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1.
Anesthesiology ; 132(4): 692-701, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32022771

RESUMO

BACKGROUND: The authors previously reported that perioperative aspirin and/or clonidine does not prevent a composite of death or myocardial infarction 30 days after noncardiac surgery. Moreover, aspirin increased the risk of major bleeding and clonidine caused hypotension and bradycardia. Whether these complications produce harm at 1 yr remains unknown. METHODS: The authors randomized 10,010 patients with or at risk of atherosclerosis and scheduled for noncardiac surgery in a 1:1:1:1 ratio to clonidine/aspirin, clonidine/aspirin placebo, clonidine placebo/aspirin, or clonidine placebo/aspirin placebo. Patients started taking aspirin or placebo just before surgery; those not previously taking aspirin continued daily for 30 days, and those taking aspirin previously continued for 7 days. Patients were also randomly assigned to receive clonidine or placebo just before surgery, with the study drug continued for 72 h. RESULTS: Neither aspirin nor clonidine had a significant effect on the primary 1-yr outcome, a composite of death or nonfatal myocardial infarction, with a 1-yr hazard ratio for aspirin of 1.00 (95% CI, 0.89 to 1.12; P = 0.948; 586 patients [11.8%] vs. 589 patients [11.8%]) and a hazard ratio for clonidine of 1.07 (95% CI, 0.96 to 1.20; P = 0.218; 608 patients [12.1%] vs. 567 patients [11.3%]), with effect on death or nonfatal infarction. Reduction in death and nonfatal myocardial infarction from aspirin in patients who previously had percutaneous coronary intervention at 30 days persisted at 1 yr. Specifically, the hazard ratio was 0.58 (95% CI, 0.35 to 0.95) in those with previous percutaneous coronary intervention and 1.03 (95% CI, 0.91to 1.16) in those without (interaction P = 0.033). There was no significant effect of either drug on death, cardiovascular complications, cancer, or chronic incisional pain at 1 yr (all P > 0.1). CONCLUSIONS: Neither perioperative aspirin nor clonidine have significant long-term effects after noncardiac surgery. Perioperative aspirin in patients with previous percutaneous coronary intervention showed persistent benefit at 1 yr, a plausible sub-group effect.

3.
BMJ Open ; 8(7): e021521, 2018 07 06.
Artigo em Inglês | MEDLINE | ID: mdl-29982215

RESUMO

OBJECTIVES: Covert stroke after non-cardiac surgery may have substantial impact on duration and quality of life. In non-surgical patients, covert stroke is more common than overt stroke and is associated with an increased risk of cognitive decline and dementia. Little is known about covert stroke after non-cardiac surgery.NeuroVISION is a multicentre, international, prospective cohort study that will characterise the association between perioperative acute covert stroke and postoperative cognitive function. SETTING AND PARTICIPANTS: We are recruiting study participants from 12 tertiary care hospitals in 10 countries on 5 continents. PARTICIPANTS: We are enrolling patients ≥65 years of age, requiring hospital admission after non-cardiac surgery, who have an anticipated length of hospital stay of at least 2 days after elective non-cardiac surgery that occurs under general or neuraxial anaesthesia. PRIMARY AND SECONDARY OUTCOME MEASURES: Patients are recruited before elective non-cardiac surgery, and their cognitive function is measured using the Montreal Cognitive Assessment (MoCA) instrument. After surgery, a brain MRI study is performed between postoperative days 2 and 9 to determine the presence of acute brain infarction. One year after surgery, the MoCA is used to assess postoperative cognitive function. Physicians and patients are blinded to the MRI study results until after the last patient follow-up visit to reduce outcome ascertainment bias.We will undertake a multivariable logistic regression analysis in which the dependent variable is the change in cognitive function 1 year after surgery, and the independent variables are acute perioperative covert stroke as well as other clinical variables that are associated with cognitive dysfunction. CONCLUSIONS: The NeuroVISION study will characterise the epidemiology of covert stroke and its clinical consequences. This will be the largest and the most comprehensive study of perioperative stroke after non-cardiac surgery. TRIAL REGISTRATION NUMBER: NCT01980511; Pre-results.


Assuntos
Disfunção Cognitiva/fisiopatologia , Tempo de Internação/estatística & dados numéricos , Complicações Pós-Operatórias/fisiopatologia , Acidente Vascular Cerebral/fisiopatologia , Procedimentos Cirúrgicos Operatórios/efeitos adversos , Idoso , Cognição , Disfunção Cognitiva/diagnóstico por imagem , Disfunção Cognitiva/etiologia , Feminino , Humanos , Imagem por Ressonância Magnética , Masculino , Período Perioperatório , Complicações Pós-Operatórias/diagnóstico por imagem , Estudos Prospectivos , Acidente Vascular Cerebral/diagnóstico por imagem
4.
BMJ Open ; 8(4): e019223, 2018 04 28.
Artigo em Inglês | MEDLINE | ID: mdl-29705752

