Peripheral arterial disease (PAD) - A challenging manifestation of atherosclerosis.

The diagnosis of peripheral arterial disease (PAD) is not always evident as symptoms and signs may show great variation. As all grades of PAD are linked to both an increased risk for cardiovascular complications and adverse limb events, awareness of the condition and knowledge about diagnostic measures, prevention and treatment is crucial. This article presents in a condensed form information on PAD and its management.

Routinely collected data and patient-centred research in anaesthesia and peri-operative care: a narrative review.

Randomised controlled trials are the gold standard in clinical research, but remain rare due to their expense and a perceived lack of 'real-world' applicability. At the same time, there has been an exponential increase in routinely collected data which presents opportunities for audit, quality improvement, adverse event reporting and more efficient clinical research. Registry-based research benefits from reduced cost, large sample size and real-world applicability, with methodological developments, particularly registry-based randomised controlled trials and causal inference techniques, showing promise. Limitations include data quality and validity, the need for data linkage, the restrictions of fixed data fields, regulatory barriers, and privacy and security concerns. However, the principal factor hampering current efforts is a lack of anaesthesia-specific datasets in the UK and the fact that most surgical registries do not collect any anaesthetic data. This presents an opportunity for anaesthetists, through enhanced engagement and collaboration, to influence and improve the design of these datasets and increase the value and volume of data collected. Better datasets, coupled with a growing appreciation of new analysis methodologies, would allow significant progress towards realising the potential of routinely collected data for patient benefit. At the same time, work should begin on the development of a minimum dataset for anaesthesia to underpin new data sharing networks and, ideally, a national registry of anaesthesia.

A systematic review of reporting quality for anaesthetic interventions in randomised controlled trials.

Interventions from randomised controlled trials can only be replicated if they are reported in sufficient detail. The results of trials can only be confidently interpreted if the delivery of the intervention was systematic and the protocol adhered to. We systematically reviewed trials of anaesthetic interventions published in 12 journals from January 2016 to September 2019. We assessed the detail with which interventions were reported, using the Consolidated Standards of Reporting Trials statement for non-pharmacological treatments. We analysed 162 interventions reported by 78 trials in 18,675 participants. Detail sufficiently precise to replicate the intervention was reported for 111 (69%) interventions. Intervention standardisation was reported for 135 (83%) out of the 162 interventions, and protocol adherence was reported for 20 (12%) interventions. Sixty (77%) out of the 78 trials reported the administrative context in which interventions were delivered and 36 (46%) trials detailed the expertise of the practitioners. We conclude that bespoke reporting tools should be developed for anaesthetic interventions and interventions in other areas such as critical care.

Scoping review of mode of anaesthesia in emergency surgery.

BACKGROUND: Emergency surgery encompasses more than 50 per cent of the surgical workload; however, research efforts are disproportionally low. The mode of anaesthesia used during emergency surgery may affect outcomes, but the extent of research and the impact of the different modes of anaesthesia used are unclear. METHODS: MEDLINE and Embase were searched using scoping review methodology with a rapid systematic search strategy, identifying any study comparing locoregional (local, nerve block, subarachnoid, epidural) anaesthesia with general anaesthesia. All studies describing outcomes of emergency surgery with differing modes of anaesthesia were identified. Excluded were: studies published before 2003, studies enrolling patients aged less than 18 years and studies using sedation only. RESULTS: Forty-two studies were identified, describing 11 surgical procedures. Most publications were retrospective cohort studies (32). A very broad range of clinical and patient-reported outcomes were described, with wide variation in the outcomes reported in different studies. CONCLUSION: Reporting of mode of anaesthesia is inconsistent across different procedures and is often absent. There is a need for directed research efforts to improve the reporting standards of anaesthesia interventions, to understand the role of different modes of anaesthesia in specific emergency surgical procedures, and to standardize outcome reporting using core outcome sets.

