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Background: Percutaneous endovascular repair (PEVAR) of infra-renal abdominal aortic aneurysms (AAA) is increasingly being performed due to the development of low profile endografts and the use of percutaneous closure devices. The feasibility and safety of the use of the INCRAFT AAA Stentgraft System and the ProGlide vascular closure system was assessed. Methods: The PUCCINI trial prospectively enrolled patients undergoing elective repair of infrarenal AAA at 3 centres in the Netherlands and 3 centres in Belgium. Patients underwent PEVAR with endograft implantation followed by closure using the ProGlide closure device. Procedural success rates, complications and 30-day follow-up outcomes were collected. Results: A total of 93 patients, 87% male, were enrolled. The mean aneurysmal diameter was 53.9 ± 10.2 mm. Successful ProGlide placement was achieved in 97.2% in the right and 89.8% in the left groin. Successful closure was achieved in 92.4% of right and 90% of left groins. One patient required surgical access and two surgical closure. Average blood loss was 155.6 ± 175.5ml. Blood transfusion was not required. Average length of hospital stay was 2.1 ± 1.3 days. Post-implantation endoleaks were present in 37 (40.2%) patients (type 1: 12, type 2: 25). At 30-days there was no aneurysmal growth and no deaths. Follow-up imaging showed endoleaks in 39 (41.9%) patients. (type 1:8, type 2:29, type 3:2). Conclusion: The results from the PUCCINI trial demonstrate that the use of a low profile endoprosthesis for treatment of infrarenal AAA with percutaneous closure has a high rate of technical success and low rates of periprocedural complication. [ABSTRACT FROM AUTHOR]

Background: The purpose of the FEMOSEAL CLOSE study was to assess the safety and effectiveness of FemoSeal™ vascular closure device in achieving haemostasis following transfemoral peripheral procedures in routine clinical practice., Materials and Methods: This prospective, European, multi-centre, single-arm, post-market clinical follow-up study enrolled patients undergoing diagnostic or interventional peripheral endovascular procedures with FemoSeal™ vascular closure device in inpatient or outpatient settings. The primary endpoint was a composite of safety and effectiveness, with effectiveness defined as cessation of arterial bleeding without adjunctive treatment, and safety as freedom from major vascular complications in the first 6 h. Secondary endpoints included: minor access-site complications and major complications 6 h to 30 days post-procedure, and time to haemostasis, ambulation and discharge. Quality of life was assessed at baseline, discharge and 30-day follow-up. Device usability was also surveyed., Results: Between December 2021 and July 2022, 230 patients were enrolled in three European centres. The primary composite endpoint was achieved in 95.1% (215/226) [95% confidence interval: 91.46-97.55] of patients. The effectiveness component was achieved in 96.9% (219/226) [95% confidence interval: 93.70-98.70], and the safety component in 95.2% (220/230) [95% confidence interval: 92.15-97.90] of patients. FemoSeal™ vascular closure device deployment failure occurred in 1.6% (4/230) of cases, with subsequent manual compression achieving haemostasis. The median time to haemostasis was 0.42 min., Conclusions: The study device provides effective haemostasis and low rates of access-site complications up to 30 days post-procedure for patients undergoing peripheral endovascular interventions. It demonstrates good performance with rapid haemostasis., Trial Registration: The study is registered at clinicaltrials.gov. (ClinicalTrials identifier: NCT05027698)., Competing Interests: Declarations. Ethics approval and consent to participate: This study was conducted in accordance with the principles outlined in the Declaration of Helsinki and adhered to ethical guidelines for medical research involving human subjects. Ethical approval for the study was obtained from the Ethic Committees in the participating sites, as listed below: Country Site Ethics Committee Competent Authority Other Belgium AZ Sint-Blasius Dendermonde CIP v1.0 approved on 13DEC2021 by Comité voor Medische Ethiek UZA (central EC) No submission required Not applicable France Hôpital Paris Saint Joseph CIP v1.0 approved on 2DEC2021 by CPP OUEST I (central EC) Accepted by ANSM on 26NOV2021 CNIL declaration n°2,223,359 performed 24AUG2021 Germany Universitäts-Herzzentrum Freiburg Bad Krozingen CIP approved on 17MAR2022 by Ethics Committee of the Albert Ludwig University of Freiburg (local EC) No submission required Not applicable All participants provided informed consent prior to their inclusion in the study. They were thoroughly informed about the study’s purpose, procedures, potential risks, and benefits. Participants were also assured of their right to withdraw from the study at any time without any repercussions. Consent was documented in written form, and copies of the consent documents are securely stored in accordance with institutional policies. In cases where participants were unable to provide consent personally, legal guardians or authorized representatives provided consent on their behalf. Additionally, confidentiality and anonymity of the participants’ data were strictly maintained. Consent for publication: Not applicable. Competing interests: YG: Research funding from: Abbott, Boston Scientific, General Electric, Veryan, WL Gore.Personal fees and grants from: Abbott, Bard, Biotronik, Boston Scientific, Cook, General Electric, Medtronic, Penumbra, Terumo, Veryan, WL Gore (medical advisory board, educational course, speaking). TZ: No conflict of interest. KD: Grant/Research from: Abbott, Biotronik, iVascular, Terumo. Consultancy from: Abbott, BD, Bently, Biotronik, Boston Scientific, Cook, GE Healthcare. MD: No conflict of interest., (© 2025. The Author(s).)

Background: Due to the heterogeneity of literature findings, stent type selection for the endovascular treatment of complex aorto-iliac occlusive disease remains challenging. The BELSTREAM study, a physician-initiated, prospective, multicenter, single-arm study, aims to report the safety and efficacy of the balloon expandable LifeStream Peripheral Stent Graft System (BD, Tempe, Arizona, USA) for the treatment of complex TASC C and D aorto-iliac artery lesions., Methods: Seventy patients and 133 lesions were included at six Belgian institutions. The primary efficacy endpoint of the study is primary patency at 12 months' follow-up. The primary safety endpoint is freedom from periprocedural serious adverse events (SAEs)., Results: Primary patency rate at 12-month follow-up was 94.5%. Target Lesion Revascularization (TLR) was reported in three patients at 12-month follow-up, resulting in a freedom from TLR rate of 95.3%. In a subgroup of patients with aorto-iliac stenting in kissing configuration, primary patency at 12-month follow-up was 97.4% with freedom from TLR 97.9%. Freedom from a negative primary safety outcome (NPSO) was 100% at 30 days in the overall study patient population., Conclusions: The patency and freedom from TLR rates, low adverse event rates, and up to one year sustained improvement in clinical outcomes demonstrate that the LifeStream™ Balloon Expandable Vascular Covered Stent is a well-suited device for the treatment of complex TASC C and D lesions, the challenging kissing configuration included.

Background: To investigate the long-term efficacy of the paclitaxel-eluting Legflow balloon catheter in the treatment of "real-world" long and complex femoropopliteal lesions., Methods: The REFLOW study was a prospective, multi-national, non-randomized, single arm study evaluating the long-term safety and efficacy of the Legflow paclitaxel-eluting balloon dilatation catheter in the treatment of stenotic or occlusive lesions >150 mm long in the femoropopliteal arteries of symptomatic patients (Rutherford 2-5). A total of 120 study subjects were enrolled in a period of 30 months, between October 2015 and May 2018. The mean age was 71.1 years and 79 patients were men (65.8%). Mean lesion length was 216.1 mm. 45.0% of the lesions were occluded, whereas 55.0% were stenotic. For this extended study follow-up, 100 out of 120 patients agreed to participate. The primary endpoint was primary patency at 24 months, defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within 24 months., Results: Primary patency was 70.50% at 2 year. Freedom from TLR was 76.10% at 2 year., Conclusions: Longer term follow-up confirms there is no safety-concern on this paclitaxel device. The excellent results of the newer drug-eluting devices, and the Legflow paclitaxel-eluting balloon in particular, is a valid and effective alternative to treat long and complex "real-world" femoropopliteal lesions.

