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2.
Front Surg ; 11: 1300625, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38562585

RESUMO

Introduction: Surgical site infections (SSI) are the most common healthcare-associated infections; however, access to healthcare services, lack of patient awareness of signs, and inadequate wound surveillance can limit timely diagnosis. Telemedicine as a method for remote postoperative follow-up has been shown to improve healthcare efficiency without compromising clinical outcomes. Furthermore, telemedicine would reduce the carbon footprint of the National Health Service (NHS) through minimising patient travel, a significant contributor of carbon dioxide equivalent (CO2e) emissions. Adopting innovative approaches, such as telemedicine, could aid in the NHS Net-Zero target by 2045. This study aimed to provide a comprehensive analysis of the feasibility and sustainability of telemedicine postoperative follow-up for remote diagnosis of SSI. Methods: Patients who underwent a lower limb vascular procedure were reviewed remotely at 30 days following the surgery, with a combined outcome measure (photographs and Bluebelle Wound Healing Questionnaire). A hybrid life-cycle assessment approach to carbon footprint analysis was used. The kilograms of carbon dioxide equivalent (kgCO2e) associated with remote methods were mapped prospectively. A simple outpatient clinic review, i.e., no further investigations or management required, was modelled for comparison. The Department of Environment, Food, and Rural Affairs (DEFRA) conversion factors plus healthcare specific sources were used to ascertain kgCO2e. Patient postcodes were applied to conversion factors based upon mode of travel to calculate kgCO2e for patient travel. Total and median (interquartile range) carbon emissions saved were presented for both patients with and without SSI. Results: Altogether 31 patients (M:F 2.4, ±11.7 years) were included. The median return distance for patient travel was 42.5 (7.2-58.7) km. Median reduction in emissions using remote follow-up was 41.2 (24.5-80.3) kgCO2e per patient (P < 0.001). The carbon offsetting value of remote follow-up is planting one tree for every 6.9 patients. Total carbon footprint of face-to-face follow-up was 2,895.3 kgCO2e, compared with 1,301.3 kgCO2e when using a remote-first approach (P < 0.001). Carbon emissions due to participants without SSI were 700.2 kgCO2e by the clinical method and 28.8 kgCO2e from the remote follow-up. Discussion: This model shows that the hybrid life-cycle assessment approach is achievable and reproducible. Implementation of an asynchronous digital follow-up model is effective in substantially reducing the carbon footprint of a tertiary vascular surgical centre. Further work is needed to corroborate these findings on a larger scale, quantify the impact of telemedicine on patient's quality of life, and incorporate kgCO2e into the cost analysis of potential SSI monitoring strategies.

3.
BJS Open ; 8(1)2024 Jan 03.
Artigo em Inglês | MEDLINE | ID: mdl-38411507

RESUMO

BACKGROUND: Guidelines recommend cardiovascular risk reduction and supervised exercise therapy as the first line of treatment in intermittent claudication, but implementation challenges and poor patient compliance lead to significant variation in management and therefore outcomes. The development of a precise risk stratification tool is proposed through a machine-learning algorithm that aims to provide personalized outcome predictions for different management strategies. METHODS: Feature selection was performed using the least absolute shrinkage and selection operator method. The model was developed using a bootstrapped sample based on patients with intermittent claudication from a vascular centre to predict chronic limb-threatening ischaemia, two or more revascularization procedures, major adverse cardiovascular events, and major adverse limb events. Algorithm performance was evaluated using the area under the receiver operating characteristic curve. Calibration curves were generated to assess the consistency between predicted and actual outcomes. Decision curve analysis was employed to evaluate the clinical utility. Validation was performed using a similar dataset. RESULTS: The bootstrapped sample of 10 000 patients was based on 255 patients. The model was validated using a similar sample of 254 patients. The area under the receiver operating characteristic curves for risk of progression to chronic limb-threatening ischaemia at 2 years (0.892), risk of progression to chronic limb-threatening ischaemia at 5 years (0.866), likelihood of major adverse cardiovascular events within 5 years (0.836), likelihood of major adverse limb events within 5 years (0.891), and likelihood of two or more revascularization procedures within 5 years (0.896) demonstrated excellent discrimination. Calibration curves demonstrated good consistency between predicted and actual outcomes and decision curve analysis confirmed clinical utility. Logistic regression yielded slightly lower area under the receiver operating characteristic curves for these outcomes compared with the least absolute shrinkage and selection operator algorithm (0.728, 0.717, 0.746, 0.756, and 0.733 respectively). External calibration curve and decision curve analysis confirmed the reliability and clinical utility of the model, surpassing traditional logistic regression. CONCLUSION: The machine-learning algorithm successfully predicts outcomes for patients with intermittent claudication across various initial treatment strategies, offering potential for improved risk stratification and patient outcomes.