RESUMO

OBJECTIVE: To identify existing prognostic delirium prediction models and evaluate their validity and statistical methodology in the older adult (≥60 years) acute hospital population. DESIGN: Systematic review. DATA SOURCES AND METHODS: PubMed, CINAHL, PsychINFO, SocINFO, Cochrane, Web of Science and Embase were searched from 1 January 1990 to 31 December 2016. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses and CHARMS Statement guided protocol development. INCLUSION CRITERIA: age >60 years, inpatient, developed/validated a prognostic delirium prediction model. EXCLUSION CRITERIA: alcohol-related delirium, sample size ≤50. The primary performance measures were calibration and discrimination statistics. Two authors independently conducted search and extracted data. The synthesis of data was done by the first author. Disagreement was resolved by the mentoring author. RESULTS: The initial search resulted in 7,502 studies. Following full-text review of 192 studies, 33 were excluded based on age criteria (<60 years) and 27 met the defined criteria. Twenty-three delirium prediction models were identified, 14 were externally validated and 3 were internally validated. The following populations were represented: 11 medical, 3 medical/surgical and 13 surgical. The assessment of delirium was often non-systematic, resulting in varied incidence. Fourteen models were externally validated with an area under the receiver operating curve range from 0.52 to 0.94. Limitations in design, data collection methods and model metric reporting statistics were identified. CONCLUSIONS: Delirium prediction models for older adults show variable and typically inadequate predictive capabilities. Our review highlights the need for development of robust models to predict delirium in older inpatients. We provide recommendations for the development of such models.


Assuntos
Delírio , Unidades de Terapia Intensiva , Modelos Teóricos , Idoso , Lista de Checagem , Previsões , Humanos , Pacientes Internados , Pessoa de Meia-Idade , Prognóstico , Síndrome de Abstinência a Substâncias , Estados Unidos
5.
BMJ Qual Saf ; 27(1): 74-84, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-28971889

RESUMO

BACKGROUND: The quality and safety movement has reinvigorated interest in optimising morbidity and mortality (M&M) rounds. We performed a systematic review to identify effective means of updating M&M rounds to (1) identify and address quality and safety issues, and (2) address contemporary educational goals. METHODS: Relevant databases (Medline, Embase, PubMed, Education Resource Information Centre, Cumulative Index to Nursing and Allied Health Literature, Healthstar, and Global Health) were searched to identify primary sources. Studies were included if they (1) investigated an intervention applied to M&M rounds, (2) reported outcomes relevant to the identification of quality and safety issues, or educational outcomes relevant to quality improvement (QI), patient safety or general medical education and (3) included a control group. Study quality was assessed using the Medical Education Research Study Quality Instrument and Newcastle-Ottawa Scale-Education instruments. Given the heterogeneity of interventions and outcome measures, results were analysed thematically. RESULTS: The final analysis included 19 studies. We identified multiple effective strategies (updating objectives, standardising elements of rounds and attaching rounds to a formal quality committee) to optimise M&M rounds for a QI/safety purpose. These efforts were associated with successful integration of quality and safety content into rounds, and increased implementation of QI interventions. Consistent effects on educational outcomes were difficult to identify, likely due to the use of methodologies ill-fitted for educational research. CONCLUSIONS: These results are encouraging for those seeking to optimise the quality and safety mission of M&M rounds. However, the inability to identify consistent educational effects suggests the investigation of M&M rounds could benefit from additional methodologies (qualitative, mixed methods) in order to understand the complex mechanisms driving learning at M&M rounds.


Assuntos
Educação Médica/organização & administração , Segurança do Paciente , Melhoria de Qualidade/organização & administração , Visitas com Preceptor/organização & administração , Humanos , Morbidade , Mortalidade , Objetivos Organizacionais
6.
Eur J Case Rep Intern Med ; 5(10): 000959, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30755984

RESUMO

Pheochromocytoma, a rare neuroendocrine tumour, is often encountered in the general internal medicine clinic as an adrenal incidentaloma. Even rarer is its presence in adult cyanotic heart disease, although there are a few documented reports of this association in various paediatric populations, with chronic hypoxia being the likely driving force. Here we present the case of a 38-year-old adult with unrepaired complex cyanotic congenital heart disease with biochemically proven pheochromocytoma presenting as an adrenal incidentaloma to a general internal medicine clinic. LEARNING POINTS: There is an association between pheochromocytoma and congenital cyanotic heart disease.It is important to maintain clinical vigilance for laboratory testing for pheochromocytoma in patients with cyanotic heart disease who are seen at general internal medicine clinics.

7.
J Stroke Cerebrovasc Dis ; 27(3): 606-619, 2018 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-29141778

RESUMO

BACKGROUND: It has been hypothesized that ischemic stroke can cause atrial fibrillation. By elucidating the mechanisms of neurogenically mediated paroxysmal atrial fibrillation, novel therapeutic strategies could be developed to prevent atrial fibrillation occurrence and perpetuation after stroke. This could result in fewer recurrent strokes and deaths, a reduction or delay in dementia onset, and in the lessening of the functional, structural, and metabolic consequences of atrial fibrillation on the heart. METHODS: The Pathophysiology and Risk of Atrial Fibrillation Detected after Ischemic Stroke (PARADISE) study is an investigator-driven, translational, integrated, and transdisciplinary initiative. It comprises 3 complementary research streams that focus on atrial fibrillation detected after stroke: experimental, clinical, and epidemiological. The experimental stream will assess pre- and poststroke electrocardiographic, autonomic, anatomic (brain and heart pathology), and inflammatory trajectories in an animal model of selective insular cortex ischemic stroke. The clinical stream will prospectively investigate autonomic, inflammatory, and neurocognitive changes among patients diagnosed with atrial fibrillation detected after stroke by employing comprehensive and validated instruments. The epidemiological stream will focus on the demographics, clinical characteristics, and outcomes of atrial fibrillation detected after stroke at the population level by means of the Ontario Stroke Registry, a prospective clinical database that comprises over 23,000 patients with ischemic stroke. CONCLUSIONS: PARADISE is a translational research initiative comprising experimental, clinical, and epidemiological research aimed at characterizing clinical features, the pathophysiology, and outcomes of neurogenic atrial fibrillation detected after stroke.


