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Funding Information: On behalf of the Public and Community Oversight Group (PCOG) of the Health Protection Research Unit in Chemical and Radiation Threats and Hazards: Ian Wright; John Phipps; Colette Kelly; Robert Goundry; Eve Smyth; Andrew Wood; Paul Dale (also of the Scottish Environment Protection Agency). On behalf of the Society and College of Radiographers Patient Advisory Group: Lynda Johnson; Philip Plant; Michelle Carmichael – Specialist Senior Staff Nurse Guy's and St Thomas’ NHS Foundation trust.

ObjectiveTo 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 SourcesMEDLINE, Embase, DARE, PROSPERO, clinical trial registries, and Cochrane databases.Review MethodsA 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.ResultsA 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.ConclusionSixty-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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The authors regret there was a mistake in Figure 6 and 13. In Figure 6, it should read ‘Compression’ for oedema, to include inelastic compression as well (green box); in Figure 13, the pressure at the ankle should read ‘≤ 40 mm Hg’, for small and recent onset ulcer (yellow box):[Formula presented][Formula presented] The authors would like to apologise for any inconvenience caused. publishersversion published

European Society for Vascular Surgery (ESVS) 2021 Clinical Practice Guidelines on the Management of Venous Thrombosis

Summary 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.

Summary 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.

ObjectivesThe optimal timing and modality of surveillance after endovascular intervention for peripheral arterial disease is controversial, and no randomised trial to assess the value of peripheral endovascular intervention has ever been performed. The aim of this systematic review was to examine the practice of surveillance following peripheral endovascular intervention in randomised trials.Data SourcesMedline, Embase, Cochrane Library, and WHO trial registry databases.MethodsSystematic review of the literature was performed to capture surveillance strategies used in randomised trials comparing endovascular interventions. Surveillance protocols were assessed for completeness, modalities used, duration, and intensity.ResultsNinety-six different surveillance protocols were reported in 103 trials comparing endovascular interventions. Protocol specification was incomplete in 32% of trials.The majority of trials used multiple surveillance modalities (mean 3.46 modalities), most commonly clinical examination (96%), ankle-brachial index (80%), duplex ultrasound (75%), and digital subtraction angiography (51%). Trials involving infrapopliteal lesions used more angiographic surveillance than trials with femoropopliteal lesions (p=0.006).The median number of surveillance visits in the first 12 months after intervention was three and the mean surveillance duration was 21 months. Trials treating infrapopliteal vessels had a higher surveillance intensity compared to those treating femoropopliteal lesions in the first 12 months after endovascular intervention (mean 5 vs. 3 surveillance visits; p=0.017). Trials with drug-eluting devices had longer surveillance duration compared to those without (mean 26 vs. 19 months; p=0.020).ConclusionsThere is a high level of variation in the modality, duration, and intensity of surveillance protocols used in randomised trials comparing different types of peripheral endovascular arterial intervention. Further research is required to determine the value and impact of post-procedural surveillance on patient outcomes.

Background This paper assesses variation in rates of emergency surgery (ES) amongst emergency admissions to hospital in patients with acute appendicitis, cholelithiasis, diverticular disease, abdominal wall hernia, and intestinal obstruction. Methods Records of emergency admissions between 1 April 2010 and 31 December 2019 for the five conditions were extracted from Hospital Episode Statistics for 136 acute National Health Service (NHS) trusts in England. Patients who had ES were identified using Office of Population Censuses and Surveys (OPCS) procedure codes, selected by consensus of a clinical panel. The differences in ES rates according to patient characteristics, and unexplained variations across NHS trusts were estimated by multilevel logistic regression, adjusting for year of emergency admission, age, sex, ethnicity, diagnostic subcategories, index of multiple deprivation, number of co-morbidities, and frailty. Results The cohort sizes ranged from 107 325 (hernia) to 268 253 (appendicitis) patients, and the proportion of patients who received ES from 11.0 per cent (diverticular disease) to 92.3 per cent (appendicitis). Older patients were generally less likely to receive ES, with adjusted odds ratios (ORs) of ES for those aged 75–79 versus those aged 45–49 years: 0.34 (appendicitis), 0.49 (cholelithiasis), 0.87 (hernia), and 0.91 (intestinal obstruction). Patients with diverticular disease aged 75–79 were more likely to receive ES than those aged 45–49 (OR 1.40). Variation in ES rates across NHS trusts remained after case mix adjustment and was greatest for cholelithiasis (trust median 18 per cent, 10th to 90th centile 7–35 per cent). Conclusion For patients presenting as emergency hospital admissions with common acute conditions, variation in ES rates between NHS trusts remained after adjustment for demographic and clinical characteristics. Age was strongly associated with the likelihood of ES receipt for some procedures., This study reports variation in rates of emergency surgery (ES) across National Health Service trusts amongst patients presenting as emergency admissions to hospital with acute appendicitis, cholelithiasis, diverticular disease, abdominal wall hernia, or intestinal obstruction, after adjustment for differences in patient-level characteristics. Older patients were less likely to have ES, after allowing for differences in other patient characteristics, including number of Charlson co-morbidities, level of frailty, and diagnostic subcategory. The decline in the rate of ES with increasing age was greatest for patients presenting with acute appendicitis and cholelithiasis.