Assuntos
Isquemia Crônica Crítica de Membro , Claudicação Intermitente , Humanos , Claudicação Intermitente/terapia , Reprodutibilidade dos Testes , Terapia por Exercício , Medição de Risco
4.
BMJ Open ; 14(2): e083488, 2024 Feb 17.
Artigo em Inglês | MEDLINE | ID: mdl-38367965

RESUMO

INTRODUCTION: Endovenous therapy is the first choice management for symptomatic varicose veins in NICE guidelines, with 56-70 000 procedures performed annually in the UK. Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a known complication of endovenous therapy, occurring at a rate of up to 3.4%. Despite 73% of UK practitioners administering pharmacological thromboprophylaxis to reduce VTE, no high-quality evidence supporting this practice exists. Pharmacological thromboprophylaxis may have clinical and cost benefit in preventing VTE; however, further evidence is needed. This study aims to establish whether when endovenous therapy is undertaken: a single dose or course of pharmacological thromboprophylaxis alters the risk of VTE; pharmacological thromboprophylaxis is associated with an increased rate of bleeding events; pharmacological prophylaxis is cost effective. METHODS AND ANALYSIS: A multi-centre, assessor-blind, randomised controlled trial (RCT) will recruit 6660 participants from 40 NHS and private sites across the UK. Participants will be randomised to intervention (single dose or extended course of pharmacological thromboprophylaxis plus compression) or control (compression alone). Participants will undergo a lower limb venous duplex ultrasound scan at 21-28 days post-procedure to identify asymptomatic DVT. The duplex scan will be conducted locally by blinded assessors. Participants will be contacted remotely for follow-up at 7 days and 90 days post-procedure. The primary outcome is imaging-confirmed lower limb DVT with or without symptoms or PE with symptoms within 90 days of treatment. The main analysis will be according to the intention-to-treat principle and will compare the rates of VTE at 90 days, using a repeated measures analysis of variance, adjusting for any pre-specified strongly prognostic baseline covariates using a mixed effects logistic regression. ETHICS AND DISSEMINATION: Ethical approval was granted by Brent Research Ethics Committee (22/LO/0261). Results will be disseminated in a peer-reviewed journal and presented at national and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN18501431.


Assuntos
Embolia Pulmonar , Tromboembolia Venosa , Trombose Venosa , Humanos , Anticoagulantes/efeitos adversos , Tromboembolia Venosa/prevenção & controle , Tromboembolia Venosa/tratamento farmacológico , Medicina Estatal , Trombose Venosa/prevenção & controle , Trombose Venosa/tratamento farmacológico , Embolia Pulmonar/prevenção & controle , Embolia Pulmonar/tratamento farmacológico , Reino Unido
5.
J Vasc Surg ; 79(1): 15-23.e3, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37714500

RESUMO

OBJECTIVE: A preoperative supervised exercise program (SEP) improves cardiorespiratory fitness and perioperative outcomes for patients undergoing elective abdominal aortic aneurysm (AAA) repair. The aim of this study was to assess the effect of a preoperative SEP on long-term survival of these patients. A secondary aim was to consider long-term changes in cardiorespiratory fitness and quality of life. METHODS: Patients scheduled for open or endovascular AAA repair were previously randomized to either a 6-week preoperative SEP or standard management, and a significant improvement in a composite outcome of cardiac, pulmonary, and renal complications was seen following SEP. For the current analysis, patients were followed up to 5 years post-surgery. The primary outcome for this analysis was all-cause mortality. Data were analyzed on an intention to treat (ITT) and per protocol (PP) basis, with the latter meaning that patients randomized to SEP who did not attend any sessions were excluded. The PP analysis was further interrogated using a complier average causal effect (CACE) analysis on an all or nothing scale, which adjusts for compliance. Additionally, patients who agreed to follow-up attended the research center for cardiopulmonary exercise testing and/or provided quality of life measures. RESULTS: ITT analysis demonstrated that the primary endpoint occurred in 24 of the 124 participants at 5 years, with eight in the SEP group and 16 in the control group (P = .08). The PP analysis demonstrated a significant survival benefit associated with SEP attendance (4 vs 16 deaths; P = .01). CACE analysis confirmed a significant intervention effect (hazard ratio, 0.36; 95% confidence interval, 0.16-0.90; P = .02). There was no difference between groups for cardiorespiratory fitness measures and most quality of life measures. CONCLUSIONS: These novel findings suggest a long-term mortality benefit for patients attending a SEP prior to elective AAA repair. The underlying mechanism remains unknown, and this merits further investigation.


Assuntos
Aneurisma da Aorta Abdominal , Procedimentos Endovasculares , Humanos , Qualidade de Vida , Procedimentos Cirúrgicos Vasculares , Exercício Físico , Fatores de Risco , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Aneurisma da Aorta Abdominal/etiologia , Terapia por Exercício , Procedimentos Cirúrgicos Eletivos/métodos , Resultado do Tratamento , Estudos Retrospectivos , Complicações Pós-Operatórias/terapia , Complicações Pós-Operatórias/cirurgia
6.
Eur J Vasc Endovasc Surg ; 67(3): 480-488, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38040103

