132 research outputs found

    Documentación e identidad en los márgenes, un acercamiento etnográfi co al proceso de identificación y documentación de la comunidad vagabunda en Temuco.

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    A continuación se expone una síntesis de una investigación antropológica de carácter etnográfica, realizada en el marco de mi participación como estudiante colaborador en un proyecto del Registro Civil e Identifi cación denominado “Identifi cando a personas con discapacidad social” que el área de marginalidad del Centro de Estudios Socioculturales de la Universidad Católica de Temuco asesoró. Esta iniciativa surgiócon el objetivo de proporcionar cédula de identidad a los “vagabundos” en la comuna de Temuco, y me permitió iniciarme como etnógrafo respecto de la “comunidad vagabunda”, interactuando directamente con los actores y recogiendo desde allí, y de manera preliminar, todo lo que antropológicamente hablara acerca de los usos y signifi caciones socioculturales que los sujetos le otorgaban al de identifi cación y documentación

    Documentación e identidad en los márgenes, un acercamiento etnográfi co al proceso de identificación y documentación de la comunidad vagabunda en Temuco.

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    A continuación se expone una síntesis de una investigación antropológica de carácter etnográfica, realizada en el marco de mi participación como estudiante colaborador en un proyecto del Registro Civil e Identifi cación denominado “Identifi cando a personas con discapacidad social” que el área de marginalidad del Centro de Estudios Socioculturales de la Universidad Católica de Temuco asesoró. Esta iniciativa surgió con el objetivo de proporcionar cédula de identidad a los “vagabundos” en la comuna de Temuco, y me permitió iniciarme como etnógrafo respecto de la “comunidad vagabunda”, interactuando directamente con los actores y recogiendo desde allí, y de manera preliminar, todo lo que antropológicamente hablara acerca de los usos y signifi caciones socioculturales que los sujetos le otorgaban al de identifi cación y documentación

    Safety and Efficacy of TAVR With a Pressure Sensor and Pacing Guidewire : SAFE-TAVI Trial

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    The SavvyWire (OpSens Inc) is a 0.035-inch preshaped guidewire with dedicated pacing properties and a distal pressure sensor allowing for continuous hemodynamic pressure monitoring. This study sought to determine the efficacy and safety of the guidewire during transcatheter aortic valve replacement (TAVR) procedures. This prospective, multicenter clinical study included patients with severe aortic stenosis undergoing TAVR in 8 European centers. The primary efficacy endpoint was defined as effective left ventricular rapid pacing runs with the guidewire translating into a significant systemic pressure drop (below 60 mm Hg). The safety outcome included the absence of major procedural complications related to the guidewire. A total of 121 patients (mean age: 82.2 ± 5.9 years, 50% women) were included in the study, and 119 (98.3%) patients were finally treated with the study device. A balloon-expandable valve was implanted in 45 (37.8%) patients. Predilatation and postdilatation were performed in 89 (74.8%) and 14 (11.8%) patients, respectively. The primary efficacy endpoint was achieved in 116 (98.3%) patients, and the mean aortic systolic arterial pressure achieved during rapid pacing was 46.6 ± 11.3 mm Hg. Hemodynamic assessment with the use of the OptoMonitor 3 (OpSens Inc) without additional catheter exchange was achieved in 117 (99.2%) patients. The safety endpoint was achieved in 117 (99.2%) patients. No procedural mortality, stroke, or ventricular perforation was reported. The use of the guidewire during TAVR procedures appeared to be efficacious and safe. This device could help minimize interventions during the procedure and improve the clinical decision making after transcatheter heart valve deployment. (SavvyWire Efficacy and Safety in Transcatheter Aortic Valve Implantation Procedures [SAFE-TAVI]; NCT05492383

    Desarrollo de indicaciones de uso apropiado del implante transcateter de protesis valvular aortica en el tratamiento de la estenosis aortica grave sintomatica

