A feasibility study of the CRISP intervention; a cardiovascular risk reduction intervention in patients with an abdominal aortic aneurysm.

Background: Abdominal aortic aneurysm (AAA) screening/surveillance is implemented widely. Those in AAA-surveillance are at high-risk of cardiovascular-events. We developed an intervention, called CRISP, using intervention-mapping, to reduce cardiovascular-risk in AAA-surveillance. This study tested the CRISP intervention in routine clinical-care. Methods: The CRISP intervention, consisting of a nurse-led cardiovascular risk assessment and subsequent lifestyle change support using a self-care workbook and low-intensity nurse input was delivered in two screening/surveillance programmes. Those consenting to take part were followed-up with cardiovascular-assessments. Fidelity of intervention-delivery was assessed quantitatively/qualitatively. Results: 40 men (mean age 75 ± 7 years) took part over four months and followed-up for a minimum six months. A sub-group of 25 patients and nine Health Care Professionals (HCPs) were interviewed. The median number of risk-factors that patients chose to focus on was two (range 0 to 4), with physical activity (n=17) being the most popular. Participants who had a 'red light' risk factor for stress, low mood, smoking or alcohol intake were offered a referral to appropriate services. Two were offered referral to mental-health services and took it up, three declined referrals to smoking or alcohol support services. The fidelity of intervention-delivery (a score intervention components delivered to each patient based on a score from 0 to 5, with 5 being highest delivery fidelity) was generally low. The highest mean score (on a 0-5 scale) for the nurse assessment was 1.5 for engaging the participant, lowest 0.5 for exploring the importance for selected lifestyle behaviours. In qualitative interviews, the intervention was liked by patients/HCPs. Based on qualitative interviews and observations, the low fidelity of intervention-delivery was due to intervention-training not being detailed. Conclusions: CRISP can be delivered in AAA-surveillance, but fidelity of delivery is low. The intervention and its training need to be refined/tested before wider implementation. Registration: ISRCTN9399399518/11/20).

Outcomes Following Vascular and Endovascular Procedures Performed During the First COVID-19 Pandemic Wave.

Objective: The first COVID-19 pandemic wave was a period of reduced surgical activity and redistribution of resources to only those with late stage or critical presentations. This Vascular and Endovascular Research Network COVID-19 Vascular Service (COVER) study aimed to describe the six-month outcomes of patients who underwent open surgery and or endovascular interventions for major vascular conditions during this period. Methods: In this international, multicentre, prospective, observational study, centres recruited consecutive patients undergoing vascular procedures over a 12-week period. The study opened in March 2020 and closed to recruitment in August 2020. Patient demographics, procedure details, and post-operative outcomes were collected on a secure online database. The reported outcomes at 30 days and six months were post-operative complications, re-interventions, and all cause in-hospital mortality rate. Multivariable logistic regression was used to assess factors associated with six-month mortality rate. Results: Data were collected on 3 150 vascular procedures, including 1 380 lower limb revascularisations, 609 amputations, 403 aortic, 289 carotid, and 469 other vascular interventions. The median age was 68 years (interquartile range 59, 76), 73.5% were men, and 1.7% had confirmed COVID-19 disease. The cumulative all cause in-hospital, 30-day, and six-month mortality rates were 9.1%, 10.4%, and 12.8%, respectively. The six-month mortality rate was 32.1% (95% CI 24.2-40.8%) in patients with confirmed COVID-19 compared with 12.0% (95% CI 10.8-13.2%) in those without. After adjustment, confirmed COVID-19 was associated with a three times higher odds of six-month death (adjusted OR 3.25, 95% CI 2.18-4.83). Increasing ASA grade (3-5 vs. 1-2), frailty scores 4-9, diabetes mellitus, and urgent and or immediate procedures were also independently associated with increased odds of death by six months, while statin use had a protective effect. Conclusion: During the first wave of the pandemic, the six-month mortality rate after vascular and endovascular procedures was higher compared with historic pre-pandemic studies and associated with COVID-19 disease.

Designing a platform/adaptive randomised controlled trial for peripheral arterial disease (PAD) - The PAEDIS international platform trial development project.

