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.

Influence of Perioperative Factors on Patency After Endovascular and Hybrid Treatments of TASC II D Aortoiliac Occlusive Lesions.

BACKGROUND: Treatment of Trans-Atlantic Inter-Society Consensus (TASC) II D aortoiliac occlusive disease (AIOD D) remains a controversial topic. Although current recommendations support conventional surgical treatment, several recent studies have reported promising results with endovascular and hybrid strategies. The purpose of this work was to describe the outcomes of endovascular and hybrid management of AIOD D and to investigate the influence of perioperative factors on patency. METHODS: This was a retrospective single-center study covering the period from 2016 to 2021. The primary end point was primary patency at 12 months. Secondary endpoints included technical success rate, 30-day mortality, early major complication rate, primary assisted and secondary patency at 12 months, and primary patency at 24 months. After descriptive statistical analysis, a survival analysis was conducted using the Kaplan-Meier method. Eighteen perioperative factors potentially associated with primary patency were studied by univariate and multivariate analysis adjusted by a Cox regression model. RESULTS: In all, 82 patients (112 limbs) had undergone an attempt at endovascular (n = 55, 67%) or hybrid (n = 27, 33%) treatment for AIOD D over the study period. The technical success rate was 99%. The 30-day mortality rate was 3%. The early major complication rate was 11%. The primary patency rates at 12 and 24 months were 87.9% [80.3; 96.3] and 77% [66.3; 89.3], respectively. The primary assisted and secondary patency rates at 12 months were 92.6% [86.3; 99.2] and 96% [91.4; 100]. Among the perioperative factors studied, the heavily calcified nature of the target lesions was the only variable significantly associated with primary patency loss in the multivariate analysis (P = 0.021). CONCLUSION: Although the results of endovascular and hybrid treatment of AOID D are acceptable, future studies should focus on improving patency rates in heavily calcified lesions. Specific tools of endovascular preparation (intravascular lithotripsy, atherectomy) may represent interesting ways of research.

Single Primary Retrograde Access to Treat Femoro-Popliteal Occlusive Lesions.

INTRODUCTION: The retrograde puncture of a distal artery is considered a bailout procedure in case of anterograde approach failure for peripheral artery disease (PAD) treatment. A single primary retrograde access has been suggested as an efficient and safe option. As scant data are available, we present our results using this approach. MATERIAL AND METHODS: Between August 2019 and October 2022, we performed this technique in selected patients with femoro-popliteal PAD. Chronic total occlusions (CTOs) were selected on the basis of the CTOP classification. An ultrasound-guided retrograde puncture of a tibial artery at the ankle level was performed, followed by the preferential use of 4F materials. Hemostasis of the puncture site was obtained using manual compression. Postoperative duplex scan examination systematically included an evaluation of the punctured artery. Demographics, intraoperative, and follow-up data were collected retrospectively. The results are expressed as means with standard deviations and numbers with percentages when appropriate. RESULTS: In total, 55 procedures were performed in 46 patients (9 bilateral). Of these, 57% (N=26) were considered at risk for femoral puncture (obesity, history of groin surgery, challenging crossover approach) and 54% (N=25) presented with critical limb-threatening ischemia (CLTI). The TASC-II femoro-popliteal classification was generally B (60%) and also C (33%) or D (7%). Mean lesion length was 105.6±49.4 mm and 65% were CTOs. Most patients were operated in an outpatient setting (N=25; 54%) under potentialized local anesthesia (N=41, 89%). The punctured site was the posterior tibial artery in 73% (N=40). The procedure time was 65.1±25.7 minutes, and the fluoroscopy time was 10.7±8.5 minutes. The technical success rate was 100%. There were no intraoperative complications. All patients could walk the same day. One CLTI patient presented an erysipelas related to the puncture in postoperative period. At 30 days, the primary patency of the treated and the punctured arteries were 98% and 100%, respectively. CONCLUSION: A single primary retrograde access can be used safely to treat femoro-popliteal PAD. It represents a valuable alternative to the femoral puncture and allows fast ambulation. Prospective and long-term studies on larger populations are necessary to confirm our results. CLINICAL IMPACT: This study demonstrates that a single primary retrograde access can be used safely without damaging the punctured artery to treat femoro-popliteal lesions, especially in claudicant patients. Chronic total occlusions can be treated successfully using this technique. This approach represents a valuable alternative to the femoral puncture and allows fast ambulation without risk of major bleeding.

