Background Global control of tuberculosis is hampered by slow, insensitive diagnostic methods, particularly for the detection of drug-resistant forms and in patients with human immunodeficiency virus infection. Early detection is essential to reduce the death rate and interrupt transmission, but the complexity and infrastructure needs of sensitive methods limit their accessibility and effect. Methods We assessed the performance of Xpert MTB/RIF, an automated molecular test for Mycobacterium tuberculosis (MTB) and resistance to rifampin (RIF), with fully integrated sample processing in 1730 patients with suspected drug-sensitive or multidrug-resistant pulmonary tuberculosis. Eligible patients in Peru, Azerbaijan, South Africa, and India provided three sputum specimens each. Two specimens were processed with N-acetyl-l-cysteine and sodium hydroxide before microscopy, solid and liquid culture, and the MTB/RIF test, and one specimen was used for direct testing with microscopy and the MTB/RIF test. Results Among culture-positive patients, a single, direct MTB/RIF test identified 551 of 561 patients with smear-positive tuberculosis (98.2%) and 124 of 171 with smear-negative tuberculosis (72.5%). The test was specific in 604 of 609 patients without tuberculosis (99.2%). Among patients with smear-negative, culture-positive tuberculosis, the addition of a second MTB/RIF test increased sensitivity by 12.6 percentage points and a third by 5.1 percentage points, to a total of 90.2%. As compared with phenotypic drug-susceptibility testing, MTB/RIF testing correctly identified 200 of 205 patients (97.6%) with rifampin-resistant bacteria and 504 of 514 (98.1%) with rifampin-sensitive bacteria. Sequencing resolved all but two cases in favor of the MTB/RIF assay. Conclusions The MTB/RIF test provided sensitive detection of tuberculosis and rifampin resistance directly from untreated sputum in less than 2 hours with minimal hands-on time. (Funded by the Foundation for Innovative New Diagnostics.)
BACKGROUND Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain. METHODS We randomly assigned 5179 patients with moderate or severe ischemia to an initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. A key secondary outcome was death from cardiovascular causes or myocardial infarction. RESULTS Over a median of 3.2 years, 318 primary outcome events occurred in the invasivestrategy group and 352 occurred in the conservative-strategy group. At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, −1.8 percentage points; 95% CI, −4.7 to 1.0). Results were similar with respect to the key secondary outcome. The incidence of the primary outcome was sensitive to the definition of myocardial infarction; a secondary analysis yielded more procedural myocardial infarctions of uncertain clinical importance. There were 145 deaths in the invasive-strategy group and 144 deaths in the conservative-strategy group (hazard ratio, 1.05; 95% CI, 0.83 to 1.32). CONCLUSIONS Among patients with stable coronary disease and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of ischemic cardiovascular events or death from any cause over a median of 3.2 years. The trial findings were sensitive to the definition of myocardial infarction that was used.
The proposed risk scores and categories have a high degree of discrimination for predicting mortality and represent an improvement over existing consensus-based methods. Risk models incorporating these measures may be used to compare mortality outcomes across institutions with differing case mixes.
Morbidity and mortality of isolated aortic valve replacement have fallen, despite gradual increases in patient age and overall risk profile. There has been a shift toward bioprostheses. Women, patients older than 70 years, and patients with ejection fraction less than 30% have worse outcomes for mortality, stroke, and postoperative stay.
Background-Estimation of an individual patient's risk for postoperative dialysis can support informed clinical decision making and patient counseling. Methods and Results-To develop a simple bedside risk algorithm for estimating patients' probability for dialysis after cardiac surgery, we evaluated data of 449 524 patients undergoing coronary artery bypass grafting (CABG) and/or valve surgery and enrolled in Ͼ600 hospitals participating in the Society of Thoracic Surgeons National Database (2002Database ( -2004. Logistic regression was used to identify major predictors of postoperative dialysis. Model coefficients were then converted into an additive risk score and internally validated. The model also was validated in a second sample of 86 009 patients undergoing cardiac surgery from January to June 2005. Postoperative dialysis was needed in 6451 patients after cardiac surgery (1.4%), ranging from 1.1% for isolated CABG procedures to 5.1% for CABG plus mitral valve surgery. Multivariable analysis identified preoperative serum creatinine, age, race, type of surgery (CABG plus valve or valve only versus CABG only), diabetes, shock, New York Heart Association class, lung disease, recent myocardial infarction, and prior cardiovascular surgery to be associated with need for postoperative dialysis (c statisticϭ0.83). The risk score accurately differentiated patients' need for postoperative dialysis across a broad risk spectrum and performed well in patients undergoing isolated CABG, off-pump CABG, isolated aortic valve surgery, aortic valve surgery plus CABG, isolated mitral valve surgery, and mitral valve surgery plus CABG (c statisticϭ0.83, 0.85, 0.81, 0.75, 0.80, and 0.75, respectively). Conclusions-Our study identifies the major patient risk factors for postoperative dialysis after cardiac surgery. These risk factors have been converted into a simple, accurate bedside risk tool. This tool should facilitate improved clinician-patient discussions about risks of postoperative dialysis.
ATIENTS WHO UNDERGO CARdiac surgery receive a significant proportion of the 14 million units of allogeneic red blood cells (RBCs) transfused annually in the United States. 1 Numerous observational studies in patients who underwent cardiac surgery have shown an association between RBC transfusion and adverse outcome, including morbidity, mortality, resource utilization, and quality of life. [2][3][4][5][6][7][8][9] To date, no large randomized trials of transfusion thresholds have been conducted in cardiac surgery to our knowledge to address this issue.Almost 20 years ago, the study by Goodnough et al 10 demonstrated that there was significant practice variability in transfusion practices at 18 US centers. However, this study and subsequent studies [11][12][13][14] were limited in size and did not adjust for hospital or patient factors. Since these earlier studies, the Society of Thoracic Surgeons (STS) and Society of Cardiovascular Anesthesiologists published transfusion recommendations in 2007. 15 However, the degree to which guidelines have resulted in consensus in community transfusion practice is unknown. Therefore, the primary goal of our study was to assess use of RBC, fresh-frozen plasma, and platelet transfusions in coronary artery bypass graft (CABG) surgery in contemporary practice. Our analyses specifically addressed the degree to which transfusion practices varied among US hospitals, after adjusting for patient characteristics. METHODS Data SourceThe STS Adult Cardiac Surgery Database (ACSD) was established in 1989 to report outcomes following cardiothoracic surgical procedures. [16][17][18][19][20] The database captures clinical information from the majority of US cardiac surgical procedures. A recent analysis demon-strated that more than 80% of patients undergoing CABG operations in the United States in 2007 were represented in the STS database. 21 Sites enter patient data using uniform definitions
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