ANTECEDENTES: La cirugía de urgencias constituye > 50% de la carga de trabajo quirúrgico, aunque los esfuerzos realizados en investigación en este ámbito son desproporcionadamente bajos. La modalidad de anestesia utilizada durante la cirugía de urgencias puede afectar a los resultados, sin embargo, la investigación realizada y el impacto de los diferentes tipos de anestesia utilizados no están claros. MÉTODOS: Se realizaron búsquedas en Medline y Embase utilizando una metodología enfocada a la recuperación de revisiones, con una estrategia de búsqueda sistemática rápida, identificando cualquier estudio que comparara la anestesia locorregional (local, bloqueo nervioso, subaracnoidea, epidural) con la anestesia general. Se identificaron todos los estudios que describían los resultados de la cirugía de urgencias con diferentes tipos de anestesia. Se excluyeron los estudios publicados antes del 2003, los estudios que reclutaron pacientes < 18 años y los estudios que solo usaron sedación. RESULTADOS: Se identificaron 42 estudios que describían 11 procedimientos quirúrgicos. La mayoría de publicaciones fueron estudios de cohortes retrospectivos (n = 32). Se describió una gama muy amplia de resultados clínicos y resultados aportados por los pacientes, con una amplia variación en los resultados de los diferentes estudios. CONCLUSIÓN: Los resultados publicados respecto a la modalidad de anestesia empleada en diferentes procedimientos quirúrgicos son inconsistentes, a menudo esta información está ausente y no se pueden establecer conclusiones sobre el impacto del tipo de anestesia en los resultados. Es necesario realizar esfuerzos dirigidos a la investigación para mejorar la notificación de los estándares de los procedimientos de anestesia, comprender el papel de los diferentes tipos de anestesia en los procedimientos quirúrgicos específicos de urgencias, y estandarizar la presentación de los resultados obtenidos utilizando un conjunto de datos principales.

Qualitative study of clinician and patient perspectives on the mode of anaesthesia for emergency surgery.

BACKGROUND: Although delivering a chosen mode of anaesthesia for certain emergency surgery procedures is potentially beneficial to patients, it is a complex intervention to evaluate. This qualitative study explored clinician and patient perspectives about mode of anaesthesia for emergency surgery. METHODS: Snowball sampling was used to recruit participants from eight National Health Service Trusts that cover the following three emergency surgery settings: ruptured abdominal aortic aneurysms, hip fractures and inguinal hernias. A qualitative researcher conducted interviews with clinicians and patients. Thematic analysis was applied to the interview transcripts. RESULTS: Interviews were conducted with 21 anaesthetists, 21 surgeons, 14 operating theatre staff and 23 patients. There were two main themes. The first, impact of mode of anaesthesia in emergency surgery, had four subthemes assessing clinician and patient ideas about: context and the 'best' mode of anaesthesia; balance in choosing it over others; change and developments in anaesthesia; and the importance of mode of anaesthesia in emergency surgery. The second, tensions in decision-making about mode of anaesthesia, comprised four subthemes: clinical autonomy and guidelines in anaesthesia; conforming to norms in mode of anaesthesia; the relationship between expertise, preference and patient involvement; and team dynamics in emergency surgery. The results highlight several interlinking factors affecting decision-making, including expertise, preference, habit, practicalities, norms and policies. CONCLUSION: There is variation in practice in choosing the mode of anaesthesia for surgery, alongside debate as to whether anaesthetic autonomy is necessary or results in a lack of willingness to change.

ANTECEDENTES: Si bien determinados tipos de anestesia en ciertos procedimientos quirúrgicos de urgencia pueden ser potencialmente beneficiosos para los pacientes, la decisión de su utilización es difícil de evaluar. Este estudio cualitativo exploró las perspectivas del clínico y del paciente sobre sobre el tipo de anestesia en cirugía de urgencia. MÉTODOS: Se utilizó un muestreo de bola de nieve para reclutar participantes de 8 corporaciones del National Health Service (NHS) que cubrían tres entornos de cirugía de urgencia: rotura de aneurismas aórticos abdominales, fracturas de cadera y hernias inguinales. Un investigador cualitativo realizó 79 entrevistas a 21 anestesistas, 21 cirujanos, 14 técnicos de quirófano y 23 pacientes. Se realizó un análisis de las transcripciones de la entrevista por temas. RESULTADOS: Dos fueron los temas principales. El primero era el impacto del tipo de anestesia en la cirugía de urgencia y tenía 4 subtemas que evaluaban las ideas del clínico y del paciente sobre: el contexto y el mejor tipo de anestesia, las ventajas e inconvenientes de la elección de un tipo sobre los otros, los cambios y avances en anestesia, y la importancia de la anestesia en cirugía de urgencias. El segundo era las dificultades en la toma de decisiones sobre el tipo de anestesia y comprendía 4 subtemas: la autonomía clínica y las guías de anestesia, el seguimiento de las normas en el tipo de anestesia, la relación entre experiencia, preferencia y opinión del paciente, así como las dinámicas del equipo en cirugía de urgencia. Los resultados resaltaron varios factores interconectados que afectan la toma de decisiones, incluyen la experiencia, las preferencias, los hábitos, algunos aspectos prácticos, las normas y las políticas. CONCLUSIÓN: En la práctica, existen variaciones en la elección del tipo de anestesia para la cirugía, junto con el debate sobre si la autonomía anestésica es necesaria o si resulta en una falta de voluntad para el cambio.

