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Adalimumab and methotrexate is more effective than adalimumab alone in patients with established rheumatoid arthritis: results from a 6-month longitudinal, observational, multicentre study.

OBJECTIVES: To compare the effectiveness of adalimumab monotherapy and adalimumab and methotrexate (MTX) combination therapy in patients with established rheumatoid arthritis. METHODS: Data from an ongoing longitudinal observational study in Norway were used to compare response to treatment with two different adalimumab regimens (monotherapy, n = 84; combination with MTX, n = 99). Patients were assessed with measures of disease activity, health status and utility scores. Within-group changes were analysed from baseline to follow-up at 3 and 6 months and the changes were compared between groups after adjustment for the propensity score. The groups were also compared for the proportions of patients achieving European League Against Rheumatism (EULAR) good response, Disease Activity Score (DAS)28 remission and treatment terminations. RESULTS: The improvement from baseline was significant for all measures in the adalimumab and MTX group, but only for DAS28, joint counts, two Short-form Health Survey with 36 questions (SF-36) dimensions and patient's and investigator's global assessment in the monotherapy group. All between-group differences were numerically in favour of combination therapy and significant for C reactive protein, joint counts, DAS28, Modified Health Assessment Questionnaire, investigator's global assessment, four SF-36 dimensions and Short Form 6D at 6 months. More patients in the combination therapy group reached EULAR good response (p<0.001) and remission (p = 0.07). At 6 months, 80.8% of the patients in the combination therapy group and 59.5% in the monotherapy group remained on treatment (p = 0.002). More withdrawals in the monotherapy group were due to adverse events. CONCLUSIONS: Our results were consistent across several categories of end points and suggest that adalimumab combined with MTX is effective in patients with rheumatoid arthritis treated in daily clinical practice and is superior to adalimumab monotherapy.

Adalimumab↗

Is albumin administration in the acutely ill associated with increased mortality? Results of the SOAP study.

INTRODUCTION: Albumin administration in the critically ill has been the subject of some controversy. We investigated the use of albumin solutions in European intensive care units (ICUs) and its relationship to outcome. METHODS: In a cohort, multicenter, observational study, all patients admitted to one of the participating ICUs between 1 May and 15 May 2002 were followed up until death, hospital discharge, or for 60 days. Patients were classified according to whether or not they received albumin at any time during their ICU stay. RESULTS: Of 3,147 admitted patients, 354 (11.2%) received albumin and 2,793 (88.8%) did not. Patients who received albumin were more likely to have cancer or liver cirrhosis, to be surgical admissions, and to have sepsis. They had a longer length of ICU stay and a higher mortality rate, but were also more severely ill, as manifested by higher simplified acute physiology score (SAPS) II and sequential organ failure assessment (SOFA) scores than the other patients. A Cox proportional hazard model indicated that albumin administration was significantly associated with decreased 30-day survival. Moreover, in 339 pairs matched according to a propensity score, ICU and hospital mortality rates were higher in the patients who had received albumin than in those who had not (34.8 versus 20.9% and 41.3 versus 27.7%, respectively, both p < 0.001). CONCLUSION: Albumin administration was associated with decreased survival in this population of acutely ill patients. Further prospective randomized controlled trials are needed to examine the effects of albumin administration in sub-groups of acutely ill patients.

Age Distribution↗

Impact of valve surgery on 6-month mortality in adults with complicated, left-sided native valve endocarditis: a propensity analysis.

