The CNIC-Polypill reduces recurrent major cardiovascular events in real-life secondary prevention patients in Spain: The NEPTUNO study.

BACKGROUND: To evaluate the effectiveness of a cardiovascular polypill including aspirin, ramipril and atorvastatin (CNIC-Polypill), on the incidence of recurrent major cardiovascular events (MACE) and risk factor control in patients with established atherosclerotic cardiovascular disease (ASCVD) vs different pharmacological therapeutic strategies. METHODS: Retrospective, observational study using data from electronic-health records. Patients were distributed into 4 different cohorts: CNIC-Polypill (case cohort) vs 3 control cohorts: same monocomponents taken separately (Monocomponents), equipotent drugs (Equipotent) and other drugs not included in the previous cohorts (Other therapies). Patients were followed for 2 years or until MACE or death. RESULTS: After propensity score matching, a total of 6456 patients (1614 patients per cohort) were analysed. After 2 years, the risk of recurrent MACE was lower in the CNIC-Polypill cohort compared to the control groups (22%; p = 0.017, 25%; p = 0.002, 27%; p = 0.001, higher in the Monocomponents, Equipotent and Other therapies cohorts, respectively). The incremental proportion of patients who achieved blood pressure (BP) and low-density lipoprotein cholesterol (LDLc) control from baseline was higher in the CNIC-Polypill cohort vs control cohorts (BP controlled patients: +12.5% vs + 6.3%; p < 0.05, +2.2%; p < 0.01, +2.4%; p < 0.01, LDLc controlled patients: +10.3% vs + 4.9%; p < 0.001, +5.7%; p < 0.001, +4.9%; p < 0.001, respectively). Medication persistence was higher in patients treated with the CNIC-Polypill (72.1% vs 62.2%, 60.0% and 54.2%, respectively; p < 0.001) at study end. CONCLUSIONS: In secondary prevention patients, compared with control groups, treatment with the CNIC-Polypill was associated with significant reductions in the accumulated incidence of recurrent MACE, improved BP and LDLc control rates, and increased medication persistence.

[Adjusted clinicals groups: a patient classification system through risk adjustment]. / Los adjusted clinicals groups: un sistema de clasificación de pacientes por ajuste de riesgos.

Adjusted Clinical Groups (ACG) are risk adjustment systems that classify people according to their age, sex and medical conditions, these people have a similar consumption of health resources over a given period of time. They were developed by Starfield and Weiner (Johns Hopkins University, USA, 1991), and their objective is to measure the degree of illness among patients based on the levels of comorbidity. Their main applications are: a) the evaluation of the efficiency in the use of health services, b) measurement of population's comorbidity, and c) to program the funding or capitation fee for groups of providers. Some of the advantages of the ACG system are the limited number of variables needed for each patient (age, sex and diagnosis) and the unit of measurement, which is the patient. Some characteristics of this population risk adjustment system are commented.

Los adjusted clinicals groups: Un sistema de clasificación de pacientes por ajuste de riesgos / Adjusted clinicals groups: A patient classification system through risk adjustment

Los Adjusted Clinical Groups (ACG) son un sistema de ajuste de riesgos que clasifica a las personas según su edad y sexo y las condiciones médicas que presentan, y estas personas tienen un consumo similar de recursos sanitarios durante un periodo. Fueron desarrollados por Starfield y Weiner (Universidad Johns Hopkins, EE. UU. 1991), y su objetivo es medir el grado de enfermedad en poblaciones de pacientes basándose en sus niveles de comorbilidad. Entre sus principales aplicaciones destacan: a) evaluar la eficiencia en la utilización de los servicios sanitarios, b) medir la comorbilidad de la población, y c) programar la financiación o pago capitativo para grupos de proveedores. Entre las ventajas del sistema ACG destaca la necesidad de un número limitado de variables para cada paciente (edad, sexo y diagnósticos) y que la unidad de medida es el paciente. Se comentan algunas características de este sistema de ajuste de riesgos poblacionales.

