Kompressionsbehandling är den basala behandlingen vid venös insufficiens och venösa bensår. Att leva med venösa bensår påverkar patienters välbefinnande och det dagliga livet. Sjuksköterskan har en viktig roll i omvårdnad vid venös insufficiens och venösa bensår att på olika sätt främja sårläkning genom samarbete med patienten. Enligt studier är patienters följsamhet till kompressionsbehandling bristfällig, vilket kan leda till uppkomst eller recidiv av bensår och förlängd läkningstid. Syftet med studien var att belysa faktorer av betydelse för följsamhet vid kompressionsbehandling hos patienter med venös insufficiens. Studien genomfördes som en allmän litteraturstudie med induktiv ansats. Resultatet utgjordes av fyra kvantitativa, fem kvalitativa och två vetenskapliga artiklar med mixad metod. I litteraturstudiens resultat framkom två huvudteman: inre faktorer och yttre faktorer med sammanlagt nio subteman. Resultatet visade att motivation, psykisk ohälsa, kunskap och förståelse, obehag, självbild, självständighet, utbildning, ekonomi och vårdrelation är faktorer med betydelse för följsamhet till kompressionsbehandling. Vidare behövs ytterligare forskning kring patienters erfarenheter för att få en ökad förståelse över patientens situation, som senare kan utformas till exempel riktlinjer eller PM, där det bland annat kan framgå vilka omvårdnadsåtgärder sjuksköterskan kan vidta för att förebygga samt hantera patienters ovilja till behandling. / Compression therapy is the basic treatment for venous insufficiency and venous leg ulcers. Living with venous leg ulcers has an impact on patients’ well-being and daily life. The nurse has an important role in promoting wound healing through collaboration with the patient. According to studies patients’ adherence to compression therapy is insufficient, which can lead to origin and recurrence of leg ulcers and extended healing time. The purpose of the study was to illustrate significant factors for adherence to compression therapy in patients with venous insufficiency. The study was conducted as a general literature study based on an inductive approach. The result is based on five qualitative studies, four quantitative studies and two studies with a mixed method approach. Two main themes emerged in the result of the literature study: Internal factors and external factors with a total of ten sub themes. The result of the literature study reveals that motivation, mental illness, knowledge and understanding, discomfort, self – image, independence, education, finances and trusting relationship between nurse and patient are key factors in adherence to compression therapy. Further research on the patients’ experiences is needed to gain better understanding, which can develop into guidelines, where it can be stated which nursing actions to prevent and manage the patients that are unwilling to be treated.

SANTRAUKA Vilniaus universiteto Medicinos fakultetas Reabilitacijos, sporto medicinos ir slaugos institutas Slaugos magistrantūros programa PACIENTŲ SERGANČIŲ LĖTINIU VENŲ NEPAKANKAMUMU OPERACINIO GYDYMO ĮTAKA GYVENIMO KOKYBEI Slaugos magistro baigiamasis darbas Darbo autorė: Renata Grigonienė Darbo vadovas: dr. Narimantas Markevičius Vilnius, 2008 m. Pagrindinės sąvokos: lėtinis venų nepakankamumas, gyvenimo kokybė prieš operaciją, gyvenimo kokybės pagerėjimas po operacijos, CIVIQ klausimynas. Tyrimo tikslas - ištirti pacientų sergančiųjų lėtiniu venų nepakankamumu gyvenimo kokybę prieš operaciją ir po jos. Tyrimo uždaviniai. Palyginti vyrų ir moterų gyvenimo kokybę sergant lėtiniu venų nepakankamumu prieš operaciją ir po jos. Ištirti gyvenimo kokybės skausmo sritį prieš operaciją ir po jos. Ištirti gyvenimo kokybės fizinę sritį prieš operaciją ir po jos. Ištirti gyvenimo kokybės psichologinę sritį prieš operaciją ir po jos. Ištirti gyvenimo kokybės socialinių santykių sritį prieš operaciją ir po jos. Tyrimo objektas. Tirta pacientų sergančių lėtiniu venų nepakankamumu gyvenimo kokybė prieš operaciją ir po jos. Buvo apklausta 51 respondentas prieš operaciją ir po jos, iš jų 41 (80,4 %) moteris ir 10 (19,6 %) vyrų. Tyrimo metodai. Teorinė mokslinės literatūros, leidinių, publikacijų apžvalga. Pacientų sergančių lėtiniu venų nepakankamumu anketinė apklausa gyvenimo kokybei ištirti prieš operaciją ir po jos. Apklausai naudotas tarptautinis CIVIQ klausimynas. Statistinė analizė... [toliau žr. visą tekstą] / The Influence of Surgical Treatment on Quality of Live of Patients Suffering from Chronic Venous Insufficiency“ Nursing Master’s final paper Author: Renata Grigonienė Supervisor: dr. Narimantas Markevičius Vilnius, 2009 m. Keywords: chronic