CONTEXT: Complicated, left-sided native valve endocarditis causes significant morbidity and mortality in adults. The presumed benefits of valve surgery remain unproven due to lack of randomized controlled trials. OBJECTIVE: To determine whether valve surgery is associated with reduced mortality in adults with complicated, left-sided native valve endocarditis. DESIGN AND SETTING: Retrospective, observational cohort study conducted from January 1990 to January 2000 at 7 Connecticut hospitals. Propensity analyses were used to control for bias in treatment assignment and prognostic imbalances. PATIENTS: Of the 513 adults with complicated, left-sided native valve endocarditis, 230 (45%) underwent valve surgery and 283 (55%) received medical therapy alone. MAIN OUTCOME MEASURE: All-cause mortality at 6 months after baseline. RESULTS: In the 6-month period after baseline, 131 patients (26%) died. In unadjusted analyses, valve surgery was associated with reduced mortality (16% vs 33%; hazard ratio [HR], 0.43; 95% confidence interval [CI], 0.29-0.63; P<.001). After adjustment for baseline variables associated with mortality (including hospital site, comorbidity, congestive heart failure, microbial etiology, immunocompromised state, abnormal mental status, and refractory infection), valve surgery remained associated with reduced mortality (adjusted HR, 0.35; 95% CI, 0.23-0.54; P<.02). In further analyses of 218 patients matched by propensity scores, valve surgery remained associated with reduced mortality (15% vs 28%; HR, 0.45; 95% CI, 0.23-0.86; P =.01). After additional adjustment for variables that contribute to heterogeneity and confounding within the propensity-matched group, surgical therapy remained significantly associated with a lower mortality (HR, 0.40; 95% CI, 0.18-0.91; P =.03). In this propensity-matched group, patients with moderate to severe congestive heart failure showed the greatest reduction in mortality with valve surgery (14% vs 51%; HR, 0.22; 95% CI, 0.09-0.53; P =.001). CONCLUSIONS: Valve surgery for patients with complicated, left-sided native valve endocarditis was independently associated with reduced 6-month mortality after adjustment for both baseline variables associated with the propensity to undergo valve surgery and baseline variables associated with mortality. The reduced mortality was particularly evident among patients with moderate to severe congestive heart failure.

Adult↗

Out-of-hospital endotracheal intubation and outcome after traumatic brain injury.

STUDY OBJECTIVE: Previous studies disagree about the effect of out-of-hospital endotracheal intubation on traumatic brain injury. This study compares the effects of out-of-hospital endotracheal intubation versus emergency department (ED) endotracheal intubation on mortality and neurologic and functional outcome after severe traumatic brain injury. METHODS: From the 2000 to 2002 Pennsylvania Trauma Outcome Study (a registry of all patients treated at trauma centers in the Commonwealth of Pennsylvania), adult patients with head/neck Abbreviated Injury Scale score of 3 or greater and undergoing out-of-hospital endotracheal intubation or ED endotracheal intubation were included. Transferred patients were excluded. The primary outcome was death (on hospital discharge). The secondary outcomes were neurologic (good versus poor, inferred from discharge to home versus long-term care facility) and functional outcome (determined from a Functional Impairment Score). The key exposure was endotracheal intubation (out-of-hospital endotracheal intubation versus ED endotracheal intubation). Using multivariate logistic regression, odds estimates for out-of-hospital endotracheal intubation were adjusted using age, sex, head/neck Abbreviated Injury Scale score, Injury Severity Score, mechanism of injury (penetrating versus blunt), admission systolic blood pressure, mode of transport (ground only versus helicopter or helicopter + ground), and the use of out-of-hospital neuromuscular blocking agents. A propensity score adjustment accounted for the potential effects of preexisting conditions, inhospital complications, and social factors (drug and alcohol use, race, and insurance coverage). RESULTS: There were 4,098 patients with head/neck Abbreviated Injury Scale score of 3 or greater who received either out-of-hospital endotracheal intubation (n=1,797, 43.9%) or ED endotracheal intubation (n=2,301, 56.1%). Adjusted odds of death were higher for out-of-hospital endotracheal intubation than ED endotracheal intubation (odds ratio [OR] 3.99; 95% confidence interval [CI] 3.21 to 4.93). Out-of-hospital endotracheal intubation was associated with an increased adjusted odds of poor neurologic outcome (OR 1.61; 95% CI 1.15 to 2.26), moderate or severe functional impairment (Functional Impairment Score 6 to 15; OR 1.92; 95% CI 1.40 to 2.64), and severe functional impairment (Functional Impairment Score 11 to 15; OR 1.80; 95% CI 1.29 to 2.52). CONCLUSION: Out-of-hospital endotracheal intubation was associated with adverse outcomes after severe traumatic brain injury. The implications for current clinical care remain undefined.

Adolescent↗

Aspirin use and all-cause mortality among patients being evaluated for known or suspected coronary artery disease: A propensity analysis.