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    En cubierta aparecen logos del Ministerio de Sanidad, Servicios Sociales e Igualdad y de la Red Espanola de Agencias de Evaluacion de Tecnologias y Prestaciones del SN

    Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis: The International FORWARD Study

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    Background Clinical outcomes in large patient populations from real-world clinical practice with a next-generation self-expanding transcatheter aortic valve are lacking. Objectives This study sought to document the clinical and device performance outcomes of transcatheter aortic valve replacement (TAVR) with a next-generation, self-expanding transcatheter heart valve (THV) system in patients with severe symptomatic aortic stenosis (AS) in routine clinical practice. Methods The FORWARD (CoreValve Evolut R FORWARD) study is a prospective, single-arm, multinational, multicenter, observational study. An independent clinical events committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms. From January 2016 to December 2016, TAVR with the next-generation self-expanding THV was attempted in 1,038 patients with symptomatic, severe AS at 53 centers on 4 continents. Results Mean age was 81.8 ± 6.2 years, 64.9% were women, the mean Society of Thoracic Surgeons Predicted Risk of Mortality was 5.5 ± 4.5%, and 33.9% of patients were deemed frail. The repositioning feature of the THV was applied in 25.8% of patients. A single valve was implanted in the proper anatomic location in 98.9% of patients. The mean aortic valve gradient was 8.5 ± 5.6 mm Hg, and moderate or severe aortic regurgitation was 1.9% at discharge. All-cause mortality was 1.9%, and disabling stroke occurred in 1.8% at 30 days. The expected-to-observed early surgical mortality ratio was 0.35. A pacemaker was implanted in 17.5% of patients. Conclusions TAVR using the next-generation THV is clinically safe and effective for treating older patients with severe AS at increased operative risk. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369

    Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial

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    Background: Glucagon-like peptide 1 receptor agonists differ in chemical structure, duration of action, and in their effects on clinical outcomes. The cardiovascular effects of once-weekly albiglutide in type 2 diabetes are unknown. We aimed to determine the safety and efficacy of albiglutide in preventing cardiovascular death, myocardial infarction, or stroke. Methods: We did a double-blind, randomised, placebo-controlled trial in 610 sites across 28 countries. We randomly assigned patients aged 40 years and older with type 2 diabetes and cardiovascular disease (at a 1:1 ratio) to groups that either received a subcutaneous injection of albiglutide (30–50 mg, based on glycaemic response and tolerability) or of a matched volume of placebo once a week, in addition to their standard care. Investigators used an interactive voice or web response system to obtain treatment assignment, and patients and all study investigators were masked to their treatment allocation. We hypothesised that albiglutide would be non-inferior to placebo for the primary outcome of the first occurrence of cardiovascular death, myocardial infarction, or stroke, which was assessed in the intention-to-treat population. If non-inferiority was confirmed by an upper limit of the 95% CI for a hazard ratio of less than 1·30, closed testing for superiority was prespecified. This study is registered with ClinicalTrials.gov, number NCT02465515. Findings: Patients were screened between July 1, 2015, and Nov 24, 2016. 10 793 patients were screened and 9463 participants were enrolled and randomly assigned to groups: 4731 patients were assigned to receive albiglutide and 4732 patients to receive placebo. On Nov 8, 2017, it was determined that 611 primary endpoints and a median follow-up of at least 1·5 years had accrued, and participants returned for a final visit and discontinuation from study treatment; the last patient visit was on March 12, 2018. These 9463 patients, the intention-to-treat population, were evaluated for a median duration of 1·6 years and were assessed for the primary outcome. The primary composite outcome occurred in 338 (7%) of 4731 patients at an incidence rate of 4·6 events per 100 person-years in the albiglutide group and in 428 (9%) of 4732 patients at an incidence rate of 5·9 events per 100 person-years in the placebo group (hazard ratio 0·78, 95% CI 0·68–0·90), which indicated that albiglutide was superior to placebo (p<0·0001 for non-inferiority; p=0·0006 for superiority). The incidence of acute pancreatitis (ten patients in the albiglutide group and seven patients in the placebo group), pancreatic cancer (six patients in the albiglutide group and five patients in the placebo group), medullary thyroid carcinoma (zero patients in both groups), and other serious adverse events did not differ between the two groups. There were three (<1%) deaths in the placebo group that were assessed by investigators, who were masked to study drug assignment, to be treatment-related and two (<1%) deaths in the albiglutide group. Interpretation: In patients with type 2 diabetes and cardiovascular disease, albiglutide was superior to placebo with respect to major adverse cardiovascular events. Evidence-based glucagon-like peptide 1 receptor agonists should therefore be considered as part of a comprehensive strategy to reduce the risk of cardiovascular events in patients with type 2 diabetes. Funding: GlaxoSmithKline

