Percutaneous autologous venous valve transplantation: short-term feasibility study in an ovine model

BACKGROUND: Limited experience with bioprosthetic venous valve percutaneously inserted into femoral veins in 15 patients has been promising in short-term results only to show disappointing long-term results. Percutaneous autogenous venous valve (PAVV) transplantation was explored in an ovine model as a possible alternative treatment. METHODS: PAVV consisted of a vein segment containing a valve that was attached to a stent template. The stent templates (n = 9) were designed and hand made in our research laboratory. They consist of two stainless steel square stents 13 or 15 mm in diameter to fit the ovine jugular veins (JV), which ranges from 10 to 15 mm in diameter. A valve-containing segment of JV was harvested and attached with sutures and barbs inside the stent template (n = 9). The valve devices were then manually folded and front loaded inside the 4 cm chamber of the 13F delivery sheath and delivered into the contralateral JV by femoral vein approach. Transplanted PAVVs were studied by immediate and 3 months venograms. Animals were euthanized at 3 months, and jugular veins harvested to perform angioscopic evaluations in vitro. RESULTS: PAVV transplantation was successful in all nine animals. Good valve function with no reflux was observed on immediate and 3 months venograms in eight valves. The transplanted maximal JV diameter ranged from 10.2 mm to 15.4 mm (mean 13.1 +/- 1.5 mm). Venoscopic examination revealed intact, flexible, nonthickened valve leaflets in eight specimens. One PAVV exhibited normal function of one leaflet only; the other cusp was accidentally cut during the transplantation procedure. All transplanted autologous valves were free of thrombus and incorporated into the vein wall of the host vessel. CONCLUSION: This study demonstrated that autogenous valve transplants remained patent and competent without long-term anticoagulation for up to 3 months. The percutaneous autogenous venous valve may provide in future minimally invasive treatment for patients with chronic deep venous insufficiency, but long-term studies need to be done to document its continued patency and function.

Diagnosis and Treatment of Venous Malformations Consensus Document of the International Union of Phlebology (IUP): updated 2013

Venous malformations (VMs) are the most common vascular developmental anomalies (birth defects) . These defects are caused by developmental arrest of the venous system during various stages of embryogenesis. VMs remain a difficult diagnostic and therapeutic challenge due to the wide range of clinical presentations, unpredictable clinical course, erratic response to the treatment with high recurrence/persistence rates, high morbidity following non-specific conventional treatment, and confusing terminology. The Consensus Panel reviewed the recent scientific literature up to the year 2013 to update a previous IUP Consensus (2009) on the same subject. ISSVA Classification with special merits for the differentiation between the congenital vascular malformation (CVM) and vascular tumors was reinforced with an additional review on syndrome-based classification. A "modified" Hamburg classification was adopted to emphasize the importance of extratruncular vs. truncular sub-types of VMs. This incorporated the embryological origin, morphological differences, unique characteristics, prognosis and recurrence rates of VMs based on this embryological classification. The definition and classification of VMs were strengthened with the addition of angiographic data that determines the hemodynamic characteristics, the anatomical pattern of draining veins and hence the risk of complication following sclerotherapy. The hemolymphatic malformations, a combined condition incorporating LMs and other CVMs, were illustrated as a separate topic to differentiate from isolated VMs and to rectify the existing confusion with name-based eponyms such as Klippel-Trenaunay syndrome. Contemporary concepts on VMs were updated with new data including genetic findings linked to the etiology of CVMs and chronic cerebrospinal venous insufficiency. Besides, newly established information on coagulopathy including the role of D-Dimer was thoroughly reviewed to provide guidelines on investigations and anticoagulation therapy in the management of VMs. Congenital vascular bone syndrome resulting in angio-osteo-hyper/hypotrophy and (lateral) marginal vein was separately reviewed. Background data on arterio-venous malformations was included to differentiate this anomaly from syndrome-based VMs. For the treatment, a new section on laser therapy and also a practical guideline for follow up assessment were added to strengthen the management principle of the multidisciplinary approach. All other therapeutic modalities were thoroughly updated to accommodate a changing concept through the years.