CONTEXT: Although aspirin has been shown to reduce cardiovascular morbidity and short-term mortality following acute myocardial infarction, the association between its use and long-term all-cause mortality has not been well defined. OBJECTIVES: To determine whether aspirin is associated with a mortality benefit in stable patients with known or suspected coronary disease and to identify patient characteristics that predict the maximum absolute mortality benefit from aspirin. DESIGN AND SETTING: Prospective, nonrandomized, observational cohort study conducted between 1990 and 1998 at an academic medical institution, with a median follow-up of 3.1 years. PATIENTS: Of 6174 consecutive adults undergoing stress echocardiography for evaluation of known or suspected coronary disease, 2310 (37%) were taking aspirin. Patients with significant valvular disease or documented contraindication to aspirin use, including peptic ulcer disease, renal insufficiency, and use of nonsteroidal anti-inflammatory drugs, were excluded. MAIN OUTCOME MEASURE: All-cause mortality according to aspirin use. RESULTS: During 3.1 years of follow-up, 276 patients (4.5%) died. In a simple univariable analysis, there was no association between aspirin use and mortality (4.5% vs 4.5%). However, after adjustment for age, sex, standard cardiovascular risk factors, use of other medications, coronary disease history, ejection fraction, exercise capacity, heart rate recovery, and echocardiographic ischemia, aspirin use was associated with reduced mortality (hazard ratio [HR], 0.67; 95% confidence interval [CI], 0.51-0.87; P =.002). In further analysis using matching by propensity score, 1351 patients who were taking aspirin were at lower risk for death than 1351 patients not using aspirin (4% vs 8%, respectively; HR, 0.53; 95% CI, 0.38-0.74; P =.002). After adjusting for the propensity for using aspirin, as well as other possible confounders and interactions, aspirin use remained associated with a lower risk for death (adjusted HR, 0.56; 95% CI, 0.40-0.78; P<.001). The patient characteristics associated with the most aspirin-related reductions in mortality were older age, known coronary artery disease, and impaired exercise capacity. CONCLUSION: Aspirin use among patients undergoing stress echocardiography was independently associated with reduced long-term all-cause mortality, particularly among older patients, those with known coronary artery disease, and those with impaired exercise capacity.

Aspirin↗

Does use of a right internal thoracic artery increase deep wound infection and risk after previous use of a left internal thoracic artery?

OBJECTIVE: To determine whether adding right internal thoracic artery to previous left internal thoracic artery bypass at reoperation increases deep sternal wound infection and hospital mortality, particularly in diabetic patients. METHODS: Reoperations (n = 2875; 2381 men) in patients with previous left internal thoracic artery bypass were performed between January 1990 and January 2003; 1939 (67%) had no repeat internal thoracic artery grafting, 923 (32%) received an additional right internal thoracic artery graft, and 13 (0.5%) had bilateral internal thoracic artery grafting with reuse of the left internal thoracic artery. Of the patients, 352 (12%) were insulin-treated and 590 (21%) non-insulin-treated diabetics. Multivariable logistic regression analysis was used to identify preoperative variables associated with right versus non-right internal thoracic artery use in diabetics and nondiabetics and to formulate propensity models. Propensity scores were used for matching and adjusted multivariable analyses of deep wound infection and hospital mortality. RESULTS: Deep wound infection occurred in 3.0% (7/230) of diabetics receiving right internal thoracic artery grafts, 2.2% (5/230) of propensity-matched diabetics receiving non-right internal thoracic artery grafts (P = .6), in 1.1% (6/538) of nondiabetics receiving right internal thoracic artery grafts, and in 1.0% (5/538) of matched non-diabetic patients receiving non-right internal thoracic artery grafts (P = .8). Corresponding hospital mortality in these matched groups was 1.7% (4/230) versus 6.1% (14/230) for diabetics (P = .02) and 2.6% (14/538) versus 3.5% (19/538) for nondiabetics (P = .4). Risk factors for deep wound infection included higher weight (P = .0003), higher New York Heart Association functional class (P = .03), and less severe left anterior descending disease (P = .03). Risk factors for death were (P < .02) emergency operation, mitral valve replacement, and greater number of saphenous vein grafts. CONCLUSIONS: Use of the right internal thoracic artery for reoperations does not increase the risk of deep wound infections in diabetics or nondiabetics and does not increase mortality.

Aged↗

Early and late outcome of myocardial revascularization with and without cardiopulmonary bypass in high risk patients (EuroSCORE > or = 6).