Assuntos
Fibrilação Atrial , Isquemia Encefálica , Comunicação Interdisciplinar , Projetos de Pesquisa , Acidente Vascular Cerebral , Pesquisa Médica Translacional/métodos , Animais , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/fisiopatologia , Isquemia Encefálica/diagnóstico , Isquemia Encefálica/epidemiologia , Isquemia Encefálica/fisiopatologia , Comportamento Cooperativo , Bases de Dados Factuais , Avaliação da Deficiência , Modelos Animais de Doenças , Eletrocardiografia Ambulatorial , Feminino , Humanos , Masculino , Ontário/epidemiologia , Prognóstico , Estudos Prospectivos , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/fisiopatologia
8.
Ann Intern Med ; 168(4): 237-244, 2018 02 20.
Artigo em Inglês | MEDLINE | ID: mdl-29132159

RESUMO

Background: Uncertainty remains about the effects of aspirin in patients with prior percutaneous coronary intervention (PCI) having noncardiac surgery. Objective: To evaluate benefits and harms of perioperative aspirin in patients with prior PCI. Design: Nonprespecified subgroup analysis of a multicenter factorial trial. Computerized Internet randomization was done between 2010 and 2013. Patients, clinicians, data collectors, and outcome adjudicators were blinded to treatment assignment. (ClinicalTrials.gov: NCT01082874). Setting: 135 centers in 23 countries. Patients: Adults aged 45 years or older who had or were at risk for atherosclerotic disease and were having noncardiac surgery. Exclusions were placement of a bare-metal stent within 6 weeks, placement of a drug-eluting stent within 1 year, or receipt of nonstudy aspirin within 72 hours before surgery. Intervention: Aspirin therapy (overall trial, n = 4998; subgroup, n = 234) or placebo (overall trial, n = 5012; subgroup, n = 236) initiated within 4 hours before surgery and continued throughout the perioperative period. Of the 470 subgroup patients, 99.9% completed follow-up. Measurements: The 30-day primary outcome was death or nonfatal myocardial infarction; bleeding was a secondary outcome. Results: In patients with prior PCI, aspirin reduced the risk for the primary outcome (absolute risk reduction, 5.5% [95% CI, 0.4% to 10.5%]; hazard ratio [HR], 0.50 [CI, 0.26 to 0.95]; P for interaction = 0.036) and for myocardial infarction (absolute risk reduction, 5.9% [CI, 1.0% to 10.8%]; HR, 0.44 [CI, 0.22 to 0.87]; P for interaction = 0.021). The effect on the composite of major and life-threatening bleeding in patients with prior PCI was uncertain (absolute risk increase, 1.3% [CI, -2.6% to 5.2%]). In the overall population, aspirin increased the risk for major bleeding (absolute risk increase, 0.8% [CI, 0.1% to 1.6%]; HR, 1.22 [CI, 1.01 to 1.48]; P for interaction = 0.50). Limitation: Nonprespecified subgroup analysis with small sample. Conclusion: Perioperative aspirin may be more likely to benefit rather than harm patients with prior PCI. Primary Funding Source: Canadian Institutes of Health Research.


Assuntos
Aspirina/uso terapêutico , Intervenção Coronária Percutânea , Inibidores da Agregação de Plaquetas/uso terapêutico , Procedimentos Cirúrgicos Operatórios , Idoso , Anti-Hipertensivos/uso terapêutico , Aspirina/efeitos adversos , Biomarcadores/sangue , Clonidina/uso terapêutico , Esquema de Medicação , Quimioterapia Combinada , Feminino , Hemorragia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/prevenção & controle , Inibidores da Agregação de Plaquetas/efeitos adversos , Complicações Pós-Operatórias/induzido quimicamente , Complicações Pós-Operatórias/prevenção & controle , Resultado do Tratamento
9.
BMJ Open ; 7(1): e013510, 2017 01 09.
Artigo em Inglês | MEDLINE | ID: mdl-28069624

