Shared by Robert Mahoney

Link: http://www.nytimes.com/2008/11/28/business/28govtest.html
Critics say drug firms worked to discredit a clinical trial that found that inexpensive pills for hypertension worked better than newer drugs.

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Diagnostic Performance of Coronary Angiography by 64-Row CT.

N Engl J Med. 2008 Nov 27;359(22):2324-2336

Authors: Miller JM, Rochitte CE, Dewey M, Arbab-Zadeh A, Niinuma H, Gottlieb I, Paul N, Clouse ME, Shapiro EP, Hoe J, Lardo AC, Bush DE, de Roos A, Cox C, Brinker J, Lima JA

BACKGROUND: The accuracy of multidetector computed tomographic (CT) angiography involving 64 detectors has not been well established. METHODS: We conducted a multicenter study to examine the accuracy of 64-row, 0.5-mm multidetector CT angiography as compared with conventional coronary angiography in patients with suspected coronary artery disease. Nine centers enrolled patients who underwent calcium scoring and multidetector CT angiography before conventional coronary angiography. In 291 patients with calcium scores of 600 or less, segments 1.5 mm or more in diameter were analyzed by means of CT and conventional angiography at independent core laboratories. Stenoses of 50% or more were considered obstructive. The area under the receiver-operating-characteristic curve (AUC) was used to evaluate diagnostic accuracy relative to that of conventional angiography and subsequent revascularization status, whereas disease severity was assessed with the use of the modified Duke Coronary Artery Disease Index. RESULTS: A total of 56% of patients had obstructive coronary artery disease. The patient-based diagnostic accuracy of quantitative CT angiography for detecting or ruling out stenoses of 50% or more according to conventional angiography revealed an AUC of 0.93 (95% confidence interval [CI], 0.90 to 0.96), with a sensitivity of 85% (95% CI, 79 to 90), a specificity of 90% (95% CI, 83 to 94), a positive predictive value of 91% (95% CI, 86 to 95), and a negative predictive value of 83% (95% CI, 75 to 89). CT angiography was similar to conventional angiography in its ability to identify patients who subsequently underwent revascularization: the AUC was 0.84 (95% CI, 0.79 to 0.88) for multidetector CT angiography and 0.82 (95% CI, 0.77 to 0.86) for conventional angiography. A per-vessel analysis of 866 vessels yielded an AUC of 0.91 (95% CI, 0.88 to 0.93). Disease severity ascertained by CT and conventional angiography was well correlated (r=0.81; 95% CI, 0.76 to 0.84). Two patients had important reactions to contrast medium after CT angiography. CONCLUSIONS: Multidetector CT angiography accurately identifies the presence and severity of obstructive coronary artery disease and subsequent revascularization in symptomatic patients. The negative and positive predictive values indicate that multidetector CT angiography cannot replace conventional coronary angiography at present. (ClinicalTrials.gov number, NCT00738218.) Copyright 2008 Massachusetts Medical Society.

PMID: 19038879 [PubMed - as supplied by publisher]

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Shared by Robert Mahoney

Link: http://content.nejm.org/cgi/content/full/359/22/2355
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Shared by Robert Mahoney

Link: http://www.bmj.com/cgi/content/full/337/nov27_1/a2538
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Diagnosis and management of patients at risk of or with metastatic spinal cord compression: summary of NICE guidance.
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Shared by Robert Mahoney

Link: http://www.bmj.com/cgi/content/full/337/nov27_1/a2555
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Commentary: Controversies in NICE guidance on metastatic spinal cord compression.
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Authors: Coleman R
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Shared by Robert Mahoney

Link: http://www.bmj.com/cgi/content/full/337/nov26_1/a2750
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Resources must be diverted to allow people to die at home.
BMJ. 2008;337:a2750
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PMID: 1903…

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Metformin-associated lactic acidosis in intensive care unit.