Comparative Evaluation of Two Paclitaxel-Coated Stents in an Experimental Setting.

INTRODUCTION: Unlike paclitaxel-coated balloons, pre-clinical data comparing different paclitaxel-coated stents (PCSs) are weak. The study objective was to compare the features of the 2 main PCSs: Eluvia® (Boston Scientific, Marlborough, MA) versus ZilverPTX® (Cook Medical, Bloomington, IN). METHOD: Analysis was carried out on 12 pigs divided into 2 groups: Eluvia® (n=6) and ZilverPTX® (n=6). The pigs received the PCS corresponding to their group in each external iliac artery and were paired one by one, to examine 6 different post-implantation timepoints: after 30 minutes, 6 hours, 24 hours, 3 days, 7 days, and 14 days. The paclitaxel concentration measurements and the histological analysis were carried out under blind testing on the plasma, arterial, lymph node, and muscle samples. A linear regression model and Wilcoxon Mann-Whitney test were used to study the variables. RESULTS: The plasma paclitaxel rate decrease over 24 hours after PCS implantation was significantly different between the two groups, expressed by the correlation coefficient 0.19 (0.14-0.23; p<0.001) with an undetectable concentration at the 10th hour for Eluvia® versus 3 days for ZilverPTX®. Significantly higher paclitaxel concentrations with ZilverPTX® PCS were observed in muscle samples at each timepoint: extensor digitorum brevis 3.2 (1.17-5.23; p=0.005), biceps femoris 4.27 (2.27-6.26; p<0.001), semi-tendinosus 3.79 (1.85-5.73; p=0.001), tibialis anterior 3.0 (1.37-4.64; p=0.001), and in the femoral nodes 2.27±1.74 ng/g versus 0.14±0.13 ng/g (p<0.001). Histological analysis revealed a trend for more marked intimal inflammation in the arteries stented with ZilverPTX® (p=0.063), especially after the 7th and 14th days. CONCLUSION: Such a difference in the concentration of paclitaxel in the plasma, muscles, and lymph nodes between the two stents was higher than expected based on differences in device design. The clinical consequences of these results remain to be elucidated, particularly regarding the concerning presence of paclitaxel in muscles and adjacent lymph nodes. CLINICAL IMPACT: This experimental study compares 2 paclitaxel-coated stents. It demonstrates that differences in stent designs and drug features (coatings and concentrations) translate into differences in terms of concentrations of paclitaxel in the plasma, muscles, and lymph nodes. Our results favor the Eluvia® stent over the ZilverPTX® stent, although more studies are required to confirm this conclusion.

Mechanical Performance Assessment of Physician Modified Aortic Stent Graft.

OBJECTIVE: This study aimed to compare various fenestration configurations of physician modified aortic stent grafts in order to identify which design parameters have a significant influence on the mechanical behaviour of the fenestration. METHODS: the fenestration configurations were considered according to different manufacturing parameters: cutting technique, fenestration reinforcement, suture material, reinforcement loop design, and number of suture points. The performance of the graft/bridging stent assembly was assessed at various levels: (1) branch pull out force; (2) fenestration enlargement and rupture strength; (3) balloon angioplasty resistance; and (4) behaviour under cyclic fatigue. RESULTS: Sixty manual fenestrations were created. The tests performed on the fenestrations had several main findings. First, reinforcement increased the radial force on the branch, which increased the pull out force; this may limit migration of the bridging stent in vivo. The phenomenon was amplified with a snare reinforced fenestration, which seemed to be the most efficient. Moreover, increasing the number of suture passes also appeared to increase the branch extraction force securing the assembly. The enlargement tests showed that non-reinforced fenestrations had the weakest radial strength. This was confirmed with the balloon angioplasty test, which showed that these latter specimens undergo the most significant textile degradation. After fatigue tests, all fenestrations were larger, showing that elastic recoil was incomplete in all samples. The largest recoil was observed in the non-reinforced ophthalmological cautery (OC) fenestrations (40%). Regarding the behaviour of the samples up to rupture, all samples behaved in a similar way; however, the double loop fenestration strength level was the highest. CONCLUSION: This study demonstrated that the snare double loop reinforcement has an advantage regarding durability of the graft branch assembly. Moreover, non-reinforced fenestrations show signs of weakness and lack of stability, which questions the in situ or laser fenestration procedures.

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.

Endovascular Repair of Narrow Distal Aortas Using an In Situ Fenestration Technique.

