Six-month safety and efficacy outcomes from the randomized-controlled arm of the WRAPSODY Arteriovenous Access Efficacy (WAVE) trial.

Stenosis within the arteriovenous fistula (AVF) of hemodialysis patients leads to vascular access dysfunction and inadequate hemodialysis. Percutaneous transluminal angioplasty (PTA) is the standard therapy for stenosis. However, rates of restenosis and loss of access patency remain high.

Noninvasive therapeutic ultrasound to increase perfusion in chronic limb-threatening ischemia: An early feasibility study.

Background: Preclinical studies have demonstrated that therapeutic ultrasound (TUS) increases perfusion in peripheral artery disease (PAD). This pilot study assessed the safety and effectiveness of a noninvasive TUS device in patients with advanced PAD.

Methods: A phased array of TUS transducers was fabricated on a wearable sleeve, designed to sonicate the posterior and anterior tibial arteries (and their collaterals) at the calf level.

The LAVA Study: A Prospective, Multicenter, Single-Arm Study of a Liquid Embolic System for Treatment of Peripheral Arterial Hemorrhage.

Purpose: To present the results of the Liquid Embolization of Arterial Hemorrhages in Peripheral Vasculature (LAVA) study evaluating safety and effectiveness of Lava Liquid Embolic System, an ethylene vinyl alcohol (EVOH), for peripheral arterial hemorrhage (PAH).

Materials And Methods: LAVA was a pivotal, prospective, multicenter, single-group, centrally adjudicated study of adults with active PAH. Patients received EVOH at 1 of 2 viscosities, administered by experienced physicians.

Editor's Choice - Quality of Life after Stenting for Iliofemoral Venous Obstruction: A Randomised Controlled Trial with One Year Follow Up.

Objective: Deep venous obstruction (DVO) is a great burden on the healthcare system and patients' quality of life (QoL). Case series show stenting is safe and effective, however most studies lack control groups and QoL changes have not been compared with conventional treatment. The aim was to assess the difference in QoL changes from baseline to 12 months between stent and conventionally treated patients with DVO.

Objective Performance Goals Based on a Systematic Review and Meta-Analysis of Clinical Outcomes for Bare-Metal Stents and Percutaneous Transluminal Angioplasty for Hemodialysis-Related Central Venous Obstruction.

Purpose: To use safety and efficacy outcomes following treatment with percutaneous transluminal angioplasty (PTA) and/or stent placement for thoracic central venous obstruction in hemodialysis-dependent patients to establish objective performance goals (OPGs).

Methods: A systematic literature review and meta-analysis were conducted for articles published between January 1, 2000, and August 31, 2021. Efficacy outcomes included primary patency rates at 6 and 12 months, and safety outcomes included adverse events (AEs) categorized as access loss, procedure-related AEs, and serious AEs (SAEs).

Midterm and Long-Term Outcomes following Dedicated Endovenous Nitinol Stent Placement for Symptomatic Iliofemoral Venous Obstruction: Three- to 5-Year Results of the VIRTUS Study.

Purpose: To assess the midterm patency and long-term safety of placement of a dedicated venous stent (Vici Venous Stent System) for the treatment of venous lesions of the iliofemoral outflow tract.

Materials And Methods: Patients with unilateral obstructive disease of the iliofemoral veins and a Clinical, Etiological, Anatomical, Pathophysiological class of 3 or higher or a Venous Clinical Severity Score of 2 or greater were enrolled in this prospective, multicenter, single-arm study at 23 sites in the United States and Europe. The patients were followed up for 36 months after the index procedure for the assessment of patency and up to 60 months for the assessment of safety.

Development of a prediction model for deep vein thrombosis in a retrospective cohort of patients with suspected deep vein thrombosis in primary care.

Objective: Early and accurate prediction and diagnosis of deep vein thrombosis (DVT) is essential to allow for immediate treatment and reduce potential complications. However, all potentially strong risk factors have not been included in pretest probability assessments such as the Wells score. In addition, the Wells score might not be suitable for use in primary care because it was developed for secondary care.