venous insufficiency, quality of life before surgery, quality of life improvement after surgery, chronic venous insufficiency questionnaire (CIVIQ). The aim of research: to investigate the quality of life of patients suffering from chronic venous insufficiency before and after surgery. The objectives of research: to compare the quality of life of male and female patients with chronic venous insufficiency before and after surgery; to investigate the pain domain of quality of life before and after surgery; to investigate the physical domain of quality of life before and after surgery; to investigate the psychological domain of quality of life before and after surgery; to investigate the social relations domain of quality of life before and after surgery. The subject of research: the quality of life of patients suffering from chronic venous insufficiency before and after surgery. 51 patients took part in the survey before and after surgery, including 41 female (80.4 %) and 10 males (19.6 %). The methods of research: Theoretical review of scientific literature and publications; questionnaire survey designed to investigate the quality of life of patients suffering from chronic venous insufficiency. International CIVIQ questionnaire was used for... [to full text]

Venous disease is a common vascular condition affecting the lower limbs and causes considerable morbidity in affected patients. National Health Service (NHS) treatment costs are substantial and there is a large demand for treatment much of which cannot be met. Roughly half a million people in the United Kingdom contact their general practitioner each year about varicose veins and associated clinical symptoms. In order to assign priorities and target interventions properly, authorities need to know which patients with venous disease will progress. Although many epidemiological studies have investigated the prevalence of venous disease, information on deterioration is scarce. The overall aim of this study is to determine the natural history of venous disease in the population and to identify lifestyle and clinical factors related to deterioration which might aid clinical decision making and health services policy. The specific objectives were to determine which risk factors were associated with deterioration of venous disease and venous reflux, and to ascertain the natural history of asymptomatic venous incompetence in terms of deteriorating to overt trunk varicose veins and chronic venous insufficiency. The study design was a population based cohort in the Edinburgh Vein Study which the survivors of the 1566 individuals aged 18 to 64 randomly sampled years from the general population at baseline underwent a 13-year follow-up examination. Details of the 1566 participants in the baseline study were sent to the Practitioner Services Division (PSD) of the NHS in Scotland who provided updated addresses and general practitioner registration details. Information collected on each subject at a follow-up clinic included lifestyle factors and medical history, height and weight measurement (by means of a questionnaire), clinical examination for classification of venous disease according to the Basle and CEAP systems, and duplex scanning to assess incompetence of venous valves in the deep and superficial systems of ten vein segments in each leg. Of the subjects from the baseline, 880 participated in the follow-up study, and 576 did not participate, providing a response rate of 60.4% of which 490 were female (55.7%) and 390 were male (44.3%). The study subjects were generally older and slightly more affluent than residents of the City of Edinburgh. For trunk varicose veins, the baseline prevalence was higher in males compared to females (p<0.01), but there was no difference in prevalence among subjects at the follow-up stage of the study (p=0.56). The overall rate of deterioration in trunk varicose veins was 3.55% per annum. More females than males deteriorated (p=0.04). Among subjects who showed deterioration in their trunk varicose veins, the commonest deterioration was from Basle Grade I (mild) at baseline to Grade II (moderate) at follow-up in both the right and left leg (28.1% and 32.9% respectively). Subjects older than 55 years of age (OR=1.59, 95% CI 1.01-2.51), who had a positive family history of varicose veins or venous ulcer (OR=1.92, 95% CI 1.20-3.07), and sat down at work for more than half the working day (OR=1.69, 95% CI 1.04-2.73) had increased risk of deteriorating trunk varicose veins. There was no significant difference between males and females in the prevalence of chronic venous insufficiency (CVI) among subjects at