A vein bypass first versus a best endovascular treatment first revascularisation strategy for patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal revascularisation procedure to restore limb perfusion (BASIL-2): an open-label, randomised, multicentre, phase 3 trial.

BACKGROUND: Chronic limb-threatening ischaemia is the severest manifestation of peripheral arterial disease and presents with ischaemic pain at rest or tissue loss (ulceration, gangrene, or both), or both. We compared the effectiveness of a vein bypass first with a best endovascular treatment first revascularisation strategy in terms of preventing major amputation and death in patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion. METHODS: Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL)-2 was an open-label, pragmatic, multicentre, phase 3, randomised trial done at 41 vascular surgery units in the UK (n=39), Sweden (n=1), and Denmark (n=1). Eligible patients were those who presented to hospital-based vascular surgery units with chronic limb-threatening ischaemia due to atherosclerotic disease and who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion. Participants were randomly assigned (1:1) to receive either vein bypass (vein bypass group) or best endovascular treatment (best endovascular treatment group) as their first revascularisation procedure through a secure online randomisation system. Participants were excluded if they had ischaemic pain or tissue loss considered not to be primarily due to atherosclerotic peripheral artery disease. Most vein bypasses used the great saphenous vein and originated from the common or superficial femoral arteries. Most endovascular interventions comprised plain balloon angioplasty with selective use of plain or drug eluting stents. Participants were followed up for a minimum of 2 years. Data were collected locally at participating centres. In England, Wales, and Sweden, centralised databases were used to collect information on amputations and deaths. Data were analysed centrally at the Birmingham Clinical Trials Unit. The primary outcome was amputation-free survival defined as time to first major (above the ankle) amputation or death from any cause measured in the intention-to-treat population. Safety was assessed by monitoring serious adverse events up to 30-days after first revascularisation. The trial is registered with the ISRCTN registry, ISRCTN27728689. FINDINGS: Between July 22, 2014, and Nov 30, 2020, 345 participants (65 [19%] women and 280 [81%] men; median age 72·5 years [62·7-79·3]) with chronic limb-threatening ischaemia were enrolled in the trial and randomly assigned: 172 (50%) to the vein bypass group and 173 (50%) to the best endovascular treatment group. Major amputation or death occurred in 108 (63%) of 172 patients in the vein bypass group and 92 (53%) of 173 patients in the best endovascular treatment group (adjusted hazard ratio [HR] 1·35 [95% CI 1·02-1·80]; p=0·037). 91 (53%) of 172 patients in the vein bypass group and 77 (45%) of 173 patients in the best endovascular treatment group died (adjusted HR 1·37 [95% CI 1·00-1·87]). In both groups the most common causes of morbidity and death, including that occurring within 30 days of their first revascularisation, were cardiovascular (61 deaths in the vein bypass group and 49 in the best endovascular treatment group) and respiratory events (25 deaths in the vein bypass group and 23 in the best endovascular treatment group; number of cardiovascular and respiratory deaths were not mutually exclusive). INTERPRETATION: In the BASIL-2 trial, a best endovascular treatment first revascularisation strategy was associated with a better amputation-free survival, which was largely driven by fewer deaths in the best endovascular treatment group. These data suggest that more patients with chronic limb-threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion should be considered for a best endovascular treatment first revascularisation strategy. FUNDING: UK National Institute of Health Research Health Technology Programme.

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.

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.

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.

Safety and effectiveness of the phoenix atherectomy device for endovascular treatment of common femoral and popliteal arteries: Results of the EN-MOBILE trial.