Peripheral arterial disease is the third leading cause of cardiovascular morbidity after coronary artery disease and stroke. Lower limb peripheral arterial disease commonly involves infrainguinal arteries, may impair walking ability (intermittent claudication) and may confer a significant risk of limb loss (chronic limb-threatening ischaemia), depending on the severity of ischaemia. Endovascular treatment has become the mainstay revascularisation option in both the femoropopliteal and the below-the-knee arterial segments. After crossing and preparing the lesion, treatment results in these arterial segments can be enhanced by using drug-coated devices (drug-eluting stents and drug-coated balloons) that mitigate the occurrence of restenosis. As for other medical devices, the use of drug-eluting devices is based on their demonstrated safety and efficacy profiles when applied in the distinct segments of the lower limb vasculature. In this state-of-the-art narrative review we provide an overview of the safety and efficacy of drug-coated devices when used in the femoropopliteal and below-the-knee arterial segments.

Objective: In two randomized controlled trials, the outcomes of endovascular treatment of complex femoropopliteal arterial lesions were compared with bypass surgery and considered a valid alternative treatment. The aim of this study was to compare both endovascular treatment options with the hypothesis that implantation of heparin-bonded self-expanding covered stents (Viabahn [SECS]) or drug-eluting stents (ZilverPTX [DES]) are related to similar clinical outcomes at 1-year follow-up., Methods: In a post-hoc analysis, the SuperB trial and Zilverpass databases were merged. Patients in the endovascular treatment arms were included, and data was analyzed in an intention-to-treat (ITT) and a per-protocol (PP) fashion. Data included baseline and lesion characteristics, procedural details, and follow-up data. The primary endpoint of this study was primary patency at 1-year follow-up. The secondary endpoints were secondary patency, target lesion revascularization (TLR), limb loss, and all-cause mortality., Results: A total of 176 patients were included; 63 in the SECS arm and 113 in the DES arm. Through 1-year follow-up, there were no significant differences in primary patency (ITT: 63.4% vs 71.1%: P = .183 and PP: 60.8% vs 71.1%; P = .100). Secondary patency rates were not significantly different in the ITT analysis (86.5% vs 95.1%; P = .054), but in the PP analysis, there was a significant difference in favor of the DES group (SECS, 85.6% vs DES, 95.1%; P = .038). There was no significant difference in freedom from TLR between groups (79.6% vs 77.0%; P = .481). No major amputations were performed in the SECS group, and two were performed in the DES group (1.8%). Survival rate was 98.2% in the SECS group, and 91.3% in the DES group after 1-year follow-up (P = .106). Based on diagnosis (intermittent claudication vs chronic limb-threatening ischemia) no differences between patients with intermittent claudication and chronic limb-threatening ischemia were observed in primary patency, secondary patency and freedom from TLR., Conclusions: Treatment of complex femoropopliteal arterial disease with the heparin-bonded Viabahn endoprosthesis and the Zilver PTX drug-eluting stent are related to similar primary and secondary patency, and TLR rates at 1 year, except for secondary patency in the PP analysis. This study further supports the endovascular treatment of long complex lesions in the femoropopliteal artery., Competing Interests: Disclosures L.v.W. received speaker fees from W.L. Gore & Associates. M.B. reports consulting for Cook Medical. K.D. reports consulting for W.L. Gore & Associates and Cook Medical. C.J.Z. reports research support, honoraria, and travel support from W.L. Gore & Associates and Cook Medical. M.R. reports consulting for W.L. Gore & Associates., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: In contemporary clinical practice, carotid artery stenting (CAS) is increasingly becoming a multispecialty field, joining operators of various training backgrounds, which bring forth their unique expertise, patient management philosophies, and procedural preferences. The best practices and approaches, however, are still debated. Therefore, real-world insights on different operator preferences and related outcomes are of utmost value, yet still rather scarce in the available literature., Methods: Using the data collected in the ROADSAVER observational, European multicenter CAS study, a prespecified comparative analysis evaluating the impact of the operator's specialization was performed. We used major adverse event (MAE) rate at 30-day follow-up, defined as the cumulative incidence of any death or stroke, and its components as outcome measures., Results: A total of 1965 procedures were analyzed; almost half 878 (44.7%) were performed by radiologists (interventional/neuro), 717 (36.5%) by cardiologists or angiologists, and 370 (18.8%) by surgeons (vascular/neuro). Patients treated by surgeons were the oldest (72.9±8.5), while radiologists treated most symptomatic patients (58.1%) and more often used radial access (37.2%). The 30-day MAE incidence achieved by cardiologists/angiologists was 2.0%, radiologists 2.5%, and surgeons 1.9%; the observed differences in rates were statistically not-significant (P=0.7027), even when adjusted for baseline patient/lesion and procedural disparities across groups. The corresponding incidence rates for death from any cause were 1.0%, 0.8%, and 0.3%, P=0.4880, and for any stroke: 1.4%, 2.3%, and 1.9%, P=0.4477, respectively., Conclusions: Despite the disparities in patient selection and procedural preferences, the outcomes achieved by different specialties in real-world, contemporary CAS practice remain similar when using modern devices and techniques.

Objective: There is a need for improved outcomes in the endovascular treatment of patients suffering from chronic limb threatening ischaemia (CLTI), highly calcified lesions, and chronic total occlusions (CTOs). The helical centreline self expanding BioMimics 3D stent might be particularly useful in these high risk subsets, combining flexibility and fracture resistance with radial strength. Herein, the performance of the BioMimics 3D stent was assessed in these high risk subsets., Methods: MIMICS-3D is a prospective, multicentre, European real world registry. This was a post hoc analysis, comparing patients with CLTI vs. intermittent claudication (IC), lesions with bilateral calcification vs. those without (peripheral arterial calcium scoring system [PACSS] 3,4 vs. PACSS 0 - 2), and CTO vs. no CTO. Propensity score matching was performed to reduce the impact of baseline variables. The 36 month endpoints were clinically driven target lesion revascularisation (CD-TLR), death, major target limb amputation, and stent patency., Results: A total of 507 patients were enrolled. At 36 months, patients with CLTI had lower freedom from major amputation than patients with IC (92.6% vs. 100%, p < .001). In terms of primary patency, patients with CTO had lower patency rates than those without (63.9% vs. 77.8%, p = .003), but the difference reduced after propensity score matching (70.5% vs. 76.8%, p = .43). Primary patency was not impaired for patients with PACSS 3,4 or patients with CLTI. Freedom from CD-TLR was not significantly different among the groups and was 73.8% for CLTI vs. 78.9% for IC (p = .15), 77.6% for PACSS 3,4 vs. 78.7% for PACSS 0 - 2 (p = .55), and 75.6% for CTO vs. 81.0% for no CTO (p = .11)., Conclusions: The outcome of the MIMICS-3D registry suggests that the BioMimics 3D stent is effective in the endovascular treatment of complex femoropopliteal lesions and in CLTI. Future randomised controlled trials should confirm its non-inferiority or superiority compared with existing alternatives., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: The BIO REACT study is designed to investigate the incremental value of Extravascular UltraSound (EVUS) added to conventional angiography, compared to conventional angiography only for the identification of Flow-Limiting Dissections (FLD) and to evaluate the safety and efficacy of the REsponse Adapted Combination Therapy (REACT) for the treatment of femoropopliteal lesions. Methods: The primary endpoints were the specificity and sensitivity of EVUS added to angiography for the detection of FLD. Secondary endpoints were primary patency of the REACT therapy within 12 months, fCD-TLR, freedom from MAE, major target limb amputations (mTLA) and survival rates within 24 months. Results: A total of 150 patients were included. EVUS added to angiography had an overall sensitivity of 29% and specificity of 93% for the detection of FLD. There was no PSVR cut-off offering a clinically acceptable trade-off between meaningful sensitivity and specificity values for the detection of FLD. At 12 months, treatment with the REACT resulted in primary patency and fCD-TLR of 81.6% and 94.3%, respectively. In addition, freedom from MAE was 94.3% at 12 months. At 24 months, the survival rate was 94.0%. No mTLA was reported up to the 24-month follow-up. Conclusions: The addition of DUS to angiography showed limited value for detecting FLD in femoropopliteal artery disease.

