French Multicentric Registry on LUMINOR Drug-Eluting Balloon for Superficial Femoral and Popliteal Arteries.

BACKGROUND: Endovascular interventions using drug-coated balloons (DCBs) have shown promise in improving outcomes for femoropopliteal revascularizations. Luminor, nanotechnology-based paclitaxel coated balloon, has demonstrated efficacy and safety in the Effpac trial. The LUMIFOLLOW registry, a large-scale, prospective, multicenter study, aims to assess the real-world performance of Luminor in femoropopliteal 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 endpoints 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 (f-TLR) and/or binary restenosis); secondary endpoints included acute device success, procedural and clinical success, major adverse events, and functional assessments. RESULTS: The mean age was 71.2 years, with 67.2% male patients. Prevalent comorbidities included diabetes (42.6% n=231/542), hypertension (72.1%, n=391/542), hyperlipidemia (56.3%, n=305/542) and current smoking (27.2%, n=147/540); 23.8% were classified as Rutherford classification (RC) 2 (n=129/542), 43.2% as RC 3 (n=234/542), 16.8% as RC 4 (n=91/542) and 16.2% as RC 5 (n=88/542). Lesions were located in the superficial femoral artery (57.5%, n=329/572) and could extend to the popliteal artery (42.5%, n=243/572), with 43.6% classified TASC II C-D; 24.2% were restenosis (n=139/575) with a 44.3% rate of total occlusions (n=255/576). Mean lesion length was 140.55±99.42mm. Provisional stenting was required in 43.1% (n=249/580) with a mean stent length shorter than the initial lesion length at 87.21±42.30mm. The acute procedural success rate was 99.4% (n=536/539), with 2 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 endpoint was 82.7% (5.7% all-cause mortality, 0.7% index limb major amputation) and estimated primary patency was 87.4% (95%CI: 84.1;90.1%), with f-TLR 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). CONCLUSION: The LUMIFOLLOW registry demonstrates that Luminor DCBs are effective and safe for femoropopliteal 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.

Implementing methods in the ELEGANCE registry to increase diversity in clinical research.

OBJECTIVE: Women and underrepresented minorities (URMs) who are at an increased risk of presenting with severe peripheral artery disease (PAD) and have different responses to treatment compared with non-Hispanic White males yet are underrepresented in PAD research. METHODS: ELEGANCE is a global, prospective, multi-center, post-market registry of PAD patients treated with drug-eluting device that aims to enroll at least 40% women and 40% URMs. The study design incorporates strategies to increase enrollment of women and URMs. Inclusion criteria are age ≥18 years and treatment with any commercially available Boston Scientific Corporation drug-eluting device marketed for peripheral vasculature lesions; exclusion criterion is life expectancy <1 year. RESULTS: Of 750 patients currently enrolled (951 lesions) across 39 sites, 324 (43.2%) are female and 350 (47.3%) are URMs (21.6% Black, 11.2% Asian, 8.5% Hispanic/Latino, and 5.3% other). Rutherford classification is distributed differently between sexes (P = .019). Treatment indication differs among race/ethnicity groups (P = .003). Chronic limb-threatening ischemia was higher for Black (38.3%) and Hispanic/Latino (28.1%) patients compared with non-Hispanic White (21.8%) and Asian patients (21.4%). De-novo stenosis was higher in Asian patients (92.3%) compared with Black, non-Hispanic White, and Hispanic/Latino patients (72.2%, 68.7%, and 77.8%, respectively; P < .001). Mean lesion length was longest for Black patients (162.7 mm), then non-Hispanic White (135.2 mm), Asian (134.8 mm), and Hispanic/Latino patients (128.1 mm; P = .008). CONCLUSIONS: Analyses of data from the ELEGANCE registry show that differences exist in baseline disease characteristics by sex and race/ethnicity; these may be the result of other underlying factors, including time to diagnosis, burden of undermanaged comorbidities, and access to care.

Evaluation of balloon and self-expandable stents for common femoral artery stenosis.