PURPOSE: To demonstrate that in situ fenestration (ISF) of an aorto-uni-iliac endograft to treat aortoiliac disease with narrow distal aorta (NDA) vessels is effective and safe. MATERIALS AND METHODS: Data for all patients treated by use of ISF between August 2014 and December 2019 were retrospectively analyzed. The series included 27 patients, aged 70 years ± standard error (SE) 11. The pathologies treated included aortoiliac occlusive disease (n = 16), asymptomatic abdominal aortic aneurysm (n = 8), and a ruptured abdominal aortic aneurysm (n = 3). The technique consisted of deploying an aorto-uni-iliac graft, which was converted into a bifurcated repair through contralateral iliac ISF. The inclusion criteria encompassed the presence of an abdominal aortic aneurysm (diameter of >50 mm, rapid growth, ruptured or symptomatic) associated with NDA or the presence of severe aortoiliac occlusive disease with NDA. NDA is defined as an aortic diameter of <16 mm. RESULTS: The mean aortic bifurcation diameter was 11.9 mm ± SE 1.5. In total, 55% of the fenestrated endografts were performed with a multifilament polyester endograft and 45% with expanded polytetrafluoroethylene endograft. Technical success was 100%. Fluoroscopy time was 28 minutes ± SE 12, and 94 mL ± SE 43 of iodinated contrast medium was used. In the postoperative course, a single minor retroperitoneal hematoma was identified. The mean hospital stay was 5 days ± SE 3. At the mean follow-up of 26 months ± SE 22, overall primary patency was 94% and no endoleak was observed at the ISF site. CONCLUSIONS: The ISF technique is safe and effective in the treatment of aortoiliac disease with NDA. Comparisons with alternative techniques are needed to determine the long-term durability.

Readmissions Following Arteriovenous Access Creation for Haemodialysis in a French National Database.

OBJECTIVE: There is a lack of large real world data on arteriovenous (AV) access results. This study aimed to describe the required hospital care during the first year following creation of AV access. METHODS: Data from all adult patients who underwent creation of AV access performed in 2017 in a public or private facility were collected through the French national hospitalisation database. Patients were classified into two groups ("de novo" and "secondary") according to their history of prior AV access creation. The primary outcome was the proportion of patients with at least one hospital readmission related to the AV access recorded during the first 12 post-operative months. RESULTS: In 2017, 10 476 adult patients underwent AV access creation in France, including 8 690 (83%) de novo creations. An AV fistula was created for 92% of the patients (95% de novo vs. 78% secondary; p < .001). During the first 12 post-operative months, 6 591 (63%) patients recorded at least one related readmission (68% secondary vs. 62% de novo; p < .001). A total of 5 557 (53%) recorded a readmission for surgical/interventional procedure and 2 852 (27%) were observed with a readmission for medical complications. The mean (± standard deviation) number of related readmissions at 12 months was 1.4 ± 1.6 per patient (1.7 ± 1.9 secondary vs. 1.3 ± 1.5 de novo; p < .001). Patients with an AV graft were more frequently readmitted than those with an AV fistula (1.8 ± 2 vs. 1.3 ± 1.5 readmission; p < .001). CONCLUSION: This study highlights the high frequency of readmissions during the first 12 months following creation of AV access, particularly in patients who had already undergone creation of a previous AV access or had an AV graft implanted. Further research should focus on tailoring AV access strategies to improve patient quality of life and decrease the healthcare cost burden.

Editor's Choice - European Society for Vascular Surgery Clinical Practice Guideline Development Scheme: An Overview of Evidence Quality Assessment Methods, Evidence to Decision Frameworks, and Reporting Standards in Guideline Development.

