Myocardial perfusion by contrast echocardiography. Establishment of normal pattern of intracoronary injection and safety in humans

OBJECTIVE: To establish the normal pattern and safety of echocardiographic contrast in patients with no significant obstruction of epicardial coronary arteries. METHODS: 67 patients with normal coronary arteries or obstructions < 50% were selected from 277 patients who underwent coronary angiography (CA). Mean age was 56 ± 11years and 36 were males. At the end CA, echocardiographic contrast was selectively injected into each coronary artery. The parasternal short axis of the left ventricle (LV) was divided into six segments: anterior (A), antero-lateral (AL), postero-lateral (PL), posterior (P), infero-septal (IS) and antero-septal (AS). Anterolateral (ALPM) and posteromedial papillary muscles (PMPM) were also considered. The pattern and intensity of the appearance of the myocardial contrast was visually analyzed. RESULTS: The right coronary artery (RCA) was dominant in 60 patients. Contrast appearance was sudden and simultaneous in the 3 muscle layers. All segments could be contrasted after the injection in both coronary arteries. 100% of the AS, A and AL segments, 97% of the PL and 98% of the ALPM were perfused by the left coronary artery (LCA). P and IS segments were perfused by the RCA in 85% and 82%, respectively, and by a dominant LCA in 71% of the cases. The PMPM was perfused by a dominant RCA in 77% and by a dominant LCA in 86%. There were no symptoms. CONCLUSION: Intracoronary injection of the sonicated solution is a safe procedure that allows for an excellent opacification of the myocardium and can potentially be used during routine CA.

Safety management of cranes on construction sites in Portugal: Critical factors of safety

The evolution of the construction caused a need to use more effective equipments, capable of meeting the increasingly demanding deadlines for the completion of works. In this context, the safety and efficiency of equipment have become key aspects in order to optimize the execution time of the works, as well as reducing labor costs and loss of materials. With the evolution of construction and construction processes, cranes have come to represent a signal of the construction of buildings, revealing to be, in most of the cases, the main equipment of construction sites. Currently, some engineers revels some apprehension regarding the use and handling of cranes which is natural and acceptable, since an equipment failure can lead to serious or fatal accidents. The factors affecting safety management of the cranes in construction sites were investigated, identified, classified and evaluated according to their degree of importance, through interviews with representatives of the general contractors of a set of selected construction sites.

Safety and efficacy of coronary stent implantation. Acute and six month outcomes of 1,126 consecutive patients treated in 1996 and 1997

PURPOSE: The authors analyzed the 30-day and 6-month outcomes of 1,126 consecutive patients who underwent coronary stent implantation in 1996 and 1997. METHODS: The 30-day results and 6-month angiographic follow-up were analyzed in patients treated with coronary stents in 1996 and 1997. All patients underwent coronary stenting with high-pressure implantation (>12 atm) and antiplatelet drug regimen (aspirin plus ticlopidine). RESULTS: During the study period, 1,390 coronary stents were implanted in 1,200 vessels of 1,126 patients; 477 patients were treated in the year 1996 and 649 in 1997. The number of percutaneous procedures performed using stents increased significantly in 1997 compared to 1996 (64 % vs 48%, p=0.0001). The 30-day results were similar in both years; the success and stent thrombosis rates were equal (97% and 0.8%, respectively). The occurrence of new Q wave MI (1.3% vs 1.1%, 1996 vs 1997, p=NS), emergency coronary bypass surgery (1% vs 0.6%, 1996 vs 1997, p=NS) and 30-day death rates (0.2% vs 0.5%, 1996 vs 1997, p=NS) were similar. The 6-month restenosis rate was 25% in 1996 and 27% in 1997 (p= NS); the target vessel revascularization rate was 15% in 1996 and 16% in 1997 (p = NS). CONCLUSIONS: Intracoronary stenting showed a high success rate and a low incidence of 30-day occurrence of new major coronary events in both periods, despite the greater angiographic complexity of the patients treated with in 1997. These adverse variables did not have a negative influence at the 6-month clinical and angiographic follow-up, with similar rates of restenosis and ischemia-driven target lesion revascularization rates.

