Análisis de la eficacia y la seguridad de distintos balones liberadores de paclitaxel en un modelo animal

Introduction and objectives

Paclitaxel-eluting balloons have shown high antiproliferative efficacy in the treatment and prevention of restenosis. Nevertheless, not all available devices are equally effective, which makes it interesting to compare results in a preclinical model. Our objective was to assess the preclinical efficacy and safety of different devices.

Methods

We implanted 51 metallic stents (Architect^®, iVascular) in 17 domestic swine (mean, 25 [3] kg), inserting 1 stent per major coronary artery. Stent postdilatation was performed with different control balloons (n = 10) or paclitaxel-eluting balloons: paclitaxel-eluting balloon 1 (iVascular) (n = 15); paclitaxel-eluting balloon 2 (iVascular) (n = 16) and In.Pact Falcon^® (Medtronic) (n = 10). The restenosis rate (using angiography and histomorphometry) and vascular healing parameters (balloon-related vascular injury score, endothelialization rate, and fibrin and inflammation scores) were analyzed at 28 days.

Results

The distinct paclitaxel-eluting balloons showed a similar degree of stenosis at follow-up, which was significantly lower than that in the control group: diameter stenosis was 9% (12%) vs 34% (18%) by angiography (P < .0001) and was 22% (8%) vs 51% (18%) by histomorphometry (P < .0001). Scores for vascular injury (mean, 0.6 [0.5]) and inflammation (mean, 0.8 [0.3]) were uniformly low across all groups. Drug effect markers differed significantly between the paclitaxel-eluting balloons and control groups, with lower endothelialization rates (87% [10%] vs 99% [2%]; P = .0007) and higher fibrin scores (2.1 [0.7] vs 0.4 [0.5]; P < .0001) in the paclitaxel-eluting balloons groups. There were no differences between the different paclitaxel-eluting balloons.

Conclusions

In this preclinical model, the paclitaxel-eluting balloons studied significantly reduced in-stent restenosis compared with the control balloons. Although there were no findings of persistent vascular injury or inflammation, delayed endothelialization and fibrin aggregate suggest a drug deposition response.Full English text available from:www.revespcardiol.org/en     

Características de los pacientes con infección crónica por el virus de la hepatitis B. Análisis de una serie de 474 pacientes

Objective

To determine the clinical, laboratory, serological and histologic characteristics of chronic hepatitis B virus carriers in our environment.

Material and methods

A retrospective cohort study was performed that included chronic AgHBs carriers aged more than 13 years attending our service since January 2000.

Results

A total of 474 patients were included. At diagnosis, 55.49% were men, with a mean age of 41.05±13.93 years. Alanine aminotransferase (ALT) levels were within the normal range in 57.17% of the patients, and 87.76% were AgHBe(−). Hepatitis C and D virus coinfection was found in 3.62% and 1.86%, respectively. Liver biopsy was performed in 31.22%; varying grades of inflammation-fibrosis were found in 63.51% and cirrhosis was found in 12.84%. Compared with AgHBe(−) patients, those who were AgHBe(+) were younger and had greater disease activity. This difference was statistically significant. Patients in the immunotolerant phase were the least numerous (5.26%), while AgHBe(−) patients with chronic HBV infection were the most numerous (48.32%). Patients in the immunoreactive phase showed greater histological involvement (16.67% cirrhosis). A familial history of chronic HBV was found in 21.52%. The percentage of non-Spanish patients increased in the last few years and accounted for 18.78%.

Conclusion

Chronic HBV infection in our environment occurs mainly in middle-aged persons. GPT values are normal in more than 50%, most are AgHBe(−), and approximately half are inactive carriers. The incidence of chronic infection has increased in the non-Spanish population in recent years.     

Asociación entre adiposidad corporal y presión arterial entre los 6 y los 16 años. Análisis en una población escolar madrileña

Introduction and objectives

The increase in the incidence of hypertension in children can be attributed to the rising prevalence of obesity. The objective is to analyze the impact of overweight and the degree or distribution of adiposity on blood pressure levels in a population of Spanish schoolchildren.

Methods

A cross-sectional study was carried out in 1511 schoolchildren between 6 years and 16 years of age. We measured weight, height, waist circumference, subcutaneous skinfolds, and blood pressure. Nutritional categories were established on the basis of body mass index, waist-to-height ratio, and percent body fat. According to the National High Blood Pressure Education Program Working Group, subjects whose blood pressure was above the 90th percentile of the standard normal distribution were considered to have high blood pressure.

