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BACKGROUND: The aim of this study is to review illness perceptions (IPs) in chronic limb-threatening ischemia (CLTI) patients undergoing revascularization (open surgical or endovascular), major lower extremity amputation, or conservative management. METHODS: MEDLINE, EMBASE, PsycINFO, CINAHL, WOS, and Scopus databases were searched from inception to August 20, 2021 for studies evaluating IP in CLTI according to Leventhal's common sense model (CSM). Since only 1 study was identified, a post hoc secondary literature search of MEDLINE was performed for reviews of IP in cardiovascular disease and diabetes to identify potential learning points for future research. All studies underwent narrative synthesis guided by tabulated data. RESULTS: One study and 7 reviews were included from the primary and secondary literature searches, respectively. Timeline and controllability were the main aspects of IP that predict prosthetic use in CLTI patients, more so at 6 months than 1 month. Other reviews in cardiovascular disease and diabetes identified important targets for future research: (1) factors that affect IP and whether IP can be used as an outcome measure, (2) relationship between IP and clinician-reported and patient-reported outcomes, and (3) methods to educate and change maladaptive IP. The importance of using valid and reliable measures of IP that encompass all components of Leventhal's' CSM was stressed. CONCLUSIONS: Knowledge of IP in CLTI patients is severely limited in contrast to other fields in cardiovascular disease and diabetes. This review helps to close this gap by raising awareness of IP and its importance within the vascular surgical community, and by providing a framework for future studies.
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Diabetes Mellitus , Procedimientos Endovasculares , Enfermedad Arterial Periférica , Humanos , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/cirugía , Enfermedad Arterial Periférica/complicaciones , Recuperación del Miembro/métodos , Isquemia/diagnóstico , Isquemia/cirugía , Isquemia/etiología , Procedimientos Endovasculares/efectos adversos , Isquemia Crónica que Amenaza las Extremidades , Factores de Riesgo , Resultado del Tratamiento , Amputación Quirúrgica , Enfermedad Crónica , Estudios RetrospectivosRESUMEN
OBJECTIVE: To identify implantable devices currently used for vascular and endovascular procedures, to ascertain how many have randomised controlled trial (RCT) evidence available, and to assess the quality of that evidence. DATA SOURCES: MEDLINE, Embase, DARE, PROSPERO, clinical trial registries, and Cochrane databases. REVIEW METHODS: A list of current devices used in both vascular and endovascular procedures was generated by searching conference proceedings, manufacturer catalogues, and websites. MEDLINE, Embase, DARE, PROSPERO, clinical trial registries, and Cochrane databases were searched from inception up to June 2020. The primary outcome was the availability of RCTs to support the use of a vascular implantable device. RCTs were then quality assessed using the Cochrane risk of bias tool. RESULTS: A total of 116 current vascular implantable devices were identified. The systematic literature review identified 165 RCTs. Eighty-three of the RCTs (50.3%) applied to 33 of the 116 (28.4%) current implantable devices. When grouped by device type, eight of the 13 types (62%) had at least one RCT performed. There was a high risk of bias across the majority of the RCTs, with only nine (5.4%) deemed to be at low risk of bias. Only 22 (13.3%) RCTs had a clear safety outcome. CONCLUSION: Sixty-two per cent of implantable device types for use in vascular and endovascular interventions had at least one RCT available to show equivalence to previous devices or safety. RCTs were generally of low quality and are decreasing in frequency with time. With medical implantable device failure being increasingly recognised as causing significant harm to patients worldwide, there is a clear need for a more robust implantable device regulation and approval systems.
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Suture-based vascular closure devices are used in percutaneous endovascular procedures. However, failures are not uncommon. We have described our initial experience with two adjunct techniques to reinforce the suture-based vascular closure device (ProGlide; Abbot Vascular, Santa Clara, Calif) after percutaneous endovascular aneurysm repair. The threads of the ProGlide device (Abbot Vascular) were passed through a pledget with the help of a needle, which was secured to the puncture site to allow for traction compression. The use of the techniques can be helpful if the suture-based vascular closure devices fail to achieve immediate and complete hemostasis. The use of these adjuncts could reduce the incidence of closure-related complications after percutaneous endovascular procedures.
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An amendment to this paper has been published and can be accessed via the original article.