OBJECTIVE: To evaluate 30-day and late results in high risk patients (European score (EuroSCORE) > or = 6) who underwent isolated myocardial revascularization with and without cardiopulmonary bypass (CPB). METHODS: From November 1994 to December 2001, 1266 patients with EuroSCORE > or = 6 underwent isolated myocardial revascularization. Among them, applying the propensity score, we were able to select 1020 patients operated on without CPB (group A, n=510) and with CPB (group B, n=510) with the same preoperative characteristics. The only differences were the higher incidence of patients with age between 61 and 65 years (9.4% in group A vs. 13.9% in group B, P=0.025) and the lower number of anastomoses/patient in group A (1.8+/-0.9 vs. 2.8+/-0.9, P<0.001). EuroSCORE were identical in both groups (7.8%). RESULTS: Thirty-day mortality was higher in group B (5.9 vs. 3.1%, P=0.035). Group A showed a lower incidence of cerebrovascular accidents (CVAs) (0.6 vs. 3.1%, P=0.003), whereas incidence of acute myocardial infarction (AMI) was similar (2.0% in group A vs. 2.5% in group B, P=ns). Early negative primary end-points and early major events incidences were higher in group B (8.2 vs. 3.9%, P=0.004, and 14.5 vs. 7.1%, P<0.001, respectively). Stepwise logistic regression confirmed that CPB was an independent predictor for higher early mortality (Odds ratio (OR) 2.0) and CVA, negative primary end-points and early major events incidences (OR 4.6, 2.3 and 2.4, respectively). Five-year freedom from the events explored (death due to any cause, cardiac death, AMI, AMI on a grafted area, redo/percutaneous transluminal coronary angioplasty (PTCA), redo/PTCA on a grafted area, target cardiac events (cardiac death, AMI in a grafted area and redo/PTCA in a grafted area) and any event were similar in both groups. CONCLUSIONS: In high risk patients myocardial revascularization without CPB shows better early outcome and similar clinical late results.

Age Factors↗

Astigmatic vector outcomes after FS-LASIK versus SMILE for high myopic astigmatism: a single-center retrospective comparative cohort study without cyclotorsion compensation.

PURPOSE: To compare astigmatic correction vector outcomes between femtosecond laser-assisted in situ keratomileusis (FS-LASIK) and small-incision lenticule extraction (SMILE, also termed Keratorefractive Lenticule Extraction, KLEx) without intraoperative cyclotorsion compensation in patients with high myopic astigmatism (-&#x2009;2.00 to&#x2009;-&#x2009;3.75 D), and to clarify procedure-specific correction tendencies under this non-standardized alignment protocol. METHODS: This single-center retrospective comparative cohort study enrolled 155 eyes (one eye randomly selected per patient) that underwent FS-LASIK (80 eyes) or SMILE/KLEx (75 eyes) for high myopic astigmatism correction from January 2023 to July 2024 in Beijing Fenglian Jiayue Lige Clinic. Intraoperative cyclotorsion compensation was intentionally disabled to isolate inherent procedural astigmatism correction characteristics. Standardized Alpins vectorial analysis was performed at 3&#xa0;months and 12&#xa0;months postoperatively. PRIMARY ENDPOINT: 12-month Alpins correction index (CI). Multivariable propensity score adjustment was applied to mitigate confounding by clinical treatment selection bias. Statistical multiplicity control was implemented for secondary vector and visual outcomes. RESULTS: Baseline demographic, refractive, corneal and ocular biometric parameters were balanced between groups after propensity matching. No statistically significant intergroup differences were detected in uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), residual cylinder, safety index or efficacy index at 3 and 12&#xa0;months (all P&#x2009;>&#x2009;0.05). Under the non-cyclotorsion-compensated protocol, significant intergroup differences were identified in the magnitude of surgically induced astigmatism (SIA), correction index (CI), and magnitude error (ME) at both follow-up timepoints (all P&#x2009;<&#x2009;0.0001). Target induced astigmatism (TIA), difference vector (DV), index of success (IOS), and angle error (AE) magnitudes were comparable between groups (all P&#x2009;>&#x2009;0.05). The vector mean axis of DV differed significantly between groups at 3 and 12&#xa0;months (Watson-Williams circular test, all P&#x2009;<&#x2009;0.0001). No reoperations were documented in clinic medical records for either cohort. No standardized dry eye questionnaires, tear film testing or corneal nerve density metrics were collected to quantify dry eye adverse events; only unstructured clinical notes were reviewed for complication screening. CONCLUSIONS: Under surgical alignment without cyclotorsion compensation, FS-LASIK and SMILE/KLEx both yielded acceptable visual and refractive safety/efficacy for high myopic astigmatism (-&#x2009;2.00 to&#x2009;-&#x2009;3.75 D) at 1-year follow-up, but demonstrated divergent astigmatism correction tendencies: FS-LASIK exhibited relative astigmatism overcorrection (vector mean DV:&#x2009;-&#x2009;0.35&#x2009;&#xb1;&#x2009;0.43 D&#x2009;&#xd7;&#x2009;91&#xb0;, CI&#x2009;>&#x2009;1), while SMILE/KLEx showed relative undercorrection (vector mean DV:&#x2009;-&#x2009;0.21&#x2009;&#xb1;&#x2009;0.53 D&#x2009;&#xd7;&#x2009;12&#xb0;, CI&#x2009;<&#x2009;1). These correction biases are specific to the study's manual limbal alignment protocol without cyclotorsion tracking and cannot be generalized to modern optimized surgical platforms equipped with automated cyclotorsion compensation. Residual refractive errors across both groups are likely multifactorial, including differential corneal stromal healing responses, divergent femtosecond/excimer laser tissue modification mechanisms, and uncorrected intraoperative ocular cyclotorsion.

