Long-Term Effect of Endothelin Receptor Antagonism With Bosentan on the Morbidity and Mortality of Patients With Severe Chronic Heart Failure: Primary Results of the ENABLE Trials.

Objectives: The objective of this clinical trial was to evaluate the long-term effect of endothelin receptor antagonism with bosentan on the morbidity and mortality of patients with severe chronic heart failure.

Background: Endothelin may play a role in heart failure, but short-term clinical trials with endothelin receptor antagonists have reported disappointing results. Long-term trials are lacking.

Value of CACS compared with ETT and myocardial perfusion imaging for predicting long-term cardiac outcome in asymptomatic and symptomatic patients at low risk for coronary disease: clinical implications in a multimodality imaging world.

Objectives: This prospective, observational study in 988 asymptomatic or symptomatic low-risk patients without prior coronary artery disease was conducted to define the relative value of coronary artery calcium score (CACS), exercise treadmill testing (ETT), and stress myocardial perfusion single-photon emission computed tomography (SPECT) variables in predicting long-term risk stratification.

Background: CACS, ETT, and stress myocardial perfusion SPECT results predict patients' outcome. There are currently no data comparing their relative value in long-term risk stratification.

Case report: Severe hypercalcemia mimicking ST-segment elevation myocardial infarction.

The identification of ST-segment elevation on the electrocardiogram is an integral part of decision making in patients who present with suspected ischemia. Unfortunately, ST-segment elevation is nonspecific and may be caused by noncardiac causes such as electrolyte abnormalities. We present a case of ST-segment elevation secondary to hypercalcemia in a patient with metastatic cancer.

Efficacy and safety of prescription omega-3 fatty acids for the prevention of recurrent symptomatic atrial fibrillation: a randomized controlled trial.

Context: Atrial fibrillation (AF) is common, yet there remains an unmet medical need for additional treatment options. Current pharmacological treatments have limited efficacy and significant adverse events. Limited data from small trials suggest omega-3 polyunsaturated fatty acids may provide a safe, effective treatment option for AF patients.

Usefulness of vernakalant hydrochloride injection for rapid conversion of atrial fibrillation.

The objective of the present study was to assess the safety and effectiveness of vernakalant hydrochloride injection (RSD1235), a novel antiarrhythmic drug, for the conversion of atrial fibrillation (AF) or atrial flutter to sinus rhythm (SR). Patients with either AF or atrial flutter were randomized in a 1:1 ratio to receive vernakalant (n = 138) or placebo (n = 138) and were stratified by an arrhythmia duration of >3 hours to ≤7 days (short duration) and 8 to ≤45 days (long duration). The first infusion of placebo or vernakalant (3 mg/kg) was given for 10 minutes followed by a second infusion of placebo or vernakalant (2 mg/kg) 15 minutes later if the arrhythmia had not terminated.

Warfarin and aspirin use in atrial fibrillation among practicing cardiologist (from the AFFECTS Registry).

Among patients with atrial fibrillation (AF), the risk of thromboembolism is a significant concern. However, the reported use of warfarin among patients with AF at elevated risk of stroke remains low. In the present study, we have provided information on anticoagulation use reported during the recent Atrial Fibrillation: Focus on Effective Clinical Treatment Strategies (AFFECTS) Registry.

Practice patterns among United States cardiologists for managing adults with atrial fibrillation (from the AFFECTS Registry).

The Atrial Fibrillation: Focus on Effective Clinical Treatment Strategies (AFFECTS) Registry was designed to examine atrial fibrillation (AF) treatment by United States cardiologists in the context of the American College of Cardiology, American Heart Association, and European Society of Cardiology guidelines after recent landmark clinical trials. Most patients in AFFECTS had AF without clinically significant structural heart disease or only uncomplicated hypertension. Among the all-enrolled population (n = 1,461), initial treatment strategies assigned were rhythm control in 64% and rate control in 36%.

Coronary artery calcium scoring in the emergency department: identifying which patients with chest pain can be safely discharged home.

Study Objective: Coronary artery calcium scoring (CACS) is a simple and readily available test for identifying coronary artery disease. Our objective is to evaluate whether a CACS of zero will identify chest pain patients who can be safely discharged home, without need for further cardiac testing.

Methods: This was a prospective observational cohort study conducted at an urban tertiary care hospital of stable patients presenting to the emergency department (ED) with chest pain of uncertain cardiac cause.

Vernakalant hydrochloride for the rapid conversion of atrial fibrillation after cardiac surgery: a randomized, double-blind, placebo-controlled trial.