Efficacy and safety of autologous platelet rich plasma for the treatment of vascular ulcers in primary care: Phase III study

Background: Vascular ulcers are commonly seen in daily practice at all levels of care and have great impact at personal, professional and social levels with a high cost in terms of human and material resources. Given that the application of autologous platelet rich plasma has been shown to decrease healing times in various different studies in the hospital setting, we considered that it would be interesting to assess the efficacy and feasibility of this treatment in primary care. The objectives of this study are to assess the potential efficacy and safety of autologous platelet rich plasma for the treatment of venous ulcers compared to the conventional treatment (moist wound care) in primary care patients with chronic venous insufficiency (C, clinical class, E, aetiology, A, anatomy and P, pathophysiology classification C6). Design: We will conduct a phase III, open-label, parallel-group, multicentre, randomized study. The subjects will be 150 patients aged between 40 and 100 years of age with an at least 2-month history of a vascular venous ulcer assigned to ten primary care centres. For the treatment with autologous platelet rich plasma, all the following tasks will be performed in the primary care setting: blood collection, centrifugation, separation of platelet rich plasma, activation of coagulation adding calcium chloride and application of the PRP topically after gelification. The control group will receive standard moist wound care. The outcome variables to be measured at baseline, and at weeks 5 and 9 later include: reduction in the ulcer area, Chronic Venous Insufficiency Quality of Life Questionnaire score, and percentage of patients who require wound care only once a week. Discussion: The results of this study will be useful to improve the protocol for using platelet rich plasma in chronic vascular ulcers and to favour wider use of this treatment in primary care.

Role of saphenous vein wall in the pathogenesis of primary varicose veins

UNLABELLED: Varicose veins may be due to weakness of the vein wall as a result of structural problems. There are conflicting findings in the literature about these problems especially concerning collagen, elastin and smooth muscle cells content. The aim of this study was to look at the structural abnormalities of varicose veins (with and without valvular incompetence).

MATERIALS AND METHODS: We studied 70 specimens of long saphenous veins from 35 patients (24 with varicose and 11 with normal veins). Two specimens were taken from each vein approximately 3-4 cm from the saphenofemoral junction. Vein specimens were processed for histological and electron microscopic studies. Both qualitative and quantitative analyses were performed to assess the degree of wall changes. Using the image analyzer, contents of collagen, elastin and smooth muscle cells, in addition to intimal and medial thickness, were measured.

RESULTS: Light microscopy revealed significant increase in intimal and medial thickness and collagen content of media and significant decrease in elastin content in varicose veins compared with normal veins. There was no statistical significant difference between varicose veins with and without saphenofemoral valve incompetence. Electron microscopy showed marked degenerative changes in intima and media of varicose veins.

CONCLUSION: The findings in our study supported the theory of primary weakness of the vein wall as a cause of varicosity. This weakness is due to intimal changes, disturbance in the connective tissue components and smooth muscle cells.

Manejo médico y quirúrgico en pacientes con insuficiencia venosa mixta : comparación de características clínicas y hemodinámicas

La insuficiencia venosa superficial puede ser causa de insuficiencia venosa profunda, por tanto el manejo quirúrgico del sistema superficial puede mejorar la insuficiencia profunda En nuestro medio no se acostumbra a intervenir quirúrgicamente pacientes con insuficiencia venosa mixta bajo la creencia de exacerbar la enfermedad o generar complicaciones. METODOLOGIA: Se realizó un estudio retrospectivo, tomando pacientes con insuficiencia venosa mixta, entre el año 2006 y 2010, comparando parámetros hemodinámicos por duplex, y parámetros clínicos, según la clasificación CEAP, en los pacientes sometidos a cirugía convencional y en pacientes que recibieron manejo médico conservador. RESULTADOS: Se obtuvieron 45 pacientes, 65% con manejo quirúrgico y 35% manejo médico, con características sociodemograficas y comorbilidades comparables. Sin diferencia en el número de complicaciones (p=0,64), existió una mejoría en el 77% de los pacientes del grupo quirúrgico en parámetros hemodinámicos y de ningún paciente en el grupo de manejo médico, y en mejoría de ulceras activas de 83% y de 33%, respectivamente. DISCUSION: Nuestro estudio constituye una primera aproximación en la investigación en pacientes con esta patología en nuestro medio que son llevados a manejo quirúrgico. Estos resultados sugieren un posible beneficio en cuanto a los parámetros hemodinámicos venosos profundos y en las características clínicas, especialmente cuando existen ulcera activas, cuando los pacientes con insuficiencia venosa mixta son llevados a manejo quirúrgico. Sin embargo, se requieren de estudios futuros que permitan demostrar así estos resultados en nuestro medio.