Background: Peripheral artery disease (PAD) is a common health problem. There are several technologies, medications, and interventions that aim to improve or treat PAD in people with symptomatic disease. Most of these technologies, however, have been untested in high-quality randomised studies assessing effectiveness and their interactions remain unknown. We developed a proposed design for an international randomised controlled trial assessing multiple PAD treatments. Methods: Over the course of 11 months (2023) several workshops and reviews of the literature took place. More specific, the proposed platform trial was designed with 44 people with PAD and 112 experts from across the world, in five work packages. The most relevant PAD treatment with unproven effectiveness were identified and key trial components as well as success criteria were defined. With input from five clinical trials units, the final format of a potential platform PAD trial in primary and secondary care was then proposed for funding. Results: The proposed platform PAD randomised trial involved two major multi-arm multi-stage randomised studies, assessing PAD treatments in the community setting (1 st package) and then secondary care (2 nd package). The 1 st package involved people with claudication and the 2 nd package involves people with chronic limb threatening ischaemia (CLTI). Conclusions: A platform PAD trial involves many challenges in terms of both design and delivery. The proposed design involving both people with claudication and CLTI will hopefully act as a blueprint for future work in this area.

Background: One in five people over 55 years of age have blockages in the arteries carrying blood to their legs. This is called peripheral artery disease or PAD. It can cause severe leg pain or skin and muscles of the legs dying due to limited blood supply. Doctors have been treating PAD using surgery for years. Keyhole artery surgery has recently been developed. Also, new medications are available for people with blocked arteries. Several new devices and medications are invented every year for PAD. Unfortunately, we don't know whether these new medications and devices actually work. This is causing uncertainty when making treatment decisions, leads to unnecessary leg amputations, and deaths. Also, these new treatments might be costing society far more money than the older treatments. In this work, we designed the best possible research to assess all these new PAD treatments in the next few years. Design & methods: This project took place in 2023 in five different stages (called work packages), involving 44 patients, carers, and 112 experts from many countries and the NHS. We looked up all treatments and medications available for this condition. We then agreed on what would make our future research successful. After that, we set up groups of patients and experts to design the research. We agreed on the final design of this research. Results: The proposed study should involve people with claudication in the 1 st stage and people with leg gangrene in the 2 nd stage. We agreed to test treatment like exercise and open surgery vs. keyhole surgery. The best way to assess treatments is to look at which one leads to less deaths and leg amputations. The results of this work described in this article will act as a blueprint for future research in this area.

Economic impact of limb-salvage strategies in chronic limb-threatening ischaemia: modelling and budget impact study based on national registry data.

BACKGROUND: Missed opportunities to reduce numbers of primary major lower-limb amputation and increase limb-salvage procedures when treating chronic limb-threatening ischaemia have previously been identified in the literature. However, the potential economic savings for healthcare providers when salvaging a chronic limb-threatening ischaemia-affected limb have not been well documented. METHODS: A model using National Health Service healthcare usage and cost data for 1.6 million individuals and averaged numbers of primary surgical procedures for chronic limb-threatening ischaemia from England and Wales in 2019-2021 was created to perform a budget impact analysis. Two scenarios were tested: the averaged national rates of major lower-limb amputation (above the ankle joint), angioplasty, open bypass surgery or arterial endarterectomy in the National Vascular Registry (current scenario); and revascularization rates adjusted based on the lowest amputation rate reported by the National Vascular Registry at the time of the study (hypothetical scenario). The primary outcome was the net impact on costs to the National Health Service over 12 months after the index procedure. RESULTS: In the current scenario, the proportions of different index procedures were 10% for lower-limb major amputation, 55% for angioplasty, 25% for open bypass surgery and 10% for arterial endarterectomy. In the hypothetical scenario, the procedure rates were 3% for major lower-limb amputation, 59% for angioplasty, 27% for open bypass surgery and 11% for arterial endarterectomy. For 16 025 index chronic limb-threatening ischaemia procedures, the total care cost in the current scenario was €243 924 927. In the hypothetical scenario, costs would be reduced for index procedures (-€10 013 814), community care (-€633 943) and major cardiovascular events (-€383 407), and increased for primary care (€59 827), outpatient appointments (€120 050) and subsequent chronic limb-threatening ischaemia-related surgery (€1 179 107). The net saving to the National Health Service would be €9 645 259. CONCLUSION: A shift away from primary major lower-limb amputation towards revascularization could lead to substantial savings for the National Health Service without major cost increases later in the care pathway, indicating that care decisions taken in hospitals have wider benefits.