Corrigendum: Volume 64, Issues 2–3, 2022, 284-285

Background: Well-designed surgical registries are essential for high-quality patient centred evaluation of implantable devices and surgical procedures. The importance of registries was highlighted in the recent Cumberlege report that detailed important innovation failures such as the use of vaginal mesh. Many surgical registries exist, but it is currently unclear how different registries are funded, governed, designed, and how their databases are hosted and utilised. There is therefore a need to understand the variation and characteristics of existing surgical registries to identify limitations and make recommendations for improvement. This work aims to understand the characteristics and heterogeneity in the design, governance, and function of existing surgical registries in the United Kingdom (UK).Methods: Existing surgical registries will be identified using multiple data sources including surgical society websites; search engine review; a targeted search of the Medline and Embase databases and expert knowledge. The data identified were reviewed following the synthesis without meta-analysis (SWiM) methodology. This information will be gathered from sources in the public domain only to fully understand registry transparency for professionals and the public. Details of each registry including disease area/condition/device evaluated; types of outcomes collected; governance, consent, and oversight; linkage to other datasets and funding will be extracted using a standardised data extraction tool. Characteristics of identified registries will be summarised into a narrative review.Dissemination: Findings will be presented at national and international conferences and published in peer-reviewed journals. Results will be presented to key stakeholders including surgeons, methodologists, trialists, regulators, data managers and patients to provide an up-to-date description of the current state of surgical registries in the UK. This work will inform a consensus process to agree how the design of new and existing registries can be optimised to support high quality research to benefit patients and the NHS.Highlights: Well-designed surgical registries are essential for high-quality patient centred evaluation of implantable devices and surgical proceduresPresently there is limited understanding on how these registries are designed, governed, what data they collect and how this data is utilised for research.This review aims to map the landscape of surgical registries in the UK, and understand how they are optimised for research.

Background: Living in deprived areas is associated with poorer outcomes after certain vascular procedures and surgical site infection in other specialties. Our primary objective was to determine whether living in more income-deprived areas was associated with groin wound surgical site infection after arterial intervention. Secondary objectives were to determine whether living in more income-deprived areas was associated with mortality and clinical consequences of surgical site infection. Methods: Postal code data for patients from the United Kingdom who were included in the Groin Wound Infection after Vascular Exposure (GIVE) multicenter cohort study was used to determine income deprivation, based on index of multiple deprivation (IMD) data. Patients were divided into three IMD groups for descriptive analysis. Income deprivation score was integrated into the final multivariable model for predicting surgical site infection. Results: Only patients from England had sufficient postal code data, analysis included 772 groin incisions (624 patients from 22 centers). Surgical site infection occurred in 9.7% incisions (10.3% of patients). Surgical site infection was equivalent between income deprivation tertiles (tertile 1 = 9.5%; tertile 2 = 10.3%; tertile 3 = 8.6%; p = 0.828) as were the clinical consequences of surgical site infection and mortality. Income deprivation was not associated with surgical site infection in multivariable regression analysis (odds ratio [OR], 0.574; 95% confidence interval [CI], 0.038-8.747; p = 0.689). Median age at time of procedure was lower for patients living in more income-deprived areas (tertile 1 = 68 years; tertile 2 = 72 years; tertile 3 = 74 years; p

Aims To assess variation in use of emergency surgery (ES) for emergency hospital admissions with acute appendicitis, cholelithiasis, diverticular disease, abdominal wall hernia or intestinal obstruction. Methods Cohorts were extracted from Hospital Episode Statistics for 136 acute NHS trusts in England. Clinical panel consensus defined ES for emergency admissions between 1/4/2010 and 31/12/2019. The association of socio-demographic characteristics with ES use was estimated by multivariable logistic regression, with adjustment for comorbidity, frailty, diagnosis and trust. Results The cohort sizes ranged from 49,385 (hernia) to 184,777 (appendicitis) patients. ES was less likely for: patients aged over 80, with odds ratios (ORs) across conditions from 0.15 to 0.84 versus those aged under 40; the most deprived, ORs 0.83 to 0.92, versus least deprived; and Asian patients, ORs 0.72 to 0.88, versus White patients. Black patients were less likely to have emergency surgery for appendicitis (OR 0.78) and cholelithiasis (OR 0.78). Females were less likely to have ES for appendicitis (OR 0.94 versus males), but more likely to have surgery for intestinal obstruction (OR 1.29), hernia (OR 1.13) and cholelithiasis (OR 1.22). Unexplained variation in ES across trusts, remained after case-mix adjustment, and was greatest for cholelithiasis (median of 16%, 10 to 90 centile 5%-34%), and hernia (61%, 52%-71%), followed by intestinal obstruction (29%, 24%-36%). appendicitis (93%, 89%-95%), and diverticular disease (15%, 11%-20%). Conclusions The socio-demographic characteristics of emergency admissions are associated with the likelihood of receiving ES. Variation in ES use between NHS trusts remained after adjustment for demographic and clinical characteristics.