RESUMO

OBJECTIVE: This study aimed to explore the long term outcomes of patients with intermittent claudication (IC) who completed supervised exercise therapy (SET) vs. those who declined or prematurely discontinued SET, focusing on the incidence of chronic limb threatening ischaemia (CLTI), revascularisation, major adverse limb events (MALE), and major adverse cardiovascular events (MACE). METHODS: A retrospective registry analysis of consecutive patients with IC who were referred for SET between March 2015 and August 2016 and followed up for a minimum of five years. Serial univariable analysis and logistic regression were performed to identify the statistically significant clinical variables that were independent predictors of each outcome measure. The resulting statistically significant variables were used to guide 1:1 propensity score matching (PSM) using the nearest neighbour method with a calliper of 0.2. Cox proportional hazards regression was used to estimate the hazard ratio (HR) and 95% confidence interval (CI) for the association between SET and the outcomes of interest. RESULTS: Two hundred and sixty-six patients were referred to SET between March 2015 and August 2016. Of these, 64 patients completed SET and 202 patients did not. After PSM, 49 patients were analysed in each cohort. The Cox proportional hazards analysis revealed a significant association between completion of SET and revascularisation requirement (HR 0.46 95% CI 0.25 - 0.84; p = .011), completion of SET and progression to CLTI (HR 0.091, 95% CI 0.04 - 0.24; p < .001), completion of SET and MACE (HR 0.52; 95% CI 0.28 - 0.99; p = .05) and completion of SET and MALE (HR 0.28, 95% CI 0.13 - 0.65; p = .003). The Harrell's C index for all of these models was greater than 0.75, indicating good predictive accuracy. CONCLUSION: Completion of SET is associated with better outcomes in patients who completed SET compared with patients who declined or discontinued SET with respect to clinically important cardiovascular outcomes over seven years.


Assuntos
Claudicação Intermitente , Doença Arterial Periférica , Humanos , Claudicação Intermitente/terapia , Estudos Retrospectivos , Pontuação de Propensão , Terapia por Exercício/métodos , Procedimentos Cirúrgicos Vasculares , Doença Arterial Periférica/cirurgia , Resultado do Tratamento , Fatores de Risco
7.
Expert Rev Mol Med ; 25: e29, 2023 10 19.
Artigo em Inglês | MEDLINE | ID: mdl-37853784

RESUMO

Negative pressure wound therapy (NPWT) has significantly advanced wound care and continues to find new applications. Its effects at a molecular level however, remain a subject of debate. The aim of this systematic review is to summarize the current evidence regarding the molecular mechanisms of action of NPWT. Medline, Embase, EBSCO databases and clinical trial registries were searched from inception to January 2023. Clinical studies, animal models or in-vitro studies that quantitatively or semi-quantitatively evaluated the influence of NPWT on growth factors, cytokine or gene-expression in the circulation or wound-bed were included. Risk of Bias assessment was performed using the RoBANS tool for non-randomized studies, the COCHRANE's Risk of Bias 2(ROB-2) tool for randomized clinical studies, OHAT tool for in-vitro studies or the SYRCLE tool for animal model studies. A descriptive summary was collated and the aggregated data is presented as a narrative synthesis. This review included 19 clinical studies, 11 animal studies and 3 in-vitro studies. The effects of NPWT on 43 biomarkers and 17 gene expressions were studied across included studies. NPWT stimulates modulation of numerous local and circulating cytokines and growth factor expressions to promote an anti-inflammatory profile. This is most likely achieved by downregulation of TNFα, upregulation of VEGF, TGF-ß and fibronectin.


Assuntos
Tratamento de Ferimentos com Pressão Negativa , Animais , Cicatrização/genética , Citocinas , Peptídeos e Proteínas de Sinalização Intercelular , Fator de Crescimento Transformador beta
8.
BMJ Open ; 13(8): e072355, 2023 08 10.
Artigo em Inglês | MEDLINE | ID: mdl-37562931

RESUMO

INTRODUCTION: The optimal antithrombotic regimen to reduce the risk of vascular events in patients with peripheral arterial disease (PAD) is contentious. This systematic review and network meta-analysis (NMA) aims to define the relative efficacy and risks of previously investigated antithrombotic medication regimens in preventing major cardiovascular events, vascular limb events and mortality in patients with PAD. METHODS AND ANALYSIS: A peer-reviewed, systematic search will be executed in English on Medline, Embase, Cochrane (CENTRAL), Web of Science and Google Scholar databases in late 2022. The WHO International Clinical Trials Registry platform will also be searched for ongoing trials. Abstracts will be screened independently by two researchers for randomised controlled trials meeting the review criteria. All associated publications including the study protocol will be sought and evaluated together against prespecified inclusion/exclusion criteria. Two researchers will extract the data into a prepiloted extraction form. Risk-of-bias assessments will be performed using the Cochrane 'Risk-of-Bias V.2' criteria by individuals with domain expertise. All differences will be resolved by consensus or a third individual for ties.Included trials will be summarised. An NMA will be performed, subject to checks of assumptions. Both primary and secondary outcomes will be analysed on a whole network basis. Pairwise comparisons and league tables will be produced. Prespecified subgroup analyses will include sex, ethnicity, disease status, conservative versus interventional management and key comorbidities. The findings will be evaluated using the Grading of Recommendation Assessment, Development and Evaluation, informed by patient and public involvement work. ETHICS AND DISSEMINATION: This is a systematic review of data in the public domain and does not require ethical approval. Dissemination will include presentations to key vascular and patient organisations, publication in a peer-reviewed journal and an open-access repository of the study data. PROSPERO REGISTRATION NUMBER: CRD42023389262.