OBJECTIVE: A structured and transparent approach is instrumental in translating research evidence to health recommendations and evidence informed clinical decisions. The aim was to conduct an overview and analysis of principles and methodologies for health guideline development. METHODS: A literature review on methodologies, strategies, and fundamental steps in the process of guideline development was performed. The clinical practice guideline development process and methodology adopted by the European Society for Vascular Surgery are also presented. RESULTS: Sophisticated methodologies for health guideline development are being applied increasingly by national and international organisations. Their overarching principle is a systematic, structured, transparent, and iterative process that is aimed at making well informed healthcare choices. Critical steps in guideline development include the assessment of the certainty of the body of evidence; evidence to decision frameworks; and guideline reporting. The goal of strength of evidence assessments is to provide well reasoned judgements about the guideline developers' confidence in study findings, and several evidence hierarchy schemes and evidence rating systems have been described for this purpose. Evidence to decision frameworks help guideline developers and users conceptualise and interpret the construct of the quality of the body of evidence. The most widely used evidence to decision frameworks are those developed by the GRADE Working Group and the WHO-INTEGRATE, and are structured into three distinct components: background; assessment; and conclusions. Health guideline reporting tools are employed to ensure methodological rigour and transparency in guideline development. Such reporting instruments include the AGREE II and RIGHT, with the former being used for guideline development and appraisal, as well as reporting. CONCLUSION: This guide will help guideline developers/expert panels enhance their methodology, and patients/clinicians/policymakers interpret guideline recommendations and put them in context. This document may be a useful methodological summary for health guideline development by other societies and organisations.

Conversion From an Outpatient to an Inpatient Setting After an Endovascular Treatment for Lower Extremity Artery Disease.

BACKGROUND: Outpatient endovascular treatment (EVT) for lower extremity artery disease (LEAD) is increasing. Some patients will, nonetheless, unexpectedly stay hospitalized for the night after the procedure. The purpose of this study was to identify the factors associated with a conversion from an outpatient setting (OS) to an inpatient setting (IS). METHODS: From April 2017 to August 2019, we performed 745 EVT for LEAD. Patients scheduled for a same-day discharge procedure were retrospectively analyzed. The factors potentially associated with a conversion to an IS were assessed. Results are expressed as odds ratio (OR) with 95% confidence intervals. RESULTS: Among the 198 (26.6%) patients scheduled for outpatient EVT, mean age was 70.8±14.1 years old, 34.3% had an ASA score≥3 and 38.4% presented a chronic limb-threatening ischemia. Twenty-eight patients (14.1%) were converted from an OS to IS. Univariate analysis found that Rutherford stage≥4 (OR = 5.09 [2.11-12.27], P < 0.001), high blood pressure (OR = 3.19 [1.06-9.63], P = 0.040), ASA score≥3 (OR = 3.61 [1.58-8.24], P = 0.002), duration of procedure ≥90 min (OR = 2.36, [1.03-5.39], P = 0.042), anterograde puncture (OR = 2.94, [1.30-6.66], P = 0.009), arrival in the operating room ≥12:00 (OR = 13.05, [5.29-32.17], P < 0.001) and general anesthesia (OR = 3.89, [1.20-12.62], P = 0.024) were associated with a conversion. The multivariate analysis revealed that an arrival in the operative room ≥12:00 (OR = 11.71, [3.85-35.60], P < 0.001) and general anesthesia (OR = 6.76, [1.28-35.82], P = 0.009) were independent factors associated with a conversion. CONCLUSION: Arrival in the operative room after 12:00 and general anesthesia represent two independent correctible factors associated with the risk of OS failure. No factor directly related to comorbidities or the LEAD severity was identified.

Outcomes of Same-Day Discharge with Manual Compression and 5F Sheath Compatible Devices for Lower Extremity Arterial Endovascular Treatment.

BACKGROUND: For same-day discharge lower extremity arterial disease (LEAD) endovascular procedures, femoral manual compression could be an alternative to arterial closure devices. The aim of this study was to assess the security and efficacy of same-day discharge after manual compression in patients treated for LEAD endovascular revascularization with 5F sheath. METHODS: FREEDOM OP was a national multicenter, prospective, single arm study. Patients with symptomatic LEAD (Rutherford 2-5) and eligible for same-day discharge were included. The primary endpoint was the total in-hospital admission rate, which includes overnight surveillance and rehospitalization rate at 1 month. RESULTS: Between September 2017 and August 2019, 114 patients were included. The mean age of the patients was 66 ± 10 years and most of them were claudicant (103; 94%). Mainly femoropopliteal lesions were treated (178; 70%) and the technical success was 97%. One hundred forty-two 5F stents and fifty one 5F drug coated balloon were delivered. The mean manual compression duration was 13 ± 4 min. Major access-related complications rate was 4.5%. Total in-hospital admission rate was 11%. Seven patients had overnight surveillance and 5 were rehospitalized (2 for the target lesion). No rehospitalisation was carried out within 24 hr after discharge. No major cardiovascular event, including death, was observed. The patients were significantly improved in term of clinical status (P < 0.0001) and hemodynamic (P < 0.0001) in comparison to baseline. CONCLUSION: FREEDOM OP showed that manual compression is feasible and safe for same-day discharge after LEAD revascularization with 5F sheath femoral approach.