Crit Care. 2008 Nov 26;12(6):R149

Authors: Peters N, Jay N, Cravoisy A, Barraud D, Nace L, Bollaert PE, Gibot S

ABSTRACT: INTRODUCTION: Metformin-associated lactic acidosis (MALA) is a classical side effect of metformin and is known to be a severe disease with a high mortality rate. MALA’s treatment by dialysis is controversial and is subject to many case reports. We aimed to assess the prevalence of MALA in a 16-bed, university-affiliated, intensive care unit (ICU), and the effect of dialysis on patients’ outcome. METHODS: Over a 5-year period, we retrospectively identified all patients who either were admitted into the ICU with metformin as a usual medication, or who attempted suicide by metformin ingestion. Within this population, we selected patients presenting with a lactic acidosis, thus defining MALA, and described their clinical and biological features. RESULTS: Metformin-associated lactic acidosis accounted for 0.84% of all admissions during the studied period (30 MALA admissions over 5 years) and was associated with a 30% mortality rate. The only factors associated with a fatal outcome were the reason for admission in the ICU and the initial prothrombin time. Although patients who went on to hemodialysis had higher illness severity scores, as compared to those who were not dialyzed, the mortality rates were similar between the two groups (31.3% versus 28.6%). CONCLUSIONS: Metformin-associated lactic acidosis can be encountered in the ICU several times a year and still remains a life-threatening condition. Treatment is mostly restricted to supportive measures, although hemodialysis may possess a protective effect.

PMID: 19036140 [PubMed - as supplied by publisher]

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Treatment of patients with gastric variceal hemorrhage: Endoscopic N-butyl-2-cyanoacrylate injection versus balloon-occluded retrograde transvenous obliteration.

J Gastroenterol Hepatol. 2008 Nov 18;

Authors: Hong CH, Kim HJ, Park JH, Park DI, Cho YK, Sohn CI, Jeon WK, Kim BI, Hong HP, Shin JH

Abstract Background and Aim: Our study aimed to evaluate the therapeutic results of endoscopic N-butyl-2-cyanoacrylate injection (EBC) and balloon-occluded retrograde transvenous obliteration (BRTO) in patients with gastric variceal hemorrhage (GVH) and/or high-risk gastric varices (GV). Methods: Twenty-seven patients with GVH and/or high-risk GV (>/= 5 mm in diameter, those with red spots, and a Child-Pugh grading of B or C liver cirrhosis) who were treated with either EBC or BRTO from April 2005 to December 2007 were included in our study. Results: EBC or BRTO was initially used for the treatment of GVH in 14 and 13 patients, respectively. Technical success was achieved in all 14 patients (100%) initially treated with EBC, and 10 of 13 patients (76.9%) initially treated with BRTO. Significant rebleeding occurred in 10 patients (71.4%) of the EBC group, and two patients (15.4%) of BRTO group (P < 0.01). Five of six patients (83.3%) treated with rescue BRTO due to rebleeding after initial EBC achieved technical success, and all six patients who were treated with rescue BRTO had no rebleeding during the median follow up of 17 (range: 2-37) months. The cumulative survival rate of the EBC with the BRTO rescue group/BRTO group was significantly higher than the EBC group. Conclusion: The therapeutic efficacies of EBC and BRTO for the treatment of active GVH and/or high-risk GV appeared to be similar. However, EBC might be associated with a higher rebleeding rate than BRTO. BRTO could be an effective rescue treatment for patients with GVH after initial treatment of EBC.

PMID: 19032446 [PubMed - as supplied by publisher]

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Disparity in drug-eluting stent utilization by insurance type.

Am Heart J. 2008 Dec;156(6):1133-1140

Authors: Kao J, Vicuna R, House JA, Rumsfeld JS, Ting HH, Spertus JA,

BACKGROUND: Because of the expense of drug-eluting stents (DES) and associated adjuvant therapy, nonclinical, socioeconomic factors may be associated with DES use in clinical practice. METHODS: Data on 112,588 patients from the National Cardiovascular Data CathPCI Registry (NCDR) between 2004 and 2005 with "on-label" indications for DES were analyzed. Insurance status was categorized as No Insurance, Governmental, and Private Insurance. Hierarchical multivariable logistic regression analyses were used to evaluate the association between insurance status and DES use, after adjusting for patient and procedural characteristics. RESULTS: Drug-eluting stent use was >96% during the study period, with utilization significantly associated with insurance status. Compared with patients with Private Insurance, patients with No Insurance (odds ratio 0.44, 95% confidence interval 0.37-0.53) and Government Insurance (odds ratio 0.73, 95% confidence interval 0.67-0.80) were significantly less likely to receive a DES than a bare metal stent. Repeat analysis of patients <65 years of age demonstrated virtually identical results. CONCLUSIONS: Despite the high penetration of DES, significant associations between insurance status and DES utilization were identified. This indicates that disparities in health care based on socioeconomic factors extend to DES utilization and highlights the need to address such disparities as novel therapies emerge.

