BACKGROUND:Fenestrated endovascular aortic repair (FEVAR) is an established treatment for complex abdominal aortic aneurysms involving the renovisceral segment. Long-term durability remains dependent on bridging stent performance, yet prospective device-specific data remain limited. The fenCo study was designed to evaluate the clinical performance and safety of the iCover balloon-expandable covered stent (iVascular) used as a bridging stent during FEVAR. METHODS:fenCo is a prospective, multicenter, open-label, single-arm European clinical investigation conducted in 24 high-volume centers under Regulation (EU) 2017/745. The study aims to include 165 patients undergoing FEVAR for juxtarenal, pararenal, suprarenal, or thoracoabdominal aneurysms using an IFU-compliant fenestrated endograft. All target vessels are bridged exclusively using the iCover balloon-expandable covered stent. Follow-up is planned at discharge, 6 months, and 12 months, with optional extension to 5 years. RESULTS:The primary efficacy endpoint is bridging-stent patency at 12 months, defined as absence of binary restenosis (≥50% stenosis) or occlusion on imaging. The primary safety endpoint is freedom from target vessel instability, defined as a composite of aneurysm rupture, target vessel occlusion, component separation, branch-related endoleak, or branch-related reintervention. Secondary endpoints include technical success, endoleaks, reinterventions, mortality, aneurysm sac evolution, and renal outcomes. CONCLUSIONS:fenCo will provide prospective multicenter European data on the safety and performance of the iCover stent used as a bridging stent during FEVAR using predefined imaging-based and clinically adjudicated endpoints. The study is expected to strengthen the evidence base for bridging stent selection in complex endovascular aortic repair.

BACKGROUND:To evaluate image quality improvements of a low-iodine contrast medium (CM) protocol optimized with dual-layer spectral CT (DLCT) in patients undergoing post-endovascular aortic repair (EVAR) follow-up. METHODS:This single-center retrospective study included 83 consecutive patients (mean age: 75 ± 7.3 years) undergoing post-EVAR CTA with a low-iodine protocol optimized for DLCT (IQon, Philips Healthcare). The CM injection protocol, adapted to eGFR and BMI, comprised eight dose-flow categories. Pre-, post-scan eGFR and radiation dose were recorded. Dose-length product (DLP) was compared between true non-contrast (TNC) and virtual non-contrast (VNC) reconstructions. Objective image quality was assessed in standardized ROIs (aorta, iliac arteries, endoleak) by measuring mean attenuation (MA), signal-to-noise ratio (SNR), and contrast-to-noise ratio (CNR) on control CTA (iDose), and virtual monoenergetic images (VMI) at 55 keV and 40 keV. Subjective image quality was rated using a 5-point Likert scale. RESULTS:No change in eGFR was observed post-CTA (p=0.5617). Substituting TNC with VNC reduced DLP by 546.2 ± 176.3 mGy·cm (-34.3 ± 1.4%, p<0.0001). Across all ROIs, MA, SNR, and CNR were highest with VMI 40 keV, followed by VMI 55 keV and control (all p<0.0001). Vascular enhancement scores were superior with VMI 40 keV versus VMI 55 keV (p=0.0014) and control (p<0.0001), while metal artifact ratings did not differ (p>0.9999). One false-positive type IIa endoleak occurred with VNC, but diagnostic confidence was unchanged (p=0.8150). CONCLUSIONS:This low-iodine protocol optimized for DLCT significantly reduced radiation dose and improved objective and subjective vascular enhancement without impairing renal function or diagnostic confidence in endoleak detection.

Background: Type IV carotid artery aneurysms are uncommon; mycotic variants are rarer and challenging. We report a distal internal carotid aneurysm managed with a two-stage hybrid approach. Case: A 28-year-old man had an enlarging left cervical mass with transient dysphagia and dysphonia. CT showed a distal internal carotid aneurysm measuring 71 × 49 mm, extending to the pre-foraminal segment. FDG-PET/CT demonstrated avid uptake (SUV 8.9). Work-up excluded endocarditis; Quantiferon was positive. Multidisciplinary review deemed endografting unsuitable and bypass unsafe given absent distal control. Intervention: Under local anesthesia, a 50-minute balloon occlusion test of the petrous internal carotid artery was followed by coil embolization and proximal vascular plug, completing arterial sacrifice. Post-procedure transient monocular visual loss corresponded to a small watershed infarct; hemodynamic augmentation achieved full recovery within 24 hours. Six days later, aneurysmectomy was performed with ligation of the common and external carotid arteries. Cultures grew Cutibacterium acnes; clindamycin then six weeks of amoxicillin were given. The patient was discharged day seven. At day 22 the wound had healed, dysphonia improved, and inflammatory markers fell without new neurologic events. Conclusion: When anatomy precludes reconstruction, staged sacrifice after a successful balloon occlusion test can enable definitive aneurysmectomy while preserving cerebral perfusion.