RESUMO

INTRODUCTION: The Revised Cardiac Risk Index (RCRI) is a popular classification system to estimate patients' risk of postoperative cardiac complications based on preoperative risk factors. Renal impairment, defined as serum creatinine >2.0 mg/dL (177 µmol/L), is a component of the RCRI. The estimated glomerular filtration rate has become accepted as a more accurate indicator of renal function. We will externally validate the RCRI in a modern cohort of patients undergoing non-cardiac surgery and update its renal component. METHODS AND ANALYSIS: The Vascular Events in Non-cardiac Surgery Patients Cohort Evaluation (VISION) study is an international prospective cohort study. In this prespecified secondary analysis of VISION, we will test the risk estimation performance of the RCRI in ∼34 000 participants who underwent elective non-cardiac surgery between 2007 and 2013 from 29 hospitals in 15 countries. Using data from the first 20 000 eligible participants (the derivation set), we will derive an optimal threshold for dichotomising preoperative renal function quantified using the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) glomerular filtration rate estimating equation in a manner that preserves the original structure of the RCRI. We will also develop a continuous risk estimating equation integrating age and CKD-Epi with existing RCRI risk factors. In the remaining (approximately) 14 000 participants, we will compare the risk estimation for cardiac complications of the original RCRI to this modified version. Cardiac complications will include 30-day non-fatal myocardial infarction, non-fatal cardiac arrest and death due to cardiac causes. We have examined an early sample to estimate the number of events and the distribution of predictors and missing data, but have not seen the validation data at the time of writing. ETHICS AND DISSEMINATION: The research ethics board at each site approved the VISION protocol prior to recruitment. We will publish our results and make our models available online at http://www.perioperativerisk.com. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT00512109.


Assuntos
Cardiopatias/etiologia , Complicações Pós-Operatórias/etiologia , Idoso , Procedimentos Cirúrgicos Eletivos/efeitos adversos , Feminino , Taxa de Filtração Glomerular/fisiologia , Humanos , Masculino , Pessoa de Meia-Idade , Cuidados Pré-Operatórios , Estudos Prospectivos , Insuficiência Renal Crônica/etiologia , Insuficiência Renal Crônica/fisiopatologia , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença
10.
BMC Cardiovasc Disord ; 16(1): 246, 2016 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-27905877

RESUMO

BACKGROUND: Mineralocorticoid receptor antagonists (MRAs) have been associated with improved patient outcomes in patients with heart failure with reduced ejection fraction (HFrEF) but not preserved ejection fraction (HFpEF). We conducted a systematic review and meta-analysis of selective and nonselective MRAs in HFrEF and HFpEF. METHODS: We searched Cochrane Central Register of Controlled Trials, MEDLINE and EMBASE. We included randomized controlled trials (RCT) of MRAs in adults with HFpEF or HFrEF if they reported data on major adverse cardiac events or drug safety. RESULTS: We identified 15 studies representing 16321 patients. MRAs were associated with a reduced risk of cardiovascular death (RR 0.81 [0.75-0.87], I2 0%), all-cause mortality (RR 0.83 [0.77-0.88], I2 0%), and cardiac hospitalizations (RR 0.80 [0.70-0.92], I2 58.4%). However, an a-priori specified subgroup analysis demonstrated that these benefits were limited to HFrEF (cardiovascular death RR 0.79 [0.73-0.86], I2 0%; all-cause mortality RR 0.81 [0.75-0.87], I2 0%; cardiac hospitalizations RR 0.76 [0.64-0.90], I2 68%), but not HFpEF (all-cause mortality RR 0.92 [0.79-1.08], I2 0%; cardiac hospitalizations RR 0.91 [0.67-1.24], I2 17%). MRAs increased the risk of hyperkalemia (RR 2.03 [1.78-2.31], I2 0%). Nonselective MRAs, but not selective MRAs increased the risk of gynecomastia (RR 7.37 [4.42-12.30], I2 0% vs. RR 0.74 [0.43-1.27], I2 0%). Evidence was of moderate quality for cardiovascular death, all-cause mortality and cardiovascular hospitalizations; and high-quality for hyperkalemia and gynecomastia. CONCLUSIONS: MRAs reduce the risk of adverse cardiac events in HFrEF but not HFpEF. MRA use in HFpEF increases the risk of harm from hyperkalemia and gynecomastia. Selective MRAs are equally effective as nonselective MRAs, without a risk of gynecomastia.


Assuntos
Insuficiência Cardíaca/tratamento farmacológico , Antagonistas de Receptores de Mineralocorticoides/uso terapêutico , Volume Sistólico/efeitos dos fármacos , Insuficiência Cardíaca/fisiopatologia , Hospitalização/tendências , Humanos
11.
J Card Surg ; 31(2): 83-8, 2016 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-26687478

RESUMO

BACKGROUND: Tricuspid valve (TV) infective endocarditis (IE) is a known complication of intravenous drug use (IVDU). This study assessed long-term outcomes of surgically and medically treated cases of TV IE. METHODS: This was a retrospective cohort study of all cases of native TV IE treated in London, Ontario between 2008 and 2011. Outcomes for medically and surgically managed cases were assessed at two years. Outcomes related to the timing of surgery were also assessed. RESULTS: Thirty-eight patients were included; seven received valve surgery: five repairs, two replacements. All patients had a history of IVDU. Baseline characteristics were equal in both groups. Death at two years was 43% in the surgical group and 26% in the nonsurgical group (p = 0.522). In those who received surgery within 30 days versus after 30 days from admission, death was 33% and 50%, respectively (p = 1.00). No patients received emergent surgery (within seven days of admission). Twenty-nine percent of the surgical group survived disease free versus 52% of the nonsurgical group. Survival with morbidity was mainly related to ongoing IVDU. The highest risk for mortality in both groups was ongoing IVDU. CONCLUSIONS: In IVDU-related TV IE the highest risk for mortality appears to be ongoing IVDU and persistent or recurrent endocarditis.


