Intraoperative Extravascular Ultrasound in the Identification of Flow-Limiting Dissections after Balloon Angioplasty in the Femoropopliteal Segment.

Background: The BIO REACT study is designed to investigate the incremental value of Extravascular UltraSound (EVUS) added to conventional angiography, compared to conventional angiography only for the identification of Flow-Limiting Dissections (FLD) and to evaluate the safety and efficacy of the REsponse Adapted Combination Therapy (REACT) for the treatment of femoropopliteal lesions. Methods: The primary endpoints were the specificity and sensitivity of EVUS added to angiography for the detection of FLD. Secondary endpoints were primary patency of the REACT therapy within 12 months, fCD-TLR, freedom from MAE, major target limb amputations (mTLA) and survival rates within 24 months. Results: A total of 150 patients were included. EVUS added to angiography had an overall sensitivity of 29% and specificity of 93% for the detection of FLD. There was no PSVR cut-off offering a clinically acceptable trade-off between meaningful sensitivity and specificity values for the detection of FLD. At 12 months, treatment with the REACT resulted in primary patency and fCD-TLR of 81.6% and 94.3%, respectively. In addition, freedom from MAE was 94.3% at 12 months. At 24 months, the survival rate was 94.0%. No mTLA was reported up to the 24-month follow-up. Conclusions: The addition of DUS to angiography showed limited value for detecting FLD in femoropopliteal artery disease.

Radial access for peripheral vascular intervention: the S.M.A.R.T. RADIANZ Vascular Stent System.

INTRODUCTION: Radial access is the standard of care for nearly all cardiac catheterization procedures. It improves patient satisfaction, reduces the length of stay, and is associated with fewer complications. However, few devices and tools are available for the treatment of peripheral arterial disease via a transradial approach (TRA). The S.M.A.R.T. RADIANZ Vascular Stent System is among the RADIANZ suite of products, which is aimed at expanding the portfolio of devices to treat peripheral arterial disease. AREAS COVERED: In this Expert review, the following areas will be covered: (1) Current Landscape of peripheral vascular intervention (PVI) using TRA (2) Detailed description of the S.M.A.R.T. RADIANZ Vascular Stent System. (3) Ongoing clinical trials to evaluate safety of this approach. (4) Future directions and current regulatory status. EXPERT OPINION: TRA for PVI is a promising approach. It holds the possibility of substantially improving the care of patients with peripheral arterial disease (PAD). Numerous challenges must be overcome to realize the full potential of a radial-to-peripheral (RTP) approach. The length of devices and the small sheath size are the main constraints of this approach. The results of the ongoing RADIANCY trial will demonstrate the safety, in selected patients, of the RADIANZ suite of products.

Efectividad de intervención basada en modelo de Nola Pender en promoción de estilos de vida saludables de universitarios peruanos / Effectiveness of an Intervention Based on the Nola Pender Model in Promoting Healthy Lifestyles in Peruvian Universities

Introducción: Los estilos de vida saludables previenen enfermedades y optimizan la salud del ser humano, mejor aún en los estudiantes universitarios quienes están vulnerables a cambiar actitudes, rutinas, hábitos y su estilo de vida. Objetivo: Determinar la efectividad de programa basado en modelo de Nola Pender para promover estilos de vida saludables en universitarios peruanos. Métodos: Estudio preexperimental con pretest y postest, en una universidad privada de Tarapoto, Perú, durante 2017. Participaron 869 estudiantes de siete carreras. Para conocer el estilo de vida de los universitarios, se utilizó el PESPS-I de Pender. La intervención tuvo una duración de ocho meses, se consideraron aspectos nutricionales, salud emocional y actividad física. En el análisis estadístico se realizó la prueba no paramétrica Wilcoxon, con nivel de significación de p = 0,05, además de la distribución de frecuencias absolutas, porcentajes, medias, rango promedio y desviación estándar. Resultados: Las medidas del postest fueron superiores a las del pretest demostrando la efectividad del programa para promover los estilos de vida saludables en el ejercicio, la responsabilidad en salud y el manejo del estrés (p < 0,05). Sin embargo, en las dimensiones: nutrición, soporte interpersonal y auto-actualización no se encontraron diferencias significativas (p > 0,05). Conclusiones: El programa para promover los estilos de vida saludables en universitarios peruanos de 16 a 22 años demostró ser efectivo para mejorar el ejercicio, la responsabilidad en salud y el manejo del estrés(AU)