BACKGROUND:Drug-coated balloon (DCB) technology is demonstrating increasing potential in lower limb revascularization; 1-year results demonstrate acceptable levels of safety and efficacy and quality of life improvements. This follow-up study assessed whether these advantages persisted over 2 years with the Luminor DCB. METHODS:The LUMIFOLLOW registry enrolled 542 patients with 580 lesions across 15 centers. It included both de novo and restenotic lesions and calcified and/or long occlusions. Primary endpoints were medical safety (freedom from periprocedural death, index limb amputation, and/or all-cause mortality) and efficacy (primary patency defined as freedom from target lesion revascularization (f-TLR) and/or restenosis). Secondary endpoints included device, procedural and clinical success, major adverse events, and functional assessments. RESULTS:The mean age was 71.2 years, with 67.2% men; 23.8% were Rutherford classification (RC) 2, 43.2% were RC 3, 16.8% RC were 4, and 16.2% were RC 5; 57.5% of lesions were in the superficial femoral artery (SFA), 42.5% extended to the popliteal artery, with 24.2% restenosis and 44.3% total occlusions. Mean lesion length was 140.55 ± 99.42 mm. Provisional stenting was required in 43.1%. Acute clinical success was 93.5%. By 2 years, 351 of 542 (64%) patients remained in the study group, 48 patients had died. Estimated primary patency was 73.9% (95% CI: 69.3-77.9%); f-TLR was 92.0% (95% CI: 88.7-94.4%). Subgroup analyses showed no differences between f-TLR and primary patency rates between disease severity (TASC classification), de-novo versus in stent restenosis, and lesion location. Improvements in quality of life (QOL) were 63.1% improved mobility, 60.2% reduced pain, and 40.2% enhanced usual activities. Walking Impairment Questionnaire scores demonstrated sustained improvements (61.2 ± 30.0, P < 0.001). CONCLUSION:Luminor DCBs are safe and effective for femoropopliteal interventions, with equity in results in severe arterial disease, restenosis, SFA, and popliteal territories Significant improvement in QOL, walking ability, high primary patency, and low complication rates underscore the benefits of Luminor DCBs in real-world settings.

Introduction: Iliac artery aneurysms (IAAs) which may coexist with abdominal aortic aneurysms (AAAs) or appear as isolated lesions, represent around 2 % of intra-abdominal aneurysms. Endovascular repair using iliac branch devices (IBDs) helps preserve internal iliac artery (IIA) perfusion, reducing complications like buttock claudication. However, device displacement and type III endoleaks are significant challenges, especially in tortuous anatomy. Report: We report two cases of type III endoleak due to displacement of Gore Iliac Branch Endoprosthesis (IBE). In the first case, a 60-year-old male with a left IAA experienced immediate postoperative IBE migration and type III endoleak, necessitating urgent reintervention with bridging stents. In the second, a 74-year-old male treated for a right IAA had recurrent IBE displacements over four years, with repeated type III endoleaks, managed by repeated stenting. Severe iliac tortuosity contributed to both cases. Discussion: These cases highlight the complexities of IAA endovascular repair with IBDs, particularly the risk of device migration and endoleaks, with severe iliac tortuosity, device properties (e.g. conformability, low friction coefficient), and response to cardiac pulsatility increasing migration risk. Future studies should address these challenges, focusing on device design improvements and predictive imaging techniques, including artificial intelligence, to enhance long-term outcomes in IAA repair.

