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February 20, 2012


Mutations in giant gene a major cause of familial DCM:  Mutations in the gene TTN, which is encoded for the sarcomeric protein titin and a recognized cause of familial dilated cardiomyopathy (DCM), are responsible for a surprisingly large share of nonischemic DCM cases in a new study published in New England Journal of Medicine .By themselves, the titin mutations seem to account for about 22% of "idiopathic" DCM. The group also looked at 231 people with hypertrophic cardiomyopathy and 249 control subjects, only 1% and 3% of whom, respectively, showed any of the TTN mutations. Moreover, "each subject with hypertrophic cardiomyopathy who had a TTN variant also had a pathogenic mutation in an established hypertrophic-cardiomyopathy gene, suggesting that TTN truncations rarely, if ever, cause hypertrophic cardiomyopathy.

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Androgen Deprivation for Prostate Cancer Ups Peripheral Vascular Risk: A population-based observational study indicates that androgen deprivation therapy for nonmetastatic prostate cancer is tied to an increased risk of venous thromboembolism (VTE) and peripheral artery disease (PAD). In the study, published online in European Urology, used data from the population-based SEER tumor registry linked to Medicare data to identify 182,757 men ages 65 and older with nonmetastatic prostate cancer. Half the men received ADT, either with gonadotropin-releasing hormone agonists (47.8%) or orchiectomy (2.2%). During a median follow-up of 5.1 years, PAD incidence rates per 1000 person years were 30.5 in the GnRH group, 27.1 in the orchiectomy group, and 21.0 without ADT. Corresponding rates of incident VTE were 13.2, 14.7 and 10.1 per 1000 person-years. After adjustment, GnRH agonist use was associated with significantly increased risk of PAD (hazard ratio 1.16) and VTE (HR 1.10). Similarly, the hazard ratios associated with orchiectomy were 1.13 and 1.27, respectively.

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Catheter Ablation Palliates Atrial Fibrillation, but Doesn't Cure It: Less than half of patients with atrial fibrillation (AF) experience long-term freedom from all atrial arrhythmias after catheter ablation, according to a single-center report. In the study published online in American Journal of Cardiology were evaluated long-term outcomes of 153 catheter ablations in 103 AF patients. The procedures were done between 2002 and 2006. During follow-up lasting at least four years (median, six years), 42 patients needed a second ablation, seven patients required a third ablation procedure, and one patient required a fourth ablation. After 62 ablation procedures (41%), patients were weaned off antiarrhythmic drugs, but atrial fibrillation recurred after 54 of those 62 cases (87%). Recurrent atrial arrhythmia was significantly more common among patients with nonparoxysmal AF than among those with paroxysmal AF, according to the researchers. Major bleeding followed 4% of all procedures, but there were no deaths, cerebrovascular events, or symptomatic pulmonary vein stenoses during follow-up. Just over half of patients (51%) were free from asymptomatic or symptomatic AF or atrial tachycardia at one year, but by six years that was still true for less than a quarter (23%). At one year after the last ablation, 63% of patients were free of all atrial arrhythmias; by six years, that proportion had fallen to 39%.

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February 13, 2012

High levels of triglycerides, VLDL and IDL lipoprotens related with increased stroke risk in postmenopausal women:  An analysis of postmenopausal women has identified novel lipid and lipoprotein biomarkers associated with the risk of ischemic stroke. In the study published online in Stroke reported that baseline triglycerides, very low-density lipoprotein (VLDL) size, and intermediate-density lipoprotein (IDL) particle number are associated with an increased risk of ischemic stroke, suggesting new therapeutics targeting these lipid and lipoproteins might confer better risk protection.
The study includes an analysis of patients enrolled in the Women's Health Initiative. In this prospective, case-control study, 972 ischemic stroke subjects were matched with 972 healthy controls to assess the relationship between traditional markers of cholesterol, including total, LDL, and HDL cholesterol; a panel of biomarkers that included VLDL particle number and size, IDL particle number and size, and lipoprotein(a); and the risk of stroke. In multivariate analysis, elevated triglycerides, VLDL size, and the IDL particle number were all significantly associated with an increased risk of stroke. Women with triglyceride levels in the highest quartile, those with levels >192 mg/dL, had a significant 56% increased risk of stroke compared with women in the lowest quartile. Similarly, for women in the highest quartile of VLDL particle size and IDL particle number, there was a significant 59% and 46% increased risk of ischemic stroke compared with women in the lowest quartile.

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Wide variation in PCI for "unclear indications": The latest study to look at appropriate use of PCI has found that 17% of hospitals in a large US sample conducted at least one-fifth of their procedures in patients with unclear indications. The study, published in American Heart Journal, found that, on average, around 4% of PCI procedures were performed for patients with unclear indications. There was not a wide variation in terms of hospital type according to organizational structure, although physician-owned specialty hospitals did perform slightly more PCIs for unclear indications. There was, however, a very large variation within individual hospitals, with potentially inappropriate PCIs ranging from 2% to 23%. For the study, the researchers assessed the indications for 1 113 554 PCIs performed in 694 hospitals participating in the CathPCI Registry between 2004 and 2007.

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Y-chromosome variant may explain CAD in men: A novel method of genetic analysis has established that a common variant on the male Y chromosome is associated with a significant 50% increased risk of coronary artery disease (CAD). The new findings may partly explain why some men develop CAD 10 years earlier than women according to the authors of the study published online in Lancet. The study used material from more than 3000, primarily white British men participating in two large UK trials: the cross-sectional British Heart Foundation (BHF) Family Heart Study and the prospective West of Scotland Coronary Prevention Study (WOSCOPS). Of nine haplogroups (groups of haplotypes, which are combinations of alleles at adjacent loci), they identified two that accounted for 90% of the variation on the Y chromosome in British men. Carriers of one of these, haplogroup I, had about a 50% higher age-adjusted risk of CAD than did men with other Y chromosome lineages. Specifically, in the BHF study, the odds ratio was 1.75 (p=0.004); in WOSCOPS it was 1.45 (p=0.012); and in a joint analysis of both populations it was 1.56 (p=0.0002).

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February 6, 2012

Heart failure is associated with a decline in mental function: The presence of heart failure is associated with a decline in mental function and loss of gray matter in the brain, which may make it more difficult for patients to follow instructions regarding their medication, according to a new study published online in the European Heart Journal. The study involved 35 patients with heart failure, 56 patients with ischemic heart disease, and 64 healthy people without either heart failure or ischemic heart disease. All participants underwent cognitive tests and MRI brain scans. Results showed that patients with heart failure had lower scores than patients with ischemic heart disease or healthy controls on cognitive tests measuring memory and psychomotor speed, although the difference between the heart-failure patients and those with ischemic heart disease was not significant.

