An International, Expert-Based Delphi Consensus Document on Controversial Issues about TransCarotid Artery Revascularization (TCAR).

OBJECTIVE: TransCarotid Artery Revascularization (TCAR) has emerged as an alternative therapeutic modality to carotid endarterectomy (CEA) and transfemoral carotid artery stenting (TFCAS) for the management of patients with carotid artery stenosis. However, certain issues regarding the indications and contraindications of TCAR remain unanswered or unresolved. The aim of this international, expert-based Delphi Consensus document was to attempt to provide some guidance on these topics. METHODS: A 3-Round Delphi Consensus process was performed including 29 experts. The aim of Round 1 was to investigate the differing views and opinions of the participants. Round 2 was carried out after the results from the literature on each topic were provided to the participants. During Round 3, the participants had the opportunity to finalize their vote. RESULTS: Most participants agreed that TCAR can/can probably/possibly be performed within 14 days of a cerebrovascular event, but it is best to avoid it in the first 48 hours. It was felt that TCAR cannot/should not replace TFCAS or CEA, as each procedure has specific indications and contraindications. Symptomatic patients >80 years should probably be treated with TCAR rather than with TFCAS. TCAR can/can probably be used for the treatment of restenosis following CEA/TFCAS. Finally, there is a need for a randomized controlled trial to provide better evidence for the unresolved issues. CONCLUSIONS: This Delphi Consensus document attempted to assist the decision-making of physicians/interventionalists/vascular surgeons involved in the management of carotid stenosis patients. Furthermore, areas requiring additional research were identified. Future studies and randomized controlled trials should provide more evidence to address the unanswered questions regarding TCAR.

Literature review on management of prosthetic graft infections after supra-aortic bypass surgery, based on a case report.

BACKGROUND: Graft infections of supra-aortic bypasses are rare, but often life-threatening. Guidelines for treatment of graft infections recommend systemic antibiotics and complete graft removal, followed by in-situ or extra-anatomic revascularisation. METHODS: Based on case report, literature search was performed on Medline, Google Scholar and Web of Science databases, focussing on infected supra-aortic bypass reconstructions. Inclusion criterium was prosthetic graft infection, excluding stent and carotid patch infections. RESULTS: A 68-year old man with clinically infected subclavian-subclavian bypass with interposition bypass to left carotid bifurcation, presented at emergency department with manifestation of sepsis. A total graft removal and an extra-anatomical prosthetic reconstruction was created, from right common carotid artery to left carotid bifurcation. Defect of prior left subclavian anastomosis was primarily closed, on right subclavian anastomosis per-operative acute bleeding occured, which was controlled by covered stent through right brachial artery. Literature review identified 16 cases. Different approaches ranging from open repair with autologous (six) or allogenic (two) material, to hybrid techniques (eight) have been described. No re-infections were reported. When comparing different types of approaches, no differences are found concerning overall complications. CONCLUSION: Complete graft removal with extra-anatomical reconstruction is challenging, but crucial in supra-aortic graft infections. Preservation of parts of vascular prosthesis depends on case-by-case basis, according to infection site and general condition of the patient. But due to rarity, only case reports are available, so no strong recommendations can be formulated. International registries should be initiated to share experiences and provide data for decent analysis of short, mid and long term outcomes.

Next-generation transcarotid artery revascularization: TransCarotid flOw Reversal Cerebral Protection And CGUARD MicroNET-Covered Embolic Prevention Stent System To Reduce Strokes - TOPGUARD Study.

