Publications by authors named "Andrew N Nicolaides"

76 Publications

Management of patients with asymptomatic carotid stenosis may need to be individualized: a multidisciplinary call for action. Republication of J Stroke 2021;23:202-212

Int Angiol 2021 07 27. Epub 2021 Jul 27.

Department of Neurology & Stroke Program, University of Maryland School of Medicine, Baltimore, MD, USA.

The optimal management of patients with asymptomatic carotid stenosis (ACS) is the subject of extensive debate. According to the 2017 European Society for Vascular Surgery guidelines, carotid endarterectomy should (Class IIa; Level of Evidence: B) or carotid artery stenting may be considered (Class IIb; Level of Evidence: B) in the presence of one or more clinical/imaging characteristics that may be associated with an increased risk of late ipsilateral stroke (e.g. silent embolic infarcts on brain computed tomography/magnetic resonance imaging, progression in the severity of ACS, a history of contralateral transient ischemic attack/stroke, microemboli detection on transcranial Doppler, etc.), provided documented perioperative stroke/death rates are <3% and the patient's life expectancy is >5 years. Besides these clinical/imaging characteristics, there are additional individual, ethnic/racial or social factors that should probably be evaluated in the decision process regarding the optimal management of these patients, such as individual patient needs/patient choice, patient compliance with best medical treatment, patient sex, culture, race/ethnicity, age and comorbidities, as well as improvements in imaging/operative techniques/outcomes. The present multispecialty position paper will present the rationale why the management of patients with ACS may need to be individualized.
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http://dx.doi.org/10.23736/S0392-9590.21.04751-9DOI Listing
July 2021

Identifying the Vulnerable Carotid Atherosclerotic Plaque in Patients With Asymptomatic Carotid Stenosis.

Angiology 2021 Jul 2:33197211028416. Epub 2021 Jul 2.

Department of Radiology, Azienda Ospedaliero Universitaria (A.O.U.) di Cagliari, Cagliari, Italy.

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http://dx.doi.org/10.1177/00033197211028416DOI Listing
July 2021

Management of Patients with Asymptomatic Carotid Stenosis May Need to Be Individualized: A Multidisciplinary Call for Action.

J Stroke 2021 May 31;23(2):202-212. Epub 2021 May 31.

Department of Neurology & Stroke Program, University of Maryland School of Medicine, Baltimore, MD, USA.

The optimal management of patients with asymptomatic carotid stenosis (ACS) is the subject of extensive debate. According to the 2017 European Society for Vascular Surgery guidelines, carotid endarterectomy should (Class IIa; Level of Evidence: B) or carotid artery stenting may be considered (Class IIb; Level of Evidence: B) in the presence of one or more clinical/imaging characteristics that may be associated with an increased risk of late ipsilateral stroke (e.g., silent embolic infarcts on brain computed tomography/magnetic resonance imaging, progression in the severity of ACS, a history of contralateral transient ischemic attack/stroke, microemboli detection on transcranial Doppler, etc.), provided documented perioperative stroke/death rates are <3% and the patient's life expectancy is >5 years. Besides these clinical/imaging characteristics, there are additional individual, ethnic/racial or social factors that should probably be evaluated in the decision process regarding the optimal management of these patients, such as individual patient needs/patient choice, patient compliance with best medical treatment, patient sex, culture, race/ethnicity, age and comorbidities, as well as improvements in imaging/operative techniques/outcomes. The present multispecialty position paper will present the rationale why the management of patients with ACS may need to be individualized.
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http://dx.doi.org/10.5853/jos.2020.04273DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8189852PMC
May 2021

Association of Intima-Media Texture With Prevalence of Clinical Cardiovascular Disease.

IEEE Trans Ultrason Ferroelectr Freq Control 2021 09 27;68(9):3017-3026. Epub 2021 Aug 27.

Recent studies have suggested that textural characteristics of the intima-media complex (IMC) may be more useful than the intima-media thickness (IMT) in evaluating cardiovascular risk. The primary aim of our study was to investigate the association between texture features of the common carotid IMC and prevalent clinical cardiovascular disease (CVD). The secondary aim was to determine whether IMT and IMC texture features vary between the left and right carotid arteries. The study was performed on 2208 longitudinal-section ultrasound images of the left (L) and right (R) common carotid artery (CCA), acquired from 569 men and 535 women out of which 125 had clinical CVD. L and R sides of the IMC were intensity normalized and despeckled. The IMC was semiautomatically delineated for all images using a semiautomated segmentation system, and 61 different texture features were extracted. The corresponding IMT semiautomated measurements (mean±SD) of the L and R sides were 0.73±0.21 mm/0.69±0.19 mm for the normal population and 0.83±0.17 mm/0.79±0.18 mm for those with CVD. IMC texture features did not differ between the right- and left-hand sides. Several texture features were independent predictors of the presence of CVD. The multivariate logistic regression analysis combining age, IMT, and texture features produced a receiver operating characteristic curve with an area under the curve of 89%. A correct classification rate of 77% for separating the normal subject (NOR) versus CVD subjects was achieved using the support vector machine classifier with a combination of clinical features, IMT, and extracted texture features. Texture features provide additional information on the presence of clinical CVD, which is over and above that provided by conventional risk factors or IMT alone. The value of IMC texture features in the prediction of future cardiovascular events should be tested in prospective studies.
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http://dx.doi.org/10.1109/TUFFC.2021.3081137DOI Listing
September 2021

Carotid Ultrasound Boundary Study (CUBS): An Open Multicenter Analysis of Computerized Intima-Media Thickness Measurement Systems and Their Clinical Impact.

