bluuebunny/crossref_metadata_2025_split huggingface dataset:
Abnormal inflammation leads to maternal coagulopathies associated with placental haemostatic alterations in a rat model of foetal loss
Authors: Falcón Bani J. , Cotechini Tiziana , Macdonald-Goodfellow Shannyn K. , Othman Maha , Graham Charles H. 
Published: January 2012

SummarySpontaneous pregnancy loss is often associated with aberrant maternal inflammation and systemic coagulopathies. However, the role of inflammation in the development of obstetric coagulopathies is poorly understood. Further, questions remain as to whether systemic coagulo-pathies are linked to placental haemostatic alterations, and whether these local alterations contribute to a negative foetal outcome. Using a model of spontaneous foetal loss in which pregnant rats are given a single injection of bacterial lipopolysaccharide (LPS), we characterised the systemic maternal coagulation status following LPS administration using thromboelastography (TEG), a global haemostatic assay that measures the kinetics of clot formation. Systemic maternal coagulopathy was evident in 82% of LPS-treated rats. Specifically, we observed stage-I, -II, and -III disseminated intravascular coagulation (DIC) and hypercoagulability. Modulation of inflammation through inhibition of tumour necrosis factor α with etanercept resulted in a 62% reduction in the proportion of rats exhibiting coagulopathy. Moreover, inflammation-induced systemic coagulopathies were associated with placental haemostatic alterations, which included increased intravascular, decidual, and labyrinth fibrin deposition in cases of DIC-I and hypercoagulability, and an almost complete absence of fibrin deposition in cases of DIC-III. Furthermore, systemic and placental haemostatic alterations were associated with impaired utero-placental haemodynamics, and inhibition of these haemostatic alterations by etanercept was associated with maintenance of utero-placental haemodynamics. These findings indicate that modulation of maternal inflammation may be useful in the prevention of coagulopathies associated with complications of pregnancy.
Validation of whole blood impedance aggregometry as a new diagnostic tool for HIT
Authors: Tan Chee , Brighton Timothy A , McRae Simon , Baker Ross , Tran Huyen , Mollee Peter , Kershaw Geoffrey , Joseph Joanne , Ward Christopher , Morel-Kopp Marie-Christine ,   the ASTH Clinical Trials Group
Published: January 2012

SummaryHeparin-induced thrombocytopenia (HIT) remains a challenge, with diagnosis confirmed only by functional assays. The gold standard 14C-se-rotonin release assay (SRA) is highly sensitive but technically challenging and unsuitable for routine use. We conducted a large study to validate whole blood impedance aggregometry (WBIA) as a suitable diagnostic tool for HIT. WBIA and SRA were used to test 181 samples positive for H-PF4 antibodies by PaGIA or ELISA. Using the same high responder donor, 77 samples were positive by WBIA (aggregation with low-dose but not high-dose heparin). Using the strict definition for SRA positivity, 72 samples were true HIT. In nine samples, serotonin release with high-dose heparin dropped by > 50% but was still >20%; these were retested after a one-half dilution and 8/9 became positive. Ten other samples were discrepant between the two assays: one strongly positive (89% release) and six weakly positive samples by SRA (average release 56%) were WBIA negative. When these samples were retested using a random donor, only two remained SRA positive. Three samples were strongly WBIA positive but SRA negative; two were retested by SRA with 0.5IU/ml heparin and one became positive. Under controlled conditions, using the same selected high-responder donor, WBIA and SRA performed similarly with slightly increased sensitivity of the WBIA when using the strict definition of SRA positivity. WBIA is easy to perform with rapid turn-around time and warrants a multi-laboratory trial to complete its validation as a confirmatory assay for platelet-activating HIT antibodies.
Structure and haemostatic effects of generic versions of enoxaparin available for clinical use in Brazil: Similarity to the original drug
Authors: Glauser Bianca , Vairo Bruno , Oliveira Stephan-Nicollas , Cinelli Leonardo , Pereira Mariana , Mourão Paulo 
Published: January 2012