INTRODUCTION:While the benefits of carotid surgery for symptomatic carotid artery disease are well-established, the management of asymptomatic carotid lesions remains controversial, with wide variation in clinical practice. Recent studies suggest that plaque characteristics, such as thrombus versus calcium content, may predict cerebral events more accurately than the degree of stenosis alone. This study investigates the feasibility of segmenting carotid lesions on computed-tomography (CT) angiography using artificial intelligence (AI), and evaluates differences in plaque composition between symptomatic and asymptomatic patients. METHODS:Carotid plaques were analyzed using 2 segmentation approaches: physician-controlled manual segmentation and fully automated segmentation with the AI-based software PRAEVAorta2 (Nurea). Thrombus content, calcium burden, and residual lumen were analyzed and compared between the 2 techniques. The AI-based software was pre-trained on 19 CT angiograms. Sensitivity, specificity, Dice similarity coefficient (DSC), and volumetric similarity were calculated to evaluate the performance of both methods. A total of 156 patients who underwent carotid artery surgery between February 2019 and February 2022 were included in the analysis, comprising 81 symptomatic and 75 asymptomatic lesions. RESULTS:The DSC between fully automatic segmentation and physician-controlled manual segmentation was strong for lumen (0.83), calcification (0.68) and plaque (0.60) assessments but weaker for thrombus (0.33). Volume similarity, intra- and inter-observer reliability were high, with correlation coefficients of 0.98 for intra-observer, 1.00 for inter-observer analyses and 0.86 for fully automatic vs physician-controlled manual segmentation. Symptomatic carotid lesions exhibited significantly larger thrombus-to-total volume ratios (p<0.0001), higher raw thrombus volumes (p<0.0001), and greater total lesion volumes (p=0.003) than asymptomatic lesions. Conversely, asymptomatic lesions demonstrated higher calcification-to-total volume ratios (p=0.002). CONCLUSION:This study demonstrates the potential of PRAEVAorta2 to automate carotid lesion analysis, offering promise for identifying high-risk asymptomatic plaques and therefore aid surgical decision-making. Symptomatic carotid lesions displayed higher thrombus volume, lower calcium content, and larger plaque volumes than asymptomatic lesions.Clinical ImpactThis study introduces an AI-based tool, PRAEVAorta2, capable of automatically segmenting and quantifying carotid plaque components on CT angiography. By distinguishing between thrombus and calcification, the tool provides a more nuanced assessment of plaque vulnerability beyond stenosis grading. Clinically, this innovation could enhance risk stratification in asymptomatic carotid stenosis, supporting more individualized decisions for surgery. The demonstrated correlation between thrombus burden and symptoms highlights the potential to identify high-risk plaques before neurological events occur. This advancement may bridge the gap between imaging and clinical decision-making, promoting proactive and targeted management of carotid artery disease.

OBJECTIVE:Computed tomography angiography (CTA) imaging is essential to evaluate and analyse complex abdominal and thoraco-abdominal aortic aneurysms. However, CTA analyses are labour intensive, time consuming, and prone to interphysician variability. Fully automatic volume segmentation (FAVS) using artificial intelligence with deep learning has been validated for infrarenal aorta imaging but requires further testing for thoracic and visceral aorta segmentation. This study assessed FAVS accuracy against physician controlled manual segmentation (PCMS) in the descending thoracic aorta, visceral abdominal aorta, and visceral vasculature. METHODS:This was a retrospective, multicentre, observational cohort study. Fifty pre-operative CTAs of patients with abdominal aortic aneurysm were randomly selected. Comparisons between FAVS and PCMS and assessment of inter- and intra-observer reliability of PCMS were performed. Volumetric segmentation performance was evaluated using sensitivity, specificity, Dice similarity coefficient (DSC), and Jaccard index (JI). Visceral vessel identification was compared by analysing branchpoint coordinates. Bland-Altman limits of agreement (BA-LoA) were calculated for proximal visceral diameters (excluding duplicate renals). RESULTS:FAVS demonstrated performance comparable with PCMS for volumetric segmentation, with a median DSC of 0.93 (interquartile range [IQR] 0.91, 0.94), JI of 0.87 (IQR 0.84, 0.89), sensitivity of 0.99 (IQR 0.98, 0.99), and specificity of 1.00 (IQR 1.00, 1.00). These metrics are similar to interphysician comparisons: median DSC 0.93 (IQR 0.86, 0.93), JI 0.87 (IQR 0.76, 0.88), sensitivity 0.90 (IQR 0.86, 0.94), and specificity 1.00 (IQR 1.00, 1.00). FAVS correctly identified 99.5% (183/184) of visceral vessels. Branchpoint coordinates for FAVS and PCMS were within the limits of CTA spatial resolution (Δx -0.33 [IQR -1.70, 1.12], Δy 0.61 [IQR -1.25, 3.60], Δz 2.10 [IQR 0.37, 5.06] mm). BA-LoA for proximal visceral diameter measurements showed reasonable agreement: FAVS vs. PCMS mean difference -0.11 ± 5.23 mm compared with interphysician variability of 0.03 ± 5.27 mm. CONCLUSION:FAVS provides accurate, efficient segmentation of the thoracic and visceral aorta, delivering performance comparable to manual segmentation by expert physicians. This technology may enhance clinical workflows for monitoring and planning treatments for complex abdominal and thoraco-abdominal aortic aneurysms.