Humans↗

The impact of verbal feedback about blushing on social discomfort and facial blood flow during embarrassing tasks.

To investigate whether verbal feedback about blushing influences subsequent social discomfort or blushing itself, changes in facial blood flow and ratings of blushing and embarrassment were investigated in high (N=28) and low scorers (N=28) on the Blushing Propensity scale while singing and reading aloud, and while listening to audiotapes of their performance. After each task half of the participants were told that they had blushed, and the rest were told that they had not blushed. Blood flow increased progressively in participants with high blushing propensity scores who were given "blushing" feedback, but not in the other participants. This finding suggests that expecting to blush may become a self-fulfilling prophecy. Verbal feedback about blushing strongly influenced subsequent social discomfort, and mimicked the effects of blushing propensity on ratings of embarrassment and blushing intensity. In sum, the findings support the view that preconceptions about blushing propensity are shaped by past learning experiences, that concern about blushing is a major source of discomfort in embarrassing situations, and that these concerns are often unrelated to the actual intensity of blushing.

Adolescent↗

Smooth quantile ratio estimation with regression: estimating medical expenditures for smoking-attributable diseases.

The methodological development of this paper is motivated by a common problem in econometrics where we are interested in estimating the difference in the average expenditures between two populations, say with and without a disease, as a function of the covariates. For example, let Y(1) and Y(2) be two non-negative random variables denoting the health expenditures for cases and controls. Smooth Quantile Ratio Estimation (SQUARE) is a novel approach for estimating Delta=E[Y(1)] - E[Y(2)] by smoothing across percentiles the log-transformed ratio of the two quantile functions. Dominici et al. (2005) have shown that SQUARE defines a large class of estimators of Delta, is more efficient than common parametric and nonparametric estimators of Delta, and is consistent and asymptotically normal. However, in applications it is often desirable to estimate Delta(x)=E[Y(1)|x]--E[Y(2)|x], that is, the difference in means as a function of x. In this paper we extend SQUARE to a regression model and we introduce a two-part regression SQUARE for estimating Delta(x) as a function of x. We use the first part of the model to estimate the probability of incurring any costs and the second part of the model to estimate the mean difference in health expenditures, given that a nonzero cost is observed. In the second part of the model, we apply the basic definition of SQUARE for positive costs to compare expenditures for the cases and controls having 'similar' covariate profiles. We determine strata of cases and control with 'similar' covariate profiles by the use of propensity score matching. We then apply two-part regression SQUARE to the 1987 National Medicare Expenditure Survey to estimate the difference Delta(x) between persons suffering from smoking-attributable diseases and persons without these diseases as a function of the propensity of getting the disease. Using a simulation study, we compare frequentist properties of two-part regression SQUARE with maximum likelihood estimators for the log-transformed expenditures.

Age Factors↗

A non-randomised pilot study to compare complementary and conventional treatments of acute sinusitis.