Umbrella review and meta-analysis of antiplatelet therapy for peripheral artery disease.

BACKGROUND: The literature on antiplatelet therapy for peripheral artery disease has historically been summarized inconsistently, leading to conflict between international guidelines. An umbrella review and meta-analysis was performed to summarize the literature, allow assessment of competing safety risks and clinical benefits, and identify weak areas for future research. METHODS: MEDLINE, Embase, DARE, PROSPERO and Cochrane databases were searched from inception until January 2019. All meta-analyses of antiplatelet therapy in peripheral artery disease were included. Quality was assessed using AMSTAR scores, and GRADE analysis was used to quantify the strength of evidence. Data were pooled using random-effects models. RESULTS: Twenty-eight meta-analyses were included. Thirty-three clinical outcomes and 41 antiplatelet comparisons in 72 181 patients were analysed. High-quality evidence showed that antiplatelet monotherapy reduced non-fatal strokes (3 (95 per cent c.i. 0 to 6) fewer per 1000 patients), In symptomatic patients, it reduced cardiovascular deaths (8 (0 to 16) fewer per 1000 patients), but increased the risk of major bleeding (7 (3 to 14) more events per 1000). In asymptomatic patients, monotherapy reduced non-fatal strokes (5 (0 to 8) fewer per 1000), but had no other clinical benefit. Dual antiplatelet therapy caused more major bleeding after intervention than monotherapy (37 (8 to 102) more events per 1000), with very low-quality evidence of improved endovascular patency (risk ratio 4·00, 95 per cent c.i. 0·91 to 17·68). CONCLUSION: Antiplatelet monotherapy has minimal clinical benefit for asymptomatic peripheral artery disease, and limited benefit for symptomatic disease, with a clear risk of major bleeding. There is a lack of evidence to guide antiplatelet prescribing after peripheral endovascular intervention.

ANTECEDENTES: Históricamente, la literatura del tratamiento antiplaquetario en la enfermedad arterial periférica se ha sintetizado inconsistentemente, lo que ha dado lugar a divergencias entre las guías internacionales. Se efectuó una amplia revision con metaanálisis para sintetizar claramente la literatura, permitiendo evaluar los riesgos competitivos de seguridad y los beneficios clínicos, e identificar áreas poco claras susceptibles de futuras investigaciones. MÉTODOS: La búsqueda se realizó en las bases de datos MEDLINE, EMBASE, DARE, PROSPERO y Cochrane desde su inicio hasta enero de 2019. Se incluyeron todos los metaanálisis del tratamiento antiplaquetario en la enfermedad arterial periférica. Se estimó su calidad utilizando la puntuación Amstar y la consistencia de su evidencia mediante el sistema GRADE. Los datos se agruparon utilizando modelos de efectos aleatorios. RESULTADOS: Se incluyeron 28 metaanálisis. Se analizaron 33 resultados clínicos y 41 comparaciones antiplaquetarias en 72.181 pacientes. Una evidencia de alta calidad demostró que la monoterapia antiplaquetaria reducía los accidentes cerebrovasculares no mortales y la muerte cardiovascular en pacientes sintomáticos (3 y 8 veces menos por 1.000 pacientes, respectivamente, i.c. del 95% 0-6 y 0-16), pero aumentó el riesgo de hemorragia grave (7 veces más por 1.000, i.c. del 95% 3-14). En pacientes asintomáticos, la monoterapia redujo los accidentes cerebrovasculares no mortales (5 veces menos por 1.000, i.c. del 95% 0-8) sin otro beneficio clínico. El doble tratamiento antiplaquetario causó más hemorragias graves después de cualquier intervención que la monoterapia (37 veces más por 1.000, i.c. del 95% 8-102), con una evidencia de muy baja calidad acerca de la mejoría de la permeabilidad endovascular (riesgo relativo 4,00, i.c. del 95% 0,91-17,68). CONCLUSIÓN: La monoterapia antiplaquetaria tiene un beneficio clínico mínimo en la enfermedad arterial periférica asintomática y un beneficio limitado en la sintomática, con un claro riesgo de hemorragia grave. No existe evidencia para recomendar la prescripción de antiagregantes plaquetarios después de una intervención endovascular periférica, situación que debería abordarse en ensayos aleatorizados con una potencia estadística adecuada.

