Delphi Consensus on Reporting Standards in Clinical Studies for Endovascular Treatment of Acute Iliofemoral Venous Thrombosis and Chronic Iliofemoral Venous Obstruction.

Acute iliofemoral deep vein thrombosis and chronic iliofemoral venous obstruction cause substantial patient harm and are increasingly managed with endovascular venous interventions, including percutaneous mechanical thrombectomy and stent placement. However, studies of these treatment elements have not been designed and reported with sufficient rigor to support confident conclusions about their clinical utility. In this project, the Trustworthy consensus-based statement approach was utilized to develop, via a structured process, consensus-based statements to guide future investigators of venous interventions. Thirty statements were drafted to encompass major topics relevant to venous study description and design, safety outcome assessment, efficacy outcome assessment, and topics specific to evaluating percutaneous venous thrombectomy and stent placement. Using modified Delphi techniques for consensus achievement, a panel of physician experts in vascular disease voted on the statements and succeeded in reaching the predefined threshold of >80% consensus (agreement or strong agreement) on all 30 statements. It is hoped that the guidance from these statements will improve standardization, objectivity, and patient-centered relevance in the reporting of clinical outcomes of endovascular interventions for acute iliofemoral deep venous thrombosis and chronic iliofemoral venous obstruction in clinical studies and thereby enhance venous patient care.

Fibromuscular dysplasia in a middle-aged transgender man: The role of hormones in disease pathogenesis.

Fibromuscular dysplasia is an uncommon non-inflammatory arteriopathy. Hormonal factors are believed to play a role in disease pathogenesis given the overwhelming female predominance of this disease. We describe a case of a 56-year-old transgender man on prolonged testosterone therapy diagnosed with renal fibromuscular dysplasia after presenting with hypertensive urgency.

Evaluation and Management of Chronic Venous Disease Using the Foundation of CEAP.

PURPOSE OF THE REVIEW: Venous disease is common. Depending on the population studied, the prevalence may be as high as 80%. Significant chronic venous disease with venous ulcers or trophic skin changes is reported to affect 1-10% of the population. A systematic assessment of the clinical findings associated with chronic venous disease will facilitate appropriate imaging. Based on imaging and assessment, patients with reflux or obstruction can be recommended proper medical and endovascular or surgical management. RECENT FINDINGS: Many types of endovascular management are available to treat reflux and eliminate varicose veins and tributaries. More recently adopted non-thermal non-tumescent techniques have been shown to be comparable with more widely performed laser or radiofrequency ablation techniques. A thorough clinical assessment, appropriate duplex ultrasound imaging, and use of advanced imaging when needed will allow clinicians to optimize therapy for patients with chronic venous disease based on the etiology, anatomy involved, and the pathophysiology.

Anticoagulation Beyond 3 to 6Months: What Does the Data Tell Us?

Patients with a history of deep vein thrombosis and pulmonary embolism are at risk for a recurrent event. This is particularly true of patients with idiopathic events or events related to low risk triggers. In these patients extending anticoagulation beyond 3 to 6months may be warranted. Using clinical risk, biomarker analysis and risk stratification protocols we can make the best recommendations to patients with respect to the risks and benefits of ongoing therapy. Trials demonstrating benefit from low-dose aspirin for secondary prophylaxis may provide an option for patients in whom ongoing anticoagulation is deemed unsafe. In addition, recent introduction of the direct oral anticoagulants have expanded options for secondary prophylaxis for preventing venous thromboembolism recurrence.

Practice patterns of adjunctive therapy for venous leg ulcers.

Objectives Venous leg ulcers (VLU) are the most severe clinical sequelae of venous reflux and post thrombotic syndrome. There is a consensus that ablation of refluxing vein segments and treatment of significant venous obstruction can heal VLUs. However, there is wide disparity in the use and choice of adjunctive therapies for VLUs. The purpose of this study was to assess these practice patterns among members of the American Venous Forum. Methods The AVF Research Committee conducted an online survey of its own members, which consisted of 16 questions designed to determine the specialty of physicians, location of treatment, treatment practices and reimbursement for treatment of VLUs Results The survey was distributed to 667 practitioners and a response rate of 18.6% was achieved. A majority of respondents (49.5%) were vascular specialists and the remaining were podiatrists, dermatologists, primary care doctors and others. It was found that 85.5% were from within the USA, while physicians from 14 other countries also responded. Most of the physicians (45%) provided adjunctive therapy at a private office setting and 58% treated less than 5 VLU patients per week. All respondents used some form of compression therapy as the primary mode of treatment for VLU. Multilayer compression therapy was the most common form of adjunctive therapy used (58.8%) and over 90% of physicians started additional modalities (biologics, negative pressure, hyperbaric oxygen and others) when VLUs failed compression therapy, with a majority (65%) waiting less than three months to start them. Medicare was the most common source of reimbursement (52.4%). Conclusions Physicians from multiple specialties treat VLU. While most physicians use compression therapy, there is wide variation in the selection and point of initiation for additional therapies once compression fails. There is a need for high-quality data to help establish guidelines for adjunctive treatment of VLUs and to disseminate them to physicians across multiple specialties to ensure standardized high-quality treatment of patients with VLUs.