Ultrasound Med Biol 2021 08 30;47(8):2442-2455. Epub 2021 Apr 30.

PolitoBIOmed Lab, Biolab, Department of Electronics and Communications, Politecnico di Torino, Torino, Italy.

Common carotid intima-media thickness (CIMT) is a commonly used marker for atherosclerosis and is often computed in carotid ultrasound images. An analysis of different computerized techniques for CIMT measurement and their clinical impacts on the same patient data set is lacking. Here we compared and assessed five computerized CIMT algorithms against three expert analysts' manual measurements on a data set of 1088 patients from two centers. Inter- and intra-observer variability was assessed, and the computerized CIMT values were compared with those manually obtained. The CIMT measurements were used to assess the correlation with clinical parameters, cardiovascular event prediction through a generalized linear model and the Kaplan-Meier hazard ratio. CIMT measurements obtained with a skilled analyst's segmentation and the computerized segmentation were comparable in statistical analyses, suggesting they can be used interchangeably for CIMT quantification and clinical outcome investigation. To facilitate future studies, the entire data set used is made publicly available for the community at http://dx.doi.org/10.17632/fpv535fss7.1.
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http://dx.doi.org/10.1016/j.ultrasmedbio.2021.03.022DOI Listing
August 2021

Compression Therapy to Prevent Recurrent Cellulitis of the Leg.

N Engl J Med 2020 11;383(19):1891

Imperial College London, London, United Kingdom.

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http://dx.doi.org/10.1056/NEJMc2029458DOI Listing
November 2020

Asymptomatic Carotid Stenosis and Risk of Stroke (ACSRS) study: what have we learned from it?

Ann Transl Med 2020 Oct;8(19):1271

Department of Vascular Surgery, University of Patras Medical School, Patras, Greece.

The Asymptomatic Carotid Stenosis and Risk of Stroke (ACSRS) study is the largest natural history study on patients with 50-99% asymptomatic carotid stenosis (ACS). It included 1,121 ACS individuals with a follow-up between 6 and 96 months (mean: 48 months). During the last 15 years, several important ACSRS substudies have been published that have contributed significantly to the optimal management of ACS patients. These studies have demonstrated that specific baseline clinical characteristics and ultrasonic plaque features after image normalization (namely carotid plaque type, gray scale median, carotid plaque area, juxtaluminal black area without a visible echogenic cup, discrete white areas in an echolucent part of a plaque, silent embolic infarcts on brain computed tomography scans, a history of contralateral transient ischemic attacks/strokes) can independently predict future ipsilateral cerebrovascular events. The ACSRS study provided proof that by use of a computer program to normalize plaque images and extract plaque texture features, a combination of features can stratify patients into various categories depending on their stroke risk. The present review will discuss the various reported predictors of future ipsilateral cerebrovascular events and how these characteristics can be used to calculate individual stroke risk.
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http://dx.doi.org/10.21037/atm.2020.02.156DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7607063PMC
October 2020

Dynamic carotid plaque imaging using ultrasonography.

J Vasc Surg 2021 05 19;73(5):1630-1638. Epub 2020 Oct 19.

Vascular Screening and Diagnostic Centre, Nicosia, Cyprus; Department of Vascular Surgery, University of Nicosia Medical School, Nicosia, Cyprus.

Objective: Dynamic image analysis of carotid plaques has demonstrated that during systole and early diastole, all plaque components will move in the same direction (concordant motion) in some plaques. However, in others, different parts of the plaque will move in different directions (discordant motion). The aim of our study was (1) to determine the prevalence of discordant motion in symptomatic and asymptomatic plaques, (2) to develop a measurement of the severity of discordant motion, and (3) to determine the correlation between the severity of discordant motion and symptom prevalence.

Methods: A total of 200 patients with 204 plaques resulting in 50% to 99% stenosis (112 asymptomatic and 92 symptomatic plaques) had video recordings available of the plaque motion during 10 cardiac cycles. Video tracking was performed using Farneback's method, which relies on frame comparisons. In our study, these were performed at 0.1-second intervals. The maximum angular spread (MAS) of the motion vectors at 10-pixel intervals in the plaque area was measured in degrees. Plaques were classified as concordant (MAS, <70°), moderately discordant (MAS, 70°-120°), and discordant (MAS, >120°).

Results: Motion was discordant in 89.1% of the symptomatic plaques but only in 17.9% of asymptomatic plaques (P < .001). The prevalence of symptoms increased with increasing MAS. For a MAS >120°, the hazard ratio for the presence of symptoms was 47.7 (95% confidence interval, 18.1-125.6) compared with the rest of the plaques after adjustment for the degree of stenosis and mean pixel motion. The area under the receiver operating characteristic curve for the prediction of the presence of symptoms using the MAS was 0.876 (95% confidence interval, 0.823-0.929). The use of the median MAS (120°) as a cutoff point classified 86% of the plaques correctly (sensitivity, 81.4%; specificity, 91.2%; positive predictive value, 90.2%; and negative predictive value, 83.0%).

Conclusions: The use of the MAS value to identify asymptomatic plaques at increased risk of developing symptoms and, in particular, stroke should be tested in prospective studies.
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http://dx.doi.org/10.1016/j.jvs.2020.10.021DOI Listing
May 2021

CEAP clinical classes C0S-C4: differences, similarities and role of Ruscus + HMC + vitamin C in patients with chronic venous disease.

Int Angiol 2020 Apr 12;39(2):118-124. Epub 2020 Feb 12.

Department of Surgery, University of Nicosia Medical School, Nicosia, Cyprus.