Purpose: To report the 60-month safety and effectiveness results of a multicenter, prospective, randomized controlled trial comparing the ZILVER PTX paclitaxel-eluting stent to prosthetic above-the-knee bypass for the treatment of symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions., Materials and Methods: Patients were enrolled between October 2013 and July 2017. One of the secondary outcomes was primary patency at 60 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex ultrasound peak systolic velocity ratio < 2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass at 60 months. Survival rates after 5 years were also analyzed., Results: 220 patients (mean age 68.6 ± 10.5 years; 159 men) were included and randomized to ZILVER PTX (n = 113, 51.40%) or BYPASS group (n = 107, 48.60%). The 60-month primary patency rate was 49.3% for the ZILVER PTX group versus 40.7% for the bypass group (p = 0.6915). Freedom from TLR was 63.8% for the ZILVER PTX group versus 52.8% for the bypass group (p = 0.2637). At 5 years, no significant difference in survival rate could be seen between the ZILVER PTX and the bypass group (69.1% vs. 71% respectively, p = 0.5503)., Conclusion: Even at 5 years, non-inferior safety and effectiveness results of the ZILVER PTX could be seen. These findings confirmed that the use of ZILVER PTX stents can be considered as a valid alternative for bypass surgery when treating long and complex femoropopliteal lesions., (© 2023. The Author(s).)

A thyroglossal duct cyst (TGDC) is the result of incomplete degeneration of the thyroglossal duct during gestation. It is the most common type of congenital cyst of the neck, and is usually seen in children. The tumor mostly appears at the midline of the neck and generally causes no symptoms, but the mass typically moves when the patient swallows. We present the unusual case of a 50-year-old man with a large cervical mass lateralized on the right side of the neck. There was no association between swallowing and movement of the mass. Clinical examination and computed tomography (CT) suggested a lymphangioma or cystic hygroma. Surgical resection showed a large cyst of 71 x 40 x 52 mm with no attachment to the hyoid bone and no invasion in blood vessels or other surrounding tissue. Histopathological investigation led to a diagnosis of TGDC.

Background: To report the 3-year safety and effectiveness results of a multicenter, prospective, randomized controlled trial comparing the ZILVER PTX paclitaxel-eluting stent to surgical bypass and to conduct a health economic analysis up to 3-year follow-up of the two treatment modalities., Methods: This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs. surgical bypass surgery using a prosthetic graft (ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.40%) or the bypass treatment group (107, 48.60%). One of the secondary outcomes was primary patency at 3-year, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex ultrasound peak systolic velocity ratio <2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass. An economic analysis was conducted to analyze the cost differences between ZILVER PTX and bypass, which shows the perspective of the public authority/organization that pays for healthcare in the two countries (payor), Germany and USA., Results: The 3-year primary patency rate was 53.30% (95% CI 61.40% to 45.20%) for the ZILVER PTX group vs. 58.20% (95% CI 67.10% to 49.30%) for the bypass arm (P=0.9721). Freedom from TLR at 3-year was 62.80% (95% CI 72.60% to 53%) for the ZILVER PTX group vs. 65.30% (95% CI 75.40% to 55.20%) for the bypass group (P=0.635). There was also no significant difference (P=0.358) in survival rate at 3-year between the ZILVER PTX group 78.50%, (95% CI to 87.70% to 69.30%) and the bypass group 87.40% (95% CI 97.6% to 77.2%). None of the deaths was categorized as related to the procedure or device. The economic analysis, taking into account procedural-, hospitalization- and reintervention costs, showed a clear cost-benefit for Zilver PTX in both investigated countries up to 3-year follow-up: Germany (Bypass €9446 per patient versus ZILVER PTX €5755) and USA (Bypass $26,373 per patient versus ZILVER PTX $19,186)., Conclusions: The non-inferior safety and effectiveness results of the ZILVER PTX stent were associated with lower costs for the payer and confirmed that ZILVER PTX stent treatment can be considered as a valid alternative for bypass surgery in long and complex femoropopliteal lesions.

Introduction: Radial access is the standard of care for nearly all cardiac catheterization procedures. It improves patient satisfaction, reduces the length of stay, and is associated with fewer complications. However, few devices and tools are available for the treatment of peripheral arterial disease via a transradial approach (TRA). The S.M.A.R.T. RADIANZ Vascular Stent System is among the RADIANZ suite of products, which is aimed at expanding the portfolio of devices to treat peripheral arterial disease., Areas Covered: In this Expert review, the following areas will be covered: (1) Current Landscape of peripheral vascular intervention (PVI) using TRA (2) Detailed description of the S.M.A.R.T. RADIANZ Vascular Stent System. (3) Ongoing clinical trials to evaluate safety of this approach. (4) Future directions and current regulatory status., Expert Opinion: TRA for PVI is a promising approach. It holds the possibility of substantially improving the care of patients with peripheral arterial disease (PAD). Numerous challenges must be overcome to realize the full potential of a radial-to-peripheral (RTP) approach. The length of devices and the small sheath size are the main constraints of this approach. The results of the ongoing RADIANCY trial will demonstrate the safety, in selected patients, of the RADIANZ suite of products.

Background: Through its helical centreline geometry, the BioMimics 3D vascular stent system is designed for the mobile femoropopliteal region, aiming to improve long-term patency and the risk of stent fractures., Methods: MIMICS 3D is a prospective, European, multi-centre, observational registry to evaluate the BioMimics 3D stent in a real-world population through 3 years. A propensity-matched comparison was performed to investigate the effect of the additional use of drug-coated balloons (DCB)., Results: The MIMICS 3D registry enrolled 507 patients (518 lesion, length 125.9 ± 91.0 mm). At 3 years, the overall survival was 85.2%, freedom from major amputation 98.5%, freedom from clinically driven target lesion revascularisation 78.0%, and primary patency 70.2%. The propensity-matched cohort included 195 patients in each cohort. At 3-year follow-up, there was no statistically significant difference in clinical outcomes, such as overall survival (87.9% in the DCB vs. 85.1% in the no DCB group), freedom from major amputation (99.4% vs. 97.2%), clinically driven TLR (76.4% vs. 80.3%), and primary patency (68.5% vs. 74.4%)., Conclusion: The MIMICS 3D registry showed good 3-year outcomes of the BioMimics 3D stent in femoropopliteal lesions, demonstrating the safety and performance of this device under real-world conditions, whether used alone or in combination with a DCB.