Background: This study aimed to assess the peri- and postprocedural outcomes of atherectomy-assisted endovascular treatment of the common femoral (CFA) and popliteal arteries. Methods: Phoenix atherectomy was used for the treatment of 73 and 53 de novo CFA and popliteal artery lesions, respectively, in 122 consecutive patients. Safety endpoints encompassed perforation and peripheral embolization. Postprocedural endpoints included freedom from clinically driven target lesion revascularization (CD-TLR) and clinical success (an improvement of ⩾ 2 Rutherford category [RC]). In addition, 531 patients treated for popliteal artery stenosis or occlusion without atherectomy were used as a comparator group. Results: Procedural success (residual stenosis < 30% after treatment) was 99.2%. The need for bail-out stenting was 2 (2.7%) and 3 (5.7%) in CFA and popliteal artery lesions, respectively. Only one (1.4%) embolization occurred in the CFA, which was treated by catheter aspiration. No perforations occurred. After 1.50 (IQR = 1.17-2.20) years, CD-TLR occurred in seven (9.2%) and six (14.6%) patients with CFA and popliteal artery lesions, respectively, whereas clinical success was achieved in 62 (91.2%) and 31 (75.6%), respectively. Patients treated with atherectomy and DCB in the popliteal artery after matching for baseline RC, lesion calcification, length, and the presence of chronic total occlusion, exhibited higher freedom from CD-TLR compared to the nondebulking group (HR = 3.1; 95% CI = 1.1-8.5, p = 0.03). Conclusion: Atherectomy can be used safely and is associated with low rates of bail-out stenting in CFA and popliteal arteries. CD-TLR and clinical success rates are clinically acceptable. In addition, for the popliteal artery, atherectomy combined with DCB demonstrates lower CD-TLR rates compared to a DCB alone strategy. (German Clinical Trials Register: DRKS00016708).

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.

Different endovascular modalities of treatment for isolated atherosclerotic popliteal artery lesions (EMO-POP) registry.

BACKGROUND: The mid-term results after treatment of isolated popliteal lesions have been limited. The aim of the present study was to report the mid-term outcomes after endovascular treatment of isolated atherosclerotic popliteal artery lesions. METHODS: A multicenter (15 hospitals in five countries) retrospective cohort study was performed. Between June 2016 and June 2021, 651 consecutive patients who had been treated for isolated popliteal lesions using endovascular methods exclusively were included in the present study. Six techniques were identified, including plain balloon angioplasty (PTA; n = 286; 43.9%), drug-coated balloon angioplasty (n = 98; 15.1%), stenting with low-chronic outward force (COF) stents (n = 84; 12.9%), stenting with high-COF stents (n = 76; 11.7%), atherectomy alone (n = 17; 2.6%), and directional atherectomy with drug-coated balloons (n = 90; 13.8%). The primary outcomes measures were primary and secondary patency and freedom from clinically driven target lesion revascularization (F-CDTLR). RESULTS: The mean patient age was 74.5 years. Most of the patients (n = 409; 62.9%) had had chronic limb-threatening ischemia. Popliteal occlusion was found in 400 cases (61.4%). High-grade calcification was present in 36.7% of cases. Immediate technical success was 94.8%. The median follow-up was 26 months (range, 6-42 months). The actuarial rate for all patients at 26 months (per outcome measure) was as follows: primary patency, 73.9%; secondary patency, 88%; and F-CDTLR, 76.5%. When comparing PTA vs all other treatments in an adjusted regression analysis, the F-CDTLR was 75.2% for PTA vs 76.5% for all other treatment (hazard ratio, 1.06; 95% confidence interval, 0.75-1.48; P = .46, adjusted regression). The difference in secondary patency also was not statistically significant (85.7% for PTA vs 88%; P = .20). Adjusted Kaplan-Meier analysis revealed that the estimated primary patency was inferior for PTA in pairwise comparisons vs other treatments (P < .001 vs atherectomy; P = .002 vs directional atherectomy with drug-coated balloons; and P = .002 vs low-COF stenting). CONCLUSIONS: The results from our study have shown that endovascular treatment of isolated popliteal lesions is safe and associated with acceptable patency and F-CDTLR in the mid-term.

Atherosclerotic renovascular disease: a clinical practice document by the European Renal Best Practice (ERBP) board of the European Renal Association (ERA) and the Working Group Hypertension and the Kidney of the European Society of Hypertension (ESH).

Atherosclerotic renovascular disease (ARVD) is the most common type of renal artery stenosis. It represents a common health problem with clinical presentations relevant to many medical specialties and carries a high risk for future cardiovascular and renal events, as well as overall mortality. The available evidence regarding the management of ARVD is conflicting. Randomized controlled trials failed to demonstrate superiority of percutaneous transluminal renal artery angioplasty (PTRA) with or without stenting in addition to standard medical therapy compared with medical therapy alone in lowering blood pressure levels or preventing adverse renal and cardiovascular outcomes in patients with ARVD, but they carried several limitations and met important criticism. Observational studies showed that PTRA is associated with future cardiorenal benefits in patients presenting with high-risk ARVD phenotypes (i.e. flash pulmonary oedema, resistant hypertension or rapid loss of kidney function). This clinical practice document, prepared by experts from the European Renal Best Practice (ERBP) board of the European Renal Association (ERA) and from the Working Group on Hypertension and the Kidney of the European Society of Hypertension (ESH), summarizes current knowledge in epidemiology, pathophysiology and diagnostic assessment of ARVD and presents, following a systematic literature review, key evidence relevant to treatment, with an aim to support clinicians in decision making and everyday management of patients with this condition.