BACKGROUND: Endovascular treatment of the common femoral artery (CFA) and its bifurcation is currently recommended for patients with hostile groin (prior femoral bifurcation open surgery, history of radiotherapy) or severe comorbidities (advanced age, frailty, obesity). Preliminary results have shown favorable outcomes. Among the different endovascular techniques (atherectomy, intravascular lithotripsy, plain balloon angioplasty, drug-coated balloon angioplasty, stenting), stents are mainly used but the best type of stent to use is still debated. The aim of this study was to assess the value of balloon-expandable stents (BES) and self-expandable stents (SES) for stenosis of the femoral bifurcation. METHODS: Consecutive patients with stenosis of the CFA and its bifurcation were included from 2016 to 2022. Demographic data, the type of stent used, procedural data, and angiographic variables were collected. Groups were defined according to the type of stent implanted. Primary patency was defined as a binary end point based on a duplex ultrasound peak systolic velocity ratio of ≤2.4 as assessed by duplex ultrasound examination, in the absence of clinically driven target lesion revascularization (TLR) or bypass of the target lesion. Secondary outcomes were clinical sustained improvement, freedom from TLR at 12 months, mean ankle-brachial index improvement, primary-assisted patency, and secondary patency. RESULTS: A total of 90 procedures conducted in 77 patients were included in this study, 26 in the SES group and 64 in the BES group. The most common symptomatology according to the Rutherford classification was class 2, 3, and 4 (28%, 48%, and 8%, respectively). The type of lesions in the CFA, assessed using the Azema classification, were comparable between both groups (SES/BES group type 2: 31%/27%; type 3: 54%/62%). At 12 months, the primary patency rates for SES and BES were 88% (26/26 patients) and 72% (58/64 patients) (P = .10). At 12 months, freedom from TLR rates for SES and BES were 97% vs 81%, respectively (P = .13). CONCLUSIONS: SES for CFA stenosis show a trend toward better patency and freedom from TLR rates at 12 months. However, controlled studies are warranted to further investigate the significance of this trend.

Polymer Everolimus-Eluting Stent as Bailout Stenting for Below-the-Knee Artery Repair in Patients with Critical Limb-Threatening Ischemia: A Real-World National Registry.

OBJECTIVES: Percutaneous old balloon angioplasty is still the preferred treatment for the treatment of below-the-knee (BTK) arteries in chronic limb-threatening ischemia (CLTI). In the case of a suboptimal angioplasty result, a bailout stenting is required. So far, few data are available to assess the outcomes of bailout stenting after BTK angioplasty. This study aims to investigate the 1-year efficacy and safety after implantation of a polymer everolimus-eluting stent (PEES) as bailout stenting for BTK repair in patients with CLTI in a real-world setting. DESIGN: This was a national multicenter prospective observational study. METHODS: Patients with CLTI (Rutherford 4 to 6) BTK lesions (including P3) and requiring a bailout PEES due to dissection, thrombosis, or residual stenosis ≥30% after angioplasty were included. The freedom of a major adverse limb event at 12 months of the target limb was the primary endpoint. RESULTS: XIENCE assessed 106 limbs (CLTI, 96.2%; chronic total occlusion, 2.8%) in 106 patients (mean age 77.1 years; males, 71.7%; diabetes mellitus, 66.9%; chronic kidney failure, 36.8%) with CLTI undergoing PEES stenting as a bailout for BTK lesions. Bailout stenting was required after 75.5% and 26.4% of residual stenosis and dissection, respectively. The mean diameter and length of the PEES were 3 mm and 3.4 ± 0.5 cm, respectively. At 1 year, the freedom of a major adverse limb event was 79.6% (95% CI, 71.5%-88.7%), the major amputation rate was 6.2% (95% CI, 1.3%-11%), and the target revascularization rate was 14.9% (95% CI, 6.5%-22.5%). CONCLUSIONS: In CLTI patients with BTK lesions, PEES stenting showed safety and efficacy as bailout stenting for BTK arterial lesions. This confirms the need for PEES stenting in a real-world practice. CLINICAL IMPACT: The XIENCE study introduces the PEES as an effective bailout stenting option for patients with CLTI undergoing BTK revascularization, particularly for lesions under 4 cm. The study focuses on real-world cases where POBA alone is insufficient, demonstrating that PEES significantly improves outcomes by enhancing limb salvage and reducing the need for major amputations. For clinicians, this innovation offers a precise, size-adaptable solution, especially in cases where bailout stenting is required for short, focal lesions, improving both clinical and procedural results.

Outcomes and Comparative Analysis of the Initial Results of Standard Balloon Angioplasty Versus Drug-Coated Balloons Alone Versus in Association With Laser-Excimer Atherectomy in the Treatment of Femoropopliteal Artery In-Stent Restenosis (INTACT).

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.

A Systematic Review and Meta-Analysis of Heparin-Bonded Expanded Polytetrafluoroethylene Grafts for Below-The-Knee Femoral Bypass Surgery.