both the baseline and follow-up stage of the study (p=0.15 and 0.16 respectively). The rate of deterioration in CVI was 1.76% per annum. Similarly, among subjects who deteriorated, the commonest deterioration was from Grade I (mild) to Grade II (moderate) CEAP classification in both the right and left leg (42.4% and 45.5% respectively). The risk of worsening of CVI among those older than 55 was nearly three times more than those aged less than 55 (OR=2.85, 95% CI 1.18-6.87), and was still significant when adjusted for gender. The prevalence of telangiectasia was higher in females than in males in both the baseline and follow-up stages of the study (both p<0.01). The rate of deterioration in telangiectasia was 1.6% per annum. The commonest deterioration was from grade I (mild) at baseline to grade II (moderate) follow-up in the left and right leg (using the Basle Classification). Females subjects (OR=1.87, 95% CI 1.35-2.64), those older than 55 (OR=1.68, 95% CI 1.19-2.36), with a positive family history of venous disease (OR=1.60 95% CI 1.14-2.24) were associated with an increased risk of deterioration from telangiectasia compared to male subjects under 55 years of age and with no family history of the disease. The risk of telangiectasia deterioration was more than twice as high in subjects with venous reflux in the greater saphenous vein (origin) (OR=2.34, 95% CI 1.53-3.57), the greater saphenous vein (lower third of the thigh) (OR=2.28, 95% CI 1.59-3.27) and in the small saphenous vein (1.89, 95% CI 1.06-3.36) compared to those with no segments affected. The age and gender adjusted risk was also more than twice as high in subjects with venous reflux in two segments of the superficial system compared to subjects with no venous reflux in any segment (OR=2.06, 95% CI 1.23-3.44), and almost four times as high in subjects with reflux in more than three segments of the superficial system (OR=3.97, 95% CI 2.16-7.31) compared to subjects with no segments affected. On duplex scanning, the prevalence of reflux was higher in females than in males in the superficial system at baseline and follow-up stages of the study (p<0.01 respectively). In the deep system, the prevalence was higher in males than females at the baseline stage (p<0.01) with no significant difference at the follow-up stage (p=0.85). The rate of deterioration in venous reflux was 1.28% per annum. Most subjects deteriorated from one to two vein segments affected in the leg, the majority of which had reflux in the greater saphenous vein (thigh) at baseline and developed reflux in the greater saphenous vein (origin) at follow-up. Subjects more than 55 years of age had significantly more deterioration than those aged less than 55 (p<0.01). Obese or overweight subjects (OR=1.59, 95% CI 1.32-3.67), those aged more than 55 (OR=2.20, 95% CI 1.32-3.67), with a family history of varicose veins (among female subjects only, OR=2.55, 95% CI 1.16-5.56), and who sat down at work more than half the working time (among male subjects only) (OR=2.26, 95%CI 0.97-5.23) had increased risk of showing deterioration in reflux in any leg and in any vein segment from baseline to follow-up. Subjects with venous reflux at baseline were over two and half times more likely to show deterioration in trunk varicose veins compared to those with no reflux (OR=2.69, 95%CI 1.44-5.01), and four times more likely to deteriorate in either trunk varicose veins or chronic venous insufficiency (OR=4.20, 95% CI 2.42-7.29). Subjects with venous reflux at baseline were twice as likely to develop new trunk varicose veins (OR=2.08, 95%CI 1.25-3.46), and 1.78 times more likely to develop either trunk varicose veins or chronic venous insufficiency (OR=1.78, 95%CI 1.12-2.80). Age and gender adjusted risk of trunk varicose veins increased more than fourfold among subjects with venous reflux in the greater saphenous veins (OR=4.04, 95% CI 2.36-6.92), and more than threefold in the greater saphenous vein (lower third of the thigh) (OR=3.13, 95% CI 1.85-5.27) and the small saphenous vein (OR=3.17, 95% CI 1.55-6.48). Subjects with venous reflux in two or more than three vein segments in the superficial system were more than five times more likely to deteriorate from trunk varicose veins (OR=5.39, 95% CI 2.64-10.99 and OR=5.96, 95% CI 2.71-13.10 respectively). The Edinburgh Vein Study follow-up identified factors linked to deterioration of trunk varicose veins and CVI. The findings of this follow-up study have important implications in decision making in NHS and a prognostic tool could be produced to assist clinicians in deciding who should receive treatment or maintained under