BACKGROUND: Stent-assisted carotid artery revascularization employing surgical cutdown for transcervical access and dynamic flow reversal (TCAR) is gaining popularity. TCAR, despite maximized intra-procedural cerebral protection, shows a marked excess of 30-day neurologic complications in symptomatic vs. asymptomatic stenoses. The TCAR conventional single-layer stent (free-cell area 5.89mm2) inability to seal embologenic lesions may be particularly relevant after the flow reversal neuroprotection is terminated. METHODS: We evaluated peri-procedural and 30-day major adverse cerebral and cardiac events (MACCE) of TCAR (ENROUTE, SilkRoad Medical) paired with MicroNET-covered neuroprotective stent (CGuard, InspireMD) in consecutive patients at elevated risk of complications with transfemoral/transradial filter-protected stenting (increased lesion-related and/or access-related risk). CGuard (MicroNET free cell area ≈0.02-0.03 mm2) has level-1 evidence for reducing intra- and abolishing post-procedural lesion-related cerebral embolism. RESULTS: One hundred and six increased-risk patients (age 72 [61-76] years, median [Q1-Q3]; 60.4% symptomatic, 49.1% diabetic, 36.8% women, 61.3% left-sided index lesion) were enrolled in three vascular surgery centers. Angiographic stenosis severity was 81 (75-91)%, lesion length 21 (15-26)mm, increased-risk lesional characteristics 87.7%. Study stent use was 100% (no other stent types). 74.5% lesions were predilated; post-dilatation rate was 90.6%. Flow reversal duration was 8 (5-11)min. One stroke (0.9%) occurred in an asymptomatic patient prior to establishing neuroprotection (index lesion disruption with the sheath insertion wire); there were no other peri-procedural MACCE. No further adverse events occurred by 30-days. 30-day stent patency was 100% with normal velocities and absence of any in-stent material by Duplex Doppler. CONCLUSIONS: Despite a high proportion of increased-risk lesions and clinically symptomatic patients in this study, TCAR employing the MicroNET-covered anti-embolic stent showed 30-day MACCE rate <1%. This suggests a clinical role for combining maximized intra-procedural prevention of cerebral embolism by dynamic flow reversal with anti-embolic stent prevention of peri- and post-procedural cerebral embolism (TOPGUARD NCT04547387).

Editor's Choice - Development and Testing of Step, Error, and Event Frameworks to Evaluate Technical Performance in Peripheral Endovascular Interventions.

OBJECTIVE: Tools for endovascular performance assessment are necessary in competency based education. This study aimed to develop and test a detailed analysis tool to assess steps, errors, and events in peripheral endovascular interventions (PVI). METHODS: A modified Delphi consensus was used to identify steps, errors, and events in iliac-femoral-popliteal endovascular interventions. International experts in vascular surgery, interventional radiology, cardiology, and angiology were identified, based on their scientific track record. In an initial open ended survey round, experts volunteered a comprehensive list of steps, errors, and events. The items were then rated on a five point Likert scale until consensus was reached with a pre-defined threshold (Cronbach's alpha > 0.7) and > 70% expert agreement. An experienced endovascular surgeon applied the finalised frameworks on 10 previously videorecorded elective PVI cases. RESULTS: The expert consensus panel was formed by 28 of 98 invited proceduralists, consisting of three angiologists, seven interventional radiologists, five cardiologists, and 13 vascular surgeons, with 29% from North America and 71% from Europe. The Delphi process was completed after three rounds (Cronbach's alpha; αsteps = 0.79; αerrors = 0.90; αevents = 0.90), with 15, 26, and 18 items included in the final step (73 - 100% agreement), error (73 - 100% agreement), and event (73 - 100% agreement) frameworks, respectively. The median rating time per case was 4.3 hours (interquartile range [IQR] 3.2, 5 hours). A median of 55 steps (IQR 40, 67), 27 errors (IQR 21, 49), and two events (IQR 1, 6) were identified per case. CONCLUSION: An evaluation tool for the procedural steps, errors, and events in iliac-femoral-popliteal endovascular procedures was developed through a modified Delphi consensus and applied to recorded intra-operative data to identify hazardous steps, common errors, and events. Procedural mastery may be promoted by using the frameworks to provide endovascular proceduralists with detailed technical performance feedback.

Editor's Choice -- European Society for Vascular Surgery (ESVS) 2024 Clinical Practice Guidelines on the Management of Abdominal Aorto-Iliac Artery Aneurysms.