BACKGROUND: Heparin-bonded expanded polytetrafluoroethylene (hb-ePTFE) synthetic grafts are an alternative to autologous vein grafts (AVG) for surgical bypass interventions in lower limb peripheral arterial disease (LLPAD). However, the clinical benefits of hb-ePTFE grafts have not been reviewed systematically for patients undergoing below-the-knee (BK) surgical bypass. This study aimed to meta-analyze available data on the utility of hb-ePTFE in patients undergoing BK surgical bypass. METHODS: Medline, Embase, and Cochrane databases were searched, restricted to material in English with no date restriction. In addition, proceedings from relevant congresses were screened going back 2 years. The search was performed in December 2021. Eligible studies included prospective or retrospective comparative studies or prospective single-arm cohorts with an hb-ePTFE arm. Methodological quality was assessed with the ROBINS-I criteria. Outcomes included primary patency, amputation/limb salvage, and overall survival. Clinical outcomes were expressed as event rates. Studies were compared using meta-analysis to generate a standardized mean event rate for each outcome, with its 95% confidence interval (95% CI), using a random-effects model. RESULTS: Following deduplication, 10,263 records were identified and 261 were assessed as full texts. No prospective comparative studies were identified. The level of evidence was uniformly low. Seventeen publications describing data from 9 individual patient cohorts met the inclusion criteria. These cohorts included a total of 1,452 patients undergoing BK surgical bypass with hb-ePTFE. The primary patency rate was 78.9% [95% CI: 72.2-85.7%] at 1 year, 68.2% [95% CI: 62.8-73.6%] at 2 years, decreasing to 48.0% [95% CI: 27.3-68.7%] at 5 years. The secondary patency rate was 84.8% [95% CI: 77.0-92.5%] at 1 year and 68.9% [95% CI: 43.0-94.9%] at 3 years; the 1-year limb salvage rate was 88.3% [95% CI: 79.6-97.1%] at 1 year and 79.0% [95% CI: 56.7-100%] at 3 years. CONCLUSIONS: In patients undergoing BK bypass surgery, hb-ePTFE synthetic grafts, compared to uncoated grafts, perform well for patency and limb salvage. However, the quality of the evidence is low, and well-performed randomized clinical trials are needed to inform clinical decision-making on the choice of synthetic graft.

Update About the Management of Low-Density Lipoprotein Cholesterol and Hypertriglyceridemia in Lower Extremity Peripheral Artery Disease Patients: Consensus of the French Society of Vascular Medicine and the French Society for Vascular and Endovascular Surgery.

BACKGROUND: A French intersociety consensus on behalf the Société Française de Médecine Vasculaire and the Société de Chirurgie Vasculaire et Endovasculaire was proposed in 2021 for the management of patients with lower extremity peripheral artery disease (LEAD). Recent studies have been published and an update of this consensus about the management of low-density lipoprotein cholesterol (LDLc) and hypertriglyceridemia was required. METHODS: A steering committee of 12 vascular physicians and surgeons defined questions of interest about LDLc and hypertriglyceridemia management. A French expert panel voted the proposals. Consensus was considered to have been achieved if more than 80% of the responses corresponded to either "Agreement" or "Disagreement". RESULTS: Among the 56 experts who were asked to participate, 46 (82%) accepted. After the first round of the Delphi procedure, the 4 proposals reached consensus. The following suggestions and recommendations were approved: 1. For LEAD patients treated by the highest tolerated statin dose ± ezetimibe and who have an LDLc ≥0.70 g/L, we recommend adding a proprotein convertase subtilisin/kexin type 9 inhibitor. 2. For LEAD patients treated by statin and who have elevated triglyceride level between ≥150 mg/dL and ≤500 mg/dL, we suggest adding Icosapent Ethyl. 3. Before adding Icosapent Ethyl in LEAD patients treated with statin, we suggest looking for symptoms that may suggest atrial fibrillation. 4. For LEAD patients treated by Icosapent Ethyl and who have symptoms that suggest atrial fibrillation, we recommend performing an electrocardiogram. CONCLUSIONS: This update will help clinicians to improve LEAD patient management.

Efficacy of a Drug-Eluting Stent Versus Bare Metal Stents for Symptomatic Femoropopliteal Peripheral Artery Disease: Primary Results of the EMINENT Randomized Trial.

BACKGROUND: A clear patency benefit of a drug-eluting stent (DES) over bare metal stents (BMSs) for treating peripheral artery disease of the femoropopliteal segment has not been definitively demonstrated. The EMINENT study (Trial Comparing Eluvia Versus Bare Metal Stent in Treatment of Superficial Femoral and/or Proximal Popliteal Artery) was designed to evaluate the patency of the Eluvia DES (Boston Scientific, Marlborough, MA), a polymer-coated paclitaxel-eluting stent, compared with BMSs for the treatment of femoropopliteal artery lesions. METHODS: EMINENT is a prospective, randomized, controlled, multicenter European study with blinded participants and outcome assessment. Patients with symptomatic peripheral artery disease (Rutherford category 2, 3, or 4) of the native superficial femoral artery or proximal popliteal artery with stenosis ≥70%, vessel diameter of 4 to 6 mm, and total lesion length of 30 to 210 mm were randomly assigned 2:1 to treatment with DES or BMS. The primary effectiveness outcome was primary patency at 12 months, defined as independent core laboratory-assessed duplex ultrasound peak systolic velocity ratio ≤2.4 in the absence of clinically driven target lesion revascularization or surgical bypass of the target lesion. Primary sustained clinical improvement was a secondary outcome defined as a decrease in Rutherford classification of ≥1 categories compared with baseline without a repeat target lesion revascularization. Health-related quality of life and walking function were assessed. RESULTS: A total of 775 patients were randomly assigned to treatment with DES (n=508) or commercially available BMSs (n=267). Baseline clinical, demographic, and lesion characteristics were similar between the study groups. Mean lesion length was 75.6±50.3 and 72.2±47.0 mm in the DES and BMS groups, respectively. The 12-month incidence of primary patency for DES treatment (83.2% [337 of 405]) was significantly greater than for BMS (74.3% [165 of 222]; P<0.01). Incidence of primary sustained clinical improvement was greater among patients treated with the DES than among those who received a BMS (83.0% versus 76.6%; P=0.045). The health-related quality of life dimensions of mobility and pain/discomfort improved for the majority of patients in both groups (for 66.4% and 53.6% of DES-treated and for 64.2% and 58.1% of BMS-treated patients, respectively) but did not differ significantly. At 12 months, no statistical difference was observed in all-cause mortality between patients treated with the DES or BMS (2.7% [13 of 474] versus 1.1% [3 of 263]; relative risk, 2.4 [95% CI, 0.69-8.36]; P=0.15). CONCLUSIONS: By demonstrating superior 1-year primary patency, the results of the EMINENT randomized study support the benefit of using a polymer-based paclitaxel-eluting stent as a first-line stent-based intervention for patients with symptomatic peripheral artery disease attributable to femoropopliteal lesions. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02921230.