Acute Kidney Injury Following Revascularization in Patients With Chronic Limb-Threatening Ischemia and Non-Dialysis-Dependent Chronic Kidney Disease: Insights From the NSQIP Database at 30-Day Follow-Up.

BACKGROUND: Patients with chronic limb-threatening ischemia (CLTI) and chronic kidney disease (CKD) are at risk of developing renal injury following revascularization. We aimed to compare the risk of adverse renal events following endovascular revascularization (ER) or open surgery (OS) in patients with CLTI and CKD. METHODS: A retrospective analysis of the National Surgical Quality Improvement Program (NSQIP) databases (2011-2017) was performed including patients with CLTI and non-dialysis-dependent CKD, comparing ER to OS. The primary outcome was a composite of postprocedural kidney injury or failure within 30 days. Thirty-day mortality, major adverse cardiac and cerebrovascular events (MACCE), amputation, readmission or target lesion revascularization (TLR) were compared using multivariate logistic regression and propensity-score matched analysis. RESULTS: A total of 5009 patients were included (ER: 2361; OS: 3409). The risk for the composite primary outcome was comparable between groups (odds ratio [OR]: 0.78, 95% confidence interval (CI): 0.53-1.17) as for kidney injury (n=54, OR: 0.97, 95% CI: 0.39-1.19) or failure (n=55, OR: 0.68, 95% CI: 0.39-1.19). In the adjusted regression, a significant benefit was observed with ER for the primary outcome (OR: 0.60, p=0.018) and renal failure (OR: 0.50, p=0.025), but not for renal injury (OR: 0.76, p=0.34). Lower rates of MACCE, TLR, and readmissions were observed after ER. Thirty-day mortality and major amputation rates did not differ. In the propensity score analysis, revascularization strategy was not associated with renal injury or failure. CONCLUSIONS: In this cohort, the incidence of renal events within 30 days of revascularization in CLTI was low and comparable between ER and OR. CLINICAL IMPACT: In a cohort of 5009 patients with chronic limb-threatening ischemia and non-end-stage chronic kidney disease (CKD), postprocedural kidney injury or failure within 30 days was comparable between patients submitted to open or endovascular revascularization (ER). Lower rates of major adverse cardiac and cerebrovascular events, target lesion revascularization, and readmissions were observed after endovascular revascularization. Based on these findings, ER should not be avoided due to fear of worsening renal function in CKD patients with chronic limb-threatening ischemia. In fact, these patients benefit more from ER regarding cardiovascular outcomes with no increased risk of kidney injury.

Acute Kidney Injury in Patients with Acute Type B Aortic Dissection.

OBJECTIVE: Acute kidney injury (AKI) is common in patients with aortic diseases; however, it has not been extensively studied in acute type B aortic dissection (TBAD). AKI is known to be associated with adverse kidney outcomes and premature death. This study investigated the incidence and impact of AKI in patients with acute TBAD. METHODS: This was a retrospective study including data from two tertiary vascular centres in the UK. Case notes and electronic records were reviewed for consecutive patients presenting with acute symptomatic TBAD. Patients were managed according to a uniform clinical protocol; both patients who underwent surgery and those managed conservatively were included in this analysis. Serum creatinine values were used to calculate the number of patients who developed AKI, based on validated Kidney Disease Improving Global Outcomes definitions. Associations between incidence of AKI, death, and Major Adverse Kidney Events (MAKE; defined as death, dialysis and/or drop in estimated glomerular filtration rate > 25%) were explored. RESULTS: Overall, 66 (42.6%) of 155 patients developed AKI within one week of presenting with TBAD. Of these, 23 patients (34.8%) had stage 1, 26 patients (39.4%) stage 2, and 17 patients (25.8%) stage 3 AKI. MAKE at 30 and 90 days occurred in 17 (11.0%) and 12 patients (7.7%), respectively. AKI was associated with significantly worse outcomes, with a 24.2% mortality rate in the AKI group compared with 7.8% among those with no AKI (p <.001); this association was also significant in adjusted analyses, both in patients who did and did not undergo surgery. CONCLUSION: AKI is very common among patients presenting with acute TBAD, even in clinically uncomplicated disease. There was a significant association with mortality and MAKE, whether patients underwent surgery or not. This warrants further investigation to better understand the underlying causes of the AKI and investigate management strategies which may improve outcomes.