Results

In all, 3.17% of the boys and 3.05% of the girls had high blood pressure. According to odds ratio analysis, the risk of high blood pressure increased in individuals with a body mass index indicative of obesity (7.87-fold in boys, 12.32-fold in girls), with a percent body fat>97th percentile (6.98-fold in boys, 18.51-fold in girls), or with a waist-to-height ratio≥0.5 (10.56-fold in boys, 7.82-fold in girls).

Conclusions

Overweight and obesity increase the risk of high blood pressure in children between 6 years and 16 years of age, although the risk level varies depending on the amount and distribution of adipose tissue. Anthropometric indicators of relative adiposity and fat distribution are especially useful in the identification of children and adolescents with high blood pressure.Full English text available from:www.revespcardiol.org/en     

Análisis transversal de la resincronización cardiaca en España. Indicaciones,técnicas de implante,optimización y seguimiento

Introduction and objectives

A cross-sectional study of cardiac resynchronization therapy use in Spain was performed to analyze problems with indications, implantation, and patient follow-up.

Methods

Spanish cardiac resynchronization therapy implanter centers were identified, then the department members were surveyed and the data were recorded by each implantation team.

Results

Eighty-eight implanter centers were identified; of these, 85 (96.6%) answered the survey. A total of 2147 device implantations were reported, comprising 85.6% of the overall number of 2518 implantations estimated by the European Confederation of Medical Suppliers Associations for the same period. The reported implantation rate was 46 per million inhabitants versus an estimated implantation rate of 51 per million (European average, 131). Cardiac resynchronization therapy devices accounted for 84% of implantations, and upgrades to previously implanted devices, 16%. The majority of cardiac resynchronization therapy devices were implanted in men (70.7%). The mean age was 68 (12) years, and the mean left ventricular ejection fraction was 26.4% (5%). Most patients (67%) were in New York Heart Association functional class III. The group of patients for whom cardiac resynchronization therapy was indicated according to the latest update of the guidelines was significant: 17.3% among New York Heart Association class II patients and more than 21.6% among patients with atrial fibrillation. In all, electrophysiologists accounted for 73.8% of implanters, followed by surgeons, accounting for 21.4%.

Conclusions

The latest update of the guidelines is being progressively implemented in Spain, according to data obtained in patients in New York Heart Association class II or with atrial fibrillation. Nevertheless, the number of cardiac resynchronization therapy device implants is still well below the European average.Full English text available from:www.revespcardiol.org     

Inflamación y apoptosis en la hipertensión arterial. Importancia de la extensión de la lesión de órgano diana

Introduction and objectives

To investigate the relationship between inflammatory and apoptotic parameters and the severity and extent of target organ damage in patients with essential hypertension.

Methods

We studied 159 consecutive patients with treated essential hypertension. An exhaustive evaluation of damage to heart, kidney, and blood vessels was performed and plasma levels of inflammatory (interleukin 6 and soluble receptor of tumor necrosis factor-alpha type 2) and apoptotic markers (soluble receptor of tumor necrosis factor-alpha type 1 and soluble Fas receptor) were determined. Patients were categorized into four groups: a) no organ damage (33 patients); b) 1 organ damaged (52 patients); c) 2 organs damaged (44 patients), and d) 3 organs damaged (30 patients).

Results

Serum levels of interleukin 6, soluble receptor of tumor necrosis factor-alpha type 1 and soluble receptor of tumor necrosis factor-alpha type 2 were higher in patients with target organ damage than in hypertensive patients without organ damage. Increasing levels of these molecules were progressively associated with an increase in the number of organs damaged, and the highest levels were observed in the group with damage to 3 organs (heart, kidney, and blood vessels). There were no differences in soluble Fas receptor levels between groups. Logistic regression analysis showed that age, smoking, diabetes mellitus, abdominal circumference, interleukin 6, and soluble receptor of tumor necrosis factor-alpha type 1 were independently related to the number of target organs damaged.

Conclusions

Extensive hypertensive disease with involvement of more target organs was associated with greater inflammatory and apoptotic activation in these hypertensive patients.Full English text available from:www.revespcardiol.org     

Divertículo de Meckel y enterolitos como complicación de la enfermedad de Crohn

We describe the case of a 43-year-old man recently diagnosed with ileal Crohn's disease complicated by a free peritoneal perforation of a Meckel's diverticulum and the presence of enteroliths in the intestinal lumen. The coexistence of Crohńs disease, Meckel's diverticulum and enteroliths has rarely been reported. Meckel's diverticulum can hamper the management of Crohn's disease.     