Purpose: Although effectiveness and safety of many different paclitaxel coated balloons in the treatment of peripheral arterial disease (PAD) are extensively studied, there is a lack of direct head-to-head comparison studies. To meet this need and to avoid potential "class-effects", the BIOPACT was set up. The purpose is to demonstrate the safety and efficacy of the Passeo-18 Lux DCB (Biotronik) for treatment of patients with symptomatic PAD due to femoropopliteal lesions., Methods: 302 patients are randomized in a 1:1 manner to treatment with either the Passeo-18 Lux DCB or the IN.PACT Admiral DCB (Medtronic) for testing of a formal non-inferiority hypothesis. The participants will be followed for 5 years. The primary efficacy endpoint is freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months, defined as any re-intervention at the target lesion due to symptoms, drop of ankle brachial index (ABI) > 20% or > 0.15 compared to post-procedural ABI. Primary safety endpoint is a composite of freedom from device/procedure-related death through 30 days post-index procedure, freedom from major target limb amputation and clinically-driven target vessel revascularization (CD-TVR) through 12 months post-index procedure. Secondary endpoints can be found at clinicaltrials.gov, ID NCT03884257., Discussion: As full enrolment was reached by the beginning of September, the investigators expect complete analysis of the primary endpoints by the end of 2022; Meanwhile preliminary results will be disclosed during 2022. As in terms of randomized head-to-head efficacy and safety analysis, this study on paclitaxel coated balloons may provide additional information to clinicians and healthcare providers. Trial registration ClinicalTrials.gov ID: NCT03884257 LEVEL OF EVIDENCE: Level 2, Randomized trial., (© 2022. Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE).)

Purpose: Ambulatory peripheral vascular interventions have been steadily increasing. In ambulatory procedures, 4F devices might be particularly useful having the potential to reduce access-site complications; however, further evidence on their safety and efficacy is needed., Materials and Methods: BIO4AMB is a prospective, non-randomized mulitcentre, non-inferiority trial conducted in 35 centres in Europe and Australia comparing the use of 4F- and 6F-compatible devices. The main exclusion criteria included an American Society of Anaesthesiologists class ≥ 4, coagulation disorders, or social isolation. The primary endpoint was access-site complications within 30 days., Results: The 4F group enrolled 390 patients and the 6F group 404 patients. Baseline characteristics were similar between the groups. Vascular closure devices were used in 7.7% (4F group) and 87.6% (6F group) of patients. Patients with vascular closure device use in the 4F group were subsequently excluded from the primary analysis, resulting in 361 patients in the 4F group. Time to haemostasis was longer for the 4F group, but the total procedure time was shorter (13.2 ± 18.8 vs. 6.4 ± 8.9 min, p < 0.0001, and 39.1 ± 25.2 vs. 46.4 ± 27.6 min, p < 0.0001). Discharge on the day of the procedure was possible in 95.0% (4F group) and 94.6% (6F group) of patients. Access-site complications were similar between the groups (2.8% and 3.2%) and included predominantly groin haematomas and pseudoaneurysms. Major adverse events through 30 days occurred in 1.7% and 2.0%, respectively., Conclusions: Ambulatory peripheral vascular interventions are feasible and safe. The use of 4F devices resulted in similar outcomes compared to that of 6F devices.

Purpose: To report the outcomes after treating stenotic or occluded femoropopliteal lesions with a drug-coated balloon (DCB) followed by the implantation of a thin-strut self-expanding bare metal stent in the BIOLUX 4EVER trial ( ClinicalTrials.gov identifier NCT02211664)., Materials and Methods: The prospective, multicenter, physician-initiated BIOLUX 4-EVER trial was conducted at 5 centers in Belgium and enrolled 120 patients (mean age 70.9±10.5 years; 79 men) with symptomatic stenotic or occluded de novo femoropopliteal lesions. A fifth of the patients had diabetes mellitus and nearly half had previous peripheral artery interventions. The lesions were a mean 83.3±49.5 mm long with a mean reference vessel diameter of 5.26±0.59 mm. Lesions were treated with a Passeo-18 Lux DCB followed by the implantation of a Pulsar-18 bare metal stent. Follow-up visits were conducted at 1, 6, 12, and 24 months postprocedure; the main outcome was primary patency at 12 months., Results: Technical success was obtained in all patients. Primary patency was observed in 89.9% of patients (95% CI 84.0% to 95.8%) at 12 months and in 83.5% at 24 months (95% CI 89.9% to 97.3%), and freedom from target lesion revascularization was 93.6% (95% CI 89.9% to 97.3%) and 86.1% (95% CI 79.9% to 92.3%), respectively. Ten patients died throughout the course of the trial (90.7% survival at 24 months), all of noncardiovascular causes. The ankle-brachial index improved from 0.68±0.09 at baseline to 0.93±0.11 and 0.93±0.12 at 12- and 24-month follow-up visits (p<0.001). An improvement of at least 1 Rutherford category was observed in 91 of 94 patients (96.8%) at 12 months and 78 of 83 patients (93.4%) at 24 months (p<0.001)., Conclusion: The combination of a Passeo-18 Lux DCB followed by a Pulsar-18 stent implantation produced safe and effective outcomes in the treatment of femoropopliteal lesions at up to 24 months. Adding paclitaxel to the bare nitinol stent platform by predilating with a Passeo-18 Lux DCB seems to increase efficacy at 1 and 2 years compared with the use of bare metal stents only, which were investigated in the precursor 4-EVER study.

Background: This clinical trial aims to evaluate the outcome (up to 24-months) of the treatment of in-stent restenotic or reoccluded lesions in the femoropopliteal arteries, by comparing the treatment of the GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface (W. L. Gore & Associates, Flagstaff, AZ, USA) with a standard PTA treatment. The primary effectiveness endpoint of the study is the primary patency at 12 months, defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-flow duplex ultrasound (PSVR≤2.5) and without target lesion revascularization (TLR) within 12 months. The primary safety endpoint is the proportion of subjects who experience serious device-related adverse events within 30 days postprocedure., Methods: A total of 83 patients meeting inclusion and exclusion criteria have been enrolled in this prospective, randomized, multicenter, controlled study in 7 sites between June 2010 and February 2012. Patients with an in-stent restenosis lesion in the femoropopliteal region and a Rutherford classification from 2 to 5 could be enrolled. After screening, the patient was randomized to either treatment with the GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface or treatment with a standard PTA balloon. After the index procedure, follow-up visits at 1 month, 6 months, 12 months and 24 months were required. A color flow Doppler ultrasound was performed on all follow-up visits and a quantitative vascular angiography at the 12-month follow-up visit., Results: In the VIABAHN ® group, 39 patients (74.4% male; mean age 67.69±9.77 years) were enrolled and in the PTA group, 44 patients (72.7% male; mean age 68.98±9.71 years) were enrolled, which is comparable for both treatment groups. In the VIABAHN ® group, 34 (87.2%) patients presented with claudication (Rutherford 2 and 3) and 5 (12.8%) patients had critical limb ischemia (Rutherford 4 and 5). In the PTA group, 36 (81.8%) patients were claudicants (Rutherford 2 and 3) and 8 (18.2%) presented with critical limb ischemia (Rutherford 4 and 5). The 12-month primary patency rates were 74.8% for the VIABAHN ® group and 28.0% for the PTA group (P<0.001). No patients were reported to have device-related serious adverse events within 30 days postprocedure. The primary patency rate for the 24-month follow-up was 58.40% in the Viabahn group and 11.60% in the PTA group (P<0.001)., Conclusions: The treatment of femoropopliteal in-stent restenosis with a VIABAHN ® Endoprosthesis shows significantly better results than the treatment with a standard PTA balloon. This demonstrates that the use of the VIABAHN ® Endoprosthesis is a very promising tool for the treatment of complex in-stent restenosis.