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US expert consensus document for TAVI rollout published: Fueled by mounting data outlining the benefits of transcatheter aortic valve implantation (TAVI), an expert consensus document published in JACC has created a map of proper TAVI use that includes the best practices for proper patient selection and treatment decisions. The document, put forth by the American College of Cardiology Foundation (ACCF), the American Association for Thoracic Surgery (AATS), the Society of Cardiovascular Angiography and Interventions (SCAI) and the Society of Thoracic Surgeons (STS), offers advice about when TAVI is most appropriate for patients. TAVI was approved for use by the FDA in November 2011, and already nearly 45,000 patients have undergone TAVI worldwide. Transcatheter aortic valve replacement is appropriate currently only for a highly select population and “the valve team should systematically identify the characteristics that define that population with most benefit and acceptable risk,” according to the statement. The consensus also focused on TAVI screening. In fact, the authors offered that screening should be integrated into each TAVI evaluation, but noted that the specific imaging protocols will vary from hospital to hospital. Some of the information pieces necessary to appropriately screen include: data to calculate STS score, preprocedural imaging for planning, assessing the annular size for device selection and assessment of the arterial anatomy.
The consensus statement also outlined the following:
•Site selection: The guidelines recommend that facilities should have experience with structural heart disease and said that all heart team members should be available on-site. Additionally, centers should providing access to the technology to patients;
•Center and Physician Experience: Performing 50 procedures within the past 12 months is the recommended number;
•Procedural Performance: TAVI should take place in hybrid rooms or cardiac catheterization laboratories. Additionally, imaging and intraprocedural echocardiograms are required for cardiopulmonary bypass to avoid complication;
•Postprocedural Care: While the authors said that postprocedural care depends on the comorbidities present, they also noted that a dedicated recovery room should be set up for patients to receive optimal postprocedural care;
•Registries: Registries should include demographic and mortality outcomes to effectively compare the various strategies to help improve outcomes

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Worsening diastolic dysfunction ups mortality: About 25% of patients initially with normal LVEF who had follow-up echocardiography up to two years later showed either improved or worsened diastolic function, and worsening diastolic function was an independent predictor of mortality, in a retrospective single-center study published online in Circulation. Of the study's 1065 outpatients with an LVEF >55% on baseline echocardiography (performed usually for evaluation of symptoms or valvular function), plus a follow-up echo six months to two years later, 72.3% were found initially with diastolic dysfunction. It was judged to be mild in about two-thirds of cases. By the follow-up echo a mean of 1.1 years later, compared with baseline, diastolic function had worsened in 16% of the total cohort and improved in 11%; it worsened to <55% in 8.3%. By a mean of 1.6 years after the second echocardiographic study, 13% of the total cohort had died. The relative risk for all cause mortality was 1.78 (95% CI 1.10 – 2.85 , p:0.02) when LVEF decrease to <55% and was 3.58 (95% CI 1.71 – 7.53 , p:0.001) when the diastolic function worsening of from "normal" to "abnormal”.

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Meta-Analysis Confirms Benefits Of Statins In Women: A new metanalysis of 18 randomized trials of primary and secondary prevention, including 141,235 men and 40,275 women published in JACC evaluated the effect of statins in decreasing cardiovascular events in women and men. According to this metanalysis statin therapy is associated with significant decreases in cardiovascular events and in all-cause mortality in women and men and should be used in appropriate patients without regard to sex. Specifically, the cardiovascular event rate was lower among those randomized to statin intervention than in those randomized to control (low-dose statin in 4 studies, placebo in 11 studies, usual care in 3 studies) and similar in women and men (OR: 0.81, 95% CI: 0.75 to 0.89; p < 0.0001, and OR: 0.77, 95% CI: 0.71 to 0.83, p < 0.0001, respectively). The benefit of statins was statistically significant in both sexes, regardless of the type of control, baseline risk, or type of endpoint and in both primary and secondary prevention. All-cause mortality was also lower with statin therapy both in women and men without significant interaction by sex (p for interaction = 0.4457).

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January 30, 2012

"High-normal" blood pressure linked to AF: Upper-normal levels of blood pressure in otherwise-healthy middle-aged men appear to predict a higher risk for the development of atrial fibrillation in older age according to a new study published online in Hypertension. In this study were recruited a group of 2014 healthy middle-aged men from 1972 to 1975, who underwent a comprehensive clinical examination including blood-pressure measurements. During up to 35 years of follow-up, 270 men were found to have developed atrial fibrillation. The majority of these developed the condition late in life, on average 20 years from baseline. Risk estimations for the development of AF were calculated by quartiles of blood pressures at baseline after adjustment for other risk factors. Results showed that in addition to those with hypertension at baseline, men with upper-normal blood-pressure levels (128-138 mm Hg systolic) were also at increased risk of AF compared with those with systolic pressure below 128 mm Hg at baseline. Specifically, men with baseline systolic BP ≥140 mm Hg and upper normal BP 128 to 138 mm Hg had 1.60-fold (95% CI 1.15–2.21) and 1.50-fold (1.10–2.03) risk of AF, respectively, compared with men with BP <128 mm Hg. Baseline diastolic BP ≥80 mm Hg increased the risk of incident AF 1.79-fold (95% CI 1.28–2.59) compared with diastolic BP <80 mm Hg. When adjusting for the occurrence of diabetes mellitus or cardiovascular diseases before an AF event, the results still maintained significance.

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Proximal balloon superior to distal protection in carotid artery stenting: Proximal balloon occlusion provides significantly greater embolic protection during carotid artery stenting (CAS) for internal artery stenosis when compared with a filter protection device according to the results of PROFI study which published online in JACC. Proximal balloon-occlusion devices do not cross the lesion before it is stented, which helps to significantly reduce embolic load in the brain during the carotid procedure, according to the authors. The study included 62 consecutive symptomatic and asymptomatic patients undergoing CAS with embolic protection who were randomly assigned proximal balloon occlusion or filter protection. Compared with the filter, which crosses the lesion before the stent is implanted and is deployed to catch debris during the procedure, the balloon-occlusion device is placed proximal to the lesion and inflated to occlude the external and common carotid arteries. Flow is reversed in the target vessel before the lesion is crossed and treated. Using DW-MRI, the researchers found that the incidence of new cerebral ischemic lesions per patient was significantly greater among patients who underwent distal protection (87.1% in the filter group vs 45.2% in the balloon-occlusion group; p=0.001). The incidence of new ischemic lesions was significantly higher with filter protection in symptomatic and asymptomatic patients, and there was a trend toward more lesions in patients >80 years of age.

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Heart disease risk begins with middle-age risk factors: According to a meta-analysis of 18 studies in which included 257.384 patients and was published in the last issue of NEJM, the differences in risk-factor burdens in middle age translate into significant differences in lifetime cardiovascular disease risk. Specifically, among participants who were 55 years of age, those with an optimal risk-factor profile (total cholesterol level, <180 mg per deciliter [4.7 mmol per liter]; blood pressure, <120 mm Hg systolic and 80 mm Hg diastolic; nonsmoking status; and nondiabetic status) had substantially lower risks of death from cardiovascular disease through the age of 80 years than participants with two or more major risk factors (4.7% vs. 29.6% among men, 6.4% vs. 20.5% among women). Those with an optimal risk-factor profile also had lower lifetime risks of fatal coronary heart disease or nonfatal myocardial infarction (3.6% vs. 37.5% among men, <1% vs. 18.3% among women) and fatal or nonfatal stroke (2.3% vs. 8.3% among men, 5.3% vs. 10.7% among women). Similar trends within risk-factor strata were observed among blacks and whites and across diverse birth cohorts.