Thrombosis of Medium-Sized and Large Arteries During Covid-19 Infection: Results of the COVIVASC Study.

BACKGROUND: COVID-19 infection is associated not only with venous thromboses but also with arterial thromboses (COV-ATs) in relation with an endothelial dysfunction, a coagulopathy and rhythm disorders. The incidence, the topography, and the prognosis of COV-ATs remain poorly known. The objective of this study was to report the overall experience of the Greater Paris University Hospitals (Assistance Publique - Hopitaux de Paris, AP-HP) during the first pandemic wave of COVID-19 infection. METHODS: After approval by the ethics committee, a study using the AP-HP clinical data warehouse was carried out between March and May 2020. Overall, 124,609 patients had a polymerase chain reaction for COVID-19 in our hospitals, of which 25,345 were positive. From 20,710 exploitable stays, patients tested positive for COVID who presented an episode of acute COV-AT (except coronary and intracranial arteries) were selected on the basis of the French medical classification for clinical procedures codes. The data are presented as absolute values with percentages and/or means with standard deviation. RESULTS: Over the studied period, 60 patients (aged 71±14 years, 42 men) presented a COV-AT at the time of their hospitalization, an incidence of 0.2%. The arterial complication occurred 3±7 days after the COVID infection and was inaugural in 30% of the cases (n = 18). The sites of COV-AT were the lower extremities (n = 35%, 58%), the abdominal aorta (n = 10%, 17%), the thoracic aorta (n = 7%, 12%), the upper limbs (n = 7%, 12%), the cerebral arteries (n = 7%, 12%), the digestive arteries (n = 6%, 10%), the renal arteries (n = 2%, 3%), and the ophthalmic artery (n = 1%, 2%). Multiple COV-ATs were observed in 13 patients (22%). At the time of diagnosis, 20 (33%) patients were in intensive care, including six (10%) patients who were intubated. On computed tomography angiography, COVID lesions were classified as moderate and severe in 25 (42%) and 21 (35%) cases, respectively. Revascularization was attempted in 27 patients (45%), by open surgery in 16 cases, using endovascular techniques in 8 cases and with a hybrid approach in three cases. Six patients (22%) required reinterventions. The duration of hospitalization was 12±9 days. Early mortality (in-hospital or at 30 days) was 30% (n = 18). Nine (15%) patients presented severe nonlethal ischemic complications. CONCLUSIONS: Arterial involvement is rare during COVID-19 infection. The aorta and the arteries of the limbs are the privileged sites. The morbi-mortality of these patients is high. Future studies will have to determine if the systematization of anticoagulation therapy decreases the incidence and the severity of the condition.

Revascularization Outcomes in Patients With Acute Limb Ischemia and Active Neoplastic Disease.

PURPOSE: To report the outcomes of surgical (ST), endovascular (ET), and hybrid (HT) treatment in cancer patients with acute limb ischemia (ALI). MATERIALS AND METHODS: A multicenter retrospective registry collected 139 patients (mean age 72.3±12.4 years; 73 men) with ALI and active malignancy treated by ET (41, 29%), ST (70, 51%), or HT (28, 20%) in 7 European centers between July 2007 and February 2019. In 22 cases (16%) ALI was the first manifestation of the malignancy. Lung cancer was the most common diagnosis (38, 27%). The primary composite outcome was amputation-free survival (AFS). Overall survival, amputation-free time (AFT), and reintervention-free time (RFT) were also assessed. Cox regression analysis was applied to identify independent risk factors for the primary and secondary outcomes. Results are presented as the hazard ratio (HR) and 95% confidence intervals (CIs). RESULTS: ET was associated with improved 12-month AFS compared with both ST (HR 2.27, 95% CI 1.20 to 4.28, p=0.002) and HT (HR 2.14, 95% CI 1.09 to 4.18, p=0.008). ST (HR 2.50, 95% CI 1.19 to 5.53, p=0.003) and HT (HR 3.10, 95% CI 1.45 to 6.65, p<0.001) were related to an increased risk for mortality compared with ET. At 12 months, the AFT was similar between the 3 groups (ET vs ST: HR 1.52, 95% CI 0.51 to 4.53, p=0.45 and ET vs HT: HR 1.21, 95% CI 0.36 to 4.11, p=0.73). The 12-month RFT also did not differ significantly between the 3 treatment options (ET vs ST: HR 1.10, 95% CI 0.49 to 2.46, p=0.79 and ET vs HT: HR 0.51, 95% CI 0.22 to 1.17, p=0.19). ST and/or HT increased the risk for the major amputation and/or death (HR 1.76, 95% CI 1.05 to 2.05, p=0.03), while Rutherford class I ischemia (HR 0.12, 95% CI 0.02 to 0.90, p=0.04) and previous vascular interventions on the index limb (HR 0.55, 95% CI 0.32 to 0.97, p=0.04) showed a protective effect. CONCLUSION: In patients with ALI and active malignant disease, ET was associated with increased AFS and overall survival compared with both ST and HT, while the limb salvage and reintervention rates were comparable among the 3 groups.