Adjusted Clinical Groups (ACG) are risk adjustment systems that classify people according to their age, sex and medical conditions, these people have a similar consumption of health resources over a given period of time. They were developed by Starfield and Weiner (Johns Hopkins University, USA, 1991), and their objective is to measure the degree of illness among patients based on the levels of comorbidity. Their main applications are: a) the evaluation of the efficiency in the use of health services, b) measurement of population’s comorbidity, and c) to program the funding or capitation fee for groups of providers. Some of the advantages of the ACG system are the limited number of variables needed for each patient (age, sex and diagnosis) and the unit of measurement, which is the patient. Some characteristics of this population risk adjustment system are commented.

Farmacoeconomía de olmesartán en combinaciones a dosis fijas para el tratamiento de la hipertensión arterial / Pharmacoeconomics of fixed-dose combinations with olmesartan in the treatment of hypertension

La hipertensión arterial constituye uno de los principales factores de riesgo por su elevada prevalencia y riesgo de complicaciones. Se ha progresado en la inercia clínica de la enfermedad, aunque el control de la presión arterial sigue siendo mejorable en colectivos específicos. La farmacoeconomía es una aplicación de la economía de la salud que nos permite conocer cuál es la eficiencia de las diferentes alternativas terapéuticas utilizables para tratar la hipertensión. Los antagonistas de los receptores de la angiotensina II (ARA II) han demostrado ser fármacos antihipertensivos efectivos y seguros, aunque la comparación entre los diferentes ARA II presenta resultados contradictorios. Olmesartán medoxomilo es un fármaco eficaz y bien tolerado, similar o ligeramente más eficaz que otros ARA II, tanto en monoterapia como en combinación fija (doble o triple). La hipertensión arterial no diagnosticada o no tratada es la principal causa de disminución de la efectividad y eficiencia en situación de práctica clínica habitual; su tratamiento requiere desarrollar estrategias basadas en análisis de coste-eficiencia, para reducir los costes sanitarios y maximizar los resultados. Los escasos estudios publicados sugieren que olmesartán en monoterapia, en comparación con otros ARA II, reduce de forma similar o superior el riesgo cardiovascular y las complicaciones a un menor coste. La terapia combinada con 2 o 3 antihipertensivos también parece tener un perfil de costeefectividad favorable, a pesar de que el coste del tratamiento es mayor. Cabe destacar la escasez de datos de coste-efectividad sobre el uso de dosis fijas de ARA II en general y de olmesartán en particular en terapias de combinación (AU)

Hypertension is a major risk factor due to its high prevalence and the risk of complications. Clinical inertia has been reduced, although blood pressure control could still be improved in certain specific groups. Pharmacoeconomics is an application of health economics that can be used to determine the efficiency of the various therapeutic alternatives available to treat hypertension. Angiotensin II receptor antagonists (ARA II) have been shown to be safe and effective hypotensive drugs, although comparisons among the distinct ARA II have yielded contradictory results. Olmesartan medoxomil is an effective and well tolerated drug with similar or slightly superior efficacy to other ARA II, both in monotherapy and in fixed-dose double- or triple-combination therapy. Undiagnosed or untreated hypertension is the main cause of reduced effectiveness and efficiency in routine clinical practice; treatment requires the development of strategies based on cost-efficiency analyses to reduce health costs and optimize results. The few published studies suggest that olmesartan monotherapy produces a similar or greater reduction in cardiovascular risk and complications than other ARA II and at a lower cost. Combination therapy with two or three antihypertensive agents also seems to have a favorable cost-effectiveness profile, even though the cost of treatment is higher. Importantly, in combination therapies, there is a scarcity of cost-effectiveness data on the use of fixed-doses of ARA II in general and of olmesartan in particular (AU)

[Incidence, resource use and costs associated with postherpetic neuralgia: a population-based retrospective study]. / Incidencia, uso de recursos y costes asociados a la neuralgia postherpetica: estudio retrospectivo de base poblacional.