Assuntos
Doenças Cardiovasculares , Doença Arterial Periférica , Humanos , Fibrinolíticos/uso terapêutico , Metanálise em Rede , Doenças Cardiovasculares/prevenção & controle , Fatores de Risco , Doença Arterial Periférica/tratamento farmacológico , Extremidade Inferior , Revisões Sistemáticas como Assunto , Metanálise como Assunto
9.
Cochrane Database Syst Rev ; 7: CD009494, 2023 07 27.
Artigo em Inglês | MEDLINE | ID: mdl-37497816

RESUMO

BACKGROUND: Venous leg ulcers (VLUs) are a serious manifestation of chronic venous disease affecting up to 3% of the adult population. This typically recalcitrant and recurring condition significantly impairs quality of life, and its treatment places a heavy financial burden upon healthcare systems. The longstanding mainstay treatment for VLUs is compression therapy. Surgical removal of incompetent veins reduces the risk of ulcer recurrence. However, open surgery is an unpopular option amongst people with VLU, and many people are unsuitable for it. The efficacy of the newer, minimally-invasive endovenous techniques has been established in uncomplicated superficial venous disease, and these techniques can also be used in the management of VLU. When used with compression, endovenous ablation aims to further reduce pressure in the veins of the leg, which may impact ulcer healing. OBJECTIVES: To determine the effects of superficial endovenous ablation on the healing and recurrence of venous leg ulcers and the quality of life of people with venous ulcer disease. SEARCH METHODS: In April 2022 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scrutinised reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions on the language of publication, but there was a restriction on publication year from 1998 to April 2022 as superficial endovenous ablation is a comparatively new technology. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing endovenous ablative techniques with compression versus compression therapy alone for the treatment of VLU were eligible for inclusion. Studies needed to have assessed at least one of the following primary review outcomes related to objective measures of ulcer healing such as: proportion of ulcers healed at a given time point; time to complete healing; change in ulcer size; proportion of ulcers recurring over a given time period or at a specific point; or ulcer-free days. Secondary outcomes of interest were patient-reported quality of life, economic data and adverse events. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed studies for eligibility, extracted data, carried out risk of bias assessment using the Cochrane RoB 1 tool, and assessed GRADE certainty of evidence. MAIN RESULTS: The previous version of this review found no RCTs meeting the inclusion criteria. In this update, we identified two eligible RCTs and included them in a meta-analysis. There was a total of 506 participants with an active VLU, with mean durations of 3.1 months ± 1.1 months in the EVRA trial and 60.5 months ± 96.4 months in the VUERT trial. Both trials randomised participants to endovenous treatment and compression or compression alone, however the compression alone group in the EVRA trial received deferred endovenous treatment (after ulcer healing or from six months). There is high-certainty evidence that combined endovenous ablation and compression compared with compression therapy alone, or compression with deferred endovenous treatment, improves time to complete ulcer healing (pooled hazard ratio (HR) 1.41, 95% CI 1.36 to 1.47; I2 = 0%; 2 studies, 466 participants). There is moderate-certainty evidence that the proportion of ulcers healed at 90 days is probably higher with combined endovenous ablation and compression compared with compression therapy alone or compression with deferred endovenous treatment (risk ratio (RR) 1.14, 95% CI 1.00 to 1.30; I2 = 0%; 2 studies, 466 participants). There is low-certainty evidence showing an unclear effect on ulcer recurrence at one year in people with healed ulcers with combined endovenous treatment and compression when compared with compression alone or compression with deferred endovenous treatment (RR 0.29, 95% CI 0.03 to 2.48; I2 = 78%; 2 studies, 460 participants). There is also low-certainty evidence that the median number of ulcer-free days at one year may not differ (306 (interquartile range (IQR) 240 to 328) days versus 278 (IQR 175 to 324) days) following combined endovenous treatment and compression when compared with compression and deferred endovenous treatment; (1 study, 450 participants). There is low-certainty evidence of an unclear effect in rates of thromboembolism between groups (RR 2.02, 95% CI 0.51 to 7.97; I2 = 78%, 2 studies, 506 participants). The addition of endovenous ablation to compression is probably cost-effective at one year (99% probability at GBP 20,000/QALY; 1 study; moderate-certainty evidence). AUTHORS' CONCLUSIONS: Endovenous ablation of superficial venous incompetence in combination with compression improves leg ulcer healing when compared with compression alone. This conclusion is based on high-certainty evidence. There is moderate-certainty evidence to suggest that it is probably cost-effective at one year and low certainty evidence of unclear effects on recurrence and complications. Further research is needed to explore the additional benefit of endovenous ablation in ulcers of greater than six months duration and the optimal modality of endovenous ablation.