Elective Surgical Repair of Popliteal Artery Aneurysms with Posterior Approach vs. Endovascular Exclusion: Early and Long Term Outcomes of Multicentre PARADE Study.

OBJECTIVE: The aim of this study was compare elective surgical repair of popliteal artery aneurysms (PAAs) via a posterior approach vs. endovascular exclusion, analysing early and five year outcomes in a multicentre retrospective study. METHODS: Between January 2010 and December 2023, a retrospectively maintained dataset of all consecutive asymptomatic PAAs that underwent open repair with posterior approach or endovascular repair in 37 centres was investigated. An aneurysm length of ≤ 60 mm was considered the only inclusion criterion. A total of 605 patients were included; 440 PAAs (72.7%) were treated via a posterior approach (open group) and the remaining 165 PAAs (27.3%) were treated using covered stents (endo group). Continuous data were expressed as median with interquartile range. Thirty day outcomes were assessed and compared. At follow up, primary outcomes were freedom from re-intervention, secondary patency, and amputation free survival. Secondary outcomes were survival and primary patency. Estimated five year outcomes were compared using log rank test. RESULTS: At 30 days, no differences were found in major morbidity, mortality, graft occlusion, or re-interventions. Three patients (0.7%) in the open group experienced nerve injury. The overall median duration of follow up was 32.1 months. At five year follow up, freedom from re-intervention was higher in the open group (82.2% vs. 68.4%; p = .021). No differences were observed in secondary patency (open group 90.7% vs. endo group 85.2%; p = .25) or amputation free survival (open group 99.0% vs. endo group 98.4%; p = .73). A posterior approach was associated with better survival outcomes (84.4% vs. 79.4%; p = .050), and primary patency (79.8% vs. 63.8%; p = .012). CONCLUSION: Early and long term outcomes following elective repair of PAAs measuring ≤ 60 mm via a posterior approach or endovascular exclusion seem comparable. Nerve injury might be a rare but potential complication for those undergoing open surgery. Endovascular repair is associated with more re-interventions.

Systematic Review and Network Meta-analysis of Vessel Preparation Techniques With Plain Balloon Angioplasty, Atherectomy, or Intravascular Lithotripsy Before Application of a Drug Coated Balloon to Treat Atherosclerotic Femoropopliteal Disease.

OBJECTIVE: To compare one year outcomes after atherectomy, intravascular lithotripsy vs. plain balloon angioplasty before application of drug coated balloons for treating femoropopliteal atherosclerotic disease. DATA SOURCES: MEDLINE, EMBASE, and Cochrane Library were screened until May 2023 for randomised controlled trials. REVIEW METHODS: This was a systematic review and network meta-analysis. The inclusion criteria were patients with claudication and those with critical limb threatening ischaemia with lesion characteristics of all lengths, stenosis, calcification, and occlusions. The primary outcome was freedom from target lesion re-intervention at one year. Secondary outcomes were rate of bailout stenting, major amputation, and all cause mortality at one year. Pooled point estimates were calculated with a standard random effects model. Further sensitivity analyses were completed with a mixed treatment Bayesian model. Risk of bias was assessed by the Revised Cochrane Risk of Bias tool 2 (RoB2) and certainty of evidence assessed via the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework. RESULTS: Four RCTs comprising 549 patients (two studies evaluating directional atherectomy, one evaluating rotational atherectomy, one evaluating intravascular lithotripsy against plain balloon angioplasty) were included. The weighted mean length of femoropopliteal lesions was 103.4 ± 6.67 mm. Results of the mixed treatment Bayesian analysis were consistent with pooled analysis for all outcomes. There were no significant differences in freedom from target lesion revascularisation (GRADE, high) (RoB2, low), major amputation (GRADE, low), or mortality (GRADE, moderate). Bailout stenting rates were significantly reduced with intravascular lithotripsy and atherectomy compared with plain balloon angioplasty (RR 0.25, 95% CI 0.07 - 0.89) (GRADE, moderate) (RoB2, low). CONCLUSION: This review found that intravascular lithotripsy or atherectomy did not appear to incur a statistically significant advantage in freedom from target lesion revascularisation, major amputation, or mortality rate at one year. There was moderate certainty of evidence that bailout stenting is significantly reduced after vessel preparation with intravascular lithotripsy and atherectomy.

Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-2 Trial: Analysis of the Timing and Causes of Death in Participants Randomised to an Infrapopliteal Vein Bypass or Best Endovascular Treatment First Revascularisation Strategy.

OBJECTIVE: The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-2 trial enrolled participants with chronic limb threatening ischaemia who required an infrapopliteal, with or without a femoropopliteal, revascularisation procedure to restore limb perfusion. Participants randomised to a vein bypass (VB) first revascularisation strategy were over one third more likely than those randomised to a best endovascular treatment (BET) first revascularisation strategy to die from any cause during a median follow up of 40.0 (interquartile range 20.9, 60.6) months. The aim of the present study was to describe the timing and causes of death in BASIL-2 as a first step towards trying to better understand why randomisation to a VB first revascularisation strategy was associated with this excess mortality. METHODS: A 10 person international panel comprising vascular and endovascular surgeons as well as vascular interventional radiologists, who had all been principal investigators in BASIL-2, took part in a modified Delphi consensus exercise to adjudicate the primary cause of death and, in particular, whether the cause was primarily cardiac or non-cardiac. RESULTS: In 151 of 168 deaths (89.9%), the Delphi panel achieved a consensus regarding the cause of death being probably cardiac or non-cardiac. In the BET group, 16 of 77 deaths (21%) were classified as probably cardiac compared with 32 of 91 (35%) in the VB group (unadjusted subdistribution hazard ratio 2.16, 95% confidence interval [CI] 1.20 - 3.87; unadjusted cause specific hazard ratio 2.15, 95% CI 1.19 - 3.90). At the point of randomisation, 64 of 344 (18.6%), 40 of 342 (11.7%), and 37 of 344 (10.8%) participants had a previous myocardial infarction (MI), percutaneous coronary intervention (PCI), and coronary artery bypass graft (CABG), respectively. There was no evidence of varying treatment effects for cause of death in subgroup analyses of previous PCI, CABG, or MI. CONCLUSION: The excess mortality observed in the VB first revascularisation strategy group in BASIL-2 was largely due to deaths that were adjudicated by the Delphi panel as probably primarily cardiac. These excess cardiac deaths were observed throughout follow up and there was no evidence of non-proportional hazards. Further work is ongoing to try to better understand the reasons for these findings.

New Horizons in Peripheral Artery Disease.

Peripheral artery disease (PAD) is the lower limb manifestation of systemic atherosclerotic disease. PAD may initially present with symptoms of intermittent claudication, whilst chronic limb-threatening ischaemia (CLTI), the end stage of PAD, presents with rest pain and/or tissue loss. PAD is an age-related condition present in over 10% of those aged ≥65 in high-income countries. Guidelines regarding definition, diagnosis and staging of PAD and CLTI have been updated to reflect the changing patterns and presentations of disease given the increasing prevalence of diabetes. Recent research has changed guidelines on optimal medical therapy, with low-dose anticoagulant plus aspirin recommended in some patients. Recently published randomised trials highlight where bypass-first or endovascular-first approaches may be optimal in infra-inguinal disease. New techniques in endovascular surgery have increased minimally invasive options for ever more complex disease. Increasing recognition has been given to the complexity of patients with CLTI where a high prevalence of both frailty and cognitive impairment are present and a significant burden of multi-morbidity and polypharmacy. Despite advances in minimally invasive revascularisation techniques and reduction in amputation incidence, survival remains poor for many with CLTI. Shared decision-making is essential, and conservative management is often appropriate for older patients. There is emerging evidence of the benefit of specialist geriatric team input in the perioperative management of older patients undergoing surgery for CLTI. Recent UK guidelines now recommend screening for frailty, cognitive impairment and delirium in older vascular surgery patients as well as recommending all vascular surgery services have support and input from specialist geriatrics teams.