Program requirements for fellowship education in venous and lymphatic medicine.

Background In every field of medicine, comprehensive education should be delivered at the graduate level. Currently, no single specialty routinely provides a standardized comprehensive curriculum in venous and lymphatic disease. Method The American Board of Venous & Lymphatic Medicine formed a task force, made up of experts from the specialties of dermatology, family practice, interventional radiology, interventional cardiology, phlebology, vascular medicine, and vascular surgery, to develop a consensus document describing the program requirements for fellowship medical education in venous and lymphatic medicine. Result The Program Requirements for Fellowship Education in Venous and Lymphatic Medicine identify the knowledge and skills that physicians must master through the course of fellowship training in venous and lymphatic medicine. They also specify the requirements for venous and lymphatic training programs. The document is based on the Core Content for Training in Venous and Lymphatic Medicine and follows the ACGME format that all subspecialties in the United States use to specify the requirements for training program accreditation. The American Board of Venous & Lymphatic Medicine Board of Directors approved this document in May 2016. Conclusion The pathway to a vein practice is diverse, and there is no standardized format available for physician education and training. The Program Requirements for Fellowship Education in Venous and Lymphatic Medicine establishes educational standards for teaching programs in venous and lymphatic medicine and will facilitate graduation of physicians who have had comprehensive training in the field.

Prevention of the Post-Thrombotic Syndrome.

OPINION STATEMENT: Post-thrombotic syndrome frequently affects patients following deep vein thrombosis. The clinical signs and symptoms of post-thrombotic syndrome reflect the underlying pathophysiology of venous obstruction, venous reflux as well as acute and chronic inflammation. Patients with post-thrombotic syndrome are at risk for long-term consequences including decreased quality of life, lost work productivity, and increased health expenditures. Unfortunately, despite recognition of pathophysiology and the clinical, physical, and economic impact of PTS, there have been few advances in prevention. PTS continues to be a frustrating condition to both prevent and manage. Preventing post-thrombotic syndrome begins with preventing deep vein thrombosis. In the setting of acute deep vein thrombosis-using available medical therapies to prevent the development of post-thrombotic syndrome is imperative. Patients should be provided optimal medical therapy with anticoagulation, maintaining therapeutic anticoagulation as much of the time as possible. Use of compression stockings, while contentious, are a low risk intervention which may provide benefit and are unlikely to be associated with harm. In the appropriate patient, considering endovenous procedures to decrease the thrombus burden and provide optimal preservation of venous valve function may be warranted.

The management of diabetic foot: A clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine.

BACKGROUND: Diabetes mellitus continues to grow in global prevalence and to consume an increasing amount of health care resources. One of the key areas of morbidity associated with diabetes is the diabetic foot. To improve the care of patients with diabetic foot and to provide an evidence-based multidisciplinary management approach, the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine developed this clinical practice guideline. METHODS: The committee made specific practice recommendations using the Grades of Recommendation Assessment, Development, and Evaluation system. This was based on five systematic reviews of the literature. Specific areas of focus included (1) prevention of diabetic foot ulceration, (2) off-loading, (3) diagnosis of osteomyelitis, (4) wound care, and (5) peripheral arterial disease. RESULTS: Although we identified only limited high-quality evidence for many of the critical questions, we used the best available evidence and considered the patients' values and preferences and the clinical context to develop these guidelines. We include preventive recommendations such as those for adequate glycemic control, periodic foot inspection, and patient and family education. We recommend using custom therapeutic footwear in high-risk diabetic patients, including those with significant neuropathy, foot deformities, or previous amputation. In patients with plantar diabetic foot ulcer (DFU), we recommend off-loading with a total contact cast or irremovable fixed ankle walking boot. In patients with a new DFU, we recommend probe to bone test and plain films to be followed by magnetic resonance imaging if a soft tissue abscess or osteomyelitis is suspected. We provide recommendations on comprehensive wound care and various débridement methods. For DFUs that fail to improve (>50% wound area reduction) after a minimum of 4 weeks of standard wound therapy, we recommend adjunctive wound therapy options. In patients with DFU who have peripheral arterial disease, we recommend revascularization by either surgical bypass or endovascular therapy. CONCLUSIONS: Whereas these guidelines have addressed five key areas in the care of DFUs, they do not cover all the aspects of this complex condition. Going forward as future evidence accumulates, we plan to update our recommendations accordingly.