Since the publication of the CEAP classification, new research has enriched our knowledge; notably on the heritability of CVD and the genetic and environmental factors involved in this condition, as well as the symptoms apparent within the spectrum of the CEAP clinical classes and the benefits of medical treatment. Using the CEAP classification as a special theme, a symposium with the same title as the present paper was held at the annual meeting of the 2019 European Venous Forum. The lectures presented much valuable information, from which some key points can be extracted. The influence of environmental factors was demonstrated, and the fact that a large amount of information can be obtained from comprehensive history taking. There is robust evidence for heritability. Many candidate genes/loci have been identified, potentially offering new targets for treatment. More research is needed, notably using genome-wide association studies and also on microbiota, which may play a role in CVD through the inflammation pathway. Ruscus + HMC + vitamin C acts by increasing venous and lymphatic tone, protecting microcirculation, and reducing inflammation. It improves quality of life in C0S to C3 CVD patients, while a review of clinical studies and a meta-analysis have confirmed its clinical efficacy across a wide spectrum of CVD clinical classes: C0S, C1S, C2, C3 and C4. It has been awarded a Grade 1A recommendation by the international guidelines.
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http://dx.doi.org/10.23736/S0392-9590.20.04341-2DOI Listing
April 2020

The Most Severe Stage of Chronic Venous Disease: An Update on the Management of Patients with Venous Leg Ulcers.

Adv Ther 2020 02 22;37(Suppl 1):19-24. Epub 2020 Jan 22.

Department of Surgery, University of Nicosia Medical School, Nicosia, Cyprus.

Venous leg ulcers (VLUs) are the most severe manifestation of chronic venous disease (CVD). Due to their chronic nature, high recurrence rate and slow healing time, VLUs account for 80% of all leg ulcers seen in patients with CVD. VLUs impose a heavy burden on patients that reduces their quality of life; VLUs also represent a major socioeconomic impact due to the cost and duration of care. The primary medical approach to treating VLUs is local compression therapy in combination with venoactive drug (VAD) pharmacotherapy to promote the reduction of the inflammatory reaction initiated by venous hypertension. Micronized purified flavonoid fraction (MPFF; Daflon) is the most widely prescribed VAD. MPFF counteracts the pathophysiologic mechanisms of CVD and ulceration and has proven to be an effective adjunct to compression therapy in patients with large and chronic VLUs. Two other non-VAD drugs, pentoxifylline and sulodexide, have also been shown to improve VLU healing and are also recommended in addition to compression therapy. However, MPFF is the only VAD with the highest strength of recommendations in the 2018 guidelines for the healing of VLUs.
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http://dx.doi.org/10.1007/s12325-020-01219-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7004438PMC
February 2020

The Benefits of Micronized Purified Flavonoid Fraction (MPFF) Throughout the Progression of Chronic Venous Disease.

Adv Ther 2020 02 22;37(Suppl 1):1-5. Epub 2020 Jan 22.

Department of Surgery, University of Nicosia Medical School, Nicosia, Cyprus.

At the 2019 European Venous Forum in Zurich Switzerland, a symposium entitled "State of the art: benefits of MPFF throughout CVD progression" was held to discuss the developing treatment strategies for patients at all stages of chronic venous disease (CVD). At the early stages of CVD, management should be focused on preventing disease progression through lifestyle changes and conservative treatment; treatment can also include venoactive drugs (VAD) such as micronized purified flavonoid fraction (MPFF; Daflon), which is the most well-known and most widely prescribed VAD in Europe. As the disease progresses, patients who require interventional procedures (e.g., endovenous procedure or sclerotherapy) can also benefit from MPFF treatment in the recovery period after the procedure, as MPFF has been shown to reduce periprocedural pain and bleeding (hematoma), and to improve CVD symptoms during this period. Management of CVD in patients with venous leg ulcers (VLU) is the most challenging; in these patients, recommended adjunct therapies to be combined with standard compression therapy include VAD (MPFF) and non-VAD drugs (pentoxifylline and sulodexide) which have been shown to speed VLU healing in comparison with compression therapy alone.
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http://dx.doi.org/10.1007/s12325-019-01218-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7004432PMC
February 2020

Screening for and Optimal Management of Small Abdominal Aortic Aneurysms: The Quest Continues.

Curr Vasc Pharmacol 2020 ;18(6):663-666

Department of Vascular Surgery, 'Attikon' University Hospital, National and Kapodistrian University of Athens, Athens, Greece.

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http://dx.doi.org/10.2174/1570161118999191126145824DOI Listing
December 2020

Chronic venous disease: from symptoms to microcirculation.

Int Angiol 2019 Jun 16;38(3):211-218. Epub 2019 May 16.

Department of Surgery, University of Nicosia Medical School, Nicosia, Cyprus.

The recently published European Venous Forum (EVF) Guidelines 2018 update on the management of chronic venous disorders of the lower limbs has focused on several new aspects: a new place for early symptoms, new data on microcirculation alterations, and a re-evaluation of veno-active drugs (VADs), based on new criteria. The symposium "Chronic Venous Disease (CVD): From Symptoms to Microcirculation", held at the annual meeting of the EVF on 28 June 2018 in Athens, Greece, highlighted this perspective by answering three questions: What do symptoms mean and how do they influence our choice of investigations? Is there a link between symptoms and microcirculation alterations? How to choose the right VAD for the right patient based on the updated EVF guidelines? The answers given led the speakers to three conclusions: early symptoms reveal the initial stage of CVD and patients with C0S disease should be properly diagnosed, investigated, and treated; damage to the microcirculation is likely to be the first evidence of the onset of venous disease; Ruscus+HMC+VitC has proven efficacy in randomized controlled trials, and has been given a strong recommendation (Grade 1A) by the 2018 EVF guidelines for treatment of pain, heaviness, feeling of swelling, paresthesia, and edema, and should be considered as one of the preferred treatments to relieve these symptoms in CVD patients.
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http://dx.doi.org/10.23736/S0392-9590.19.04116-6DOI Listing
June 2019

Burden and Suffering in Chronic Venous Disease.