Perioperative adverse events in percutaneous versus open brachial access.

OBJECTIVE: The objective of the present study was to compare the incidence of complications at the access site after percutaneous brachial access (PBA) and open brachial access (OBA) in the treatment of peripheral arterial disease. METHODS: From November 2016 to November 2021, all patients who had undergone peripheral artery revascularization with brachial access were included. The primary outcome was the 30-day rate of postoperative complications at the access site. The complications included hematoma, arteriovenous fistula, and pseudoaneurysms that had resulted in prolonged hospitalization and/or reintervention. RESULTS: Overall, 259 procedures with brachial access had been performed (PBA, n = 101; OBA, n = 158). The baseline clinical and demographic characteristics were well-balanced between the two groups. The sheath size was larger for the OBA procedures. Complications had occurred in 11 of 101 patients (11.1%) in the PBA group and 5 of 158 patients (3.2%) in the OBA group (P = .01). The mean duration of the procedure was significantly shorter for the PBA group (73.5 ± 46.5 minutes vs 101.2 ± 60.8 minutes; P = .0001). CONCLUSIONS: For patients who had undergone brachial access for peripheral vascular disease, the rate of access site-related complications was significantly lower for the patients who had undergone open access compared with that for the patients who had undergone percutaneous access.

Systematic Review and Meta-analysis of Clinical Outcomes After Endovascular Treatment in Patients With Femoropopliteal Lesions Greater Than 150 mm.

OBJECTIVE: Indications for endovascular treatment of femoropopliteal (FP) lesions have steadily increased over the past decade. Accordingly, the number of devices has also increased but the choice of the best endovascular treatment remains to be defined. The aim of this meta-analysis was to summarize all studies investigating endovascular treatment of FP lesions greater than 150 mm from 2010 to 2021. METHODS: Articles were searched using PubMed, Scopus, and Cochrane. Included studies were randomized controlled trials (RCTs), cohort studies, and case series (prospective and retrospective) that evaluated any endovascular procedure in patients with long FP lesions classified TASC (Trans-Atlantic Inter-Society Consensus document II on management of peripheral arterial disease) C and/or D, and a mean length >150 mm, primary outcome had to be the 1-year primary patency. Overall estimate of primary patency, secondary patency, and freedom from target lesion revascularization (TLR) at 1 year depending on the different devices were investigated. The meta-analysis was conducted following the requirements of the MOOSE (Meta-analysis of Observational Studies in Epidemiology) checklist. RESULTS: Forty-four papers comprising 4847 patients and 5282 treated limbs were included. Mean lesions length ranged from 150.5 to 330 mm. The pooled 1-year primary and secondary patencies, and freedom from TLR rates were 0.71 (95% CI: 0.67-0.74), 0.87 (95% CI: 0.83-0.91), and 0.79 (95% CI: 0.74-0.84), respectively. Primary permeability at 1 year were 0.68 (95% CI: 0.62-0.73), 0.67 (95% CI: 0.60-0.74), 0.74 (95% CI: 0.64-0.84), and 0.83 (95% CI: 0.78-0.88) for bare metal stents, covered stents (CSs), drug-eluting stents, and drug-coated balloons (DCBs), respectively. Lesions treated with DCB had the highest 1-year primary patency rate. CONCLUSIONS: At 1-year, endovascular procedures for FP lesions greater than 150 mm obtain satisfactory results. High primary patency rates were obtained with drug-coated devices, while CSs obtained less favorable results. Randomized studies comparing different devices in the treatment of long FP lesions remain necessary to determine the most optimal approach for the management of these patients. CLINICAL IMPACT: This paper highlights on the one hand the satisfactory results of endovascular treatment on complex femoropopliteal lesions formerly reserved for conventional surgery. On the other hand, among the available devices, paclitaxel-eluting devices seem to show superior results which should make them recommended as first-line treatment.

