DETOUR2 trial outcomes demonstrate clinical utility of percutaneous transmural bypass for the treatment of long segment, complex femoropopliteal disease.

Objective: Percutaneous transmural arterial bypass (PTAB) using the DETOUR system aims to create a percutaneous, endovascular femoropopliteal bypass for the treatment of long segment, complex superficial femoral and proximal popliteal artery disease. The goal of the DETOUR2 study is to investigate the safety and effectiveness of the therapy in comparison with pre-established performance goals.

Methods: The DETOUR2 investigational device exemption study is a prospective, single-arm, multicenter, international trial of symptomatic peripheral arterial disease patients (Rutherford classes 3-5) undergoing the DETOUR procedure for long segment (>20 cm) superficial femoral artery disease.

Cost-effectiveness analysis of intravascular ultrasound-guided peripheral vascular interventions in patients with femoropopliteal peripheral artery disease.

Intravascular ultrasound (IVUS)-guided percutaneous transluminal angioplasty (PTA) might offer clinical benefits compared to angiography-guided PTA in patients with peripheral artery disease (PAD). A cost-effectiveness model was developed to examine the benefits and costs of IVUS-guided PTA versus angiography-guided PTA in PAD patients with femoropopliteal (FP) occlusive disease. A two-step model (a one-year decision tree followed by a lifetime semi-Markov model) was developed from a German healthcare payer perspective to estimate the costs and outcomes over a one-year and lifetime horizon.

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

Background: Effective and durable options for infrapopliteal artery revascularization for patients with chronic limb-threatening ischemia (CLTI) are limited.

Methods: The SAVAL trial is a prospective, multicenter, randomized trial of patients with CLTI and infrapopliteal artery lesions with total lesion length ⩽ 140 mm, stenosis ⩾ 70%, and Rutherford category 4-5 assigned 2:1 to treatment with the SAVAL self-expandable paclitaxel drug-eluting stent (DES) or percutaneous transluminal angioplasty (PTA) with an uncoated balloon. The primary effectiveness endpoint was primary vessel patency (i.

Incidence of adverse cardiovascular events in patients with insomnia: A systematic review and meta-analysis of real-world data.

Insomnia is a prevalent sleeping disorder associated with increasing cardiovascular (CV) mortality and morbidity. However, data incorporating recent clinical studies evaluating these outcomes is scarce. Hence, we aimed to investigate the association of insomnia with CV mortality, myocardial infarction (MI), all-cause mortality, and incidence of CV disease by conducting the first-ever meta-analysis of real-world data evaluating these CV outcomes.

Outcomes of Orbital Atherectomy in Patients with Critical Limb Threatening Ischemia and Diabetes.

Purpose: Patients with diabetes and critical limb threatening ischemia (CLTI) are at significantly higher risk of limb loss and death. Here we evaluate the outcomes of orbital atherectomy (OA) for treatment of CLTI in patients with and without diabetes.

Methods: Retrospective analysis of the LIBERTY 360 study was performed to evaluate baseline demographics, and peri-procedural outcomes between patients with CLTI, and with and without diabetes.

Best crossing of peripheral chronic total occlusions.

Together with colleagues from different disciplines, including cardiologists, interventional radiologists and vascular surgeons, committee members of the of the German Society of Angiology ( []), developed a novel algorithm for the endovascular treatment of peripheral chronic total occlusive lesions (CTOs). Our aim is to improve patient and limb related outcomes, by increasing the success rate of endovascular procedures. This can be achieved by adherence to the proposed crossing algorithm, aiding the standardization of endovascular procedures.

Crossing Algorithm for Infrainguinal Chronic Total Occlusions: An Interdisciplinary Expert Opinion Statement.

A crossing algorithm was developed for the endovascular treatment of peripheral chronic total occlusive lesions (CTOs) to educate, guide, and appropriately influence clinical practice aiming at harmonization and standardization of endovascular procedures. The following steps are proposed: One, duplex sonography and if required computed tomography or magnetic resonance angiography for the selection of the optimal access site. Two, angiographic evaluation of the proximal/distal cap morphology, presence of collaterals at the origin of the proximal cap and at the distal vessel refilling site.

Percutaneous Deep Venous Arterialization: Treatment of Patients with End-Stage Plantar Disease.