BACKGROUND: Diabetic foot ulceration (DFU) is a challenging clinical problem that affects up to a quarter of patients with diabetes in their lifetime. An agreed set of outcomes for assessing treatments or interventions for DFU has not previously been considered. The aim of this study was to identify outcomes that are reported in clinical studies assessing a treatment or intervention for DFU, to inform the development of a core outcome set (COS).METHODS: Systematic literature searches were performed between January 2016 and March 2019. The search strategy was pre-registered with PROSPERO (CRD42019128250). Two authors independently screened abstracts for full text review. Outcomes were extracted from selected papers verbatim and categorized into domains according to established taxonomy. Consistency of outcome reporting was assessed. Overlapping outcomes were merged independently to condense the extracted list of outcomes for use in forthcoming consensus processes.RESULTS: Of 4645 abstracts identified, 114 studies met the inclusion criteria. There were 69 randomized studies, 40 prospective studies and 5 protocols. Some 948 outcomes were extracted verbatim. Outcome reporting was consistent for 474 (53%) outcomes. De-duplication left 714 unique verbatim outcomes across 33 domains. Merging of overlapping unique verbatim outcomes established 95 merged outcomes.CONCLUSION: This study describes contemporary outcomes reported in studies assessing interventions for DFU. Outcome reporting is considered to be poor as it was consistent in just over half of outcomes extracted. Merging of outcomes has identified 95 outcomes that can be taken forward in the development of a COS.

Aim The General Medical Council (GMC) requires all newly qualified doctors to be competent in certain surgical skills, including the provision of basic wound closure. Yet there is a profound lack of undergraduate competence in, and exposure to, basic surgical skills such as wound closure. The Surgical Skills Day (SSD) aimed to provide medical students with additional skills training. Method Student self-assessment and instructors’ assessment forms were completed prior to and following a workshop on basic wound closure skills. Paired t-tests were used to statistically compare the two pre- and post-instruction data sets. Results A total of 46 students attended the SSD; 29 consented to the skills assessment. 100% (n = 29) self-reported improved competency in at least one of the skills following tuition (p Conclusions Current clinical teaching in basic suturing is unsuitable for long term retention. SSDs can improve skills acquisition and elevate student confidence. This data builds on our previous work by documenting the high efficacy in skills acquisition as a result of SSD tuition. We recommend that SSDs be integrated into medical school curricula in order to address shortcomings in current undergraduate programmes.

OBJECTIVE To perform a scoping review of how patients with COVID-19 are affected by acute limb ischaemia (ALI) and evaluate the recommendations of the 2020 ESVS ALI Guidelines for these patients. METHODS Research questions were defined, and a systematic literature search was performed following the PRISMA guidelines. Abstracts and unpublished literature were not included. The definition of ALI in this review is in accordance with the ESVS guidelines. RESULTS Most identified papers were case reports or case series, although population based data and data from randomised controlled trials were also identified. In total, 114 unique and relevant papers were retrieved. Data were conflicting concerning whether the incidence of ALI increased, or remained unchanged, during the pandemic. Case reports and series reported ALI in patients who were younger and healthier than usual, with a greater proportion affecting the upper limb. Whether or not this is coincidental remains uncertain. The proportion of men/women affected seems unchanged. Most reported cases were in hospitalised patients with severe COVID-19. Patients with ALI as their first manifestation of COVID-19 were reported. Patients with ALI have a worse outcome if they have a simultaneous COVID-19 infection. High levels of D-dimer may predict the occurrence of arterial thromboembolic events in patients with COVID-19. Heparin resistance was observed. Anticoagulation should be given to hospitalised COVID-19 patients in prophylactic dosage. Most of the treatment recommendations from the ESVS Guidelines remained relevant, but the following were modified regarding patients with COVID-19 and ALI: 1) CTA imaging before revascularisation should include the entire aorta and iliac arteries; 2) there should be a high index of suspicion, early testing for COVID-19 infection and protective measures are advised; and 3) there should be preferential use of local or locoregional anaesthesia during revascularisation. CONCLUSION Although the epidemiology of ALI has changed during the pandemic, the recommendations of the ESVS ALI Guidelines remain valid. The above mentioned minor modifications should be considered in patients with COVID-19 and ALI.