Background: Postoperative atrial arrhythmias are common and are associated with considerable morbidity. This study was designed to evaluate the efficacy and safety of vernakalant for the conversion of atrial fibrillation (AF) or atrial flutter (AFL) after cardiac surgery.

Methods And Results: This was a prospective, randomized, double-blind, placebo-controlled trial of vernakalant for the conversion of AF or AFL after coronary artery bypass graft, valvular surgery, or both.

The coronary artery calcium score and stress myocardial perfusion imaging provide independent and complementary prediction of cardiac risk.

Objectives: This study sought to examine the relationship between coronary artery calcium score (CACS) and single-photon emission computed tomography (SPECT) results for predicting the short- and long-term risk of cardiac events.

Background: The CACS and SPECT results both provide important prognostic information. It is unclear whether integrating these tests will better predict patient outcome.

Efficacy and safety of prescription omega-3-acid ethyl esters for the prevention of recurrent symptomatic atrial fibrillation: a prospective study.

Background: Atrial fibrillation (AF) continues to be one of the most common cardiac problems, placing an expanding burden on the public health system. In several circumstances, AF can increase the risk of stroke and heart failure. Current pharmacologic treatment options are associated with the potential for significant adverse events, which often outweigh the benefits of achieving sinus rhythm.

Azimilide reduces emergency department visits and hospitalizations in patients with an implantable cardioverter-defibrillator in a placebo-controlled clinical trial.

Objectives: The goal of this study was to determine whether azimilide, as compared with placebo, will reduce the number of emergency department (ED) visits and hospitalizations caused by arrhythmias or cardiac events in patients with an implantable cardioverter-defibrillator (ICD).

Background: Patients with an ICD may require ED visits and hospitalizations because of arrhythmias, which trigger ICD therapies. The effect of adjunctive antiarrhythmic therapy on these outcomes is not known.

Vernakalant hydrochloride for rapid conversion of atrial fibrillation: a phase 3, randomized, placebo-controlled trial.

Background: The present study assessed the efficacy and safety of vernakalant hydrochloride (RSD1235), a novel compound, for the conversion of atrial fibrillation (AF).

Methods And Results: Patients were randomized in a 2:1 ratio to receive vernakalant or placebo and were stratified by AF duration of 3 hours to 7 days (short duration) and 8 to 45 days (long duration). A first infusion of placebo or vernakalant (3 mg/kg) was given for 10 minutes, followed by a second infusion of placebo or vernakalant (2 mg/kg) 15 minutes later if AF was not terminated.

Results of a non-specific immunomodulation therapy in chronic heart failure (ACCLAIM trial): a placebo-controlled randomised trial.

Background: Evidence suggests that inflammatory mediators contribute to development and progression of chronic heart failure. We therefore tested the hypothesis that immunomodulation might counteract this pathophysiological mechanism in patients.

Methods: We did a double-blind, placebo-controlled study of a device-based non-specific immunomodulation therapy (IMT) in patients with New York Heart Association (NYHA) functional class II-IV chronic heart failure, left ventricular (LV) systolic dysfunction, and hospitalisation for heart failure or intravenous drug therapy in an outpatient setting within the past 12 months.

An initial strategy of intensive medical therapy is comparable to that of coronary revascularization for suppression of scintigraphic ischemia in high-risk but stable survivors of acute myocardial infarction.

Objectives: The purpose of this study was to determine the relative benefit of intensive medical therapy compared with coronary revascularization for suppressing scintigraphic ischemia.

Background: Although medical therapies can reduce myocardial ischemia and improve patient survival after acute myocardial infarction, the relative benefit of medical therapy versus coronary revascularization for reducing ischemia is unknown.

Methods: A prospective randomized trial in 205 stable survivors of acute myocardial infarction was made to define the relative efficacy of an intensive medical therapy strategy versus coronary revascularization for suppressing scintigraphic ischemia as assessed by serial gated adenosine Tc-99m sestamibi myocardial perfusion tomography.

A multinational study to establish the value of early adenosine technetium-99m sestamibi myocardial perfusion imaging in identifying a low-risk group for early hospital discharge after acute myocardial infarction.

Objectives: The purpose of this study was to determine whether gated adenosine Tc-99m sestamibi single-photon emission computed tomography (ADSPECT) could accurately define risk and thereby guide therapeutic decision making in stable survivors of acute myocardial infarction (AMI).

Background: Controversy continues as to the role of noninvasive stress imaging in stratifying risk early after AMI.

