Efficacy of a personalised activity plan for BREAKing UP sitting time in patients with intermittent claudication (the BREAK UP study).

INTRODUCTION: The aim of this study was to investigate the concept of an 8-week personalised activity plan, using short periods of physical activity to break up sitting time in people with Intermittent Claudication (IC), to improve walking ability, and reduce time spent sitting. METHODS: The study was designed as a single centre, single arm, before and after study and is registered with clinicaltrials.gov (NCT04572737). The co-primary outcomes are time spent sitting and walking ability measured via the walking impairment questionnaire. Normally distributed data was analysed using paired samples T-tests; non-normally distributed data was analysed using related-samples Wilcoxon signed rank tests. RESULTS: There was a significant improvement in both co-primary outcomes: walking ability and time spent sitting, as well as the following secondary outcomes: total bouts and time spent in prolonged sitting, time spent standing and stepping, anxiety, depression, and activity levels reported on the vascular quality of life questionnaire. CONCLUSION: An 8-week personalised activity plan to break up sitting time shows promise as a treatment for people with IC, improving walking ability and reducing time spent sitting. This study supports the use of large randomised controlled trials to further develop this treatment in people with IC.

Device-measured physical activity behaviours, and physical function, in people with type 2 diabetes mellitus and peripheral artery disease: A cross-sectional study.

AIM: To quantify differences in device-measured physical activity (PA) behaviours, and physical function (PF), in people with type 2 diabetes mellitus (T2DM) with and without peripheral artery disease (PAD). MATERIALS AND METHODS: Participants from the Chronotype of Patients with T2DM and Effect on Glycaemic Control cross-sectional study wore accelerometers on their non-dominant wrist for up to 8-days to quantify: volume and intensity distribution of PA, time spent inactive, time in light PA, moderate-to-vigorous PA in at least 1-minute bouts (MVPA1min), and the average intensity achieved during the most active continuous 2, 5, 10, 30, and 60-minute periods of the 24-h day. PF was assessed using the short physical performance battery (SPPB), the Duke Activity Status Index (DASI), sit-to-stand repetitions in 60 s (STS-60); hand-grip strength was also assessed. Differences between subjects with and without PAD were estimated using regressions adjusted for possible confounders. RESULTS: 736 participants with T2DM (without diabetic foot ulcers) were included in the analysis, 689 had no PAD. People with T2DM and PAD undertake less PA (MVPA1min: -9.2 min [95 % CI: -15.3 to -3.0; p = 0.004]) (light intensity PA: -18.7 min [-36.4 to -1.0; p = 0.039]), spend more time inactive (49.2 min [12.1 to 86.2; p = 0.009]), and have reduced PF (SPPB score: -1.6 [-2.5 to -0.8; p = 0.001]) (DASI score: -14.8 [-19.8 to -9.8; p = 0.001]) (STS-60 repetitions: -7.1 [-10.5 to -3.8; p = 0.001]) compared to people without; some differences in PA were attenuated by confounders. Reduced intensity of activity for the most active continuous 2-30 min in the 24-h day, and reduced PF, persisted after accounting for confounders. There were no significant differences in hand-grip strength. CONCLUSIONS: Findings from this cross-sectional study suggest that, the presence of PAD in T2DM may have been associated with lower PA levels and PF.

Effect of high-pain versus low-pain structured exercise on walking ability in people with intermittent claudication: meta-analysis.

BACKGROUND: The aim was to determine the comparative benefits of structured high-pain exercise, structured low-pain exercise, and usual-care control, to identify which has the largest effect on walking ability in people with intermittent claudication (IC). METHODS: A network meta-analysis was undertaken to assess two outcomes: pain-free walking ability (PFWA) and maximal walking ability (MWA). Nine electronic databases were searched. Trials were included if they were: RCTS; involved adults with IC; had at least two of the following arms-structured low-pain exercise, structured high--pain exercise or usual-care control; and a maximal or pain-free treadmill walking outcome. RESULTS: Some 14 trials were included; results were pooled using the standardized mean difference (MD). Structured low-pain exercise had a significant large positive effect on MWA (MD 2.23, 95 percent c.i. 1.11 to 3.35) and PFWA (MD 2.26, 1.26 to 3.26) compared with usual-care control. Structured high-pain exercise had a significant large positive effect on MWA (MD 0.95, 0.20 to 1.70) and a moderate positive effect on PFWA (0.77, 0.01 to 1.53) compared with usual-care control. In an analysis of structured low- versus high pain exercise, there was a large positive effect in favour of low-pain exercise on MWA (MD 1.28, -0.07 to 2.62) and PFWA (1.50, 0.24 to 2.75); however, this was significant only for PFWA. CONCLUSION: There is strong evidence in support of use of structured high-pain exercise, and some evidence in support of structured low-pain exercise, to improve walking ability in people with IC compared with usual-care control (unstructured exercise advice).