ABSTRACT Introduction: Healthy lifestyles prevent diseases and optimize the health of the human being, even better among university students, who are vulnerable to changing attitudes, routines, habits, and their lifestyle. Objective: To determine the effectiveness of a program based on the Nola Pender model to promote healthy lifestyles in Peruvian university students. Methods: Pre-experimental study with pre-test and post-test, in a private university in Tarapoto, Peru, during 2017. 869 students from seven majors participated. To know the lifestyle of university students, the Pender PESPS-I was used. The intervention lasted eight months. Nutritional aspects, emotional health and physical activity were considered. In the statistical analysis, the non-parametric Wilcoxon test was performed, with a significance level of p=0.05, in addition to the distribution of absolute frequencies, percentages, means, average range and standard deviation. Results: The post-test measures were higher than to those of the pre-test, which demonstrated the effectiveness of the program to promote healthy lifestyles through exercising, health responsibility and stress management (p < 0.05). However, in the dimensions nutrition, interpersonal support and self-update, no significant differences were found (p >0.05). Conclusions: The program to promote healthy lifestyles in Peruvian university students aged 16 to 22 years proved to be effective in improving exercise, health responsibility and stress management(AU)

Eficacia de los fármacos antirreumáticos modificadores de la enfermedad sintéticos en artritis psoriásica: una revisión sistemática / Effectiveness of conventional disease-modifying antirheumatic drugs in psoriatic arthritis: a systematic review

Antecedentes. Dada la heterogeneidad clínica de la artritis psoriásica (APs), se han elaborado recomendaciones por grupos internacionales para orientar las decisiones terapéuticas del reumatólogo. Esta revisión sistemática (RS) tiene el objetivo de evaluar la evidencia sobre la eficacia de los FAME en APs. Métodos. Búsqueda bibliográfica en Medline, Embase, Cochrane Library, desde 2008 hasta 2014. Se incluyeron RS, EC y estudios observacionales, en pacientes con APs con evaluación de eficacia de FAME sintéticos (metotrexato, sulfasalazina y leflunomida), los siguientes desenlaces: síntomas periféricos; daño estructural radiológico periférico; síntomas axiales; entesopatía por ecografía o resonancia magnética (número de entesis antes y después del estudio); dactilitis, y uveítis. Resultados. Se recuperaron 1.662 documentos para revisar por título y «abstract» (Medline, n=433; Embase n=1.132; Cochrane, n=97), se seleccionaron 48 estudios para su lectura detallada, y se incluyeron 8 estudios. Conclusiones. Ya que los estudios incluidos no son consistentes, y hay argumentos para apoyar la eficacia del metotrexato, la evidencia observada con el tratamiento de FAME en APs no es concluyente (AU)

Background. Due to the clinical heterogeneity of psoriatic arthritis (PsA), recommendations have been developed by international groups to guide therapeutic decisions of the rheumatologist. The objective of the current systematic review (RS) was to evaluate the evidence of efficacy of disease-modifying antirheumatic drugs (DMARDs) in PsA. Methods. Literature search in Medline, EMBASE, Cochrane Library, from 2008 to 2014. We included RS, randomized clinical trials and observational studies, in patients with PsA and an evaluation of efficiency of conventional DMARDs (methotrexate, sulfasalazine, leflunomide), according to the following outcomes: peripheral and axial symptoms; peripheral radiological damage; enthesitis according to power Doppler ultrasound or magnetic resonance imaging (enthesitis count before and after therapy); dactylitis; uveitis. Results. Title and abstract were used to retrieve 1,662 documents for this review (Medline, n=433; EMBASE n=1,132; Cochrane, n=97), and 48 studies were selected for detailed reading; finally, 8 studies were included. Conclusions. Since the studies included are not robust, and there are arguments to support the effectiveness of methotrexate, the evidence observed with the treatment of DMARDs in PsA is not conclusive (AU)

Effectiveness of conventional disease-modifying antirheumatic drugs in psoriatic arthritis: A systematic review. / Eficacia de los fármacos antirreumáticos modificadores de la enfermedad sintéticos en artritis psoriásica: una revisión sistemática.