Food safety in wine: removal of ochratoxin A in contaminated white wine using commercial fining agents

The presence of mycotoxins in foodstuff is a matter of concern for food safety. Mycotoxins are toxic secondary metabolites produced by certain molds, being ochratoxin A (OTA) one of the most relevant. Wines can also be contaminated with these toxicants. Several authors have demonstrated the presence of mycotoxins in wine, especially ochratoxin A (OTA) [1]. Its chemical structure is a dihydro-isocoumarin connected at the 7-carboxy group to a molecule of L--phenylalanine via an amide bond. As these toxicants can never be completely removed from the food chain, many countries have defined levels in food in order to attend health concerns. OTA contamination of wines might be a risk to consumer health, thus requiring treatments to achieve acceptable standards for human consumption [2]. The maximum acceptable level of OTA in wines is 2.0 g/kg according to the Commission regulation No. 1881/2006 [3]. Therefore, the aim of this work was to reduce OTA to safer levels using different fining agents, as well as their impact on white wine physicochemical characteristics. To evaluate their efficiency, 11 commercial fining agents (mineral, synthetic, animal and vegetable proteins) were used to get new approaches on OTA removal from white wine. Trials (including a control without addition of a fining agent) were performed in white wine artificially supplemented with OTA (10 µg/L). OTA analysis were performed after wine fining. Wine was centrifuged at 4000 rpm for 10 min and 1 mL of the supernatant was collected and added of an equal volume of acetonitrile/methanol/acetic acid (78:20:2 v/v/v). Also, the solid fractions obtained after fining, were centrifuged (4000 rpm, 15 min), the resulting supernatant discarded, and the pellet extracted with 1 mL of the above solution and 1 mL of H2O. OTA analysis was performed by HPLC with fluorescence detection according to Abrunhosa and Venâncio [4]. The most effective fining agent in removing OTA (80%) from white wine was a commercial formulation that contains gelatine, bentonite and activated carbon. Removals between 10-30% were obtained with potassium caseinate, yeast cell walls and pea protein. With bentonites, carboxymethylcellulose, polyvinylpolypyrrolidone and chitosan no considerable OTA removal was verified. Following, the effectiveness of seven commercial activated carbons was also evaluated and compared with the commercial formulation that contains gelatine, bentonite and activated carbon. The different activated carbons were applied at the concentration recommended by the manufacturer in order to evaluate their efficiency in reducing OTA levels. Trial and OTA analysis were performed as explained previously. The results showed that in white wine all activated carbons except one reduced 100% of OTA. The commercial formulation that contains gelatine, bentonite and activated carbon (C8) reduced only 73% of OTA concentration. These results may provide useful information for winemakers, namely for the selection of the most appropriate oenological product for OTA removal, reducing wine toxicity and simultaneously enhancing food safety and wine quality.

Introduction [to Food Safety in the Seafood Industry: A practical guide for ISO 22000 and FSSC 22000 implementation]

The prelims comprise: * Half-Title Page * Dedication Page * Title Page * Copyright Page * Table of Contents * Foreword * Acknowledgements * Disclaimer * Introduction

Safety and efficacy of angioplasty with intracoronary stenting in patients with unstable coronary syndromes. Comparison with stable coronary syndromes

OBJECTIVE: To assess safety and efficacy of coronary angioplasty with stent implantation in unstable coronary syndromes. METHODS: Retrospective analysis of in-hospital and late evolution of 74 patients with unstable coronary syndromes (unstable angina or infarction without elevation of the ST segment) undergoing coronary angioplasty with stent placement. These 74 patients were compared with 31 patients with stable coronary syndromes (stable angina or stable silent ischemia) undergoing the same procedure. RESULTS: No death and no need for revascularization of the culprit artery occurred in the in-hospital phase. The incidences of acute non-Q-wave myocardial infarction were 1.4% and 3.2% (p=0.6) in the unstable and stable coronary syndrome groups, respectively. In the late follow-up (11.2±7.5 months), the incidences of these events combined were 5.7% in the unstable coronary syndrome group and 6.9% (p=0.8) in the stable coronary syndrome group. In the multivariate analysis, the only variable with a tendency to significance as an event predictor was diabetes mellitus (p=0.07; OR=5.2; 95% CI=0.9-29.9). CONCLUSION: The in-hospital and late evolutions of patients with unstable coronary syndrome undergoing angioplasty with intracoronary stent implantation are similar to those of the stable coronary syndrome group, suggesting that this procedure is safe and efficacious when performed in unstable coronary syndrome patients.