Feasibility of arterial spin labeling in evaluating high- and low-flow peripheral vascular malformations: a case series.

We present a case series highlighting a novel use of arterial spin labeling (ASL), a MRI perfusion technique, to evaluate both high- and low-flow peripheral vascular malformations (PVMs) across a range of anatomical locations. While the role of ASL in assessing intracranial vascular malformations is more established, there is limited evidence for PVMs. Our results provide preliminary evidence for the feasibility of ASL in imaging PVMs and its potential ability to distinguish between high- and low-flow PVMs. In addition, we demonstrate its ability to identify focal high blood flow, which may indicate the nidus in arteriovenous malformations. Together, these findings have important implications for patient management. We also outline the potential benefits and limitations of ASL in the imaging of PVMs, and provide justification for further validation of its diagnostic performance.

Associations of Clinical Frailty with Severity of Limb Threat and Outcomes in Chronic Limb-threatening Ischaemia.

OBJECTIVE: Investigate the relationship of frailty and severity of chronic limb-threatening ischaemia (CLTI), and their comparative associations with one-year outcomes, in patients presenting to a vascular limb salvage (VaLS) clinic. METHODS: This retrospective cohort study utilised data collected from a prospectively maintained VaLS clinic database. Patients aged ≥50 presenting to the VaLS clinic with CLTI between February 2018 and April 2019 were included. Frailty was measured using the Clinical Frailty Scale (CFS) and limb threat severity by the Wound, Ischaemia, and foot Infection (WIfI) score. Excessive polypharmacy was defined as ≥10 medications. Anticholinergic burden (ACB) score and Charlson comorbidity index (CCI) were calculated for all patients. The primary outcome measure was a composite endpoint of death or amputation at one-year. Associations with outcome were assessed using Cox regression and reported as hazards ratios (HR) with 95% confidence intervals (CI). RESULTS: A total of 198 patients were included, with CFS scores available for 190 patients. 98 patients (52%) were frail (CFS ≥5). 127 patients (67%) initially underwent endovascular revascularisation. Excessive polypharmacy was common (55 patients; 28%). Frailty was associated with increased WIfI stage (P = 0.025) as well as age, female sex, CCI score, number of medications, excessive polypharmacy but not ACB score. Frail patients were more frequently managed non-operatively (P = 0.017). Frailty (HR 1.91; 95% CI 1.09, 3.34; P = 0.024) and WIfI stage 4 (HR 3.29; 95%CI 1.23, 8.80; P = 0.018) were associated with death or amputation on univariable analysis. WIfI stage 4 (HR 2.80; 95%CI 1.04, 7.57; P = 0.042) and CCI score (HR 1.21; 95%CI 1.03, 1.41; P = 0.015), but not frailty (HR 1.25; 95%CI 0.67, 2.33; P = 0.474), were independently associated with death or amputation on multivariable analysis. CONCLUSIONS: Frailty is highly prevalent among CLTI patients and related to severity of limb threat. The CFS may be a useful adjunct to patient risk assessment in CLTI.

Prevalence of Cognitive Impairment in Individuals with Vascular Surgical Pathology: a Systematic Review and Meta-Analysis.