OBJECTIVE: The European Society for Vascular Surgery (ESVS) has developed clinical practice guidelines for the care of patients with aneurysms of the abdominal aorta and iliac arteries in succession to the 2011 and 2019 versions, with the aim of assisting physicians and patients in selecting the best management strategy. METHODS: The guideline is based on scientific evidence completed with expert opinion on the matter. By summarising and evaluating the best available evidence, recommendations for the evaluation and treatment of patients have been formulated. The recommendations are graded according to a modified European Society of Cardiology grading system, where the strength (class) of each recommendation is graded from I to III and the letters A to C mark the level of evidence. RESULTS: A total of 160 recommendations have been issued on the following topics: Service standards, including surgical volume and training; Epidemiology, diagnosis, and screening; Management of patients with small abdominal aortic aneurysm (AAA), including surveillance, cardiovascular risk reduction, and indication for repair; Elective AAA repair, including operative risk assessment, open and endovascular repair, and early complications; Ruptured and symptomatic AAA, including peri-operative management, such as permissive hypotension and use of aortic occlusion balloon, open and endovascular repair, and early complications, such as abdominal compartment syndrome and colonic ischaemia; Long term outcome and follow up after AAA repair, including graft infection, endoleaks and follow up routines; Management of complex AAA, including open and endovascular repair; Management of iliac artery aneurysm, including indication for repair and open and endovascular repair; and Miscellaneous aortic problems, including mycotic, inflammatory, and saccular aortic aneurysm. In addition, Shared decision making is being addressed, with supporting information for patients, and Unresolved issues are discussed. CONCLUSION: The ESVS Clinical Practice Guidelines provide the most comprehensive, up to date, and unbiased advice to clinicians and patients on the management of abdominal aorto-iliac artery aneurysms.

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.

Behavioral sciences applied to acute care teams: a research agenda for the years ahead by a European research network.

BACKGROUND: Multi-disciplinary behavioral research on acute care teams has focused on understanding how teams work and on identifying behaviors characteristic of efficient and effective team performance. We aimed to define important knowledge gaps and establish a research agenda for the years ahead of prioritized research questions in this field of applied health research. METHODS: In the first step, high-priority research questions were generated by a small highly specialized group of 29 experts in the field, recruited from the multinational and multidisciplinary "Behavioral Sciences applied to Acute care teams and Surgery (BSAS)" research network - a cross-European, interdisciplinary network of researchers from social sciences as well as from the medical field committed to understanding the role of behavioral sciences in the context of acute care teams. A consolidated list of 59 research questions was established. In the second step, 19 experts attending the 2020 BSAS annual conference quantitatively rated the importance of each research question based on four criteria - usefulness, answerability, effectiveness, and translation into practice. In the third step, during half a day of the BSAS conference, the same group of 19 experts discussed the prioritization of the research questions in three online focus group meetings and established recommendations. RESULTS: Research priorities identified were categorized into six topics: (1) interventions to improve team process; (2) dealing with and implementing new technologies; (3) understanding and measuring team processes; (4) organizational aspects impacting teamwork; (5) training and health professions education; and (6) organizational and patient safety culture in the healthcare domain. Experts rated the first three topics as particularly relevant in terms of research priorities; the focus groups identified specific research needs within each topic. CONCLUSIONS: Based on research priorities within the BSAS community and the broader field of applied health sciences identified through this work, we advocate for the prioritization for funding in these areas.

Editor's Choice - Systematic Review and Meta-Analysis of Contemporary Abdominal Aortic Aneurysm Growth Rates.

OBJECTIVE: To evaluate the contemporary growth rate of small abdominal aortic aneurysms (AAAs) in view of recent epidemiological changes, such as decreasing smoking rates and establishment of population screening programmes. DATA SOURCES: MEDLINE, CENTRAL, PsycINFO, Web of Science Core Collection, and OpenGrey databases. REVIEW METHODS: Systematic review following the PRISMA guidelines. In October 2021, databases were queried for studies reporting on AAA growth rates published from 2015 onwards. The primary outcome was contemporary AAA growth rates in mm/year. Data were pooled in a random effects model meta-analysis, and heterogeneity was assessed through the I2 statistic. GRADE assessment of the findings was performed. The protocol was published in PROSPERO (CRD42022297404). RESULTS: Of 8 717 titles identified, 43 studies and 28 277 patients were included: 1 241 patients from randomised controlled trials (RCTs), 23 941 from clinical observational studies, and 3 095 from radiological or translational research studies. The mean AAA growth rate was 2.38 mm/year (95% CI 2.16 - 2.60 mm/year; GRADE = low), with meta-regression analysis adjusted for baseline diameter showing an increase of 0.08 mm/year (95% CI 0.024 - 0.137 mm/year; p = .005) for each millimetre of increased baseline diameter. When analysed by study type, the growth rate estimated from RCTs was 1.88 mm/year (95% CI 1.69 - 2.06 mm/year; GRADE = high), while it was 2.31 mm/year (95% CI 1.95 - 2.67 mm/year; GRADE = moderate) from clinical observational studies, and 2.85 mm/year (95% CI 2.44 - 3.26 mm/year; GRADE = low) from translational and radiology based studies (p < .001). Heterogeneity was high, and small study publication bias was present (p = .003), with 27 studies presenting a moderate to high risk of bias. The estimated growth rate from low risk studies was 2.09 mm/year (95% CI 1.87 - 2.32; GRADE = high). CONCLUSION: This study estimated a contemporaneous AAA growth rate of 2.38 mm/year, being unable to demonstrate any clinically meaningful AAA growth rate reduction concomitant with changed AAA epidemiology. This suggests that the RESCAN recommendations on small AAA surveillance are still valid. However, sub-analysis results from RCTs and high quality study data indicate potential lower AAA growth rates of 1.88 - 2.09 mm/year, findings that should be validated in a high quality prospective registry.