Assuntos
Úlcera da Perna , Úlcera Varicosa , Adulto , Humanos , Úlcera Varicosa/cirurgia , Recidiva Local de Neoplasia , Cicatrização , Veias
10.
Expert Rev Cardiovasc Ther ; 21(5): 347-356, 2023 May.
Artigo em Inglês | MEDLINE | ID: mdl-37128666

RESUMO

OBJECTIVES: This umbrella review aims to quality assess published meta-analyses, conduct a de-novo meta-analysis of the available randomized control trials (RCTs), and test the hypothesis that there is a long-term difference in mortality between OSR and EVAR. METHODS: A systematic search was conducted in MEDLINE and EMBASE's bibliographic databases (June 2022). Data were extracted using standardized extraction forms. The methodological quality of publications was assessed using the ROBIS tool. Data were analyzed with 'one-stage' and 'two-stage' approaches. RESULTS: According to two-stage analysis, EVAR has significantly favorable mortality for up to four years (increasing evidence). Subsequently, until the longest available time period, there is no difference between EVAR and OSR; all the results are statistically non-significant.In one stage analysis, the Cox model demonstrated a non-significant (weak evidence) hazard ratio of 1.03 (95% confidence interval [CI]: 0.94-1.12) in favor of OSR. The best-fitting parametric model (generalized gamma), leads to an hazard ratio of 0.97 (95% CI: 0.93-1.01) in favor of EVAR, with the results approaching significance (weak evidence). CONCLUSION: The results of this umbrella systematic review and meta-analysis failed to demonstrate any difference in long-term mortality following planned EVAR, compared with OSR of infrarenal AAA.


Assuntos
Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Humanos , Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/efeitos adversos , Procedimentos Endovasculares/métodos , Complicações Pós-Operatórias , Fatores de Risco , Resultado do Tratamento
11.
Br J Surg ; 110(5): 562-567, 2023 04 12.
Artigo em Inglês | MEDLINE | ID: mdl-36894167

RESUMO

BACKGROUND: Mechanochemical ablation (MOCA) is an alternative method to endovenous thermal ablation (EVTA) for the treatment of superficial venous incompetence that does not require tumescent anaesthesia. The aim of this study was to compare the outcomes from RCTs of MOCA versus EVTA. METHODS: A search was conducted in MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL). Meta-analysis inclusion was restricted to RCTs comparing MOCA against EVTA. Outcomes included anatomical occlusion rate, disease-specific quality of life using the Aberdeen Varicose Vein Questionnaire, procedural and postprocedural pain, and rates of venous thromboembolism. RESULTS: Four RCTs were included in the meta-analysis comprising 654 patients. The anatomical occlusion rate at 1 year was lower after MOCA than EVTA (risk ratio 0.85, 95 per cent c.i. 0.78 to 0.91; P < 0.001). No significant differences were detected in procedural pain (mean difference -3.25, -14.25 to 7.74; P = 0.560) or postprocedural pain (mean difference -0.63, -2.15 to 0.89; P = 0.420). There were no significant differences in Aberdeen Varicose Vein Questionnaire score at 1 year (mean difference 0.06, -0.50 to 0.62; P = 0.830) or in incidence of venous thromboembolism (risk ratio 0.72, 95 per cent c.i. 0.14 to 3.61; P = 0.690). CONCLUSION: The rate of successful anatomical occlusion after MOCA is significantly lower than that after EVTA, but there is no difference in procedural and postprocedural pain between the two interventions. Long-term data are required to assess the impact of the reduced vein occlusion rate on clinical outcomes such as quality of life and reintervention.


The current first-line treatment for varicose veins uses heat to block the diseased veins and is called endovenous thermal ablation (EVTA). Mechanochemical ablation (MOCA) is an alternative method of treatment using a chemical and a fast-spinning wire to block the veins instead. The potential benefits of MOCA include less pain and fewer complications. The aim of this study was to identify high-quality clinical trials comparing MOCA with EVTA, and to assess any differences in the results of treatment. The results showed that MOCA was less successful in blocking the diseased veins than EVTA. There were no differences in the amount of pain or discomfort during or after the procedures (which was low). At 1 year, those treated with both techniques reported the same quality of life. Both techniques were effective over 1 year in terms of improving quality of life; however, the potential benefits of MOCA were not clearly proven in the trials, and the poorer rates of successfully blocking the veins may cause the varicose veins to come back sooner, or the quality-of-life improvement to be shorter lived. There was no evidence to support MOCA replacing EVTA as the first-line treatment in the majority of patients, but it is a viable treatment for selected people.


Assuntos
Varizes , Insuficiência Venosa , Tromboembolia Venosa , Humanos , Insuficiência Venosa/terapia , Qualidade de Vida , Varizes/cirurgia , Dor
12.
J Wound Care ; 32(3): 182-192, 2023 Mar 02.
Artigo em Inglês | MEDLINE | ID: mdl-36930191