IntroductionLower limb amputation is a life-changing event for patients and can be associated with high mortality and morbidity rates. Research into this critical part of vascular surgery is limited. The Vascular Society of Great Britain and Ireland (VSGBI) in partnership with the James Lind Alliance (JLA) process, aimed to identify and develop key research priorities for amputation.MethodsA modified JLA Priority Setting Partnership was undertaken, encompassing all vascular practice. Two separate Delphi processes to identify research topics were undertaken with healthcare professionals, patients and carers, led by the VSGBI. The priorities were then ranked by the same participants and amalgamated to produce a list for final prioritisation. The final consensus meeting was attended by patients, carers and healthcare professionals from a variety of backgrounds involved in the care of people with amputation. Using a nominal group technique, the top ten research priorities were identified.ResultsA total of 481 clinicians submitted 1231 research questions relating to vascular surgery in general. 63 amputation-specific research questions were combined into 5 final clinical questions. 373 patients or carers submitted 582 research questions related to vascular surgery in general. Nine amputation-specific research questions were identified after combining similar questions. Amalgamating both the clinician and patient questions, 12 questions were discussed at the final prioritisation meeting and the top 10 identified. These related to amputation prevention, supporting rehabilitation, improving clinical outcomes following amputation (preventing/treating pain including phantom limb pain and improving wound healing) and research into information provision for patients undergoing amputation.ConclusionThe top 10 research priority areas in vascular amputation provide guidance for researchers, clinicians, and funders on the direction of future research questions that are important to both healthcare professionals and patients.

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., Although delivering a chosen mode of anaesthesia for certain emergency surgery procedures is potentially beneficial to patients, it is a complex intervention to evaluate. Seventy‐nine interviews with clinicians and patients were analysed thematically to explore experiences of anaesthesia in emergency surgery. The results highlight several interlinking factors affecting decision‐making, including expertise, preference, habit, practicalities, norms and policies. General anaesthesia or not?

Foot complications are a common cause of hospital admission of people with diabetes and a frequent cause of amputation. Neuropathy and arterial disease make the foot particularly vulnerable, but infection is often the pathology precipitating presentation. Recognition of the patient at risk may prevent the development of foot complications, but if they do occur urgent treatment is required to prevent limb loss. The infected foot in a patient with diabetes is a surgical emergency. In addition to antibiotics, debridement and surgical drainage of infection should be considered within the first 24 hours. Once the foot is made safe, revascularization should be undertaken in those with significant arterial disease. Adoption of a multidisciplinary team approach to managing diabetic foot complications has resulted in reduction in major amputations in some European countries.

Objective: Most major lower limb amputations are related to peripheral artery disease (PAD) or diabetes. Just 40% of patients who undergo major lower limb amputation will use a prosthesis, yet measures of surgical success commonly focus on prosthesis use. Patient-reported outcome measures (PROMs) are valuable to comprehensively evaluate health-related quality of life (HRQL) after surgery. This systematic review aimed to identify and describe PROMs available to assess HRQL in patients after amputation for PAD or diabetes.Methods: A search was conducted based on the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) for systematic reviews of PROMs. Ovid MEDLINE, Ovid EMBASE, PsycINFO, CINAHL, and Cochrane CENTRAL were also searched from inception until August 2019. Included were articles describing the development, measurement properties, or evaluation of HRQL via a PROM in adult patients after amputation for PAD or diabetes. Studies of amputation exclusively for trauma or malignancy were excluded. Data were collected on study characteristics, PROM characteristics (generic/disease specific), and properties of amputation-specific PROMs.Results: Of 3 317 abstracts screened, 111 full-text articles were assessed for eligibility and 64 included. Fifty-six studies evaluated HRQL, with 23 (46%) of these using an amputation-specific PROM to do so. Eleven different amputation-specific PROMs were identified, 10 (91%) of which were developed only for prosthesis users. One measure was suitable for use in all patients after amputation. This “Amputee single item mobility measure” includes a single item evaluating mobility. Nine studies reported some psychometric testing of an amputation-specific PROM.Conclusion: A well-tested, multidimensional PROM applicable to wheelchair and prosthetic users after amputation is lacking and urgently needed for studies in this field. Future work to develop an appropriate measure is required.

Introduction Guideline recommendations for antithrombotic (antiplatelet and anticoagulant) therapy during and after endovascular intervention are patchy and conflicted, in part due to a lack of evidence. The aim of this systematic review was to examine the antithrombotic specifications in randomised trials for peripheral arterial endovascular intervention. Method This review was conducted according to PRISMA guidelines. Randomised trials including participants with peripheral arterial disease undergoing 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 protocols were classed as periprocedural (preceding/during intervention), immediate postprocedural (up to 14 days following intervention) and maintenance postprocedural (therapy continuing beyond 14 days). Trials were stratified according to type of intervention. Result Ninety-four trials were included. Only 29% of trials had complete periprocedural antithrombotic protocols, and 34% had complete post-procedural protocols. In total, 64 different periprocedural protocols, and 51 separate postprocedural protocols were specified. Antiplatelet monotherapy and unfractionated heparin were the most common choices of regimen in the periprocedural setting, and dual antiplatelet therapy (55%) was most commonly utilised postprocedure. There is an increasing tendency to use dual antiplatelet therapy with time or for drug-coated technologies. Conclusion Randomised trials comparing different types of peripheral endovascular arterial intervention have a high level of heterogeneity in their antithrombotic regimens, and there has been an increasing tendency to use dual antiplatelet therapy over time. Antiplatelet regimes need to be standardised in trials comparing endovascular technologies. Take-home message To determine the benefits of any endovascular intervention within a randomised trial, antithrombotic regimens should be standardised to prevent confounding. This systematic review demonstrates a high level of heterogeneity of antithrombotic prescribing in randomised trials of endovascular intervention, and an increasing tendency to utilise dual antiplatelet therapy, despite a lack of evidence of benefit, but an increased risk of harm.