surveillance. Increasing age, and family history will likely lead to worsening of trunk varicose veins and CVI. The findings also confirm the association between asymptomatic and symptomatic venous valvular incompetence with worsening and developing new cases of venous disease. Such information will be essential for policy makers facing difficult decisions over prioritisation of services in the future. Further research might include trials of surgical and non-surgical interventions designed to limit deterioration in high risk individuals and enable surgeons to target interventions appropriately. Larger prognostic studies of many factors, including genotype, might be conducted to link progression of venous disease, and to provide further information on high risk individuals who might benefit from treatment.

Chronic Venous Insufficiency (CVI) is characterized by chronic venous hypertension from blood pooling in the lower limbs. The resulting symptoms include leg pain, varicose veins, fatigue, venous edema, skin pigmentation, inflammation, induration, and ulceration. Reflux from incompetent venous valves is a factor in up to 94% of individuals with CVI. Current treatments of CVI include compression stockings, drug therapy, vein disabling, venous stenting, and surgical correction with varying rates of success. However, a minimally invasive correction of deep venous reflux does not currently exist. A transcatheter prosthetic venous valve has the potential to be an effective, minimally invasive treatment for deep venous reflux which could treat up to 1.4 million individuals in the United States suffering from venous ulceration and make more than 1.7 billion dollars each year. Previously developed prosthetic venous valves have had problems with competency, patency, thrombogenicity, biocompatibility, and incorrect sizing. To meet the clinical need a prosthetic valve needs to be developed which succeeds where previous valves have failed. This thesis describes the design, analysis, pre-clinical testing, and evaluation of a novel prosthetic venous valve. Design specifications for an effective prosthetic venous valve were created. Verification tests were developed and performed which demonstrated that the valve met every design specification. Finite element and computational fluid dynamics simulations were performed to analyze the valve and calculated a maximum shear rate of 2300 s-1 in the valve during the high forward flow after a Valsalva maneuver. The valve is made of a biocompatible material that has low thrombogenicity, Poly(vinyl-alcohol) cryogel. On the average, the valve allows less than 0.5 mL/min of reflux at low and high retrograde pressures even after 500,000 cycles, indicating that it will reduce the reflux of individuals with venous reflux by more than 99.4%. The valve closes in less than 0.07 seconds and allows the distal pressure to rise to an average of 7% of the equilibrium pressure 30 seconds after a simulated ankle flexion. The valve increases the outflow resistance an average of 2.3 mmHg*min/L which is much less than obstruction levels,≥ 5 mmHg*min/L. The valve can fit in a 16 French catheter and is capable of percutaneous delivery. The base of the valve is 1.5 times the diameter of the vein in which it is to be implanted to help correct orientation upon deployment. Fluid behind the valve’s leaflets is ejected with a forward flow rate of 400 mL/min, suggesting that thrombus formation will not occur at this location. A stented valve remained patent in a porcine blood flow loop for 3 hours. The valve remains competent without buckling in a constricted vein at rest. The valve can expand to fit a vein with a maximum diameter 1.4 times the valve's initial diameter with low risk of tearing or leaflet prolapse. An IACUC protocol for a 12 week study to test the valve in sheep was prepared and approved. A study to evaluate the valve in humans is proposed with endpoints that can be tested for statistical significance and compared with other treatments for CVI. A set of valves which will correct reflux in the majority of common femoral, femoral, and popliteal deep veins is proposed and a sizing guide for surgeons is provided. The minimum distance between prosthetic valves placed in the same vein segment is 13 cm. A comparison of this valve with previously developed prosthetic venous valves and recommendations for work to be performed in the future are given. The valve proposed in this work is the only valve to meet all design specification for an effective prosthetic venous valve, and therefore shows great potential to be a minimally invasive treatment for deep venous reflux.

