Aspectos éticos de los congresos y reuniones de invierno conjuntas de las áreas de la Sociedad Española de Neumología y Cirugía Torácica

The pharmaceutical industry contributes to the development of new drugs, provides funding for research and collaborates in continuing medical education. Although this relationship with medical practice is beneficial and desirable, commercial interests could potentially eclipse patient benefits and compromise professional integrity. Congresses and meetings of the Spanish Society of Pneumology and Thoracic Surgery (SEPAR) agglutinate different spheres of knowledge, including aspects such as bioethics, management and communication, always centered on patient and their well-being. SEPAR congresses and meetings should provide sufficient economic benefits to be reinvested in research and other purposes which are reflected in SEPAR statutes in order to ensure the solvency, sustainability and economic independence of the Society. SEPAR has developed strict regulations governing the sponsorship and accreditation of training activities while striving for a balance between the interests of the industry and its own necessary independence, which results from the constant concern for maintaining good medical practice and complying with ethical aspects. This regulation is useful from an organizational and logistical standpoint, and it is necessary to prevent or resolve any possible conflicts of interest. Scientific societies should regulate common practices that could potentially result in conflicts of interest.     

Registro Español de Marcapasos. IX Informe Oficial de la Sección de Estimulación Cardiaca de la Sociedad Española de Cardiología (2011)

Introduction and objectives

To describe the results of the analysis of pacemaker implantations reported to the Spanish Pacemaker Registry in 2011, with particular reference to the population distribution and the selection of pacing modes.

Methods

Information provided by the European Pacemaker Patient Identification Card was processed using a purpose-built computer application.

Results

Data from 115 hospitals were analyzed, totaling 13 373 cards, representing an estimated 38% of implantations. The number of pacemaker generators and resynchronization devices implanted was 738 and 56.2 units per million population, respectively. The mean age of the patients who received a device was 76.7 years. Overall, 57.2% of first implantations and 56.5% of replacements were performed in men. Most implantations (38.7%) and generator replacements (41.9%) were performed in patients aged between 80 and 89 years. Of the pacemaker leads used, 99.7% were bipolar and 63% used an active fixation system. Overall, 20% of the patients with atrioventricular block or sick sinus syndrome were paced in VVI/R mode despite being in sinus rhythm.

Conclusions

With respect to previous years, the use of conventional pacemakers remained stable and the implantation of resynchronization devices has increased. The number of implantation procedures continues to be higher in men and in younger patients. Age and the degree of blockage remain as factors influencing the appropriate choice of pacing mode.Full English text available from: www.revespcardiol.org     

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     

Efecto en los resultados de la intervención y los resultados clínicos a largo plazo de la predilatación de la rama lateral para lesiones coronarias en bifurcación tratadas con la técnica de stent condicional

Introduction and objectives

It is uncertain whether side branch predilatation before main vessel stenting is necessary. We evaluated the effect of side branch predilatation on outcomes in percutaneous coronary intervention for true nonleft main bifurcation determined by the Medina classification using the provisional approach.

Methods

Target vessel failures (composite of cardiac death, myocardial infarction, or target vessel revascularization) were compared between patients who underwent side branch predilatation (predilatation group, n = 175) and those who did not (nonpredilatation group, n = 662).

Results

Final kissing-balloon inflation (57.1% vs 35.8%; P < .001) was performed more frequently and the cross-over rate to a 2-stent technique (14.9% vs 5.1%; P < .001) was higher in the predilatation group. During a median follow-up of 21 months, the predilatation group had a higher incidence of target vessel failures (14.3% vs 6.8%; P = .002) and target vessel revascularization (12.0% vs 5.6%; P = .003), but not of cardiac death or myocardial infarction compared with the nonpredilatation group. On multivariate analysis, side branch predilatation was associated with a higher occurrence of target vessel failures (adjusted hazard ratio = 2.11; 95% confidence interval, 1.27-3.50; P = .004). These results remained consistent after a propensity score-matched population analysis (for target vessel failures, adjusted hazard ratio = 2.63; 95% confidence interval, 1.09-6.34; P = .0031) and they were also constant among the various subgroups, according to the bifurcation angle, calcification, and diameter stenosis of the side branch.