Core content for training in venous and lymphatic medicine.

The major venous societies in the United States share a common mission to improve the standards of medical practitioners, the educational goals for teaching and training programs in venous disease, and the quality of patient care related to the treatment of venous disorders. With these important goals in mind, a task force made up of experts from the specialties of dermatology, interventional radiology, phlebology, vascular medicine, and vascular surgery was formed to develop a consensus document describing the Core Content for venous and lymphatic medicine and to develop a core educational content outline for training. This outline describes the areas of knowledge considered essential for practice in the field, which encompasses the study, diagnosis, and treatment of patients with acute and chronic venous and lymphatic disorders. The American Venous Forum and the American College of Phlebology have endorsed the Core Content.

Pulse volume recording does not enhance segmental pressure readings for peripheral arterial disease stratification.

BACKGROUND: Noninvasive vascular laboratory determinations for peripheral arterial disease (PAD) often combine pulse volume recordings (PVRs), segmental pressure readings (SPs), and Doppler waveform traces (DWs) into a single diagnostic report. Our objective was to assess the corresponding diagnostic values for each test when subjected to interpretation by 4 vascular specialists. METHODS: A total of 2226 non-invasive diagnostic reports were reviewed through our institutional database between January 2009 and December 2011. Data from noninvasive records with corresponding angiograms performed within 3 months led to a cohort of 76 patients (89 limbs) for analysis. Four vascular specialists, blinded to the angiographic results, stratified the noninvasive studies as representative of normal, <50% "subcritical," or ≥50% "critical" stenosis at the upper thigh, lower thigh, popliteal, and calf segments using 4 randomized noninvasive modalities: (1) PVR alone; (2) SP alone; (3) SP+DW; and (4) SP+DW+PVR. The angiographic records were independently graded by another 3 evaluators and used as a standard to determine the noninvasive diagnostic values and interobserver agreements for each modality. Statistical tests used include the Fleiss-modified kappa analysis, Kruskal-Wallis analysis of variance with Dunn's multiple comparison test, the Kolmogorov-Smirnov test, and the unpaired t-test with Welch's correction. RESULTS: Interobserver variance for all modalities was high, except for SP. When surveying for any stenosis (<50% and ≥50%), sensitivity (range 25-75%) was lower than specificity (range 50-84%) for all modalities. When surveying for critical stenosis only (≥50%), sensitivity (range 27-54%) was also lower than specificity (range 68-92%). Accuracy for detecting any stenosis with SP+DW was significantly higher than with PVR alone (66 ± 7% vs. 56 ± 12%, P = 0.017). There was a significant reduction in accuracy when including incompressible readings within the SP-only analysis compared with exclusion of incompressible vessels (P = 0.0006). However, the effect of vessel incompressibility on accuracy was removed with the addition of DW (P = 0.17) to the protocol. CONCLUSIONS: SP has the greatest interobserver agreement in evaluation of PAD and can be used preferentially for PAD stratification. Given the lower accuracy of PVR for detecting either subcritical or critical disease, PVR tests can be omitted from the noninvasive vascular examination without a significant reduction in overall diagnostic value and can be reserved for patients with incompressible vessels.

C-reactive protein predicts 96-week carotid intima media thickness progression in HIV-infected adults naive to antiretroviral therapy.

: This is a 96-week prospective cohort study of antiretroviral therapy (ART)-naive HIV-infected adults and matched healthy controls to assess progression of carotid intima media thickness (CIMT) and its relationship to inflammation. Median common carotid artery (CCA) CIMT increased significantly but similarly in both groups [CCA: 0.02 (interquartile range: 0-0.05); P < 0.01 within HIV-infected adults vs. 0.01 (0-0.05) mm; P < 0.01 within controls; and P = 0.83 between groups]. Change in bulb CIMT yielded similar results. Independent predictors of CCA CIMT progression in HIV-infected adults were higher systolic blood pressure, total cholesterol, and high sensitivity C-reactive protein. Independent predictors of bulb CIMT progression were higher non-high-density lipoprotein cholesterol and high sensitivity C-reactive protein. Other inflammation markers were not associated with CIMT progression.