Treatment of Long Femoropopliteal Lesions With Self-Expanding Interwoven Nitinol Stent: 24 Month Outcomes of the STELLA-SUPERA Trial.

PURPOSE: The performance of self-expanding interwoven nitinol stent (Supera) in femoropopliteal interventions has been proven through trials with short lesions and with relatively low proportion of occlusions. There is limited evidence of Supera stent in long lesions. The aim of this study was to assess the clinical safety and efficiency of the Supera stent in the treatment of long femoropopliteal lesions (Trans-Atlantic Inter-Society Consensus [TASC] C/D) in patients with symptomatic peripheral arterial disease (PAD). METHODS: The STELLA SUPERA (STEnting Long de L'Artère fémorale superficielle par le stent métallique Supera) is a prospective, 2-center, single-arm study. Patients with symptomatic (Rutherford stages 2-6) de novo and TASC C/D lesions of the femoropopliteal segment were treated with Supera stent. The primary endpoint was the primary sustained clinical improvement at 12 months. Follow-up included clinical examination, duplex scan, and biplane X-ray up to 24 months. RESULTS: Between December 2016 and October 2018, 48 symptomatic patients with 49 femoropopliteal lesions (TASC D = 32, 65%) were treated. The mean lesion length was 234 ± 123 mm, and 78% were total occlusion. The mean stented lesion length was 273 ± 127 mm. At 12 and 24 months, the primary sustained clinical improvement rate was 87.2% and 79.7%, respectively. The Rutherford category assessment was significantly improved at 24 months compared with baseline (p=0.02). At 24 months, the primary patency and freedom from target lesion revascularization (TLR) rates were 77.9% and 86.9%, respectively. The ankle-brachial pressure index increased from 0.62 ± 0.15 at baseline to 0.93 ± 0.15 at 24 months (p<0.0001). There were no stent fractures at 24 months. CONCLUSION: The use of Supera stent in long lesions (TASC C/D) is a safe and effective endovascular alternative. These results reinforce the need for randomized clinical trials to assess the value of interwoven stents for long femoropopliteal lesions.

Treatment of Long Femoropopliteal Occlusive Lesions With Self-expanding Interwoven Nitinol Stent: 24 Month Outcomes of the STELLA-SUPERA-SIBERIA Register Trial.

PURPOSE: The efficacy and safety of the Supera stent in superficial femoral artery (SFA) have been reported mostly in shorter lesions with relatively low proportion of occlusions. There are little data on the effectiveness of the Supera stent in long lesions. The aim of this study was to assess the clinical safety and efficiency of the Supera stent in the treatment of long femoropopliteal occlusive lesions (Trans-Atlantic Inter-Society Consensus [TASC] C/D) in patients with symptomatic peripheral artery disease. MATERIALS AND METHODS: The STELLA-SUPERA-SIBERIA is a prospective, single-center, single-arm study. Patients with symptomatic (Rutherford stages 3-6) de novo and TASC C/D occlusive lesions of the femoropopliteal segment were treated with Supera stent. The primary endpoint was the 12 month rate of primary sustained clinical improvement (upward shift on the Rutherford classification to a one level without the need for repeated target lesion revascularization (TLR) in surviving patients without the need for unplanned amputation). Secondary endpoints were the 24 month of primary sustained clinical improvement, MALE, limb salvage, the primary patency, the secondary patency, 24 month MACE. Follow-up included clinical examination, duplex scan, and biplane x-ray up to 24 months. RESULTS: Between April 2019 and January 2020, 52 symptomatic patients with 55 long femoropopliteal occlusive lesions (52.7% TASC D lesions and 47.3% TASC C lesions) were treated. The mean target lesion length was 205±72 mm. All patients had total occlusions. The mean lesion length of the implanted Supera stents was 198±82 mm. At 12 and 24 months, the primary sustained clinical improvement rate was 80.2% and 63.6%, respectively. The Rutherford category assessment was significantly improved at 24 months compared with baseline (p=0.02). The primary patency rate at 12 and 24 months was 78.1% and 60.0%, respectively. At 12 and 24 months, freedom from TLR was 83.5% and 81.8%, respectively. There were no stent fractures at 24 months. CONCLUSION: Supera Stent implantation for TASC C/D femoropopliteal lesions revascularization appears to be a safe and efficient implant given the complexity of the treated lesions. Head-to-head studies are mandatory to establish Supera Stent as an alternative tool to open surgery for long femoropopliteal lesions. CLINICAL IMPACT: Our study indicated, that using self-expanding interwoven nitinol stent for TASC C/D femoropopliteal lesions revascularization appears to be a safe and efficient implant given the complexity of the treated lesions. Although bypass grafting is recommended for prolonged femoropopliteal lesions, open surgery is more traumatic and is associated with greater risks than endovascular procedures. Our findings suggest that the use of interwoven nitinol stents can overcome the disadvantages of traditional stents in such cases, which may help to improve patients' outcomes and reduce the risk of adverse events.