AIM: To determine the incidence rate, the treatment administered and the use of health resources and health, and their respective costs in patients with postherpetic neuralgia (PHN). PATIENTS AND METHODS: We performed an observational design, made from retrospective review of patient records from six primary care centers and one hospital. All patients > 30 years consulting for PHN between 1/1/2007 and 31/12/2010 were included. Prepared two study groups according to presence / absence of PHN. Follow up was for one year. MAIN MEASURES: socio-demographic, treatment and co-morbidity. The cost model differed direct healthcare costs (primary care/specialist) and indirect (productivity). STATISTICAL ANALYSIS: logistic regression models and analysis of covariance (p < 0.05). RESULTS: 1506 patients were recruited, age: 61.2 years female: 59.2%. 15.1% (n = 228, 95% CI = 8.1-22.1%) had a PHN (incidence rate: 0.8/1,000 inhabitants/year; 95% CI = 0.7-0.9/1,000 population/year), and increased with age (≥ 65 years: 19.7%). The PHN was principally associated with: psychosis (OR = 3.9), dementia (OR = 2.3), depression (OR = 1.8) and age (OR = 1.1), p < 0.03. Drugs use was higher (5.3 vs. 3.3; p < 0.001). The cost in primary care was 63.1% and 24.7% indirect. Total cost €1827.1 vs. €457.5 (p = 0.003), respectively, due to higher labour productivity losses (€692.2 vs. €62.4) and health costs (€1135 vs. €395.1); p < 0.001. All cost components maintained these differences. CONCLUSIONS: PHN is a frequent complication. These patients have a significant economic burden. The cost increases with age.

Incidencia, uso de recursos y costes asociados a la neuralgia postherpética: estudio retrospectivo de base poblacional / Incidence, resource use and costs associated with postherpetic neuralgia: a population-based retrospective study

Objetivo. Determinar la tasa de incidencia, los tratamientos administrados y la utilización de recursos sanitarios y no sanitarios, y sus costes respectivos, en pacientes con neuralgia postherpética (NPH). Pacientes y métodos. Se efectuó un estudio observacional, realizado a partir de la revisión retrospectiva de registros de pacientes de seis centros de atención primaria y un hospital. Se incluyeron todos los pacientes mayores de 30 años que demandaron atención por NPH entre el 1 de enero de 2007 y el 31 de diciembre de 2010. Se elaboraron dos grupos de estudio según la presencia/ausencia de NPH. El seguimiento fue durante un año, y las principales medidas fueron sociodemográficas, tratamientos y comorbilidad. El modelo de costes diferenció los costes sanitarios directos (atención primaria/ especializada) e indirectos (productividad laboral). Se realizó un análisis estadístico con modelos de regresión logística y análisis de la covarianza (p < 0,05). Resultados. Se reclutaron 1.506 pacientes, con una edad media de 61,2 años, de los cuales el 59,2% eran mujeres. El 15,1% (n = 228; intervalo de confianza al 95%, IC 95% = 8,1-22,1%) presentó NPH (tasa de incidencia: 0,8/1.000 habitantes/ año; IC 95% = 0,7-0,9/1.000 habitantes/año) y el porcentaje aumentó con la edad (≥ 65 años: 19,7%). La NPH se asoció principalmente a psicosis (odds ratio, OR = 3,9), demencia (OR = 2,3), depresión (OR = 1,8) y edad (OR = 1,1); p < 0,03. El uso de medicamentos fue superior (5,3 frente a 3,3; p < 0,001). El coste en atención primaria fue del 63,1% y los costes indirectos del 24,7%. Los costes totales fueron de 1.827,1 frente a 457,5 euros (p = 0,003), respectivamente, debido a mayores pérdidas de productividad laboral (692,2 frente a 62,4 euros) y costes sanitarios (1.135 frente a 395,1 euros; p < 0,001). Todos los componentes del coste mantuvieron estas diferencias. Conclusiones. La NPH es una complicación frecuente. Estos pacientes presentan una importante carga económica y el coste aumenta con la edad (AU)