Regional anaesthesia practice for arteriovenous fistula formation surgery.

We conducted a survey and semi-structured qualitative interviews to investigate current anaesthetic practice for arteriovenous fistula formation surgery in the UK. Responses were received from 39 out of 59 vascular centres where arteriovenous access surgery is performed, a response rate of 66%. Thirty-five centres reported routine use of brachial plexus blocks, but variation in anaesthetic skill-mix and practice were observed. Interviews were conducted with 19 clinicians from 10 NHS Trusts including anaesthetists, vascular access and renal nurses, surgeons and nephrologists. Thematic analysis identified five key findings: (1) current anaesthetic practice showed that centres could be classified as 'regional anaesthesia dominant' or 'local anaesthesia/mixed'; (2) decision making around mode of anaesthesia highlighted the key role of surgeons as frontline decision makers across both centre types; (3) perceived barriers and facilitators of regional block use included clinicians' beliefs and preferences, resource considerations and patients' treatment preferences; (4) anaesthetists' preference for supraclavicular blocks emerged, alongside acknowledgement of varied practice; (5) there was widespread support for a future randomised controlled trial, although clinician equipoise issues and logistical/resource-related concerns were viewed as potential challenges. The use of regional anaesthesia for arteriovenous fistula formation in the UK is varied and influenced by a multitude of factors. Despite the availability of anaesthetists capable of performing regional blocks, there are other limiting factors that influence the routine use of this technique. The study also highlighted the perceived need for a large multicentre, randomised controlled trial to provide an evidence base to inform current practice.

Local anaesthesia for endovascular repair of ruptured abdominal aortic aneurysm.

BACKGROUND: Case series and a post hoc subgroup analysis of a large randomized trial have suggested a potential benefit in treating ruptured abdominal aortic aneurysms (rAAAs) using endovascular aneurysm repair (EVAR) with local anaesthesia (LA) rather than general anaesthesia (GA). The uptake and outcomes of LA in clinical practice remain unknown. METHODS: The UK National Vascular Registry was interrogated for patients presenting with rAAA managed with EVAR under different modes of anaesthesia between 1 January 2014 and 31 December 2016. The primary outcome was in-hospital mortality. Secondary outcomes included: the number of centres performing EVAR under LA; the proportion of patients receiving this technique; duration of hospital stay; and postoperative complications. RESULTS: Some 3101 patients with rAAA were treated in 72 hospitals during the study: 2306 underwent on open procedure and 795 had EVAR (LA, 319; GA, 435; regional anaesthesia, 41). Overall, 56 of 72 hospitals (78 per cent) offered LA for EVAR of rAAA. Baseline characteristics and morphology were similar across the three EVAR subgroups. Patients who had surgery under LA had a lower in-hospital mortality rate than patients who received GA (59 of 319 (18·5 per cent) versus 122 of 435 (28·0 per cent)), and this was unchanged after adjustment for factors known to influence survival (adjusted hazard ratio 0·62, 95 per cent c.i. 0·45 to 0·85; P = 0·003). Median hospital stay and postoperative morbidity from other complications were similar. CONCLUSION: The use of LA for EVAR of rAAA has been adopted widely in the UK. Mortality rates appear lower than in patients undergoing EVAR with GA.

Value of risk scores in the decision to palliate patients with ruptured abdominal aortic aneurysm.

BACKGROUND: The aim of this study was to develop a 48-h mortality risk score, which included morphology data, for patients with ruptured abdominal aortic aneurysm presenting to an emergency department, and to assess its predictive accuracy and clinical effectiveness in triaging patients to immediate aneurysm repair, transfer or palliative care. METHODS: Data from patients in the IMPROVE (Immediate Management of the Patient With Ruptured Aneurysm: Open Versus Endovascular Repair) randomized trial were used to develop the risk score. Variables considered included age, sex, haemodynamic markers and aortic morphology. Backwards selection was used to identify relevant predictors. Predictive performance was assessed using calibration plots and the C-statistic. Validation of the newly developed and other previously published scores was conducted in four external populations. The net benefit of treating patients based on a risk threshold compared with treating none was quantified. RESULTS: Data from 536 patients in the IMPROVE trial were included. The final variables retained were age, sex, haemoglobin level, serum creatinine level, systolic BP, aortic neck length and angle, and acute myocardial ischaemia. The discrimination of the score for 48-h mortality in the IMPROVE data was reasonable (C-statistic 0·710, 95 per cent c.i. 0·659 to 0·760), but varied in external populations (from 0·652 to 0·761). The new score outperformed other published risk scores in some, but not all, populations. An 8 (95 per cent c.i. 5 to 11) per cent improvement in the C-statistic was estimated compared with using age alone. CONCLUSION: The assessed risk scores did not have sufficient accuracy to enable potentially life-saving decisions to be made regarding intervention. Focus should therefore shift to offering repair to more patients and reducing non-intervention rates, while respecting the wishes of the patient and family.