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January 23, 2012

Cangrelor Proposed As Bridge To Surgery: In the last issue of the Journal of the American Medical Association (JAMA) published the results of the BRIDGE study which was first presented at TCT 2011 last November, showing that the intravenous P2Y12 receptor antagonist cangrelor could represent an effective bridging therapy for patients taking thienopyridine antiplatelet agents such as clopidogrel who are scheduled for surgery.
In the BRIDGE study, 210 patients taking thienopyridines for ACS or after stent placement who were awaiting CABG had their thienopyridine stopped, and they were then randomized to either cangrelor (0.75 µg/kg per minute) or placebo for at least 48 hours. Study drug was discontinued one to six hours before CABG surgery. Results showed that more patients had low levels of platelet reactivity—under 240 platelet reactivity units (PRU)—throughout the treatment period compared with placebo. There was no significant difference in major bleeding prior to CABG surgery, although minor bleeding episodes were numerically higher with cangrelor.

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"High-normal" blood pressure linked to AF: Upper-normal levels of blood pressure in otherwise-healthy middle-aged men appear to predict a higher risk for the development of atrial fibrillation in older age according to a new study published online in Hypertension Journal. In the study recruited a group of 2014 healthy middle-aged men from 1972 to 1975, who underwent a comprehensive clinical examination including blood-pressure measurements. During up to 35 years of follow-up, 270 men were found to have developed atrial fibrillation. The majority of these developed the condition late in life, on average 20 years from baseline. Risk estimations for the development of AF were calculated by quartiles of blood pressures at baseline after adjustment for other risk factors. Results showed that in addition to those with hypertension at baseline, men with upper-normal blood-pressure levels (128-138 mm Hg systolic) were also at increased risk of AF compared with those with systolic pressure below 116 mm Hg at baseline. When using systolic blood pressure below 128 mm Hg as the reference, those with "high-normal" systolic pressure (quartile 3) had a 1.5-fold risk of AF, and those with pressures over 140 mm Hg (quartile 4) had a 1.6-fold risk. In terms of diastolic pressures, those with levels above 80 mm Hg had a relative risk of 1.79 for developing AF compared with those with values below 80 mm Hg.

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Lower Mortality Rates at Two Years With Transradial PCI: Transradial PCI in acute MI (AMI) is associated with a reduction in two-year mortality rates when compared with conventional interventions via the femoral artery according to a registry published in the JACC Cardiovasc. Interv. Transradial PCI was also associated with a significant reduction in the need for vascular surgery and blood transfusions. The findings are based on data from the Registro Regionale Angioplastiche dell'Emilia-Romagna (REAL) registry, a large, prospective database designed to collect clinical and angiographic data on PCIs performed in a region in Northern Italy. Between January 2003 and June 2009, 11 068 patients from 12 hospitals underwent PCI for AMI, including 8000 patients treated via the femoral artery and 3068 patients treated via the radial artery. The interventional strategy and device use, including stent type, were selected by the physician.
Before propensity-score matching, patients undergoing transfemoral PCI tended to be male and younger, had no previous history of CABG surgery, were hemodynamically stable, had a higher body-mass index, and were less likely to have had a previous blood transfusion. At two years, the unadjusted mortality rate was significantly lower among patients treated via the radial artery (9.3% vs 17.3%; p<0.001). The mortality difference was driven primarily by a reduction in death within the first 30 days following PCI. Unadjusted rates of major bleeding or vascular events at 30 days and two years were also significantly reduced in the transradial PCI patients (1.1% vs 2.6% at 30 days and 4.9% vs 6.9% at two years; p<0.001 for both).

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EMA investigating CV problems with fingolimod: The European Medicines Agency has begun a review of the benefits and risks of the multiple-sclerosis medicine Gilenya. This follows concerns over the effects of the medicine on the heart after the first dose.

The review was started following reports of heart problems in patients taking Gilenya, as well as the death of one patient in the United States less than 24 hours after the first dose. The exact cause of this patient’s death is still unexplained.

Gilenya has been authorised in the European Union since March 2011 for the treatment of relapsing-remitting multiple sclerosis in patients whose disease has failed to respond to a beta-interferon or is severe and getting worse rapidly. It contains the active substance fingolimod. More than 30,000 patients have received Gilenya worldwide.

While the review is ongoing, the Agency’s Committee for Medicinal Products for Human Use (CHMP) is advising doctors to increase their level of monitoring of patients after the first dose of the medicine. This includes electrocardiogram (ECG) monitoring before treatment and then continuously for the first six hours after the first dose, and measurement of blood pressure and heart rate every hour. After six hours, any patients with clinically important heart-related effects, such as bradycardia (a slow heart rate) or atrioventricular block (a problem with the conduction of electricity in the heart), should continue to be managed and monitored until their condition has improved.

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HEART VESSELS & STROKE 2012




THE HEART VESSELS & STROKE 2012 CONGRESS was held at the Divani Apollon Palace Hotel, Kavouri, Athens, on 20 - 22 January 2012. The meeting was organised under the auspices of the Hellenic Cardiovascular Research Society.
Scientific Organiser: K. Vemmos.
FINAL PROGRAM IS ATTACHED HERE



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January 16, 2012


Silent atrial fibrillation increases stroke risk: In the last issue of NEJM was published the results of the Asymptomatic AF and Stroke Evaluation in Pacemaker Patients and the AF Reduction Atrial Pacing Trial (ASSERT) which showed that, in pacemaker patients with hypertension but no history of atrial fibrillation (AF), episodes of device-detected atrial tachycardia greater than six minutes were seen in approximately one-third of patients over almost three years of mean follow-up. Furthermore, these arrhythmias were associated with a 2.5-fold increase in the risk for ischemic stroke and systemic embolism. In a subgroup of patients with a CHADS2 score of 2 or higher, device-detected atrial tachyarrhythmias increased the absolute risk for stroke to 3.78% per year.

In the trial were included 2580 patients 65 years of age or older, with hypertension and no history of atrial fibrillation, in whom a pacemaker or defibrillator had recently been implanted. Subclinical atrial tachyarrhythmias were associated with an increased risk of clinical atrial fibrillation (hazard ratio, 5.56; 95% confidence interval [CI], 3.78 to 8.17; P<0.001) and of ischemic stroke or systemic embolism (hazard ratio, 2.49; 95% CI, 1.28 to 4.85; P=0.007).