BACKGROUND: Due to the clinical heterogeneity of psoriatic arthritis (PsA), recommendations have been developed by international groups to guide therapeutic decisions of the rheumatologist. The objective of the current systematic review (RS) was to evaluate the evidence of efficacy of disease-modifying antirheumatic drugs (DMARDs) in PsA. METHODS: Literature search in Medline, EMBASE, Cochrane Library, from 2008 to 2014. We included RS, randomized clinical trials and observational studies, in patients with PsA and an evaluation of efficiency of conventional DMARDs (methotrexate, sulfasalazine, leflunomide), according to the following outcomes: peripheral and axial symptoms; peripheral radiological damage; enthesitis according to power Doppler ultrasound or magnetic resonance imaging (enthesitis count before and after therapy); dactylitis; uveitis. RESULTS: Title and abstract were used to retrieve 1,662 documents for this review (Medline, n=433; EMBASE n=1,132; Cochrane, n=97), and 48 studies were selected for detailed reading; finally, 8 studies were included. CONCLUSIONS: Since the studies included are not robust, and there are arguments to support the effectiveness of methotrexate, the evidence observed with the treatment of DMARDs in PsA is not conclusive.

The effect of smoking on clinical and structural damage in patients with axial spondyloarthritis: A systematic literature review.

OBJECTIVES: To evaluate the association between smoking and clinical parameters and structural damage in axial spondyloarthritis (axSpA). METHODS: We systematically searched MEDLINE, EMBASE and Cochrane Library till November 2015. We selected articles that analysed the smoking impact on disease activity, functional status, structural damage, physical mobility and life quality. Independent extraction of articles by 2 authors using predefined data fields was performed. Studies quality was graded according to the Oxford Level of Evidence scale. RESULTS: A total of 17 articles were selected for inclusion: 2 case-control, 11 cross-sectional and 4 prospective cohort studies, which analysed 4694 patients. Weak evidence suggested a smoking effect on pain, overall assessment of health, disease activity, physical mobility and life quality in ankylosing spondylitis (AS). Moderate-good evidence revealed higher HAQ-AS among smokers (0.025units/y; 95% CI: 0.0071-0.0429; p = 0.007). Every additional unit of ASDAS resulted in an increase of 1.9 vs. 0.4 mSASSS units/2y in AS smokers vs. non-smokers. Good evidence revealed that cigarette smoking and smoking intensity was associated with spinal radiographic progression in axSpA [mSASSS ≥2 units/2y: OR = 2.75, 95% CI: 1.25-6.05, p=0.012; mSASSS progression in heavy smokers (>10 cigarettes/d): OR = 3.57, 95% IC: 1.33-9.60, p = 0.012]. CONCLUSIONS: Published data indicate that smoking has a dose-dependent impact on structural damage progression in axSpA. There is worse HAQ among AS smokers compared to non-smokers. Respect to pain, overall assessment of health, disease activity, physical mobility and life quality, although the evidence level is poor, all evidence points in the same direction: smoking AS patients are worse than non-smoking.

Multidisciplinary dermatology-rheumatology management for patients with moderate-to-severe psoriasis and psoriatic arthritis: a systematic review.

The aim of the study was to analyze the efficacy and satisfaction of multidisciplinary dermatology-rheumatology management for patients with moderate-to-severe psoriasis and psoriatic arthritis (PsA). We conducted a systematic literature search in MEDLINE, EMBASE, and Cochrane Library up to September 2015. Selection criteria include (1) adult patients with moderate-to-severe psoriasis and PsA, (2) assessed in a multidisciplinary consultation, (3) comparison with routine separate consultations, and (4) outcome measures to evaluate efficacy and/or satisfaction. Meta-analyses, systematic reviews, clinical trials, cohort studies, and case series were included. The quality of the studies included was graded according to the Oxford Level of Evidence scale. Of 195 articles, three studies complied with the inclusion criteria: two case series and one descriptive study in which 506 patients were evaluated. Patients were referred to the multidisciplinary consultation from dermatology and rheumatology consultations in all but one study, in which primary care was also involved. The reason for the referral was to confirm the diagnosis and/or treatment. Patients were evaluated on a weekly and monthly basis in two and one study, respectively. The evidence obtained is scarce but suggests the efficacy of multidisciplinary consultations in terms of improved skin and joint symptoms after changing treatment (82-56 %), showing higher scores for this type of consultation compared to the usual [4.91 vs. 2.85 (0-5)] and a high level of satisfaction among patients (94 % "very satisfied"). However, waiting times were higher. With the limited evidence found, multidisciplinary management seems to be more effective and more satisfactory for patients with moderate-to-severe psoriasis and PsA than conventional consultations, though this could not be conclusively demonstrated. The results of this review support the benefit of implementing this type of consultation.