This critical synopsis of prior work by Clive Beggs is submitted in support of a PhD by published work. The work focuses on venous and cerebrospinal fluid (CSF) anomalies associated with multiple sclerosis (MS) and other neurological diseases. MS is characterized by focal inflammatory lesions, which are often venocentric. Recently a vascular syndrome, chronic cerebrospinal venous insufficiency (CCSVI) has been linked with MS. This syndrome, which is characterized by constricted cerebral venous outflow, has become mired in controversy, with various studies producing conflicting findings, with the result that the science associated with CCSVI has become obscured. Clive Beggs work seeks to bring clarity to the debate surrounding CCSVI by characterizing physiological changes associated with constricted cerebral venous outflow. The work submitted here involves collaborative studies with Robert Zivadinov (University of Buffalo), Paolo Zamboni (University of Ferrara), and Chih- Ping Chung (National Yang Ming University of Medicine). The key findings of these studies are: (i) MS patients, diagnosed with CCSVI, exhibit greatly increased hydraulic resistance of the cerebral venous drainage system; (ii) MS patients experience loss of the small cerebral veins; (iii) MS patients exhibit reduced CSF bulk flow, consistent with mild venous hypertension; (iv) MS patients exhibit increased CSF pulsatility in the Aqueduct of Sylvius, which appears to be linked with mild venous hypertension associated with CCSVI; and (v) jugular venous reflux is associated with white matter and parenchymal volumetric changes in Alzheimer’s patients. Collectively, these findings suggest that extracranial venous anomalies are associated with changes in the intracranial physiology.

O objetivo deste trabalho foi avaliar os efeitos da estimulação elétrica com corrente de alta voltagem na cicatrização da úlcera de hipertensão venosa crônica, bem como na dor referida, em 13 pacientes portadores de 20 úlceras. Os pacientes diferiram quanto à variação da área da ferida ao longo do tratamento. As curvas individuais indicaram a eficácia do estudo. Dos 13 pacientes que participaram do estudo, observamos que em quatro as feridas cicatrizaram totalmente, enquanto em seis elas reduziram o seu tamanho e em três, aumentaram. Não foram observados efeitos adversos causados pela eletroestimulação. A dor apresentou melhora significativa ou cessação em todos os pacientes / The objectives of this study was to evaluate high voltage electric stimulation effects over chronic venous hypertension ulcer, as well over the referred pain, in 13 patients bearing 20 ulcers. The patients have differed among themselves in relation to the ulcer area throughout the study. The individuals curves indicated the treatment efficacy. It was observed that the ulcer area have been healed in four patients, reduced in six and increased in three of the thirteen patients who has participated in this study. It was not observed adverse effects due to electrical stimulation. The pain has showed meaningful advance or ceasing in all patients

Title: The effect of manual lymphatic drainage on the musculus soleus muscle tension in patients with chronic venous insufficiency. Aims: The aim of this thesis is to summarize theoretical knowledge about chronic venous insufficiency, muscle tension and manual lymphatic drainage and then to perform a pilot study to determine whether people suffering from chronic venous insufficiency have changed muscle tone of musculus soleus and to verify whether the implementation of a single manual lymphatic drainage of the lower limbs results in a change of muscle tension of musculus soleus. Methods: There were three patients who participated in the experiment. Anthropometric examinations of circuits of both lower limbs on all patients was carried out, using measuring tape and then a muscle tone of musculus soleus was measured using a device called myotonometer. After that the single manual lymphatic drainage of one lower limb (more affected lower extremity) was performed. The second, untreated leg was considered to be the control limb. There was also performed basal treatment of the neck, before every manual lymphatic drainage of lower limb. Circumferential dimensions of both lower limbs were measured immediately after manual lymphatic drainage and then 15 minutes later again. After that the muscle tone of...