Background: Vascular access is indispensable for performing hemodialysis in patients with end-stage renal disease. The Kidney Disease Outcome Quality Initiative and the French Health Authority advocate for native arteriovenous fistulas (AVFs) as a primary option owing to their association with lower morbidity, mortality, and enhanced quality of life. However, a significant proportion of AVFs fail to mature, and many require multiple re-interventions, increasing overall costs. To address these issues, endovascular techniques for AVF creation have been developed. These methods use energy-based technologies, avoiding vessel dissection and preserving perivascular tissues. Initial results are promising, but these devices are expensive, and the technical act of creating an endovenous fistula is not recorded in the coding of the common classification of medical procedures and, as such, cannot be reimbursed by health insurance in France. Although international studies suggest their effectiveness, no French studies have yet replicated or confirmed these findings in the local context, which would help to support a reimbursement request from health insurance. Methods: This protocol represents the first French medicoeconomic study to compare the two available endovascular AVF creation devices (Ellipsys and WaveLinQ) with traditional open surgery. This multicenter, comparative clinical trial will randomize patients into two parallel groups: (1) endovascular AVF creation using either the WaveLinQ or Ellipsys device, and (2) surgical proximal AVF creation (brachiocephalic/brachiobasilic). Randomization will be balanced and stratified by center and dialysis timing. Follow-up assessments will occur at 1 week and 1, 3, 6, 12, and 18 months. The primary objective is to evaluate the cost effectiveness of endovascular AVF creation compared with open surgery from the perspective of the French health care system. The primary end point is the cost-utility ratio (cost per quality-adjusted life year gained) of endovascular AVF vs open surgery. Utility is assessed using the EQ-5D-5 L questionnaire, with costs derived from micro-costing and the National Health Data System. Secondary outcomes include health economics with total costs at 18 and 36 months, success rate of vascular access creation, AVF maturation and functionality, recirculation rates, early and late access failures, cannulation success, primary and secondary patency, reintervention rates, and adverse events. Based on a cost-utility threshold of V30,000 per quality-adjusted life year, cost difference estimates, and standard deviations from previous studies, anticipated sample size is 126 patients per group (endovascular and surgical), totaling 252 patients with approximately 142 patients for the Ellipsys device and 110 patients for WaveLinQ, based on the capacity of 7 centers using Ellipsys and 4 centers using WaveLinQ. Conclusions: This multicenter randomized controlled trial will provide contemporary data on the clinical outcomes and prognoses for endovascular AVF techniques, potentially establishing endovascular methods as a viable and cost-effective alternative to traditional surgical AVF creation. (JVS-Vascular Insights 2025;3:100163.)

Spontaneous recanalization (SR) of an internal carotid artery (ICA) is a rare phenomenon. Cases reported in literature described the evolution of dissection or atherothrombotic / cardioembolic acute occlusions. No case of post-endarterectomy ICA occlusion resolved by SR has never been reported. Herein, we describe the case of a 64-year old male patient who presented an ipsilateral ischemic stroke due to the ICA occlusion in the second post-operative day of a carotid endarterectomy (CEA) and SR 6 months later, without anticoagulant therapy administration. The aim of this report was to increase awareness of this unusual entity and to highlight the usefulness of duplex ultrasound (DUS) surveillance of ICA eventual postoperative occlusions in order to detect accidental recanalization and to propose an adjunctive treatment whenever needed.