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OBJECTIVE: Randomised trials of new devices for peripheral arterial endovascular intervention are published regularly. The evidence for which antiplatelet and/or anticoagulant (antithrombotic) therapy to use after an intervention is lacking. The aim of this systematic review was to examine the antithrombotic regimens in randomised trials for peripheral arterial endovascular intervention to understand choices made and trends with time or type of device. METHODS: Data sources were the Medline, Embase, and Cochrane Library databases. Randomised trials including participants with peripheral arterial disease undergoing any endovascular arterial intervention were included. Trial methods were assessed to determine whether an antithrombotic protocol had been specified, its completeness, and the agent(s) prescribed. Antithrombotic therapy protocols were classed as peri-procedural (preceding and during intervention), immediate post-procedural (up to 30 days following intervention), and maintenance post-procedural (therapy continuing beyond 30 days). RESULTS: Ninety-four trials were included in narrative synthesis. Study quality was low. None of the trials justified their antithrombotic therapy protocol. Only 29% of trials had complete peri-procedural antithrombotic protocols, and 34% had complete post-procedural protocols. In total, 64 different peri-procedural protocols, and 51 separate post-procedural protocols were specified. Antiplatelet monotherapy and unfractionated heparin were the most common regimen choices in the peri-procedural setting, and dual antiplatelet therapy (55%) was most commonly utilised post procedure. Over time there has been an increasing tendency to use dual therapy (p < .001). This corresponds with the introduction of newer technologies and trials focussed on below knee intervention. CONCLUSION: Randomised trials comparing different types of peripheral endovascular arterial intervention have a high level of heterogeneity in their antithrombotic regimens. Antiplatelet therapy needs to be standardised in trials comparing endovascular technologies to reduce potential confounding. To do this, an independent randomised trial specifically examining antiplatelet therapy following peripheral arterial endovascular intervention is needed.
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Anticoagulantes/uso terapéutico , Procedimientos Endovasculares/métodos , Enfermedad Arterial Periférica/cirugía , Inhibidores de Agregación Plaquetaria/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , HumanosRESUMEN
INTRODUCTION: There is significant variation in how anaesthesia is defined and reported in clinical research. This lack of standardisation complicates the interpretation of published evidence and planning of future clinical trials. This systematic review will assess the reporting of anaesthesia as an intervention in randomised controlled trials (RCT) against the Consolidated Standards of Reporting Trials for Non-Pharmacological Treatments (CONSORT-NPT) framework. METHODS AND ANALYSIS: Online archives of the top six journals ranked by impact factor for anaesthesia and the top three general medicine and general surgery journals will be systematically hand searched over a 42-month time period to identify RCTs describing the use of anaesthetic interventions for any invasive procedure. All modes of anaesthesia and anaesthesia techniques will be included. All study data, including the type of anaesthetic intervention described, will be extracted in keeping with the CONSORT-NPT checklist. Descriptive statistics will be used to summarise general study details including types/modes of anaesthetic interventions, and reporting standards of the trials. ETHICS AND DISSEMINATION: No ethical approval is required. The results will be used to inform a funding application to formally standardise general, local, regional anaesthesia and sedation for use in clinical research. The systematic review will be disseminated via peer-reviewed manuscript and conferences. PROSPERO REGISTRATION NUMBER: CRD42019141670.
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Anestesia/normas , Lista de Verificación/normas , Ensayos Clínicos Controlados Aleatorios como Asunto , Humanos , Revisiones Sistemáticas como AsuntoRESUMEN
BACKGROUND: Antiplatelet and anticoagulant therapy are commonly used before, during and after peripheral arterial endovascular intervention. This survey aimed to establish antiplatelet and anticoagulant choice for peripheral arterial endovascular intervention in contemporary clinical practice. METHODS: Pilot-tested questionnaire distributed via collaborative research networks. RESULTS: One hundred and sixty-two complete responses were collected from responders in 22 countries, predominantly the UK (48%) and the rest of the European Union (44%). Antiplatelet monotherapy was the most common choice pre-procedurally (62%). In the UK, there was no difference between dual and single antiplatelet therapy use post procedure (50% vs. 37% p = 0.107). However, a significant majority of EU respondents used dual therapy (68% vs. 20% p < 0.001). There was variation in choice of antiplatelet therapy by the device used and the anatomical location of the intervention artery. The majority (82%) of respondents believed there was insufficient evidence to guide antithrombotic therapy after peripheral endovascular intervention and most (92%) would support a randomised trial. CONCLUSIONS: There is widespread variation in the use of antiplatelet therapy, especially post peripheral arterial endovascular intervention. Clinicians would support the development of a randomised trial comparing dual antiplatelet therapy with monotherapy.