Clinical examination and non-invasive screening tests in the diagnosis of peripheral artery disease in people with diabetes-related foot ulceration.

AIM: Peripheral artery disease is common in people with diabetes-related foot ulceration and is a risk factor for amputation. The best method for the detection or exclusion of peripheral artery disease is unknown. This study investigated the utility of clinical examination and non-invasive bedside tests in screening for peripheral artery disease in diabetes-related foot ulceration. METHODS: Some 60 people presenting with new-onset ulceration participated. Accuracy of pulses, ankle pressure, toe pressure, toe-brachial index (TBI), ankle-brachial pressure index (ABPI), pole test at ankle, transcutaneous oxygen pressure and distal tibial waveform on ultrasound were examined. The gold standard diagnostic test used was > 50% stenosis in any artery or monophasic flow distal to calcification in any ipsilateral vessel on duplex ultrasound. RESULTS: The negative and positive likelihood ratios of pedal pulse assessment (0.75, 1.38) and the other clinical assessment tools were poor. The negative and positive likelihood ratios of ABPI (0.53, 1.69), transcutaneous oxygen pressure (1.10, 0.81) and ankle pressure (0.67, 2.25) were unsatisfactory. The lowest negative likelihood ratios were for tibial waveform assessment (0.15) and TBI (0.24). The highest positive likelihood ratios were for toe pressure (17.55) and pole test at the ankle (10.29) but the negative likelihood ratios were poor at 0.56 and 0.74. CONCLUSIONS: Pulse assessment and ABPI have limited utility in the detection of peripheral artery disease in people with diabetes foot ulceration. TBI and distal tibial waveforms are useful for selecting those needing diagnostic testing.

Quality of life, symptoms and treatment satisfaction in patients with aortic aneurysm using new abdominal aortic aneurysm-specific patient-reported outcome measures.

BACKGROUND: The aim of this study was to present preliminary data on quality of life (QoL), symptoms and treatment satisfaction gathered using three new abdominal aortic aneurysm (AAA)-specific patient-reported outcome measures (PROMs). METHODS: Patients with AAA were recruited from five National Health Service Trusts to complete the three new PROMs: the AneurysmDQoL, AneurysmSRQ and AneurysmTSQ. Patients were either under surveillance or had undergone AAA repair (open or endovascular) during the preceding 24 months. Data were initially collected as part of a study assessing the psychometric properties of the new measures, before being used in the observational analysis of outcomes presented here. RESULTS: Results, although largely non-significant, showed interesting trends. The impact of AAA repair on QoL appeared to worsen progressively after open repair (OR) and improve progressively after endovascular aneurysm repair (EVAR). Conversely, symptoms seemed to become progressively worse after EVAR and progressively better after OR. Information and understanding were key sources of dissatisfaction before the intervention, whereas postoperative dissatisfaction was related to bother from symptoms, follow-up and feedback about scan results. CONCLUSION: Although a larger, prospective data set is necessary to explore outcomes more fully with the new AAA-specific PROMs, the observational data presented here suggest there may be clinically important differences in the symptoms, impact on QoL and treatment satisfaction associated with OR and EVAR.

Design of new patient-reported outcome measures to assess quality of life, symptoms and treatment satisfaction in patients with abdominal aortic aneurysm.