Background: The aim of this study is to investigate the efficacy of the paclitaxel-eluting Legflow balloon catheter in the treatment of "real-world" long and complex femoropopliteal lesions., Methods: The REFLOW study was a prospective, multi-national, non-randomized, single arm study evaluating the safety and efficacy of the Legflow paclitaxel-eluting balloon dilatation catheter in the treatment of stenotic or occlusive lesions >150 mm long in the femoropopliteal arteries of symptomatic patients (Rutherford 2-5). A total of 120 study subjects were enrolled in a period of 30 months, between October 2015 and May 2018. The mean age was 71.1 years and 79 patients were men (65.8%). Mean lesion length was 216.1 mm. 45.0% of the lesions were occluded, whereas 55.0% were stenotic. Primary endpoint was primary patency at 12 months, defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within 12 months., Results: Technical and procedural success (<30.0% residual angiographic stenosis without major complications) was achieved in all 120 cases (100.0%). Primary patency was 84.6% at 6 months and 71.1% at 1 year. Freedom from TLR was 79.9% at 1 year., Conclusions: If longer term follow-up confirms there is no safety-concern on these paclitaxel device, the excellent results of the newer drug-eluting devices, and the Legflow paclitaxel-eluting balloon in particular, is a valid and effective alternative to treat long and complex "real-world" femoropopliteal lesions.

Background: The aim of this study was to investigate the efficacy of the balloon expandable Promus Element and Promus Element Plus stents (both Boston Scientific, Marlborough, MA, USA), coated with everolimus, in the treatment of short, focal infrapopliteal lesions., Methods: The PREVENT study was a prospective, multicenter, non-randomized, single arm study evaluating the safety and efficacy of the Promus Element and Promus Element Plus stent in the treatment of stenotic or occlusive lesions ≤40 mm long in the tibioperoneal arteries of patients with critical limb ischemia (CLI). A total of 70 study subjects were enrolled in a period of 26 months, between November 2012 and December 2014. The mean age was 77.84±6.62 years (62-90 years) and 47 patients were men (67.1%). Mean lesion length was 22.83±8.78 mm (5-40 mm). Twenty percent of the lesions were occluded, whereas 80.00% were stenotic. Primary endpoint was primary patency at 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on angiography. Secondary outcomes included hemodynamic primary patency on duplex ultrasound (PSV ratio ≤2.4), limb salvage and freedom from target lesion revascularization (TLR)., Results: Technical and procedural success (<30% residual angiographic stenosis without major complications) was achieved in all 70 cases (100%). Primary patency was 93.8% at 6 months and 86.2% at 1 year. Freedom from TLR was 93% at 1 year. Limb salvage rate at 12-month follow-up, defined as absence of major amputation, was 100%., Conclusions: This study shows the safety and efficacy of the everolimus-eluting, balloon expandable Promus Element and Promus Element Plus stent in the treatment of below-the-knee lesions in patients with critical limb ischemia.

Objectives: This study sought to evaluate 1-year safety and efficacy of dual-layered mesh-covered carotid stent systems (DLS) for carotid artery stenting (CAS)., Background: Small clinical studies evaluating 1-year outcomes of CAS performed with 2 available DLS, Roadsaver (RS) (Terumo Corp., Tokyo, Japan) and CGuard (CG) (InspireMD, Boston, Massachusetts), have been published., Methods: The authors performed an individual patient-level meta-analysis including studies enrolling more than 100 CAS with DLS. The primary endpoint was the death and stroke rate; secondary endpoints were restenosis and in-stent thrombosis rates at 1 year., Results: Patients were divided into 2 groups according to DLS (RS n = 250; CG n = 306). At 1 year, 11 patients died (1.97%), 7 patients in the group RS (2.8%) and 4 patients in the CG one (1.31%); and 10 strokes occurred, 4 in the group RS (1.6%) and 6 in the CG one (1.96%). Overall death and stroke rate was 3.77% (n = 21), 11 events in the group RS group (4.4%) and 10 in the CG group (3.27%). Symptomatic status was the only predictor of death and or stroke. At 1 year, restenosis occurred in 12 patients (2.1%), 10 in the group RS (4%) and 2 in the CG one (0.65%) (p = 0.007). In-stent thrombosis occurred in 1 patient (0.18%) in the CG group (0.32%). RS use was the only independent predictor of restenosis., Conclusions: This study suggests that DLS use for CAS is associated with a low 1-year death and stroke rate, and the specific DLS stent used could affect the restenosis rate., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Purpose: To report the 12-month results of a multicenter, prospective, randomized controlled trial to determine if the ZILVER PTX paclitaxel-eluting stent was noninferior in terms of safety and efficacy compared with surgical bypass. Materials and Methods: This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs surgical bypass surgery using a prosthetic graft ( ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.4%) or the bypass treatment group (107, 48.6%). Most of the lesions were occlusions (208, 94.5%); the mean lesion length was 247.1±69.3 mm. The primary outcome measure was primary patency at 12 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex-derived peak systolic velocity ratio <2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass. Results: The estimated 12-month primary patency rate was 74.5% (95% CI 66.3% to 82.7%) for the ZILVER PTX group vs 72.5% (95% CI 63.7% to 81.3%) for the bypass arm (p=0.998). Freedom from TLR at 12 months was 80.9% (95% CI 73.3% to 88.5%) for the ZILVER PTX group vs 76.2% (95% CI 68.0% to 84.4%) for the bypass group (p=0.471). The 30-day complication rate was significantly lower in the ZILVER PTX group (4.4% vs 11.3%, p=0.004). Also, procedure time and hospital stay were significantly shorter in the ZILVER PTX group (p<0.001 for both). Conclusion: With noninferior patency results, a lower complication rate, and shorter procedures and hospital stays, paclitaxel-eluting stenting might become a recommended treatment for long TASC C and D femoropopliteal lesions.

Background: According to the guidelines, bypass surgery is still the golden standard treatment in patients with femoropopliteal TASC C and D lesions and life-style limiting claudication or critical limb ischemia. Over the past few decades, endovascular therapy has made great advancements. However, the success rates of surgical and endovascular procedures cannot be directly compared. According to the surgical term "patency," vessel patency can be maintained even in case of a high grade stenosis, whereas according to the endovascular primary patency definition, being binary restenosis, patency is lost from the moment there is a re-narrowing at any location within the treated segment., Methods: One hundred consecutive patients with a previously implanted femoropopliteal bypass which was primary patent according to the surgical definition were included in this study. Once enrolled, duplex ultrasonography was performed, measuring the Peak Systolic Velocity Ratio for proximal and distal anastomosis., Results: Out of the 100 bypasses that were considered patent according to the surgical definition, Peak Velocity Ratio of ≥2.4 were detected in 11 patients., Conclusions: Based on these findings a 78% primary patency according to the open vascular criteria turned into ~70% primary patency using the stricter endovascular criteria. In the light of these findings, one might conclude that modern endovascular treatment of long TASC C and D femoropopliteal lesions yielded similar results in terms of primary patency as above-the-knee bypasses.

Purpose: To assess the incidence and predictors of severe, persistent postprocedural hypotension (PPH) after carotid artery stenting (CAS). Materials and Methods: A total of 146 patients (mean age 72.8 years; 104 men) who underwent 160 CAS procedures using a standardized protocol at 3 vascular centers were retrospectively analyzed. The primary endpoint was postprocedural hypotension, defined as a reduction in systolic blood pressure (SBP) >40 mm Hg from baseline or an SBP of <90 mm Hg sustained for >1 hour after CAS. Potential prognostic factors for postprocedural hypotension were identified and subjected to logistic regression analyses; outcomes are presented as the odds ratios (ORs) with 95% confidence intervals (CIs). Results: PPH developed in 36 (24.7%) patients after 37 (23.1%) CAS procedures. These patients had significantly longer intensive care unit and hospital stays than those who did not develop hypotension (p<0.001). PPH was associated with severe lesion calcification (OR 6.28, 95% CI 1.81 to 21.98, p=0.004) and contrast volume (OR 1.02, 95% CI 1.01 to 1.02, p<0.001). A 4-fold increase in the risk of PPH (OR 4.22, 95% CI 1.38 to 13.33, p=0.012) was found between the embolic protection device most associated with PPH (Angioguard) and the device least associated with PPH (Emboshield NAV6). A similar trend was also observed for the Precise vs Xact stents (OR 6, 95% CI 2.08 to 17.6, p=0.001). Bootstrapped multivariable modeling identified the Precise stent and contrast volume as significant predictors of persistent postprocedural hypotension. Further investigation of the contrast volume revealed associations with sex, severe calcification, arch type, previous coronary artery bypass surgery, and primary stenting, suggesting that the contrast volume reflects the complexity of the procedure. Conclusion: The complexity of the procedure and type of stent may play a role in the development of postprocedural hypotension after CAS.