Calidad de vida en salud en pacientes con insuficiencia venosa mixta luego de varicosafenectomia

INTRODUCCIÓN: Estudios demuestran la mejoría de la insuficiencia venosa profunda luego de realizar varicosafenectomía, la amplia brecha entre resultados positivos (30-70%) deja en cuestionamiento la realización de cirugía para esta condición. Sin embargo, la mejoría en la calidad de vida en el postoperatorio pudiera ser otra razón para realizar varicosafenectomía en pacientes con insuficiencia venosa mixta. METODOLOGÍA: Se realizó un estudio de corte transversal en pacientes con diagnóstico de insuficiencia venosa mixta llevados a varicosafenectomía. En el periodo post operatorio se practicaron encuestas de calidad de vida de tipo genérico y específico realizando un análisis uni y bivariado de dicha información mediante el programa Stata. RESULTADOS: Se obtuvieron 60 pacientes, al practicar las encuestas de calidad de vida se encontraron datos estadísticamente significativos (p 0.04) en la percepción de su salud con respecto al año anterior y escalas de las encuestas referentes a estados generales de salud como función física y vitalidad. Adicionalmente, se encontró mejoría en el estado de la piel y no se evidenciaron complicaciones tales como Tromboembolismo pulmonar o Trombosis venosa profunda. CONCLUSIONES: Los resultados del presente estudio demuestran que la mayor parte de los pacientes luego de varicosafenectomía tienen una buena percepción de calidad de vida en salud, reflejada en las altas puntuaciones en la mayoría de las escalas de la SF-36, y los bajos puntajes en el cuestionario específico de insuficiencia venosa. La mejoría en la piel de la mayoría de los pacientes en el periodo postoperatorio y la mínima presencia de complicaciones como TEP o TVP hacen que la remoción de los troncos safenos incompetentes en este tipo de pacientes pueda establecerse como indicación quirúrgica

Tratamiento de la ulcera venosa con escleroespuma versus manejo conservador

La úlcera venosa es una revelación clínica severa de la insuficiencia venosa crónica. Es la causa del 54-76% de las úlceras venosas de miembros inferiores. La ciencia médica ha generado diversos procedimientos en el manejo de esta patología, es así como a partir de conocimientos en fisiopatología de la ulceración venosa, se han aplicado procedimientos como opción de tratamiento. Objetivos: Valorar si el uso de rutina de la oclusión endoluminal con espuma guiada por ecografía del sistema venoso superficial insuficiente, en adicción al manejo convencional de la ulcera venosa (vendaje no compresivo, gasa vaselinada y curaciones) podría mejorar la tasa de curación a las 24 semanas de tratamiento. Diseño: Estudio clínico aleatorizado prospectivo de pacientes de la consulta externa de cirugía vascular del Hospital Occidente de Kennedy-Bogotá, durante el 01 de junio del 2011 hasta el 30 junio del 2012. Métodos: Un total de 44 pacientes con ulcera activa que cumplieron criterios de selección ingresaron al estudio, correspondientes a 48 extremidades con clasificación CEAP (C6), los pacientes fueron a aleatorizados a manejo convencional (control) o con manejo adicional de oclusión endoluminal con espuma eco-guiada. El objetivo principal fue el cierre de la ulcera a las 24 semanas. Resultados: La Curación de la ulcera a las 24 semanas de la aleatorización fue de 20 (83.3%) extremidades del grupo de oclusión endoluminal con espuma eco-guiada Vs 3(12.5%) para el grupo de control P: 0.0005 Discusión: Las tasas de curación de la ulcera luego de la oclusión endoluminal con espuma eco-guiada es muy superior al manejo convencional con curaciones y vendaje no compresivo, las tasa de curación son tan altas como las reportadas con sistemas de alta compresión y cirugía a las 24 semanas. La oclusión endoluminal eco-guiada es segura, mínimamente invasiva y clínicamente efectiva.