BACKGROUND:This study aimed to evaluate the outcomes of a multidisciplinary team approach managing infections of complex aortic endografts, focusing on conservative treatment as an alternative to surgical explantation in selected cases. This was a retrospective, monocentric study conducted at Bordeaux University Hospital. METHODS:From January 2018 to July 2024, we reviewed cases of complex aortic endografts (chimney endovascular aortic repair [ChEVAR], fenestrated endovascular aortic repair [BEVAR], and fenestrated endovascular aortic repair [FEVAR]) infections, managed by our multidisciplinary vascular infection team (MDVIT). The primary end points were in-hospital mortality and overall survival. Secondary end points included complications during hospitalization and follow-up. RESULTS:All 11 cases of complex endografts infections managed by our MDVIT were scrutinized, infected FEVARS n = 10 and infected ChEVAR n = 1. The mean age was 72 years. The patients were divided into 2 groups: group A (7 patients) managed with conservative treatment with antimicrobial therapy ± percutaneous drainage, and group B (4 patients) undergoing surgical treatment due to complications. Group A demonstrated infection remission in 6/7 patients (86%) with antimicrobial therapy. One patient from group A required emergent surgery due to sepsis and was reassigned to group B. All patients in group B presented with complications such as aorto-duodenal fistulas n = 3 and pseudoaneurysms n = 1; 3 underwent graft explantations, and one underwent sacotomy and duodenal fistula repair without graft removal. The overall in-hospital mortality was 9%, and the mean follow-up was 15 months (range 3-37). The overall survival was 82% at 1 year. Long-term vascular complications were limited, and suppressive antimicrobial therapy was effective with high rate of remission of infection. CONCLUSIONS:Multidisciplinary team management enables a tailored approach to complex aortic endograft infections. Conservative treatment was first-line treatment, but for cases complicated by fistula or pseudoaneurysm surgical explantation was performed. Antimicrobial grafts and visceral debranching played a pivotal role in the surgical cases. This study highlights the importance of multidisciplinary decision-making and follow-up to optimize patient outcomes and inform future multicenter research.

BACKGROUND:Over the past decade, drug-coated balloons (DCBs) delivering paclitaxel have become widely used for the treatment of peripheral artery disease (PAD). The safety and efficacy of various DCBs have been extensively studied, but differences in device design and drug delivery matrices may influence outcomes. The publication aim was to report long-term safety and efficacy data of the Passeo-18 Lux DCB for the treatment of symptomatic PAD due to stenosis, restenosis or occlusion of the femoral and/or popliteal arteries. METHODS:Three hundred and two patients were randomized 1:1 and assigned to the Passeo-18 Lux DCB (study device) group or to the IN.PACT Admiral DCB (control device) group for testing of noninferiority. An efficacy endpoint was freedom from clinically-driven target lesion revascularization (CD-TLR) at 36 months. In terms of safety, a composite endpoint of freedom from device-/procedure-related death at 30 days post-index procedure, - major target limb amputation and clinically-driven target vessel revascularization (CD-TVR) at 36 months was investigated. RESULTS:At 36 months, freedom from CD-TLR-was achieved in 119 out of 128 patients in the IN.PACT Admiral group (93.0%) and in 116 out of 127 patients in the Passeo-18 Lux group (91.3%). The null hypothesis of inferiority was rejected with a P value of 0.0095, confirming the non-inferiority of Passeo-18 Lux compared to IN.PACT Admiral in terms of efficacy. Both treatment groups demonstrated sustained clinical improvement, as shown by the evolution of the Rutherford Clinical Category (RCC). At 36 months, the mean change in target limb RCC class compared to baseline was -2.5 in both groups, indicating comparable and significant clinical improvement over time. CONCLUSIONS:The Passeo-18 Lux and the IN.PACT Admiral DCBs demonstrate comparable results with excellent effectiveness and safety through 36 months for femoropopliteal interventions.