Endovascular treatment of peripheral artery disease has recently become more important due to its minimally invasive nature. Elderly patients as well as fragile patients, like diabetics and those with end-stage renal disease, can benefit from this low-morbidity/-mortality treatment. Very successful results have been achieved with percutaneous balloon angioplasty and stenting in the superficial femoral and iliac arteries. In some areas, however, such as the common femoral artery and the popliteal artery, vascular physicians remain somewhat reluctant to use endovascular strategies. Common femoral endarterectomy, the most often used technique for treatment of common femoral artery lesions, has shown very good long-term results, but is associated with relatively high complication rates, such as superficial and deep wound problems and lymph leakage. This article describes less-invasive endovascular alternatives, such as atherectomy, drug-coated balloons and stenting, and their results. The popliteal artery is also difficult to treat in an endovascular manner due to biomechanical forces during bending and stretching of the knee or leg. Thus, we also describe currently available minimally invasive treatment options for the popliteal artery.

Background: The EVOLUTION Study is a prospective, non-randomized study, investigating the iVolution stent (iVascular, Barcelona, Spain). The study was conducted at the vascular departments of four hospitals in Belgium. This manuscript reports the findings up to 12-month follow-up time for the total cohort. The primary endpoint of the study is primary patency at 12 months. Primary patency is defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.4) and without Target Lesion Revascularization (TLR) within 12 months., Methods: Between April 2015 and November 2016, 120 patients with TASC A&B femoropopliteal lesions were included. The mean lesion length was 89.63 mm. Most of the lesions were stenotic lesions (60.00%)., Results: Primary patency rate for the total patient population was 86.30% at 12-month follow-up. Freedom from TLR at 12-month was 88.00%., Conclusions: These results confirm the already existing enthusiasm of the use of bare metal self-expandable nitinol stents in the treatment of TASC A&B femoropopliteal lesions. Longer follow-up and a comparison or addition with drug-eluting technology has to be studied in the future.

Background: The BeGraft Peripheral PMCF study is a prospective, non-randomized study, conducted at the vascular departments of 4 hospitals in Belgium. This manuscript reports the findings up to 12-month follow-up time for the total cohort. The primary endpoint of the study is primary patency at 12 months. Primary patency is defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, systolic velocity ratio no greater than 2.4) and without target lesion revascularization (TLR) within 12 months., Methods: Between June 2014 and March 2015, 70 patients with TASC II Class A (77.1%), B (14.3%), C (5.7%) or D (2.9%) aortoiliac lesions were included. The mean lesion length was 34.3 mm with a mean degree of stenosis of 83.16%., Results: Primary patency rate for the total patient population was 94.4% at 12-month follow-up. Freedom from TLR at 12-month was 96.7%., Conclusions: These results confirm the already existing enthusiasm of the use of covered stents in the aorto-iliac field. Longer follow-up and more complex lesions have to be studied in the upcoming future.

Common femoral artery (CFA) atherosclerotic lesions currently remain one of the last limitations for adoption of endovascular repair as the first-line treatment. The bulky, eccentric, heavily calcified character of the CFA plaques, frequent involvement of the femoral bifurcation, easy surgical accessibility and last but not least, favorable long-term outcomes still make CFA disease treatment part of the surgical domain. In the last 5 years, improvement of the endovascular equipment and technical skills of the operators have led to an increase in percutaneous CFA procedures. Especially the vascular mimetic implant Supera Peripheral Stent system (Abbott Vascular), with its extreme crush resistance (if correctly implanted), seems to be an ideal tool to deal with eccentric calcified plaques, crush risk and maintaining access possibilities. The multicentric, prospective, single arm VMI-CFA Trial evaluates the outcome of treatment of symptomatic (Rutherford 2-4) CFA stenotic or occlusive lesions with the Supera Peripheral Stent System. A 6-month cumulative primary patency rate of 100% is noticed, up to 210 days. The cumulative freedom from TLR rate is 100%. Four patients died, not procedure or device related. From a clinical point of view, a tremendous switch from Rutherford 2-4 towards Rutherford 0-1 happened. No procedure nor device related adverse events are noticed. These short-term data confirm the safety and feasibility of an endovascular approach with the Supera stent to the "no-stent zone" CFA. Of course 12- and 24-month data are essential to bring more clarification in this interesting field.

Although evidence supports that the performance of drug coated balloons seems to be lesion complexity independent, it is quite clear that in long lesions, severe calcified lesions and chronic total occlusions, the bail out stent ratio is very high and that the "leaving nothing behind" strategy remains a dream in a lot of our daily cases. On the other side of the spectrum, "full metal jackets" of nitinol stents are creating even more problems. Stent fractures, intimal hyperplasia and reintervention difficulties complicate the recurrent vascular disease treatment. The go-between with the "As Less As Reasonably Achievable Stenting" strategy (ALARAS), earlier named with a bad name "spot" stenting, seems the most attractive one. Scaffolding where needed and allowing freedom of vessel motion will lead to reduction of target lesion revascularization (TLR) rates. New technologies like the Tack Endovascular System and the Vascuflex MultiLOC MSD are responding very well tot this idea. Animal tests and pivotal trials (like TOBA and LOCOMOTIVE trials) already showed with both devices good results in terms of patencies and freedom from target lesion revascularizations, and with less metallic implants. Primary patency at 12 months was 76.4% and 85.7% in the TOBA and LOCOMOTIVE trial respectively. Target lesion revascularization at 12 months was 10.5% and 9.3%, respectively. In an era of "leaving nothing behind," post-angioplasty dissections are more frequent than ever. With a direct link between lesion complexity, dissections and increase of TLR rates, scaffolding solutions remains essential. The ALARAS strategy tries to leave as little metal behind as possible, minimizing the risk of stent fractures, allowing freedom of vessel motion and reducing TLR rates. However, the lack of clear strategies and guidelines in where to scaffold which kind of dissections is the biggest issue at the moment. More objective classifications based on newer types of imaging like intraoperative ultrasound, intravascular ultrasound, optical coherence tomography, and/or fractional flow reserve pressure wire gradient measurements will potentially offer more solutions in this interesting field.

The selection of an optimal vascular access strategy for lower limb endovascular intervention is key for procedural safety and success, and is particularly relevant in diabetic patients, in whom extensive occlusive disease commonly involves the infrapopliteal arteries. Individualizing vascular access requires careful planning, including determining normal and abnormal arterial anatomy; the patient's co-medical conditions, especially renal insufficiency; and review of noninvasive vascular laboratory testing. It is essential to be cognizant of the technical nuances, relative safety, advantages, and disadvantages of each potential access site. Retrograde and antegrade femoral approaches; upper extremity access via the radial, brachial, or axillary arteries; or retrograde access via the below-the-knee popliteal or pedal arteries should all be considered in endovascular intervention planning., (Copyright © 2018. Published by Elsevier Inc.)