Primary results of the SAVAL randomized trial of a paclitaxel-eluting nitinol stent versus percutaneous transluminal angioplasty in infrapopliteal arteries.

BACKGROUND: Effective and durable options for infrapopliteal artery revascularization for patients with chronic limb-threatening ischemia (CLTI) are limited. METHODS: The SAVAL trial is a prospective, multicenter, randomized trial of patients with CLTI and infrapopliteal artery lesions with total lesion length ⩽ 140 mm, stenosis ⩾ 70%, and Rutherford category 4-5 assigned 2:1 to treatment with the SAVAL self-expandable paclitaxel drug-eluting stent (DES) or percutaneous transluminal angioplasty (PTA) with an uncoated balloon. The primary effectiveness endpoint was primary vessel patency (i.e., core lab-adjudicated duplex ultrasound-based flow at 12 months in the absence of clinically driven target lesion revascularization or surgical bypass of the target lesion). The primary safety endpoint was the 12-month major adverse event (MAE)-free rate; MAEs were defined as a composite of above-ankle index limb amputation, major reintervention, and 30-day mortality. The endpoints were prespecified for superiority (effectiveness) and noninferiority (safety) at a one-sided significance level of 2.5%. RESULTS: A total of 201 patients were enrolled and randomly assigned to treatment (N = 130 DES, N = 71 PTA). Target lesion length was 68.1 ± 35.2 mm for the DES group and 68.7 ± 49.2 mm for the PTA group, and 31.0% and 27.6% of patients, respectively, had occlusions. The 12-month primary patency rates were 68.0% for the DES group and 76.0% for the PTA group (Psuperiority = 0.8552). The MAE-free rates were 91.6% and 95.3%, respectively (Pnoninferiority = 0.0433). CONCLUSION: The SAVAL trial did not show benefit related to effectiveness and safety with the nitinol DES compared with PTA in infrapopliteal artery lesions up to 140 mm in length. Continued innovation to provide optimal treatments for CLTI is needed. (ClinicalTrials.gov Identifier: NCT03551496).

Costs and Budget Impact of Collagen-Based Vascular Closure Device Versus Manual Compression Following Peripheral Endovascular Procedures.

BACKGROUND: The objective of this study was to evaluate the annual costs and budget impact of using a vascular closure device to achieve hemostasis following femoral access endovascular procedures in England, compared with manual compression. METHODS: A budget impact model was developed in Microsoft® Excel, based on the estimated number of peripheral endovascular procedures eligible for day-case management performed annually by the National Health Service in England. The clinical effectiveness of vascular closure devices was captured based on the requirement for inpatient stays and the incidence of complications. Data for endovascular procedures, time to hemostasis, length of hospital stay, and complications were collected from public sources and the published literature. There were no patients involved in this study. Model outcomes are reported as estimated number of bed days and annual costs to the National Health Service for all peripheral endovascular procedures in England, and the average cost per procedure. The robustness of the model was tested in a sensitivity analysis. RESULTS: The model estimated savings for the National Health Service of up to £4.5 million annually if vascular closure devices were used in every procedure instead of manual compression. The model estimated an average cost saving of £176 per procedure for vascular closure devices over manual compression, primarily due to fewer inpatient stays. The sensitivity analysis demonstrated that the proportion of day-case procedures for vascular closure devices and manual compression was a key driver of costs and savings. CONCLUSIONS: The use of vascular closure devices for achieving hemostasis after peripheral endovascular procedures may be associated with lower resource use and cost burden, compared with manual compression, based on shorter time to hemostasis and ambulation and an increased likelihood of a day-case procedure.

Arterial Reconstruction for En-Bloc Resection of Soft Tissue Sarcoma: A Single Tertiary Center Experience.

BACKGROUND: Tertiary centers recruit a number of locally advanced or recurrent soft tissue sarcomas (STSs) that require large tissue loss including vessels. Arterial reconstruction (AR) in the context of patients with cancer who may receive radiotherapy (RT) and chemotherapy (CT) is challenging. METHODS: This retrospective single centre cohort study includes patients affected by extremities or trunk STS who underwent an AR during sarcoma resection, between October 2015 and February 2021 at Institut Curie. The endpoints of this study were to analyze the morbidity, the patency, and the impact on surgical margins of such associations. RESULTS: Of 976 patients operated, 21 (2.15%) had AR. Seventeen (81%) had American Society of Anesthesiologists (ASA) scores ≥2. Locations were as follows: intra-abdominal n = 9 (43%), lower limb n = 8 (38%), upper limb n = 3 (14%), and cervical n = 1 (5%). N = 11 (52.3%) and n = 5 (23.8%) received RT or were operated on a preirradiated field, respectively. N = 7 (34%) patients received CT. Vein graft was used in n = 12 (57%). Musculo-cutaneous flaps were associated in n = 13 (62%) patients. Margins of resection were R0 n = 19 (90.4%), R1 n = 2, and R2 n = 0. The median follow-up was 16 months [6-44]. No postoperative death occurred. Two patients died of metastasis. At 1, 6, 12, and 24 months the primary patency was 80.9%, 71.4%, 87.5%, and 88.9%, respectively. Seven patients (33%) presented perioperative infection. Reoperation rate at 1, 6, and 12 months were 38%, 14%, and 5%, respectively. Ten patients (48%) presented persistent lymphoedema during follow-up. CONCLUSIONS: AR enlarges the possibilities of STS excision with healthy margins and achieves good patency. Majority of patients were ASA ≥ 2 and received adjuvant treatments. In this particular context, morbidity is high and requires an upfront multidisciplinary management taking into account all these specific issues.