BACKGROUND: No condition-specific patient-reported outcome measures exist for patients with abdominal aortic aneurysm (AAA). The aim of this work was to develop three questionnaires to assess quality of life (QoL), symptoms and treatment satisfaction in patients with AAA. METHODS: Semistructured interview techniques were used to explore patients' experiences of having an AAA in a series of focus groups and in-depth interviews. The information gathered was used to inform design and selection of items for the new tools; the overall structure of the new questionnaires was based on tools developed previously for patients with diabetes and other conditions. RESULTS: Fifty-four patients (51 men, 3 women; mean age 71·9 years) were recruited from four NHS Trusts to participate in focus groups or interviews, either while under surveillance, or following AAA repair (using open or endovascular techniques). The Aneurysm-Dependent Quality of Life Questionnaire (AneurysmDQoL) is an individualized measure of the impact of AAA on patients' QoL. Twenty-three domains were chosen specifically for their relevance to patients with AAA, with a further two overview items to assess overall QoL and the impact of AAA on QoL. The Aneurysm Symptom Rating Questionnaire (AneurysmSRQ) is a 44-item measure assessing physical and psychological symptoms reported by patients with AAA. The Aneurysm Treatment Satisfaction Questionnaire (AneurysmTSQ) contains 11 items, suitable for patients before and after surgical intervention. CONCLUSION: The iterative development process reported here has confirmed that these three new tools have good face and content validity for patients with AAA.

Expansion rate of descending thoracic aortic aneurysms.

BACKGROUND: Surveillance is mandatory for all patients with a thoracic aortic aneurysm (TAA). The frequency of surveillance imaging, however, is not evidence-based, as few data exist regarding TAA growth rates. This study aimed to determine the rate of TAA expansion and to inform surveillance intervals based on TAA diameter. METHODS: Patients with a TAA for whom morphological data were available from serial CT scans were studied. Annualized growth rates based on diameter at presentation and time taken to reach a theoretical intervention threshold of 55 mm were calculated. The number of patients who would have achieved the threshold undetected was determined based on simulated imaging intervals of 6 months, 1, 2 and 3 years. RESULTS: A total of 2916 scans from 995 patients were analysed. The mean aortic expansion rate was 2·76 mm per year for all patients, with an exponential increase observed at sizes above 45 mm. Only 3·9 per cent of patients with a starting diameter of 30-39 mm and 5·3 per cent of those with a diameter of 40-44 mm achieved threshold size within 2 years. Conversely, the probability of expansion to more than 55 mm was 74·5 per cent in 2 years for patients with a starting diameter of 50-54 mm, rising to 85·7 per cent at 3 years. CONCLUSION: Based on a threshold of 55 mm for intervention, most patients with a maximum aortic diameter below 40 mm could safely undergo surveillance at 2-yearly intervals. Above 45 mm, annual surveillance is recommended. Patients with a diameter greater than 50 mm could be optimized for possible repair, if this is clinically appropriate.

Effectiveness of interventions to enhance healing of chronic ulcers of the foot in diabetes: a systematic review.

The outcome of management of diabetic foot ulcers remains a challenge, and there remains continuing uncertainty concerning optimal approaches to management. It is for these reasons that in 2008 and 2012, the International Working Group of the Diabetic Foot (IWGDF) working group on wound healing published systematic reviews of the evidence to inform protocols for routine care and to highlight areas, which should be considered for further study. The same working group has now updated this review by considering papers on the interventions to improve the healing of chronic ulcers published between June 2010 and June 2014. Methodological quality of selected studies was independently assessed by two reviewers using Scottish Intercollegiate Guidelines Network criteria. Selected studies fell into the following ten categories: sharp debridement and wound bed preparation with larvae or hydrotherapy; wound bed preparation using antiseptics, applications and dressing products; resection of the chronic wound; oxygen and other gases, compression or negative pressure therapy; products designed to correct aspects of wound biochemistry and cell biology associated with impaired wound healing; application of cells, including platelets and stem cells; bioengineered skin and skin grafts; electrical, electromagnetic, lasers, shockwaves and ultrasound and other systemic therapies, which did not fit in the aforementioned categories. Heterogeneity of studies prevented pooled analysis of results. Of the 2161 papers identified, 30 were selected for grading following full text review. The present report is an update of the earlier IWGDF systematic reviews, and the conclusion is similar: that with the possible exception of negative pressure wound therapy in post-operative wounds, there is little published evidence to justify the use of newer therapies. Analysis of the evidence continues to present difficulties in this field as controlled studies remain few and the majority continue to be of poor methodological quality.

Performance of prognostic markers in the prediction of wound healing or amputation among patients with foot ulcers in diabetes: a systematic review.