Background: Recent advances in endovascular techniques have made it a seductive choice in the management of TASC C and D lesions. Currently, this tendency remains controversial, despite high success rates. The aim of the study was to regroup and harmonize the results of three surgical teams in 5 centers in order to obtain the largest series ever published on TASC C and D femoro-popliteal lesions primary stenting., Methods: Two hundred and three patients and 209 lower limbs were included from March 2008 to October 2013. Each patient underwent primary stenting for TASC C or D femoro-popliteal lesions., Results: Mean age was 70±10; 71.4% were male with a 39.8% rate of coronary heart disease, 20.1% of renal insufficiency and 35.9% of diabetes; 57,4% suffered from claudication and 42.6% from critical limb ischemia (CLI); 61.8% of the 144 limbs analyzed for run-off presented with 3 patent infra-popliteal arteries. Four hundred and three stents were implanted in the 209 limbs included. Median stented length was 252 mm. Associated procedures were performed in 35 patients (17.0%) including 4.3% minor amputations. The 30-day mortality rate was 1.4% (3 patients). Major complications occurred in 19 patients (9.3%) including 7 patients (3.4%) presented with early in-stent thrombosis. Median follow-up duration was 12 months (range 9.5-17.2 months). The 12-month mortality rate was 11.8% (24 patients). The 3, 6 and 12 months primary patency rates according to Kaplan Meier estimates were 98.1±0.9, 85.2±2.5 and 67.0±3.3% respectively. Secondary patency rates were 96.1±1.9, 89.3±3.0 and 75.7±4.2% respectively. A subgroup analysis reported significantly higher patency rates for TASC C lesions compared to TASC D lesions (82.1% vs. 44% respectively, P=0.009). The 12-month in-stent thrombosis and restenosis rates were 19.6% and 13.9% respectively. A subgroup analysis showed higher rates of in-stent restenosis for TASC D lesions compared to TASC C lesions (35% vs. 10% respectively, P=0.005). The stent fracture rate was equal to 10.2% (30 stents). Occurrence of in-stent thrombosis and restenosis were associated with 3 and 5 cases of stent fracture (type II to IV) respectively. Freedom from TLR was 70.5%. Rutherford class decreased from 3.7 to 0.9 (3.52±1.06 to 0.75±1.24) (P<0.0001). At 12 months 61.3% were asymptomatic, 33.3% suffered from claudication (21.3% Rutherford 1) and 5.4% suffered from CLI. Healing rates were 63.9% with a limb salvage rate of 95.5% and a major amputation rate of 3.8%., Conclusions: This is the largest series of TASC C and D femoro-popliteal lesions primary stenting to our knowledge. The results are encouraging with acceptable primary patency and clinical improvement at 12 months. Results from mid- to long-term follow-up are awaited.

Introduction: Vascular closure devices (VCDs) are designed to achieve rapid hemostasis during percutaneous coronary and peripheral vascular procedures. Studies demonstrate that VCDs improve time to hemostasis (TTH) and time to ambulation (TTA) in comparison to standard manual compression. The available products, however, typically have 13-17 steps in their application, often require hemostatic collagen or other agents as part of the process, and can result in significant scarring at the puncture site that can impact future access. The aim of this study was to investigate the performance of a three-step, novel VCD for access site TTH, short-term and long-term histology, and a first-in-man clinical study., Materials and Methods: This study evaluated AbsorbaSeal™ (CyndRx, LLC, Brentwood, Tennessee), a simple, three-step, VCD with bio-absorbable components. Following an institutional review board (IRB) approval, a 6-F sheath was placed directly into the porcine aorta, AbsorbaSeal™ was used to seal the puncture site, and a measure of total time of deployment (TTD) and TTH was performed, as well as histologic evaluation at 30, 60, and 180 days. A complement activation test was performed to determine the potential for activation of the complement system as a mediator of inflammation. The test was performed by directly incubating the VCDs AbsorbaSeal™ and Angio-Seal™ (Terumo Interventional Systems, Tokyo, Japan) in human serum. Serum samples were removed after 30, 60, and 90 minutes and tested for the presence and amount of complement protein SC5b-9. In the first in-man trial, the device was deployed in anticoagulated patients undergoing interventional vascular procedures. The TTH, estimated blood loss, patient pain scores, and procedural and follow-up complications were recorded., Results: In the acute and chronic porcine studies, TTD averaged 25 seconds (17-29 seconds). Vascular control was immediate, yielding a TTH of effectively zero seconds. Histologic evaluation demonstrated complete endothelial coverage of the device by 30 days without evidence of bleeding, clotting, or inflammation. At 60 days, the significant mass of the device had dissolved and normal appearing collagen surrounded the devices with essentially no inflammatory response. By six months, all but one microscopic segment of one of the devices had been absorbed with normal appearing vascular endothelium, and no, or minimal, scarring appreciated. The complement test demonstrated that the AbsorbaSeal™ had similar, or lower, complement concentrations than the negative controls and significantly less than Angio-Seal™. This supported the histologic findings of minimal to no inflammation. The VCD was deployed in 20 patients undergoing interventional vascular procedures. The mean TTH was 2.3 ± 1.5 minutes. Estimated blood loss was 11.7 mL ± 3.5 mL, and no significant hematoma was noted. Post-procedure pain scores were low, with a mean of 1.4 ± 0.8 on a 0-10 pain rating scale. There were no perioperative complications and no adverse events at follow-up., Conclusions: The AbsorbaSeal™ is safe and simple to use for vascular closure after interventional vascular procedures with favorable outcomes including a short TTH, minimal procedural blood loss, low postoperative pain scores, and no perioperative complications or adverse effects. Histologic evaluation reveals rapid device absorption and little scar formation both short- and long-term. A direct study of complement activation supports that AbsorbaSeal™ evokes a minimal inflammatory response that is significantly less than Angioseal.

Background: The MISAGO ILIAC Study is a prospective, non-randomized, multicenter, bi-national, monitored trial, conducted in 3 hospitals in Belgium and 2 hospitals in Germany. This manuscript reports the findings up to 12-month follow-up time for the total cohort. The primary endpoint of the study was primary patency, defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, peak systolic velocity ratio no greater than 2.0) and without target lesion revascularization (TLR), within 12 months., Methods: Between September 2011 and April 2012, 120 patients with TASC II Class A or TASC II Class B aortoiliac lesions were included. The cumulative lesion length in the overall population was 45.49 mm with a maximum stenosis pre-treatment of 83.76%. The demographic data were compatible for the TASC II class A and TASC II class B cohort. One patient with a TASC II class C was included as a protocol deviation., Results: The primary patency rate for the total patient population was 97.4%. The primary patency rates at 12 months for the TASC II class A and TASC II class B(C) lesions were respectively 98.3% and 96.6%. No statistical significant difference was shown when comparing these 2 groups (P=0.6407)., Conclusions: Our findings confirm that nowadays primary stenting with modern generation stents replaced the more invasive surgery as the golden standard treatment for patients with TASC II class A and B aortoiliac lesions.

Background: The aim of this study was to evaluate the short and mid-term safety and efficacy of the EPIC™ nitinol vascular stent system for the treatment of lesions located in the superficial femoral artery (SFA)., Methods: From October 2010 to June 2012, 83 subjects were enrolled in a prospective, multicenter, non-randomized study designed to demonstrate that the EPIC nitinol vascular stent system for SFA lesions is non-inferior to the published patency rates found in literature. Inclusion criteria were stenosis or occlusion of the SFA or SFA and proximal popliteal artery, with total length from 4 to 11 cm and amenable for treatment with a single stent, in patients with a score from 2 to 5 on Rutherford classification. The primary endpoint was primary patency rate at 12 months as determined by Duplex ultrasound. The secondary endpoints evaluated were: initial arteriographic success, primary patency rate at 6 months, major adverse event rate at one year and technical success. Follow-up with a complete clinical and physical exam, including ABI and Duplex ultrasound was performed at 6 and 12 months., Results: Most patients (56.6%) were men and the mean age was 68.59 (33.1-99.15) years. 25.3% of the total population had intermittent claudication and 73.5% presented with critical limb ischemia. Most lesions were total occlusions (75.9%) and the mean lesion length was 71.16 mm. Contralateral femoral access was performed in 26.5%cases, and ipsilateral femoral approach was used for the remaining 73.5% patients. Technical and arteriographic success was obtained in all 83 (100.00%) patients. Duplex controlled primary patency rate at 6 and 12 months was 95.8% and 76.1%, respectively. The freedom from target lesion revascularization rate was 98.7% and 92.6% at 6 and 12 months, respectively. No stent fractures were observed in this study. Major adverse event rate at 1 year (clinically driven TLR, major amputation, and all-cause mortality) was 15.7%: two target lesion revascularizations (2.4%), one major amputation (1.2%) and ten deaths not related to the procedure (12%)., Conclusions: In conclusion, this study demonstrates the safety and efficacy of the EPIC™ Nitinol Vascular Stent System for the treatment of SFA lesions.