BACKGROUND: It is still under discussion whether antibiotics are effective in the treatment of acute sinusitis. Moreover, they are known to have considerable side-effects. In contrast, complementary approaches are reported to have little side-effects and an equivalent efficiency. OBJECTIVES: To assess the success of conventional and complementary treatments of acute sinusitis and to estimate the patient numbers needed to confirm therapeutic equivalence. Treatment success was measured by three different scores, assessed by both patients and physicians. METHODS: Multicentre (2 complementary and 3 conventional ENT centres), non-randomised, controlled clinical trial with 63 patients (complementary group 30, conventional group 33 patients). To control for confounders treatment differences were estimated by propensity score techniques. TREATMENTS: The choice of medication was entirely left to the physician. We recommended to use antibiotics, secretolytics and symptomimetics in the conventional group and a combination of the herbal remedy Sinupret((R)) and the homeopathic remedy Cinnabaris 3X in the complementary group. RESULTS: Treatment differences varied substantially depending on the outcome measure, but they were always not clinically relevant. Conventional treatment was slightly better when the outcome was assessed by the physicians (1.8 score points) but slightly worse when it was assessed by patients (0.2 score points) or in terms of the HCG-5 quality of life score (0.8 score points). p values were always > 0.3. CONCLUSIONS: Both treatments appear to be equally effective (or ineffective). Results might be biased because both treatment groups differed substantially. Randomised trials including at least 400 patients are needed to produce valid results.

Acute Disease↗

Prognostic importance of concomitant heparin with eptifibatide in acute coronary syndromes. PURSUIT Investigators. Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy.

Platelet glycoprotein IIb/IIIa inhibitors have been extensively studied in the treatment of patients with ischemic heart disease. Data regarding the use of these agents in the absence of concomitant intravenous heparin have been conflicting. We sought to determine, using propensity analysis, whether the benefit of eptifibatide, a IIb/IIIa inhibitor, in the treatment of acute coronary syndromes is affected by the concurrent administration of heparin. By trial design, patients were randomized to either eptifibatide or placebo, whereas use of intravenous heparin was left to the discretion of treating physicians. The effect of eptifibatide on the 30-day composite end point of death or myocardial infarction was studied in patients who received heparin and those who did not. Propensity analysis methods were used to control for confounding and presumed selection biases. Among 5,576 patients who were receiving heparin when the bolus dose of the study drug was administered, eptifibatide was associated with a reduced composite end point rate (13%) compared with that of placebo (14.5% vs 16.6%, p = 0.03). In contrast, among 1,441 patients who were not receiving heparin, there was no difference in 30-day event rates with eptifibatide compared with placebo (13.7% vs 13.1%, p > 0.7). After a propensity score for use of heparin was developed, however, use of heparin did not affect the reduced risk associated with eptifibatide (adjusted relative risk [RR] for heparin-eptifibatide interaction term 0.90, 95% confidence interval [CI] 0.61 to 1.32, p > 0.5), but the propensity for heparin use was a strong predictor of events (adjusted RR 1.76, 95% CI 1.42 to 2.17, p < 0.001). The use of eptifibatide independently predicted a lower risk of events (adjusted RR 0.31, 95% CI 0.10 to 0.93, p = 0.04). Thus, the apparent positive impact of heparin on the benefits of eptifibatide therapy was largely due to confounding and bias.

Aged↗

Effects of early enteral feeding on the outcome of critically ill mechanically ventilated medical patients.

STUDY OBJECTIVES: To determine the impact of early enteral feeding on the outcome of critically ill medical patients. DESIGN: Retrospective analysis of a prospectively collected large multi-institutional ICU database. PATIENTS: A total of 4,049 patients requiring mechanical ventilation for > 2 days. MEASUREMENTS AND RESULTS: Patients were classified according to whether or not they received enteral feeding within 48 h of mechanical ventilation onset. The 2,537 patients (63%) who did receive enteral feeding were labeled as the "early feeding group," and the remaining 1,512 patients (37%) were labeled as the "late feeding group." The overall ICU and hospital mortality were lower in the early feeding group (18.1% vs 21.4%, p = 0.01; and 28.7% vs 33.5%, p = 0.001, respectively). The lower mortality rates in the early feeding group were most evident in the sickest group as defined by quartiles of severity of illness scores. Three separate models were done using each of the different scores (acute physiology and chronic health evaluation II, simplified acute physiology score II, and mortality prediction model at time 0). In all models, early enteral feeding was associated with an approximately 20% decrease in ICU mortality and a 25% decrease in hospital mortality. We also analyzed the data after controlling for confounding by matching for propensity score. In this analysis, early feeding was again associated with decreased ICU and hospital mortality. In all adjusted analysis, early feeding was found to be independently associated with an increased risk of ventilator-associated pneumonia (VAP) developing. CONCLUSION: Early feeding significantly reduces ICU and hospital mortality based mainly on improvements in the sickest patients, despite being associated with an increased risk of VAP developing. Routine administration of such therapy in medical patients receiving mechanical ventilation is suggested, especially in patients at high risk of death.

