to be cost-effective at a willingness to pa
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.
Rolls A, Sudarsanam A, Luo X, et al., 2020, COVID-19 and vascular surgery at a Central London teaching hospital, British Journal of Surgery, Vol: 107, Pages: e311-e312, ISSN: 0007-1323
Tan K, Goodall R, Hughes W, et al., 2020, A methodological assessment of diabetic foot syndrome clinical practice guidelines, European Journal of Vascular and Endovascular Surgery, Vol: 60, Pages: 274-281, ISSN: 1078-5884
Objectives: Diabetic foot syndrome (DFS) contributes to significant morbidity in diabetic patients. Diagnostic and therapeutic approaches to DFS may be summarised in clinical practice guidelines (CPGs) to aid clinical practice but may only benefit patients if the CPG is of high quality. This study determines the methodological quality of DFS CPGs using a validated assessment tool to identify CPGs adequate for use in clinical practice.Methods: Medline, EMBASE and CPG databases were searched to 31st May 2019. Reference lists were also searched. Full text English evidence-based DFS CPGs were included. CPGs based on expert consensus, guideline summaries or only available if purchased were excluded. Four reviewers independently assessed methodological quality using Appraisal of Guidelines for Research and Evaluation II instrument. An overall guideline assessment scaled score of ≥80% was considered of adequate quality to recommend use.Results: 16 CPGs were identified. Good inter-reviewer reliability (ICC 0.985, 95% CI 0.980-0.989) was achieved. Poor scores were noted in domains 2 (stakeholder involvement), 5 (applicability), and 6 (editorial independence). Significant methodological heterogeneity was observed in all domains with the most noted in domain 6 (mean scaled score 43.2±32.1%). Four CPGs achieved overall assessment scores of ≥80%.Conclusion: Four CPGs were considered adequate for clinical practice based on methodological quality. However, elements of methodological quality were still lacking, and all CPGs showed areas for improvement, potentially through increased multidisciplinary team involvement and trial application of recommendations. Methodological rigour may be improved using structured approaches with validated CPG creation tools in the future. Future work should also assess recommendation accuracy using available validated assessment tools.
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
Heatley F, Saghdaoui LB, Salim S, et al., 2020, UK primary care survey of venous leg ulceration management and referral - Post-EVRA trial, Phlebology, Vol: 36, Pages: 48-53, ISSN: 0268-3555
ObjectiveDetermine standards of referral and management of patients with venous leg ulceration in primary care after the release of the EVRA (A Randomized Trial of Early Endovenous Ablation in Venous Ulceration) study results.MethodsAn online questionnaire was disseminated over four months to professionals working within primary care.ResultsThe survey received 643 responses. Of respondents, 90 (14%) had heard of the EVRA trial and 51 (8%) were familiar with the results. Of those who answered the following questions, 410 (69.1%) stated that referral to a vascular specialist must be made by the General Practitioner and 13 (2.2%) reported that they would always refer patients for secondary care assessment before the publication of EVRA. Considering the EVRA results, 128 (29%) reported that they would change practice regarding referral and would experience no barriers and 198 (45%) reported that they would like to refer earlier but is not their decision. Barriers to changing practice included local referral policies, training and time restrictions, 266 (59%) had heard of the NICE guideline (CG168) and 194 (43%) were aware of the recommendations for referral to a vascular service within two weeks for patients with an open or healed ulcer.ConclusionThere is a considerable variation in local referral pathways for venous leg ulceration, and despite clinicians wanting to refer promptly, many primary care professionals are unable to. Unfortunately, the EVRA study alone may not change the overall practice, and work is needed to overcome barriers faced by primary care professionals.
Ding A, Onida S, Davies AH, 2020, The painful cost of cancelling surgery due toCOVID-19-can we do anything about it?, British Journal of Surgery, Vol: 107, Pages: e336-e336, ISSN: 0007-1323
Karia M, Onida S, Singh P, et al., 2020, Chemoprophylaxis in lower limb immobilization : A systematic review and meta-analysis, ACTA ORTHOPAEDICA BELGICA, Vol: 86, Pages: 66-73, ISSN: 0001-6462
Goodall R, Langridge B, Onida S, et al., 2020, Median arcuate ligament syndrome, Journal of Vascular Surgery, Vol: 71, Pages: 2170-2176, ISSN: 0741-5214
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.