OBJECTIVE: A significant proportion of vascular surgery patients may have undiagnosed cognitive impairment; however, its true prevalence and impact on outcomes are unknown. The aim of this review was to estimate the prevalence of cognitive impairment among individuals with clinically significant vascular surgical pathology and investigate its associations with post-operative outcomes in those undergoing vascular surgery. METHODS: MEDLINE, EMBASE, EMCare, CINAHL, PsycINFO, and Scopus were searched for relevant studies. Included studies assessed cognitive function among individuals with either symptomatic vascular surgical pathology, or disease above threshold for intervention, using a validated cognitive assessment tool. The primary outcome measure was prevalence of cognitive impairment. Secondary outcomes included incidence of post-operative delirium (POD). Two reviewers independently extracted relevant study data and assessed risk of bias (ROBINS-E or RoB 2 tool). Prevalence (%) of cognitive impairment was calculated for individual studies and presented with 95% confidence intervals (CI). Prevalence data from comparable studies were pooled using the Mantel-Haenszel method (random effects model) for separate vascular disease types. Certainty of effect estimates was assessed using the GRADE criteria. RESULTS: Twenty-four studies (2 564 participants) were included in the systematic review, and nine studies (1 310 participants) were included in the meta-analyses. The prevalence of cognitive impairment was 61% (95% CI 48 - 74; 391 participants; low certainty) in studies including multiple vascular surgical pathologies, 38% (95% CI 32 - 44; 278 participants; very low certainty) in carotid artery disease, and 19% (95% CI 10 - 33; 641 participants; low certainty) in those with intermittent claudication. Lower cognitive assessment scores were associated with POD (five studies; 841 participants), but data were not suitable for pooling. CONCLUSION: Screening elective vascular surgery patients for cognitive impairment may be appropriate given its high prevalence, and the association of worse cognition with POD, among individuals with clinically significant vascular surgical pathology.

Novel use of arterial spin labelling in the imaging of peripheral vascular malformations.

We present a novel use of arterial spin labelling (ASL), a MRI perfusion technique, to assess a high-flow, peripheral vascular malformation (PVM), specifically a large arteriovenous malformation in the left forearm of a 20-year-old female. While there has been experience with ASL in the assessment of intracranial vascular malformations, there has been no known use of ASL in the evaluation of PVMs. We also discuss the potential benefits and limitations of ASL in the imaging of PVMs. The promising results from this case warrant further research on ASL in the investigation of PVMs.

Frailty Factors and Outcomes in Vascular Surgery Patients: A Systematic Review and Meta-analysis.

OBJECTIVE: To describe and critique tools used to assess frailty in vascular surgery patients, and investigate its associations with patient factors and outcomes. BACKGROUND: Increasing evidence shows negative impacts of frailty on outcomes in surgical patients, but little investigation of its associations with patient factors has been undertaken. METHODS: Systematic review and meta-analysis of studies reporting frailty in vascular surgery patients (PROSPERO registration: CRD42018116253) searching Medline, Embase, CINAHL, PsycINFO, and Scopus. Quality of studies was assessed using Newcastle-Ottawa scores (NOS) and quality of evidence using Grading of Recommendations Assessment, Development, and Evaluation criteria. Associations of frailty with patient factors were investigated by difference in means (MD) or expressed as risk ratios (RRs), and associations with outcomes expressed as odds ratios (ORs) or hazard ratios (HRs). Data were pooled using random-effects models. RESULTS: Fifty-three studies were included in the review and only 8 (15%) were both good quality (NOS ≥ 7) and used a well-validated frailty measure. Eighteen studies (62,976 patients) provided data for the meta-analysis. Frailty was associated with increased age [MD 4.05 years; 95% confidence interval (CI) 3.35, 4.75], female sex (RR 1.32; 95% CI 1.14, 1.54), and lower body mass index (MD -1.81; 95% CI -2.94, -0.68). Frailty was associated with 30-day mortality [adjusted OR (AOR) 2.77; 95% CI 2.01-3.81), postoperative complications (AOR 2.16; 95% CI 1.55, 3.02), and long-term mortality (HR 1.85; 95% CI 1.31, 2.62). Sarcopenia was not associated with any outcomes. CONCLUSION: Frailty, but not sarcopenia, is associated with worse outcomes in vascular surgery patients. Well-validated frailty assessment tools should be preferred clinically, and in future research.

Leg ischaemia management collaboration (LIMb): study protocol for a prospective cohort study at a single UK centre.