Adult↗

Fast-track failure after cardiac surgery: development of a prediction model.

OBJECTIVE: Risk factors for unsuccessful fast-tracking of cardiac surgery patients have not been collectively defined in the literature. The aim of this study was to determine risk factors for fast-track failure and incorporate them into a predictive fast-track failure score. DESIGN: Prospective observational study. SETTING: Cardiothoracic Department of St Mary's Hospital, London. PATIENTS: Data were collected from April 2003 to April 2005 including 1,084 patients undergoing heart surgery who were admitted into the fast-track unit. INTERVENTIONS: Multifactorial logistic regression was used to develop a propensity score for estimating the likelihood of fast-track failure. MEASUREMENTS AND MAIN RESULTS: One hundred and sixty-nine patients failed fast-track management (15.6%). Independent predictors for fast-track failure were impaired left ventricular function with or without recent acute coronary syndrome (odds ratios 2.89 and 1.65 respectively), re-do operation (one, two, or more vs. none, odds ratio 1.75, 7.98), extracardiac arteriopathy (odds ratio 2.63), preoperative intra-aortic balloon pump (odds ratio 3.09), raised serum creatinine in micromol/L (120-150, >150 vs. <120, odds ratio 1.57, 11.24), and nonelective (odds ratio 3.43) and complex surgery (odds ratio 2.70). Model validation showed very good discrimination (area under the curve = 0.815) and calibration (ĉ statistic = 8.527, p = .129). CONCLUSIONS: The fast-track failure score incorporates several preoperative factors and has been successfully internally validated; after undergoing external validation and possible recalibration it may be used as a tool to facilitate planning and flow of cardiac surgery patients, based on the predicted probability of failure. Application of this score may limit fast-track failure rates and help to reduce morbidity and cost.

Aged↗

The role of reperfusion therapy in paced patients with acute myocardial infarction.

BACKGROUND/OBJECTIVE: Our purpose was to evaluate the effectiveness of reperfusion therapy among elderly paced patients with acute myocardial infarction (MI). Current guidelines make no recommendation for the use of reperfusion therapy among patients who have a paced rhythm during MI. METHODS: We evaluated 1954 Medicare beneficiaries 65 years and older treated for acute MI between 1994 and 1996 who had a paced rhythm for use of reperfusion therapy. Use of reperfusion therapy was evaluated for associations with outcomes by logistic regression and Cox proportional hazards models incorporating propensity score analysis. RESULTS: Reperfusion therapy was used in 171 (8.8%) patients; 70 were treated with primary PTCA and 101 with thrombolytic therapy. Patients who received reperfusion therapy had 30-day mortality rates similar to those who did not receive reperfusion (26.3% vs 25.7%, P =.87). Multivariate adjustment for mortality risk factors and treatment propensity indicated no survival benefit associated with reperfusion therapy at 30 days (relative risk [RR] 1.07, 95% confidence interval [CI] 0.77-1.43) or long-term follow-up (hazard ratio [HR] 0.86, 95% CI 0.68-1.10). Mortality risks varied by type of reperfusion therapy. Patients treated with primary percutaneous transluminal coronary angioplasty were at comparable risk of mortality at 30 days (RR 0.73, 95% CI 0.40-1.23) but at lower risk at long-term follow-up (HR 0.60, 95% CI 0.40-0.88). Mortality risks were unchanged among patients treated with thrombolytics at 30 days (RR 1.32, 95% CI 0.92-1.79) and long-term follow-up (HR 1.08, 95% CI 0.82-1.43). CONCLUSION: We find suggestive evidence that primary percutaneous transluminal coronary angioplasty provides a long-term survival benefit in the treatment of elderly patients with acute MI who have a paced rhythm.

Age Factors↗

Cannulation of the axillary artery with a side graft reduces morbidity.