Single-Session Treatment of Patients with Symptomatic Iliocaval and Iliofemoral Deep Vein Thrombosis: Technical Results of a Prospective Pilot Study.

Purpose: To investigate the short-term results of single-session treatment of iliocaval and iliofemoral DVT using a single thrombectomy device.

Materials And Methods: This prospective pilot study analyzed patients with acute iliocaval or iliofemoral DVT treated in a single session using the JETi thrombectomy system. All analyses were performed on an intention-to-treat basis.

Effect of Stent Strut Interval on Neointima Formation After Venous Stenting in an Ovine Model.

Objective: The impact of stent design on venous patency is not well studied. The purpose of this study was to investigate the effect of stent material burden on endothelial coverage of stented venous segments, which may contribute to vessel healing and patency.

Methods: Segmented self expanding bare nitinol stents (18 × 50 mm) comprising 5 mm long attached metallic rings separated by 2, 5, or 8 mm gaps were implanted in the inferior vena cava (IVC) of 10 sheep.

A risk score for iliofemoral patients with deep vein thrombosis.

Objective: Deep vein thrombosis (DVT) is a common condition with a high risk of post-thrombotic morbidity, especially in patients with a proximal thrombus. Successful iliofemoral clot removal has been shown to decrease the severity of post-thrombotic syndrome. It is assumed that earlier thrombus lysis is associated with a better outcome.

A Real-Time Blood Flow Measurement Device for Patients with Peripheral Artery Disease.

Purpose: To evaluate the feasibility of a new optical device that measures peripheral blood flow as a diagnostic and monitoring tool for patients with peripheral artery disease (PAD).

Materials And Methods: In this prospective study, 167 limbs of 90 patients (mean age, 76 y; 53% men) with suspected PAD were evaluated with the FlowMet device, which uses a new type of dynamic light-scattering technology to assess blood flow in real time. Measurements of magnitude and phasicity of blood flow were combined into a single-value flow-waveform score and compared vs ankle-brachial index (ABI), toe-brachial index (TBI), and clinical presentation of patients per Rutherford category (RC).

Iliocaval Skip Stent Reconstruction Technique for Chronic Bilateral Iliocaval Venous Occlusion.

Purpose: To report safety and efficacy of a skip stent technique using nitinol stents in patients with chronic bilateral iliocaval venous occlusions.

Materials And Methods: A retrospective analysis of 48 consecutive patients (32 men; mean age, 40.7 years; age range, 18-68 years) with chronic bilateral iliocaval obstructions treated using a nonoverlapping stent technique was conducted at a single center.

A Surgeon's Guide for Various Lung Nodule Localization Techniques and the Newest Technologies.

Preoperative image-guided localization of lung nodules is necessary for successful intraoperative localization and resection. However, current localization techniques carry significant intraoperative disadvantages for surgeons. Articles were selected through multiple search engines using key search terms and reviewed to compare results, outcomes, advantages, limitations, and complications of various localization methods.

Correlation between Post-Procedure Residual Thrombus and Clinical Outcome in Deep Vein Thrombosis Patients Receiving Pharmacomechanical Thrombolysis in a Multicenter Randomized Trial.

Purpose: To evaluate relationships between immediate venographic results and clinical outcomes of pharmacomechanical catheter-directed thrombolysis (PCDT).

Materials And Methods: Venograms from 317 patients with acute proximal deep vein thrombosis (DVT) who received PCDT in a multicenter randomized trial were reviewed. Quantitative thrombus resolution was assessed by independent readers using a modified Marder scale.

Overview of the safety and efficacy of the Surfacer® Inside-Out® Access Catheter System for obtaining central venous access in patients with thoracic central venous obstructions.

Introduction: The development of thoracic central venous obstruction (TCVO) leads to narrowing of the vessel lumen which impacts blood flow and the placement of central venous access. The most common cause of TCVO is central venous catheters (CVCs) which can induce intravascular scarring or endoluminal obstruction via thrombus formation.

Areas Covered: The Surfacer® System is used to obtain central venous access (CVA) in patients with TCVO by facilitating catheter insertion via the novel Inside-Out® approach.