Assuntos
Antibacterianos/uso terapêutico , Endocardite/etiologia , Endocardite/cirurgia , Abuso de Substâncias por Via Intravenosa/complicações , Valva Tricúspide , Adulto , Procedimentos Cirúrgicos Cardíacos/mortalidade , Estudos de Coortes , Endocardite/tratamento farmacológico , Endocardite/microbiologia , Feminino , Humanos , Londres , Masculino , Pessoa de Meia-Idade , Ontário , Recidiva , Estudos Retrospectivos , Risco , Taxa de Sobrevida , Fatores de Tempo , Resultado do Tratamento , Valva Tricúspide/cirurgia , Adulto Jovem
12.
BMJ ; 350: h1907, 2015 Apr 22.
Artigo em Inglês | MEDLINE | ID: mdl-25902738

RESUMO

OBJECTIVES: To determine if coronary computed tomographic angiography enhances prediction of perioperative risk in patients before non-cardiac surgery and to assess the preoperative coronary anatomy in patients who experience a myocardial infarction after non-cardiac surgery. DESIGN: Prospective cohort study. SETTING: 12 centers in eight countries. PARTICIPANTS: 955 patients with, or at risk of, atherosclerotic disease who underwent non-cardiac surgery. INTERVENTIONS: Coronary computed tomographic angiography was performed preoperatively; clinicians were blinded to the results unless left main disease was suspected. Results were classified as normal, non-obstructive (<50% stenosis), obstructive (one or two vessels with ≥ 50% stenosis), or extensive obstructive (≥ 50% stenosis in two vessels including the proximal left anterior descending artery, three vessels, or left main). MAIN OUTCOME MEASURE: Composite of cardiovascular death and non-fatal myocardial infarction within 30 days after surgery (primary outcome). This was the dependent variable in Cox regression. The independent variables were scores on the revised cardiac risk index and findings on coronary computed tomographic angiography. RESULTS: The primary outcome occurred in 74 patients (8%). The model that included both scores on the revised cardiac risk index and findings on coronary computed tomographic angiography showed that coronary computed tomographic angiography provided independent prognostic information (P=0.014; C index=0.66). The adjusted hazard ratios were 1.51 (95% confidence interval 0.45 to 5.10) for non-obstructive disease; 2.05 (0.62 to 6.74) for obstructive disease; and 3.76 (1.12 to 12.62) for extensive obstructive disease. For the model with coronary computed tomographic angiography compared with the model based on the revised cardiac risk index alone, with 30 day risk categories of <5%, 5-15%, and >15% for the primary outcome, the results of risk reclassification indicate that in a sample of 1000 patients that coronary computed tomographic angiography would have resulted appropriately in 17 net patients receiving a higher risk estimation among the 77 patients who would have experienced the primary outcome (P<0.001). Coronary computed tomographic angiography, however, would have resulted inappropriately in 98 net patients receiving a higher risk estimation, among the 923 patients who would not have experienced the primary outcome (P<0.001). Among patients who had a perioperative myocardial infarction, preoperative coronary anatomy showed extensive obstructive disease in 31% (22/71), obstructive disease in 41% (29/71), non-obstructive disease in 24% (17/71), and normal findings in 4% (3/71). CONCLUSIONS: Though findings on coronary computed tomographic angiography can improve estimation of risk for patients who will experience perioperative cardiovascular death or myocardial infarction, findings are more than five times as likely to lead to an inappropriate overestimation of risk among patients who will not experience these outcomes. Perioperative myocardial infarction occurs across the spectrum of coronary artery disease, suggesting that there could be several pathophysiologic mechanisms.


Assuntos
Angiografia Coronária , Morte Súbita Cardíaca/prevenção & controle , Infarto do Miocárdio/prevenção & controle , Complicações Pós-Operatórias/prevenção & controle , Cuidados Pré-Operatórios , Procedimentos Cirúrgicos Operatórios , Idoso , Estudos de Coortes , Morte Súbita Cardíaca/etiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Complicações Pós-Operatórias/etiologia , Guias de Prática Clínica como Assunto , Valor Preditivo dos Testes , Prognóstico , Estudos Prospectivos , Medição de Risco , Fatores de Risco
14.
JAMA ; 312(21): 2254-64, 2014 Dec 03.
Artigo em Inglês | MEDLINE | ID: mdl-25399007