Health technology assessment-based development of a Spanish breast cancer patient decision aid.

OBJECTIVES: The aim of this study was to develop a breast cancer Patient Decision Aid (PDA), using a Health Technology Assessment (HTA) process, to assist patients in their choice of therapeutic options, and to promote shared decision making among patients, healthcare professionals, and other interested parties. METHODS: A systematic review (SR) was conducted of existing breast cancer patient Decision Aids encountered in the main scientific journal databases and on institutional Web sites that create PDAs, together with a Qualitative Research (QR) study, using semi-structured interviews and focus group with stakeholders (patients, family members, and health professionals), with the aim of developing a PDA for breast cancer. RESULTS: The SR shows that PDAs in breast cancer not only increase patient knowledge of the illness, leading to more realistic expectations of treatment outcomes, but also reduce passivity in the decision-making process and facilitate the appropriate choice of treatment options in accordance with patient medical and personal preferences. The analysis of QR shows that both breast cancer patients and healthcare professionals agree that surgery, adjuvant treatments, and breast reconstruction represent the most important decisions to be made. Worry, anxiety, optimism, and trust in healthcare professionals were determined as factors that most affected patients subjective experiences of the illness. This HTA was used as the basis for developing a PDA software program. CONCLUSIONS: The SR and QR used in the development of this PDA for breast cancer allowed patients to access information, gain additional knowledge of their illness, make shared treatment decisions, and gave healthcare professionals a deeper insight into patient experiences of the disease.

Herramientas de ayuda a la toma de decisiones en cáncer colorrectal: una revisión / Pacient decision aids in colorectal cancer: A review

Objetivo: El objetivo de este trabajo es conocer los estudios publicados es los diez últimos años sobre la utilización de herramientas de ayuda a la toma de decisiones en pacientes con cáncer colorrectal, en cualquiera de las fases de la enfermedad. Así como localizar las herramientas de ayuda a la toma de decisiones que están disponibles. Método: Se ha realizado una revisión de la literatura desde el 2000 hasta el 2010 en las bases MEDLINE, PsycINFO, EMBASE y Cochrane. Así como una búsqueda en páginas webs de distintas organizaciones para la localización de herramientas disponibles Resultados: Una vez realizada la selección de los artículos, se contó con 10 artículos que presentan herramientas, evalúan las preferencias de los pacientes a la hora de tomar decisiones, evalúan las estrategias de distribución de dichas herramientas o se evalúa la forma más eficaz de presentar la información en las herramientas. A través de la búsqueda realizada mediante las páginas webs de las organizaciones se encontraron seis herramientas propiamente dichas sobre el cribado de cáncer colorrectal. Conclusiones: cada vez es mayor el interés por implicar al paciente en la toma de decisiones con respecto al cáncer colorrectal. Para ello se hace necesaria la evaluación de las preferencias y valores de los pacientes y por eso el uso de herramientas de ayuda a la toma de decisiones puede ayudar a los profesionales en esa evaluación y a los pacientes, además de a tomar la decisión, a sentirse satisfecho con ella (AU)

Aim: The objective is to collect available patient decision aids (PDA) for colorectal cancer in any of the stages of the disease and to gather published studies about the use of these tools in the last ten years Methods: A systematic review (SR) of tools for Decision-making Aid in colorectal cancer was performed since year 2000. Search includes main databases (MEDLINE, PsycINFO, EMBASE, Cochrane) as well as websites of institutions working with PDAs to search available tools. Results: After the appraisal of the found articles, we finally selected 10 studies with PDA for colorectal cancer in which patients preferences in the decision making process, disseminating strategies of the tools or the way of presenting patient information were assessed. Through the websites of institutions working with PDAs we found six tools about screening in colorectal cancer. Conclusions: There is a growing interest to involve patients with colorectal cancer in the decision making process. To do so, it’s necessary to assess patients’ values and preferences and that’s why PDAs are effective in helping both, professionals and patients. They are useful for professionals for this assessment process, and also for patients, not just to make a decision but also for being satisfied with the final decision (AU)

Economic assessment of cardiac resynchronization therapy.