Management of common femoral artery occlusive disease: the current gap in the evidence and future perspectives.

The common femoral artery (CFA) is the most common site affected by peripheral artery disease. Due its various anatomical and morphological features, common femoral endarterectomy has long since been the preferred treatment option. However, there are complications associated with common femoral endarterectomy including, but not limited to, surgical site infections, hematoma formation, bleeding, and nerve injury. Unfortunately, this has been further complicated by the ageing population and increasing epidemic of obesity and diabetes mellitus. Within vascular surgery, there has been a rise in use of endovascular techniques for peripheral artery disease. Endovascular repair of the CFA is safe and feasible. One clear advantage is that they can be performed under local or regional anesthesia, thus reducing morbidity. This narrative review seeks to describe the current gap in the evidence and future perspectives in the management of common femoral artery occlusive disease.

Cost Analysis of Target Lesion Revascularisation in Patients With Femoropopliteal In Stent Re-Stenosis or Occlusion: The COSTLY-TLR Study.

OBJECTIVE: To report the cost of target lesion revascularisation procedures (TLR) for femoropopliteal peripheral artery disease (PAD) following stenting, from a healthcare payer's perspective. METHODS: European multicentre study involving consecutive patients requiring femoropopliteal TLR (January 2017 - December 2021). The primary outcome was overall cost (euros) associated with a TLR procedure from presentation to discharge. Exact costs per constituent, clinical characteristics, and early outcomes were reported. RESULTS: This study included 482 TLR procedures (retrospectively, 13 hospitals, six countries): 56% were female, mean age was 75 ± 2 years, 61% were Rutherford class 5 or 6, 67% had Tosaka class 3 disease, and 16% had common femoral or iliac involvement. A total of 52% were hybrid procedures and 6% involved open surgery only. Technical success was 70%, 30 day mortality rate was 1%, and the 30 day major amputation rate was 4%. Most costs were for operating time during the TLR (healthcare professionals' salaries, indirect and estate costs), with a mean of: €21 917 ± €2 110 for all procedures; €23 337 ± €8 920 for open procedures; €12 903 ± €3 108 for endovascular procedures; and €22 806 ± €3 977 for hybrid procedures. In a regression analysis, procedure duration was the main parameter associated with higher overall TLR costs (coefficient, 2.77; standard error, 0.88; p < .001). The mean cost per operating minute of TLR (indirect, estate costs, all salaried staff present included) was €177 and the mean cost per night stay in hospital (outside intensive care unit) was €356. The mean cost per overnight intensive care unit stay (minimum of 8 hours per night) was €1 193. CONCLUSION: The main driver of the considerable peri-procedure costs associated with femoropopliteal TLR was procedure time.

Improving cardiovascular health in patients with an abdominal aortic aneurysm: development of the cardiovascular risk reduction in patients with aneurysms (CRISP) behaviour change intervention.

BACKGROUND: Abdominal aortic aneurysm (AAA) is an important cardiovascular health problem. Ultrasound screening is proven to reduce AAA mortality and programmes have been implemented in some healthcare systems. Those who are identified as having a small AAA in screening enter into a surveillance programme to monitor AAA size. Individuals in AAA surveillance are at elevated risk of cardiovascular events, which is not currently addressed sufficiently. We aimed to develop a simple intervention to reduce cardiovascular risk, which could be embedded in AAA surveillance pathways. METHODS: Intervention mapping methods were used to co-develop the intervention with individuals with AAA, families/carers, and healthcare staff. We identified "targets for change" by synthesising research evidence and international guidelines and consulting with patients, caregivers and health service providers. We conducted a series of workshops to identify barriers to and facilitators of change and used taxonomies of behaviour change theories and techniques to match intervention strategies to each target. Further stakeholder involvement work helped refine the intervention. RESULTS: The developed intervention focusses on assessment and individually tailored discussion of risk factors, exchanging information, building motivation and action planning, followed by review of progress and problem-solving. Workbooks covering physical activity, diet, stress management, alcohol, smoking, blood pressure and mental health are provided to support behaviour change. The intervention is facilitated by trained healthcare professionals during the patient's AAA screening appointment for the duration that they are in surveillance. DISCUSSION: The developed intervention will now be tested to assess whether it can be integrated with the current AAA screening programme. The developed intervention is a novel approach to reducing cardiovascular disease in the AAA population, it is also the first intervention which tries to do this in this population. TRIAL REGISTRATION: International Clinical Trial Registration: ISRCTN93993995.