Factores de riesgo para el desarrollo de complicaciones: infecciones en varicosafenectomia

La enfermedad venosa periférica de miembros inferiores se considera una de las afecciones más prevalentes, con morbilidad considerable, deterioro de la calidad de vida, e importante demanda de recursos de salud, que en la mayoría de casos requiere manejo quirúrgico como parte del tratamiento. Este estudio busca analizar si la técnica quirúrgica es un factor de riesgo, que incrementa la aparición de infección de sitio quirúrgico en 257 pacientes a quienes se les realizó varicosafenectomia. Metodología: Se realizó un estudio de cohorte retrospectiva; se recolectaron los datos a partir de los registros clínicos y quirúrgicos de pacientes que cumplieron con los criterios de inclusión, registrando factores de riesgo, descripción quirúrgica, complicaciones, y evolución post operatoria hasta 8 semanas. El análisis estadístico se realizó mediante el cálculo de riesgo relativo y regresión logística binomial. Resultados: Se demostró asociación entre la presencia de infección de sitio quirúrgico y tipo de cirugía con un RR = 3,05 (P= 0,01), clasificación CEAP con 29% menos riesgo en varicosafenectomia total (P= 0,008). Conclusiones: Existen variables clínicas y quirúrgicas que influyen en la probabilidad de desarrollar infección del sitio quirúrgico.

Comparación de cambios clínicos y hemodinámicos en pacientes con insuficiencia venosa mixta según tipo de manejo.

Existen varias causas de la insuficiencia venosa profunda, la insuficiencia venosa superficial es una de ellas; por tal motivo, una intervención activa de la insuficiencia superficial ya sea cirugía convencional, esclerosis o radiofrecuencia mejora el reflujo del sistema venoso profundo. En nuestro medio no se acostumbra a intervenir los pacientes con insuficiencia venosa mixta bajo la creencia de exacerbar la enfermedad o generar complicaciones. Se pretende documentar los cambios clínicos y hemodinámicos en pacientes con insuficiencia venosa mixta según tipo de manejo, médico vs quirúrgico

Qualidade de vida de pessoas com úlceras venosas atendidos no ambulatório de um hospital universitário

Descriptive study aimed to analyze the quality of life (QOL) of patients with venous ulcers (UV) outpatient clinic of a university hospital in Natal / RN. The aim of the study population was composed of 50 patients with UV treated at the cardiology clinic of a university teaching hospital at the tertiary level. The study was approved by the Ethics Committee of the Federal University of Rio Grande do Norte (Protocol 279/09). Data collection was performed over a period of two months by the very a masters degree and an academic nursing through the application of a form concerning the socio-demographic, clinical, and health care, and the instruments WHOQOL and WHOQOL - old. The data were analyzed with SPSS 15.0, using descriptive and inferential statistics presented in the form of tables, charts and graphs. Of the surveyed, female predominance, age range 59 years, Catholic, low education, married, with up to 03 children, not working, retired, or with occupations requiring long periods in one position, wage income of up to 02 minimum wages, inadequate sleep, patients with chronic venous insufficiency and other chronic diseases such as diabetes and hypertension, were taking medications for treatment, being a minority to IVC. In patients with predominant only one injury, time of injury up to five years, inadequate rest, pain, edema and lesions colonized. The assistance the UV patients began treatment of the injury until four months after the onset of the ulcer, and services primary health care most wanted, access to angiologist by reference form, commuted by public transportation, received support regarding the treatment of injuries. The topical product most used in the lesion was healing, and few were using compression therapy. respondents suffer discrimination in society, showed changes in quality of life after the occurrence of ulcer in relation to leisure, pain, restriction of social / school / transportation; barring employment / financial / social ladder; Physical appearance / discrimination and restriction of domestic activity. These changes were related to the time of injury and found that the more chronic injury is the most negative changes occur in their QV (ρ = 0.000). Analyzing the characteristics of QV measured by the WHOQOL-bref, we found for the two general questions they are dissatisfied with their health (ρ = 0.023) and all areas have significant difference compared with the worst QV have the injury of more than 5 years (ρ = 0.000). The QV measured by the WHOQOL-old, we found that these patients had no changes from the time of injury. We conclude that the QV of patients with UV was considered unsatisfactory when compared to the time of injury on more than 5 years which shows that the quality of life worsens with time the chronic UV.