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Inactivity is a universal risk factor for heart attack: A new analysis of the INTERHEART study which published online in the European Heart Journal., drilling down into exactly how physical activity and its different components contribute to the risk of MI, doesn't turn up any huge surprises but does confirm that inactivity is "a universal cardiovascular risk factor". The findings reveal a large discrepancy between physical-activity levels in different economies, with close to 70% of individuals in low-income nations being sedentary during leisure time compared with around 40% in higher-income countries. In their new look at INTERHEART—a case-control study of over 29 000 people from 52 countries in Asia, Europe, the Middle East, Africa, Australia, and North and South America—thw authors specifically examine how physical activity during work and leisure time contribute to the risk of MI. The researchers found that subjects whose occupation involved either light [multivariable adjusted odds ratio 0.78] or moderate [OR 0.89] physical activity were at lower risk of MI, whereas those who did heavy physical labor were not (OR 1.02) compared with sedentary subjects. Mild exercise (OR 0.87) as well as moderate or strenuous exercise (OR 0.76) was also protective. Those who owned both a car and a TV were at higher risk of MI compared with those who owned neither (OR 1.27).

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Revised ablation guidelines previewed at Boston AF: At Boston AF, Hugh Calkins (director of Cardiac Arrhythmia Service, Johns Hopkins Medical Center, Baltimore, Maryland, USA) gave a sneak preview of the forthcoming 2012 Heart Rhythm Society (HRS), European Heart Rhythm Association (EHRA), and European Cardiac Arrhythmia Society (ECAS) consensus document on catheter ablation for atrial fibrillation. Calkins explained that the new guidelines, which are due to published in early March, are an update of the 2007 HRS/EHRA/ECAS catheter ablation (for atrial fibrillation) guidelines. However, he stressed that they were not a “brief update” but a “comprehensive review” of catheter and surgical ablation for atrial fibrillation. He added that the new guidelines ran to 210 pages and had 11 different sections. Regarding what the changes were in the new guidelines compared with the 2007 guidelines, Calkins said that the “biggest change” was that the guidelines now specified the class and level of evidence for catheter ablation for different types of atrial fibrillation (paroxysmal, persistent, and long-standing persistent). Another major change was that HRS/EHRA/ECAS now recommend using the CHADS2-VASc score as well as the CHADS2 score to assess a patient’s risk of stroke after undergoing catheter ablation.

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FDA expands use of endovascular graft to treat aortic tears: The U.S. Food and Drug Administration today expanded the approved usage for an endovascular graft manufactured by W.L. Gore and Associates Inc. to include treatment of life-threatening tears or ruptures of the aorta (thoracic aortic transection). The Gore TAG Thoracic Endoprosthesis is the first endovascular graft approved by the FDA to treat a variety of thoracic lesions, including dangerously large bulges in the aorta (aneurysms) as well as thoracic aortic transections. The expanded approval of the Gore TAG endovascular graft provides surgeons with a minimally invasive and potentially less risky alterative to open chest surgery for the treatment of thoracic aortic transection and other lesions. FDA first approved the Gore TAG in 2005 to treat aortic aneurysms to reduce the risk of rupture. The expanded approval represents the latest design, which features materials that conform to the bends and angles common in the area where thoracic aortic transections typically occur. FDA based its expanded approval on data from 51 patients implanted with the Gore TAG to treat thoracic aortic transection caused by trauma. Patients were monitored for 30 days with physician exams and follow-up X-ray and CT scans. All survived the implant procedure; four patients died from causes unrelated to the device or implant procedure. The company will continue to follow patients for five years.

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January 10, 2012

EVEREST II published: Encouraging results for Mitraclip in nonsurgical patients: In the last issue of JACC pyblished the results from the high-surgical-risk arm of the EVEREST II trial with the percutaneous MitraClip device which suggesting reduced mitral regurgitation and improvement in clinical symptoms and left ventricular reverse remodeling at 12 months.

The main EVEREST II trial, published last April, compared the MitraClip procedure with surgical repair of the mitral valve and suggested that the MitraClip was significantly less effective than surgery at improving mitral regurgitation but seemed safer. The trial also included a high-surgical-risk arm, made up of 78 symptomatic patients with 3+ to 4+ mitral regurgitation who were judged too high risk to undergo surgery (with an estimated perioperative mortality risk of 12% or more). These patients underwent the MitraClip procedure and were compared with a group of 36 patients with similar degrees of mitral regurgitation, risks, and comorbidities who were screened for the study but were not enrolled for various reasons. Results from this high-surgical-risk arm, published in the Journal of the American College of Cardiology, showed that the procedure-related mortality rate at 30 days was similar in the patients who underwent MitraClip placement and in the comparator group (7.7% vs 8.3%), but the MitraClip patients appeared to have a better one-year survival (76% vs 55%). In surviving patients with matched baseline and 12-month data, 78% of the MitraClip patients had a mitral regurgitation grade of 2+ or less, and there were improvements in left ventricular end diastolic and systolic volumes, NYHA functional class, and quality of life, the EVEREST authors report. The annual rate of hospitalization for congestive heart failure in surviving patients with matched data decreased from 0.59 to 0.32.

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Gene analysis helps identify basis of rare infant heart disorder: Researchers from USA have found differences in gene expression that could indicate a predisposition for histiocytoid cardiomyopathy (HC) in infants―a rare arrhythmogenic disorder characterised by persistent ventricular tachycardia, cardiomegaly, and often sudden death before a child reaches two years of age. The study published in the Pediatric and Developmental Pathology journal compared cardiac tissue from 12 patients with HC and 12 age-matched controls. Researchers found differences in gene expression that could indicate an inherited mutation and predisposition for histiocytoid cardiomyopathy.

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BRCA1 cancer gene affects cardiac function: Canadian researchers have discovered that the BRCA1 gene is an essential regulator of cardiac function, at least in mice, and may therefore represent a new therapeutic target for heart failure. The findings are also important for cancer patients who have mutations in the BRCA1 and BRCA2 genes—who are at higher risk of breast and ovarian cancer—because it means these individuals could be at increased risk of heart problems as well according to the authors of the study which published online in Nature Communications. In this study mice with BRCA1/2 mutations had much more severe MIs than those without the mutations and a subsequent three to five times higher rate of death, largely due to the development of heart failure. The results may explain recent observations that BRCA1/2 mutation carriers have an increased risk of nonneoplastic death, particularly in older age, say the researchers.

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December 27, 2011

Increasing heart rate over time linked with heart disease mortality: Increases in resting heart rate over a 10-year period are associated with a significant increase in the risk of death from ischemic heart disease, as well as a smaller, but statistically significant, increase in all-cause mortality, according to a new study published in JAMA. For individuals who lowered their resting heart rate, there did not appear to be a benefit in relation to ischemic heart disease mortality. In this prospective study of 13 499 men and 15 826 women without cardiovascular disease the authors assessed the association between long-term longitudinal changes and the risk of ischemic heart disease mortality. Resting heart rate was measured twice, first at baseline and then approximately 10 years later. During a mean follow-up of 12 years, 3098 subjects died. Of these, 975 deaths were the result of cardiovascular disease and 388 deaths due to ischemic heart disease.
Compared with subjects who had a resting heart rate <70 beats per minute (bpm) at both measurements, those who had an increase in resting heart rate at baseline from <70 bpm to >85 bpm during the follow-up visit were nearly two times more likely to die from ischemic heart disease (adjusted hazard ratio [AHR] 1.9; 95% CI 1.0-3.6). The rate of ischemic heart disease mortality for those who retained a resting heart rate of <70 bpm over the 10 years was 8.2 deaths/10 000 person-years, whereas as the rate of ischemic heart disease mortality for those who increased their resting heart rate from <70 bpm to >85 bpm was 17.2 deaths/10 000 person-years.

