Two-year outcome of the paclitaxel-eluting Legflow balloon catheter in the treatment of long and complex femoropopliteal lesions.

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.

Drug-eluting devices for lower limb peripheral arterial disease.

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.

Comparative analysis of carotid artery stenting practice and outcomes across operator specialties: insights from a prespecified subanalysis of a large real-world patient cohort (ROADSAVER Study).

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.

Post hoc analysis of the SuperB and Zilverpass trials for treatment of long and complex superficial femoral artery lesions.

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.

Intraoperative Extravascular Ultrasound in the Identification of Flow-Limiting Dissections after Balloon Angioplasty in the Femoropopliteal Segment.

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. 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.

The BioMimics 3D Helical Centreline Nitinol Stent in Chronic Limb Threatening Ischaemia and Complex Lesions: Three Year Outcomes of the MIMICS-3D Registry.

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.

Head-to-Head Comparison of 2 Paclitaxel-Coated Balloons for Femoropopliteal Lesions.

Background: There is a scarcity of published head-to-head comparisons between different paclitaxel-coated angioplasty balloons. More prospective safety data to support the health care economic reimbursement processes are needed.

Objectives: The aim of this study was to report the safety and efficacy of the Passeo-18 Lux drug-coated balloon (DCB) (Biotronik AG) for the treatment of symptomatic peripheral artery disease caused by stenosis, restenosis, or occlusion of the femoral and/or popliteal arteries.

ZILVERPASS Study: ZILVER PTX Stent versus Prosthetic Above-the-Knee Bypass Surgery in Femoropopliteal Lesions, 5-year Results.

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.

Radial access for peripheral vascular intervention: the S.M.A.R.T. RADIANZ Vascular Stent System.

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).

ZILVERPASS Study: ZILVER PTX Stent vs. Bypass Surgery in Femoropopliteal Lesions, 3 year results and economic analysis.

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.

BioMimics 3D Stent in Femoropopliteal Lesions: 3-Year Outcomes with Propensity Matching for Drug-Coated Balloons.

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).

Thyroglossal Duct Cyst Mimicking a Hygroma Colli - An Unusual Presentation.

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.

Methodology of the BIOPACT RCT, a Multi-center, Randomized, Non-inferiority Trial Evaluating Safety and Efficacy of Passeo-18 Lux Drug-Coated Balloon (DCB) of Biotronik Compared to the Medtronic IN.PACT Admiral DCB in the Treatment of Subjects with Lesions of the Femoropopliteal Artery.

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.

Clinical Outcomes of Ambulatory Endovascular Treatment Using 4-French and 6-French Femoral Access Strategies: The Bio4amb Multicentre Trial.

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.

Stent-grafts are the best way to treat complex in-stent restenosis lesions in the superficial femoral artery: 24-month results from a multicenter randomized trial.

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.

Combining the Passeo-18 Lux Drug-Coated Balloon and the Pulsar-18 Bare Metal Stent: 12- and 24-Month Outcomes of the BIOLUX 4EVER Investigator-Initiated Trial.

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 ( 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.

Use of Dual-Layered Stents for Carotid Artery Angioplasty: 1-Year Results of a Patient-Based Meta-Analysis.

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.

One-year outcome of the paclitaxel-eluting Legflow balloon catheter in the treatment of long and complex femoropopliteal lesions.

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.

ZILVERPASS Study: ZILVER PTX Stent vs Bypass Surgery in Femoropopliteal Lesions.

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. 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 ( identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.

Endovascular Treatment of No-Stent Zones… Quo Vadis?

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.

Multivariable Analysis of Patients With Severe Persistent Postprocedural Hypotension After Carotid Artery Stenting.

To assess the incidence and predictors of severe, persistent postprocedural hypotension (PPH) after carotid artery stenting (CAS). 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.

One-year outcome of the everolimus-eluting, balloon-expandable Promus Element and Promus Element Plus stent in the treatment of below-the-knee lesions in CLI patients.

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.