ObjectivesLittle is known about how innovative surgical procedures are introduced and discussed with patients. This qualitative study aimed to explore perspectives on information provision and consent prior to innovative surgical procedures.DesignQualitative study involving semi-structured interviews. Interviews were audio recorded, transcribed and analysed thematically.Participants42 interviews were conducted (26 surgeons and 16 governance representatives).SettingSurgeons and governance representatives recruited from various surgical specialties and National Health Service (NHS) Trusts across England, UK.ResultsParticipants stated that if a procedure was innovative, patients should be provided with additional information extending beyond that given during routine surgical consultations. However, difficulty defining innovation had implications for whether patients were informed about novel components of surgery and how the procedure was introduced (ie, as part of a research study, trust approval or in routine clinical practice). Furthermore, data suggest surgeons found it difficult to establish what information is essential and how much detail is sufficient, and governance surrounding written and verbal information provision differed between NHS Trusts. Generally, surgeons believed patients held a view that ‘new’ was best and reported that managing these expectations could be difficult, particularly if patient views aligned with their own.ConclusionsThis study highlights the challenges of information provision and obtaining informed consent in the context of innovative surgery, including establishing if and how a procedure is truly innovative, determining the key information to discuss with patients, ensuring information provision is objective and balanced, and managing patient expectations and preferences. This suggests that surgeons may require support and training to discuss novel procedures with patients. Further work should capture consultations where new procedures are discussed with patients and patients’ views of these information exchanges.

BACKGROUND: Symptomatic peripheral arterial disease (PAD) has several treatment options, including angioplasty, stenting, exercise therapy, and bypass surgery. Atherectomy is an alternative procedure, in which atheroma is cut or ground away within the artery. This is the first update of a Cochrane Review published in 2014.OBJECTIVES: To evaluate the effectiveness of atherectomy for peripheral arterial disease compared to other established treatments.SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Allied and Complementary Medicine (AMED) databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 12 August 2019.SELECTION CRITERIA: We included all randomised controlled trials that compared atherectomy with other established treatments. All participants had symptomatic PAD with either claudication or critical limb ischaemia and evidence of lower limb arterial disease.DATA COLLECTION AND ANALYSIS: Two review authors screened studies for inclusion, extracted data, assessed risk of bias and used GRADE criteria to assess the certainty of the evidence. We resolved any disagreements through discussion. Outcomes of interest were: primary patency (at six and 12 months), all-cause mortality, fatal and non-fatal cardiovascular events, initial technical failure rates, target vessel revascularisation rates (TVR; at six and 12 months); and complications.MAIN RESULTS: We included seven studies, with a total of 527 participants and 581 treated lesions. We found two comparisons: atherectomy versus balloon angioplasty (BA) and atherectomy versus BA with primary stenting. No studies compared atherectomy with bypass surgery. Overall, the evidence from this review was of very low certainty, due to a high risk of bias, imprecision and inconsistency. Six studies (372 participants, 427 treated lesions) compared atherectomy versus BA. We found no clear difference between atherectomy and BA for the primary outcomes: six-month primary patency rates (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.94 to 1.20; 3 studies, 186 participants; very low-certainty evidence); 12-month primary patency rates (RR 1.20, 95% CI 0.78 to 1.84; 2 studies, 149 participants; very low-certainty evidence) or mortality rates (RR 0.50, 95% CI 0.10 to 2.66, 3 studies, 210 participants, very low-certainty evidence). One study reported cardiac failure and acute coronary syndrome as causes of death at 24 months but it was unclear which arm the participants belonged to, and one study reported no cardiovascular events. There was no clear difference when examining: initial technical failure rates (RR 0.48, 95% CI 0.22 to 1.08; 6 studies, 425 treated vessels; very low-certainty evidence), six-month TVR (RR 0.51, 95% CI 0.06 to 4.42; 2 studies, 136 treated vessels; very low-certainty evidence) or 12-month TVR (RR 0.59, 95% CI 0.25 to 1.42; 3 studies, 176 treated vessels; very low-certainty evidence). All six studies reported complication rates (RR 0.69, 95% CI 0.28 to 1.68; 6 studies, 387 participants; very low-certainty evidence) and embolisation events (RR 2.51, 95% CI 0.64 to 9.80; 6 studies, 387 participants; very low-certainty evidence). Atherectomy may be less likely to cause dissection (RR 0.28, 95% CI 0.14 to 0.54; 4 studies, 290 participants; very low-certainty evidence) and may be associated with a reduction in bailout stenting (RR 0.26, 95% CI 0.09 to 0.74; 4 studies, 315 treated vessels; very low-certainty evidence). Four studies reported amputation rates, with only one amputation event recorded in a BA participant. We used subgroup analysis to compare the effect of plain balloons/stents and drug-eluting balloons/stents, but did not detect any differences between the subgroups. One study (155 participants, 155 treated lesions) compared atherectomy versus BA and primary stenting, so comparison was extremely limited and subject to imprecision. This study did not report primary patency. The study reported one death (RR 0.38, 95% CI 0.04 to 3.23; 155 participants; very low-certainty evidence) and three complication events (RR 7.04, 95% CI 0.80 to 62.23; 155 participants; very low-certainty evidence) in a very small data set, making conclusions unreliable. We found no clear difference between the treatment arms in cardiovascular events (RR 0.38, 95% CI 0.04 to 3.23; 155 participants; very low-certainty evidence). This study found no initial technical failure events, and TVR rates at six and 24 months showed little difference between treatment arms (RR 2.27, 95% CI 0.95 to 5.46; 155 participants; very low-certainty evidence and RR 2.05, 95% CI 0.96 to 4.37; 155 participants; very low-certainty evidence, respectively).AUTHORS' CONCLUSIONS: This review update shows that the evidence is very uncertain about the effect of atherectomy on patency, mortality and cardiovascular event rates compared to plain balloon angioplasty, with or without stenting. We detected no clear differences in initial technical failure rates or TVR, but there may be reduced dissection and bailout stenting after atherectomy although this is uncertain. Included studies were small, heterogenous and at high risk of bias. Larger studies powered to detect clinically meaningful, patient-centred outcomes are required.