Purpose: To investigate the efficacy of the paclitaxel-coated, self-expanding, nitinol Stentys Stent System in tibioperoneal lesions ≤50 mm long., Methods: The prospective, single-arm, multicenter PES-BTK-70 trial ( ClinicalTrials.gov identifier NCT01630070) evaluated the safety and efficacy of the coronary Stentys Stent System in the treatment of a stenotic or occlusive lesion ≤50 mm long in the tibioperoneal arteries of patients with critical limb ischemia (CLI). Between January 2012 and May 2013, 70 patients (mean age 74.6±9.4 years; 45 men) with CLI [Rutherford category 4 (37, 52.9%) or 5 (33, 47.1%)] received a Stentys drug-eluting stent for the treatment of infrapopliteal stenosis (60, 85.7%) or occlusion (10, 14.3%). The mean lesion length was 17.2 mm (4.0-58.5). The primary outcome measures were primary patency at 6 months (duplex ultrasound) and 12 months (angiography). Secondary outcomes included limb salvage and freedom from target lesion revascularization (TLR). Kaplan-Meier estimates of the outcomes are given with the 95% confidence intervals (CI)., Results: Technical and procedure success (<30% residual stenosis without major complications) was achieved in 68 (97.1%) of 70 cases. Primary patency was 87.6% (95% CI 83.5% to 91.7%) at 6 months and 72.6% (95% CI 66.9% to 78.3%) at 1 year. Freedom from TLR was 79.1% at 1 year (95% CI 73.9% to 84.3) and limb salvage was 98.5% (95% CI 97.0 to 100.0). No stent fractures were found by core laboratory review of all follow-up imaging data available up to 12 months., Conclusion: In this study, the self-expanding, nitinol, paclitaxel-eluting, coronary Stentys stent was found to be safe and effective in the below-the-knee region, with results similar to the most recent limus-eluting stent trials.

Background: The superiority of drug eluting stents versus bare metal stents or balloon angioplasty in the treatment of patients with critical limb ischemia and infrapopliteal lesions has been established. However, only shorter lesions were evaluated. This study was designed to evaluate the immediate and long-term (up to 12 months) outcome of the Xience Prime™ Everolimus-Eluting Coronary Stent System (Abbott Vascular) in a controlled, prospective, multi-center investigation for long lesions up to 10 cm., Methods: All patients with critical limb ischemia and long infrapopliteal lesions between 30 and 100 mm, who met the inclusion criteria, were included in this study. The primary endpoint was primary patency at 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion based on quantitative analysis of contrast angiography., Results: Between August 2011 and October 2013, 60 patients were enrolled in this study with a mean lesion length of 47.40±25.06 mm (range 2-100 mm). The primary patency rate at 12 months was 75.4%. Freedom from target lesion revascularization was 84.9%. The amputation rate was rare (94.4% freedom from amputation). At the 12-month follow-up time point, a total of 36 out of 42 (85.7%) patients improved in their Rutherford classification by at least 1 class., Conclusions: The use of everolimus-eluting stents in longer infrapopliteal lesions in the treatment of critical limb ischemia is safe and effective with a comparable primary patency, freedom from target lesion revascularization and amputation free survival as in short lesions.

Endovascular techniques have improved markedly over the past several decades. Plain old balloon angioplasty can only reach patencies around 40% after 1 year. Scaffolding stents have resulted in improved short-term results but encountered limitations for longer-term durability. With the introduction of drug-eluting technologies the process of intimal hyperplasia might be slowed, resulting in improved long-term patency results. At first, limus-eluting technologies were not able to transfer the enthusiasm from the coronaries to the infrainguinal vascular bed. However, the newer generation paclitaxel-eluting technologies perform significantly better in femoropopliteal arteries than their non-eluting or non-coated counterparts. The results of a prospective randomized trial comparing DES versus DCB is eagerly awaited. For the moment there seems, based on the meta-analysis, no difference between the two treatment modalities. Although, we need to keep in mind that DCB perform worse in long calcified lesions.

Aims: The aim of this study was to evaluate the 30-day clinical outcome of treatment using the Roadsaver carotid stent in non-consecutive subjects at high risk for carotid endarterectomy requiring revascularisation., Methods and Results: The CLEAR-ROAD study is a prospective, multinational, single-arm, physician-initiated study planned to include 100 patients in nine centres in Belgium, Italy and Germany. The primary endpoint was the 30-day rate of major adverse events (MAE), defined as the cumulative incidence of any death, stroke or myocardial infarction (MI). The use of embolic protection devices (EPDs) was not mandatory; 31.0% of the patients were symptomatic and in 58.0% of the patients EPDs were used. Technical success was achieved in all cases. The 30-day MAE rate was 2.1% (one patient experienced MI followed by death; another patient experienced a stroke within the first 30 days after procedure). While no statistical analysis could be performed, subgroup data suggested that there were no notable differences in the 30-day MAE rate between symptomatic and asymptomatic patients, or between EPD use., Conclusions: The 30-day clinical outcome of 100 patients treated with a dual layer micromesh carotid stent (Roadsaver) shows promising results. The Roadsaver stent is a safe and effective device for endovascular treatment of subjects at high risk for carotid endarterectomy.

Objectives: This is the first-in-human study of a drug-eluting bioresorbable vascular scaffold (BVS) for treatment of peripheral artery disease (PAD) involving the external iliac artery (EIA) and superficial femoral artery (SFA)., Background: Drug-eluting BVS has shown promise in coronary arteries., Methods: The ESPRIT BVS system is a device-drug combination consisting of an everolimus-eluting poly-l-lactide scaffold. Safety and performance were evaluated in 35 subjects with symptomatic claudication., Results: Lesions were located in the SFA (88.6%) and EIA (11.4%). Mean lesion length was 35.7 ± 16.0 mm. The study device was successfully deployed in 100% of cases, without recoil. Procedure-related minor complications were observed in 3 patients (groin hematoma, dissection). Within 2 years there was 1 unrelated death, but no patients in this cohort had an amputation. At 1 and 2 years, the binary restenosis rates were 12.1% and 16.1%, respectively, and target lesion revascularization was performed in 3 of 34 patients (8.8%) and 4 of 32 patients (11.8%), respectively. The ankle brachial index 0.75 ± 0.14 improved from pre-procedure to 0.96 ± 0.16 at 2 years' follow-up. At 2 years, 71.0% of the patients were Rutherford-Becker 0, and 93.5% achieved a maximum walking distance of 1,500 feet., Conclusions: The safety of the ESPRIT BVS was demonstrated with no procedure or device-related deaths or amputations within 2 years. The low occurrence of revascularizations was consistent with duplex-ultrasonography showing sustained patency at 2-years. (A Clinical Evaluation of the Abbott Vascular ESPRIT BVS [Bioresorbable Vascular Scaffold] System [ESPRIT I]; NCT01468974)., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)