RESUMO

IMPORTANCE: Acute kidney injury, a common complication of surgery, is associated with poor outcomes and high health care costs. Some studies suggest aspirin or clonidine administered during the perioperative period reduces the risk of acute kidney injury; however, these effects are uncertain and each intervention has the potential for harm. OBJECTIVE: To determine whether aspirin compared with placebo, and clonidine compared with placebo, alters the risk of perioperative acute kidney injury. DESIGN, SETTING, AND PARTICIPANTS: A 2 × 2 factorial randomized, blinded, clinical trial of 6905 patients undergoing noncardiac surgery from 88 centers in 22 countries with consecutive patients enrolled between January 2011 and December 2013. INTERVENTIONS: Patients were assigned to take aspirin (200 mg) or placebo 2 to 4 hours before surgery and then aspirin (100 mg) or placebo daily up to 30 days after surgery, and were assigned to take oral clonidine (0.2 mg) or placebo 2 to 4 hours before surgery, and then a transdermal clonidine patch (which provided clonidine at 0.2 mg/d) or placebo patch that remained until 72 hours after surgery. MAIN OUTCOMES AND MEASURES: Acute kidney injury was primarily defined as an increase in serum creatinine concentration from the preoperative concentration by either an increase of 0.3 mg/dL or greater (≥26.5 µmol/L) within 48 hours of surgery or an increase of 50% or greater within 7 days of surgery. RESULTS: Aspirin (n = 3443) vs placebo (n = 3462) did not alter the risk of acute kidney injury (13.4% vs 12.3%, respectively; adjusted relative risk, 1.10; 95% CI, 0.96-1.25). Clonidine (n = 3453) vs placebo (n = 3452) did not alter the risk of acute kidney injury (13.0% vs 12.7%, respectively; adjusted relative risk, 1.03; 95% CI, 0.90-1.18). Aspirin increased the risk of major bleeding. In a post hoc analysis, major bleeding was associated with a greater risk of subsequent acute kidney injury (23.3% when bleeding was present vs 12.3% when bleeding was absent; adjusted hazard ratio, 2.20; 95% CI, 1.72-2.83). Similarly, clonidine increased the risk of clinically important hypotension. In a post hoc analysis, clinically important hypotension was associated with a greater risk of subsequent acute kidney injury (14.3% when hypotension was present vs 11.8% when hypotension was absent; adjusted hazard ratio, 1.34; 95% CI, 1.14-1.58). CONCLUSIONS AND RELEVANCE: Among patients undergoing major noncardiac surgery, neither aspirin nor clonidine administered perioperatively reduced the risk of acute kidney injury. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01082874.


Assuntos
Lesão Renal Aguda/prevenção & controle , Agonistas de Receptores Adrenérgicos alfa 2/administração & dosagem , Aspirina/administração & dosagem , Aspirina/efeitos adversos , Clonidina/administração & dosagem , Inibidores da Agregação de Plaquetas/administração & dosagem , Administração Cutânea , Administração Oral , Agonistas de Receptores Adrenérgicos alfa 2/efeitos adversos , Idoso , Clonidina/efeitos adversos , Creatinina/sangue , Esquema de Medicação , Feminino , Hemorragia/induzido quimicamente , Humanos , Hipotensão/induzido quimicamente , Masculino , Pessoa de Meia-Idade , Assistência Perioperatória , Inibidores da Agregação de Plaquetas/efeitos adversos , Complicações Pós-Operatórias , Risco
15.
Hemoglobin ; 38(6): 409-21, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-25307964

RESUMO

ß-Thalassemia major (ß-TM) patients require life-long blood transfusions, resulting in iron overload with multi-organ morbidity and mortality. Evidence from small randomized controlled trials (RCTs) published to date for deferiprone (DFP) monotherapy or in combination with deferoxamine (DFO) is unclear. We summarized evidence on the efficacy of DFP monotherapy compared to DFO, and DFP-DFO combination therapy compared to DFP or DFO monotherapy in chronically transfused ß-TM. We searched four electronic databases and examined the grey literature. Two authors independently assessed trial quality and extracted data. We calculated the relative risk for dichotomous outcomes and mean difference (MD) for continuous outcomes. We identified 15 RCTs (1003 participants) that met the inclusion criteria. Deferiprone was more efficacious than DFO in improving cardiac ejection fraction [MD 2.88, 95% CI (95% confidence interval) 1.12 to 4.64, p = 0.001) and endocrine dysfunction (MD 0.09, 95% CI 0.08 to 0.10, p < 0.00001). The DFP-DFO combination therapy was more efficacious than DFP or DFO monotherapy in improving cardiac ejection fraction (MD 5.67, 95% CI 1.32 to 10.02, p = 0.008). There was no significant difference in all other outcomes examined. Meta-analysis on changes in myocardial iron content was not possible due to differences in data presentation. The quality of evidence for all outcomes was low. There is currently insufficient evidence to show that DFP is superior to DFO in the treatment of iron overload. The use of DFP must be weighed against the potential side-effects, patient compliance and preference. Large RCTs with clinically relevant outcomes are required.