Psoriasis and cardiovascular risk factors: increased serum myeloperoxidase and corresponding immunocellular overexpression by Cd11b(+) CD68(+) macrophages in skin lesions.

BACKGROUND: Recent studies report independent associations between psoriasis, cardiovascular (CV) events and risk factors. Blood Myeloperoxidase (MPO) from activated myeloid cells is associated with CV risk mainly through lipid oxidation, induction of endothelial dysfunction and release of IL-12 from macrophages. OBJECTIVES: To elucidate associations between psoriasis and conventional CV risk factors. METHODS: We performed a cross-sectional study of 100 psoriasis patients and 53 controls, group matched on age, gender and body mass index, to assess levels of MPO in serum, as well as immunohistochemical staining from psoriasis skin lesions, psoriasis uninvolved skin, and normal skin. RESULTS: Although the groups did not differ on waist circumference, glucose, cholesterol, triglycerides, creatinine or personal history of CV events, psoriasis patients had significantly higher waist-to-hip ratios, blood pressures, proportion of current smokers, and lower high density lipoprotein level than controls. Serum MPO level was elevated 2.5 fold (P<0.001) in psoriasis patients, even after adjusting for the CV risk factors on which the groups differed. MPO did correlate with coronary artery calcification, carotid plaque, carotid intima media thickness and flow mediated dilation, but did not correlate with psoriasis severity. However, MPO was highly expressed in lesional psoriatic skin and colocalized predominantly with CD45(+) CD11b(+) leukocytes. CD11b(+) cell density correlated with circulation MPO levels. CONCLUSION: Lesional skin CD11b(+) leukocytes activated to generate MPO may contribute to serum levels of MPO. Lesional CD11b(+) cell activity may be an alternative measure of disease burden to PASI that underlies the MPO biomarker for systemic inflammation related to Cardiovascular Disease.

Rate and predictors of carotid artery intima media thickness progression in antiretroviral-naive HIV-infected and uninfected adults: a 48-week matched prospective cohort study.

BACKGROUND: Carotid intima media thickness (CIMT) progresses faster in HIV-infected adults on antiretroviral therapy (ART) than the general population. It is unclear if the rate of progression is similarly faster in ART-naive, HIV-infected adults. METHODS: This was a 48-week prospective cohort study to compare change in CIMT and inflammation markers in ART-naive, HIV-infected adults in no immediate need of ART (HIV-positive/ART-naive) and age/sex/body mass index (BMI)-matched controls (HIV-negative). RESULTS: A total of 85 HIV-positive/ART-naive and 45 HIV-negative participants were enrolled. In the HIV-positive/ART-naive group, median baseline CD4+ T-cell count and HIV-1 RNA were 535 cells/mm3 and 6,916 copies/ml. Baseline common carotid artery (CCA) and bulb CIMTs were similar between groups. Changes in CIMT to 48 weeks at both sites were not different within- or between-groups (median [IQR] change in HIV-positive/ART-naive versus HIV-negative CCA CIMT -0.0071 mm [-0.0267-0.0233] versus 0.0113 mm [-0.0117-0.0306]; P = 0.19 between-groups; and bulb CIMT 0.0017 mm [-0.0367-0.06167] versus 0.01 mm [-0.0383-0.0625]; P = 0.54). After adjustment for cardiovascular disease (CVD) risk factors, change in CCA CIMT was greater in HIV-negative participants (-0.0046 versus 0.0177 mm for HIV-positive/ART-naive versus HIV-negative; P = 0.01). In HIV-positive/ART-naive, interleukin (IL)-6, soluble tumour necrosis factor-α receptor (sTNFR)-II, vascular cell adhesion molecule-1 and intercellular adhesion molecule (ICAM)-1 were higher at both time points and D-dimer was higher at week 48 (P < 0.01 for all). IL-6, sTNFR-I and D-dimer increased over 48 weeks in HIV-positive/ART-naive participants (P < 0.01 for all). In HIV-positive/ART-naive participants, independent predictors of greater change in CCA CIMT were higher BMI (P = 0.05) and family history of CVD (P < 0.01) and of greater change in bulb CIMT were higher sTNFR-I (P = 0.03) and higher diastolic blood pressure (P < 0.01). CONCLUSIONS: In ART-naive HIV-infected adults at low risk of HIV disease progression and low cardiovascular risk, CIMT progression rate was similar to matched controls. In addition to traditional CVD risk factors, higher levels of sTNFR-I predicted greater bulb CIMT changes.