BACKGROUND: The axillary artery is our preferred arterial cannulation site when the ascending aorta cannot be cannulated. Previously, we cannulated the artery directly; now we use a side graft. The purposes of this study were to (1) investigate cannulation-related morbidity and (2) determine whether use of a side graft reduces it. METHODS: From January 1993 to January 2001, 392 patients underwent 399 axillary artery cannulations. Indications included calcified ascending aorta (129, 32%), ascending aortic aneurysm (115, 29%), type I aortic dissection (85, 21%), cardiac reoperation (70, 18%), and calcified femoral artery (26, 6%). The axillary artery was cannulated directly in 212 (53%) and with a side graft in 187 (47%). Comparisons of cannulation-related morbidity between the direct cannulation and side graft groups were made overall and after both adjusting and matching for propensity score. RESULTS: Cannulation-related morbidity was infrequent, with brachial plexus injury in 7 (1.8%), axillary artery damage in 7 (1.8%), aortic dissection in 3 (0.8%), and arm ischemia in 3 (0.8%). Only 4 of 187 (2.1%) occurred in the side graft group, versus 16 of 212 (7.0%) with direct cannulation (p = 0.03). After propensity adjustment, the odds ratio for reduction of risk of cannulation-related morbidity with use of a side graft was 0.15 (p = 0.002). CONCLUSIONS: Use of the axillary artery as inflow for cardiopulmonary bypass is associated with low morbidity. However, cannulation with a side graft was associated with less cannulation-related morbidity than direct cannulation. Routine use of a side graft is recommended whenever axillary artery cannulation is indicated.

Adolescent↗

C-reactive protein concentration as a predictor of intensive care unit readmission: a nested case-control study.

PURPOSE: The purpose of this study is to assess the ability of potential clinical predictors and inflammatory markers to predict intensive care unit (ICU) readmission during the same hospitalization. MATERIALS AND METHODS: A nested case-control study utilized prospectively collected de-identified data of a 22-bed multidisciplinary ICU in a university hospital. RESULTS: There were 1,405 consecutive ICU admissions in 2004, and of these, 18 were regarded as ICU readmissions (1.3%). The destination and timing of ICU discharge, the Sequential Organ Failure Assessment scores, white cell counts, and fibrinogen concentrations at discharge were not associated with ICU readmission. C-reactive protein (CRP) concentration within 24 hours before ICU discharge was associated with ICU readmission (mean CRP concentrations of cases vs controls, 177.8 vs 56.5 mg/L, respectively; P < .0001). The results remained unchanged after adjustment with the propensity scores. The area under the receiver operating characteristic curve for the CRP concentrations to predict ICU readmission was 0.884 (95% confidence interval, 0.765-0.999; P < .0001). Patients readmitted to the ICU had a higher predicted mortality in their second ICU admission (34.9% vs 26.1%; P < .01) and a longer total hospital stay (33.3 vs 20.3 days; P < .003) than patients without ICU readmission. CONCLUSIONS: A high CRP concentration within 24 hours before ICU discharge is associated with a higher risk of readmission to the ICU.

Biomarkers↗

Red cell transfusion is associated with an increased risk for postoperative atrial fibrillation.

BACKGROUND: Atrial fibrillation (AF) is a common complication after cardiac surgery and is associated with increased resource utilization. Recent evidence supports a role of inflammation in the development of AF. It is also known that red blood cell transfusion modulates inflammation by increasing plasma levels of inflammatory markers. Therefore, we tested the hypothesis that red blood cell transfusion increases the risk of postoperative AF for patients undergoing cardiac surgery. METHODS: Between February 2002 and January 2005, 5,841 patients underwent isolated coronary artery bypass grafting with or without valve replacement. Patient and procedural variables associated with development of new-onset AF were identified by logistic regression. Propensity score matching was used to confirm results. RESULTS: In addition to older age, prior history of AF, higher preoperative hematocrit, beta-blocker withdrawal, longer aortic clamp time, valve surgery, and intensive care unit inotropic usage, intensive care unit red blood cell transfusion increased risk for AF (odds ratio per unit transfused, 1.18; 95% confidence limits, 1.14, 1.23; p < 0.0001). For the 1,360 propensity-matched pairs, intensive care unit red blood cell transfusion was associated with a significant increase in new-onset AF (620 [46%] versus 522 [38%]; p < 0.001). CONCLUSIONS: Intensive care unit red blood cell transfusion is associated with increased occurrence of postoperative AF after cardiac surgery. This factor should be considered in identifying patients who might benefit from prophylaxis to prevent this common postoperative complication.

Aged↗