Adv Ther 2019 03 13;36(Suppl 1):1-4. Epub 2019 Feb 13.

Department of Surgery, Stony Brook University Medical Center, Stony Brook, NY, USA.

Chronic venous disease (CVD) is widespread, underdiagnosed, and can progress to chronic venous insufficiency and venous ulcers, which can require extensive treatment and hospitalization. These conditions negatively impact patient quality of life and place substantial burdens on healthcare resources. The two main risk factors for CVD are age and obesity. Thus, with the growing prevalence of obesity and the increasing longevity of the population, the burden of CVD is expected to increase dramatically in the coming decades. Appropriate lifestyle changes and care, which may include treatment with venoactive drugs, can slow disease progression, improve quality of life, and are likely to reduce healthcare costs. Physicians should be aware of this growing problem and of the effective treatments available for CVD. We recommend the accompanying short summaries from a symposium held at the recent European Venous Forum as a means for our colleagues to learn more about the burden and suffering associated with CVD.Funding: Servier.
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http://dx.doi.org/10.1007/s12325-019-0882-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6824337PMC
March 2019

Efficacy of micronized purified flavonoid fraction (Daflon®) on improving individual symptoms, signs and quality of life in patients with chronic venous disease: a systematic review and meta-analysis of randomized double-blind placebo-controlled trials.

Int Angiol 2018 Apr 31;37(2):143-154. Epub 2018 Jan 31.

Imperial College London, London, UK.

Introduction: The use of a venoactive drug is considered an important component of medical treatment of chronic venous disease (CVD), although the efficacy of certain venoactive drugs (VADs) on one or more individual leg symptoms or signs may have not been extensively studied to justify a strong recommendation in guidelines on CVD. The aim of this systematic review and meta-analysis was to study the effectiveness of the micronized purified flavonoid fraction (MPFF, Daflon®) across the spectrum of defined venous symptoms, signs, quality of life (QoL) and treatment assessment by the physician.

Evidence Acquisition: On September 9, 2017, a systematic review of the databases MEDLINE, Scopus and Cochrane Central was performed, supplemented by hand searching, to identify randomized double-blind placebo-controlled trials on MPFF in patients with CVD.

Evidence Synthesis: The main outcome measures were the individual and global symptoms, leg edema and redness, skin changes, QoL and evaluation of the overall effectiveness of the treatment by the physician. The effectiveness of MPFF compared with placebo was expressed as risk ratio (RR) or standardized mean difference (SMD) with 95% confidence interval (CI). Trial quality of evidence was graded using the GRADE system.

Results: We identified 7 trials, mostly with low risk of bias, involving 1,692 patients. On qualitative analysis, MPFF significantly improved nine defined leg symptoms, including pain, heaviness, feeling of swelling, cramps, paresthesia, burning sensation, and pruritus (itching), but also functional discomfort compared with placebo, leg redness, skin changes and QoL. On quantitative analysis, MPFF compared with placebo, assessed as a categorical variable, reduced leg pain (RR 0.53, P=0.0001, NNT=4.2), heaviness (RR 0.35, P<0.00001, NNT=2.0), feeling of swelling (RR 0.39, P<0.00001, NNT=3.1), cramps (RR 0.51, P=0.02, NNT=4.8), paresthesia (RR 0.45, P=0.03, NNT=3.5), and functional discomfort (RR 0.41, P=0.0004, NNT=3.0). Similarly, MPFF compared with placebo, assessed as a continuous variable reduced pain (SMD -0.25, 95% CI -0.38 to -0.11), heaviness (SMD -0.80, 95% CI -1.05 to -0.54), feeling of swelling (SMD -0.99, 95% CI -1.25 to -0.73), burning sensation (SMD -0.46, 95% CI -0.78 to -0.14), cramps (SMD -0.46, 95% CI -0.78 to -0.14), and functional discomfort (SMD -0.87, 95% CI -1.13 to -0.61). Regarding objective assessments of leg edema, the use of MPFF compared with placebo reduced ankle circumference (SMD -0.59, 95% CI -1.15 to -0.02), and leg redness (SMD -0.32, 95% CI -0.56 to -0.07, RR 0.50, P=0.03, NNT=3.6), improved skin changes (RR 0.18, P=0.0003, NNT=1.6) and quality of life (SMD -0.21, 95% CI -0.37 to -0.04) and was associated with clinical improvement as assessed by the physician (RR 0.28, P<0.00001, NNT=2.5). Heterogeneity was mostly minimal. The existing evidence where sufficient was mostly of high quality.

Conclusions: Based on high quality evidence, MPFF is highly effective in improving leg symptoms, edema and quality of life in patients with CVD.
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http://dx.doi.org/10.23736/S0392-9590.18.03975-5DOI Listing
April 2018

New data on chronic venous disease: a new place for Cyclo 3® Fort.

Int Angiol 2018 Feb 23;37(1):85-92. Epub 2017 Oct 23.

Department of Surgery, University of Nicosia Medical School, Nicosia, Cyprus.