Análisis coste-efectividad de dabigatrán para la prevención de ictus y embolia sistémica en fibrilación auricular no valvular en España

Introduction and objectives

Assessment of the cost-effectiveness of dabigatran for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation in Spain, from the perspective of the National Health System.

Methods

Adaptation of a Markov chain model that simulates the natural history of the disease over the lifetime of a cohort of 10 000 patients with non-valvular atrial fibrillation. Model comparators were warfarin in a first scenario, and a real world prescribing pattern in a second scenario, in which 60% of the patients were treated with vitamin K antagonists, 30% with acetylsalicylic acid, and 10% received no treatment. Deterministic and probabilistic sensitivity analyses were performed.

Results

Dabigatran reduced the occurrence of clinical events in both scenarios, providing gains in quantity and quality of life. The incremental cost-effectiveness ratio for dabigatran compared to warfarin was 17 581 euros/quality-adjusted life year gained and 14 118 euros/quality-adjusted life year gained when compared to the real world prescribing pattern. Efficiency in subgroups was demonstrated. When the social costs were incorporated into the analysis, dabigatran was found to be a dominant strategy (ie, more effective and less costly). The model proved to be robust.

Conclusions

From the perspective of the Spanish National Health System, dabigatran is an efficient strategy for the prevention of stroke in patients with non-valvular atrial fibrillation compared to warfarin and to the real-world prescribing pattern; incremental cost-effectiveness ratios were below the 30 000 euros/quality-adjusted life year threshold in both scenarios. Dabigatran would also be a dominant strategy from the societal perspective, providing society with a more effective therapy at a lower cost compared to the other 2 alternatives.Full English text available from:www.revespcardiol.org     

Valores pretratamiento e inducidos por el tratamiento de enolasa específica de neurona en pacientes con cáncer de pulmón microcítico: estudio prospectivo,abierto

Background

Neuron-specific enolase (NSE) is the most sensitive tumor marker for small-cell lung carcinoma (SCLC) at the time of diagnosis. The main purpose of this study was to review the usefulness of serum NSE level as a prognostic factor in patients with SCLC and to determine the correlation between the NSE level and the stage of disease and response to chemotherapy.

Methods

In this prospective study, patients with SCLC were evaluated for response to chemotherapy, survival without disease progression, and overall survival. The end point was designated at patient death due to SCLC. NSE assays were performed before and after completion of chemotherapy.

Results

Sixty-five patients were included in study. NSE levels were significantly higher in patients who died of SCLC. The pre-treatment NSE levels in patients who responded to treatment were significantly lower. The post-treatment NSE levels were not significantly correlated with response to chemotherapy, progression-free survival, overall survival, and prognosis of patients. Change in the NSE level between the pre- and post-treatment periods was not significantly correlated with response to treatment, progression-free survival, and overall survival.

Conclusions

NSE levels might not be related with the stage of the disease. However, a low pre-treatment NSE level might be used in predicting good response to chemotherapy in patients with SCLC. The post-treatment serum NSE levels and the rate of change between pre- and post-treatment serum levels of NSE were not related with response to chemotherapy, progression-free survival, and overall survival.     

Efecto de la fluticasona inhalada sobre la inflamación pulmonar administrada durante y después de la sensibilización de cobayas

Objective

The effect of an inhaled corticosteroid, fluticasone propionate (FP) lung inflammation of sensitized guinea pig was examined.

Material and methods

Four groups of guinea pigs (n=8) were sensitized (S) with ovalbumin (OA). Control group was given similar solutions without OA. One S group was treated with inhaled 250 μg inhaled FP twice/day during, other group after sensitization for 18 days and two groups were treated with placebo, one during, and the other after sensitization. One day after the last treatment, tracheal responses of all animal groups to methacholine and OA were examined. Total and differential white blood cell (WBC) counts of lung lavage and lung pathology were also examined.

Results

Tracheal responsiveness to both methacholine and OA and WBC of both placebo groups were significantly higher than those of control group (P<0.001 for all cases). The lungs of placebo groups showed variable pathological changes (non significant to P<0.001) compared to control group. Tracheal responsiveness in two treated groups with FP to both methacholine and OA were significantly decreased compared to placebo groups (P<0.01 to P<0.001). Treatment with FP leads to improvement in total (P<0.001) and differential WBC counts (non significant to P<0.001) as well as mucosal detachment (P<0.001), but not other pathological changes.

Conclusions

These results showed a protective effect of FP on tracheal responsiveness and lung inflammation. In addition, this study showed that treatment with inhaled fluticasone propionate, during sensitization (development of inflammation and pathological changes) was more effective than after sensitization (establishment of inflammation and pathological changes).