Background: Surgical site infections (SSIs) of groin wounds are a common and potentially preventable cause of morbidity, mortality and healthcare costs in vascular surgery. Our aim was to define the contemporaneous rate of groin SSIs, determine clinical sequelae, and identify risk factors for SSI. Method: An international multicentre prospective observational cohort study of consecutive patients undergoing groin incision for femoral vessel access in vascular surgery was undertaken over 3 months, follow up was 90 days. The primary outcome was incidence of groin wound SSI. Results: 1337 groin incisions (1039 patients) from 37 centres were included. 115 groin incisions (8.6%) developed SSI, of which 62 (4.6%) were superficial. Patients who developed an SSI had a significantly longer length of hospital stay (6 vs 5 days, p=0.005), a significantly higher rate of post-operative acute kidney injury (19.6% vs 11.7%, p=0.018), with no significant difference in 90-day mortality. Female sex, Body Mass Index≥30kg/m2, ischaemic heart disease, aqueous betadine skin preparation, bypass/patch use (vein, xenograft or prosthetic) and increased operative time were independent predictors of SSI. Conclusion: Groin infections which are clinically apparent to the treating vascular unit are frequent and their development carries significant clinical sequelae. Risk factors include modifiable and non-modifiable variables.

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.

ObjectivesAntiplatelet therapy following peripheral arterial endovascular intervention lacks high quality evidence to guide practice. The aim of this study was to assess the effect of three months of dual antiplatelet therapy on amputation-free survival following peripheral arterial endovascular intervention in patients with chronic limb threatening ischemia.MethodsA retrospective review of symptomatic patients undergoing primary peripheral arterial endovascular intervention over a seven-year period was performed. The primary outcome measure was amputation-free survival. A sample size calculation based on previous cohort studies suggested that 629 limbs would be required to show a difference between single and dual therapy. Kaplan-Meier estimates and multivariate logistic regression analysis of recorded baseline characteristics was performed to determine predictors of amputation-free survival. Dual antiplatelet therapy was routinely given for 3 months.Results754 limbs were treated with primary angioplasty and/or stenting over a 7-year period, 508 of these for chronic limb threatening ischemia. There was no difference in unadjusted amputation-free survival between patients with chronic limb threatening ischaemia taking single vs. dual antiplatelet therapy (69% vs. 74% respectively Log rank Chi2 = 0.1, p = .72). After adjusting for confounders, at 1 year there was also no significant difference in amputation-free survival between patients taking single vs. dual antiplatelet therapy [OR 0.8, 95% CI 0.5–1.2, p = .3]. There was no difference in rates of major bleeding between single and dual antiplatelet therapy.ConclusionsThere was no clear evidence of reduced amputation-free survival in patients with chronic limb threatening ischemia undergoing peripheral arterial endovascular intervention being treated with dual antiplatelet therapy for 3 months. This is at odds with other retrospective case series and highlights the limitations in basing clinical practice on such data. There is a need for an adequately powered, independent randomised trial to definitively answer the question.