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.

Influence of cardiometabolic medications on abdominal aortic aneurysm growth in the UK Aneurysm Growth Study: metformin and angiotensin-converting enzyme inhibitors associated with slower aneurysm growth.

BACKGROUND: There is a clinical need for treatments that can slow or prevent the growth of an abdominal aortic aneurysm, not only to reduce the need for surgery, but to provide a means to treat those who cannot undergo surgery. METHODS: Analysis of the UK Aneurysm Growth Study (UKAGS) prospective cohort was conducted to test for an association between cardiometabolic medications and the growth of an abdominal aortic aneurysm above 30 mm in diameter, using linear mixed-effect models. RESULTS: A total of 3670 male participants with data available on abdominal aortic aneurysm growth, smoking status, co-morbidities, and medication history were included. The mean age at recruitment was 69.5 years, the median number of surveillance scans was 6, and the mean(s.e.) unadjusted abdominal aortic aneurysm growth rate was 1.75(0.03) mm/year. In a multivariate linear mixed-effect model, smoking (mean(s.e.) +0.305(0.07) mm/year, P = 0.00003) and antiplatelet use (mean(s.e.) +0.235(0.06) mm/year, P = 0.00018) were found to be associated with more rapid abdominal aortic aneurysm growth, whilst metformin was strongly associated with slower abdominal aortic aneurysm growth (mean(s.e.) -0.38(0.1) mm/year, P = 0.00019), as were angiotensin-converting enzyme inhibitors (mean(s.e.) -0.243(0.07) mm/year, P = 0.0004), angiotensin II receptor antagonists (mean(s.e.) -0.253(0.08) mm/year, P = 0.00255), and thiazides/related diuretics (mean(s.e.) -0.307(0.09) mm/year, P = 0.00078). CONCLUSION: The strong association of metformin with slower abdominal aortic aneurysm growth highlights the importance of the ongoing clinical trials assessing the effectiveness of metformin with regard to the prevention of abdominal aortic aneurysm growth and/or rupture. The association of angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, and diuretics with slower abdominal aortic aneurysm growth points to the possibility that optimization of cardiovascular risk management as part of abdominal aortic aneurysm surveillance may have the secondary benefit of also reducing abdominal aortic aneurysm growth rates.

Outcomes and use of healthcare resources after an intervention for chronic limb-threatening ischaemia.

BACKGROUND: The fate of patients with chronic limb-threatening ischaemia undergoing revascularization or a primary amputation is unclear. The aim of this study was to assess the postoperative outcomes and post-procedural healthcare resource use/costs over 1 year after revascularization or a primary amputation for chronic limb-threatening ischaemia. METHODS: The UK Kent Integrated Dataset, which links primary, community, and secondary care for 1.6 million people, was interrogated. All patients with a new diagnosis of chronic limb-threatening ischaemia undergoing revascularization or a major amputation between January 2016 and January 2019 (3 years) were identified. Postoperative events across all healthcare settings and post-procedure healthcare resource use were analysed over 1 year (until the end of 2019). RESULTS: Overall, 4252 patients with a new diagnosis of chronic limb-threatening ischaemia were identified (65 per cent were male and the mean age was 73 years) between January 2016 and January 2019, of whom 579 (14 per cent) underwent an intervention (studied population); 296 (7 per cent) had an angioplasty, 75 (2 per cent) had bypass surgery, 141 (3 per cent) had a primary major lower limb amputation, 11 had a thrombo-embolectomy (0.3 per cent), and 56 had an endarterectomy (1.3 per cent). Readmissions (median of 2) were similar amongst different procedures within 1 year; bypass surgery was associated with more hospital appointments (median of 4 versus 2; P = 0.002). Patients undergoing a primary amputation had the highest number of cardiovascular events and 1-year mortality. In a linear regression model, index procedure type and Charlson co-morbidity index score were not predictors of appointments in primary/secondary care, community care visits, or readmissions after discharge. There were no statistically significant differences regarding post-procedural healthcare costs between procedures over 1 year. CONCLUSION: Revascularization is not associated with more hospital, primary/community care appointments or increased post-procedural healthcare costs over 1 year when compared with primary amputation, in people with chronic limb-threatening ischaemia.