Aim. To determine the incidence rate, the treatment administered and the use of health resources and health, and their respective costs in patients with postherpetic neuralgia (PHN). Patients and methods. We performed an observational design, made from retrospective review of patient records from six primary care centers and one hospital. All patients > 30 years consulting for PHN between 1/1/2007 and 31/12/2010 were included. Prepared two study groups according to presence / absence of PHN. Follow up was for one year. Main measures: socio-demographic, treatment and co-morbidity. The cost model differed direct healthcare costs (primary care/ specialist) and indirect (productivity). Statistical analysis: logistic regression models and analysis of covariance (p < 0.05). Results. 1506 patients were recruited, age: 61.2 years female: 59.2%. 15.1% (n = 228, 95% CI = 8.1-22.1%) had a PHN (incidence rate: 0.8/1,000 inhabitants/year; 95% CI = 0.7-0.9/1,000 population/year), and increased with age (≥ 65 years:19.7%). The PHN was principally associated with: psychosis (OR = 3.9), dementia (OR = 2.3), depression (OR = 1.8) and age (OR = 1.1), p < 0.03. Drugs use was higher (5.3 vs. 3.3; p < 0.001). The cost in primary care was 63.1% and 24.7% indirect. Total cost €1827.1 vs. €457.5 (p = 0.003), respectively, due to higher labour productivity losses (€692.2 vs. €62.4) and health costs (€1135 vs. €395.1); p < 0.001. All cost components maintained these differences. Conclusions. PHN is a frequent complication. These patients have a significant economic burden. The cost increases with age (AU)

Healthcare use and costs associated with obesity in Badalona, Spain: a study protocol.

Introduction The objectives of the study are twofold. First, to calculate healthcare resource utilisation and costs for a cohort of adult overweight and obese patients observed in primary and hospital care centres during eight consecutive years (2003-2010) in an urban setting in Spain. An analysis of whether these costs vary by groups of individuals and types of disease, and of how they compare with the previous literature, is carried out in order to predict actions or policies for resource optimisation. The second objective is to estimate the impact of overweight and obesity on the consumption of resources and costs, accounting for a wide array of controls. Methods and analysis Observational and retrospective cohort data are used, consisting of medical records of patients followed up in outpatient and hospital care facilities during the years 2003-2010. Three cohorts of patients are analysed: normal weight (18.5≥ body mass index (BMI) <25), overweight (25≥ BMI <30) and obese (BMI ≥30); BMI is computed using clinical information. Individual-level data on comorbidity, resource utilisation and costs are available, and external information provided by the population census regarding socioeconomic status is used. Utilisation and associated costs across BMI groups are compared by computing ratios for overweight and obese individuals relative to those of normal weight. Count data regression models (hurdle and finite mixture models) are used, together with two-part model regression models and taking into account the panel structure of the data set to explore the impact of overweight and obesity on the increased utilisation of health services and costs, accounting for a wide set of controls.

Endovascular treatment of a haemodynamically unstable massive pulmonary embolism using fibrinolysis and fragmentation. Experience with 111 patients in a single centre. Why don't we follow ACCP recommendations?

INTRODUCTION: Fibrinolysis is recommended in several consensus documents for the treatment of a haemodynamically unstable massive pulmonary embolism (HUMPE). MATERIAL AND METHODS: A total of 111 patients were treated in a single centre from January 2001 to December 2009. They were 55 males and 56 females diagnosed with HUMPE (systolic arterial pressure>90 mmHg) with at least two of the following criteria: Miller index>0, ventricular dysfunction, and need of vasoactive drugs. Local fibrinolysis with urokinase was performed in all cases, and fragmentation with a pig-tail catheter in the majority of them. An inferior vena cava (IVC) filter was implanted in 94 patients as a prophylactic measure. RESULTS: Technical success was 100%. The Miller index improved from 0.7 ± 0.12, pre-treatment, to 0.09 ± 0.16. The mean pulmonary arterial pressure fell from 39.93 ± 7.0 mmHg to 20.47 ± 3.3 mmHg in the 30-90 days review. Of the 94 patients with IVC filters implanted, 79% were withdrawn satisfactorily. Seven patients died: 3 due to their neoplasia, 3 due to right cardiac failure at 1, 7 and 30 days, and another died of a brain haemorrhage in the first 24 hours. There were complications in 12.6% of the cases, of which 4.5% were major. CONCLUSION: Local fibrinolysis with fragmentation achieves a rapid return to normal of the pulmonary pressure and is a safe and effective method for the treatment of HUMPE.