Introdução: A Insuficiência Venosa Crônica (IVC) é responsável pela grande maioria dos sintomas vasculares que acometem os membros inferiores, podendo levar a graves sintomas. A Síndrome de compressão Venosa Cavo-ilíaca (SCVCI) é cada vez mais reconhecida como importante causa da IVC e os métodos de imagem utilizados para o seu diagnóstico fornecem informações anatômicas, mas não trazem informações fisiológicas claras. A importância diagnóstica dos Gradientes pressóricos venosos Cavo-ilíacos precisa ser mais bem estudada e esses ainda não foram comparados ao método padrão-ouro atualmente disponível, o Ultrassom Intravascular (UI). Esse estudo tem como objetivo avaliar a correlação entre as medidas de Pressão intravenosa (PI) e Gradientes pressóricos (GP) e a presença de obstrução venosa significativa no Sistema Cavo-Ilíaco (SCI) estabelecida pelo UI, para o diagnóstico da SCVCI em pacientes portadores de IVC avançada dos membros inferiores. Método: Foram incluídos 50 pacientes com IVC avançada (Classificação CEAP 3 ou superior) de, ao menos, um dos membros inferiores, sem melhora após um ano de tratamento clínico, totalizando 100 membros inferiores. Todos os pacientes foram submetidos, prospectivamente, aos exames de Ultrassom Vascular com Doppler Colorido (UVDC), Angiotomografia Computadorizada Helicoidal (ACTH), Flebografia Multiplanar Ascendente (FMA), Medidas de pressão intravenosa e Ultrassom Intravascular (UI). Os membros inferiores estudados foram divididos em dois grupos: Grupo 1 com obstrução <50% ao UI e Grupo 2 com obstrução >= 50% ao UI. A correlação entre os gradientes e demais variáveis quantitativas foi realizada utilizando o Coeficiente de Spearman. As Curvas ROC foram utilizadas para avaliar qual o melhor desempenho entre os gradientes, na discriminação do grau de obstrução. O desempenho diagnóstico isolado dos GP em comparação com o UI foi avaliado por meio das medidas de Sensibilidade, Especificidade, Valor Preditivo Positivo, Valor Preditivo Negativo e Acurácia. A concordância dos exames com o UI foi realizada por meio do Kappa e do teste de McNemar. A Análise de Regressão Logística foi utilizada para avaliar a contribuição dos GP com a Flebografia, na identificação de pacientes com obstrução significativa. Foram utilizados os programas R (Versão 3.1.0) e SPSS (Versão 2.0). Valores de p<0,05 foram considerados significativos. Resultados: O Grupo 2 apresentou maior predomínio de acometimento do membro inferior esquerdo e maior pontuação nas escalas Visual Analógica para Dor (EVAD), no Escore de Severidade Clínica Venosa (ESCV) e no Questionário de Qualidade de Vida SF-36 (QQV SF-36). As pressões Femorais em repouso (PVF-r) e após hiperemia (PVF-h), bem como os Gradientes Fêmoro-Cava após hiperemia (GFC-h) e o Gradiente Femoral hiperemia-repouso (GFh-r) mostraram-se significativamente mais elevados no Grupo 2 (p=0,001; <0,001; 0,002 e 0,006, respectivamente). As mesmas pressões e gradientes apresentaram correlação significativa com o grau de estenose ao UI, pela análise do Coeficiente de Sperman (PVF-r 0,350, p<0,001; PVF-h 0,379, p<0,001; GFC-h 0,302, p=0,002; GFh-r 0,218, p=0,029), sendo que o melhor desempenho para diagnóstico entre esses parâmetros, pela análise de Curva ROC, foi alcançado pelos gradientes GFC-h e GFh-r. Entretanto, o desempenho diagnóstico isolado dos GP, quando comparados ao UI, apresenta baixos valores de Sensibilidade (<40%), Valor preditivo Negativo (<60%) e Acurácia (<30%), bem como, valores de concordância baixos ao Kappa (<0,3) e discordância desproporcional com o UI pelo teste de McNemar (p<0,05). Os melhores resultados foram encontrados com o UVDC, com ACTH e com a FMA. Ao combinar os resultados da FMA com os GP, ocorre melhora significativa no desempenho diagnóstico, especialmente com a associação da FMA com o GFC-h. Conclusão: Existe correlação significativa entre as Pressões e GP venosos e o grau de estenose aferido ao UI. Entretanto, essa correlação não se traduz em