Onida S, Davies A, 2020, Long-haul travel venous thromboembolism – an update, Phlebolymphology, ISSN: 1286-0107
Shalhoub J, Lawton R, Hudson J, et al., 2020, Graduated compression stockings as an adjuvant to pharmaco-thromboprophylaxis in elective surgical patients (GAPS study): a randomised controlled trial, BMJ: British Medical Journal, Vol: 369, ISSN: 0959-535X
Objectives: Does the use of GCS offer any adjuvant benefit when pharmaco-thromboprophylaxis is used for VTE prophylaxis?Design: Open, multicentre, randomised, controlled, non-inferiority trial.Setting:Seven National Health Service tertiary hospitals in the United Kingdom.Participants: 1905 elective surgical inpatients, aged >18 years assessed as being at moderate or high risk of VTE were eligible and consented to participate. Intervention: Participants were randomly assigned (1:1) to receive either low molecular weight heparin (LMWH) pharmaco-thromboprophylaxis alone or LMWH pharmaco-thromboprophylaxis and graduated compression stockings (GCS).Outcome measures: The primary endpoint was a combination of imaging confirmed asymptomatic and symptomatic lower limb deep vein thrombosis and/or symptomatic pulmonary embolism within 90 days of surgery. Secondary outcome measures were quality of life, compliance with stockings and LMWH, GCS-related lower limb complications, bleeding complications, adverse reactions to LMWH, and all-cause mortality.Results: Between May 2016 and January 2019, 1905 participants were randomised, of which 1858 were included in the intention-to-treat analysis (17 identified as ineligible post-randomisation and 30 did not undergo surgery). A primary-outcome event occurred in 16/937 (1.7%) patients in the LMWH alone arm compared to 13/921 (1.4%) in the LMWH and GCS arm. The risk difference between LMWH and LMWH and GCS was 0.30% (95% confidence interval [CI} -0.65% to 1.26%). As the 95% CI did not cross the non-inferiority margin of 3.5% (p-value <0.001 for non-inferiority), LMWH alone was confirmed as being non-inferior.Conclusions: For elective surgical patients at moderate or high risk of VTE, administration of pharmaco-thromboprophylaxis alone is non-inferior to a combination of pharmaco-thromboprophylaxis and graduated compression stockings. These findings indicate that graduated compression stockings may be unnecessary in most elective su
Davies A, Onida S, Shalhoub J, et al., 2020, Rapid Response to: Clinical features of covid-19, BMJ: British Medical Journal, ISSN: 0959-535X
Kolluri R, Chung J, Kim S, et al., 2020, Network meta-analysis to compare VenaSeal with other superficial venous therapies for chronic venous insufficiency, JOURNAL OF VASCULAR SURGERY-VENOUS AND LYMPHATIC DISORDERS, Vol: 8, Pages: 472-+, ISSN: 2213-333X
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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
Wittens C, Davies AH, Baekgaard N, et al., 2020, Management of Chronic Venous Disease: Clinical Practice Guidelines (vol 49, pg 678, 2015), EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY, Vol: 59, Pages: 495-495, ISSN: 1078-5884
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
Khan K, Li M, Erridge S, et al., 2020, The management and referral of iliofemoral deep venous thrombosis in North West London, Journal of vascular surgery. Venous and lymphatic disorders, Vol: 8, Pages: 182-186, ISSN: 2213-3348
BackgroundPost-thrombotic syndrome is a common complication of iliofemoral deep venous thrombosis (IFDVT). Existing evidence and National Institute for Health and Care Excellence guidelines suggest that this can be reduced by prompt thrombolytic therapy or thrombectomy. We aimed to evaluate the characteristics of IFDVT patients and to identify whether patients are being offered the recommended treatment pathway.MethodsA multicenter cross-sectional study was conducted across eight hospital sites in the North West London region, of which two were hub hospitals in their local vascular service networks. Patients with proximal DVT were identified using International Classification of Diseases, Tenth Revision coding during a 1-year period. Data on demographics, diagnostic methods used, interventions, and referrals were extracted from electronic and paper medical records.ResultsDuring the study period, 132 patients with IFDVT were identified (mean age, 59.4 years; 55% female); 75% of these patients had an IFDVT. In this cohort, the biggest predisposing factors were previous DVT (n = 35), malignant disease (n = 35), and immobility (n = 20). In total, 104 patients were administered anticoagulation, and 88 of these patients received anticoagulation within 24 hours. The cases of 45 patients were either discussed with or promptly referred to a vascular service, after which 20 patients were treated solely with anticoagulation, whereas 20 patients received thrombolysis of varying methods.ConclusionsA significant proportion (56%) of symptomatic IFDVT patients are not being appropriately referred to or discussed with vascular services. Of these, 43% would have been eligible for consideration of early thrombus removal. Adherence to the National Institute for Health and Care Excellence guidelines could be improved by increasing awareness among emergency department colleagues.
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