Tratamiento endovascular mediante fibrinolisis y fragmentación del embolismo pulmonar masivo con inestabilidad hemodinámica. Experiencia de un solo centro en 111 pacientes. ¿Por qué no seguimos las recomendaciones de la ACCP? / Endovascular Treatment of a Haemodynamically Unstable Massive Pulmonary Embolism using Fibrinolysis and Fragmentation. Experience with 111 Patients in a Single Centre. Why don’t we follow ACCP Recommendations?

IntroducciónLa fibrinolisis está recomendada en los diferentes consensos para el tratamiento del embolismo pulmonar masivo hemodinámicamente inestable (EPmHI).Material y métodosEn un solo centro desde enero de 2001 hasta diciembre de 2009 se han tratado 111 pacientes (55 hombres y 56 mujeres) diagnosticados de EPmHI (presión arterial sistólica<90 mmHg) con al menos dos de los siguientes criterios: índice de Miller > 0, disfunción ventricular y necesidad de drogas vasoactivas. En todos los casos se realizó fibrinolisis local con uroquinasa y en la mayoría fragmentación con catéter pig-tail. Se implantó un filtro de vena cava inferior (VCI) en 94 pacientes como medida profiláctica.ResultadosEl éxito técnico fue del 100%. El índice de Miller mejoró de 0,7±0,12 pre-tratamiento a 0,09±0,16. La presión arterial pulmonar media pasó de 39,93±7,0 mmHg a 20,47±3,3 mmHg en el control de 30-90 días. A 94 pacientes se les implantó un filtro de VCI que se pudo retirar en el 79% de forma satisfactoria. Siete pacientes fallecieron: 3 en el curso de su neoplasia, 3 por insuficiencia cardíaca derecha a 1, 7 y 30 días y otro falleció de hemorragia cerebral en las primeras 24 horas. Hubo complicaciones en el 12,6% de los casos, de las que 4,5% fuer mayor.ConclusiónLa fibrinolisis local con fragmentación consigue la normalización rápida de la presión pulmonar y constituye un método seguro y eficaz para el tratamiento del EPmHI(AU)

IntroductionFibrinolysis is recommended in several consensus documents for the treatment of a haemodynamically unstable massive pulmonary embolism (HUMPE).Material and methodsA total of 111 patients were treated in a single centre from January 2001 to December 2009. They were 55 males and 56 females diagnosed with HUMPE (systolic arterial pressure>90 mmHg) with at least two of the following criteria: Miller index>0, ventricular dysfunction, and need of vasoactive drugs. Local fibrinolysis with urokinase was performed in all cases, and fragmentation with a pig-tail catheter in the majority of them. An inferior vena cava (IVC) filter was implanted in 94 patients as a prophylactic measure.ResultsTechnical success was 100%. The Miller index improved from 0.7±0.12, pre-treatment, to 0.09±0.16. The mean pulmonary arterial pressure fell from 39.93±7.0 mmHg to 20.47±3.3 mmHg in the 30-90 days review. Of the 94 patients with IVC filters implanted, 79% were withdrawn satisfactorily. Seven patients died: 3 due to their neoplasia, 3 due to right cardiac failure at 1, 7 and 30 days, and another died of a brain haemorrhage in the first 24hours. There were complications in 12.6% of the cases, of which 4.5% were major.ConclusionLocal fibrinolysis with fragmentation achieves a rapid return to normal of the pulmonary pressure and is a safe and effective method for the treatment of HUMPE(AU)

[Image-guided minimally invasive treatment of pulmonary arterial hypertension due to embolic disease]. / Tratamiento de la hipertensión arterial pulmonar postembólica mediante técnicas mínimamente invasivas guiadas por imagen.