INTRODUCTION AND OBJECTIVES: Cardiac resynchronization devices have been shown to be effective in treating heart failure. They reduce overall mortality, heart failure mortality and hospitalizations due to heart failure. The aim of this study was to compare the cost-effectiveness of cardiac resynchronization therapy (CRT) with that of optimal drug therapy (ODT) by carrying out an economic assessment in the Spanish healthcare setting. METHODS: An existing model was adapted for use in the Spanish healthcare setting. The effectiveness of cardiac resynchronization therapy was determined from published systematic reviews. The costs of the various interventions were determined using a range of Spanish data sources. The model adopted the perspective of the public health system and the time horizon considered was the remainder of the patient's life. The outcome variables were life-years gained and quality-adjusted life-years (QALYs) gained. RESULTS: Overall, ODT, CRT and CRT with a defibrillator resulted in gains of 2.11, 2.8 and 3.19 QALYs, respectively, at a cost of €11,722, €31,629 and €52,592, respectively. Consequently, each QALY gained with CRT relative to ODT involved the consumption of €28,612 of additional resources. Similarly, the use of CRT with a defibrillator cost an additional €53,547 per QALY relative to CRT without a defibrillator. CONCLUSIONS: The use of CRT without a defibrillator could be a cost-effective alternative to ODT for treating heart failure in a carefully selected group of patients. The study results were sensitive to uncertainties in many of the variables used in the model.

Evaluación económica de la terapia de resincronización cardiaca / Economic assessment of cardiac resynchronization therapy

Introducción y objetivos. La terapia de resincronización cardiaca es un tratamiento de eficacia demostrada para la insuficiencia cardiaca y reduce el número de hospitalizaciones y la mortalidad por progresión de la insuficiencia y total. El objetivo de nuestro trabajo es determinar la eficiencia de la terapia de resincronización cardiaca comparada con la terapia farmacológica mediante una evaluación económica adaptada a nuestro entorno sanitario. Métodos. Se realiza la adaptación al ámbito sanitario español de un modelo previamente existente. Las fuentes de efectividad utilizadas son revisiones sistemáticas de la literatura publicadas. Los costes de las distintas intervenciones se determinan de acuerdo con diversas fuentes de datos españolas. Se utiliza la perspectiva del sistema sanitario; como horizonte temporal, el resto de vida de los pacientes, y como variables de resultado, años de vida y años de vida ajustados por calidad (AVAC). Resultados. El tratamiento farmacológico, la resincronización y resincronización + desfibrilador alcanzaron 2,11, 2,8 y 3,19 AVAC, a un coste de 11.722, 31.629 y 52.592 euros respectivamente. Cada AVAC obtenido con resincronización frente a medicación requiere el uso de 28.612 euros de recursos adicionales. De modo análogo, la resincronización con desfibrilador cuesta 53.547 euros/ AVAC respecto a la resincronización sin desfibrilador. Conclusiones. La terapia de resincronización cardiaca sin desfibrilador puede ser una opción de tratamiento coste-efectiva para el grupo de pacientes adecuadamente seleccionados, comparada con la terapia farmacológica óptima. Este resultado es sensible por la incertidumbre en numerosas variables del modelo (AU)

Introduction and objectives. Cardiac resynchronization devices have been shown to be effective in treating heart failure. They reduce overall mortality, heart failure mortality and hospitalizations due to heart failure. The aim of this study was to compare the cost-effectiveness of cardiac resynchronization therapy (CRT) with that of optimal drug therapy (ODT) by carrying out an economic assessment in the Spanish healthcare setting. Methods. An existing model was adapted for use in the Spanish healthcare setting. The effectiveness of cardiac resynchronization therapy was determined from published systematic reviews. The costs of the various interventions were determined using a range of Spanish data sources. The model adopted the perspective of the public health system and the time horizon considered was the remainder of the patient’s life. The outcome variables were life-years gained and quality-adjusted life-years (QALYs) gained. Results. Overall, ODT, CRT and CRT with a defibrillator resulted in gains of 2.11, 2.8 and 3.19 QALYs, respectively, at a cost of € 11,722, € 31,629 and € 52,592, respectively. Consequently, each QALY gained with CRT relative to ODT involved the consumption of € 28,612 of additional resources. Similarly, the use of CRT with a defibrillator cost an additional € 53,547 per QALY relative to CRT without a defibrillator. Conclusions. The use of CRT without a defibrillator could be a cost-effective alternative to ODT for treating heart failure in a carefully selected group of patients. The study results were sensitive to uncertainties in many of the variables used in the model (AU)