Background: Percutaneous deep venous arterialization (pDVA) is a minimally invasive technique connecting the tibial arteries below the knee to the tibial venous system into plantar venous circulation to deliver oxygenated blood to otherwise nonperfused foot. This study demonstrated outcomes of pDVA with commercially available equipment and described single-center experience on pDVA for critical limb-threatening ischemia patients with small artery diseases and end-stage plantar disease (ESPD) who were deemed no-option cases.

Methods: A single-center retrospective review was performed on patients who underwent pDVA.

Clinical Outcomes of Additional Below-The-Ankle Intervention Compared to Below-The-Knee Intervention Alone: A Post-Hoc Analysis of a Prospective Multicenter Study.

Purpose: To investigate the clinical implication of additional below-the-ankle (BTA) intervention in patients with chronic limb-threatening ischemia (CLTI) undergoing below-the-knee (BTK) intervention.

Materials And Methods: A sub-analysis was performed using data from the LIBERTY trial (.gov identifier NCT01855412), a prospective, observational, core-laboratory adjudicated, multicenter study of endovascular intervention in 1204 patients.

Closing the Gaps in Racial Disparities in Critical Limb Ischemia Outcome and Amputation Rates: Proceedings from a Society of Interventional Radiology Foundation Research Consensus Panel.

Minority patients such as Blacks, Hispanics, and Native Americans are disproportionately impacted by critical limb ischemia and amputation due to multiple factors such as socioeconomic status, type or lack of insurance, lack of access to health care, capacity and expertise of local hospitals, prevalence of diabetes, and unconscious bias. The Society of Interventional Radiology Foundation recognizes that it is imperative to close the disparity gaps and funded a Research Consensus Panel to prioritize a research agenda. The following research priorities were ultimately prioritized: (a) randomized controlled trial with peripheral arterial disease screening of at-risk patients with oversampling of high-risk racial groups, (b) prospective trial with the introduction of an intervention to alter a social determinant of health, and (c) a prospective trial with the implementation of an algorithm that requires criteria be met prior to an amputation.

PROMISE I: Early feasibility study of the LimFlow System for percutaneous deep vein arterialization in no-option chronic limb-threatening ischemia: 12-month results.

Objective: We report the 6- and 12-month outcomes of the PROMISE I early feasibility study after treatment of no-option chronic limb-threatening ischemia (CLTI) with percutaneous deep vein arterialization (pDVA) using the LimFlow System.

Methods: Thirty-two patients with no-option CLTI, previously offered major amputation, were enrolled in this single-arm early feasibility study of the LimFlow pDVA System. No-option CLTI was defined as being ineligible for surgical or endovascular arterial revascularization.

A systematic review of the ipsilateral retrograde approach to the treatment of femoropopliteal arterial lesions.

Objective: The endovascular treatment of femoropopliteal lesions is an integral part of managing peripheral arterial disease. The antegrade approach is the most widely used technique with good evidence for its safety and efficacy. However, crossing a lesion, particularly chronic total occlusions (CTO), can be technically challenging and so the retrograde approach is increasingly used to maximize the chances of procedural success.

Two-year PAD-related health care costs in patients undergoing lower extremity endovascular revascularization: results from the LIBERTY 360° trial.

Background: Multiple studies have demonstrated the high economic burden related to the management of lower extremity peripheral artery disease (PAD). This is the first study to examine long-term PAD-related costs among unselected patients undergoing endovascular intervention, and to investigate how clinical and anatomic factors impact cost outcomes over time.

Methods And Results: We performed a prospective health economic study alongside the LIBERTY 360° trial (ClinicalTrials.

Modern multidisciplinary team approach is crucial in treatment for critical limb threatening ischemia.

The aim of this study was to provide a brief overview of the history the multidisciplinary team approach, highlighting the benefit to the patient with critical limb threatening ischemia in relation to health care economics. Furthermore, we provided a description of the requisites and key components, showing how to build a multidisciplinary team.

Utilization Rates of Diagnostic and Therapeutic Vascular Procedures Among Patients Undergoing Lower Extremity Amputations in a Rural Community Hospital: A Clinicopathological Correlation.

Background: Significant geographical variations exist in amputation rates and utilization of diagnostic and therapeutic vascular procedures before lower extremity amputations in the United States. The purpose of this study was to evaluate the rates of diagnostic and therapeutic vascular procedures in the year prior to amputation in a contemporary population and correlate with pathological findings of the amputation specimens.

Methods: A retrospective analysis was conducted of non-traumatic amputations from 2011 to 2017 at a rural community hospital.

Characteristics and Outcomes of Patients With Diabetes Mellitus Undergoing Peripheral Vascular Intervention for Infrainguinal Symptomatic Peripheral Artery Disease.