SummaryPatent protection for enoxaparin has expired. Generic preparations are developed and approved for clinical use in different countries. However, there is still skepticism about the possibility of making an exact copy of the original drug due to the complex processes involved in generating low-molecular-weight heparins. We have undertaken a careful analysis of generic versions of enoxaparin available for clinical use in Brazil. Thirty-three batches of active ingredient and 70 of the final pharmaceutical product were obtained from six different suppliers. They were analysed for their chemical composition, molecular size distribution, in vitro anticoagulant activity and pharmacological effects on animal models of experimental thrombosis and bleeding. Clearly, the generic versions of enoxaparin available for clinical use in Brazil are similar to the original drug. Only three out of 33 batches of active ingredient from one supplier showed differences in molecular size distribution, resulting from a low percentage of tetrasaccharide or the presence of a minor component eluted as monosaccharide. Three out of 70 batches of the final pharmaceutical products contained lower amounts of the active ingredient than that declared by the suppliers. Our results suggest that the generic versions of enoxaparin are a viable therapeutic option, but their use requires strict regulations to ensure accurate standards.
The incidence of venous thromboembolism in patients with overt hyperthyroidism
Authors: Stuijver Danka J. F. , Dekkers Olaf M. , van Zaane Bregje , Fliers Eric , Cannegieter Suzanne C. , Gerdes Victor E. A. , Kootte Ruud S. 
Published: January 2012

SummaryHyperthyroidism is associated with several changes in the haemostatic system resulting in a hypercoagulable state. It is uncertain at this stage whether this leads to an increased risk of venous thromboembolism (VTE). The aim of this retrospective cohort study was to determine the risk of VTE in all patients with overt hyperthyroidism and to compare this to the risk of VTE in the general population. In three hospitals in the Netherlands, patients with biochemically confirmed hyperthyroidism caused by Graves’ disease, multinodular goiter or toxic adenoma were included. All available electronic and handwritten records were examined. Primary outcome was the occurrence of VTE within six months before and until six months after the diagnosis of hyperthyroidism. We included a total of 587 patients. Five patients experienced a VTE during the study period, resulting in an incidence rate of 8.7 (95% CI 2.8 – 20.2) per 1,000 person-years. Three of these five patients had a first VTE (incidence rate for first VTE was 5.3 [95% CI 1.1 – 15.6] per 1,000 person-years). Incidence rates of VTE in the general population are between 0.6 and 1.6 per 1,000 person-years for first VTE and 0.7 and 1.8 per 1,000 person-years for all VTE. In conclusion, the incidence rate of VTE in patients with hyperthyroidism appears to be high. Future prospective studies are needed to further explore this possible association and to address its clinical implications.
Isolated Left Ventricular Noncompaction in Sub-Saharan Africa: A Clinical and Echocardiographic Perspective
Authors: Peters Ferande , Khandheria Bijoy K. , dos Santos Claudia , Matioda Hiral , Maharaj Nirvarthi , Libhaber Elena , Mamdoo Farouk , Essop Mohammed R. 
Published: January 2012

Background—
Isolated left ventricular noncompaction (ILVNC) is a cardiomyopathy caused by intrauterine failure of the myocardium to compact. Common clinical complications are heart failure, arrhythmias, and cardioembolism. A paucity of data exists relating to clinical and echocardiographic features of ILVNC in Africans.

Methods and Results—
This study is a single-center, prospective case-control study, whereby subjects attending a dedicated cardiomyopathy clinic were screened for and diagnosed with ILVNC, provided they had no other associated structural heart disease and fulfilled all the accompanying echocardiographic criteria: (1) end-systolic ratio of noncompacted layer to compacted layer >2, (2) presence of >3 prominent apical trabeculations, and (3) deep intertrabecular recesses that fill with blood from the ventricular cavity visualized using color Doppler ultrasound. Fifty-four subjects were identified, age 45.4±13.1 years (mean±SD), 95% confidence interval 3.6 to 10.2, 55.6% male, and 63.0% New York Health Association Class II, and prevalence of LVNC in our clinic was 6.9%, 95% confidence interval 3.6 to 10.2. Heart failure because of systolic dysfunction was the most common clinical presentation (53 subjects, 98.1%). Left ventricular end-diastolic diameter was 61.4±7.2 mm (mean±SD) and ejection fraction 26.7±11.9% (mean±SD). Common sites of noncompaction were the apical (100%), midinferior (74.1%), and midlateral (64.8%) walls. Right ventricular noncompaction occurred in 12 subjects (22.2%). Pulmonary hypertension was documented in 45 cases (83.3%). Right ventricular dilation was noted in 40 subjects (74.1%), while right ventricular function was depressed in 32 (59.3%). Tricuspid S' was 9.6±2.8 cm/s (mean±SD). No echocardiographic features suggestive of ILVNC were noted in a healthy control group of African descent.