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European CRT Survey Bolsters Support for CRT-D Over CRT-P: Cardiac resynchronization defibrillators (CRT-D) outperformed cardiac resynchronization pacing alone (CRT-P) in an observational study that includes patients not well-represented in the previous randomized trials. The one-year results of the European CRT Survey, published in the January 2012 issue of the European Journal of Heart Failure, shows that worse NYHA functional class, atrial fibrillation, and ischemic etiology were associated with poorer survival. Women in the survey generally had better outcomes than men, and CRT-D patients had better survival rates and reported better symptom control than patients treated with CRT-P. The survey included 2438 patients who had a successful CRT implantation at 141 centers in 13 countries between November 2008 and June 2009. A total of 2111 patients were followed for nine to 15 months. The population included "important groups of patients poorly represented in randomized controlled trials," such as women, elderly patients, and those with prior device implantation, atrial fibrillation, or QRS duration > 120 ms. In addition to the mortality and hospitalization benefits of the devices, patient self-assessment data show that 81% of the patients felt their symptoms improved and only 4% reported deterioration.

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First Data to Show Antihypertensive Therapy Prolongs Life: The first long-term data from a high-blood-pressure study, the Systolic Hypertension in the Elderly Program (SHEP), show that each month of chlorthalidone-based therapy was associated with approximately one day of extension in life, free from cardiovascular death. The main findings are that after 22 years of follow-up, when about 60% of the participants in SHEP were dead, there was a prolonged life expectancy in those who took the active treatment for 4.5 years, and that is the first time this has been reported in studies of hypertension. The SHEP trial was conducted between March 1985 and January 1988, and just over 4700 patients aged, on average, 72 years were randomized to active treatment with chlorthalidone--with atenolol added if antihypertensive control was not sufficient--or placebo for 4.5 years. After this time, all patients were asked to go on active therapy. At 22 years later, life-expectancy gain--expressed as the area between the active and placebo survival curves--was 105 days for all-cause mortality and 158 days for cardiovascular death.The active-treatment group had higher survival free from cardiovascular death vs the placebo group (hazard ratio 0.89; p=0.03), but similar survival for all-cause mortality (HR 0.97; p=0.42). There were 1416 deaths (59.9%) in the active-treatment group and 1435 in the placebo group (60.5%). But cardiovascular death was lower in the active-treatment group--669 deaths (28.3%) vs 735 deaths (31.0%) in the placebo group (p=0.03).

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December 19, 2011

FDA approves mechanical cardiac assist device for children with heart failure: The U.S. Food and Drug Administration today approved a medical device that supports the weakened heart of children with heart failure to help keep them alive until a donor for a heart transplant can be found. The mechanical pulsatile cardiac assist device is called the EXCOR Pediatric System, made by a German company, Berlin Heart. The device comes in graduated sizes to fit children from newborns to teens.The device consists of one or two external pneumatic (driven by air) blood pumps, multiple tubes to connect the blood pumps to heart chambers and the great arteries, and the driving unit. Heart failure in children is much less common than in adults. Heart transplantation offers effective relief from symptoms. However, far fewer pediatric sized donor hearts are available for transplantation than for adults, limiting the use of heart transplantation in children and prolonging the waiting period until transplant can occur. In infants, the median waiting time for a donor heart is 119 days. Overall a reported 12-17 percent of children and 23 percent of infants die while on the wait list for a heart transplant.

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AHA Releases Update of Heart and Stroke Statistics: Americans are more obese and spending more on treatment of cardiovascular disease than ever before, but the rate of mortality from cardiovascular disease continues to decline, the American Heart Association (AHA) reports in its latest update on cardiovascular health in the US which published online in Circulation. The AHA's "Heart Disease and Stroke Statistical Survey 2012shows that cardiovascular disease continues to be a major killer in the US, causing about 2200 deaths a day in the US. The direct and indirect costs of cardiovascular disease and stroke are about $300 billion. Only 6% of US adults are free of risk factors in all of these categories, and 38% of US adults score in the "poor" range for at least three of the seven categories. Obesity in children is an especially worrying trend, as about one in three US kids are overweight and the prevalence of childhood obesity has grown from 4% to over 20% since the early 1980s. Half of children 12 to 19 have at least three of the seven major risk factors.

Although the study shows that Americans are not, in general, doing a great job of taking care of their own cardiovascular health, the mortality rate from cardiovascular disease continues to fall, probably because treatments for MI, congestive heart failure, and other acute cardiovascular conditions has improved. Last year's AHA report showed that heart-disease mortality declined by 27.8% and stroke mortality fell by 44.8% between 1997 and 2007. This year's report shows that the cardiovascular disease mortality rate fell from 30.6% from 1998 to 2008. During that same period, the stroke death rate fell 34.8%.

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CPAP benefits in metabolic syndrome: Three months of treatment with continuous positive airway pressure (CPAP) was associated with improvements in many different components of the metabolic syndrome in a new study published in the last issue of the New England Journal of Medicine in patients with both metabolic syndrome and obstructive sleep apnea .In the study, CPAP therapy was associated with a decrease in both systolic and diastolic blood pressure, lipids, glycated hemoglobin, body mass index, and abdominal fat. Following CPAP therapy, 14 patients (20%) no longer met the criteria for metabolic syndrome, with the specific criterion resolved being blood pressure (five patients), fasting blood glucose (two patients), triglycerides (two patients), HDL cholesterol (three patients), triglycerides and HDL cholesterol (one patient), and triglycerides, HDL cholesterol, and fasting blood glucose (one patient).

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December 12, 2011

FDA Advisory Panel Votes Against Implantable CardioMEMS HF Pressure Measurement System: Members of the FDA Circulatory System Devices Panel today recommended against approval of the implantable CardioMEMS HF Pressure Measurement System. Although panel members agreed that the device was safe by a 9-1 vote, they voted 7-3 that the device had not been shown to be effective and 6-4 that the benefits did not outweigh the risks. Panel members were basing their decision on the randomized, single-blind, company-sponsored CHAMPION trial. The device keeps track of changes in PA pressures that might alert clinicians to impending decompensation, prompting early adjustments to medications such as vasodilators or diuretics. The trial suggested that the strategy works: patients implanted with the monitor showed a significant drop in risk of heart-failure-related hospitalizations (p<0.0001) over six months with virtually no important device-related complications.