Purpose: Patients with diabetes mellitus (DM) are known to be at higher risk for peripheral artery disease (PAD), amputations, and major adverse cardiovascular events, though it is unclear whether they are at any higher risk for repeat intervention. LIBERTY 360 offered an opportunity to study a real-world cohort of patients who underwent distal superficial femoral artery endovascular revascularizations. We aimed to describe patients with DM, their outcomes following peripheral vascular intervention, and the effect of DM on outcomes in the LIBERTY 360 cohort.

Three-Year Outcomes From the LIBERTY 360 Study of Endovascular Interventions for Peripheral Artery Disease Stratified by Rutherford Category.

Purpose: To report the 3-year results of the LIBERTY 360 study, which investigated outcomes of endovascular treatment of symptomatic peripheral artery disease (PAD).

Materials And Methods: The LIBERTY trial ( identifier NCT01855412) was a prospective, observational, core laboratory-assessed, multicenter study of endovascular interventions enrolling >1200 participants treated at 51 sites. Data from 1189 patients were stratified according to Rutherford category (RC) and analyzed [RC 2-3 (n=500), RC 4-5 (n=589), and RC 6 (n=100)].

The impact of chronic kidney disease on outcomes following peripheral vascular intervention.

Background: Patients with chronic kidney disease (CKD) have worsened clinical outcomes following percutaneous coronary intervention; however, limited evidence exists in patients undergoing peripheral vascular intervention (PVI).

Purpose: We aimed to assess the effect of CKD on outcomes following PVI for symptomatic peripheral artery disease.

Methods: Using patients from the LIBERTY 360 study, we compared the rates of 30 day and 1 year major adverse vascular events (MAVE), a composite of all-cause mortality, major amputation, and target vessel/lesion revascularization, between patients with and without CKD (estimated glomular filtration rate less than 60) following PVI.

Three-Year Outcomes of Orbital Atherectomy for the Endovascular Treatment of Infrainguinal Claudication or Chronic Limb-Threatening Ischemia.

To investigate the outcomes of orbital atherectomy (OA) for the treatment of patients with peripheral artery disease (PAD) manifesting as claudication or chronic limb-threatening ischemia (CLTI). The database from the LIBERTY study ( identifier NCT01855412) was interrogated to identify 503 PAD patients treated with any commercially available endovascular devices and adjunctive OA for 617 femoropopliteal and/or infrapopliteal lesions. Cox regression analyses were employed to examine the association between baseline Rutherford category (RC) stratified as RC 2-3 (n=214), RC 4-5 (n=233), or RC 6 (n=56) and all-cause mortality, target vessel revascularization (TVR), major amputation, major adverse event (MAE), and major amputation/death at up to 3 years of follow-up.

Lower extremity revascularization via endovascular and surgical approaches: A systematic review with emphasis on combined inflow and outflow revascularization.

This review is intended to help clinicians and patients understand the present state of peripheral artery disease, appreciate the progression and presentation of critical limb ischemia/chronic limb-threatening ischemia, and make informed decisions regarding inflow and outflow endovascular revascularization and surgical treatment options within the context of current debates in the medical community. A controlled literature search was performed to obtain research on outcomes of critical limb ischemia patients undergoing complete leg revascularization for peripheral artery disease inflow and outflow disease. Data for this review were identified by queries of medical and life science databases, expert referral, and references from relevant papers published between 1997 and 2019, resulting in 48 articles.

Digital Subtraction Angiography Prior to an Amputation for Critical Limb Ischemia (CLI): An Expert Recommendation Statement From the CLI Global Society to Optimize Limb Salvage.

Despite recent guideline updates on peripheral artery disease (PAD) and critical limb ischemia (CLI) treatment, the optimal treatment for CLI is still being debated. As a result, care is inconsistent, with many CLI patients undergoing an amputation prior to what many consider to be mandatory: consultation with an interdisciplinary specialty care team and a comprehensive imaging assessment. More importantly, quality imaging is critical in CLI patients with below-the-knee disease.

Intravascular Ultrasound Imaging Versus Digital Subtraction Angiography in Patients with Peripheral Vascular Disease.

Objectives: The evaluation of arterial plaque morphology and vessel diameter is a vital component of peripheral vascular interventions. Historically, digital subtraction angiography (DSA) has been considered the gold standard for vessel sizing and treatment. However, this modality has the limitation of providing a two-dimensional image of a three-dimensional luminal structure.