Assistência aos portadores de úlceras venosas: proposta de protocolo

Venous ulcers (VU), recurrent chronic wounds resulting from Chronic Venous Insufficiency (CVI), affect different age groups and would severely affect ambulation of patients. The lesions require treatment lasting and complex and are responsible for significant morbidity and mortality. Thus, this study aims to identify the important aspects covered in the scientific literature protocol for assisting patients with venous ulcers, identifying the issues to be proposed by the judges of the study (nurses, doctors and physiotherapists) to the protocol of care provided to patients venous ulcers and present the structure of protocol proposed by the judges of the study to assist patients with venous ulcers treated at a referral hospital of Rio Grande do Norte. This is a descriptive study using a quantitative approach, carried out at the dressings, located in the outpatient surgical clinic of the Hospital University Onofre Lopes (HUOL), located in East Sanitary District, Natal-RN. The sample consisted of 39 professionals, 30 nurses, seven doctors and two physical therapists, team members HUOL surgical clinic and other public and private institutions of Rio Grande do Norte and Jequié/Bahia. These professionals were the judges responsible for selecting the guidelines already proposed in the literature on VU protocols. Approved by the Ethics in Research HUOL (Report n.o 081/07), began the first stage of the study which consisted of reviewing the scientific literature about the relevant aspects to be included in a protocol for assisting patients with VU. These aspects were organized into a proposed questionnaire to the judges of the study. Following examination, held on the content validation with application of the Kappa (K), accepting a score higher than 0.80 and the Likert Scale, whereas rates from 4.0 to 5.0. The data collected were organized in Microsoft Excel and exported into Statistical Package for Social Sciences (SPSS) 15.0. The literature review included national and international scientific articles, thesis, dissertation and institutional protocols. Regarding the characterization of professional nurses predominated (76.1%), between 34 and 45 years (41.0%), female (79.5%), married/consensual union (46.2%), with specialization in VU care (61.5%), working in the hospital network (46.1%), with up to 5 years experience in VU (69.2%) and claiming to feel prepared to care for these injuries (92.3 %). With regard to aspects that had very good agreement (K ≥ 0.81), remained the items found in the literature with some modifications. In the analysis of the proposed evaluation items had very important, ranging from 4.1 (drug treatment) to 4.9 (patient assessment and care of the injury and the injured and perilesional skin). The proposition of the protocol is arranged in eleven items: A) Evaluation of patient and lesion, B) Registration and documentation, C) the wound and perilesional skin, D) an indication of coverage, E) Use of antibiotic and pain treatment, F) Surgical treatment of CVI, G) Drug treatment, H) Improving venous return and prevetion of recurrence, I) Referral of patients, J) Training and K) Reference and counter reference

Evidências de validação de um protocolo para assistência às pessoas com úlceras venosas em serviços de alta complexidade

Venous ulcers are lesions resulting from chronic venous insufficiency, venous valvular abnormalities and venous thrombosis. Its occurrence has been growing with the increase in life expectancy of the world population. Considered as fundamental aspects in the approach to the person with venous ulcer care with the interdisciplinary approach, adoption of protocol-specific knowledge, technical skill, coordination between levels of care complexity of the Health System and active participation of patients and their families, a holistic perspective. The construction of a clinical protocol for people with venous ulcers can help professionals of high complexity services in patient assessment and the establishment of quality care in a systematic way and focused on the factors that interfere with wound healing. Thus, this study aimed to analyze the evidence of validation of a clinical protocol for people with venous ulcers treated at high-complexity services. This is a methodological study with a quantitative approach, developed in three stages: literature review, evidence of content validity and evidence of validation in the clinical context. Approved by the Federal University of Rio Grande do Norte Research Ethics Committee (Opinion: 147.452 and CAAE: 07556312.0.0000.5537). The literature review was conducted in August and September 2012, becoming the basis for the construction of the protocol. Then the evidence of content validity, which included 53 judges (experts) selected by the Lattes platform to evaluate the protocol items was performed. The judges were contacted by e-mail and rated the protocol via Google Docs . After analyzing the ratios obtained in this step, which reported kappa between 0.75 and 0.96 and between 0.80 and 0.98 IVC, and the suggestions of the judges, the protocol was adjusted and subjected to empirical evidence to validate the clinical setting at the University Hospital Onofre Lopes in Natal / RN. Evidence of validation in the clinical setting involved 4 judges who acted in pairs (paired) evaluated 32 patients with venous ulcers in the clinical context of high complexity. In both stages, we used the Kappa Index and Content Validity Index to analyze the responses of the judges. The parameters set as acceptable for these indices were: Kappa ≥ 0.61 and Content Validity Index > 0.80. Any evidence of content validity, as evidence of validation in the clinical context, the protocol items that have not reached Kappa and Content Validity Index established indices were excluded and some items were modified or added after suggestions. The process of content validation evidence and evidence of validation in the clinical setting allowed the improvement of the protocol for the care of people with venous ulcers initially proposed. The initial version of the protocol, built from the literature, contained 15 categories and 108 items; after evidence of content validity, remained the reduction to 15 categories with 91 items; the final version, clinically validated, is composed of the same 15 categories, 76 items. The protocol was validated in its content and in the clinical aspect, so we accepted the alternative hypothesis in the study. This protocol may contribute to the care system, allowing tailor behaviors and promote greater resolution in the treatment of people with venous ulcers in health services of high complexity