With our increasing knowledge of the epidemiology, pathophysiology, investigation and clinical aspects of chronic venous disease (CVD) and new data on the various therapies available, an update of the recommendations on CVD and its management appears to be necessary. The symposium New Data on Chronic Venous Disease: A New Place for Cyclo 3® Fort, held during the annual meeting of the European Venous Forum on June 30th, 2017 in Porto, Portugal, reported the recent developments on the Ruscus, hesperidin methyl chalcone (HMC), and vitamin C combination (Cyclo 3® Fort), including the results of a series of in-vivo pharmacological experiments and a recent meta-analysis. Additionally, the symposium provided first-hand information on the process, rules, main findings, and expected contents of the prospective 2018 CVD guidelines. Analysis of the evidence showed that the effect of the Ruscus, HMC, and vitamin C combination on pain, heaviness, feeling of swelling, tingling, ankle circumference and global symptoms score reached Grade A. Therefore, the new guidelines should specify that the Ruscus, HMC, and vitamin C combination merits a Grade 1A recommendation.
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http://dx.doi.org/10.23736/S0392-9590.17.03935-9DOI Listing
February 2018

The place of Ruscus extract, hesperidin methyl chalcone, and vitamin C in the management of chronic venous disease.

Int Angiol 2017 Feb;36(1):31-41

Department of Surgery, University of Nicosia Medical School, Nicosia, Cyprus.

Despite continuous improvement in our knowledge and management of chronic venous disease (CVD), certain areas, such as the role of muscarinic receptors in the pathology and treatment of CVD, remain unexplored. The symposium "The place of Ruscus extract, hesperidin methyl chalcone, and vitamin C in the management of CVD", held at the Annual Meeting of the European Venous Forum on 7-9 July 2016 in London, presented an update on the pathophysiology of CVD and highlighted how the combination of Ruscus extract, hesperidin methyl chalcone, and vitamin C (Ruscus/HMC/VitC; Cyclo 3® Fort), may counteract the deleterious processes underlying CVD. The data presented during this symposium are reported here. The pathophysiology of CVD is driven by a complex process involving numerous factors, with the two key players being venous hypertension and the inflammatory response. The cascade of reactions induced by disturbed venous flow, inflammation, and tissue alterations results in the early appearance of symptoms and progressive development of clinical signs of disease. Previous studies have shown that Ruscus extract acts at three levels: on the veins, capillaries and lymphatics, and has anti-inflammatory properties. A series of recent experiments has shed new light on the mechanism of action of the combination of Ruscus/HMC/VitC. The efficacy of Ruscus/HMC/VitC in CVD is supported by clinical studies, while two meta-analyses have confirmed a significant decrease of several symptoms and ankle circumference in response to treatment with this agent, leading to the conclusion that Ruscus/HMC/VitC deserves a Grade A rating.
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http://dx.doi.org/10.23736/S0392-9590.16.03788-3DOI Listing
February 2017

Combined intermittent pneumatic leg compression and pharmacological prophylaxis for prevention of venous thromboembolism.

Cochrane Database Syst Rev 2016 Sep 7;9:CD005258. Epub 2016 Sep 7.

Department of Vascular Surgery, University of Patras Medical School, Hippocrates Ave, Rio, Patras, Achaia, Greece, 26504.

Background: It is generally assumed by practitioners and guideline authors that combined modalities (methods of treatment) are more effective than single modalities in preventing venous thromboembolism (VTE), defined as deep vein thrombosis (DVT) or pulmonary embolism (PE), or both. This is an update of the review first published in 2008.

Objectives: The aim of this review was to assess the efficacy of combined intermittent pneumatic leg compression (IPC) and pharmacological prophylaxis versus single modalities in preventing venous thromboembolism.

Search Methods: For this update the Cochrane Vascular Information Specialist (CIS) searched the Specialised Register (May 2016). In addition the CIS searched the Cochrane Register of Studies (CENTRAL (2016, Issue 4)). Clinical trials databases were searched for details of ongoing or unpublished studies.

Selection Criteria: Randomized controlled trials (RCTs) or controlled clinical trials (CCTs) of combined IPC and pharmacological interventions used to prevent VTE.

Data Collection And Analysis: We independently selected trials and extracted data. Disagreements were resolved by discussion. We performed fixed-effect model meta-analyses with odds ratios (ORs) and 95% confidence intervals (CIs). We used a random-effects model when there was heterogeneity.

Main Results: We included a total of 22 trials (9137 participants) of which 15 were randomized trials (7762 participants). The overall risk of bias was mostly unclear or high due to selection and performance bias. We used GRADE to assess the quality of the evidence and this was downgraded from high to moderate or very low due to the risk of bias, imprecision or indirectness.The rate of PE in the studies comparing IPC alone with combined IPC and pharmacological prophylaxis was low, underpowering the analyses. The incidence of symptomatic PE was 0.79% with IPC, but ranged between 0.1 to 1% with combined IPC and pharmacological prophylaxis (OR 0.49, 95% CI 0.18 to 1.34; 12 studies, 3017 participants, moderate quality evidence). The incidence of DVT was 4.10% in the IPC group and 2.19% in the combined group showing a reduced incidence of DVT in favour of the combined group (OR 0.52, 95% CI 0.33 to 0.82; 11 studies, 2934 participants, moderate quality evidence). The addition of an anticoagulant to IPC, however, increased the risk of any bleeding compared to IPC alone; 0.66% (7/1053) in the IPC group and 4.0% (44/1102) in the combined group (OR 5.04, 95% CI 2.36 to 10.77; 7 studies, 2155 participants, moderate quality evidence). Major bleeding followed a similar pattern; 0.1% (1/1053) in the IPC group to 1.5% (17/1102) in the combined group (OR 6.81, 95% CI 1.99 to 23.28; 7 studies, 2155 participants, moderate quality evidence).We detected no difference between the type of surgery subgroups such as orthopedic and non-orthopedic participants for DVT incidence (P = 0.16). Tests for differences between type of surgery subgroups were not possible for PE incidence.Compared with pharmacological prophylaxis alone, the use of combined IPC and pharmacological prophylaxis modalities reduced the incidence of symptomatic PE from 2.92% to 1.20% (OR 0.39, 95% CI 0.23 to 0.64; 10 studies, 3544 participants, moderate quality evidence). The incidence of DVT was 6.2% in the pharmacological prophylaxis group and 2.9% in the combined group showing no difference between the combined and pharmacological prophylaxis groups (OR 0.42, 95% CI 0.18 to 1.03; 11 studies, 2866 participants, moderate quality evidence). Increased bleeding side effects were not observed for IPC when it was added to anticoagulation (bleeding: OR 0.80, 95% CI 0.30 to 2.14, very low quality evidence; major bleeding: OR 1.21, 95% CI 0.35 to 4.18, very low quality evidence, 3 studies, 244 participants).No difference was detected between the type of surgery subgroups for PE incidence (P = 0.68) or for DVT incidence (P = 0.10).