Conclusions

Side branch predilatation before main vessel stenting may be associated with an increased risk of repeat revascularization in patients with true nonleft main bifurcation treated by the provisional approach.Trial registration: ClinicalTrials.gov number: NCT00851526.Full English text available from: www.revespcardiol.org/en     

Registro Español de Ablación con Catéter. XI Informe Oficial de la Sección de Electrofisiología y Arritmias de la Sociedad Española de Cardiología (2011)

Introduction and objectives

The findings of the 2011 Spanish Catheter Ablation Registry are presented.

Methods

Data were collected in two ways: retrospectively using a standardized questionnaire, and prospectively from a central database. Each participating center selected its own preferred method of data collection.

Results

Sixty-six Spanish centers voluntarily contributed data to the survey. Some 9662 ablation procedures were analyzed, averaging 146 (104) per center. The three main conditions treated were atrioventricular nodal reentrant tachycardia (n=2537; 26%), typical atrial flutter (n=2205; 23%) and accessory pathways (n=1813; 19%). Atrial fibrillation was the fourth most common substrate treated (n=1535; 16%) and showed a slight increase over figures for 2010. Ventricular arrhythmia ablation has increased considerably. The overall success rate was 94%; major complications occurred in 2.2% and overall mortality was 0.04%.

Conclusions

Data from the 2011 registry show a continued increase in the number of ablations performed with a generally high success rate and few complications. The use of complex substrate ablation continues to grow.     

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).     

Evaluación del impacto del nuevo marco legal sanitario sobre los inmigrantes en situación irregular en España: el caso de la infección por el virus de la inmunodeficiencia humana

The immigrant population in Spain, whether legal or not, has been entitled to healthcare under the same conditions as the Spanish population since the year 2000. The entry into vigour of the Royal Decree-Law 12/2012 of 20 April has significantly restricted this right, so that unauthorized or non-resident foreigners may now only receive emergency care, if they are under 18 or pregnant women. Out of an estimated 459,909 illegal immigrants in our country, 2,700 to 4,600 are probably infected with HIV; 1,800 to 3,220 know that they are infected, and 80% of the latter could receive antiretroviral treatment. The Royal Decree-Law is likely to cause many undesirable consequences in this population infected with HIV: increasing mortality, promoting the emergence of opportunistic diseases, increasing hospital admissions, increasing infections in the population (by HIV and other pathogens), or contributing to mother to child transmission of HIV. The expected increase in morbidity and mortality will be a greater cost in patient care, a cost which will be significantly higher in the more immunosuppressed patients. Therefore, the enforcement of the Royal Decree-Law will be much less cost-effective in the short term than was expected, and will negatively affect our country's public health, especially for those patients infected with HIV who will not be covered, thus increasing healthcare medium to long term costs, and moving away from the international health goals that were established.     

Cirugía de la regurgitación tricuspídea grave: resultados a corto y largo plazo

Introduction and objectives

There is little data available for Spain on the outcomes of surgical treatment for severe tricuspid regurgitation. The aim of this study was to analyze clinical and echocardiographic outcomes in a series of patients who received surgical treatment for severe tricuspid regurgitation and to compare outcomes according to the operative approach to valve repair or replacement.

Methods

Retrospective study in 119 consecutive patients with severe tricuspid regurgitation undergoing valve surgery between April 1996 and February 2010.

Results

A total of 61 ringless and 23 ring annuloplasties were performed and 11 bioprostheses and 24 mechanical prostheses were implanted. Perioperative mortality was 18.5% and was associated with age and cardiopulmonary bypass time. During clinical follow-up (median, 41 [interquartile range, 24-89] months), 2 reoperations were required in the ring annuloplasty and mechanical prosthesis groups; prosthetic thrombosis was diagnosed in 4 patients in the latter group. Total mortality after follow-up was 29.9% and was associated with age>70 years and extracorporeal circulation time. The emergence of new severe tricuspid regurgitation was associated with age and ringless annuloplasty (P=.04).