BackgroundThe General Medical Council (GMC) requires all newly qualified doctors to be competent in certain surgical skills, including the provision of basic wound closure. Yet there is a profound lack of undergraduate competence in, and exposure to, basic surgical skills such as wound closure. The Surgical Skills Day (SSD) aimed to provide medical students with additional skills training.MethodsStudent self-assessment and instructors’ assessment forms were completed prior to and following a workshop on basic wound closure skills. Paired t-tests was used to statistically compare the two pre and post-instruction data sets.ResultsA total of 46 students attended the SSD; 29 consented to the skills assessment. 100% (n = 29) self-reported improved competency in at least one of the skills following tuition (p < 0.001). Instructors’ assessment agreed that 100% (n = 29) of students improved in at least one of the skills assessed (p < 0.001). 100% of the attendees agreed that additional practical surgical skills should be incorporated into the undergraduate curriculum. 64% (n = 21) of students also confirmed that they were more likely to pursue a career in surgery following the SSD.ConclusionCurrent clinical teaching in basic suturing is unsuitable for long term retention. SSDs can improve skills acquisition and elevate student confidence. This data builds on our previous work by documenting the high efficacy in skills acquisition as a result of SSD tuition. We recommend that SSDs be integrated into medical school curricula in order to address shortcomings in current undergraduate programmes.

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Objective Endovascular aneurysm repair (EVAR) is the most commonly used method to repair abdominal aortic aneurysms. EVAR can be performed using a variety of anaesthetic techniques, including general anaesthetic (GA), regional anaesthetic (RA), and local anaesthetic (LA), but little is known about the effects that each of these anaesthetic modes have on patient outcome. The aim of this study was to assess the effect of anaesthetic technique on early outcomes after elective EVAR. Methods Data from the UK's National Vascular Registry were analysed. All patients undergoing elective standard infrarenal EVAR between 1 January 2014 and 31 December 2016 were included. Patients with a symptomatic aneurysm treated semi-electively were excluded. The primary outcome was in hospital death within 30 days of surgery. Secondary outcomes included post-operative complications and length of hospital stay. Time to event outcomes were compared using Cox proportional hazards regression adjusted for confounders, including British Aneurysm Repair score (a validated aneurysm risk prediction score that is calculated using age, sex, creatinine, cardiac disease, electrocardiogram, previous aortic surgery, white blood cell count, serum sodium, abdominal aortic aneurysm diameter, and American Society of Anaesthesiologists grade) and chronic lung disease. Results A total of 9783 patients received an elective, standard infrarenal EVAR (GA, n = 7069; RA, n = 2347; and LA, n = 367) across 89 hospitals. RA and/or LA was used in 82 hospitals. There were 64 in hospital deaths within 30 days, 50 (0.9% mortality at 30 days, 95% confidence interval [CI] 0.7–1.2) in the GA group, 11 (0.6%, 95% CI 0.3–1.1) in the RA group, and three (1.5%, 95% CI 0.5–4.7) in the LA group. The mortality rate differed between groups (p = .03) and was significantly lower in the RA group compared with the GA group (adjusted hazard ratio [aHR] RA/GA 0.37 [95% CI 0.17–0.81]; LA/GA 0.63 [95% CI 0.15–2.69]). The median length of stay was two days for all modes of anaesthesia, but patients were discharged from hospital more quickly in the RA and LA groups than the GA group (aHR RA/GA 1.10 [95% CI 1.03–1.17]; LA/GA 1.15 [95% CI 1.02–1.29]). Overall, 20.7% of patients experienced one or more complications (GA group, 22.1%; RA group, 16.8%; LA group, 17.7%) and pulmonary complications occurred with similar frequency in the three groups (overall 2.4%, adjusted odds ratio RA/GA 0.93 [95% CI 0.66–1.32]; LA/GA 0.82 [95% CI 0.41–1.63]). Conclusion Thirty day mortality was lower with RA than with GA, but mode of anaesthesia was not associated with increased complications for patients undergoing elective standard infrarenal EVAR.

Diabetic foot disease results in a major global burden for patients and the health care system. The International Working Group on the Diabetic Foot (IWGDF) has been producing evidence-based guidelines on the prevention and management of diabetic foot disease since 1999. In 2019, all IWGDF Guidelines have been updated based on systematic reviews of the literature and formulation of recommendations by multidisciplinary experts from all over the world. In this document, the IWGDF Practical Guidelines, we describe the basic principles of prevention, classification, and treatment of diabetic foot disease, based on the six IWGDF Guideline chapters. We also describe the organizational levels to successfully prevent and treat diabetic foot disease according to these principles and provide addenda to assist with foot screening. The information in these practical guidelines is aimed at the global community of health care professionals who are involved in the care of persons with diabetes. Many studies around the world support our belief that implementing these prevention and management principles is associated with a decrease in the frequency of diabetes-related lower extremity amputations. We hope that these updated practical guidelines continue to serve as reference document to aid health care providers in reducing the global burden of diabetic foot disease.