PMID: 19033009 [PubMed - as supplied by publisher]

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Cholesterol levels and in-hospital mortality in patients with acute decompensated heart failure.

Am Heart J. 2008 Dec;156(6):1170-1176

Authors: Horwich TB, Hernandez AF, Dai D, Yancy CW, Fonarow GC,

BACKGROUND: In chronic heart failure (HF), lower total cholesterol (TC) levels have been associated with increased mortality. However, the relationship between lipid levels and outcomes in acute HF has not been studied. This study investigates the relationship between cholesterol levels and in-hospital mortality in patients hospitalized with acute HF. METHODS: The Get With the Guidelines-Heart Failure registry prospectively collects data on patients hospitalized with HF. We analyzed data on 17,791 patients admitted between January 2005 and June 2007 at 236 participating hospitals who had TC levels recorded. Baseline patient characteristics, treatment regimens, and in-hospital mortality were examined by TC level (mg/dL) quartiles (Q) as follows: Q1 (TC </=118), Q2 (TC 119-145), Q3 (TC 146-179), and Q4 (TC >/=180). RESULTS: Mean TC level was 150 +/- 47 mg/dL. Patients with lower TC were older and had higher prevalence of ischemic heart disease. Of the patients, 46% were on a lipid-lowering drug, including 58%, 50%, 43%, and 34% of patients in TC Q1 to Q4, respectively. In-hospital mortality in TC Q1 to Q4 was 3.3%, 2.5%, 2.0%, and 1.3%, respectively (P < .0001). On multivariable adjusted analyses, each 10-mg/dL increase in TC level was associated with 4% decreased risk of in-hospital mortality (odds ratio 0.96, 95% CI 0.93-0.98). CONCLUSIONS: In patients hospitalized with HF, lower TC levels independently predict increased in-hospital mortality risk. Further evaluation of optimal cholesterol levels and influence of lipid-lowering medication use on outcomes in this population is warranted.

PMID: 19033015 [PubMed - as supplied by publisher]

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Independent prognostic value of echocardiography and N-terminal pro-B-type natriuretic peptide in patients with heart failure.

Am Heart J. 2008 Dec;156(6):1191-5

Authors: Hinderliter AL, Blumenthal JA, O’Conner C, Adams KF, Dupree CS, Waugh RA, Bensimhon D, Christenson RH, Sherwood A

BACKGROUND: Echocardiographic indices of cardiac structure and function and natriuretic peptide levels are strong predictors of mortality in patients with heart failure. Whether cardiac ultrasound and natriuretic peptides provide independent prognostic information is uncertain. METHODS: Echocardiograms and measurements of N-terminal pro-brain natriuretic peptide (NT-proBNP) were prospectively performed in 211 patients with left ventricular systolic dysfunction who were followed for a median of 4 years. Echocardiographic variables and NT-proBNP were examined as predictors of all-cause mortality in univariable and multivariable proportional hazards models. RESULTS: Participants averaged 57 years old (SD 12 years) and had a mean left ventricular ejection fraction of 32% (SD 11%). A total of 71 patients (34%) died during the follow-up period. N-terminal pro-brain natriuretic peptide was a strong predictor of mortality (P < .001) as were multiple echocardiographic measures. In models that included age and NT-proBNP, with other clinical variables eligible for entry by stepwise selection, significant predictors of death included left ventricular ejection fraction (P = .013) and end-diastolic volume (P < .001), left atrial volume index (P = .005), right atrial volume index (P = .003), and tricuspid regurgitation area (P = .015). In models that also included left ventricular ejection fraction, end-diastolic volume of the left ventricle (P = .019), left atrial volume (P = .026), and right atrial volume (P = .020) remained significant predictors of mortality. CONCLUSIONS: Left ventricular size and function and left atrial and right atrial sizes are significant predictors of all-cause mortality in patients with heart failure, independent of NT-proBNP levels and other clinical variables.

PMID: 19033018 [PubMed - in process]

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Enhanced external counterpulsation improves systolic blood pressure in patients with refractory angina.