Authors' Conclusions: Moderate quality evidence suggests that combining IPC and pharmacological prophylaxis, compared with IPC or pharmacological prophylaxis alone, decreases the incidence of DVT when compared to compression, and incidence of PE when compared to anticoagulation. Moderate quality evidence suggests that there is no difference between combined and single modalities in the incidence of PE when compared with compression alone and DVT when compared with anticoagulation alone. The quality of evidence for PE or DVT was downgraded to moderate due to imprecision or risk of bias in study methodology, highlighting the need for further research. Moderate quality evidence suggests the addition of pharmacological prophylaxis to IPC, increased the risk of bleeding compared to IPC alone, a side effect not observed for IPC when added to pharmacological prophylaxis (very low quality evidence), as expected for a physical method of thromboprophylaxis. The quality of evidence for bleeding was downgraded to moderate due to indirectness or very low due to risk of bias in study methodology, indirectness and imprecision highlighting the need for further research. Nevertheless, the results of the current review agree with current guideline recommendations, which support the use of combined modalities in hospitalised patients (limited to those with trauma or undergoing surgery) at risk of developing VTE. More studies on the role of combined modalities in VTE prevention are needed.
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http://dx.doi.org/10.1002/14651858.CD005258.pub3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6457599PMC
September 2016

Venous hemodynamic changes in lower limb venous disease: the UIP consensus according to scientific evidence.

Int Angiol 2016 06 24;35(3):236-352. Epub 2016 Mar 24.

Division of Vascular Surgery, Department of Surgery, George Washington University, Washington DC, WA, USA -

There are excellent guidelines for clinicians to manage venous diseases but few reviews to assess their hemodynamic background. Hemodynamic concepts that evolved in the past have largely remained unchallenged in recent decades, perhaps due to their often complicated nature and in part due to emergence of new diagnostic techniques. Duplex ultrasound scanning and other imaging techniques which evolved in the latter part of the 20th century have dominated investigation. They have greatly improved our understanding of the anatomical patterns of venous reflux and obstruction. However, they do not provide the physiological basis for understanding the hemodynamics of flow, pressure, compliance and resistance. Hemodynamic investigations appear to provide a better correlation with post-treatment clinical outcome and quality of life than ultrasound findings. There is a far better prospect for understanding the complete picture of the patient's disability and response to management by combining ultrasound with hemodynamic studies. Accordingly, at the instigation of Dr Angelo Scuderi, the Union Internationale de Phlebologie (UIP) executive board commissioned a large number of experts to assess all aspects of management for venous disease by evidence-based principles. These included experts from various member societies including the European Venous Forum (EVF), American Venous Forum (AVF), American College of Phlebology (ACP) and Cardiovascular Disease Educational and Research Trust (CDERT). Their aim was to confirm or dispel long-held hemodynamic principles and to provide a comprehensive review of venous hemodynamic concepts underlying the pathophysiology of lower limb venous disorders, their usefulness for investigating patients and the relevant hemodynamic changes associated with various forms of treatment. Chapter 1 is devoted to basic hemodynamic concepts and normal venous physiology. Chapter 2 presents the mechanism and magnitude of hemodynamic changes in acute deep vein thrombosis indicating their pathophysiological and clinical significance. Chapter 3 describes the hemodynamic changes that occur in different classes of chronic venous disease and their relation to the anatomic extent of disease in the macrocirculation and microcirculation. The next four chapters (Chapters 4-7) describe the hemodynamic changes resulting from treatmen by compression using different materials, intermittent compression devices, pharmacological agents and finally surgical or endovenous ablation. Chapter 8 discusses the unique hemodynamic features associated with alternative treatment techniques used by the CHIVA and ASVAL. Chapter 9 describes the hemodynamic effects following treatment to relieve pelvic reflux and obstruction. Finally, Chapter 10 demonstrates that contrary to general belief there is a moderate to good correlation between certain hemodynamic measurements and clinical severity of chronic venous disease. The authors believe that this document will be a timely asset to both clinicians and researchers alike. It is directed towards surgeons and physicians who are anxious to incorporate the conclusions of research into their daily practice. It is also directed to postgraduate trainees, vascular technologists and bioengineers, particularly to help them understand the hemodynamic background to pathophysiology, investigations and treatment of patients with venous disorders. Hopefully it will be a platform for those who would like to embark on new research in the field of venous disease.
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June 2016

Improving outcomes in patients with carotid stenosis: call for better research opportunities and standards.

Stroke 2015 Jan 18;46(1):7-8. Epub 2014 Nov 18.