OBJECTIVE: Although surgical pulmonary thromboendarterectomy is the treatment of choice for pulmonary hypertension due to chronic thrombotic and/or embolic disease, minimally invasive endovascular techniques such as angioplasty or placement of a metallic stent can provide acceptable results when surgery is not indicated or has been refused by the patient. PATIENTS AND METHODS: Eight patients (5 men, 3 women; mean age, 62.6 years) were treated. The patients were in New York Heart Association (NYHA) class III or IV and had a mean pulmonary artery pressure of 40 mm Hg and more, a capillary wedge pressure of 15 mm Hg or less, or a Miller index greater than 0.5. In all cases, diagnosis was based on Doppler echocardiography, pulmonary angiography, hemodynamic evaluation, and ventilation-perfusion scintigraphy. All patients received fibrinolytic therapy and underwent angioplasty. A metallic stent was implanted in 3 patients. Follow-up echocardiographic assessment and ventilation-perfusion scans were scheduled at 1, 3, 6, and 12 months. RESULTS: The procedures were technically successful in all cases. The mean follow-up period was 18.7 months. Minor complications were extrasystoles (3 cases), slight bruising at the site of puncture (1 case), and rectal bleeding that resolved without treatment (1 case). One patient died from an unknown cause 24 hours after the procedure. In all other cases, improvements were noted in NYHA functional class, in hemodynamics demonstrated by echocardiography, and in vascular structure as shown by arteriography and scintigraphy. CONCLUSIONS: Minimally invasive endovascular interventions can help improve pulmonary arterial hypertension due to chronic thrombotic and/or embolic disease in patients for whom medical or surgical treatment is not possible.

Tratamiento de la hipertensión arterial pulmonar postembólica mediante técnicas mínimamente invasivas guiadas por imagen / Image-guided minimally invasive treatment of pulmonary arterial hypertension due to embolic disease

OBJETIVO: Aunque la tromboendarterectomía pulmonar quirúrgica es el tratamiento de elección en la hipertensión arterial crónica de origen tromboembólico, cuando no hay indicación quirúrgica o el paciente rechaza la cirugía se puede recurrir a técnicas endovasculares de mínima invasión (angioplastia y prótesis metálica) con aceptables resultados. PACIENTES Y MÉTODOS: Se trató a 8 pacientes (5 varones y 3 mujeres) con una media de edad de 62,6 años, en clase III o IV de la clasificación de la New York Heart Association (NYHA), con presión arterial pulmonar media de 40 mmHg o superior, presión capilar enclavada de 15 mmHg o menor e índice de Miller mayor de 0,5. En todos los casos el diagnóstico se estableció por ecografía Doppler cardíaca, angiografía pulmonar, estudio hemodinámico y gammagrafía de ventilación-perfusión. Se realizó tratamiento fibrinolítico seguido de angioplastia en todos los casos, y se colocó una prótesis metálica en 3. Se realizaron revisiones clínicas al cabo de 1; 3; 6, y 12 meses mediante ecografía y gammagrafía. RESULTADOS: El éxito técnico del procedimiento fue del 100%. El seguimiento medio fue de 18,7 meses. Como complicaciones menores se produjeron extrasístoles en 3 casos; hematoma leve en la zona de punción en un caso, y rectorragia, que remitió sin tratamiento, en otro. Una paciente murió por causa desconocida al cabo de 24 h. En todos los casos revisados se observaron una mejoría en la clasificación de la NYHA, mejora hemodinámica evidenciada por ecografía y mejora morfológica objetivada por arteriografía y gammagrafía. CONCLUSIONES: Las técnicas endovasculares de mínima invasión pueden contribuir a mejorar la hipertensión arterial pulmonar crónica debida a tromboembolia en la que no es posible otro tratamiento (farmacológico o quirúrgico)

OBJECTIVE: Although surgical pulmonary thromboendarterectomy is the treatment of choice for pulmonary hypertension due to chronic thrombotic and/or embolic disease, minimally invasive endovascular techniques such as angioplasty or placement of a metallic stent can provide acceptable results when surgery is not indicated or has been refused by the patient. PATIENTS AND METHODS: Eight patients (5 men, 3 women; mean age, 62.6 years) were treated. The patients were in New York Heart Association (NYHA) class III or IV and had a mean pulmonary artery pressure of 40 mm Hg and more, a capillary wedge pressure of 15 mm Hg or less, or a Miller index greater than 0.5. In all cases, diagnosis was based on Doppler echocardiography, pulmonary angiography, hemodynamic evaluation, and ventilation-perfusion scintigraphy. All patients received fibrinolytic therapy and underwent angioplasty. A metallic stent was implanted in 3 patients. Follow-up echocardiographic assessment and ventilation-perfusion scans were scheduled at 1, 3, 6, and 12 months. RESULTS: The procedures were technically successful in all cases. The mean follow-up period was 18.7 months. Minor complications were extrasystoles (3 cases), slight bruising at the site of puncture (1 case), and rectal bleeding that resolved without treatment (1 case). One patient died from an unknown cause 24 hours after the procedure. In all other cases, improvements were noted in NYHA functional class, in hemodynamics demonstrated by echocardiography, and in vascular structure as shown by arteriography and scintigraphy. CONCLUSIONS: Minimally invasive endovascular interventions can help improve pulmonary arterial hypertension due to chronic thrombotic and/or embolic disease in patients for whom medical or surgical treatment is not possible