Conclusions—
ILVNC in patients of African descent can be characterized by biventricular abnormality and pulmonary hypertension, in addition to isolated left-sided abnormality.
Get With The Guidelines Program Participation, Process of Care, and Outcome for Medicare Patients Hospitalized With Heart Failure
Authors: Heidenreich Paul A. , Hernandez Adrian F. , Yancy Clyde W. , Liang Li , Peterson Eric D. , Fonarow Gregg C. 
Published: January 2012

Background—
Hospitals enrolled in the American Heart Association's Get With The Guidelines Program for heart failure (GWTG-HF) have improved their process of care. However, it is unclear if process of care and outcomes are better in the GWTG-HF hospitals compared with hospitals not enrolled.

Methods and Results—

We compared hospitals enrolled in GWTG-HF from 2006 to 2007 with other hospitals using data on 4 process of heart failure care measures, 5 noncardiac process measures, risk-adjusted 30-day mortality, and 30-day all-cause readmission after a heart failure hospitalization, as reported by the Center for Medicare and Medicaid Services (CMS). Among the 4460 hospitals reporting data to CMS, 215 (5%) were enrolled in GWTG-HF. Of the 4 CMS heart failure performance measures, GWTG-HF hospitals had significantly higher documentation of the left ventricular ejection fraction (93.4% versus 88.8%), use of angiotensin-converting enzyme inhibitor or angiotensin receptor antagonist (88.3% versus 86.6%), and discharge instructions (74.9% versus 70.5%) (
P
<0.005 for all). Smoking cessation counseling rates were similar (94.1% versus 94.0%;
P
=0.51). There was no significant difference in compliance with noncardiac process of care. After heart failure discharge, all-cause readmission at 30 days was 24.5% and mortality at 30 days after admission was 11.1%. After adjustment for hospital characteristics, 30-day mortality rates were no different (
P
=0.45). However, 30-day readmission was lower for GWTG hospitals (−0.33%; 95% CI, −0.53% to −0.12%;
P
=0.002).

Conclusions—
Although there was evidence that hospitals enrolled in the GTWG-HF program demonstrated better processes of care than other hospitals, there were few clinically important differences in outcomes. Further identification of opportunities to improve outcomes, and inclusion of these metrics in GTWG-HF, may further support the value of GTWG-HF in improving care for patients with HF.
Bivalirudin Therapy Is Associated With Improved Clinical and Economic Outcomes in ST-Elevation Myocardial Infarction Patients Undergoing Percutaneous Coronary Intervention: Results From an Observational Database
Authors: Pinto Duane S. , Ogbonnaya Augustina , Sherman Steven A. , Tung Patricia , Normand Sharon-Lise T. 
Published: January 2012

Background—
Randomized trials show improved outcomes among acute coronary syndrome patients treated with bivalirudin. The objective of this analysis was to compare clinical and economic outcomes in ST-elevation myocardial infarction (STEMI) patients encountered in routine clinical practice undergoing primary percutaneous coronary intervention (PPCI), treated with bivalirudin or heparin+GP IIb/IIIa receptor inhibitor (heparin+GPI).

Methods and Results—

STEMI admissions from January 1, 2004 through March 31, 2008 among patients receiving PPCI and bivalirudin or heparin+GPI in the Premier hospital database were identified. The probability of receiving bivalirudin was estimated using individual and hospital variables; using propensity scores, each bivalirudin patient was matched to 3 heparin+GPI treated patients. The primary outcome was in-hospital death. Rates of bleeding, transfusion, length of stay, and in-hospital cost were secondary outcomes. There were 59 917 STEMI PPCIs receiving bivalirudin (n=6735) or heparin+GPI (n=53 182). Seventy-nine percent of bivalirudin patients matched, resulting in 21 316 STEMI PPCIs for analysis. Compared with heparin+GPI patients, bivalirudin patients had fewer deaths (3.2% versus 4.0%;
P
=0.011) and less inpatient bleeding (clinically apparent bleeding [6.9% versus 10.5%,
P
<0.0001], clinically apparent bleeding with transfusion [1.6% versus 3.0%,
P
<0.0001], and transfusion [5.9% versus 7.6%,
P
<0.0001]). Patients receiving bivalirudin had shorter average length of stay (mean 4.3 versus 4.5 days;
P
<0.0001), with lower in-hospital cost (mean $18 640 versus $19 967 [median $14 462 versus $16 003],
P
<0.0001).