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Background Although well characterised in adults, less is known about post-thrombotic syndrome in children. In this review, current knowledge regarding paediatric post-thrombotic syndrome is summarised, with particular emphasis on pathophysiology, aetiology, diagnosis and management. Methods A Medline literature review was performed using search terms 'post thrombotic syndrome', 'post phlebitic syndrome', paediatric and children. Relevant articles were identified and included for summation analysis. Results The incident of paediatric venous thromboembolism is rising. Deep vein thrombosis can cause venous hypertension through a combination of venous reflux, venous obstruction and impairment of the calf muscle pump, leading to development of post-thrombotic syndrome. In children, this is more likely to occur if deep vein thrombosis diagnosis and treatment are delayed, if a higher number of vessels are involved, and if factors such as D-dimer are elevated at diagnosis and throughout treatment. Post-thrombotic syndrome occurs in about 26% of paediatric deep vein thrombosis, though the results of individual studies vary widely. A number of tools exist to diagnose paediatric post-thrombotic syndrome, including the modified Villalta scale and Manco-Johnson instrument. Once post-thrombotic syndrome develops, the mainstay of treatment remains supportive, with little evidence of benefit from pharmacological measures. Conclusion Surgical or interventional treatment is not advised except in exceptional cirumstances, due to variable prognosis of PTS in paediatric populations with rising incidence of paediatric venous thromboembolism, it follows that the prevalence of post-thrombotic syndrome in children may also increase. Evidence-based venous thromboembolism prevention strategies need to be implemented for prevention of deep vein thrombosis, but when it does occur, deep vein thrombosis requires prompt and effective treatment to prevent post-thrombotic syndrome. Optimum treatment strategies for post-thrombotic syndrome require further investigation.
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Productos de Degradación de Fibrina-Fibrinógeno/metabolismo , Síndrome Postrombótico , Tromboembolia Venosa , Adolescente , Niño , Preescolar , Femenino , Humanos , Incidencia , Lactante , MEDLINE , Masculino , Síndrome Postrombótico/sangre , Síndrome Postrombótico/diagnóstico , Síndrome Postrombótico/etiología , Síndrome Postrombótico/terapia , Tromboembolia Venosa/sangre , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/prevención & controlRESUMEN
Endovascular aneurysm repair (EVAR) has become the intervention of choice for supra-threshold aortic aneurysms due to the lower 30-day mortality of EVAR as compared with open surgery, despite no long-term longevity gains. Trials such as EVAR-1 that established the current status of endovascular aortic intervention often excluded participants over the age of 80, and specific studies of EVAR in the elderly reveal higher mortality than accepted averages. Analyses of the cost-effectiveness of EVAR have not demonstrated superiority of endovascular intervention over open repair, in particular when considering complications such as endoleak. Post-intervention surveillance and the frequent need for re-intervention following EVAR has a detrimental impact on quality of life. Taking these factors into consideration, combined with an ageing population and the likely increase in octogenarian endovascular intervention, there is a clear clinical need for appropriate risk-stratification of elderly patients with supra-threshold aneurysms to determine who will benefit from endovascular repair.
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Aneurisma de la Aorta/cirugía , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Factores de Edad , Anciano de 80 o más Años , Aneurisma de la Aorta/diagnóstico por imagen , Aneurisma de la Aorta/mortalidad , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Toma de Decisiones Clínicas , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Humanos , Seguridad del Paciente , Selección de Paciente , Complicaciones Posoperatorias/etiología , Medición de Riesgo , Factores de Riesgo , Resultado del TratamientoRESUMEN
Abdominal aortic aneurysm (AAA) is a complex disease posing diagnostic and therapeutic challenges. Metabonomics may aid in the diagnosis of AAA, determination of individualized risk, discovery of therapeutic targets, and improve understanding of pathogenesis. A systematic review of the diversity and outcomes of existing AAA metabonomic research has been performed. Original research studies applying metabonomics to human aneurysmal disease are included. Seven relevant articles were identified: four studies were based on plasma/serum metabolite profiling, and three studies examined aneurysmal tissue. Aminomalonic acid, guanidinosuccinic acid, and glycerol emerge as potential plasma biomarkers of large aneurysm. Lipid profiling improves predictive models of aneurysm presence. Patterns of metabolite variation associated with AAA relate to carbohydrate and lipid metabolism. Perioperative perturbations in metabolites suggest differential systemic inflammatory responses to surgery, generating hypotheses for adjunctive perioperative therapy. Significant limitations include small study sizes, lack of correction for multiple testing false discovery rates, and single time-point sampling. Metabolic profiling carries the potential to identify biomarkers of AAA and elucidate pathways underlying aneurysmal disease. Statistically and methodologically robust studies are required for validation, addressing the hiatus in understanding mechanisms of aneurysm growth and developing effective treatment strategies.