Certification of Basic Skills in Endovascular Aortic Repair Through a Modular Simulation Course With Real Time Performance Assessment.

OBJECTIVE: Endovascular aortic repair (EVAR) is being used increasingly for the treatment of infrarenal abdominal aortic aneurysms. Improvement in educational strategies is required to teach future vascular surgeons EVAR skills, but a comprehensive, pre-defined e-learning and simulation curriculum remains to be developed and tested. EndoVascular Aortic Repair Assessment of Technical Expertise (EVARATE), an assessment tool for simulation based education (SBE) in EVAR, has previously been designed to assess EVAR skills, and a pass limit defining mastery level has been set. However, EVARATE was developed for anonymous video ratings in a research setting, and its feasibility for real time ratings in a standardised SBE programme in EVAR is unproven. This study aimed to test the effect of a newly developed simulation based modular course in EVAR. In addition, the applicability of EVARATE for real time performance assessments was investigated. METHODS: The European Society of Vascular Surgery (ESVS) and Copenhagen Certification Programme in EVAR (ENHANCE-EVAR) was tested in a prospective cohort study. ENHANCE-EVAR is a modular SBE programme in EVAR consisting of e-learning and hands-on SBE. Participants were rated with the EVARATE tool by experienced EVAR surgeons. RESULTS: Twenty-four physicians completed the study. The mean improvement in EVARATE score during the course was +11.8 (95% confidence interval 9.8 - 13.7) points (p < .001). Twenty-two participants (92%) passed with a mean number of 2.8 ± 0.7 test attempts to reach the pass limit. Cronbach's alpha coefficient was 0.91, corresponding to excellent reliability of the EVARATE scale. Differences between instructors' EVARATE ratings were insignificant (p = .16), with a maximum variation between instructors of ± 1.3 points. CONCLUSION: ENHANCE-EVAR, a comprehensive certifying EVAR course, was proven to be effective. EndoVascular Aortic Repair Assessment of Technical Expertise (EVARATE) is a trustworthy tool for assessing performance within an authentic educational setting, enabling real time feedback.

Development, Feasibility, and Knowledge Impact of a Massive Open Online Course on Radiation Safety: A Multicentre Prospective Cohort Study.