Background: Despite improved patency with newer-generation nitinol stents, one-half of patients will require secondary interventions for in-stent restenosis (ISR). The best treatment strategy remains unclear. This study aimed to compare drug-coated balloons (DCBs) used alone or in association with excimer laser atherectomy (ELA) to simple percutaneous transluminal angioplasty (PTA) in the treatment of femoropopliteal-ISR. Methods: The INTACT trial is a multicenter, prospective, triple-arm randomized trial conducted across 14 centers from December 2015 to November 2019. Patients Rutherford Class 2-5 with ISR≥70% were followed-up for 18 months. The primary efficacy endpoint was recurrent ISR>70% by duplex ultrasound analysis. The primary safety endpoint was major adverse events (MAEs) defined as death, major amputation, or target lesion revascularization (TLR). Results: Around 134 subjects were randomized to PTA alone (n=41), PTA+DCB (n=43) or PTA+ELA+DCB (n=50). Procedural success was similar (p=.74), as was clinical success (p=.17). The number of recurrent ISR>70% decreased after PTA+ELA+DCB (30.0%; p=.04) and PTA+DCB (30.2%; p=.05) compared to PTA alone (51.2%). Primary patency was higher after PTA+ELA+DCB (log-rank p=.04) and PTA+DCB (log-rank p=.02) compared to PTA alone at 12 months (78.7% and 70.4% vs 61.5%) and 18 months (61.6% and 67.7% vs 37.3%). Freedom from MAEs was lower after PTA+DCB (27.9%) compared to PTA alone (53.7%; p=.02) but did not differ with PTA+ELA+DCB (40.0%). It was primarily driven by TLR; 2 major amputations occurred after PTA+ELA+DCB (4.0%; p=.18). Conclusion: This independent study demonstrated a decrease in recurrent ISR>70% and increase in primary patency up to 18 months after PTA+ELA+DCB and PTA+DCB compared to PTA alone in the treatment of FP-ISR. It did not show an increase in MAEs but could have lacked power. Clinical Impact This multicenter, prospective, triple-arm randomized, controlled trial focuses on the results of adjunctive therapies, such as excimer laser atherectomy (ELA) and/or drug-coated balloons (DCBs) in the treatment of in-stent restenosis (ISR) in femoropopliteal lesions in 134 patients. It has the originality of being an independent study funded by a grant from the French Ministry of Health. This study confirms a significant decrease in recurrent ISR >70% and increase in primary patency up to 18 months after the use of ELA+DCB and DCBs compared to simple percutaneous transluminal angioplasty in the treatment of femoropopliteal ISR without an increase in major adverse events.

ObjectivePatients with an unruptured abdominal aortic aneurysm (AAA) at the surgical threshold may benefit from aneurysmal exclusion either by open surgery or endovascular repair. A patient decision aid (PtDA) could be useful to help patients and their surgeons choose between the two techniques. The aim of this study was to develop a shared medical decision support tool, in french language, for the surgical treatment of AAA.MethodsFollowing the steps recommended by the International Patient Decision Aids Standards, we carried out a qualitative study using semi-structured interviews with patients and vascular surgeons and focus group with patients to identify their main points of interest. After analyzing the interviews using grounded theory with independent double coding, the verbatims were discussed at a steering committee, at the end of which a prototype of the tool was created.Results4 surgeons and 14 patients were interviewed. No new codes emerged from the last two interviews. At the end of the steering committee meeting, the informations selected for inclusion in the PtDA tool were the definition of an AAA, a description of the two surgical techniques (approach, duration of operation), the main complications, the peri-operative mortality rate, and post operative follow-up (length of hospital stay, monitoring frequency, risk of re-intervention). It had to be produced on a synthetic paper format, with six illustrations and a simple vocabulary.ConclusionWe developed a PtDA tool for use in a sharing decision making process with the patient during the consultation with the vascular surgeon and the general practitioner. Further studies are needed to validate the tool and to test it in clinical practice.

BackgroundChronic limb-threatening ischemia (CLTI) is the end-stage of peripheral arterial disease (PAD) posing a high risk for limb loss and mortality. This study aims to evaluate and list possible predictors of major adverse limb events (MALEs) in CLTI patients with tissue loss.MethodsThis retrospective study included all Rutherford-Becker stage 5 or 6 patients who required foot debridement and revascularization in our department from January 2016 to December 2018. The limbs were classified according to the TASC II, GLASS and WiFI grading systems. The primary composite outcome was MALEs at 2 years. The secondary outcomes included all-cause mortality, primary patency, freedom from reintervention, and major amputation. Kaplan-Meier estimates were used to determine the event rates, and Cox proportional hazards model with the index MALE as a time-dependent covariate was used to search for MALEs predictors.ResultsOf 241 included patients, 19 underwent open surgeries (7.9 %) 207 had endovascular interventions (85.9 %) and 15 required a hybrid approach (6.2 %). On univariate analysis, patients who experienced MALEs (n = 111) more often required hemodialysis (25 vs 15; p = .02), presented with more complex lesions (TASC D on femoropopliteal (p = .05) or below the knee (BTK) arteries (p = .006) with increasing infra-inguinal GLASS Stage (p < .0001)), a history of index limb open (p = .009) or endovascular (p = .049) revascularization, an occluded tibial artery (p = .002 for the posterior tibial and p = .052 for the anterior tibial), or a “desert foot” (p = .02). The CRP level was also higher at admission (p = .001). Technical success of BTK revascularization significantly reduced MALEs (p < .0001) along with the number of patent BTK vessels (p = .0007). Independent predictors of MALEs included hemodialysis (HR = 2.00; 95%CI: 1.14 to 3.39), pulsatile arterial pressure (HR = 1.01; 95%CI: 1.00 to 1.03) and the infra-inguinal GLASS Stage (HR = 2.50; 95%CI: 1.17 to 5.82). We could not correlate our results with the WiFI scores for amputation risk and revascularization benefit.ConclusionFor patients with CLTI at the stage of trophic disorders, with or without a history of index limb revascularization, the GLASS successfully predicted MALEs. Hemodialysis and high pulsatile arterial pressure increased the risk of MALEs. The WiFI score did not demonstrate its interest in this subgroup of patients.