Methods: The INSPIRE (Adenosine Sestamibi Post-Infarction Evaluation) trial is a prospective multicenter trial which enrolled 728 clinically stable survivors of AMI who had gated ADSPECT within 10 days of hospital admission and subsequent 1-year follow-up.

Electrical storm in patients with an implantable defibrillator: incidence, features, and preventive therapy: insights from a randomized trial.

Aims: The purpose of this study was to assess the incidence, features, and clinical sequelae of 'electrical storm' (ES).

Methods And Results: This study is a prospectively designed secondary analysis of SHIELD; a randomized trial of azimilide for suppression of ventricular tachycardia/fibrillation (VT/VF) leading to implanted cardioverter defibrillator (ICD) therapies. Systematic and rigorous follow-up and blinded adjudication of ICD therapy allowed identification of all ESs (>/=3 separate VT/VF episodes leading to ICD therapies within 24 h).

Cumulative experience of azimilide-associated torsades de pointes ventricular tachycardia in the 19 clinical studies comprising the azimilide database.

Objectives: The purpose of this study was to assess the incidence, temporal characteristics, and risk factors associated with azimilide-associated torsades de pointes (TdP) ventricular tachycardia.

Background: Azimilide dihydrochloride is a class III antiarrhythmic drug possessing Ikr and Iks channel-blocking properties.

Methods: Oral azimilide (75 to 125 mg/day) was taken by 5,375 patients in 19 clinical trials conducted at 775 international centers.

Comparison of management patterns and clinical outcomes in patients with atrial fibrillation in Canada and the United States (from the analysis of the Atrial Fibrillation Follow-up Investigation of Rhythm Management [AFFIRM] database).

Little is known about differences in practice patterns or outcomes in the management of patients who have atrial fibrillation in Canada compared with those in the United States (US). We evaluated the effect that the country of enrollment may have on the management patterns and clinical outcomes in patients who participated in the AFFIRM study. Three thousand four hundred patients came from the US and 660 from Canada.

Prognostic value of adenosine Tl-201 myocardial perfusion imaging after acute myocardial infarction: results of a prospective clinical trial.

Background: We have previously shown in retrospective studies that adenosine myocardial perfusion imaging (MPI) done after acute myocardial infarction (AMI) can effectively predict the risk of future cardiac events in these patients. The objective of this study was to validate these observations in a prospective clinical trial.

Methods And Results: One hundred twenty-six stable patients underwent quantitative adenosine MPI at a mean of 4.

First experience with a Mobile Cardiac Outpatient Telemetry (MCOT) system for the diagnosis and management of cardiac arrhythmia.

Recently, a mobile cardiac outpatient telemetry (MCOT) system has become available that monitors the electrocardiogram continuously, recognizes arrhythmias automatically, and transmits abnormal rhythms instantaneously. MCOT does not require activation by the patient. We report data from the first 100 consecutive patients monitored by this new technology.

Design of the SHock Inhibition Evaluation with Azimilide (SHIELD) study: a novel method to assess antiarrhythmic drug effect in patients with an implantable cardioverter-defibrillator.

This report presents the rationale and study design details of the SHock Inhibition Evaluation with Azimilide study, which is recruiting 624 patients with implantable cardioverter-defibrillators (ICDs) who are at risk for life-threatening ventricular arrhythmia, randomized to azimilide 75 mg, azimilide 125 mg, or placebo and followed for 1 year. The objective of this study is to determine the effect of azimilide versus placebo on the symptomatic ventricular arrhythmia burden using a unique statistical analysis based on the unusual temporal distribution of symptomatic ICD therapies. The primary efficacy end points are time to all-cause shocks and time to all-cause shocks plus symptomatic ventricular arrhythmic events triggering antitachycardia pacing measured from randomization.

Placebo-controlled, randomized clinical trial of azimilide for prevention of ventricular tachyarrhythmias in patients with an implantable cardioverter defibrillator.

Background: Although implanted cardioverter defibrillators (ICDs) effectively treat sustained ventricular tachyarrhythmias, up to 50% of ICD recipients eventually require concomitant antiarrhythmic drug therapy to prevent symptomatic arrhythmia recurrences and hence reduce the number of device therapies.

Methods And Results: A total of 633 ICD recipients were enrolled in a randomized, double-blind, placebo-controlled study to evaluate the effect of daily doses of 75 or 125 mg of azimilide on recurrent symptomatic ventricular tachyarrhythmias and ICD therapies. Total all-cause shocks plus symptomatic ventricular tachycardia (VT) terminated by antitachycardia pacing (ATP) were significantly reduced by azimilide, with relative risk reductions of 57% (hazard ratio [HR]=0.