bom desempenho diagnóstico dos GP. O GFC-h acrescenta informação significativa à Flebografia, na identificação dos casos com obstrução >-50% ao UI. / Introduction: Chronic venous insufficiency (CVI) is responsible for most of the vascular symptoms affecting the lower limbs, and can lead to severe complications. Iliac vein compression syndrome (IVCS) is increasingly recognized as an important cause of CVI. The imaging methods used for its diagnosis provide anatomical information but not clear physiological information. The diagnostic importance of the cavo-iliac vein pressure gradients (VPG) requires further study, and they have not yet been compared with the currently available gold standard, the Intravascular ultrasound (IVUS). The aim of this study was to evaluate the correlations between intravenous pressure (IP) and VPG, and the presence of significant IVUS-diagnosed venous obstruction in the cavo-iliac system, for assessment of IVCS in patients with advanced CVI of the lower limbs. Method: The study included 100 lower limbs of 50 patients with advanced CVI (Clinical-Etiology-Anatomy-Pathophysiology - CEAP classification 3 or higher), without symptoms improvement after one year of clinical treatment. All patients prospectively underwent Color Doppler vascular Ultrasound (CDVU), Helical Computed Tomography Angiography (HCTA), Multiplane Ascending Phlebography (MAP), IP measurements, and IVUS. The studied limbs were divided into Group 1 with obstruction <50% by IVUS and Group 2 with obstruction >=50% by IVUS. Spearman\'s correlation coefficient was used to compare gradients and other quantitative variables. Receiver operating characteristic (ROC) curves were used to evaluate the best performance among the gradients for determination of the degree of obstruction. Isolated diagnostic performance of PGs was compared with the IVUS for Sensitivity, Specificity, Positive predictive value, Negative predictive value, and Accuracy. The agreement between the evaluation methods and IVUS was determined using the Kappa statistic and McNemar\'s test. Logistic regression analysis was used to evaluate the contribution of PG to the MAP in identifying patients with significant obstruction. R (Version 3.1.0) and SPSS (Version 2.0) were used for statistical analysis. Values of p<0.05 were considered significant. Results: Group 2 showed a higher prevalence of left lower limb impairment and higher scores on the Visual Analogue Pain Scale (VAPS), the Venous Clinical Severity Score (VCSS), and the Short Form (SF)-36 Quality of Life questionnaire (QOL SF-36). Femoral pressures at rest (FP-r) and after hyperemia (FP-h), Femorocaval gradient after hyperemia (FCG-h), and Femoral gradient after hyperemia (FG-h) were significantly higher in Group 2 (p=0.001, <0.001, 0.002, and 0.006, respectively). Using Spearman\'s correlation coefficient, the same pressures and gradients showed a significant association with the degree of stenosis by IVUS, (FP-r 0.350, p<0.001; FP-h 0.379, p<0.001; FCG-h 0.302, p = 0.002; FG-h 0.218, p=0.029), and the best diagnostic performance among these parameters, using ROC curve analysis, was obtained with the FCG-h and FG-h gradients. However, the isolated diagnostic performance of the PG, when compared with the IVUS, showed low values for sensitivity (<40%), negative predictive value (<60%), and accuracy (<30%), as well as low kappa concordance values (<0.3) and inconsistent disagreement with IVUS, using McNemar\'s test (p <0.05). The best results were found with CDVU, HCTA, and MAP. Combining MAP results with PG led to a significant improvement in diagnostic performance, especially for the association between MAP and FCG-h. Conclusion: There was a significant correlation between VP and PG and the degree of stenosis measured by IVUS. However, this correlation did not result in good diagnostic performance by the PG. The FCG-h adds significant information to MAP in the identification of cases with obstruction >-50% by IVUS.