Assuntos
Transfusão de Sangue , Desferroxamina/uso terapêutico , Quelantes de Ferro/uso terapêutico , Sobrecarga de Ferro , Piridonas/uso terapêutico , Talassemia beta , Deferiprona , Feminino , Humanos , Sobrecarga de Ferro/sangue , Sobrecarga de Ferro/etiologia , Sobrecarga de Ferro/fisiopatologia , Sobrecarga de Ferro/prevenção & controle , Masculino , Talassemia beta/sangue , Talassemia beta/fisiopatologia , Talassemia beta/terapia
16.
Ann Med ; 46(8): 653-63, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-25307362

RESUMO

Cardiac biomarker troponin can be elevated in patients without a primary cardiac diagnosis and may have prognostic value. We conducted a systematic review to estimate the prevalence and prognostic significance of elevated troponin levels in patients admitted to hospital without a primary cardiac diagnosis. Literature search was done using MEDLINE (1946 to November 2012), EMBASE (1974 to Week 45, 2012), and Cochrane Central Register of Controlled Trials (November 2012). Two independent investigators reviewed full-text studies for final inclusion. We included studies of patients admitted without a primary cardiac diagnosis. Eligible studies compared adverse outcomes in patients with normal versus elevated troponin levels. Twenty-seven studies were included in the meta-analysis. Elevated troponin was associated with increased in-hospital and 30-day mortality (25 studies, 7255 patients, OR 3.88, 95% CI 2.90-5.19, P < 0.0001). Elevated troponin was also associated with increased risk of long-term mortality at 6 months (9 studies, 5368 patients, OR 4.21, 95% CI 1.84-9.64, P < 0.00001). Troponin is an independent predictor of short-term mortality with a pooled adjusted OR of 2.36, 95% CI 1.47-3.76, P < 0.0003. In conclusion, elevated troponin in non-cardiac patients is independently associated with increased mortality.


Assuntos
Mortalidade Hospitalar , Troponina/sangue , Biomarcadores/sangue , Hospitalização , Humanos , Prognóstico , Fatores de Tempo , Troponina I/sangue , Troponina T/sangue
17.
N Engl J Med ; 370(16): 1504-13, 2014 Apr 17.
Artigo em Inglês | MEDLINE | ID: mdl-24679061

RESUMO

BACKGROUND: Marked activation of the sympathetic nervous system occurs during and after noncardiac surgery. Low-dose clonidine, which blunts central sympathetic outflow, may prevent perioperative myocardial infarction and death without inducing hemodynamic instability. METHODS: We performed a blinded, randomized trial with a 2-by-2 factorial design to allow separate evaluation of low-dose clonidine versus placebo and low-dose aspirin versus placebo in patients with, or at risk for, atherosclerotic disease who were undergoing noncardiac surgery. A total of 10,010 patients at 135 centers in 23 countries were enrolled. For the comparison of clonidine with placebo, patients were randomly assigned to receive clonidine (0.2 mg per day) or placebo just before surgery, with the study drug continued until 72 hours after surgery. The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days. RESULTS: Clonidine, as compared with placebo, did not reduce the number of primary-outcome events (367 and 339, respectively; hazard ratio with clonidine, 1.08; 95% confidence interval [CI], 0.93 to 1.26; P=0.29). Myocardial infarction occurred in 329 patients (6.6%) assigned to clonidine and in 295 patients (5.9%) assigned to placebo (hazard ratio, 1.11; 95% CI, 0.95 to 1.30; P=0.18). Significantly more patients in the clonidine group than in the placebo group had clinically important hypotension (2385 patients [47.6%] vs. 1854 patients [37.1%]; hazard ratio 1.32; 95% CI, 1.24 to 1.40; P<0.001). Clonidine, as compared with placebo, was associated with an increased rate of nonfatal cardiac arrest (0.3% [16 patients] vs. 0.1% [5 patients]; hazard ratio, 3.20; 95% CI, 1.17 to 8.73; P=0.02). CONCLUSIONS: Administration of low-dose clonidine in patients undergoing noncardiac surgery did not reduce the rate of the composite outcome of death or nonfatal myocardial infarction; it did, however, increase the risk of clinically important hypotension and nonfatal cardiac arrest. (Funded by the Canadian Institutes of Health Research and others; POISE-2 ClinicalTrials.gov number, NCT01082874.).


Assuntos
Agonistas de Receptores Adrenérgicos alfa 2/uso terapêutico , Clonidina/uso terapêutico , Hipotensão/induzido quimicamente , Infarto do Miocárdio/prevenção & controle , Complicações Pós-Operatórias/prevenção & controle , Procedimentos Cirúrgicos Operatórios/mortalidade , Agonistas de Receptores Adrenérgicos alfa 2/efeitos adversos , Idoso , Clonidina/efeitos adversos , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Assistência Perioperatória , Complicações Pós-Operatórias/induzido quimicamente , Falha de Tratamento
18.
N Engl J Med ; 370(16): 1494-503, 2014 Apr 17.
Artigo em Inglês | MEDLINE | ID: mdl-24679062