Efeitos do tratamento com Hidrogel na cicatrização de úlceras venosas de membros inferiores: revisão sistemática

Chronic venous disease (CVD) is evident among the chronic diseases and affects the elderly population and primarily is responsible for leg ulcers in this population. The use of dressings in the care of a venous ulcer is a fundamental part of the treatment for healing, however, evidence to assist in choosing the best dressing is scarce. The main objective of this study was to evaluate the effectiveness of treatment with hydrogel in the healing of venous ulcers using search methods, synthesis of information and statistical research through a systematic review and meta-analysis. Randomized controlled trials were selected in the following databases: CENTRAL; DARE; NHS EED; MEDLINE; EMBASE; CINAHL. Beyond these databases three websites were consulted to identify ongoing studies: ClinicalTrials.gov, OMS ICTRP e ISRCTN. The primary outcomes were analyzed: complete wound healing, incidence of wound infection and the secondary were: changes in ulcer size, time to ulcer healing, recurrence of ulcer, quality of life of participants, pain and costs of treatment. Four studies are currently included in the review with a total of 250 participants. The use of hydrogel appears to be superior to conventional dressing, gauze soaked in saline, for the healing of venous leg ulcers; 16/30 patients showed complete healing of ulcers (RR 5,33, 95%CI [1,73,16,42]). The alginate gel was shown to be more effective when compared to the hydrogel dressing in reduction of the wound area; 61,2% (± 26,2%) with alginate e 19,4% (± 24,3%) with hydrogel at the end of four weeks of treatment. Manuka honey has shown to be similar to the hydrogel dressings in percentage of area reduction. This review demonstrated that there is no evidence available about the effectiveness of the hydrogel compared to other types of dressings on the healing of venous leg ulcers of the lower limbs, thus demonstrating the need of future studies to assist health professionals in choosing the correct dressing.

Preservação da veia safena magna na cirurgia de varizes dos membros inferiores

A veia safena magna autóloga é o melhor substituto arterial nas revascularizações dos membros inferiores, importante na revascularização do miocárdio e pode ser utilizada nas cirurgias do sistema venoso e nos traumas das extremidades. A fleboextração aumenta os riscos de lesões linfáticas e neurológicas. Assim, no tratamento das varizes primárias dos membros inferiores por meio da cirurgia ou de outras técnicas, a preservação da safena é recomendável se ela for normal ou apresentar alterações que ainda permitam sua preservação pela correção da causa desencadeante. Tal correção pode ser feita por técnicas cirúrgicas. Entre elas, a cura hemodinâmica da insuficiência venosa em ambulatório (CHIVA) tem mostrado bons resultados. Recentemente, um ensaio clínico randomizado e controlado foi publicado comprovando sua eficácia. Outra técnica bastante utilizada é a da ligadura rasante da junção safenofemoral + crossectomia + ligadura das tributárias de crossa, com a qual se tem obtido resultados contraditórios. Finalmente, as técnicas que corrigem a insuficiência da safena reparando as valvas ostial e pré-ostial (valvoplastia externa) são mais fisiológicas. Um ensaio clínico internacional multicêntrico, randomizado e controlado, testando um novo dispositivo, está sendo realizado, com resultados iniciais favoráveis. Este estudo pretende fazer uma revisão sobre as técnicas utilizadas na preservação da safena magna.