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Obese STEMI patients continue to present 'paradox': Extremely obese patients present with STEMI at younger ages, yet have less extensive coronary artery disease and better left ventricular systolic function, adhering to the “obesity paradox,” according to a new study published in the Journal of the American College of Cardiology found. Additionally, obese patients have similar processes and quality of care when compared with normal-weight patients, but see higher risk-adjusted in-hospital mortality rates. In the study were analyzed data from 50,149 STEMI patients from the National Cardiovascular Data Registry (NCDR) ACTION Registry-Get With the Guidelines between Jan.1, 2007, and June 30, 2009, and recorded the relationship between BMI and baseline patient characteristics, treatment patterns and risk-adjusted in-hospital outcomes. During the study, the researchers classified patients with STEMI by BMI categories: 1.6% was underweight, 23.5 % were of normal weight, 38.7 % were overweight, 22.4% were Class I obese, 8.7 % were Class II obese and 5.1% were Class III obese. Those STEMI patients classified with Class III obesity were more than a decade younger than their normal-weight counterparts, and these patients were more likely to be women and African-American. Class III obese patients had a higher prevalence of obesity (three-fold) compared with those who were in normal weight class. Three-fourths of STEMI patients were overweight or obese in the current study and Class III obesity affected one in 20 STEMI patients.

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Stroke Risk Reduced With Treatment of Prehypertension: Patients with prehypertension who take blood pressure–lowering therapy have a highly statistically significant 22% reduced risk for stroke according to a a new meta-analysis published online in Stroke Journal. The reduction in stroke risk observed in the study was evident among all classes of antihypertensive drugs studied. Prehypertension is defined as a blood pressure of 120 to 139 mm Hg systolic and 80 to 89 mm Hg diastolic. Current guidelines recommend lowering blood pressure to 140/90 mm Hg or less. The meta-analysis included 16 randomized controlled trials enrolling a total of 70,664 patients. To be considered for the analysis, studies had to have included patients with an average baseline systolic blood pressure of between 120 and 140 mm Hg and a diastolic blood pressure lower than 90 mm Hg. The trials also had to have had at least 1 comparator group treated with placebo, have reported stroke incidence, and used an antihypertensive drug. Eight of the trials studied ACE inhibitors, 4 studied ARBs, 2 studied calcium channel blockers, 1 had both calcium channel blocker and ACE inhibitor groups, and 1 used an ACE inhibitor and/or calcium channel blocker. Both patients and investigators were blinded to treatment allocation in all but 2 trials (Irbesartan in Heart Failure With Preserved Systolic Function [I-PRESERVE] and Appropriate Blood Pressure Control in Diabetes [ABCD]), which were single-blind. The analysis found that compared with patients who received the placebo, those taking antihypertensive treatments had a 22% reduction in incident stroke (relative risk, 0.78; 95% confidence interval, 0.71 - 0.86; P < .000001).

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December 5, 2011

ICPES ATHENS 2011, 11-14 DECEMBER 2011


The World Society of Arrhythmias (WSA) organizes its 14th Congress at Athens Hilton, from 11 to 14 December 2011. More than 300 distinguished, Key Opinion Leaders Cardiologists will present the latest research during the Conference. The WSA Secretary General, Professor Panos Vardas announced that the ICPES scientific programme offers an excellent opportunity for participants to share professional knowledge and experience on the latest developments in cardiovascular medicine.

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Anticoagulation self-monitoring halves thromboembolic risk: Results of a meta-analysis published online in Lancet showed that self-monitoring of oral anticoagulation by patients was superior to usual care in reducing thromboembolic events, with a risk reduction of 49% . Self-management of anticoagulation, where patients not only self-test international normalized ratios (INR) themselves but actually were trained to self-adjust the warfarin dose based on these results, was superior to self-testing alone, where dose adjustments were made by physicians. Rates of bleeding and mortality were similar between groups. The most striking reductions in risk were seen in patients younger than 55 years and in those taking anticoagulation because of a mechanical heart valve, the authors note, but there was no safety signal from this approach even among the very elderly.

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Diet rich in antioxidants may cut stroke risk: Women who eat an antioxidant-rich diet may significantly cut their stroke risk, particularly for those without a history of CVD, new research published online in Stroke Journal suggests. This prospective study found that women with no history of CVD who consumed the highest amount of antioxidants in foods such as fruit, vegetables, tea, whole grains, and chocolate had 17% fewer strokes than those who ate the least amount. Among women with a history of CVD, those who consumed the most antioxidants had 45% fewer hemorrhagic strokes.

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Noncardiac chest pain not always a low-risk diagnosis: Patients discharged from the hospital with noncardiac chest pain have always been thought of as low risk, but a new study shows a worrying one-year mortality rate of around 4% in this group, which is higher in patients with a previous psychiatric hospitalization. Around one-third of the deaths were cardiovascular, suggesting that a fairly substantial number of patients with heart disease are being missed when presenting to hospitals with chest pain. The study, published online in the European Heart Journal.

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FDA agrees to review apixaban for AF patients: The FDA accepted for review a new drug application (NDA) for the anticoagulant apixaban and assigned a priority review designation. The goal date for issuing a decision is March 28, 2012. Apixaban is a factor Xa inhibitor developed to prevent stroke and systemic embolism in patients with atrial fibrillation (AF). The submission was based on results from two Phase 3 clinical trials, ARISTOTLE and AVERROES. ARISTOTLE found that apixaban reduced the risk of stroke or systemic embolism by 21 percent, major bleeding by 31 percent and death by 11 percent. AVERROES results showed that apixaban significantly reduced the risk of stroke or systemic embolism without increasing the risk of major bleeding or intracranial hemorrhage in AF patients. AVERROES was stopped early, based on the beneficial findings. Apixaban is one of several novel anticoagulants under study as alternatives to warfarin, including direct thrombin inhibitor dabigatran and the factor Xa inhibitor rivaroxaban.

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November 28, 2011

UK NICE Gives Nod to Apixaban for DVT Prevention: The UK's National Institute for Health and Clinical Excellence (NICE) has published final draft guidance recommending NHS reimbursement for the use of apixaban as an option for the prevention of venous thromboembolism (VTE) in adults who have undergone planned total hip or total knee replacement surgery .The committee concluded that apixaban was more clinically effective and cheaper than enoxaparin. It also concluded that there was insufficient clinical evidence to determine whether or not apixaban was more or less clinically effective than rivaroxaban and dabigatran. The draft guidance has been sent to the formal consultees for appraisal who have 15 working days to consider whether they wish to appeal against it. Subject to appeal, the draft guidance will be used as the basis for final guidance.

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Four Drugs Cause Most Adverse-Event Hospital Stays for Seniors: Adverse drug events (ADEs) cause an estimated 100,000 emergency hospitalizations for seniors each year, yet two thirds involve just a handful of anticoagulants and diabetes medications, according to a study published in the last issue of the New England Journal of Medicine. The study, singles out 4 drugs and drug classes — warfarin, oral antiplatelet medications, insulins, and oral hypoglycemic agents. Alone or together, they account for 67% of emergency ADE hospitalizations of adults 65 years and older. Warfarin was implicated in 33%. In contrast, medications red-flagged as high risk or inappropriate by health authorities explained only 1.2% and 6.6%, respectively, of such hospital admissions. For clinicians, the take-home message of the study is clear: Improved management of antithrombotic and antidiabetes drugs can keep thousands of seniors out of the hospital.