RESUMO

BACKGROUND: There is substantial variability in the perioperative administration of aspirin in patients undergoing noncardiac surgery, both among patients who are already on an aspirin regimen and among those who are not. METHODS: Using a 2-by-2 factorial trial design, we randomly assigned 10,010 patients who were preparing to undergo noncardiac surgery and were at risk for vascular complications to receive aspirin or placebo and clonidine or placebo. The results of the aspirin trial are reported here. The patients were stratified according to whether they had not been taking aspirin before the study (initiation stratum, with 5628 patients) or they were already on an aspirin regimen (continuation stratum, with 4382 patients). Patients started taking aspirin (at a dose of 200 mg) or placebo just before surgery and continued it daily (at a dose of 100 mg) for 30 days in the initiation stratum and for 7 days in the continuation stratum, after which patients resumed their regular aspirin regimen. The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days. RESULTS: The primary outcome occurred in 351 of 4998 patients (7.0%) in the aspirin group and in 355 of 5012 patients (7.1%) in the placebo group (hazard ratio in the aspirin group, 0.99; 95% confidence interval [CI], 0.86 to 1.15; P=0.92). Major bleeding was more common in the aspirin group than in the placebo group (230 patients [4.6%] vs. 188 patients [3.8%]; hazard ratio, 1.23; 95% CI, 1.01, to 1.49; P=0.04). The primary and secondary outcome results were similar in the two aspirin strata. CONCLUSIONS: Administration of aspirin before surgery and throughout the early postsurgical period had no significant effect on the rate of a composite of death or nonfatal myocardial infarction but increased the risk of major bleeding. (Funded by the Canadian Institutes of Health Research and others; POISE-2 ClinicalTrials.gov number, NCT01082874.).


Assuntos
Aspirina/uso terapêutico , Infarto do Miocárdio/prevenção & controle , Inibidores da Agregação de Plaquetas/uso terapêutico , Complicações Pós-Operatórias/prevenção & controle , Hemorragia Pós-Operatória/induzido quimicamente , Procedimentos Cirúrgicos Operatórios/mortalidade , Idoso , Aspirina/efeitos adversos , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Assistência Perioperatória , Inibidores da Agregação de Plaquetas/efeitos adversos , Falha de Tratamento
19.
BMC Nephrol ; 15: 53, 2014 Apr 02.
Artigo em Inglês | MEDLINE | ID: mdl-24694072

RESUMO

BACKGROUND: Some studies but not others suggest angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) use prior to major surgery associates with a higher risk of postoperative acute kidney injury (AKI) and death. METHODS: We conducted a large population-based retrospective cohort study of patients aged 66 years or older who received major elective surgery in 118 hospitals in Ontario, Canada from 1995 to 2010 (n = 237,208). We grouped the cohort into ACEi/ARB users (n = 101,494) and non-users (n = 135,714) according to whether the patient filled at least one prescription for an ACEi or ARB (or not) in the 120 days prior to surgery. Our study outcomes were acute kidney injury treated with dialysis (AKI-D) within 14 days of surgery and all-cause mortality within 90 days of surgery. RESULTS: After adjusting for potential confounders, preoperative ACEi/ARB use versus non-use was associated with 17% lower risk of post-operative AKI-D (adjusted relative risk (RR): 0.83; 95% confidence interval (CI): 0.71 to 0.98) and 9% lower risk of all-cause mortality (adjusted RR: 0.91; 95% CI: 0.87 to 0.95). Propensity score matched analyses provided similar results. The association between ACEi/ARB and AKI-D was significantly modified by the presence of preoperative chronic kidney disease (CKD) (P value for interaction < 0.001) with the observed association evident only in patients with CKD (CKD - adjusted RR: 0.62; 95% CI: 0.50 to 0.78 versus No CKD: adjusted RR: 1.00; 95% CI: 0.81 to 1.24). CONCLUSIONS: In this cohort study, preoperative ACEi/ARB use versus non-use was associated with a lower risk of AKI-D, and the association was primarily evident in patients with CKD. Large, multi-centre randomized trials are needed to inform optimal ACEi/ARB use in the peri-operative setting.


Assuntos
Lesão Renal Aguda/induzido quimicamente , Lesão Renal Aguda/mortalidade , Antagonistas de Receptores de Angiotensina/efeitos adversos , Inibidores da Enzima Conversora de Angiotensina/efeitos adversos , Procedimentos Cirúrgicos Eletivos/efeitos adversos , Procedimentos Cirúrgicos Eletivos/estatística & dados numéricos , Diálise Renal/mortalidade , Lesão Renal Aguda/terapia , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Incidência , Masculino , Ontário/epidemiologia , Pré-Medicação , Estudos Retrospectivos , Fatores de Risco , Taxa de Sobrevida , Resultado do Tratamento
20.
J Clin Epidemiol ; 67(6): 622-8, 2014 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-24508144

RESUMO

OBJECTIVES: A P-value <0.05 is one metric used to evaluate the results of a randomized controlled trial (RCT). We wondered how often statistically significant results in RCTs may be lost with small changes in the numbers of outcomes. STUDY DESIGN AND SETTING: A review of RCTs in high-impact medical journals that reported a statistically significant result for at least one dichotomous or time-to-event outcome in the abstract. In the group with the smallest number of events, we changed the status of patients without an event to an event until the P-value exceeded 0.05. We labeled this number the Fragility Index; smaller numbers indicated a more fragile result. RESULTS: The 399 eligible trials had a median sample size of 682 patients (range: 15-112,604) and a median of 112 events (range: 8-5,142); 53% reported a P-value <0.01. The median Fragility Index was 8 (range: 0-109); 25% had a Fragility Index of 3 or less. In 53% of trials, the Fragility Index was less than the number of patients lost to follow-up. CONCLUSION: The statistically significant results of many RCTs hinge on small numbers of events. The Fragility Index complements the P-value and helps identify less robust results.


Assuntos
Interpretação Estatística de Dados , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Perda de Seguimento , Tamanho da Amostra
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