Paclitaxel-Coated Balloons for the Treatment of Symptomatic Central Venous Stenosis in Vascular Access: Results From a European, Multicenter, Single-Arm Retrospective Analysis.

INTRODUCTION: This was a European, multicenter, investigator-initiated and run, single-arm retrospective analysis to assess the safety and the clinical benefit of the use of paclitaxel-coated balloon (PCB) for the treatment of symptomatic central venous stenosis (CVS). MATERIALS AND METHODS: Eleven centers from 7 countries across Europe, submitted 86 cases performed during the period between October 2015 and June 2018. Minimum follow-up was 6 months. Patient baseline demographics and procedural details were collected. Mean age was 62.6 years (SD 15.2 years). Median vascular access age was 3.0 years (IQR 1.2-4.8 years). A total of 55 were arteriovenous fistulas (64%) the rest arteriovenous grafts (31/86, 36%). Vessels treated were 43 subclavian veins, 42 brachiocephalic veins and 1 superior vena cava. Median drug-coated balloon diameter was 10 mm (IQR 8-12 mm). Primary outcome measures were clinically assessed intervention-free period (IFP) of the treated segment at 6 months and procedure-related minor and major complications. Secondary outcome measures included access circuit survival, patient survival, and the investigation of independent factors that influence the IFP. RESULTS: IFP was 62.7% at 6 months. Median patient follow-up time was 1.0 year (IQR 0.5-2.2 years). There was 1 minor complication (1/86; 1.2%) and no major complications. Access circuit survival was 87.7% at 6 months. Patient survival was 79.7% at 2 years according to Kaplan-Meier survival analysis. Higher balloon diameters significantly favored IFP [HR 0.71 (0.55-0.92), p=0.006; 5-7 mm group vs 8-12 mm group, p=0.025]. CONCLUSION: In this analysis, use of PCBs for the treatment of symptomatic CVS was safe. Efficacy was comparable to previous trials. Increased balloon size had a significant effect on patency rates.

Mechanical Behaviour of Fenestrations in Current Aortic Endografts.

OBJECTIVE: The aim of this study was to assess the mechanical characteristics of current commercially available fenestrated endografts (FE). The performance of the fenestrations according to the design were compared as the relationship between a bridging covered stent graft (CSG) and the fenestration. METHODS: A total of 21 Zenith (Cook Medical, Bloomington, IN, USA) and 17 Anaconda (Terumo Company, Inchinnan, UK) fenestrations were studied. Radial extension tests were performed, inserting two half cylinders spaced up to 2 mm in a 7 mm diameter fenestration from each device. Branch pull out force was measured to test the stability of the assembly with a calibrated 8 mm branch and two CSGs: Advanta V12 (Atrium Medical; Hudson, NH, USA) and BeGraft Peripheral Stent Graft (Bentley InnoMed GmbH, Hechingen, Germany). A branch was inserted in both the 7 mm diameter fenestrations and in a control 7 mm fenestration. Fatigue tests were performed on the devices to assess long term outcomes of the endograft. RESULTS: Over a 2 mm vertical displacement, the resulting loading curves look similar for both devices. The force value level was 33.4 ± 6.9 N for the Cook fenestration and 54.45 ± 18 N for the Anaconda fenestration (p = .001). With respect to an 8 mm calibrated branch, the required extraction strength from the fenestration was statistically significantly greater with the Anaconda device (9.5 ± 4.7 N vs. 4.49 ± 0.28 N; p = .001). The required strength to extract the V12 CSG from a control cylindered shape was statistically significantly higher than for the BeGraft CSG (6.75 ± 2.86 N vs. 1.83 ± 0.67 N; p = .003). The surface area of the fenestration of the Cook device was increased with cycling (7 200 cycles) compared with the Anaconda device (15.5% vs. 6.5% hole surface area increase). CONCLUSION: The mechanical performance of the fenestration can be fine tuned by considering its design. A CSG optimising the performance of the fenestration and the CGS-fenestration interface could reduce the risk of leakage in clinical practice.