Over seven million Americans suffer from Chronic Venous Insufficiency (CVI), a painful and debilitating disease that affects the superficial and deep veins of the legs. Problems associated with CVI include varicose veins, bleeding, ulcerations, severe swelling, deep vein thrombosis, and pulmonary embolism, which may lead to death. The presence of CVI results from damaged (incompetent) one-way vein valves in leg veins. These valves normally allow forward flow of blood to the heart, and prevent blood from pooling at the feet. However, incompetent valves allow reflux of blood, causing clinical problems. There are few effective clinical therapies for treating CVI. Vein valve transplantation is a surgical option for treatment. However, it is often difficult to find suitable donor valves. Very few prosthetic valves developed in the past have demonstrated sufficient clinical or mechanical functionality. Persistent problems include thrombus formation, leaking valves, and valves that do not open at physiologic pressure gradient. The primary objective of this research was to develop a clinically relevant functional prosthetic vein valve. The novel prosthetic valve is flexible, biocompatible, has low thrombogenecity, and is easy to manufacture. It was designed to address well-defined consumer needs and functional design requirements. The valve was required to 1) withstand 300 mmHg of backpressure with leakage less than 1.0 mL/min, 2) open with a pressure gradient less than 5 mmHg, and 3) meet criteria 1 and 2 after 500,000 cycles of operation. The valve met these design requirements in bench testing. The valve can open with a pressure gradient of 2.6 0.7 mmHg, and can withstand 300 mmHg with leakage less than 0.5 mL/min. The valve remained functional after opening and closing over 500,000 times. The valve presented in this research is operationally functional, and is a potential solution for treating venous incompetence in CVI patients.

Chronic Venous Insufficiency (CVI) is a condition in present in almost 27% of adults in which an insufficient amount of blood is pumped back to the heart due to damaged or poorly apposed one-way valves in the leg veins. During forward flow, vein valves allow blood to return to the heart while posing very little resistance to the flow. During gravity-driven reverse flow, normal valves close and prevent blood from flowing backward through the valve. Incompetent, or damaged, vein valves cannot prevent this reverse flow and lead to a pooling of blood at the feet. CVI is a painful disease presents itself in various ways, including varicose veins, ulcerations of the lower extremities, and severe swelling. Current therapies and treatments include compressive stockings, destruction or removal of affected veins, valve repair, and valve transplants. The implantation of prosthetic vein valves is a future treatment option that does not require an invasive surgery, human donor, or lengthy hospital stay. While no prosthetic vein valves are currently commercially available, this thesis describes the design, verification, and validation of a novel prosthetic vein valve. Verification tests include CFD simulations, functional tests, mechanical tests, and in vitro thromogenicity tests. The validation of the device was done through an animal study in sheep external jugular veins. CFD analysis verified that shear rates within the valve support its lower thrombogenicity as compared to a previous vein valve. Benchtop tests demonstrate superiority in short-term patency over a previous polymer valve. In a sheep study, patency was shown at 6 weeks, surpassing many autograft valves and showing great potential to meet the goal of 3 month patency in sheep.