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Surgery ups survival in infective endocarditis with heart failure: Around the world, surgery decreased in-hospital mortality by 25% and one-year mortality by more than 50% compared with medical therapy in patients with infective endocarditis and heart failure, new research has found. The cohort study, which included over 4000 patients, probably represents the largest number of people with infective endocarditis ever prospectively followed as a group and published in the last issue of JAMA. Yet, according to an analysis from the International Collaboration on Endocarditis-Prospective Cohort Study, valve-replacement surgery is performed in less than two-thirds of such endocarditis cases with heart failure. Other independent predictors of in-hospital and one-year mortality included older age, diabetes, and a history of stroke; infection with Staphylococcus aureus or fungi also raised both mortality risks, while other types of infection did not. Of note, heart-failure severity was also a mortality predictor, but surgery conferred a significant benefit whether NYHA status was 3-4 or 1-2. The study included 4075 patients with confirmed native- or prosthetic-valve infective endocarditis and known HF status enrolled at 61 centers in 28 countries from 2000 through 2006. Of those patients, 1359 (33.4%) had heart failure, two-thirds of whom had NYHA functional status 3 or 4. Not surprisingly, in-hospital mortality in infective endocarditis rose significantly with the presence of heart failure, with an odds ratio (OR) of 2.80 (95% CI 2.38–3.29) vs no heart failure. However, surgery during that hospitalization cut the risk by a third, with an OR of 0.66 (95% CI 0.56–0.77) vs medical therapy alone. Both risk reductions were significant at p<0.001. The effect was much more pronounced in NYHA 3-4 patients, but remained significant in those who were less symptomatic.

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Patients With Prior Stroke and Diabetes Benefits from Thrombolysis after an acute stroke: Ischemic stroke patients with prior stroke and diabetes might still be candidates for thrombolytic therapy according to a new study published in the last issue of Neurology. The study suggests that these patients derive just as much benefit from treatment as those without these conditions. In this study, they used data from the Safe Implementation of Thrombolysis Stroke-International Stroke Thrombolysis Register (SITS-ISTR) on stroke patients who received thrombolytic therapy from December 2002 to November 2009; control stroke patients did not receive thrombolytic therapy but participated in neuroprotection trials registered in the Virtual International Stroke Trials Archive (VISTA). Information from VISTA was limited to trials of neuroprotective agents that weren't vasoactive or expected to interfere with clotting mechanisms, or from the placebo groups.In all, they reviewed the outcomes of 29,500 ischemic stroke patients, looking at age, baseline National Institutes of Health Stroke Scale score, and 90-day Modified Rankin Scale (mRS) outcome score. Benefit was defined as improved distribution of mRS scores for the groups. The adjusted mRS outcomes were better in patients with diabetes, prior stroke, or both who were treated with tPA than in those who were not. These mRS scores were comparable to outcomes in treated stroke patients without diabetes or prior stroke (odds ratio, 1.53; 95% confidence interval, 1.42 to 1.63; P < .0001).

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November 21, 2011

Low blood pressure linked to recurrent stroke, boosting J-curve hypothesis: A new study points again to evidence of the fabled J-curve of cardiovascular-event risk associated with blood-pressure levels. Among patients with recent noncardioembolic stroke, systolic blood pressures (SBP) >140 mm Hg and <120 mg Hg were both associated with increased risk of recurrent stroke. The study, a post hoc analysis of data from the Prevention Regimen for Effectively Avoiding Second Strokes (PROFESS) trial, is published in last issue of the Journal of American Medical Association. In this analysis, the authors used data from the PROFESS trial, a 2x2 factorial trial comparing four regimens: a combination of aspirin and extended-release dipyridamole compared with clopidogrel and telmisartan compared with placebo. All patients also received antihypertensive medications at the discretion of the investigator. In all, 20.330 patients from 695 centers in 35 countries were randomized within about 30 days of having a noncardioembolic ischemic stroke. The main results of the trial didn't show any significant difference between these treatments, the authors note, so all patients were combined for this study. Patients were categorized by their mean SBP level over follow-up as very low normal (<120 mm Hg), low normal (120 to <130 mm Hg), high normal (130 to <140 mm Hg), high (140 to <150 mm Hg) and very high (>150 mm Hg). The primary outcome was first recurrence of stroke of any type, and the secondary outcome was a composite of stroke, MI, or death from vascular disease. The adjusted hazard ratio for stroke, MI, or vascular death (95% CI) was 1.31 (1.13-1.52) for patients with Very low- normal blood pressure and 1.24 (1.11-1.39) and 1.94 (1.74-2.16)for patients with high and very high blood pressure respectively.

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Survival after first MI paradoxically worse with fewer CHD risk factors: As the number of traditional CHD risk factors increased, the likelihood of in-hospital death after a first MI decreased, in a large, observational study published in the last issue of JAMA. The study, was based on data from over 500 000 patients listed in the 1994-2006 National Registry of Myocardial Infarction (NRMI). Hypertension was the most common risk factor (52.3% of patients), followed by smoking (31.3%), dyslipidemia (28.0%), family history of CHD (28.0%), and diabetes (22.4%). Only 14.4% of the patients had no CHD risk factors. Almost all patients (85.6%) had at least one of the five risk factors—hypertension, smoking, dyslipidemia, diabetes, or an immediate relative diagnosed with CHD before age 60. Compared with patients who had all five risk factors, patients with no risk factors were 54% more likely to have a fatal first MI (odds ratio 1.54; 95% CI 1.23-1.94), after adjustment for age, weight, sex, race/ethnicity, payer status, systolic blood pressure, prehospital delay, Killip class, hospital characteristics, region, type of MI, and calendar year.

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European Medicines Agency updates on safety of Pradaxa: The European Medicines Agency announced that despite the number of deaths from serious bleeding seen with Boehringer Ingelheim’s Pradaxa (dabigatran), it believes that changes to the product's label recommended last month can "adequately manage the risk." The regulator added that the efficacy of the anticoagulant "demonstrated in clinical trials remains unchanged." The drug, which has been approved in Europe since 2008 for the prevention of venous thromboembolic events in adults who have had certain surgeries, and more recently for the prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation, has been linked to 256 reports of serious bleeding resulting in death as of November 6. The EMA noted that 21 of these deaths have occurred within the EU. According to the agency, the number of reports should be viewed in "context of the rapidly increasing use of Pradaxa worldwide," due in part to recent authorisation in several markets for the prevention of stroke, as well as increased awareness of the drug, which "is known to lead to higher than usual reporting of side effects." Last month, the EMA recommended that the label of Pradaxa be updated to include advice that renal function is assessed in all patients before starting treatment with the drug. The EMA also reiterated that the anticoagulant should be "used with caution and at lower doses" in elderly patients and those with moderate kidney impairment. The agency said it "will continue to closely monitor this issue and the overall safety profile" of Pradaxa, including determining whether the frequency of fatal bleeding events has increased.

