Biomimetic Stents for Infrainguinal Peripheral Arterial Disease: Systematic Review and Meta-Analysis.

OBJECTIVE: Biomimetic stents are peripheral infrainguinal self expanding stents that mimic the anatomy of the vasculature and artery movement. They are indicated for use in infrainguinal arteries. This research aimed to synthesise all current evidence on the use of biomimetic stents as adjuncts for endovascular treatment of infrainguinal peripheral arterial disease (PAD), helping to guide clinical decision making. DATA SOURCES: MEDLINE, Embase, CINAHL and Cochrane databases. REVIEW METHODS: Random effects meta-analysis following PRISMA guidelines (PROSPERO registration CRD42022385256). Study quality was assessed using the Joanna Briggs Institute critical appraisal tools checklist, and certainty assessment through the Grading of Recommendations, Assessment, Development and Evaluation (GRADE). Endpoints included primary patency, target lesion revascularisation, stent fracture, secondary patency, and Death at one year. RESULTS: In total, 37 studies were included in the meta-analysis (33 cohort studies, two case series, and two randomised controlled trials [RCTs]), representing 4 480 participants. Of these, 34 studies included data on the Supera (81.5% of participants) and three studies reported data on the BioMimics 3D (18.5% of participants) stents. The pooled primary patency rate of 33 studies at one year follow up was 81.4% (95% confidence interval [CI] 78.7 - 83.9%), and the pooled target lesion revascularisation rate of 18 studies at one year was 12.2% (95% CI 9.6 - 15.0%). The certainty of evidence outcome rating as qualified by GRADE was very low for both. Only one study reported a positive stent fracture rate at one year follow up of 0.4% with a certainty of evidence outcome of low. CONCLUSION: Using biomimetic stents for infrainguinal PAD may be associated with acceptable one year primary patency and target lesion revascularisation rates, with a near negligible one year stent fracture rate. Their use should be considered in those presenting with infrainguinal PAD undergoing endovascular revascularisation. A RCT is necessary to determine their clinical and cost effectiveness.

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.

The Impact of the COVID-19 Pandemic on a Dedicated Vascular Emergency Clinic.

BACKGROUND: Vascular Emergency Clinics (VEC) improve patient outcomes in chronic limb-threatening ischemia (CLTI). They provide a "1 stop" open access policy, whereby "suspicion of CLTI" by a healthcare professional or patient leads to a direct review. We assessed the resilience of the outpatient VEC model to the first year of the coronavirus disease (COVID-19) pandemic. METHODS: A retrospective review of a prospectively maintained database of all patients assessed in our VEC for lower limb pathologies between March 2020 and April 2021 was performed. This was cross-referenced to national and loco-regional Governmental COVID-19 data. Individuals with CLTI were further analysed to determine Peripheral Arterial Disease-Quality Improvement Framework compliance. RESULTS: Seven hundred and ninety one patients attended for 1,084 assessments (Male n = 484, 61%; Age 72.5 ± standard deviation 12.2 years; White British n = 645, 81.7%). In total, 322 patients were diagnosed with CLTI (40.7%). A total of 188 individuals (58.6%) underwent a first revascularization strategy (Endovascular n = 128, 39.8%; Hybrid n = 41, 12.7%; Open surgery n = 19, 5.9%; Conservative n = 134, 41.6%). Major lower limb amputation rate was 10.9% (n = 35) and mortality rate was 25.8% (n = 83) at 12 months of follow-up. Median referral to assessment time was 3 days (interquartile range: 1-5). For the nonadmitted patient with CLTI, the median assessment to intervention was 8 days (interquartile range: 6-15) and median referral to intervention time of 11 days (11-18). CONCLUSIONS: The VEC model has demonstrated strong resilience to the COVID-19 pandemic with rapid treatment timelines maintained for patients with CLTI.

Selecting Portable Ankle/Toe Brachial Pressure Index Systems for a Peripheral Arterial Disease Population Screening Programme: a Systematic Review, Clinical Evaluation Exercise, and Consensus Process.