RESUMO

OBJECTIVE: The purpose of this study was to assess the feasibility of delivering extracorporeal shockwave therapy (ESWT) to patients with diabetic foot ulcers (DFUs). It also aimed to explore any potential clinical effect of ESWT on wound healing and investigate whether ESWT offers any patient-reported benefits. METHOD: In this single-centre, mixed methods feasibility study, patients with a DFU who met the eligibility criteria underwent ESWT three times over a seven-day period. Primary outcome was feasibility of delivering the intervention. Secondary outcomes included wound size, number of DFUs healed at 12 weeks and quality of life (QoL). Semi-structured interviews explored participants' experience of undergoing ESWT. RESULTS: Of 106 patients screened, 24 (22.6%) were recruited. Following recruitment, two patients were withdrawn from the study with 22 patients included in the final analysis. The mean attendance at clinic was 90.9% and 65.1% for follow-up. The mean score for acceptability and tolerability was 9.86±0.48 (95% confidence interval (CI): 9.62-10.01) and 9.15±2.57 (95% CI: 7.87-10.42), respectively. There were no serious adverse events or side-effects. Of the DFUs, 45.5% healed during follow-up and QoL scores improved until eight weeks. Key themes identified from the qualitative interviews were: desire for fast healing; improved QoL; flexibility of new treatments; and accessibility of transport. CONCLUSION: This study has shown that it is possible to recruit and retain patents into a single-arm study of ESWT for DFUs. This study supports development of a large randomised control trial to determine the clinical and cost-effectiveness of ESWT for DFU healing.


Assuntos
Diabetes Mellitus , Pé Diabético , Tratamento por Ondas de Choque Extracorpóreas , Humanos , Estudos de Viabilidade , Qualidade de Vida , Tratamento por Ondas de Choque Extracorpóreas/métodos , Resultado do Tratamento
13.
Br J Surg ; 110(2): 225-232, 2023 01 10.
Artigo em Inglês | MEDLINE | ID: mdl-36448204

RESUMO

BACKGROUND: Standardization of access to treatment and compliance with clinical guidelines are important to ensure the delivery of high-quality care to people with varicose veins. In the National Health Service (NHS) in England, commissioning of care for people with varicose veins is performed by Clinical Commissioning Groups (CCGs) and clinical guidelines have been developed by the National Institute for Health and Care Excellence (NICE CG168). The Evidence-Based Intervention (EBI) programme was introduced in the NHS with the aim of improving care quality and supporting implementation of NICE CG168. The aim of this study was to assess access to varicose vein treatments in the NHS and the impact of EBI. METHODS: CCG policies for the delivery of varicose vein treatments in the NHS in England were obtained from 2017 (before EBI introduction) and 2019 (after EBI introduction) and categorized by two independent reviewers into levels of compliance with NICE CG168. Hospital Episode Statistics data were compared with the NICE commissioning model predictions. A quality-adjusted life-year was valued at £20 000 (Euro 23 000 15 November 2022). RESULTS: Despite the introduction of the EBI programme, CCG compliance with NICE CG168 fell from 34.0 per cent (64 of 191) to 29.0 per cent (55 of 191). Some 33.0 per cent of CCG policies (63 of 191) became less compliant and only 7.3 per cent (14 of 191) changed to become fully compliant. Overall, 66.5 per cent of CCGs (127 of 191) provided less than the recommended intervention rate before EBI and this increased to 73.3 per cent (140 of191) after EBI. The overall proportion of patients estimated to require treatment annually who received treatment fell from 44.0 to 37.0 per cent. The associated estimated loss in net health benefit was between £164 and 174 million (Euro 188 million and 199 million 15 November 2022) over 3 years. A compliant policy was associated with a higher intervention rate; however, commissioning policy was associated with only 16.8 per cent of the variation in intervention rate (R2 = 0.168, P < 0.001). CONCLUSION: Many local varicose vein commissioning policies in the NHS are not compliant with NICE CG168. More than half of patients who should be offered varicose vein treatment are not receiving it, and there is widespread geographical variation. The EBI programme has not been associated with any improvement in commissioning or access to varicose vein treatment.


Assuntos
Medicina Estatal , Varizes , Humanos , Inglaterra , Varizes/terapia , Inquéritos e Questionários , Qualidade da Assistência à Saúde
15.
Int Wound J ; 20(6): 2303-2320, 2023 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-36461894

RESUMO

Emerging evidence suggests that extracorporeal shockwave therapy (ESWT) may improve time to DFU healing. The aim of this review was to appraise the evidence on role of ESWT in DFU healing and impact of different ESWT doses. Databases were searched for trials comparing ESWT plus standard care to standard care alone in participants with DFUs. Search results were reviewed by two independent reviewers. The Cochrane Risk of Bias 2 tool and GRADE approach was used to assess bias and certainty. The primary outcome was time to healing. The search identified 345 papers after duplicates removed. Six trials consisting of 471 participants were included. There was unclear or high risk of bias across all domains. Time to ulcer healing was probably shorter in patients treated with ESWT compared with standard ulcer care alone (GRADE: low certainty). Patients treated with ESWT were more likely to heal at 20 weeks post-ESWT compared with those treated with standard ulcer care alone (GRADE: low certainty). There was significant heterogeneity. ESWT remains a promising new treatment but the translation into routine clinical practice is still limited by the low certainty of evidence surrounding its effectiveness, case selection and optimum dose.