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November 14, 2011

ATLAS ACS 2 TIMI 51: Low dose of rivaroxaban has a good benefit/risk balance in patients with acute coronary syndromes: The lower of the two doses of the new oral anticoagulant rivaroxaban (Xarelto, Bayer/Johnson & Johnson) tested in the ATLAS ACS 2 TIMI 51 trial has shown promising results, with a reduction in overall and cardiovascular mortality vs placebo, despite an increased risk of bleeding and intracranial hemorrhage (ICH). The trial, presented at the American Heart Association (AHA) 2011 Scientific Sessions and published online in NEJM, compared two doses of rivaroxaban with placebo in ACS patients. All patients were taking low-dose (75-100 mg) aspirin and 93% were also on clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi-Aventis). Study treatment was started an average of 4.6 days after the ACS event. Patients with a previous stroke or transient ischemic attack (TIA) were excluded, as this group has been shown to have a particularly high risk of ICH in previous trials of other antithrombotic agents. The population was high risk, with half having had a STEMI. Both rivaroxaban doses reduced the primary end point of cardiovascular death/MI/stroke, at the cost of increased bleeding rates. The 2.5-mg twice-daily dose had the better benefit/risk balance, due to a lower bleeding risk than the 5-mg twice-daily dose.

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New-onset AF in sepsis increases stroke and death rates: New-onset atrial fibrillation (AF) in patients with severe sepsis is associated with a significant increase in in-hospital stroke and death compared with both sepsis patients who don't develop AF and those with preexisting AF, according to new research presented at the American Heart Association 2011 Scientific Sessions and published simultaneously online in JAMA. In this retrospective study were participated 3. 144. 787 hospitalized adults, whereas 49.082 of them suffered from severe sepsis. New-onset AF was defined as AF that occurred during hospital admission, excluding patients who had AF at admission. Outcome measures were in-hospital stroke or death. New-onset AF was significantly more common in patients with severe sepsis than in hospitalized patients without severe sepsis. Severe sepsis was present in 14% of all new cases of AF among hospitalized adults

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NHBLI-appointed expert panel recommends universal cholesterol screening for kids: An expert panel is recommending that all children, regardless of family history, undergo universal screening for elevated cholesterol levels. The panel recommends that adolescents undergo lipid screening for nonfasting non-HDL-cholesterol levels or a fasting lipid panel between the ages of 9 and 11 years followed by another full lipid screening test between 18 and 21 years of age. The guidelines, from the Expert Panel on Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents, appointed by the National Health, Lung, and Blood Institute (NHLBI) and endorsed by the American Academy of Pediatrics (AAP), also recommend measuring fasting glucose levels to test for diabetes in children 10 years of age (or at the onset of puberty) who are overweight with other risk factors, including a family history, for type 2 diabetes mellitus.

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ISAR-REACT 4: Bivalirudin preferable to combination abciximab/heparin in NSTEMI: The ISAR-REACT-4 trial has shown that bivalirudin is preferable to abciximab plus heparin in NSTEMI patients undergoing PCI. In the trial, presented at the American Heart Association 2011 Scientific Sessions and simultaneously published online in the New England Journal of Medicine, the primary end point was not significantly different between the two groups, but bivalirudin was associated with less bleeding. In the study were participated 1721 NSTEMI patients who were randomized to receive abciximab plus unfractionated heparin or bivalirudin immediately before PCI. Results showed that abciximab and unfractionated heparin failed to reduce the rate of the primary end point and increased the risk of bleeding.

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TRACER: Varopaxar failed to improve the prognosis of patients with acute coronary syndromes and increased the risk of major bleedings: A novel oral antithrombotic agent, given to high-risk patients with non-ST-elevation ACS who were mostly already on dual-agent antiplatelet therapy, failed to hit that coveted treatment sweet-spot—reduced ischemic risk without more bleeding—in an huge international trial reported here today at the American Heart Association (AHA) 2011 Scientific Sessions and published online in NEJM. In the Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRACER) trial with >12 000 patients, adding the investigational vorapaxar (a PAR1 antagonist) to standard therapy significantly raised the risk of major bleeding complications, including intracranial hemorrhage (ICH), over two years.

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November 7, 2011

NICE recommended Dabigatran etexilate as a cost effective option for the prevention of stroke in patients with atrial fibrillation: The National Institute for Health and Clinical Excellence (NICE) has reviewed the numbers and is now recommending use of dabigatran etexilate (Pradaxa, Boehringer Ingelheim) as a treatment option for the prevention of stroke and systemic embolism in individuals with nonvalvular atrial fibrillation. In August, the agency had requested a cost-effectiveness analysis of patients 80 years of age and younger who begin treatment with dabigatran 150 mg twice daily and patients 80 years of age and older who switch to dabigatran 110 mg twice daily from warfarin. In its final appraisal, NICE has concluded that the "most plausible" incremental cost-effectiveness ratios for all patients eligible for dabigatran are within the range considered cost-effective for use in the UK National Health Service (NHS), that being less than £20 000 per quality-adjusted life-year (QALY) gained. Based on the review, the NICE committee recommends treatment with the novel anticoagulant "after an informed discussion between the clinician and the person about the risks and benefits of dabigatran compared with warfarin."

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Rivaroxaban Approved by FDA to prevent stroke in patients with AF: The FDA has approved rivaroxaban (Xarelto, Johnson & Johnson) for stroke reduction in people with non-valvular atrial fibrillation. The label will include a boxed warning that people should not discontinue taking the drug without talking with a healthcare professional. The FDA will also require that patients getting the drug receive a Medication Guide describing the risks and adverse reactions associated with the drug.

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FDA approved first artificial aortic heart valve placed without open-heart surgery (Sapien) for patients with inoperable aortic valve disease: The US Food and Drug Administration has approved the first-ever transcatheter valve for the treatment of inoperable aortic-stenosis disease, the Sapien (Edwards Lifesciences). The FDA’s approval of the Sapien THV is based on PARTNER cohort B study with 365 patients who were not eligible for open-heart surgery. Half of the patients received the Sapien valve. The other study patients received another treatment that did not require open-heart surgery. One alternative procedure involved enlarging the aortic valve opening by stretching it with a balloon (balloon valvuloplasty). Patients receiving the Sapien valve experienced two and a half times more strokes and eight times as many vascular and bleeding complications than patients who did not receive the implant; however, they were more likely to survive one year after surgery. After a year, 69 percent of the Sapien patients were alive compared with 50 percent of those who received an alternative treatment.

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ACC/AHA updates secondary-prevention guidelines: The American Heart Association and American College of Cardiology Foundation have issued new guidelines for secondary prevention and risk reduction in patients with atherosclerotic vascular disease, even though it is still waiting for the new Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 8) guidelines and new Adult Treatment Panel 4 (ATP 4) guidance on lipid management [1]. The new guidelines, published online in Circulation, update the 2006 guidelines on secondary prevention and change the title to include risk-factor reduction, "because important evidence from clinical trials has emerged that further supports and broadens the merits of intensive risk-reduction therapies for patients with established coronary and other atherosclerotic vascular disease," including peripheral artery disease, the writing committee explains.

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