OBJECTIVE: To provide an overview of systems available for peripheral arterial disease (PAD) screening, together with respective accuracies and a clinical evaluation to identify a system suitable for use in a community screening programme. METHODS: A systematic review of the diagnostic accuracy of six ankle brachial pressure index (ABPI) and toe brachial pressure index (TBPI) devices deemed to be portable, which were Conformité Européenne (CE) marked, and were automated or semi-automated was carried out compared with gold standard handheld Doppler and duplex ultrasound. The devices were MESI-ABPI-MD, Huntleigh Dopplex Ability, Huntleigh ABPI and TBPI systems, Systoe TBPI system, and BlueDop. Seven databases (MEDLINE, EMBASE, Scopus, Web of Science, Cochrane Database of Systematic Reviews, Cochrane Register of Controlled Trials (CENTRAL), and Cumulative Index to Nursing and Allied Health Literature (CINAHL)) were searched, and 11 studies were identified as eligible for review. This was followed by hands on clinical evaluation by abdominal aortic aneurysm (AAA) screening staff (n = 39). During this, devices were demonstrated to staff which they then tested on volunteers and gave feedback using pre-designed questionnaires on their suitability for use in a screening programme. Finally, accuracy data and staff preferences were combined during a consensus conference that was held between study and screening staff to determine the most appropriate device to use in a community screening programme. RESULTS: Generally, the evaluated systems have a moderate level of sensitivity and a high level of specificity: Dopplex ability sensitivity 20% - 70%, specificity 86% - 96%; MESI sensitivity 57% - 74%, specificity 85% - 99%; BlueDop sensitivity 95%, specificity 89%; and Systoe sensitivity 71%, specificity 77%. Clinical evaluation by screening staff identified a preference for the MESI system. The consensus conference concluded that the MESI device was a good candidate for use in a community PAD screening programme. CONCLUSION: The MESI system is a good candidate to consider for community PAD screening.

Improving health behaviors in patients with peripheral arterial disease - A pilot study of supported self-management.

PURPOSE OF THE RESEARCH: This pilot study reports the feasibility of a future randomized controlled trial (RCT) investigating the effect of supported self-management through low-intensity psychological intervention in patients with peripheral arterial disease (PAD) resulting in claudication. The study protocol, measurement instrument, data collection, and analysis were evaluated. Clinical outcome measures include depression and anxiety scores, smoking cessation, activity (step count), weight, and quality of life. Both Quantitative and Qualitative data were collected to evaluate participant experience and the clinical impact of a supported self-management intervention delivered in a routine clinical setting. METHODS: Participants received an initial one to one assessment with a health psychologist. Demographic data and baseline clinical outcome measures were recorded. These included Hospital Anxiety and Depression Scale score (HADS), health-related quality of life questionnaire (EQ-5D-3 L), number of cigarettes smoked daily, weight/BMI, and daily step count. Participants each received an activity tracker to record daily step count and were followed up weekly to provide psychological input, including goal setting, overcoming barriers, and preventing relapse. Quantitative data collection was scheduled at baseline, 3 and 6 months (final follow-up). At the final follow-up, participants provided qualitative feedback reflecting upon their experience of the intervention and its impact. Descriptive statistical analysis and simple paired samples t-test were employed in data evaluation. RESULTS: The sample size was small (n = 30). Twenty-three participants were followed up to 6 months. Depression scores improved with statistical significance from baseline to 6-month follow-up. Eight participants stopped smoking (47% reduction); a further 9 greatly reduced their intake. A borderline statistically significant increase of daily step count was achieved between baseline and 6-month follow-up. In addition, positive weight loss trends were observed in a predominantly obese or overweight cohort. The qualitative feedback highlighted participants understood and embraced the information delivered regarding the importance of health behavior change. Participants were able to link tailored action plans with what mattered to them with the help of the Health Psychologist. CONCLUSION: This study embraces the contemporary ideology of enabling self-management of long-term conditions to improve clinical outcomes. As a pilot study, we have shown that an expanded, randomized controlled trial is both safe and feasible. A positive trend in clinical outcomes suggests this patient group may benefit from supported self-management through low-intensity psychological intervention, where other forms of early intervention have historically faltered.