Retrieval of Gunther Tulip optional vena cava filters 30 days after implantation: a prospective clinical study.

PURPOSE: To report on the feasibility and safety of retrieval of the Günther Tulip optional vena cava filter 30 days after initial implantation. MATERIALS AND METHODS: From March 2004 to September 2005, a single-center prospective study was undertaken in 35 patients who required inferior vena cava (IVC) filtration. All the Günther Tulip filters (GTFs) were implanted with the intention to be removed 30 days after initial implantation. A modified commercial dynamometer was used to measure the force required to remove the device. The degree of difficulty to remove the GTF was classified into four levels: N (no difficulty, force of 0-4.41 N), M (medium difficulty, force of 4.41-5.88 N), G (great difficulty, force of 5.88-9.8 N), and U (unable to remove). Clinical follow-up was performed 1, 3, 6, and 12 months after filter retrieval by review of medical records and imaging. RESULTS: Two of the 35 patients experienced extensive thrombosis in the IVC as revealed by abdominal computed tomography, and their filters were left in place on a permanent basis. One patient died of respiratory and cardiac failure during follow-up within the first 30 days after GTF insertion. Filter retrieval was attempted in the remaining 32 patients, and 31 of these attempts were successful (98%). The force necessary to disengage the GTF from the caval wall was less than 9.8 N (N, 79%; M, 13%; G, 6%). Attempts to remove the GTF failed in only one patient (2%). On follow-up times ranging between 14 and 640 days (mean, 342.5 d), no complications or cases of recurrent pulmonary embolism were observed in this patient population. CONCLUSION: The Günther Tulip optional IVC filter can be safely placed and retrieved percutaneously 30 days after initial implantation.

Colon stenting: a review.

Up to 85% of patients who present with colonic obstruction have a colorectal cancer. Between 7% and 29% of these patients present with total or partial intestinal obstruction. Only 20% of these patients presenting with acute colonic obstruction due to malignancy survive 5 years. Emergent surgical intervention in patients with colonic obstruction is associated with significant morbidity and mortality rates. Only 40% of patients with obstructive carcinoma of the left colon can be treated with surgical resection without the need for a colostomy. The use of a temporary or permanent colostomy has a significant impact on quality of life. The decompressive effect seen with colonic stenting is a durable, simple, and effective palliative treatment of patients with advanced disease. Stent deployment provides an effective solution to acute colonic obstruction and allows surgical treatment of the patient in an elective and more favorable condition. In addition, colonic stenting reduces costs and avoids the need for a colostomy.

The Günther Tulip retrievable filter: prolonged temporary filtration by repositioning within the inferior vena cava.