Efficacy of the Da Vinci surgical system in abdominal surgery compared with that of laparoscopy: a systematic review and meta-analysis.

AIM: The main aim of this review was to compare the safety and efficacy of the Da Vinci Surgical System (DVSS) and conventional laparoscopic surgery (CLS) in different types of abdominal intervention. SUMMARY OF BACKGROUND DATA: DVSS is an emerging laparoscopic technology. The surgeon directs the robotic arms of the system through a console by means of hand controls and pedals, making use of a stereoscopic viewing system. DVSS is currently being used in general, urological, gynecologic, and cardiothoracic surgery. METHODS: This systematic review analyses the best scientific evidence available regarding the safety and efficacy of DVSS in abdominal surgery. The results found were subjected to meta-analysis whenever possible. RESULTS: Thirty-one studies, 6 of them randomized control trials, involving 2166 patients that compared DVSS and CLS were examined. The procedures undertaken were fundoplication (9 studies, one also examining cholecystectomy), Heller myotomy (3 studies), gastric bypass (4), gastrectomy (2), bariatric surgery (1), cholecystectomy (4), splenectomy (1), colorectal resection (7), and rectopexy (1). DVSS was found to be associated with fewer Heller myotomy-related perforations, a more rapid intestinal recovery time after gastrectomy-and therefore a shorter hospital stay, a shorter hospital stay following cholecystectomy (although the duration of surgery was longer), longer colorectal resection surgery times, and a larger number of conversions to open surgery during gastric bypass. CONCLUSIONS: The publications reviewed revealed DVSS to offer certain advantages with respect to Heller myotomy, gastrectomy, and cholecystectomy. However, these results should be interpreted with caution until randomized clinical trials are performed and, with respect to oncologic indications, studies include variables such as survival.

Desmontaje de un irradiador autoblindado de investigación del tipo MPX--25M / Methodology for the dismantling of an investigation of irradiators type selfshielded MPX--25M

RESUMEN En el trabajo se describe el desmontaje de una instalación de irradiación gamma autoblindada de categoría I, modelo MPX--25M. Los objetivos específicos son: identificar los aspectos del aseguramiento contractual, de recursos humanos y técnicos; evaluar la situación radiológica del proceso y analizar los potenciales sucesos radiológicos extraordinarios en cada uno de los pasos del proceso, garantizando las respuestas adecuadas. La evaluación de sucesos radiológicos descritos puede servir de referencia para abordar el proceso de desmontaje de otros irradiadores similares.

ABSTRACT This paper describes the dismantling of a category I selfshielded gamma irradiation facility model MPX--25M. The following specific objectives were established: a) to identify aspects of the insurance contract, human and technical resources b) to assess the radiological situation of the process and c) to analyze the potential radiological extraordinary events in each step of the process by providing the appropriate answers. The assessment of radiological events may serve as a reference for addressing the process of dismantling other similar irradiators.

Cuerpos extraños bronquiales en adultos. Presentación de 4 casos y revisión de la literatura / Bronchial foreign bodies in adults. Report of 4 cases and literature review

Los cuerpos extraños bronquiales son una patología relativamente frecuente en niños pero se dan con carácter muy ocasional en adultos. Presentamos una revisión propia de 4 pacientes (3 mujeres y 1 varón) , ingresados en nuestro hospital, con diferente sintomatología clínica y aspectos radiológicos derivados principalmente de la naturaleza y tiempo de evolución del cuerpo extraño desde su aspiración hasta su diagnóstico final. En dos casos la radiografía de tórax fue normal; en un paciente mostraba claros signos de atelectasia pulmonar y en otro un síndrome de Jano. Describimos el tratamiento efectuado en cada caso clínico y su evolución posterior para realizar finalmente una revisión bibliográfica sobre esta entidad (AU)