Endovascular Versus Surgical Treatment for All Comer Patients With Prosthetic Bypass Graft Occlusion: The Multicentre ENSUPRO Study.

OBJECTIVE: Bypass surgery plays a key role in complex lower limb lesions. However, there is a lack of evidence regarding the management of symptomatic prosthetic bypass graft (PBG) occlusion. This study aimed to report outcomes following open, hybrid, or endovascular management of patients presenting with symptomatic PBG occlusion. METHODS: A multicentre, retrospective cohort study was conducted, including patients presenting with PBG occlusion between January 2014 and December 2021 from 18 centres. It assessed the comparative value of treatment strategies, including (1) recanalisation of native vessels, (2) endovascular treatment of the failed PBG, (3) hybrid treatment, and (4) open surgery. The primary outcome measure was amputation free survival (AFS, time to major amputation and or death), whereas all cause mortality, major amputation, PBG re-occlusion, target lesion revascularisation (TLR), and Rutherford category (RC) improvement during follow up were considered as secondary endpoints. RESULTS: Of 260 patients with occluded PBGs, 108 (41.5%) were treated endovascularly (24 [22.2%] by recanalisation of native vessels and 84 [77.7%] by PBG re-opening), 57 (21.9%) underwent hybrid revascularisation, and 58 (22.3%) had surgery. In addition, 27 (10.4%) were treated conservatively and 10 (3.8%) received systemic thrombolysis. With a median follow up of 1.4 (0.6 - 3.0) years, AFS was 95.5%, 76.4%, 45.5%, and 37.1%, respectively in Groups 1 - 4 (p = .007). Older age and non-endovascular treatment (HR 1.05 and 1.70; p < .01 for both) were independent predictors of poor AFS. Endovascular treatment was associated with lower rates of major amputation (p = .04), PBG re-occlusion (p < .001), and TLR (p = .037), and higher RC improvements (p < .001), whereas all cause mortality was comparable between treatment groups (p = .21). CONCLUSION: Endovascular treatment is associated with higher rates of AFS and RC improvement and lower rates of PBG re-occlusion and TLR in patients with PBG occlusion.

Editor's Choice - RANDOMisation Screening for Drug coated or Drug Eluting Device Randomised Trials Among Patients Undergoing Endovascular FemorOPopliteal Procedures (RANDOM-STOP study).

OBJECTIVE: The aim was to assess the proportion of patients undergoing endovascular therapy for femoropopliteal arterial disease (FP) who would be eligible to take part in seven major randomised controlled trials (RCTs) that investigated the efficacy of some of the currently available paclitaxel based (PTX) devices used in this clinical context. Various RCTs have shown a potential clinical benefit from the use of paclitaxel in FP endovascular therapy. Nonetheless, patients enrolled were highly selected and the generalisability of these findings in pragmatic cohorts is unclear. METHODS: Between 1 January and 31 December 2021, all consecutive patients who underwent endovascular procedures for symptomatic FP disease in 16 European centres were retrospectively screened and included in this analysis. The primary outcome measure was individual patient eligibility for inclusion into at least one of the seven RCTs. The reasons for exclusion (clinical and or radiological) as well as in hospital death and morbidity were also reported. RESULTS: A total of 1 567 consecutive patients (959 male, 61%), corresponding to 1 567 lower limbs, were included. Most patients (1 009 patients, 64.39%) were treated for chronic limb threatening ischaemia (CLTI). A total 1 280 patients (81.68%) were not eligible for inclusion in any of the evaluated RCTs. Of them, 741 (47.28%) were excluded for clinical and 1 125 (71.79%) for radiological reasons. CONCLUSION: The analysed RCTs assessing the efficacy or effectiveness of PTX based endovascular therapies do not seem representative of the patient population with FP disease receiving endovascular therapy in routine clinical practice.