Conclusions

Ringless repair was significantly associated with recurrence of severe tricuspid regurgitation. The use of mechanical prostheses was associated with a high rate of thrombosis. No significant differences in perioperative or total mortality were found between the different methods used for repair or valve replacement.Full English text available from:www.revespcardiol.org/en.     

Elevación de las enzimas de función hepática en nuestro medio: estudio etiológico y de la eficacia de una consulta de acto único

Background

Liver enzyme (LE) elevation is a common finding in routine blood analysis. There is very little information on the most prevalent causes of these alterations in our population. In addition, a number of tests and several visits to the specialist are required to reach a diagnosis. For these reasons, we designed a protocol to streamline the evaluation of patients with LE elevations in a single-act office visit.

Methods

From March 2008 until June 2010, we studied all patients with incidental LE elevation (isolated transaminase elevation, combined elevation of alkaline phosphatase [FA] and gamma-glutamyl transpeptidase [GGT], or isolated elevation of GGT) who were referred by their primary care physicians. At the time of referral, a complete biochemistry analysis was performed (LE, viral serology, autoantibodies, ceruloplasmin, iron metabolism, alpha-1-antitrypsin and thyroid hormones) and the patients underwent an abdominal ultrasound scan on the day of the office evaluation by the hepatologist.

Results

A total of 427 patients were included in our study. The most common cause of transaminase elevation was non-alcoholic fatty liver disease (NAFLD) (40%), followed by alcohol intake (17%), and hepatitis C virus infection (13%). Elevated GGT levels were most commonly related to NAFLD (30%), closely followed by alcohol intake (27%), and hepatotoxicity (8%). Combined elevation of GGT and FA was associated with NAFLD (21%), alcohol (17%), and hepatotoxicity (11%). Self-limited elevation was seen in 9% of the patients and we could not identify a definite cause in 11%. A definitive diagnosis was reached in 79% of the patients.

Conclusions

The single-act office visit has proven to be efficient, yielding a diagnosis in most of the patients. The most common cause of elevated LE was NAFLD. Transaminase elevation must be confirmed before a more thorough work-up is started.     

Predicción en tiempo real de la malignidad de ganglios linfáticos mediastínicos mediante ecografía endobronquial

Objective

To evaluate the utility of different ultrasonographic (US) features in differentiating benign and malignant lymph node (LN) by endobronchial ultrasound (EBUS) and validate a score for real-time clinical application.

Methods

208 mediastinal LN acquired from 141 patients were analyzed. Six different US criteria were evaluated (short axis ≥ 10 mm, shape, margin, echogenicity, and central hilar structure [CHS], and presence of hyperechoic density) by two observers independently. A simplified score was generated where the presence of margin distinction, round shape and short axis ≥ 10 mm were scored as 1 and heterogeneous echogenicity and absence of CHS were scored as 1.5. The score was evaluated prospectively for real-time clinical application in 65 LN during EBUS procedure in 39 patients undertaken by two experienced operators. These criteria were correlated with the histopathological results and the sensitivity, specificity, positive and negative predictive values (PPV and NPV) were calculated.

Results

Both heterogenicity and absence of CHS had the highest sensitivity and NPV (≥ 90%) for predicting LN malignancy with acceptable inter-observer agreement (92% and 87% respectively). On real-time application, the sensitivity and specificity of the score > 5 were 78% and 86% respectively; only the absence of CHS, round shape and size of LN were significantly associated with malignant LN.

Conclusions

Combination of different US criteria can be useful for prediction of mediastinal LN malignancy and valid for real-time clinical application.     

El cáncer de pulmón en España. Epidemiología,supervivencia y tratamiento actuales

In 2005, 19 115 people died of lung cancer in Spain. In spite of the increase since 1950 in absolute mortality rates, the adjusted rate for men has declined. The incidence among women is lower in Spain than in other countries but it has increased (with a ratio of 1 woman for every 8.5 men). More than 50% of the patients are over 70 years of age. While the proportion of adenocarcinomas relative to other histological types has increased worldwide, squamous cell carcinoma still predominates in Spain (ranging from 24%–50.5%). The number of patients treated by surgical resection has not increased (14.8% in Spain in 2003).