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Aneurisma de la Aorta Abdominal/diagnóstico , Aneurisma de la Aorta Abdominal/metabolismo , Glicerol/metabolismo , Guanidinas/metabolismo , Malonatos/metabolismo , Succinatos/metabolismo , Aneurisma de la Aorta Abdominal/patología , Aneurisma de la Aorta Abdominal/cirugía , Biomarcadores/metabolismo , Progresión de la Enfermedad , Humanos , Lipoxinas/metabolismo , Metaboloma , Metabolómica/métodos , Pronóstico , Tromboxano B2/metabolismoRESUMEN
The application of metabonomic science to interrogate stroke permits the study of metabolite entities, small enough to cross the blood-brain barrier, that provide insight into neuronal dysfunction, and may serve as reservoirs of biomarker discovery. This systematic review examines the applicability of metabolic profiling in ischemic stroke research. Six human studies utilizing metabolic profiling to analyze biofluids from ischemic stroke patients have been included, employing 1H-NMR and/or mass spectrometry to analyze plasma, serum, and/or urine in a targeted or untargeted fashion. Three are diagnostic studies, and one investigates prognostic biomarkers of stroke recurrence following transient ischemic attack. Two studies focus on metabolic distinguishers of depression or cognitive impairment following stroke. Identified biomarkers from blood and urine predominantly relate to homocysteine and folate, branched chain amino acid, and lipid metabolism. Statistical models are well fitted and reproducible, with excellent validation outcomes, demonstrating the feasibility of metabolic profiling to study a complex disorder with multicausal pathology, such as stroke.
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Metabolómica/métodos , Accidente Cerebrovascular/metabolismo , Accidente Cerebrovascular/patología , Animales , Biomarcadores , Humanos , Espectroscopía de Resonancia Magnética/métodos , Espectrometría de Masas , Tritio/metabolismoAsunto(s)
Índice de Severidad de la Enfermedad , Accidente Cerebrovascular/diagnóstico , Historia del Siglo XVI , Historia del Siglo XVII , Historia del Siglo XVIII , Historia del Siglo XIX , Historia del Siglo XX , Historia del Siglo XXI , Historia Antigua , Humanos , Sociedades Médicas , Accidente Cerebrovascular/historia , Accidente Cerebrovascular/patología , Estados UnidosRESUMEN
Transient ischaemic attack secondary to carotid stenosis has the highest risk of stroke recurrence compared with other aetiological subtypes. International guidelines advocate carotid intervention within one to two weeks of the index neurological event. Traditionally, delayed carotid intervention was perceived to be a safer management strategy, yet classic trials of endarterectomy and recent meta-analysis of carotid intervention demonstrate the safety of hyperacute carotid intervention. Data from international studies suggest that targets are not being met, the reasons for which are multifactorial, but patients suffering transient or ocular symptoms are particularly delayed. Efforts should be made to conduct regional studies investigating the root causes of delayed intervention, with subsequent policy adjustment to expedite intervention, and interim optimisation of medical management to reduce the incidence of recurrent stroke.