Fusion imaging guidance for endovascular recanalization of peripheral occlusive disease.

OBJECTIVE: Endovascular procedures are now the first line option for treatment of lower extremity arterial disease. Fusion imaging guidance has been reported to reduce radiation exposure and reintervention rates during fenestrated and branched endovascular repairs, but limited literature exists on its benefits during lower extremity arterial disease endovascular procedures, and more specifically peripheral occlusive disease (POD). This study aims to evaluate the radiation exposure and technical success benefits of fusion imaging guidance in a large cohort of patients treated endovascularly for complex POD. METHODS: From January 2017 to September 2019, in a single center, all consecutive patients presenting symptomatic occlusions (Rutherford Baker categories 3 to 6) in the setting of POD and treated endovascularly were retrospectively assessed for inclusion. All procedures were performed under augmented fluoroscopy guidance (Vessel ASSIST, GE Healthcare), overlaying on live imaging the 3D path for transluminal recanalization based on the preoperative computed tomography angiography. Technical success, dose area product (DAP), total cumulated air kerma (CAK), and fluoroscopy time were collected. DAP results were compared with the literature. RESULTS: During the study period, 179 patients were treated for iliac (n = 56) or femoropopliteal (n = 123) symptomatic arterial occlusions. Technical success was reported in 171 of 179 procedures (95.5%). The use of a re-entry catheter was required to achieve technical success in 11 patients (6.1%). Mean DAP and CAK were 12.70 Gy·cm2 and 135 mGy, respectively, with a mean fluoroscopy time of 15.26 minutes. DAP and CAK were significantly higher in the iliac group when compared with the femoropopliteal group, although fluoroscopy time was not significantly different. DAP was lower than levels reported in the literature. CONCLUSIONS: Routine use of fusion imaging guidance during POD endovascular treatment is associated with low radiation exposure, high technical success, and reduced need for re-entry systems.

Fusion Imaging Guidance Does Not Affect Radiation Exposure During Endovascular Procedures for Lower Extremity Arterial Disease: A Randomized Controlled Trial.

PURPOSE: Radiation exposure for vascular interventionalists is still a concern. The aim of this study was to assess the value of advanced imaging guidance on radiation exposure and iodinated contrast volume during endovascular treatment of lower extremity arterial disease (LEAD). MATERIALS AND METHODS: It was a prospective, randomized, monocentric, pilot, single-operator study, conducted from June 2018 to October 2019. Consecutive patients requiring a preoperative computed tomography angiography (CTA) for a symptomatic LEAD and scheduled for an iliac and/or femoropopliteal endovascular repair in a hybrid room were included. Patients were randomly assigned to the use of fusion imaging guidance (Vessel Navigator®, Philips) or not. The primary endpoint was the dose area product (DAP, Gy.cm²). Secondary endpoints were DAP for fluoroscopy, DAP for fluorography, Air Kerma, fluoroscopy time, volume of contrast, and number of digital subtraction angiography (DSA). Data were expressed in median [Q1-Q3]. RESULTS: In all, 64 of the 77 patients enrolled (34 in fusion group, 30 in control group, 82% men, 65.8 years [61-71]) were included. Groups were similar in terms of comorbidities, BMI (26 kg/cm2 [24-28]), but lesion location were not equally distributed (p=0.004). There was no significant difference between the groups regarding DAP (31.6 Gy.cm2 [23.4; 46.9] for fusion group vs 25.6[16.9; 34.0] Gy.cm2; p=0.07), Air Kerma (160 mGy [96;3365] vs 115 mGy [76;201]; p=0.12, fluoroscopy time (560 seconds [326;960] vs 454 seconds [228;1022]; p=0.44), contrast volume (60 ml [42;80] vs 50 ml [40;66]; p=0.10), or operative time (68 minutes [55;90] vs 46 minutes [30;80]; p=0.06). The median number of DSA was 14 [10-18] in the fusion group versus 11 [6-18]; p=0.049. CONCLUSION: Fusion imaging guidance does not affect radiation exposure and contrast volume during endovascular revascularisation of iliac and femoropopliteal occlusive disease in a hybrid room environment.

Late Outcomes of Carotid Artery Stenting for Radiation Therapy-Induced Carotid Stenosis.