Conclusions—
This large “real-world” retrospective analysis demonstrates that bivalirudin therapy compared with heparin+GPI is associated with a lower rate of inpatient death, inpatient bleeding, and decreased overall in-hospital cost in STEMI patients undergoing PPCI.
Care and Outcomes of Asian-American Acute Myocardial Infarction Patients: Findings From the American Heart Association Get With The Guidelines-Coronary Artery Disease Program
Authors: Qian Feng , Ling Frederick S. , Deedwania Prakash , Hernandez Adrian F. , Fonarow Gregg C. , Cannon Christopher P. , Peterson Eric D. , Peacock W. Frank , Kaltenbach Lisa A. , Laskey Warren K. , Schwamm Lee H. , Bhatt Deepak L. 
Published: January 2012

Background—
Asian-Americans represent an important United States minority population, yet there are limited data regarding the clinical care and outcomes of Asian-Americans following acute myocardial infarction (AMI). Using data from the American Heart Association Get With The Guidelines-Coronary Artery Disease (GWTG-CAD) program, we compared use of and trends in evidence-based care AMI processes and outcome in Asian-American versus white patients.

Methods and Results—

We analyzed 107 403 AMI patients (4412 Asian-Americans, 4.1%) from 382 United States centers participating in the Get With The Guidelines-Coronary Artery Disease program between 2003 and 2008. Use of 6 AMI performance measures, composite “defect-free” care (proportion receiving all eligible performance measures), door-to-balloon time, and in-hospital mortality were examined. Trends in care over this time period were explored. Compared with whites, Asian-American AMI patients were significantly older, more likely to be covered by Medicaid and recruited in the west region, and had a higher prevalence of diabetes, hypertension, heart failure, and smoking. In-hospital unadjusted mortality was higher among Asian-American patients. Overall, Asian-Americans were comparable with whites regarding the baseline quality of care, except that Asian-Americans were less likely to get smoking cessation counseling (65.6% versus 81.5%). Asian-American AMI patients experienced improvement in the 6 individual measures (
P
≤0.048), defect-free care (
P
<0.001), and door-to-balloon time (
P
<0.001). The improvement rates were similar for both Asian-Americans and whites. Compared with whites, the adjusted in-hospital mortality rate was higher for Asian-Americans (adjusted relative risk: 1.16; 95% confidence interval: 1.00–1.35;
P
=0.04).

Conclusions—
Evidence-based care for AMI processes improved significantly over the period of 2003 to 2008 for Asian-American and white patients in the Get With The Guidelines-Coronary Artery Disease program. Differences in care between Asian-Americans and whites, when present, were reduced over time.
A Comparison of Long-Term Mortality for Off-Pump and On-Pump Coronary Artery Bypass Graft Surgery
Authors: Wu Chuntao , Camacho Fabian T. , Culliford Alfred T. , Gold Jeffrey P. , Wechsler Andrew S. , Higgins Robert S.D. , Lahey Stephen J. , Smith Craig R. , Jordan Desmond , Hannan Edward L. 
Published: January 2012

Background—
The survival difference between off-pump and on-pump coronary artery bypass graft surgery for follow-up longer than 5 years is not well-understood. The objective of this study is to examine the difference in 7-year mortality after these 2 procedures.

Methods and Results—

The state of New York's Cardiac Surgery Reporting System was used to identify the 2640 off-pump and 5940 on-pump patients discharged from July through December 2000. The National Death Index was used to ascertain patients' vital statuses through 2007. A logistic regression model was fit to predict the probability of receiving an off-pump procedure using baseline patient characteristics. Off-pump and on-pump patients were matched with a 1:1 ratio based on the probability of receiving an off-pump procedure. Kaplan-Meier survival curves for the 2 procedures were compared using the propensity-matched data, and the hazard ratio for death for off-pump in comparison with on-pump procedures was obtained. In subgroup analyses, the significance of interactions between type of surgery and baseline risk factors was tested. In this study, 2631 pairs of off-pump and on-pump patients were propensity matched. The 7-year Kaplan-Meier survival rates were 71.2% and 73.4% (
P
=0.07) for off-pump and on-pump surgery, respectively. The hazard ratio for death (off-pump versus on-pump) was 1.10 (95% confidence interval: 0.99 to 1.21,
P
=0.07). No statistical significance was detected for the interaction terms between the type of surgery and a number of different baseline risk factors.