International Cross-Sectional Survey of Bullying, Undermining, and Harassment in the Vascular Workplace.

OBJECTIVE: Bullying, undermining behaviour, and harassment (BUH) may exist in healthcare settings, impacting on patient care. The aim of this international study was to evaluate the characteristics of BUH experienced by physicians treating vascular diseases at various career stages. METHODS: This was an anonymous international structured non-validated cross-sectional survey distributed via relevant professional societies in collaboration with the Research Collaborative in Peripheral Artery Disease. The survey was disseminated through societies' newsletters, emails, and social media. Data were collected online, allowing free text entries alongside structured multiple choice questions based on previous surveys. Demographics, geographical information, and data relating to stage and training environment were collected. RESULTS: Of 587 respondents from 28 countries, 86% were working in vascular surgery, mostly at a university hospital (56%); 81% were aged between 31 and 60 years, 57% were working as a consultant, and 23% as a resident. Respondents were mostly white (83%), male (63%), heterosexual (94%), and without disability (96%). Overall, 253 (43%) reported experiencing BUH personally, 75% had witnessed BUH toward colleagues, and 51% witnessed these in the last 12 months. Female sex and non-white ethnicity were associated with BUH (53% vs. 38% and 57% vs. 40% respectively; p < .001 in both cases). While working as a consultant, 171 (50%) reported experiencing BUH, more often among females, non-heterosexuals, those who were not working in their country of birth, and non-white people. Specialty and hospital type were not associated with BUH. CONCLUSION: BUH remains a major problem in the vascular workplace. Female sex, non-heterosexuality, and non-white ethnicity are associated with BUH at various career stages.

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.

The Role of High-Fidelity Simulation in the Acquisition of Endovascular Surgical Skills: A Systematic Review.

BACKGROUND: The widespread introduction of minimally invasive endovascular techniques in cardiovascular surgery has necessitated a transition in the psychomotor skillset of trainees and surgeons. Simulation has previously been used in surgical training; however, there is limited high-quality evidence regarding the role of simulation-based training on the acquisition of endovascular skills. This systematic review aimed to systematically appraise the currently available evidence regarding endovascular high-fidelity simulation interventions, to describe the overarching strategies used, the learning outcomes addressed, the choice of assessment methodology, and the impact of education on learner performance. METHODS: A comprehensive literature review was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement using relevant keywords to identify studies evaluating simulation in the acquisition of endovascular surgical skills. References of review articles were screened for additional studies. RESULTS: A total of 1,081 studies were identified (474 after removal of duplicates). There was marked heterogeneity in methodologies and reporting of outcomes. Quantitative analysis was deemed inappropriate due to the risk of serious confounding and bias. Instead, a descriptive synthesis was performed, summarizing key findings and quality components. Eighteen studies were included in the synthesis (15 observational, 2 case-control and 1 randomized control studies). Most studies measured procedure time, contrast usage, and fluoroscopy time. Other metrics were recorded to a lesser extent. Significant reductions were noted in both procedure and fluoroscopy times with the introduction of simulation-based endovascular training. CONCLUSIONS: The evidence regarding the use of high-fidelity simulation in endovascular training is very heterogeneous. The current literature suggests simulation-based training leads to improvements in performance, mostly in terms of procedure and fluoroscopy time. High-quality randomized control trials are needed to establish the clinical benefits of simulation training, sustainability of improvements, transferability of skills and its cost-effectiveness.

Long-Term Effects of Acute Kidney Injury Following Endovascular Femoropopliteal Intervention: Insights From a Multicenter Trial.

