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OBJECTIVE: Two-year follow-up results from a first-in-human study of patients implanted with the VenoValve are evaluated for supporting the long-term clinical safety and performance of the device. BACKGROUND: Chronic Venous Insufficiency (CVI) involves improper functioning of lower limb vein valves and inability of these valves to move blood back towards the heart. CVI symptoms include swelling, varicose veins, pain, and leg ulcers. Currently, there is no cure for this condition and treatment options are limited. This study provides 2-year outcomes for 8 patients who were implanted with the bioprosthetic VenoValve for treating severe CVI with deep venous reflux measured at the mid-popliteal vein. The 6-month and 1-year results were previously published. METHODS: Eleven patients with C5 & C6 CVI were implanted with VenoValve into the midthigh femoral vein and followed for 2 years. Assessed clinical outcomes include device-related adverse events, reflux time, disease severity, and pain scores. RESULTS: All 11 implant procedures were successful. Two-year follow-up data was obtained for 8 subjects: 1 patient died of non-device related causes, 1 was lost to follow-up, and 1 refused to follow-up due to the COVID-19 pandemic. No device-related adverse events occurred between the first and second years of follow-up. Reported 2-year clinical performance outcomes included significant decreases in mean reflux times of the mid-popliteal vein (61%), and significant improvements in mean scores for disease severity rVCSS (56%) and VAS pain (87%). CONCLUSIONS: Results from this study support long-term safety and effectiveness of the VenoValve for improving CVI severity by reducing reflux and thereby venous pressures in the lower extremities. With limited treatments for valvular incompetence involved in severe, deep venous CVI, the device may be considered as a novel therapy. A pivotal trial in the United States is currently being conducted to assess the device in a larger number of patients.

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OBJECTIVE: In deep venous valve repair, transcommissural external valvuloplasty (TEV) is the commonly used technique. In some cases, external banding (EB) is combined with this procedure to improve the patency and durability of the surgical procedure. METHODS: We retrospectively analyzed patients who underwent deep venous valve repair from 1998 through 2018. Patients were divided according to the surgical procedure: Group A: TEV alone and Group B: TEV+EB. Early postoperative outcomes of the procedure were compared between the groups. RESULTS: There were 265 patients in Group A and 165 patients in Group B. The mean follow-up period was 4.2±3.7. The rate of recurrence of venous reflux, ulcer, and reoperation were 31.9 versus 30.9, 21.2 versus 21.8, and 16.7 versus 13.9 in Group A and Group B, respectively. There were 67 reoperations in the follow-up period. At reoperation, external valvuloplasty was performed in 64% of the reoperations in Group A, while this rate was 13% for Group B. CONCLUSIONS: There is no more need for EB during the venous valve repair with the increased experience of valvuloplasty techniques. TEV might be enough with acceptable long-term outcomes during deep venous reconstruction.

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Objective: Among the veins used as a graft in myocardial revascularizations and ends, great saphenous vein is the most used. Knowing the presence and location of valves has great importance when evaluating the surgical anatomy of the great saphenous vein. Despite major surgical application and many works involving great saphenous vein, the number of valves present in it from the saphenous hiatus to the medial epicondyle of the femur is still described inaccurately. The objective of this study is to quantify the valves of the great saphenous vein from the saphenous hiatus to the medial epicondyle of the femur to determine the best portion of the great saphenous vein to perform revascularization surgeries. Methods: This is a crosssectional observational study in which it was analyzed great saphenous vein extracted from 30 cadavers. It was measured the length of the veins; (diameter) at its proximal, middle and distal, quantifying the number of valves in each one and the total number of valves at the great saphenous vein. Results: The frequency of valves in the great saphenous vein taken from the medial epicondyle of the femur to the saphenous hiatus was 4.82, ranging between 2 and 9. Moreover, there is a significant difference in the number of valves in the proximal and distal relative to the average. Conclusion: the median and distal portions of the saphenous vein in the thigh, are the best options for the realization of bridges due to the fact that these portions have fewer valves which therefore would tend to decrease the risk of complications connected with the valves in these grafts. .