PURPOSE: To report experience with the retrievable Günther Tulip filter (GTF) as a means of temporary caval filtration for the prevention of pulmonary embolism (PE) with use of a technique that prolongs filter dwell time beyond 14 days. MATERIALS AND METHODS: Eighty-eight GTFs were implanted in 87 patients. The GTFs were placed with the intention of retrieval in all patients within 14 days after initial implantation. In 23 of the 87 patients (26%), there was a need to prolong temporary caval filtration beyond the recommended period of 14 days. This was successfully achieved with use of percutaneous techniques from the right internal jugular vein whereby the filter was repositioned to a different location within the inferior vena cava (IVC) before definitive device removal. RESULTS: Of 88 GTFs implanted in 87 patients, 70 were successfully retrieved and 18 were left in place permanently. Forty-seven filters in 46 patients were removed after initial implantation with no need for percutaneous repositioning within the IVC to prolong dwell time (mean dwell time, 13 days). In the 23 patients who required repositioning of 23 GTFs within the IVC to prolong temporary caval filtration, the mean dwell time was 34.8 days; the mean number of repositioning procedures was 1.5, the mean time between repositioning procedures was 13.8 days, and the mean fluoroscopy time was 4.4 minutes in patients in whom filter retrieval was attempted. One patient underwent placement and subsequent removal of the GTF twice for perioperative prophylaxis against PE on two separate occasions. No filters were misplaced in an unintended location or tilted (>15 degrees ) in relation to the main caval axis after deployment. In one patient, a GTF became permanently fixed in the IVC 16 days after initial implantation and could not be removed percutaneously. Nine patients had mild or moderate-sized cervical hematomas. One patient had recurrent asymptomatic PE 2 months after filter insertion. CONCLUSION: Dwell times of 14 days can be achieved in most patients before device removal. Prolongation of the dwell time beyond 14 days can be safely and easily achieved by performing percutaneous repositioning of the device within the IVC via a jugular approach.

Percutaneous treatment of superior vena cava syndrome using metallic stents.

The purpose of this study was to evaluate the results of treatment of superior vena cava syndrome (SVCS) in patients with benign and malignant disease using expandable metallic stent. From January 1995 to April 2000, 87 expandable stents were implanted in 82 patients (59 men, 23 women; mean age 57.8 years, age range 39-79 years) for the treatment of SVCS. The SVCS was defined as symptomatic bilateral obstruction of venous drainage from head, neck and upper extremities. In 68 patients SVCS was due to malignant neoplasia, and in 14 cases it was due to benign aetiology. All patients were treated with expandable stent. We implanted 81 Wallstent prostheses and 6 Palmaz stents. Adjuvant thrombolysis was applied in 12 patients who required fibrinolysis. After recanalization, the stent was implanted in all cases in SVC (infra- or supra-azygos vein). All patients were treated with heparin of low molecular weight (HBPM) during 6 months. Patency was analyzed according to clinical symptoms and Doppler US or venograms exploration. Technical success was observed in all cases. Clinical success was reached in 78 of 82 patients (95.1%) (absence of symptoms in 2 or 3 days). Four patients suffered immediate thrombosis which required fibrinolitic treatment with a new prosthesis placement in 1 case. The follow-up for the malignant process was of 7.1 months (range 1-39 months) and in benign cases was 31.2 months (range 11-61 months). Sixty-two (91.1%) patients with malignancy died without SVCS symptomatology. All the patients with benign pathology are alive. Clinical primary patency in malignant cases was 87% with assisted patency of 96.2%. Endovascular therapy using metallic stent and thrombolysis is a successful method to treat SVCS due to benign or malignant aetiology.

Use of an introducer sheath for colonic stent placement.

We describe a technical modification of Wallstent implantation for the treatment of malignant rectosigmoid and descending colonic obstructions. The modification is the routine placement of an introducer sheath via the rectum before stent implantation in order to straighten the rectosigmoid region. This device facilitates catheter and guide wire manipulations and obtaining specimen biopsies for histopathological studies. The introducer sheath has been used without complications in 21 consecutive patients.

Rotura de endoprótesis biliares metálicas autoexpansibles: cuatro casos / Metallic self expanding endoprosthesis breaking: 4 cases

Se presenta un tipo de complicación tardía muy infrecuente en las prótesis biliares. Son cuatro casos de rotura de prótesis metálicas autoexpansibles de nitinol (Mermotherm, Angiomed, Bard, Paris). Los cuatro pacientes padecían obstrucción biliar maligna no susceptible de tratamiento quirúrgico. Todos fueros tratados con drenaje biliar percutáneo seguido de endoprótesis. Después de un periodo variable de buen funcionamiento se comprobó la rotura de las prótesis en todos ellos. Dos cursaron con reobstrucción biliar, uno permaneció asintomático y en el otro los fragmentos emigraron al duodeno y fueron expulsados. En tres pacientes se colocó una nueva prótesis con buen resultado (AU)