The Relationship Between Obesity and Amputation-free Survival in Patients Undergoing Lower-limb Revascularisation for Chronic Limb-threatening Ischaemia: A Retrospective Cohort Study

BackgroundThe obesity paradox is a well-documented phenomenon in cardiovascular disease, however it remains poorly understood. We aimed to investigate the relationship between body mass (as measured by body mass index [BMI]) and 1-year amputation-free survival (AFS) for patients undergoing lower limb revascularisation for chronic limb-threatening ischaemia (CLTI).MethodsA retrospective analysis was undertaken of all consecutive patients undergoing lower limb revascularisation for CLTI at the Leicester Vascular Institute between February 2018–19. Baseline demographics and outcomes were collected using electronic records. BMI was stratified using the World Health Organization criteria. One-year AFS (composite of major amputation/death) was the primary outcome. Kaplan-Meier survival analysis and adjusted Cox's proportional hazard models were used to compare groups to patients of normal mass.ResultsOne-hundred and ninety patients were included. Overall, no difference was identified in 1-year AFS across all groups (pooled P = 0.335). Compared to patients with normal BMI (n = 66), obese patients (n = 43) had a significantly lower adjusted combined risk of amputation/death (aHR 0.39, 95% CI 0.16–0.92, P = 0.032), however no significant differences were observed for overweight (aHR 0.89, 95% CI 0.47–1.70, P = 0.741), morbidly obese (aHR 1.15, 95% CI 0.41–3.20, P = 0.797) and underweight individuals (aHR 1.86, 95% CI 0.56–6.20, P = 0.314).ConclusionsIn the context of CLTI, obesity is potentially associated with favourable amputation-free survival at 1 year, compared to normal body mass. The results of this study support the notion of an obesity paradox existing within CLTI and question whether current guidance on weight management requires a more patient-specific approach.</div

A systematic review investigating the identification, causes, and outcomes of delays in the management of chronic limb-threatening ischemia and diabetic foot ulceration

Objectives Patients presenting with chronic limb threatening ischaemia (CLTI) and diabetic foot ulceration (DFU) are at high risk of major lower limb amputation. Long-standing concern exists regarding late presentation and delayed management contributing to increased amputation rates. Despite multiple guidelines existing on the management of both conditions, there is currently no accepted timeframe in which to enact specialist care and treatment. This systematic review aims to investigate potential time delays in the identification, referral and management of both CLTI and DFU. Methods A systematic review, conforming to the Preferred Reporting Items for Systematic Review of Meta-Analysis (PRISMA) statement standards, was performed searching MEDLINE, Embase, The Cochrane Library and CINAHL from inception to 14 13 th November 2018. All English language qualitative and quantitative articles investigating or reporting the identification, causes and outcomes of time delays within ‘high income’ countries (annual gross domestic product per person >$15,000) were included. Data were extracted independently by the investigators. Given the clinical cross-over, both conditions were investigated together. A study protocol was designed and registered at the International Prospective Register of Systematic Reviews (PROSPERO) (registration number: CRD42018115286). Results A total of 4780 articles were screened, of which 32 articles, involving 71,310 patients and 1,388 healthcare professionals were included. Twenty-three articles focussed predominantly on DFU. Considerable heterogeneity was noted and only 12 articles were deemed of high quality. Only 4 articles defined a ‘delay’ however this was not consistent between studies. Median times from symptom onset to specialist healthcare assessment ranged from 15 to 126 days with subsequent median times from assessment to treatment ranging from 1 to 91 days. A number of patient and healthcare factors were consistently reported as potentially causative including, poor patient symptom recognition, inaccurate healthcare assessment and difficulties in accessing specialist services. Twenty articles reported outcomes of delays, namely rates of major amputation, ulcer healing and all-cause mortality. Although results were heterogeneous, they elude to delays being associated with detrimental outcomes for patients. Conclusions Time delays exist in all aspects of the management pathway, which are in some cases considerable in length. The causes of these are complex but reflect poor patient health-seeking behaviours, inaccurate healthcare assessment and barriers to referral and treatment within the care pathway. The adoption of standardised limits for referral and treatment times, exploration of missed opportunities for diagnosis and investigation of novel strategies for providing specialist care are required to help reduce delays.</div

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 GRADE criteria. Associations of frailty with patient factors were investigated by difference in means (MD) or expressed as risk ratios (RR), and associations with outcomes expressed as odds ratios (OR) or hazard ratios (HR). 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 [A]OR 2.77; 95%CI 2.01-3.81), post-operative 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.</div

Report of a Delphi exercise to inform the design of a research programme on screening for thoracic aortic disease

Objectives: To inform the design of a clinical trial of a targeted screening programme for relatives of individuals affected by thoracic aortic disease, we performed a consensus exercise as to the acceptability of screening, the optimal sequence and choice of tests, long-term patient management, and choice of trial design. Methods: Working with the Aortic Dissection Awareness UK & Ireland patient association, we performed a Delphi exercise with clinical experts, patients, and carers, consisting of three rounds of consultation followed by a final multi-stakeholder face-to-face workshop. Results: Thirty-five experts and 84 members of the public took part in the surveys, with 164 patients and clinicians attending the final workshop. There was substantial agreement on the need for a targeted screening pathway that would employ a combined approach (imaging + genetic testing). The target population would include the first- and second-degree adult (> 15 years) relatives, with no upper age limit of affected patients. Disagreement persisted about the screening process, sequence, personnel, the imaging method to adopt, computed tomography (CT) scan vs magnetic resonance imaging (MRI), and the specifics of a potential trial, including willingness to undergo randomisation, and measures of effectiveness and acceptability. Conclusion: A Delphi process, initiated by patients, identified areas of uncertainty with respect to behaviour, process, and the design of a targeted screening programme for thoracic aortic disease that requires further research prior to any future trial

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.</p

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 is 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 & 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 post-recruitment. Those undergoing cardiac MRI and/or frailty assessments will receive additional follow-up during the first 12 months to investigate for peri-operative 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 & 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, peerreviewed medical journals and social media. Study registration ClinicalTrials.gov [NCT04027244