Sex-Related Differences in the Long-Term Outcomes of Patients with Femoropopliteal Arterial Disease Treated with the IN.PACT Drug-Coated Balloon in the IN.PACT SFA Randomized Controlled Trial: A Post Hoc Analysis.

Purpose: To evaluate sex-related disparities in long-term outcomes of patients with peripheral artery disease (PAD) treated with IN.PACT drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA).

Materials And Methods: A post hoc analysis of the IN.

Efficacy and safety associated with the use of the Surfacer Inside-Out Access Catheter System: Results from a prospective, multicenter Food and Drug Administration-approved Investigational Device Exemption study.

Purpose: Thoracic central venous obstruction is commonly associated with the use of central venous catheters. The Study was an Food and Drug Administration-approved US Investigational Device Exemption study designed to evaluate the performance and safety of the Surfacer System when used to facilitate central venous access in patients with thoracic central venous obstruction.

Methods: Thirty patients were enrolled in this prospective, multicenter, single-arm study between December 2017 and May 2019.

Quality of life after pharmacomechanical catheter-directed thrombolysis for proximal deep venous thrombosis.

Background: After deep venous thrombosis (DVT), many patients have impaired quality of life (QOL). We aimed to assess whether pharmacomechanical catheter-directed thrombolysis (PCDT) improves short-term or long-term QOL in patients with proximal DVT and whether QOL is related to extent of DVT.

Methods: The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial was an assessor-blinded randomized trial that compared PCDT with no PCDT in patients with DVT of the femoral, common femoral, or iliac veins.

Pivotal Study of Endovenous Stent Placement for Symptomatic Iliofemoral Venous Obstruction.

Background: Chronic venous insufficiency is characterized by inadequate venous return from the lower extremities, which may arise from intravenous obstruction after deep vein thrombosis or from extrinsic venous compression. The purpose of this study was to determine the safety and effectiveness of a dedicated endovenous stent for symptomatic iliofemoral venous obstruction.

Methods: The VIRTUS trial (VIRTUS Safety and Efficacy of the Veniti Vici Venous Stent System [Veniti, Inc] When Used to Treat Clinically Significant Chronic Non-Malignant Obstruction of the Iliofemoral Venous Segment) was a prospective, international, single-arm, pivotal study of endovenous stent placement in patients with symptomatic iliofemoral venous obstruction.

Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years.

Background: A recent summary-level meta-analysis comprising randomized, controlled trials (RCTs) of femoropopliteal paclitaxel-coated balloon and stent intervention identified excess late mortality in the paclitaxel-treated patients.

Methods: We evaluated the safety of the Stellarex drug-coated balloon (DCB) for femoropopliteal artery disease with an independently performed meta-analysis of patient-level data from all patients in the Stellarex femoropopliteal clinical program. To compare mortality after DCB or uncoated percutaneous transluminal angioplasty (PTA), we aggregated data from 2 RCTs comprising 419 patients treated with DCB and 170 patients treated with PTA.

Total IN.PACT drug-coated balloon initiative reporting pooled imaging and propensity-matched cohorts.

Objective: Randomized controlled trials have shown that drug-coated balloons (DCBs) provide superior results compared with percutaneous transluminal angioplasty (PTA) for the treatment of femoropopliteal artery disease. However, these trials have generally included short lesions, few occlusions, and small sample sizes. The present study was an individual-level pooled analysis of duplex ultrasonography (DUS) core laboratory-adjudicated and clinical events committee-adjudicated IN.

Relationships between the use of pharmacomechanical catheter-directed thrombolysis, sonographic findings, and clinical outcomes in patients with acute proximal DVT: Results from the ATTRACT Multicenter Randomized Trial.

Few studies have documented relationships between endovascular therapy, duplex ultrasonography (DUS), post-thrombotic syndrome (PTS), and quality of life (QOL). The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial randomized 692 patients with acute proximal deep vein thrombosis (DVT) to receive anticoagulation or anticoagulation plus pharmacomechanical catheter-directed thrombolysis (PCDT). Compression DUS was obtained at baseline, 1 month and 12 months.