PURPOSE: To examine the association between acute kidney injury (AKI) severity and duration with cardiovascular mortality, following endovascular treatment of femoropopliteal disease, and whether it is AKI in itself that confers an increased risk of cardiovascular mortality. METHODS: A retrospective analysis of prospectively collected data obtained between 2014 and 2019 from 3 vascular centers. Renal function was followed up for a minimum of 90 days. Electronic records were queried to establish a cause of death, where applicable. Patients were excluded if unable to provide written informed consent or if presenting with acute limb ischemia. Primary outcomes were the hazard ratios for cardiovascular death (AKI patients vs no AKI; no AKI vs stage 1 AKI vs stage 3 AKI; and no AKI vs transient AKI vs established AKI). Propensity score-matched analysis was used to establish whether developing AKI, in patients with similar demographics and procedural characteristics, is associated with a higher risk of cardiovascular death. RESULTS: Overall 239 patients developed AKI, and this was associated with an increased risk of cardiovascular mortality (hazard risk [HR]: 4.3, 95% confidence intervals [CIs]: 2.1-6.8, pairwise comparison p value=0.006]. This was dependent on the severity of the AKI stage (HR 5.4, 95% CI: 2.4-7.3, pairwise comparison p value=0.01) and duration (HR 4.2, 95% CI: 2.3-6.2, pairwise comparison p value=0.04). The propensity score-matched analysis showed that even when patients are matched for comorbidity and procedural characteristics, AKI confers an increased risk of mortality (p=0.04). CONCLUSIONS: Acute kidney injury is common after femoropopliteal endovascular therapy. It confers an increased risk of long-term cardiovascular mortality, which is still present when renal decline is transient, and highest for patients with established decline in renal function. CLINICAL IMPACT: This is the first study in the setting of peripheral arterial disease to show that acute kidney injury has an adverse effect on cardiovascular mortality, in the long-term, that is dependent on its severity, and present even when the AKI is transient. We have also shown that this difference in cardiovascular mortality becomes more pronounced from the medium-term, and thus closer follow-up of these patients is required.

A Systematic Review and Meta-Analysis of 12-Month Patency After Intervention for Iliofemoral Obstruction Using Dedicated or Non-Dedicated Venous Stents.

BACKGROUND: Endovascular stenting of the deep venous system has been proposed as a method to treat patients with symptomatic iliofemoral outflow obstruction. The purpose of this systematic review and meta-analysis was to compare the effectiveness of this treatment at 1-year following the development of dedicated venous stents. METHOD AND RESULTS: We searched MEDLINE and EMBASE for studies evaluating the effectiveness of venous stent placement. Data were extracted by disease pathogenesis: non-thrombotic iliac vein lesions (NIVL), acute thrombotic (DVT), or post-thrombotic syndrome (PTS). Main outcomes included technical success, stent patency at 1 year and symptom relief. A total of 49 studies reporting outcomes in 5154 patients (NIVL, 1431; DVT, 950; PTS, 2773) were included in the meta-analysis. Technical success rates were comparable among groups (97%-100%). There were no periprocedural deaths. Minor bleeding was reported in up to 5% of patients and major bleeding in 0.5% upon intervention. Transient back pain was noted in 55% of PTS patients following intervention. There was significant heterogeneity between studies reporting outcomes in PTS patients. Primary and cumulative patency at 1 year was: NIVL-96% and 100%; DVT-91% and 97%; PTS (stents above the ligament)-77% and 94%, and; PTS (stents across the ligament)-78% and 94%. There were insufficient data to compare patency outcomes of dedicated and nondedicated venous stents in patients with acute DVT. In NIVL and PTS patients, stent patency was comparable at 1 year. There was inconsistency in the use of validated tools for the measurement of symptoms before and after intervention. When reported, venous claudication, improved in 83% of PTS patients and 90% of NIVL patients, and ulcer healing occurred in 80% of PTS patients and 32% of NIVL patients. CONCLUSIONS: The first generation of dedicated venous stents perform comparably in terms of patency and clinical outcomes to non-dedicated technologies at 1 year for the treatment of patients with NIVL and PTS. However, significant heterogeneity exists between studies and standardized criteria are urgently needed to report outcomes in patients undergoing deep venous stenting.

Editor's Choice - Covered vs. Bare Metal Stents in the Reconstruction of the Aortic Bifurcation: Early and Midterm Outcomes from the COBRA European Multicentre Registry.