Prediction of wound healing and major amputation in patients with diabetic foot ulceration is clinically important to stratify risk and target interventions for limb salvage. No consensus exists as to which measure of peripheral artery disease (PAD) can best predict outcomes. To evaluate the prognostic utility of index PAD measures for the prediction of healing and/or major amputation among patients with active diabetic foot ulceration, two reviewers independently screened potential studies for inclusion. Two further reviewers independently extracted study data and performed an assessment of methodological quality using the Quality in Prognostic Studies instrument. Of 9476 citations reviewed, 11 studies reporting on 9 markers of PAD met the inclusion criteria. Annualized healing rates varied from 18% to 61%; corresponding major amputation rates varied from 3% to 19%. Among 10 studies, skin perfusion pressure ≥ 40 mmHg, toe pressure ≥ 30 mmHg (and ≥ 45 mmHg) and transcutaneous pressure of oxygen (TcPO2 ) ≥ 25 mmHg were associated with at least a 25% higher chance of healing. Four studies evaluated PAD measures for predicting major amputation. Ankle pressure < 70 mmHg and fluorescein toe slope < 18 units each increased the likelihood of major amputation by around 25%. The combined test of ankle pressure < 50 mmHg or an ankle brachial index (ABI) < 0.5 increased the likelihood of major amputation by approximately 40%. Among patients with diabetic foot ulceration, the measurement of skin perfusion pressures, toe pressures and TcPO2 appear to be more useful in predicting ulcer healing than ankle pressures or the ABI. Conversely, an ankle pressure of < 50 mmHg or an ABI < 0.5 is associated with a significant increase in the incidence of major amputation.

Effectiveness of bedside investigations to diagnose peripheral artery disease among people with diabetes mellitus: a systematic review.

Non-invasive tests for the detection of peripheral artery disease (PAD) among individuals with diabetes mellitus are important to estimate the risk of amputation, ulceration, wound healing and the presence of cardiovascular disease, yet there are no consensus recommendations to support a particular diagnostic modality over another and to evaluate the performance of index non-invasive diagnostic tests against reference standard imaging techniques (magnetic resonance angiography, computed tomography angiography, digital subtraction angiography and colour duplex ultrasound) for the detection of PAD among patients with diabetes. Two reviewers independently screened potential studies for inclusion and extracted study data. Eligible studies evaluated an index test for PAD against a reference test. An assessment of methodological quality was performed using the quality assessment for diagnostic accuracy studies instrument. Of the 6629 studies identified, ten met the criteria for inclusion. In these studies, the patients had a median age of 60-74 years and a median duration of diabetes of 9-24 years. Two studies reported exclusively on patients with symptomatic (ulcerated/infected) feet, two on patients with asymptomatic (intact) feet only, and the remaining six on patients both with and without foot ulceration. Ankle brachial index (ABI) was the most widely assessed index test. Overall, the positive likelihood ratio and negative likelihood ratio (NLR) of an ABI threshold <0.9 ranged from 2 to 25 (median 8) and <0.1 to 0.7 (median 0.3), respectively. In patients with neuropathy, the NLR of the ABI was generally higher (two out of three studies), indicating poorer performance, and ranged between 0.3 and 0.5. A toe brachial index <0.75 was associated with a median positive likelihood ratio and NLRs of 3 and ≤ 0.1, respectively, and was less affected by neuropathy in one study. Also, in two separate studies, pulse oximetry used to measure the oxygen saturation of peripheral blood and Doppler wave form analyses had NLRs of 0.2 and <0.1. The reported performance of ABI for the diagnosis of PAD in patients with diabetes mellitus is variable and is adversely affected by the presence of neuropathy. Limited evidence suggests that toe brachial index, pulse oximetry and wave form analysis may be superior to ABI for diagnosing PAD in patients with neuropathy with and without foot ulcers. There were insufficient data to support the adoption of one particular diagnostic modality over another and no comparisons existed with clinical examination. The quality of studies evaluating diagnostic techniques for the detection of PAD in individuals with diabetes is poor. Improved compliance with guidelines for methodological quality is needed in future studies.

Effectiveness of revascularization of the ulcerated foot in patients with diabetes and peripheral artery disease: a systematic review.

Symptoms or signs of peripheral artery disease (PAD) can be observed in up to 50% of the patients with a diabetic foot ulcer and is a risk factor for poor healing and amputation. In 2012, a multidisciplinary working group of the International Working Group on the Diabetic Foot published a systematic review on the effectiveness of revascularization of the ulcerated foot in patients with diabetes and PAD. This publication is an update of this review and now includes the results of a systematic search for therapies to revascularize the ulcerated foot in patients with diabetes and PAD from 1980 to June 2014. Only clinically relevant outcomes were assessed. The research conformed to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines, and Scottish Intercollegiate Guidelines Network methodological scores were assigned. A total of 56 articles were eligible for full-text review. There were no randomized controlled trials, but there were four nonrandomized studies with a control group. The major outcomes following endovascular or open bypass surgery were broadly similar among the studies. Following open surgery, the 1-year limb salvage rates were a median of 85% (interquartile range of 80-90%), and following endovascular revascularization, these rates were 78% (70-89%). At 1-year follow-up, 60% or more of ulcers had healed following revascularization with either open bypass surgery or endovascular techniques. Studies appeared to demonstrate improved rates of limb salvage associated with revascularization compared with the results of conservatively treated patients in the literature. There were insufficient data to recommend one method of revascularization over another. There is a real need for standardized reporting of baseline demographic data, severity of disease and outcome reporting in this group of patients.