The accurate identification of peripheral artery disease (PAD) in patients with diabetes and foot ulceration is important, in order to inform timely management and to plan intervention including revascularisation. A variety of non-invasive tests are available to diagnose PAD at the bedside, but there is no consensus as to the most useful test, or the accuracy of these bedside investigations when compared to reference imaging tests such as magnetic resonance angiography, computed tomography angiography, digital subtraction angiography or colour duplex ultrasound. Members of the International Working Group of the Diabetic Foot updated our previous systematic review, to include all eligible studies published between 1980 and 2018. Some 15,380 titles were screened, resulting in 15 eligible studies (comprising 1563 patients, of which >80% in each study had diabetes) that evaluated an index bedside test for PAD against a reference imaging test. The primary endpoints were positive and negative likelihood ratios (PLR and NLR). We found that the most commonly evaluated test parameter was ankle brachial index (ABI) 0.75 makes the diagnosis of PAD less likely (NLR 0.14-0.24), whereas pulse oximetry may be used to suggest the presence of PAD (if toe saturation

The International Working Group on the Diabetic Foot (IWGDF) has published evidence-based guidelines on the prevention and management of diabetic foot disease since 1999. This guideline is on the diagnosis, prognosis, and management of peripheral artery disease (PAD) in patients with foot ulcers and diabetes and updates the previous IWGDF Guideline. Up to 50% of patients with diabetes and foot ulceration have concurrent PAD, which confers a significantly elevated risk of adverse limb events and cardiovascular disease. We know that the diagnosis, prognosis, and treatment of these patients are markedly different to patients with diabetes who do not have PAD and yet there are few good quality studies addressing this important subset of patients. We followed the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology to devise clinical questions and critically important outcomes in the patient-intervention-comparison-outcome (PICO) format, to conduct a systematic review of the medical-scientific literature, and to write recommendations and their rationale. The recommendations are based on the quality of evidence found in the systematic review, expert opinion where evidence was not available, and a weighing of the benefits and harms, patient preferences, feasibility and applicability, and costs related to the intervention. We here present the updated 2019 guidelines on diagnosis, prognosis, and management of PAD in patients with a foot ulcer and diabetes, and we suggest some key future topics of particular research interest.

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.

In patients with diabetes, foot ulceration and peripheral artery disease (PAD), it is often difficult to determine whether, when and how to revascularise the affected lower extremity. The presence of PAD is a major risk factor for non-healing and yet clinical outcomes of revascularisation are not necessarily related to technical success. The International Working Group of the Diabetic Foot updated systematic review on the effectiveness of revascularisation of the ulcerated foot in patients with diabetes and PAD is comprised of 64 studies describing >13,000 patients. Amongst 60 case series and 4 non-randomised controlled studies, we summarised clinically relevant outcomes and found them to be broadly similar between patients treated with open versus endovascular therapy. Following endovascular revascularisation, the 1 year and 2 year limb salvage rates were 80% (IQR 78-82%) and 78% (IQR 75-83%), whereas open therapy was associated with rates of 85% (IQR 80-90%) at 1 year and 87% (IQR 85-88%) at 2 years, however these results were based on a varying combination of studies and cannot therefore be interpreted as cumulative. Overall, wound healing was achieved in a median of 60% of patients (IQR 50-69%) at 1 year in those treated by endovascular or surgical therapy, and the major amputation rate of endovascular versus open therapy was 2% vs 5% at 30 days, 10% vs 9% at 1 year and 13% vs 9% at 2 years. For both strategies, overall mortality was found to be high, with 2% (1-6%) peri-operative (or 30 day) mortality, rising sharply to 13% (9-23%) at 1 year, 29% (19-48%) at 2 years and 47% (39-71%) at 5 years. Both the angiosome concept (revascularisation directly to the area of tissue loss via its main feeding artery) or indirect revascularisation through collaterals, appear to be equally effective strategies for restoring perfusion.Overall, the available data do not allow us to recommend one method of revascularisation over the other and more studies are required to determine the best revascularisation approach in diabetic foot ulceration.

Diabetic foot disease is a source of major patient suffering and societal costs. Investing in evidence-based international guidelines on diabetic foot disease is likely among the most cost-effective forms of healthcare expenditure, provided the guidelines are outcome-focused, evidence-based and properly implemented. The International Working Group on the Diabetic Foot (IWGDF) has published and updated international guidelines since 1999. The 2019 updates are based on formulating relevant clinical questions and outcomes, rigorous systematic reviews of the literature, and recommendations that are specific, and unambiguous along with their transparent rationale, all using the Grading of Recommendations Assessment Development and Evaluation (GRADE) framework. We herein describe the development of the 2019 IWGDF Guidelines on the prevention and management of diabetic foot disease, which consists of six chapters, each prepared by a separate working group of international experts. These documents provide guidelines related to diabetic foot disease on: prevention; offloading; peripheral artery disease; infection; wound healing interventions; and, classification of diabetic foot ulcers. Based on these six chapters, the IWGDF Editorial Board also produced a set of practical guidelines. Each guideline underwent extensive review by the members of the IWGDF Editorial Board as well as independent international experts in each field.We believe that adoption and implementation of the 2019 IWGDF guidelines by healthcare providers, public health agencies, and policy makers has the potential to improve prevention and management of diabetic foot disease, and to subsequently reduce the worldwide patient and societal burden this disease causes.

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.