OBJECTIVE: To report outcomes following endovascular revascularisation for severe aorto-iliac occlusive disease (AIOD) using covered (CS) or bare metal (BMS) stent(s). METHODS: This was a retrospective cohort study including patients who underwent treatment with CS or BMS for AIOD between November 2012 and March 2020 in 12 European centres. Outcome measures included death, freedom from target lesion revascularisation (TLR), major amputation, and major adverse cardiac and cerebrovascular events (MACCE). RESULTS: Overall, 252 patients (53% males; mean age 65 ± 10 years) were included (102 with a bare metal and 150 with a covered aortic stent); 122 (48%) presented with chronic limb threatening ischaemia (CLTI). Severe arterial calcification was noted in > 65% of patients, 70% presented with Trans-Atlantic Societies Consensus (TASC) D lesions, 32% and 46% had aortic or iliac chronic total occlusion (CTO), respectively. Median follow up was 17 months (range 6 - 40; none lost to follow up). Median inpatient stay was two days (range two to four). During the first 30 days, two patients died (both with covered aortic stents, because of cardiovascular events), none required TLR, two (1%) patients had a major amputation (all presented with CLTI), and three (1%) had a MACCE. At 17 months, mortality (BMS 14% vs. CS 7%, hazard ratio [HR] 0.97, 95% confidence interval [CI] 0.42 - 2.26, p = .94, log rank test) and TLR (11% vs. 10%, HR 1.98, 95% CI 0.89 - 4.43, p = .095) did not differ statistically significantly between the two groups; only three patients had a major limb amputation during late follow up (all with a covered stent). In a multivariable model, the use of an aortic CS did not influence TLR. In a conditional Cox regression, however, the concomitant use of aortic and iliac CSs was associated with improved freedom from TLR. CONCLUSION: Endovascular reconstruction with aortic CSs or BMSs for severe AIOD showed comparable midterm performance. The use of both aortic and iliac CSs seems to be associated with reduced TLR.

Antithrombotic Therapy for Aortic Aneurysms: A Systematic Review and Meta-Analysis.

OBJECTIVES: The role of antithrombotic therapy in the management of aortic and peripheral aneurysms is unclear. This systematic review and meta-analysis aimed to assess the impact of antithrombotics on clinical outcomes for aortic and peripheral aneurysms. METHODS: Medline, Embase, and CENTRAL databases were searched. Randomised controlled trials and observational studies investigating the effect of antithrombotic therapy on clinical outcomes for patients with any aortic or peripheral artery aneurysm were included. RESULTS: Fifty-nine studies (28 with antiplatelet agents, 12 anticoagulants, two intra-operative heparin, and 16 any antithrombotic agent) involving 122 102 patients were included. Abdominal aortic aneurysm (AAA) growth rate was not significantly associated with the use of antiplatelet therapy (SMD -0.36 mm/year; 95% CI -0.75 - 0.02; p = .060; GRADE certainty: very low). Antithrombotics were associated with increased 30 day mortality for patients with AAAs undergoing intervention (OR 2.30; 95% CI 1.51 - 3.51; p < .001; GRADE certainty: low). Following intervention, antiplatelet therapy was associated with reduced long term all cause mortality (HR 0.84; 95% CI 0.76 - 0.92; p < .001; GRADE certainty: moderate), whilst anticoagulants were associated with increased all cause mortality (HR 1.64; 95% CI 1.14 - 2.37; p = .008; GRADE certainty: very low), endoleak within three years (OR 1.99; 95% CI 1.10 - 3.60; p = .020; I2 = 60%; GRADE certainty: very low), and an increased re-intervention rate at one year (OR 3.25; 95% CI 1.82 - 5.82; p < .001; I2 = 35%; GRADE certainty: moderate). Five studies examined antithrombotic therapy for popliteal aneurysms. Meta-analysis was not possible due to heterogeneity. CONCLUSIONS: There was a lack of high quality data examining antithrombotic therapy for patients with aneurysms. Antiplatelet therapy was associated with a reduction in post-intervention all cause mortality for AAA, whilst anticoagulants were associated with an increased risk of all cause mortality, endoleak, and re-intervention. Large, well designed trials are still required to determine the therapeutic benefits of antithrombotic agents in this setting.