    Timing of Complete Multivessel Revascularization in Acute Coronary Syndrome: 2-Year Results of the BIOVASC Study

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    Background: In patients with acute coronary syndromes (ACS) and multivessel coronary disease, immediate complete revascularization was noninferior to staged complete revascularization for the primary composite outcome at 1 year. The authors report clinical outcomes at 2 years of follow-up. Methods: Patients with ACS and multivessel coronary disease were randomly assigned to immediate complete revascularization or to staged complete revascularization at 29 sites in Europe. The primary outcome was the composite of all-cause mortality, myocardial infarction, any unplanned ischemia-driven revascularization, and cerebrovascular event. Results: In total, 764 patients were enrolled and randomly allocated to the immediate complete revascularization arm and 761 to the staged complete revascularization arm. Two-year follow-up was complete for 97.6% of patients. At 2 years, the primary outcome had occurred in 12.5% of patients in the immediate complete revascularization group and 12.4% of patients in the staged complete revascularization group (HR: 0.98; 95% CI: 0.73-1.30; P = 0.88). Myocardial infarction occurred more frequently in the staged complete revascularization group (6.2% vs 3.8%; HR: 0.60; 95% CI: 0.37-0.96; P = 0.032). In the immediate complete revascularization and staged complete revascularization groups, the rates of all-cause mortality (3.3% vs 2.0%; HR: 1.67; 95% CI: 0.88-3.16; P = 0.12), any unplanned ischemia-driven revascularization (7.0% vs 7.9%; HR: 0.87; 95% CI: 0.60-1.26; P = 0.57), and cerebrovascular event (2.5% vs 1.7%; HR: 1.39; 95% CI: 0.68-2.83; P = 0.37) were not significantly different. Conclusions: In patients with ACS and multivessel disease, there was no significant difference between immediate complete revascularization and staged complete revascularization with respect to the composite outcome of all-cause mortality, myocardial infarction, any unplanned ischemia-driven revascularization, and cerebrovascular event at 2 years. Immediate complete revascularization was associated with a significant reduction in myocardial infarction, mainly due to fewer early events

    Documentación e identidad en los márgenes, un acercamiento etnográfi co al proceso de identificación y documentación de la comunidad vagabunda en Temuco.

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    A continuación se expone una síntesis de una investigación antropológica de carácter etnográfica, realizada en el marco de mi participación como estudiante colaborador en un proyecto del Registro Civil e Identifi cación denominado “Identifi cando a personas con discapacidad social” que el área de marginalidad del Centro de Estudios Socioculturales de la Universidad Católica de Temuco asesoró. Esta iniciativa surgiócon el objetivo de proporcionar cédula de identidad a los “vagabundos” en la comuna de Temuco, y me permitió iniciarme como etnógrafo respecto de la “comunidad vagabunda”, interactuando directamente con los actores y recogiendo desde allí, y de manera preliminar, todo lo que antropológicamente hablara acerca de los usos y signifi caciones socioculturales que los sujetos le otorgaban al de identifi cación y documentación.</jats:p
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