“Safety and health” as a criterion in the choice of tunneling method

Risk management is of paramount importance in the success of tunnelling works and is linked to the tunnelling method and to the constraints of the works. Sequencial Excavation Method (SEM) and Tun-nel Boring Machine (TBM) method have been competing for years. This article, part of a wider study on the influence of the â Safety and Healthâ criterion in the choice of method, reviews the existing literature about the criteria usually employed to choose the tunnelling method and on the criterion â Safety and Healthâ . This crite-rion is particularly important, due to the financial impacts of work accidents and occupational diseases. This article is especially useful to the scientific and technical community, since it synthesizes the relevance of each one of the choice criteria used and it shows why â Safety and Healthâ must be a criterion in the decision mak-ing process to choose the tunnelling method.

A multicenter, open-label study of the efficacy and safety of telmisartan in mild to moderate hypertensive patients

OBJECTIVE: To evaluate the efficacy and tolerability of telmisartan, given once a day to patients with mild to moderate hypertension, as well as to assess the 24-hour blood pressure profile with ABPM. METHODS: Initially, 163 patients over 18 were selected, regardless of sex, with blood pressure levels >140/90mmHg at visit 1, which was confirmed at visit 2. One hundred thirty-four patients completed the study. After a 4-week placebo run-in phase, telmisartan 40mg/daily was given for 6 weeks. In those patients whose blood pressure (BP) levels were lower than 140/90mmHg, the same dosage was kept for an additional period of 6 weeks. For those who had BP higher than 140/90mmHg, the dosage was increased to 80mg/daily. Sixty-two patients were included in a subgroup that underwent ABPM 3 different times during the study. RESULTS: In the overall group, blood pressure reduction ranged from 162.3±14.5/101.3±5.75 mmHg (baseline) to 147.3±20.1/90.8±10.9 mmHg (week 12) (p<0.05). Mean blood pressure decreases were 14.4mmHg for systolic BP and 10.3mmHg for diastolic BP, after 12 weeks of active treatment. A subanalysis showed that 47 (35%) patients took telmisartan 40mg throughout the study and 81 (65%) had the dosage increased to 80mg daily. Using ABPM, an 8-mmHg reduction in systolic BP as well as a 5-mmHg reduction in diastolic BP were observed, when compared with baseline values in the final 6 hours (18-24 hours after the last dose of study medication). CONCLUSION: Our results confirm that telmisartan given once a day is effective in reducing blood pressure levels in mild to moderate hypertensive patients. This reduction occurs in a sustained and gradual manner during a 24-hour period confirmed by ABPM.

Safety, feasibility, and results of exercise testing for stratifying patients with chest pain in the emergency room

OBJECTIVE: To assess safety, feasibility, and the results of early exercise testing in patients with chest pain admitted to the emergency room of the chest pain unit, in whom acute myocardial infarction and high-risk unstable angina had been ruled out. METHODS: A study including 1060 consecutive patients with chest pain admitted to the emergency room of the chest pain unit was carried out. Of them, 677 (64%) patients were eligible for exercise testing, but only 268 (40%) underwent the test. RESULTS: The mean age of the patients studied was 51.7±12.1 years, and 188 (70%) were males. Twenty-eight (10%) patients had a previous history of coronary artery disease, 244 (91%) had a normal or unspecific electrocardiogram, and 150 (56%) underwent exercise testing within a 12-hour interval. The results of the exercise test in the latter group were as follows: 34 (13%) were positive, 191 (71%) were negative, and 43 (16%) were inconclusive. In the group of patients with a positive exercise test, 21 (62%) underwent coronary angiography, 11 underwent angioplasty, and 2 underwent myocardial revascularization. In a univariate analysis, type A/B chest pain (definitely/probably anginal) (p<0.0001), previous coronary artery disease (p<0.0001), and route 2 (patients at higher risk) correlated with a positive or inconclusive test (p<0.0001). CONCLUSION: In patients with chest pain and in whom acute myocardial infarction and high-risk unstable angina had been ruled out, the exercise test proved to be feasible, safe, and well tolerated.