Multimodal Structural Analysis of the Human Aorta: From Valve to Bifurcation.

OBJECTIVE: The aims of the present study were to assess the relative proportion of collagen and elastin in the arterial wall and to evaluate the collagen microstructure from the aortic root to the external iliac artery. METHODS: Arterial wall tissue samples sampled during post-mortem examination from 16 sites in 14 individuals without aneurysm disease were fixed and stained for collagen and elastin. Stained sections were imaged and analysed to calculate collagen and elastin content as a percentage of overall tissue area. Scanning electron microscopy was used to quantify the collagen microstructure at six specific arterial regions. RESULTS: From the aortic root to the level of the suprarenal aorta, the percentages (area fractions) of collagen (ascending, descending, and suprarenal aorta respectively with 95% confidence interval [CI] 37.5%, 31.7 - 43.2; 38.9%, 33.1 - 44.7; 44.8%, 37.4 - 52.1) and elastin (43.0%, 37.3 - 48.8; 40.3%, 34.8 - 46.1; 32.4%, 25.2 - 39.6) in the aortic wall were similar. From the suprarenal aorta to the internal iliac arteries, the percentage of collagen increased (abdominal aorta, common and internal iliac arteries and external iliac artery respectively with 95% CI 50.6%, 42.7 - 58.7; 51.2%, 45.5 - 56.9; 49.2%, 42.0 - 56.4) reaching a double percentage for elastin (23.6%, 15.7 - 31.6; 20.8%, 15.1 - 26.5; 22.2%, 14.9 - 29.5). Mean collagen fibre diameter (MFD) and average segment length (ASL) were significantly larger in the external iliac artery (MFD 6.03, 95% CI 5.95 - 6.11; ASL 22.21, 95% CI 20.80 - 23.61) than in the ascending aorta (MFD 5.81, 5.72 - 5.89; ASL 19.47, 18.07 - 20.88) and the abdominal aorta (MFD 5.92, 5.84 - 6.00; ASL 21.10, 19.69 - 22.50). CONCLUSION: In subjects lacking aneurysmal disease, the aorta and iliac arteries are not structurally uniform along their length. There is an increase in collagen percentage and decrease in elastin percentage progressing distally along the aorta. Mean collagen fibre diameter and average segment length are larger in the external iliac artery, compared with the ascending and the abdominal aorta.

Editor's Choice - Eligibility of Common Femoral Artery Atherosclerotic Disease for Endovascular Treatment - the CONFESS Study.

OBJECTIVE: Advances in endovascular technologies have allowed the treatment of common femoral artery (CFA) steno-occlusive disease by minimally invasive means; however, the proportion of lesions treated with common femoral artery endarterectomy (CFAE) which would be amenable to endovascular treatment is unknown. This observational study aimed to describe the morphology and composition of CFA lesions treated with CFAE and report the proportion that would be amenable to endovascular treatment with modern technologies. METHODS: Patients presenting with symptomatic peripheral artery disease who underwent CFAE from January 2014 to December 2018 in two tertiary NHS hospitals were included. Extensive data relating to patient demographics, risk factors, clinical outcomes, as well as anatomical and morphological characteristics of the CFA atherosclerotic lesions, were collected which included detailed plaque analysis using 3D reconstruction of pre-operative computed tomography angiograms. CFA lesions were considered suitable for endovascular treatment if presented with patent iliac inflow, at least one patent outflow vessel (superficial femoral artery [SFA] or profunda femoral artery [PFA]), and stenotic rather than occluded CFA. RESULTS: A total of 829 CFAs in 737 consecutive patients who underwent CFAE were included (mean age 71 ± 10 years; 526 males, 71%); 451 (62%) presented with chronic limb threatening ischaemia. Overall, 35% of CFAs had a localised lesion (no bifurcation disease) that could possibly be treated endovascularly. In total, 376 (45%) target vessels did not feature severe calcium load, with a patent CFA, PFA, and proximal SFA and therefore would have been amenable to endovascular treatment; while 271 CFAs (33%) featured a significant calcium load which would have potentially required stenting. CONCLUSION: A significant proportion of patients with atherosclerotic CFA lesions who undergo surgery could potentially be candidates for endovascular treatment. A randomised trial comparing CFAE and new endovascular techniques in this clinical context is required.