Am Heart J. 2008 Dec;156(6):1217-22

Authors: Campbell AR, Satran D, Zenovich AG, Campbell KM, Espel JC, Arndt TL, Poulose AK, Boisjolie CR, Juusola K, Bart BA, Henry TD

BACKGROUND: Enhanced external counterpulsation (EECP) is a noninvasive treatment of patients with refractory angina. The immediate hemodynamic effects of EECP are similar to intra-aortic balloon pump counterpulsation, but EECP's effects on standard blood pressure measurements during and after treatment are unknown. METHODS: We evaluated systolic blood pressure (SBP) and diastolic blood pressure (DBP) for 108 consecutive patients undergoing EECP. Baseline SBP, DBP, and heart rate were compared for each patient before and after each EECP session, at the end of the course of EECP, and 6 weeks after the final EECP session. RESULTS: One hundred eight patients (mean age 66.4 +/- 11.2 years, 81% male) completed 36.5 +/- 5.1 EECP sessions per patient. Overall, based on 3,586 individual readings, EECP resulted in a decrease in mean SBP of 1.1 +/- 15.3 mm Hg at the end of each EECP session (P < .001), 6.4 +/- 18.2 mm Hg at the end the course of EECP (P < .001), and 3.7 +/- 17.8 mm Hg 6 weeks after the final EECP session (P = .07), with no significant change in DBP or heart rate. Stratifying by baseline SBP, a differential response was demonstrated: SBP increased in the 2 lowest strata (<100 mm Hg and 101-110 mm Hg) and decreased in the remaining strata (P < .001). Stratified differences were sustained after individual EECP sessions, at the end of the course of EECP, and 6 weeks after the final EECP session and were independent of changes in cardiovascular medications. CONCLUSIONS: Enhanced external counterpulsation improved SBP in patients with refractory angina. On average, EECP decreased SBP during treatment and follow-up; but for patients with low baseline SBP (<110 mm Hg), EECP increased SBP. The improvements in SBP may contribute to the clinical benefit of EECP.

PMID: 19033023 [PubMed - in process]

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Direction of blood flow from the left ventricle during cardiopulmonary resuscitation in humans-its implications for mechanism of blood flow.

Am Heart J. 2008 Dec;156(6):1222.e1-7

Authors: Kim H, Hwang SO, Lee CC, Lee KH, Kim JY, Yoo BS, Lee SH, Yoon JH, Choe KH, Singer AJ

BACKGROUND: Common mechanisms proposed to explain forward blood flow during cardiopulmonary resuscitation (CPR) include the cardiac and thoracic pumps. However, the exact role of the left ventricle in promoting forward blood flow during standard CPR in humans is mostly unknown. The aim of this study was to explore the role of the left ventricle in generating forward blood flow during standard CPR in humans by observing the direction of blood flow during CPR. METHODS: Ten patients with non-traumatic cardiac arrest were enrolled in this study. During CPR, contrast echocardiography with agitated saline was performed in the left ventricle and the aorta, and the direction of contrast flow was assessed using transesophageal echocardiography. RESULTS: On injecting the contrast in the aortic root, anterograde flow from the aorta during the compression phase was observed. No aortic regurgitation was present. Retrograde blood flow from the left ventricle into the left atrium as well as anterograde blood flow from the left ventricle into the aorta during the compression phase of CPR was observed in all cases. On injecting the contrast in the aortic root, anterograde flow from the aorta during the compression phase was observed. During each cycle of chest compression, the mitral valve closed during compression and opened during relaxation, and the aortic valve opened during compression and closed during relaxation. CONCLUSIONS: Retrograde flow to the left atrium and forward blood flow onto the aorta on left ventricular contrast echocardiography during the compression phase suggests that extrinsic compression of the left ventricle by external chest compression acts as a pump in generating blood flow during standard CPR in humans.

PMID: 19033024 [PubMed - in process]

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Long-term Outcomes and Costs of Ventricular Assist Devices Among Medicare Beneficiaries.

JAMA. 2008 Nov 26;300(20):2398-406

Authors: Hernandez AF, Shea AM, Milano CA, Rogers JG, Hammill BG, O’Connor CM, Schulman KA, Peterson ED, Curtis LH