INTRODUCTION: Severe limb ischaemia (SLI) is the end stage of peripheral arterial occlusive disease where the viability of the limb is threatened. Around 25% of patients with SLI will ultimately require a major lower limb amputation, which has a substantial adverse impact on quality of life. A newly established rapid-access vascular limb salvage clinic and modern revascularisation techniques may reduce amputation rate. The aim of this study was to investigate the 12-month amputation rate in a contemporary cohort of patients and compare this to a historical cohort. Secondary aims are to investigate the use of frailty and cognitive assessments, and cardiac MRI in risk-stratifying patients with SLI undergoing intervention and establish a biobank for future biomarker analyses. METHODS AND ANALYSIS: This single-centre prospective cohort study will recruit patients aged 18-110 years presenting with SLI. Those undergoing intervention will be eligible to undergo additional venepuncture (for biomarker analysis) and/or cardiac MRI. Those aged ≥65 years and undergoing intervention will also be eligible to undergo additional frailty and cognitive assessments. Follow-up will be at 12 and 24 months and subsequently via data linkage with NHS Digital to 10 years postrecruitment. Those undergoing cardiac MRI and/or frailty assessments will receive additional follow-up during the first 12 months to investigate for perioperative myocardial infarction and frailty-related outcomes, respectively. A sample size of 420 patients will be required to detect a 10% reduction in amputation rate in comparison to a similar sized historical cohort, with 90% power and 5% type I error rate. Statistical analysis of this comparison will be by adjusted and unadjusted logistic regression analyses. ETHICS AND DISSEMINATION: Ethical approval for this study has been granted by the UK National Research Ethics Service (19/LO/0132). Results will be disseminated to participants via scientific meetings, peer-reviewed medical journals and social media. TRIAL REGISTRATION NUMBER: NCT04027244.

Coagulation, Fibrinolysis, and Platelet Activation Following Open Surgical or Percutaneous Angioplasty Revascularization for Symptomatic Lower Limb Chronic Ischemia.

INTRODUCTION: Critical limb ischemia (CLI) is associated with a prothrombotic diathesis that involves a complex balance between the coagulation and fibrinolytic systems. Knowledge of this is essential when considering revascularization procedures but is often overlooked. The aim of this review is to summarize the available literature and provide an overview of the effects of lower limb angioplasty and open surgical revascularization on coagulation, fibrinolysis, and platelet activation. METHODS: A MEDLINE and EMBASE search was conducted between 1973 and 2014 for articles relating to the effects of revascularization for patients with CLI on the fibrinolytic and coagulation pathways. Studies with a small cohort of patients (<5) were rejected. RESULTS: Many of the studies included in this analysis had small cohorts. Multiple markers were assessed across the published literature including von Willebrand factor, tissue factor, prothrombin fragments 1 and 2, platelets, soluble platelet selectin, plasminogen activator inhibitor 1, tissue plasminogen activator, and thrombin-antithrombin complex. Percutaneous intervention causes an exaggerated prothrombotic and a disturbed fibrinolytic effect. Surgery seems to cause a similar prothrombotic derangement with reduced fibrinolysis and platelet hyperactivity, but this appears to be maintained for a considerable amount of time postoperatively. CONCLUSION: There is a sparse amount published on the effects of the coagulation and fibrinolytic systems in patients undergoing intervention for CLI. Much of these studies are small, historical, and completely heterogeneous, making it difficult to draw meaningful conclusions. The literature does identify a prothrombotic state in patients with CLI, which appears to be exacerbated by any form of intervention and prolonged in those having surgery. Understanding this may allow us to tailor the intervention offered to patients and prevent limb loss.

Can surgeons assess CT suitability for endovascular repair (EVAR) in ruptured abdominal aortic aneurysm? Implications for a ruptured EVAR trial.

The purpose of this study was to determine whether surgeons without formal radiological training are able to assess suitability of patients with ruptured abdominal aortic aneurysms (AAA) for EVAR. The CT scans of 20 patients with AAA were reviewed under timed conditions by six vascular surgeons. Twenty minutes was allocated per scan. They were asked to determine if each aneurysm would be treatable by EVAR in the emergency setting and, if so, to measure for device selection. The results were then compared with those of a vascular radiologist. Six surgeons agreed on the suitability of endovascular repair in 45% of cases (95% CI, 23.1-68.5%; 9/20 scans; kappa = 0.41 [p = 0.01]) and concurred with the radiologist in eight of these. Individually, agreement ranged from 13 to 16 of the 20 scans, 65-80% between surgeons. The kappa value for agreement between all the surgeons and the radiologist was 0.47 (p = 0.01, moderate agreement). For the individual surgeons, this ranged from 0.3 to 0.6 (p = 0.01). In conclusion, while overall agreement was moderate between the surgeons and the radiologist, it is clear that if surgeons are to assess patients for ruptured EVAR in the future, focused training of surgical trainees is required.