Assuntos
Diabetes Mellitus , Pé Diabético , Tratamento por Ondas de Choque Extracorpóreas , Humanos , Pé Diabético/terapia , Tratamento por Ondas de Choque Extracorpóreas/métodos , Resultado do Tratamento , Cicatrização
16.
J Vasc Access ; : 11297298221141497, 2022 Dec 06.
Artigo em Inglês | MEDLINE | ID: mdl-36474333

RESUMO

BACKGROUND: The reduction in distal arterial flow following arteriovenous fistula (AVF) creation can cause a perfusion deficit known as haemodialysis access induced distal ischemia (HAIDI). Various techniques have been advocated to treat this difficult problem with varying success. We present the long-term outcomes following a novel banding technique. METHODS: 46 patients in this cohort from 2008 to 2021 underwent a novel banding procedure using a Dacron™ patch shaped with one slit-end and saw-tooth edges (resulting in a 'Christmas-tree' pattern) to provide a ratchet mechanism to progressively constrict the fistula outflow. Real-time finger perfusion pressure monitoring allowed an accurate reduction in AVF flow whilst increasing distal arterial perfusion pressure. Baseline characteristic were recorded and Kaplan-Meier survival curves were obtained to calculate the post-intervention primary, assisted primary and secondary patency. RESULTS: 29 patients presented with rest pain and 11 presented with tissue loss due to distal ischemia. The post-intervention primary access patency was 100%, 98%, 78% and 61% at 30, 60 and 180 days and 1 year respectively. Complete resolution of symptoms was achieved in 74% (n = 34) of patients and a partial response needing no further intervention was achieved in 11% (n = 5) of patients. A Youden index calculation suggested that digital pressures of 41 mm Hg or lower in an open AVF were highly sensitive for symptomatic hand ischemia whereas pressures greater than 65 mm Hg ruled out distal ischemia. CONCLUSION: 'Christmas-tree' banding with on table finger systolic pressures is not only an efficacious and durable method for treating HAIDI but also preserves fistula patency.

17.
Br J Surg ; 109(8): 679-685, 2022 07 15.
Artigo em Inglês | MEDLINE | ID: mdl-35639496

RESUMO

BACKGROUND: International guidelines recommend postprocedural compression when treating symptomatic superficial venous incompetence (SVI). This updated review of RCTs investigated the requirement for postprocedural compression and how it can be applied optimally. METHODS: The National Institute for Health and Care Excellence's Healthcare Databases Advanced Search engine was used to identify all English-language RCTs of compression following treatment for SVI. Outcomes of interest included postprocedural pain, venous thromboembolism, health-related quality of life (HRQoL), and anatomical occlusion. RESULTS: A total of 18 studies were included comprising some 2584 treated limbs. Compression was compared with no compression in four studies, nine studies compared different durations of compression, and a further five compared different types of compression. A 1-2-week period of compression was associated with a mean reduction of 11 (95 per cent c.i. 8 to 13) points in pain score on a 100-mm visual analogue scale compared with a shorter duration (P < 0.001). This was associated with improved HRQoL and patient satisfaction. Longer durations of compression did not add further benefit. There was low-quality evidence suggesting that 35-mmHg compression with eccentric thigh compression achieved lower pain scores than lower interface pressures. There were no significant differences in venous thromboembolism rates or technical success in any group, including no compression. CONCLUSION: Postprocedural compression of 1-2 weeks after SVI treatment is associated with reduced pain compared with a shorter duration. The optimal interface pressure and type of compression, and the impact on venous thromboembolism risk, remain to be determined.


Assuntos
Qualidade de Vida , Tromboembolia Venosa , Humanos , Dor , Medição da Dor , Veias
18.
Br J Surg ; 109(5): 426-432, 2022 04 19.
Artigo em Inglês | MEDLINE | ID: mdl-35325055

RESUMO

BACKGROUND: Lower limb amputation (LLA) is typically described as 'clean surgery', but surgical-site infection (SSI) rates are high and there is significant variation in antibiotic prophylaxis practice. This study aimed to determine whether an extended period of antibiotic prophylaxis (5-day course) is superior to a short course (24 h) in preventing SSI in patients undergoing minor and major LLA. METHODS: Patients undergoing minor and major amputation from a single vascular unit were recruited and randomized to receive either a 5-day or a 24-h prophylactic course of antibiotics. Patients with significant baseline infection were excluded. Outcomes included the incidence of SSI and impaired wound healing (IWH), both measured using ASEPSIS criteria, the need for further surgery, duration of hospital stay, and mortality up to 1 year. RESULTS: Some 161 patients were recruited to the study, and 152 were included in the analysis. A 5-day course of antibiotics was associated with a lower incidence of SSI (11.8 versus 39.5 per cent; P < 0.001) and lower incidence of IWH (22.4 versus 58 per cent; P < 0.001). Fewer patients receiving the 5-day course required amputation revisional surgery (6.6 versus 21 per cent; P = 0.010). Duration of hospital stay and mortality rates were similar. The presence of SSI (odds ratio (OR) 5.14, 95 per cent c.i. 1.96 to 13.45; P < 0.001) and IWH (OR 4.62, 1.68 to 12.72; P = 0.003) increased the need for revisional surgery. SSI increased the duration of hospital stay: median 28 (i.q.r. 16-40) versus 14 (9-21) days (P = 0.045). CONCLUSION: SSI and IWH are common after LLA and have a significant impact on outcome. A 5-day course of antibiotic prophylaxis was associated with a reduction in both SSI and IWH compared with a 24-h course, and this reduced the need for further surgery. Registration number: NCT02018094 (http://www.clinicaltrials.gov); EudraCT 2012-003146-32 (https://www.clinicaltrialsregister.eu).