From the School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia (A.L.A.); Imperial College, London, United Kingdom (A.N.N.); and St Georges London/Nicosia Medical School, University of Nicosia, Egkomi, Cyprus (A.N.N.).

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http://dx.doi.org/10.1161/STROKEAHA.114.007437DOI Listing
January 2015

Carotid endarterectomy may be required in addition to best medical treatment for some patient subgroups with asymptomatic carotid stenosis.

Vascular 2015 Feb 11;23(1):62-4. Epub 2014 Nov 11.

Divisions of Vascular Surgery, New York University Langone Medical Center and The Cleveland Clinic, New York and Cleveland, USA.

Several guidelines recommend carotid endarterectomy for patients with severe asymptomatic carotid stenosis to reduce the risk of a future cerebrovascular event, as long as the perioperative stroke/death rate is <3%. Based on improvements in best medical treatment, it was argued that currently best medical treatment alone should comprise the treatment-of-choice for asymptomatic carotid stenosis patients and that no intervention is warranted in these individuals. While it is true that best medical treatment should be used for the management of all asymptomatic carotid stenosis patients, emerging evidence suggests that best medical treatment alone may not prevent disease progression and the development of symptoms in some asymptomatic carotid stenosis patient subgroups. This article analyzes the results of two recent independent studies demonstrating that medical therapy alone may not be adequate for stroke prevention in some asymptomatic carotid stenosis patient subgroups. These results suggest that besides best medical treatment, additional carotid endarterectomy should be considered for specific asymptomatic carotid stenosis patients.
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http://dx.doi.org/10.1177/1708538114560463DOI Listing
February 2015

Identifying which patients with asymptomatic carotid stenosis could benefit from intervention.

Stroke 2014 Dec 30;45(12):3720-4. Epub 2014 Oct 30.

From the Sheffield Vascular Institute, Northern General Hospital, Sheffield, UK (K.I.P.); Stroke Prevention and Atherosclerosis Research Centre, Robarts Research Institute, Western University, London, Ontario, Canada (J.D.S.); Division of Vascular Surgery, New York University Langone Medical Center, New York (F.J.V.); Department of Vascular Surgery, The Cleveland Clinic, OH (F.J.V.); and St. George's London/Nicosia University Medical School, University of Nicosia, Engomi, Cyprus (A.N.N.).

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http://dx.doi.org/10.1161/STROKEAHA.114.006912DOI Listing
December 2014

Association between alcohol and cardiovascular disease: Mendelian randomisation analysis based on individual participant data.

BMJ 2014 Jul 10;349:g4164. Epub 2014 Jul 10.

Unit of Cancer Epidemiology, San Giovanni Battista Hospital and Center for Cancer Prevention (CPO-Piemonte), 10129, Torino, Italy.

Objective: To use the rs1229984 variant in the alcohol dehydrogenase 1B gene (ADH1B) as an instrument to investigate the causal role of alcohol in cardiovascular disease.

Design: Mendelian randomisation meta-analysis of 56 epidemiological studies.

Participants: 261 991 individuals of European descent, including 20 259 coronary heart disease cases and 10 164 stroke events. Data were available on ADH1B rs1229984 variant, alcohol phenotypes, and cardiovascular biomarkers.

Main Outcome Measures: Odds ratio for coronary heart disease and stroke associated with the ADH1B variant in all individuals and by categories of alcohol consumption.

Results: Carriers of the A-allele of ADH1B rs1229984 consumed 17.2% fewer units of alcohol per week (95% confidence interval 15.6% to 18.9%), had a lower prevalence of binge drinking (odds ratio 0.78 (95% CI 0.73 to 0.84)), and had higher abstention (odds ratio 1.27 (1.21 to 1.34)) than non-carriers. Rs1229984 A-allele carriers had lower systolic blood pressure (-0.88 (-1.19 to -0.56) mm Hg), interleukin-6 levels (-5.2% (-7.8 to -2.4%)), waist circumference (-0.3 (-0.6 to -0.1) cm), and body mass index (-0.17 (-0.24 to -0.10) kg/m(2)). Rs1229984 A-allele carriers had lower odds of coronary heart disease (odds ratio 0.90 (0.84 to 0.96)). The protective association of the ADH1B rs1229984 A-allele variant remained the same across all categories of alcohol consumption (P=0.83 for heterogeneity). Although no association of rs1229984 was identified with the combined subtypes of stroke, carriers of the A-allele had lower odds of ischaemic stroke (odds ratio 0.83 (0.72 to 0.95)).

Conclusions: Individuals with a genetic variant associated with non-drinking and lower alcohol consumption had a more favourable cardiovascular profile and a reduced risk of coronary heart disease than those without the genetic variant. This suggests that reduction of alcohol consumption, even for light to moderate drinkers, is beneficial for cardiovascular health.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4091648PMC
http://dx.doi.org/10.1136/bmj.g4164DOI Listing
July 2014

Genetic association study of QT interval highlights role for calcium signaling pathways in myocardial repolarization.

Nat Genet 2014 Aug 22;46(8):826-36. Epub 2014 Jun 22.

Center for Biomedicine, European Academy Bozen/Bolzano (EURAC), Bolzano, Italy (affiliated institute of the University of Lübeck, Lübeck, Germany).