Comprehensive Review of Physician Modified Aortic Stent Grafts: Technical and Clinical Outcomes.

OBJECTIVE: Physician modified stent grafts (PMSGs) present satisfactory results in selected cases of complex aortic pathologies. However, the technique lacks standardisation and depends on the surgeon and aortic segment. The aim of this article is to review comprehensively the technical details and clinical results of PMSGs related to patients with pathology in all aortic locations. METHODS: A MEDLINE search (last search 20 April 2020) identified 20 relevant papers in the English language published over the last 20 years evaluating clinical outcomes after a PMSG and specifying the technical details to design it. RESULTS: Seven hundred and eleven patients were included in the analyses, with 59% being operated on as an emergency. Ninety-two per cent of abdominal aortic segment PMSGs (A-PMSGs) were performed either as an emergency or before 2012. The main indications were available in 670 cases; 435 were degenerative aneurysms (64.9%) and 171 were aortic dissections (25.5%). Most of the endografts used were composed of polyethylene terephthalate, except for the Ankura (expanded polytetrafluoroethylene [Lifetech Scientific, Shenzhen, China]; n = 50, 7.5%). The Valiant (Medtronic, Minneapolis, MN, USA) represented 65% (n = 169) of aortic arch PMSGs (aa-PMSGs) and the Zenith platform (Cook Medical, Bloomington, IN, USA) 51% (n = 139) of A-PMSGs. A snare was used to reinforce the fenestration in 458 PMSGs (66%) and a cautery device cut the fenestration in 484 (75%) PMSGs. No bridging stent was used in 47 (7.0%) PMSGs (these aa-PMSGs had large fenestrations). Technical success ranged from 87.5% to 100% and 30 day mortality from 0% to 8%. Primary branch patency ranged from 96.3% to 100% at 12 month follow up. Zero to 14% of patients experienced type 3 or type 1 endoleak at 14.8 month follow up. CONCLUSION: PMSG is a useful technique, particularly when validated treatments are not available. However, it is a non-standardised technique and the long term consequences of modifications remain unknown.

Endovascular Treatment of Long Femoropopliteal Lesions with Contiguous Bare Metal Stents.

OBJECTIVES: Recent controversies on the use of drug coated/eluting devices in the arteries of the lower extremities renewed the focus on the evaluation of more conventional techniques. The results of the stenting of short and/or intermediate femoro-popliteal lesions are well known, but little data relate to the endovascular treatment of long femoro-popliteal lesions with contiguous bare metal stents (ETLFBS). The objective of this study was to report our results of ETLFBS. MATERIAL AND METHODS: Between January 2014 and December 2017, 1233 patients had an infrainguinal angioplasty in our center. The files of patients treated for femoropopliteal lesions longer than 250 mm using extensive stenting with contiguous bare metal stents were reviewed and analyzed. The primary outcome was the 12-month primary patency, defined by the absence of restenosis (≥50%) and/or reintervention on the target lesion. Continuous data were expressed as mean and standard deviation. Survival analysis was carried out according to Kaplan-Meier. RESULTS: Overall, 64 patients aged 80 ± 11 years were included, with 49 (76.6%) presenting with critical limb ischemia. Lesions were classified as TASC D in 54.7% of the cases. The length of the lesions was 295 ± 64 mm and 3 ± 1 stents were implanted. The 30-day mortality was null but two patients (3.1%) presented nonvascular major complications. With a follow-up of 27 ± 17 months, 22 patients (34.3%) died including three of vascular causes. The healing of the trophic disorder was obtained in 77.5% of the cases. The rate of amputation was 10.9%. The 6-, 12-, and 24-month primary patency rates were 79.7%, 66.6%, and 60.9%, respectively. The 6-, 12-, and 24-month rates of freedom from target lesion revascularization were 96.3%, 73.9%, and 71.9%, respectively. The 6-, 12-, and 24-month survival rates were 90.3%, 83.6%, and 65.6%, respectively. CONCLUSIONS: The 12-month primary patency rate of ETLFBS is acceptable. This strategy constitutes an acceptable alternative in patients presenting with critical limb ischemia and a limited life expectancy.