Early Post-operative Mortality After Major Lower Limb Amputation: A Systematic Review of Population and Regional Based Studies.

OBJECTIVE: Lower limb amputation is often associated with a high risk of early post-operative mortality. Mortality rates are also increasingly being put forward as a possible benchmark for surgical performance. The primary aim of this systematic review is to investigate early post-operative mortality following a major lower limb amputation in population/regional based studies, and reported factors that might influence these mortality outcomes. METHODS: Embase, PubMed, Cinahl and Psycinfo were searched for publications in any language on 30 day or in hospital mortality after major lower limb amputation in population/regional based studies. PRISMA guidelines were followed. A self developed checklist was used to assess quality and susceptibility to bias. Summary data were extracted for the percentage of the population who died; pooling of quantitative results was not possible because of methodological differences between studies. RESULTS: Of the 9,082 publications identified, results were included from 21. The percentage of the population undergoing amputation who died within 30 days ranged from 7% to 22%, the in hospital equivalent was 4-20%. Transfemoral amputation and older age were found to have a higher proportion of early post-operative mortality, compared with transtibial and younger age, respectively. Other patient factors or surgical treatment choices related to increased early post-operative mortality varied between studies. CONCLUSIONS: Early post-operative mortality rates vary from 4% to 22%. There are very limited data presented for patient related factors (age, comorbidities) that influence mortality. Even less is known about factors related to surgical treatment choices, being limited to amputation level. More information is needed to allow comparison across studies or for any benchmarking of acceptable mortality rates. Agreement is needed on key factors to be reported.

The Endovascular Sealing Device in Combination with Parallel Grafts for Treatment of Juxta/Suprarenal Abdominal Aortic Aneurysms: Short-term Results of a Novel Alternative.

BACKGROUND: The chimney technique using parallel grafts offers an alternative to fenestrated or branched endovascular solutions for juxtarenal and suprarenal aneurysms. Endograft deployment proximal to the renal or visceral ostia is combined with parallel stents to the aortic side branches. Application of the chimney technique using the Nellix device (Ch-EVAS) may offer some potential advantages with respect to the seal between the endograft and the parallel grafts. This study aimed to investigate the feasibility and efficacy of the Nellix endovascular aneurysm sealing (EVAS) system in conjunction with parallel grafts for the treatment of juxtarenal and suprarenal aneurysms. METHODS: A prospective evaluation of patients treated for juxtarenal and suprarenal non-ruptured aortic aneurysms using Ch-EVAS was undertaken in a single vascular unit. Patients were treated with this technique if they were unsuitable for either open repair or a custom-made complex branched/fenestrated endograft. Procedural, postoperative morbidity, and mortality data were recorded. RESULTS: Between March 2013 and April 2015, 28 patients were treated with Ch-EVAS. The median age was 75 years (range 60-87 years) and the median aneurysm diameter 66 mm (IQR 60-73 mm). Eight patients underwent suprarenal aneurysm repair including parallel grafts in the superior mesenteric artery and renal arteries. Five patients had a double chimney configuration; all the other patients were treated with a single chimney configuration. There was one 30-day or in-hospital mortality in a patient with a symptomatic aneurysm (4%) and three further deaths within 1 year of follow-up. One proximal type I endoleak and one type II endoleak occurred. Four patients underwent a reintervention. One patient experienced a transient ischemic attack and two patients suffered from a minor stroke (7%), therefore the total number of cerebrovascular complications was 11%. No patient required postoperative renal replacement therapy. CONCLUSIONS: Ch-EVAS appears to offer a feasible solution for juxtarenal and suprarenal aneurysms with adverse morphology. In this short-term follow-up endoleak rates were low and re-intervention rates were acceptable. Outcomes over extended follow-up will determine the application of this novel technique and better define which patients and aneurysm morphology can be treated effectively.