The QT interval, an electrocardiographic measure reflecting myocardial repolarization, is a heritable trait. QT prolongation is a risk factor for ventricular arrhythmias and sudden cardiac death (SCD) and could indicate the presence of the potentially lethal mendelian long-QT syndrome (LQTS). Using a genome-wide association and replication study in up to 100,000 individuals, we identified 35 common variant loci associated with QT interval that collectively explain ∼8-10% of QT-interval variation and highlight the importance of calcium regulation in myocardial repolarization. Rare variant analysis of 6 new QT interval-associated loci in 298 unrelated probands with LQTS identified coding variants not found in controls but of uncertain causality and therefore requiring validation. Several newly identified loci encode proteins that physically interact with other recognized repolarization proteins. Our integration of common variant association, expression and orthogonal protein-protein interaction screens provides new insights into cardiac electrophysiology and identifies new candidate genes for ventricular arrhythmias, LQTS and SCD.
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http://dx.doi.org/10.1038/ng.3014DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4124521PMC
August 2014

Regarding "Progression of asymptomatic carotid stenosis despite optimal medical therapy".

J Vasc Surg 2014 Jun;59(6):1752-3

Division of Vascular Surgery, The Cleveland Clinic, Cleveland, Ohio; Division of Vascular Surgery, New York University Medical Center, New York, NY.

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http://dx.doi.org/10.1016/j.jvs.2014.02.015DOI Listing
June 2014

Predictors and clinical significance of progression or regression of asymptomatic carotid stenosis.

J Vasc Surg 2014 Apr 28;59(4):956-967.e1. Epub 2013 Dec 28.

School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia; Preventive Health Division of Baker IDI Heart and Diabetes Institute, Melbourne, Australia; Stroke Division of the Florey Institute of Neuroscience and Mental Health, Melbourne, Australia.

Objective: To determine baseline clinical and ultrasonographic plaque factors predictive of progression or regression of asymptomatic carotid stenosis and the predictive value of changes in stenosis severity on risk of first ipsilateral cerebral or retinal ischemic events (including stroke).

Methods: A total of 1121 patients with asymptomatic carotid stenosis of 50% to 99% in relation to the bulb diameter (European Carotid Surgery Trial [ECST] method) underwent six monthly clinical assessments and carotid duplexes for up to 8 years (mean follow-up, 4 years). Progression or regression was considered present if there was a change of at least one grade higher or lower, respectively, persisting for at least two consecutive examinations.

Results: Regression occurred in 43 (3.8%), no change in 856 (76.4%), and progression in 222 (19.8%) patients. Younger age, high grades of stenosis, absence of discrete white areas in the plaque, and taking lipid lowering therapy were independent baseline predictors of increased incidence of regression. High serum creatinine, male gender, not taking lipid lowering therapy, low grades of stenosis, and increased plaque area were independent baseline predictors of progression. One hundred and thirty first ipsilateral cerebral or retinal ischemic events, including 59 strokes, occurred. Forty (67.8%) of the strokes occurred in patients whose stenosis was unchanged, 19 (32.2%) in those with progression, and zero in those with regression. For the entire cohort, the 8-year cumulative ipsilateral cerebral ischemic stroke rate was zero in patients with regression, 9% if the stenosis was unchanged, and 16% if there was progression (average annual stroke rates of 0%, 1.1%, and 2.0%, respectively; log-rank, P = .05; relative risk in patients with progression, 1.92; 95% confidence interval, 1.14-3.25). For patients with baseline stenosis 70% to 99% in relation to the distal internal carotid (North American Symptomatic Carotid Endarterectomy Trial [NASCET] method), in the absence of progression (n = 349), the 8-year cumulative ipsilateral cerebral ischemic stroke rate was 12%. In the presence of progression (n = 77), it was 21% (average annual stroke rates of 1.5% and 2.6%, respectively; log-rank, P = .34). Only nine (30%) of the 30 strokes occurred in the progression group.

Conclusions: Progressive asymptomatic carotid stenosis identified a subgroup with about twice the risk of ipsilateral stroke compared with those without progression. However, the clinical value of screening for progression simply for selecting patients for carotid procedures is limited because of the low frequency of progression and its relatively low associated stroke rate. The cost effectiveness of screening for change in stenosis severity to better direct current optimal medical treatment needs testing.
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http://dx.doi.org/10.1016/j.jvs.2013.10.073DOI Listing
April 2014

Association of genotypes at the matrix metalloproteinase (MMP) loci with carotid IMT and presence of carotid and femoral atherosclerotic plaques.

Vasc Med 2013 Oct 16;18(5):298-306. Epub 2013 Sep 16.

Cyprus International Institute for Environmental and Public Health in association with Harvard School of Public Health, Cyprus University of Technology, Limassol, Cyprus.

We aimed to test the association between matrix metalloproteinase (MMP) genetic polymorphisms and (a) intima-media thickness in the common carotid (IMTcc) and (b) the presence of plaques in the carotid and femoral bifurcations. Carotid and femoral bifurcations were scanned with ultrasound in 762 Cypriot community dwellers (46% men) over the age of 40 years. IMTcc and the presence of plaques were recorded. The MMP1 1G/2G, MMP3 5A/6A, MMP7 -181A>G, MMP9 R279Q, and MMP12 -82A>G polymorphisms were determined with the TaqMan method. In men, the presence of plaques in any bifurcation was associated with the MMP9 279Q allele (OR adjusted=4.50; 95% CI=2.0 to 10.1; p<0.001) and the MMP7 -181A allele was associated with the presence of femoral plaques (OR adjusted=2.61; 95% CI=1.36 to 4.99; p=0.004). In women, the presence of femoral plaques was associated with the MMP12 -82G allele (OR adjusted=1.9; 95% CI=1.14 to 3.16; p=0.014). Our results suggest that the effect of common MMP genotypes on plaque presence may be site- and sex-dependent.
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http://dx.doi.org/10.1177/1358863X13502698DOI Listing
October 2013
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