A Simple Technique to Perform Endovascular Repair of Abdominal Aortic Aneurysms with a Very Low Dose of Iodine Contrast Media.

Iodinated contrast media (ICM) dose is a major factor for postoperative acute kidney injury (AKI) in patients with severe chronic kidney disease (glomerular function rate [GFR] <30 mL/min) during endovascular aortic repair (EVAR). Fusion imaging in hybrid rooms and carbon dioxide angiography represent alternatives but are limited by significant cost and availability. We here describe a simple technique allowing EVAR with a limited ICM dose (<5 mL). Using a standard C-arm, the lowest renal artery and the hypogastric arteries are blindly catheterized based on noncontrast pre-operative imaging (duplex-scan associated with noncontrast computed tomography scan and/or magnetic resonance angiography). An injection of diluted ICM (1 mL ICM + 4 mL saline) can be performed to confirm the correct catheterisation and angiography catheters are let in place as landmarks. Ten patients with GFRs between 17 and 29 ml/min were successfully treated using these tips (median ICM = 3 mL) without postoperative AKI and satisfactory mid-term results.

Persistence of Intraluminal Thrombus Makes Saccular Aneurysm More Biologically Active than Fusiform in an Experimental Rat Model.

INTRODUCTION: Saccular aneurysms are thought to have a worse prognosis than fusiform aneurysms in humans, due to hemodynamic reasons. However, data comparing hemodynamic and biology in saccular and fusiform aneurysms are lacking. The main objective was to evaluate the impact of aneurysm morphology on intra-luminal thrombus (ILT) formation and activity. METHODS: Forty Lewis rats were ran-domly divided into 2 groups of 20: "saccular" (Group A) and "fusiform" (Group B) aneurysms. Decellularized thoracic aortas from guinea pigs were xenografted to create saccular or fusiform aneurysms. Final imaging evaluation of the aneurysms was carried out during the third week, by quantitative Doppler ultrasound and magnetic resonance imaging. Assays of myeloperoxidase (MPO), platelet factor 4 (PF4), advanced oxidation protein products (AOPPs) iron and matrix metallopeptidase-9 (MMP-9) were performed as biological criteria. RESULTS: Quantitatively, saccular aneurysms are characterized by a more thicker ILT, lower inflow velocities and more important relative backflow velocities as compared to fusiform aneurysms. Compared to fusiform, saccular aneurysms released significantly more MPO (p = 0.004), PF4 (p = 0.02), AOPPs (p < 0.002), iron (p < 0.0001) and MMP-9 (p < 0.04). CONCLUSION: Experimental saccular and fusiform aneurysms show differential specific hemodynamics, which seem to impact the histology and the biology of the ILT in each type of aneurysm.

Artificial intelligence in abdominal aortic aneurysm.

OBJECTIVE: Abdominal aortic aneurysm (AAA) is a life-threatening disease, and the only curative treatment relies on open or endovascular repair. The decision to treat relies on the evaluation of the risk of AAA growth and rupture, which can be difficult to assess in practice. Artificial intelligence (AI) has revealed new insights into the management of cardiovascular diseases, but its application in AAA has so far been poorly described. The aim of this review was to summarize the current knowledge on the potential applications of AI in patients with AAA. METHODS: A comprehensive literature review was performed. The MEDLINE database was searched according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The search strategy used a combination of keywords and included studies using AI in patients with AAA published between May 2019 and January 2000. Two authors independently screened titles and abstracts and performed data extraction. The search of published literature identified 34 studies with distinct methodologies, aims, and study designs. RESULTS: AI was used in patients with AAA to improve image segmentation and for quantitative analysis and characterization of AAA morphology, geometry, and fluid dynamics. AI allowed computation of large data sets to identify patterns that may be predictive of AAA growth and rupture. Several predictive and prognostic programs were also developed to assess patients' postoperative outcomes, including mortality and complications after endovascular aneurysm repair. CONCLUSIONS: AI represents a useful tool in the interpretation and analysis of AAA imaging by enabling automatic quantitative measurements and morphologic characterization. It could be used to help surgeons in preoperative planning. AI-driven data management may lead to the development of computational programs for the prediction of AAA evolution and risk of rupture as well as postoperative outcomes. AI could also be used to better evaluate the indications and types of surgical treatment and to plan the postoperative follow-up. AI represents an attractive tool for decision-making and may facilitate development of personalized therapeutic approaches for patients with AAA.