PURPOSE: Carotid artery stenting (CAS) appears as a promising alternative treatment to carotid endarterectomy for radiation therapy (RT)-induced carotid stenosis. However, this is based on a poor level of evidence studies (small sample size, primarily single institution reports, few long-term data). The purpose of this study was to report the long-term outcomes of a multicentric series of CAS for RT-induced stenosis. METHODS: All CAS for RT-induced stenosis performed in 11 French academic institutions from 2005 to 2017 were collected in this retrospective study. Patient demographics, clinical risk factors, elapsed time from RT, clinical presentation and imaging parameters of carotid stenosis were preoperatively gathered. Long-term outcomes were determined by clinical follow-up and duplex ultrasound. The primary endpoint was the occurrence of cerebrovascular events during follow-up. Secondary endpoints included perioperative morbidity and mortality rate, long-term mortality rate, primary patency, and target lesion revascularization. RESULTS: One hundred and twenty-one CAS procedures were performed in 112 patients. The mean interval between irradiation and CAS was 15 ± 12 years. In 31.4% of cases, the lesion was symptomatic. Mean follow-up was 42.5 ± 32.6 months (range 1-141 months). The mortality rate at 5 years was 23%. The neurologic event-free survival and the in-stent restenosis rates at 5 years were 87.8% and 38.9%, respectively. Diabetes mellitus (p=0.02) and single postoperative antiplatelet therapy (p=0.001) were found to be significant predictors of in-stent restenosis. Freedom from target lesion revascularization was 91.9% at 5 years. CONCLUSION: This study showed that CAS is an effective option for RT-induced stenosis in patients not favorable to carotid endarterectomy. The CAS was associated with a low rate of neurological events and reinterventions at long-term follow-up.

Geographical Ambulatory Endovascular Revascularisation Disparities in France From 2015 to 2019.

OBJECTIVE: Despite efficiency and safety evidence, ambulatory endovascular revascularisation for lower extremity arterial disease (LEAD) accounted for only 5% of interventions in France in 2016. Such a low rate suggests temporal and geographical space disparities. The aim of this study was to describe the space-time development of ambulatory endovascular revascularisation for LEAD in France and to investigate the contributions of healthcare services and population characteristics as potential determinants. METHODS: A retrospective study of discharge data from French hospitals that performed endovascular procedures for LEAD between 2015 and 2019 was conducted. Space-time analyses with Moran's Index, zero inflated Poisson regression, and clustering approaches were applied. Spatial clusters were compared on the basis of healthcare services and population characteristics (including poverty and single man household as proxies of social isolation). RESULTS: Between 2015 and 2019, the number of ambulatory interventions tripled (1 104 vs.3 130). Of the 86 French departments, the proportion with >5% of ambulatory interventions increased from 10.7% to 28.7% over the study period. In 2019, ambulatory activity in French departments ranged from 0% to 39%. This change was accompanied by a northwest to northeast spatial trend. The clusters of 27 departments with substantial ambulatory activity differed from the others notably by the mortality rate of lower limb arterial thromboembolic diseases in males (OR 3.15, 95% CI 1.2-8.1), the proportion of single man households of age ≥75 (OR 0.37, 95% CI 0.2-0.8), and the poverty rate of people aged 50-59 years (OR 0.69, 95% CI 0.5-0.9). CONCLUSIONS: The development of ambulatory interventions for LEAD in France is encouraging but heterogeneous. Some determinants of this evolution are clearly population based, with a positive impact of needs to take care of the burden of LEAD but negative effects of social isolation and poverty. Research should be conducted to overcome some patient constraints such as isolation.

Antegrade Superficial Femoral Artery Approach Using Manual Compression and 4-F Delivery System for Infrainguinal Occlusive Disease.

BACKGROUND: This study sought to assess the feasibility and safety of antegrade superficial femoral artery (SFA) duplex-guided puncture using a 4-F catheter sheath and manual compression for the treatment of infrainguinal occlusive lesions. METHODS: From March 2017 to March 2019, all patients who underwent endovascular treatment employing an antegrade SFA approach for femoropopliteal or below-the-knee lesions were included in this study. Follow-up included clinical and duplex ultrasound examinations at 1 month. The primary endpoint was the frequency of major complications at the puncture site. RESULTS: In all, 71 procedures were performed in 70 patients (46 men; mean age: 79.1 ± 11.5 years), most of whom presented with critical limb-threatening ischemia (n = 59; 83%). Of these 71 procedures, 35 (49.3%) were performed for isolated femoropopliteal lesions and 24 (33.8%) for multilevel lesions. The primary endpoint was observed in 4 patients (5.6%). There were 3 observed hematomas (4.2%): 2 required surgical treatment, and 1 necessitated transfusion without intervention. At 30 days, we reported 1 pseudoaneurysm (1.4%). CONCLUSIONS: Our results showed that antegrade SFA puncture is feasible and safe with duplex ultrasound guidance and use of a 4-F catheter sheath.