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Angioplastia , Estenosis Carotídea/terapia , Endarterectomía Carotidea , Ataque Isquémico Transitorio/etiología , Tiempo de Tratamiento , Angioplastia/efectos adversos , Angioplastia/instrumentación , Estenosis Carotídea/complicaciones , Estenosis Carotídea/diagnóstico por imagen , Endarterectomía Carotidea/efectos adversos , Humanos , Ataque Isquémico Transitorio/diagnóstico por imagen , Recurrencia , Factores de Riesgo , Stents , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVE: To systematically review temporal changes in perioperative safety of carotid endarterectomy (CEA) in asymptomatic individuals in trial and registry studies. METHODS: The MEDLINE and EMBASE databases were searched using the terms "carotid" and "endarterectomy" and "asymptomatic" from 1947 to August 23, 2014. Articles dealing with 50%-99% stenosis in asymptomatic individuals were included and low-volume studies were excluded. The primary endpoint was 30-day stroke or death and the secondary endpoint was 30-day all-cause mortality. Statistical analysis was performed using random-effects meta-regression for registry data and for trial data graphical interpretation alone was used. RESULTS: Six trials (n = 4,431 procedures) and 47 community registries (n = 204,622 procedures) reported data between 1983 and 2013. Registry data showed a significant decrease in postoperative stroke or death incidence over the period 1991-2010, equivalent to a 6% average proportional annual reduction (95% credible interval [CrI] 4%-7%; p < 0.001). Considering postoperative all-cause mortality, registry data showed a significant 5% average proportional annual reduction (95% CrI 3%-9%; p < 0.001). Trial data showed a similar visual trend. CONCLUSIONS: CEA is safer than ever before and high-volume registry results closely mirror the results of trials. New benchmarks for CEA are a stroke or death risk of 1.2% and a mortality risk of 0.4%. This information will prove useful for quality improvement programs, for health care funders, and for those re-examining the long-term benefits of asymptomatic revascularization in future trials.
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Causas de Muerte/tendencias , Endarterectomía Carotidea/efectos adversos , Endarterectomía Carotidea/mortalidad , Seguridad del Paciente/estadística & datos numéricos , Complicaciones Posoperatorias/epidemiología , Accidente Cerebrovascular/epidemiología , Bases de Datos Factuales , Humanos , Incidencia , Sistema de RegistrosRESUMEN
OBJECTIVE: The cost of health care is increasingly becoming an international issue, with many health care systems requiring evaluation of cost when agreeing to fund health care. In the United Kingdom (UK), for example, the National Institute for Health and Care Excellence highlights the importance of using cost-effectiveness analyses to facilitate the effective use of resources. This study evaluates the use of cost-effectiveness analyses and the provision of vascular surgery. METHODS: A systematic review of published literature was performed. UK-based studies assessing cost-effectiveness or cost-utility of superficial venous interventions, abdominal aortic aneurysm (AAA) repair, and carotid endarterectomy (CEA) were included. All included studies were quality assessed to determine the overall strength of UK economic evidence for each intervention. RESULTS: Four superficial venous, six AAA, and two CEA studies met the inclusion criteria. After quality assessment, the UK evidence supporting the cost-effectiveness of superficial venous intervention was graded strong. The economic evidence for asymptomatic and symptomatic CEA was graded limited and insufficient, respectively, owing to a paucity of UK literature in this field. There was strong UK economic evidence affirming that endovascular aneurysm repair (EVAR) is unlikely to be a cost-effective alternative to open repair. CONCLUSIONS: There is strong economic evidence for symptomatic superficial venous intervention. However, funding for varicose vein treatments remains controversial. Future economic analyses are required for symptomatic and asymptomatic CEA to better advise national policy. Despite strong economic evidence, current UK guidance is for EVAR over open repair in the elective setting, with the majority of elective AAA repairs being EVAR.
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Análisis Costo-Beneficio/economía , Medicina Estatal/economía , Procedimientos Quirúrgicos Vasculares/economía , Aneurisma de la Aorta Abdominal/economía , Aneurisma de la Aorta Abdominal/cirugía , Endarterectomía Carotidea/economía , Procedimientos Endovasculares/economía , Humanos , Cobertura del Seguro/economía , Reino UnidoRESUMEN
OBJECTIVE: This study assessed patterns of superficial reflux in patients with primary chronic venous disease. METHODS: Retrospective review of all patient venous duplex ultrasonography reports at one institution between 2000 and 2009. Legs with secondary, deep or no superficial reflux were excluded. RESULTS: In total, 8654 limbs were scanned; 2559 legs from 2053 patients (mean age 52.3 years) were included for analysis. Great saphenous vein reflux predominated (68%), followed by combined great saphenous vein/small saphenous vein reflux (20%) and small saphenous vein reflux (7%). The majority of legs with competent saphenofemoral junction had below-knee great saphenous vein reflux (53%); incompetent saphenofemoral junction was associated with combined above and below-knee great saphenous vein reflux (72%). Isolated small saphenous vein reflux was associated with saphenopopliteal junction incompetence (61%), although the majority of all small saphenous vein reflux limbs had a competent saphenopopliteal junction (57%). CONCLUSION: Superficial venous reflux does not necessarily originate from a saphenous junction. Large prospective studies with interval duplex ultrasonography are required to unravel the natural history of primary chronic venous disease.