Assuntos
Antibioticoprofilaxia , Infecção da Ferida Cirúrgica , Amputação Cirúrgica , Antibacterianos/uso terapêutico , Humanos , Extremidade Inferior/cirurgia , Infecção da Ferida Cirúrgica/epidemiologia
19.
Cochrane Database Syst Rev ; 12: CD013839, 2021 12 14.
Artigo em Inglês | MEDLINE | ID: mdl-34904714

RESUMO

BACKGROUND: Diabetes and vascular disease are the leading causes of lower limb amputation. Currently, 463 million adults are living with diabetes, and 202 million with peripheral vascular disease, worldwide. When a lower limb amputation is considered, preservation of the knee in a below-knee amputation allows for superior functional recovery when compared with amputation at a higher level. When a below-knee amputation is not feasible, the most common alternative performed is an above-knee amputation. Another possible option, which is less commonly performed, is a through-knee amputation which may offer some potential functional benefits over an above-knee amputation. OBJECTIVES: To assess the effects of through-knee amputation compared to above-knee amputation on clinical and rehabilitation outcomes and complication rates for all patients undergoing vascular and non-vascular major lower limb amputation. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases; the World Health Organization International Clinical Trials Registry Platform; and the ClinicalTrials.gov trials register to 17 February 2021. We undertook reference checking, citation searching, and contact with study authors to identify additional studies. SELECTION CRITERIA: Published and unpublished randomised controlled trials (RCTs) comparing through-knee amputation and above-knee amputation were eligible for inclusion in this study. Primary outcomes were uncomplicated primary wound healing and prosthetic limb fitting. Secondary outcomes included time taken to achieve independent mobility with a prosthesis, health-related quality of life, walking speed, pain, and 30-day survival. DATA COLLECTION AND ANALYSIS: Two review authors independently reviewed all records identified by the search. Data collection and extraction were planned in line with recommendations outlined in the Cochrane Handbook for Systematic Reviews of Interventions. We planned to assess the certainty of evidence using the GRADE approach. MAIN RESULTS: We did not identify RCTs that met the inclusion criteria for this review. AUTHORS' CONCLUSIONS: No RCTs have been conducted to determine comparative clinical or rehabilitation outcomes of through-knee amputation and above-knee amputation, or complication rates. It is unknown whether either of these approaches offers improved outcomes for patients. RCTs are needed to guide practice and to ensure the best outcomes for this patient group.


Assuntos
Amputação Cirúrgica , Doenças Vasculares Periféricas , Adulto , Humanos , Extremidade Inferior/cirurgia , Doenças Vasculares Periféricas/cirurgia , Ensaios Clínicos Controlados Aleatórios como Assunto , Revisões Sistemáticas como Assunto , Caminhada
20.
Ann Surg ; 273(6): e188-e195, 2021 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-31977509

RESUMO

OBJECTIVE: This RCT compares the clinical, technical and quality of life outcomes after EVLA and MOCA. SUMMARY OF BACKGROUND DATA: Thermal ablation is the current mainstay treatment for SVI. Newer nonthermal methods of treatment have been developed which do not require the use of tumescent anesthesia. The potential advantages of these newer methods should be tested in RCTs to ascertain their role in the future treatments of SVI. METHODS: This single-center RCT enrolled patients with symptomatic, unilateral, single-axis SVI. Eligible patients were equally randomized to either EVLA or MOCA, both with concomitant phlebectomy when necessary. The joint primary outcomes were intraprocedural axial ablation pain scores and anatomical occlusion at 1 year. Secondary outcomes included postprocedural pain, venous clinical severity score (VCSS), quality of life (Aberdeen varicose veins questionnaire and EuroQol 5-domain utility index), patient satisfaction and complication rates. RESULTS: One hundred fifty patients were randomized equally between the 2 interventions. Both groups reported low intraprocedural pain scores; on a 100 mm visual analog scale, pain during axial EVLA was 22 (9-44) compared to 15 (9-29) during MOCA; P = 0.210. At 1 year, duplex derived anatomical occlusion rates after EVLA were 63/69 (91%) compared to 53/69 (77%) in the MOCA group; P = 0.020. Both groups experienced significant improvement in VCSS and AVVQ after treatment, without a significant difference between groups. Median VCSS improved from 6 (5-8) to 0 (0-1) at one year; P < 0.001. Median AVVQ improved from 13.8 (10.0-17.7) to 2.0 (0.0-4.9); P < 0.001. One patient in the MOCA group experienced DVT. CONCLUSIONS: Both EVLA and MOCA were highly efficacious in treating SVI; patients improved significantly in terms of disease severity, symptoms, and QoL. Both resulted in low procedural pain with a short recovery time. Axial occlusion rates were higher after EVLA. Long term follow-up is warranted to assess the effect of recanalization on the rate of clinical recurrence.


Assuntos
Procedimentos Endovasculares/métodos , Terapia a Laser , Qualidade de Vida , Insuficiência Venosa/cirurgia , Técnicas de Ablação/métodos , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
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