Desarrollo sustentable de geoestructuras compuestas por suelo loéssico compactado mejorado con agregado de materiales estabilizantes. Sustainable development of compacted loess soil geo-structures with addition of stabilizing materials.

Los suelos estabilizados mediante compactación, permiten obtener materiales con ventajas ténicas y economicas en diferentes tipos de obras de ingeniería. Ejemplos de su uso se tiene en bases viales de autopistas, rutas o calles urbanas, pistas de aterrizaje, barreras de contención para enterramientos sanitarios o lagunas de estabilización, apoyos de plateas para fundación de edificios, losas industriales, entre otras aplicaciones. Las fallas en este tipo de construcciones pueden resultar en catástrofes ambientales, sociales y elevadas pérdidas económicas, por lo que resulta de gran importancia optimizar el diseño e incrementar la seguridad de este tipo de construcciones. Las obras con estas características involucran grandes volúmenes y/o superficies que requieren controles sistemáticos durante su desarrollo, a los fines de garantizar el cumplimiento de las propiedades de los materiales establecidos en la etapa de diseño. De esta forma, es necesario contar con ensayos de campo sencillos, confiables y eficientes que permitan identificar propiedades físicas, mecánicas e hidráulicas. Las geoestructuras generadas mediante la compactación del suelo próximo al sector de construcción pueden funcionar adecuadamente, con reducidos costos de material y transporte. Su estabilización puede ejecutarse en forma natural, o con la incorporación de agregados minerales como bentonita, cal o cemento. Estas incorporaciones mejoran las propiedades hidráulicas y mecánicas del material, optimizando el comportamiento requerido para la obra. Para establecer la forma en la que estos minerales modifican el comportamiento del suelo local compactado deben realizarse investigaciones especiales con los materiales involucrados. En el ámbito internacional existen numerosas investigaciones sobre comportamiento de suelos compactados, no obstante, si bien aportan antecedentes para la planificación de estudios locales, sus resultados no pueden trasladarse de manera directa. Las características propias del suelo local constituye la principal variable debido a la diversidad en las propiedades geotécnicas de cada Región. Esta investigación, se focaliza en el empleo de suelos limosos de la formación loéssica de la zona central de Argentina. Los suelos de la llanura cordobesa poseen comportamientos particulares, los cuales son contemplados en los diseños presentados como resutado de las investigaciones internacionales. Esta particularidad se relaciona con su inestabilidad, lo que los clasifica como suelos colapsables. Los resultados obtenidos en este trabajo podrán ser extendidos a una gran superficie de la Provincia de Córdoba y a la Región Pampeana en general, a los fines de establecer recomendaciones de diseño y construcción para la confección de Pliegos de Especificaciones Técnicas de diferentes tipos de obras públicas y privadas. El estudio contempla la ejecución de un plan experimental a escala de laboratorio y campo. Los materiales corresponden a suelo limosos puros, y diferentes agregados tales como bentonita, cal y cemento. Se planifican ensayos para evaluar el desempeño del material, a partir de la confección de muestras preparadas con diferentes condiciones de compactación (energía, humedad y método), y en forma de mezcla con los distintos tipos de agregados. Se realizarán ensayos de permeabilidad en celdas de pared rígida y flexible, junto a ensayos mecánicos de compresión confinada, simple y triaxial. Para el trabajo experimental de campo se prevé la ejecución de terraplenes de prueba instrumentados con tensiómetros e infiltrómetros para evaluar el comportamiento hidraúlico en el tiempo, junto con ensayos de penetración y plato de carga para la caracterización mecánica. En forma conjunta se propone el desarrollo de modelos numéricos de caracterización hidromecánica. Stabilized soils by compaction, produce materials technical and economic advantages in different types of engineering works. For example, road bases in highways, roads or city streets, containment barriers for sanitary landfill or stabilization ponds, foundation support of building, industrial flat, and other applications. Failures can result in environmental catastrophes, social, and economic loss, so it is important to optimize the design and increase the safety of such buildings. These works involve large surfaces that require systematic tests during construction, so it is necessary to have simple field tests, reliable and efficient to identify physical, mechanical and hydraulic properties. The geo-structures generated by local soil compaction have reduced material and transportation costs. Stabilization can be naturally, or with the addition of mineral aggregates as bentonite, lime and cement. These additions improve the hydraulic and mechanical properties of the material. So, special investigations should be conducted with the materials involved. There are many international studies on compacted soils behavior but their results can not be transferred directly due to the particularities of regional soils. For this research silty soils of central Argentina are the main focus. The soils of Córdoba plains are instability, so are classified as collapsible soils. The results obtained in this work may be extended to a large area of the Province of Cordoba and the Pampas region in general, in order to establish design and construction recommendations. The study includes laboratory and field tests. The materials are pure silty soil, and different aggregates such as bentonite, lime and cement. Tests are planned to evaluate the performance. Laboratory includes rigid and flexible wall cells, confined, triaxial and simple compression tests. For field experimental instrumented embankments will be constructed. A numerical hydromechanical model will be developed.