Conclusions—
The difference in long-term mortality between on-pump and off-pump coronary artery bypass graft surgery is not statistically significant.
Long-Term Survival and Unnatural Deaths of Patients With Repaired Tetralogy of Fallot in an Asian Cohort
Authors: Chiu Shuenn-Nan , Wang Jou-Kou , Chen Hui-Chi , Lin Ming-Tai , Wu En-Ting , Chen Chun-An , Huang Shu-Chien , Chang Chung-I , Chen Yih-Sharng , Chiu Ing-Sh , Chen Chi-Ling , Wu Mei-Hwan 
Published: January 2012

Background—
Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart disease in Taiwan. This study investigates the long-term survival and risks of TOF in an Asian cohort.

Methods and Results—

This study enrolled 819 consecutive patients with TOF (61.1% male), who received total correction between 1970 and 2002, as participants. Patient medical records were reviewed, and the survival status of those out of contact was confirmed by death records retrieved from the National Health database. The mean (±SD) patient age at cardiac repair was 6.5±7.6 years, and a prior shunt operation was performed in 119 (14.5%) of the patients. At cardiac repair, a transannular patch for right ventricle outlet reconstruction was required in 444 (54.2%) of the patients. After 13 808 patient-years of follow-up, the 30-year survival rate was 90.5%. The annual mortality rate increased from 0.123% in the initial 15 years after repair to 0.395% thereafter (
P
<0.05). The presence of major aortopulmonary collateral arteries, older operative age, and previous shunt operation are independent risks of late cardiac deaths. Secondary to cardiac mortality, unnatural deaths (accident and suicide) accounted for 27.6% of late deaths, significantly higher compared with that of the general population (odds ratio, 2.18;
P
=0.028).

Conclusions—
In this Asian TOF cohort, except for a late decrease after 15 years, long-term survival after cardiac repair was satisfactory. Although cardiac death was the most common cause of late death, accidents or suicide may also be associated with late mortality, suggesting a potential role for psychosocial support.
Outcomes of Elective Total Laryngectomy for Laryngopharyngeal Dysfunction in Disease‐Free Head and Neck Cancer Survivors
Authors: Hutcheson Katherine A. , Alvarez Clare P. , Barringer Denise A. , Kupferman Michael E. , Lapine Peter R. , Lewin Jan S. 
Published: January 2012

ObjectiveTotal laryngectomy (TL) can be offered for management of chronic aspiration, radionecrosis, and/or airway compromise after head and neck cancer (HNC) treatment. The objective of this study was to evaluate functional outcomes after TL in disease‐free HNC survivors.DesignRetrospective case series with chart review.SettingThe University of Texas MD Anderson Cancer Center.PatientsTwenty‐three disease‐free HNC survivors who underwent TL for laryngopharyngeal dysfunction.InterventionTL ± pharyngectomy.Main Outcome MeasuresPost‐TL swallowing‐related (diet, gastrostomy dependence, and pneumonia rates) and communication outcomes.ResultsAll patients who underwent TL for dysfunction were previously treated with radiotherapy (12/23, 52%) or chemoradiotherapy (11/23, 48%). Preoperative complications included aspiration (22/23, 96%), pneumonia (16/23, 70%), tracheostomy (9/23, 39%), and stricture (7/23, 30%); 17 patients (74%) required enteral/parenteral nutrition, and 13 of 23 (57%) were nothing per oral (NPO). Rates of pneumonia, NPO status, and feeding tube dependence significantly decreased after TL (P <. 001). At last follow‐up after TL, all patients tolerated oral intake, but 4 (17%) required supplemental enteral nutrition. Continued smoking after radiotherapy and a preoperative history of recurrent pneumonia were significantly (P <. 05) associated with final tube dependence and/or diet level. Sixteen patients (70%) underwent tracheoesophageal (TE) puncture, and 57% (13 of 23) communicated using TE voice after TL.ConclusionSalvage TL may improve health status by significantly decreasing the rate of pneumonia and improve quality of life by restoring oral intake in patients with refractory laryngopharyngeal dysfunction after HNC treatment. TE voice restoration may enhance functional outcomes in select patients treated with elective TL for dysfunction.