OBJECTIVE: This study reports the development of an innovative, interactive Massive Open Online Course (MOOC) teaching radiation safety principles in the vascular workplace, using stepwise e-learning with multiple choice question tests (MCQs), educational videos, and a serious game. The aim was to study the MOOC impact on radiation safety knowledge and assess its feasibility and acceptability. METHODS: An international multicentre prospective study included team members active in the hybrid operating room. The MOOC was offered voluntarily via a secure online learning platform. A standardised MCQ test (15 questions) assessed radiation safety knowledge pre- and post-course (range 0 - 100%). Acceptability and feasibility were tested via the previously validated, Evaluating e-learning system success (EESS) model, using five point Likert scales. RESULTS: In eight centres across four countries, 150 of 203 invited endovascular team members consented. Over a seven week study period, surgeons (28%, including vascular surgery trainees and consultants), nurses (27%, including scrub, circulating and anaesthetic nurses), anaesthetists (43%, including trainees and consultants), and radiographers (3%) participated. Of those, 67% completed the course. The average radiation knowledge improved by 22.8% (95% CI 19.5 - 26.0%; p < .001) after MOOC completion, from 48% to 71% (standard deviation [SD] 14 and 15% respectively), requiring a mean time investment of 169 minutes (SD 89 minutes). In centres with a radiographer, mean knowledge gain after MOOC completion was significantly smaller (14%, SD 19% vs. 24%, SD 16%, p = .036). The course was deemed feasible and acceptable according to the EESS model with a total mean score of 3.68/5. CONCLUSION: This newly developed, multimodal MOOC was deemed feasible and effective across multiple international centres. The MOOC significantly contributes to radiation safety education of the entire endovascular team, improving radiation safety knowledge. The course may optimise workplace radiation safety behaviour and therefore enhance team and patient safety.

Assessing Chest Tube Insertion Skills Using a Porcine Rib Model-A Validity Study.

INTRODUCTION: Assessments require sufficient validity evidence before their use. The Assessment for Competence in Chest Tube Insertion (ACTION) tool evaluates proficiency in chest tube insertion (CTI), combining a rating scale and an error checklist. The aim of this study was to collect validity evidence for the ACTION tool on a porcine rib model according to the Messick framework. METHODS: A rib model, consisting of a porcine hemithorax that was placed in a wooden frame, was used as simulator. Participants were recruited from the departments of surgery, pulmonology, and emergency medicine. After familiarization with the rib model and the equipment, standardized instructions and clinical context were provided. They performed 2 CTIs while being scored with the ACTION tool. All performances were assessed live by 1 rater and by 3 blinded raters using video recordings. Generalizability-analysis was performed and mean scores and errors of both groups on the first performance were compared. A pass/fail score was established using the contrasting groups' method. RESULTS: Nine novice and 8 experienced participants completed the study. Generalizability coefficients where high for the rating scale (0.92) and the error checklist (0.87). In the first CTI, novices scored lower than the experienced group (38.1/68 vs. 47.1/68, P = 0.042), but no difference was observed on the error checklist. A pass/fail score of 44/68 was established. CONCLUSION: A solid validity argument for the ACTION tool's rating scale on a porcine rib model is presented, allowing formative and summative assessment of procedural skills during training before patient contact.

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.

Stroke risk management in carotid atherosclerotic disease: A Clinical Consensus Statement of the ESC Council on Stroke and the ESC Working Group on Aorta and Peripheral Vascular Diseases.

Carotid atherosclerotic disease continues to be an important cause of stroke, often disabling or fatal. Such strokes could be largely prevented through optimal medical therapy and carotid revascularization. Advancements in discovery research and imaging along with evidence from recent pharmacology and interventional clinical trials and registries and the progress in acute stroke management have markedly expanded knowledge base for clinical decisions in carotid stenosis. Nevertheless, there is variability in carotid-related stroke prevention and management strategies across medical specialities. Optimal patient care can be achieved by (1) establishing a unified knowledge foundation and (2) fostering multi-specialty collaborative guidelines. The emergent Neuro-Vascular Team concept, mirroring the multi-disciplinary Heart Team, embraces diverse specializations, tailores personalized, stratified medicine approaches to individual patient needs, and integrates innovative imaging and risk-assessment biomarkers. Proposed approach integrates collaboration of multiple specialists central to carotid artery stenosis management such as neurology, stroke medicine, cardiology, angiology, ophthalmology, vascular surgery, endovascular interventions, neuroradiology and neurosurgery. Moreover, patient education regarding current treatment options, their risks and advantages, is pivotal, promting patient's active role in clinical care decisions. This enables optimization of interventions ranging from lifestyle modification, carotid revascularization by stenting or endarterectomy, as well as pharmacological management encompassing statins, novel lipid-lowering and antithrombotic strategies and targeting inflammation and vascular dysfunction. This consensus document provides a harmonized multi-specialty approach to multimorbidity prevention in carotid stenosis patients, based on comprehensive knowledge review, pinpointing research gaps in an evidence-based medicine approach. It aims to be a foundational tool for interdisciplinary collaboration and prioritized patient-centric decision-making.

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.