Qualitative and quantitative formal model-based safety analysis : push the safety button

Magdeburg, Univ., Fak. für Informatik, Diss., 2011

Evaluation of Sexual Dimorphism in the Efficacy and Safety of Simvastatin/Atorvastatin Therapy in a Southern Brazilian Cohort

Background: Dyslipidemia is the primary risk factor for cardiovascular disease, and statins have been effective in controlling lipid levels. Sex differences in the pharmacokinetics and pharmacodynamics of statins contribute to interindividual variations in drug efficacy and toxicity. Objective: To evaluate the presence of sexual dimorphism in the efficacy and safety of simvastatin/atorvastatin treatment. Methods: Lipid levels of 495 patients (331 women and 164 men) were measured at baseline and after 6 ± 3 months of simvastatin/atorvastatin treatment to assess the efficacy and safety profiles of both drugs. Results: Women had higher baseline levels of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) compared with men (p < 0.0001). After treatment, women exhibited a greater decrease in plasma TC and LDL-C levels compared with men. After adjustment for covariates, baseline levels of TC and LDL-C influenced more than 30% of the efficacy of lipid-lowering therapy (p < 0.001), regardless of sex. Myalgia [with or without changes in creatine phosphokinase (CPK) levels] occurred more frequently in women (25.9%; p = 0.002), whereas an increase in CPK and/or abnormal liver function was more frequent in in men (17.9%; p = 0.017). Conclusions: Our results show that baseline TC and LDL-C levels are the main predictors of simvastatin/atorvastatin therapy efficacy, regardless of sex. In addition, they suggest the presence of sexual dimorphism in the safety of simvastatin/atorvastatin. The effect of sex differences on receptors, transporter proteins, and gene expression pathways needs to be better evaluated and characterized to confirm these observations.

Efficacy and Safety of Drug-Eluting Stents in the Real World: 8-Year Follow-Up

Background: Drug-eluting stents have been used in daily practice since 2002, with the clear advantages of reducing the risk of target vessel revascularization and an impressive reduction in restenosis rate by 50%-70%. However, the occurrence of a late thrombosis can compromise long-term results, particularly if the risks of this event were sustained. In this context, a registry of clinical cases gains special value. Objective: To evaluate the efficacy and safety of drug-eluting stents in the real world. Methods: We report on the clinical findings and 8-year follow-up parameters of all patients that underwent percutaneous coronary intervention with a drug-eluting stent from January 2002 to April 2007. Drug-eluting stents were used in accordance with the clinical and interventional cardiologist decision and availability of the stent. Results: A total of 611 patients were included, and clinical follow-up of up to 8 years was obtained for 96.2% of the patients. Total mortality was 8.7% and nonfatal infarctions occurred in 4.3% of the cases. Target vessel revascularization occurred in 12.4% of the cases, and target lesion revascularization occurred in 8% of the cases. The rate of stent thrombosis was 2.1%. There were no new episodes of stent thrombosis after the fifth year of follow-up. Comparative subanalysis showed no outcome differences between the different types of stents used, including Cypher®, Taxus®, and Endeavor®. Conclusion: These findings indicate that drug-eluting stents remain safe and effective at very long-term follow-up. Patients in the "real world" may benefit from drug-eluting stenting with excellent, long-term results.

System-analytic safety evaluation of the hydrogen cycle for energetic utilization

Hydrogen, energy, safety, risk, production, transport, storage, filling station, fuelcell

Robust learning in safety-related domains : machine learning methods for solving safety-related application problems

Magdeburg, Univ., Fak. für Informatik, Diss., 2009