Objetivo: Dentre as veias empregadas para revascularizações do miocárdio e de extremidades, a veia safena magna é a mais utilizada. Conhecer a presença e localização de válvulas é de grande importância quando se avalia a anatomia cirúrgica da veia safena magna. Apesar de grande aplicação cirúrgica e de muitos trabalhos envolvendo a veia safena magna, o número de válvulas presente nela desde o hiato safeno até o epicôndilo medial do fêmur ainda é descrito de forma imprecisa. O objetivo do presente trabalho é quantificar as válvulas da veia safena magna desde o hiato safeno até o epicôndilo medial do fêmur para determinar a melhor porção da veia safena magna para a realização de cirurgias de revascularização. Métodos: Este é um estudo transversal e observacional em que foram analisadas veias safena magna extraídas de 30 cadáveres. Foram realizadas as medidas das variáveis do comprimento das veias; (diâmetro) em suas porções proximal, média e distal; quantificação do número de válvulas nestas e número de válvulas total na veia safena magna. Resultados: A frequência de válvulas da veia safena contadas desde o epicôndilo medial do fêmur até o hiato safeno foi de 4,82, podendo variar entre 2 e 9. Além disso, houve diferença significante do número de válvulas da porção proximal em relação à média e distal. Conclusão: As porções média e distal da veia safena magna na coxa são as melhores opções para a realização de pontes em decorrência do fato destas porções terem menor quantidade de válvulas o que, portanto, tenderia a diminuir o risco de complicações relacionadas as válvulas nestes enxertos. .

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Las enfermedades venosas de los miembros inferiores se describen desde épocas muy antiguas, todavía en la actualidad repercute en los pacientes de forma frecuente causando un importante impacto socioeconómico.Objetivo: caracterización de la insuficiencia venosa crónica profunda por reflujo valvular.Método: se realizó un estudio descriptivo y longitudinal con todos los pacientes atendidos en consulta de angiología con el diagnóstico de insuficiencia venosa crónica profunda, en el Hospital Provincial Universitario Docente Manuel Ascunce Domenech de Camagüey, desde marzo de 2012 a junio de 2013. El universo estuvo constituido por 60 pacientes, se aplicó un muestreo no probabilístico, que reunió los criterios de inclusión y exclusión establecidos. La información obtenida se procesó mediante programa estadístico SPSS-11,5 para Windows y estadística descriptiva para obtener distribuciones de frecuencias y por cientos. Los resultados del estudio se expusieron en tablas.Resultado: se encontró que el mayor número correspondió al sexo femenino y predominó el intervalo de 46 a 55 años. Se pudo detectar que predominaron los antecedentes patológicos familiares de insuficiencia venosa crónica, seguido del estreñimiento crónico, la obesidad- sedentarismo, antecedentes patológicos personales de trombosis venosa profunda y la multipariedad. El mayor número de casos según clasificación clínica se encontraron en los estadios cuatro y tres.Conclusiones: la insuficiencia venosa crónica es una enfermedad progresiva con una alta morbilidad y gran repercusión socio-económica. Conocer sus factores predisponentes así como sus formas de presentación, ayuda a prevenir y evitar sus estadios avanzados y mejorar la calidad de vida de estos pacientes...

Venous diseases of the lower extremities have been described since ancient times; at present, they still frequently have an effect in patients and cause an important socioeconomic impact.Objective: to characterize the chronic deep venous insufficiency produced by valve reflux.Method: a descriptive, longitudinal study was carried out to all the patients that assisted to the consultation of angiology with the diagnosis of chronic deep venous insufficiency at Manuel Ascunce Domenech University Provincial Hospital of Camagüey, from March, 2012 to June, 2013. The universe was composed of 60 patients. A non-probabilistic sampling, including the established inclusion and exclusion criteria, was applied. The information obtained was processed through the statistical program SPSS-11.5 for Windows and through descriptive statistics to obtain distributions of frequencies and percents. The results of the study were presented in charts.Result: most of patients were female with 30 cases (61.2 percent)The ages between 46 and 55 years old predominated with 22 patients. Pathological family history of chronic venous insufficiency predominated with 44 cases (89.8 percent), followed by chronic constipation, obesity and sedentary lifestyle, pathological medical history of deep vein thrombosis, and multiparity. According to the clinical classification, most of cases were in stages three and four.Conclusions: chronic venous insufficiency is a progressive disease with a high morbidity and a great socioeconomic repercussion. Knowing the predisposing factors, as well as the ways of presentation of the disease, helps to prevent the advanced stages and improve the quality of life of patients...

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OBJECTIVE: Among the veins used as a graft in myocardial revascularizations and ends, great saphenous vein is the most used. Knowing the presence and location of valves has great importance when evaluating the surgical anatomy of the great saphenous vein. Despite major surgical application and many works involving great saphenous vein, the number of valves present in it from the saphenous hiatus to the medial epicondyle of the femur is still described inaccurately. The objective of this study is to quantify the valves of the great saphenous vein from the saphenous hiatus to the medial epicondyle of the femur to determine the best portion of the great saphenous vein to perform revascularization surgeries. METHODS: This is a cross sectional observational study in which it was analyzed great saphenous vein extracted from 30 cadavers. It was measured the length of the veins; (diameter) at its proximal, middle and distal, quantifying the number of valves in each one and the total number of valves at the great saphenous vein. RESULTS: The frequency of valves in the great saphenous vein taken from the medial epicondyle of the femur to the saphenous hiatus was 4.82, ranging between 2 and 9. Moreover, there is a significant difference in the number of valves in the proximal and distal relative to the average. CONCLUSION: the median and distal portions of the saphenous vein in the thigh, are the best options for the realization of bridges due to the fact that these portions have fewer valves which therefore would tend to decrease the risk of complications connected with the valves in these grafts.