CONTEXT: In 2003, Medicare expanded coverage of ventricular assist devices as destination, or permanent, therapy for end-stage heart failure. Little is known about the long-term outcomes and costs associated with these devices. OBJECTIVE: To examine the acute and long-term outcomes of Medicare beneficiaries receiving ventricular assist devices alone or after open-heart surgery. Design, Setting, and PATIENTS: Analysis of inpatient claims from the Centers for Medicare & Medicaid Services for the period 2000 through 2006. Patients were Medicare fee-for-service beneficiaries who received a ventricular assist device between February 2000 and June 2006 alone as primary therapy (primary device group; n = 1476) or after cardiotomy in the previous 30 days (postcardiotomy group; n = 1467). MAIN OUTCOME MEASURES: Cumulative incidence of device replacement, device removal, heart transplantation, readmission, and death, accounting for censoring and competing risks. Patients were followed up for at least 6 months and factors independently associated with long-term survival were identified. Medicare payments were used to calculate total inpatient costs and costs per day outside the hospital. RESULTS: Overall 1-year survival was 51.6% (n = 669) in the primary device group and 30.8% (n = 424) in the postcardiotomy group. Among primary device patients, 815 (55.2%) were discharged alive with a device. Of those, 450 (55.6%) were readmitted within 6 months and 504 (73.2%) were alive at 1 year. Of the 493 (33.6%) postcardiotomy patients discharged alive with a device, 237 (48.3%) were readmitted within 6 months and 355 (76.6%) were alive at 1 year. Mean 1-year Medicare payments for inpatient care for patients in the 2000-2005 cohorts were $178 714 (SD, $142 549) in the primary device group and $111 769 (SD, $95 413) in the postcardiotomy group. CONCLUSIONS: Among Medicare beneficiaries receiving a ventricular assist device, early mortality, morbidity, and costs remain high. Improving patient selection and reducing perioperative mortality are critical for improving overall outcomes.

PMID: 19033590 [PubMed - in process]

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Inhaled Corticosteroids in Patients With Stable Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-analysis.

JAMA. 2008 Nov 26;300(20):2407-16

Authors: Drummond MB, Dasenbrook EC, Pitz MW, Murphy DJ, Fan E

CONTEXT: Recent studies of inhaled corticosteroid (ICS) therapy for managing stable chronic obstructive pulmonary disease (COPD) have yielded conflicting results regarding survival and risk of adverse events. OBJECTIVE: To systematically review and quantitatively synthesize the effects of ICS therapy on mortality and adverse events in patients with stable COPD. DATA SOURCES: Search of MEDLINE, CENTRAL, EMBASE, CINAHL, Web of Science, and PsychInfo through February 9, 2008. STUDY SELECTION: Eligible studies were double-blind, randomized controlled trials comparing ICS therapy for 6 or more months with nonsteroid inhaled therapy in patients with COPD. DATA EXTRACTION: Two authors independently abstracted data including study characteristics, all-cause mortality, pneumonia, and bone fractures. The I(2) statistic was used to assess heterogeneity. Study-level data were pooled using a random-effects model (when I(2) >/= 50%) or a fixed-effects model (when I(2) < 50%). For the primary outcome of all-cause mortality at 1 year, our meta-analysis was powered to detect a 1.0% absolute difference in mortality, assuming a 2-sided alpha of .05 and power of 0.80. RESULTS: Eleven eligible randomized controlled trials (14 426 participants) were included. In trials with mortality data, no difference was observed in 1-year all-cause mortality (128 deaths among 4636 patients in the treatment group and 148 deaths among 4597 patients in the control group; relative risk [RR], 0.86; 95% confidence interval [CI], 0.68-1.09; P = .20; I(2) = 0%). In the trials with data on pneumonia, ICS therapy was associated with a significantly higher incidence of pneumonia (777 cases among 5405 patients in the treatment group and 561 cases among 5371 patients in the control group; RR, 1.34; 95% CI, 1.03-1.75; P = .03; I(2) = 72%). Subgroup analyses indicated an increased risk of pneumonia in the following subgroups: highest ICS dose (RR, 1.46; 95% CI, 1.10-1.92; P = .008; I(2) = 78%), shorter duration of ICS use (RR, 2.12; 95% CI, 1.47-3.05; P < .001; I(2) = 0%), lowest baseline forced expiratory volume in the first second of expiration (RR, 1.90; 95% CI, 1.26-2.85; P = .002; I(2) = 0%), and combined ICS and bronchodilator therapy (RR, 1.57; 95% CI, 1.35-1.82; P < .001; I(2) = 24%). CONCLUSIONS: Among patients with COPD, ICS therapy does not affect 1-year all-cause mortality. ICS therapy is associated with a higher risk of pneumonia. Future studies should determine whether specific subsets of patients with COPD benefit from ICS therapy.

PMID: 19033591 [PubMed - in process]

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