BACKGROUND:Endovascular interventions using drug-coated balloons (DCBs) have shown promise in improving outcomes for femoropopliteal (FP) revascularizations. Luminor, a nanotechnology-based paclitaxel coated balloon, has demonstrated efficacy and safety in Effpac (Effectiveness of Paclitaxel-coated Luminor Balloon Catheter Versus Uncoated Balloon Catheter in the Arteria Femoralis Superficialis). The LUMIFOLLOW (European All-comers' Multicentric Prospective REGISTRY on LUMINOR Drug Eluting Balloon in the Superficial Femoral Artery and Popliteal Artery With 5 Years Follow-up) registry, a large-scale, prospective, multicenter study, aims to assess the real-world performance of Luminor in FP lesions. METHODS:LUMIFOLLOW enrolled 542 patients with 580 lesions across 15 French centers. It included both de novo and restenotic lesions, with calcified and/or long occlusions. Primary end points were medical safety (defined as freedom from peri-procedural death, index limb amputation, and/or all-cause mortality) and efficacy (primary patency defined as freedom from target lesion revascularization and/or binary restenosis); secondary end points included acute device success, procedural and clinical success, major adverse events, and functional assessments. RESULTS:The mean patient age was 71.2 years, with 67.2% male patients. Prevalent comorbidities included diabetes (n = 231/542 [42.6%]), hypertension (n = 391/542 [72.1%]), hyperlipidemia (n = 305/542 [56.3%]), and current smoking (n = 147/540 [27.2%]); 23.8% were classified as Rutherford category 2 (n = 129/542), 43.2% as Rutherford category 3 (n = 234/542), 16.8% as Rutherford category 4 (n = 91/542), and 16.2% as Rutherford category 5 (n = 88/542). Lesions were located in the superficial femoral artery (n = 329/572 [57.5%]) and could extend to the popliteal artery (n = 243/572 [42.5%]), with 43.6% classified as Trans-Atlantic Inter-Society Consensus II C or D; 24.2% were restenosis (n = 139/575) with a 44.3% rate of total occlusions (n = 255/576). The mean lesion length was 140.55 ± 99.42 mm. Provisional stenting was required in 43.1% of patients (n = 249/580), with a mean stent length shorter than the initial lesion length at 87.21 ± 42.30 mm. The acute procedural success rate was 99.4% (n = 536/539), with two in-hospital deaths and one thrombosis of target lesion. Acute clinical success was achieved in 93.5% (n = 504/539). The 12-month composite safety end point was 82.7% (5.7% all-cause mortality, 0.7% index limb major amputation) and the estimated primary patency was 87.4% (95% confidence interval [CI], 84.1%-90.1%), with freedom from target lesion revascularization at 96.2% (95% CI, 93.9%-97.6%) and from target vessel revascularization at 94.9% (95% CI, 92.5%-96.6%). The EQ-5D-5L questionnaire indicated significant improvements in quality of life at 12 months, with 67.4% improved mobility, 63.5% reduced pain and discomfort, and 47.8% enhanced usual activities. Walking Impairment Questionnaire scores increased significantly in walking distance, speed, and stair-climbing ability (from 31.4 ± 24.7 to 62.5 ± 31.0; P < .001). CONCLUSIONS:The LUMIFOLLOW registry demonstrates that Luminor DCBs are effective and safe for FP interventions. The significant improvement in quality of life and walking ability, along with high primary patency and low complication rates, underscore the benefits of Luminor DCBs in real-world settings. However, the high rate of provisional stenting underscores the need for these devices to be used alongside other endovascular techniques in challenging lesions.