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The aim was to understand the anatomical features of the venous valve in Macaca fascicularis and to compare it with that of humans. The bilateral lower limbs (24 limbs from 12 animals) of Macaca fascicularis cadavers were dissected, and the femoral veins (FVs) were equally divided into distal, intermediate, and proximal sections. The external diameter of the FV in each section was measured. The venous valves were observed microscopically and stained with hematoxylin and eosin as well as trichrome. Data describing the human venous valve were collected from the current literature. No great saphenous veins were found among the 24 lower limbs from the Macaca fascicularis cadavers. The external diameters of the FVs in the distal, intermediate, and proximal sections were 3.53 ± 0.37 mm, 3.42 ± 0.55 mm, and 3.37 ± 0.54 mm, respectively. In most cases, there was one venous bivalve located in the FV approximately 0-2.71 mm below the junction of the FV and the deep femoral vein. Endothelium covered the luminal and sinusal surfaces of the leaflets. Abundant collagen fibers were found under the endothelial cells beneath the luminal surface of the leaflets. An elastin fiber network was located under the sinus endothelial surface. Smooth muscle cells in the FV extend to the edge of the valve. The venous valve of Macaca fascicularis is similar to that of humans, both morphologically and histologically. However, there is only one venous bivalve and no great saphenous vein in Macaca fascicularis.

El objetivo fue comprender las características anatómicas de la válvula venosa en Macaca fascicularis y compararla con la de los humanos. Fueron disecados bilateralmente los miembros pélvicos (24 miembros de 12 animales) de cadáveres de Macaca fascicularis; las venas femorales (VF) fueron divididas en secciones distal, media y proximal. Se midió el diámetro externo de las VFs en cada sección. Las válvulas venosas se observaron microscópicamente y se tiñeron con H-E y tricrómico. Los datos para describir la válvula venosa humana se obtuvieron desde la literatura. No se encontraron venas safenas magnas entre los 24 miembros inferiores. Los diámetros externos de las VFs en las secciones distal, media y proximal fueron 3,53±0,37 mm, 3,42 mm±0,55, y 3,37±0,54 mm, respectivamente. En la mayoría de los casos, hubo vena bivalva situada aproximadamente 0-2,71 mm debajo de la unión de la VF y la vena femoral profunda. El endotelio cubrió las superficies luminal y sinusal. Se observaron abundantes fibras de colágeno en las células endoteliales bajo la superficie luminal de las válvulas. Una red de fibras de elastina se encontró bajo la superficie del seno endotelial. Las células musculares lisas en las VFs se extiendían hasta el margen de la válvula. La válvula venosa del Macaca fascicularis es similar a la de los seres humanos, morfológica e histológicamente. Sin embargo, sólo hubo una vena bivalvular, y no se observaron venas safenas en Macaca fascicularis.

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BACKGROUND AND PURPOSE: Transient global amnesia (TGA) is the inability to retain new information and to recall past events during a period of minutes or hours. Its etiology is unclear, and flow disturbances in the mesial temporal lobes secondary to venous congestion have been proposed as a potential cause. Ultrasonographic evaluation of the internal jugular vein (IJV) has demonstrated valvular insufficiency in TGA. The prevalence of valvular insufficiency in the IJV in patients with TGA was assessed. Subjects without TGA of similar sex, age, and vascular risk factor profiles served as controls. METHODS: A group of 142 patients with a clinical diagnosis of TGA within 7 days of the clinical event and 40 controls were prospectively evaluated. Venous Doppler examination of both IJVs was performed at baseline and after a manometer-controlled Valsalva maneuver. Valvular insufficiency was diagnosed when there was reflux for >0.8 seconds during the Valsalva maneuver. RESULTS: Valve insufficiency was found in at least one jugular vein in 113 of 142 patients with TGA (79.5%) and in 10 of 40 controls (25.0%), P<0.01. The right side was affected more often than the left side, P<0.01, and 26.8% of the patients had bilateral incompetence. CONCLUSIONS: Patients with TGA have a high prevalence of IJV valve insufficiency. This finding may have pathophysiologic implications. Doppler evaluation of the IJVs with dynamic maneuvers may help in the evaluation of this usually benign condition.

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