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    Mean arterial pressure of 65 mm Hg versus 85-100 mm Hg in comatose survivors after cardiac arrest: Rationale and study design of the Neuroprotect post-cardiac arrest trial.
    Am Heart J 2017 Sep 23;191:91-98. Epub 2017 Jun 23.
    Department of Cardiology, University Hospitals Leuven, Leuven, Belgium.
    Background: Post-cardiac arrest (CA) patients admitted to the intensive care unit (ICU) have a poor prognosis, with estimated survival rates of around 30%-50%. On admission, these patients have a large cerebral penumbra at risk for additional damage in case of suboptimal brain oxygenation during their stay in the ICU. The aim of the Neuroprotect post-CA trial is to investigate whether forcing mean arterial blood pressure (MAP) and mixed venous oxygen saturation (SVO2) in a specific range (MAP 85-100 mm Hg, SVO2 65%-75%) with additional pharmacological support (goal-directed hemodynamic optimization) may better salvage the penumbra, reduce cerebral ischemia, and improve functional outcome when compared with current standard of care (MAP 65 mm Hg). Read More

    Blood pressure reactivity to psychological stress is associated with clinical outcomes in patients with heart failure.
    Am Heart J 2017 Sep 12;191:82-90. Epub 2017 Jul 12.
    University of North Carolina School of Medicine, Chapel Hill, NC.
    Introduction: Cardiovascular (CV) reactivity to psychological stress has been implicated in the development and exacerbation of cardiovascular disease (CVD). Although high CV reactivity traditionally is thought to convey greater risk of CVD, the relationship between reactivity and clinical outcomes is inconsistent and may depend on the patient population under investigation. The present study examined CV reactivity in patients with heart failure (HF) and its potential association with long-term clinical outcomes. Read More

    Multinational and multiethnic variations in health-related quality of life in patients with chronic heart failure.
    Am Heart J 2017 Sep 1;191:75-81. Epub 2017 Jul 1.
    Duke University Medical Center, Duke Clinical Research Institute, Durham, NC.
    Background: Assessing health-related quality of life (HRQoL) in patients with heart failure (HF) is an important goal of clinical care and HF research. We sought to investigate ethnic differences in perceived HRQoL and its association with mortality among patients with HF and left ventricular ejection fraction ≤35%, controlling for demographic characteristics and HF severity.

    Methods And Results: We compared 5697 chronic HF patients of Indian (26%), white (23%), Chinese (17%), Japanese/Koreans (12%), black (12%), and Malay (10%) ethnicities from the HF-ACTION and ASIAN-HF multinational studies using the Kansas City Cardiomyopathy Questionnaire (KCCQ; range 0-100; higher scores reflect better health status). Read More

    Gender differences in coronary angiography, subsequent interventions, and outcomes among patients with acute coronary syndromes.
    Am Heart J 2017 Sep 30;191:65-74. Epub 2017 Jun 30.
    Landspitali University Hospital, Reykjavik, Iceland; Dep. of Cardiology and Cardiovascular Research Center, University of Iceland, Reykjavik, Iceland.
    Background: The objective was to investigate whether gender disparities are found in referrals of patients with acute coronary syndromes to percutaneous coronary interventions (PCIs) or coronary artery bypass grafting (CABG) and, furthermore, to study gender differences in complications and mortality.

    Methods: All consecutive coronary angiographies (CAs) and PCIs performed in Sweden and Iceland are prospectively registered in the Swedish Coronary Angiography and Angioplasty Registry. For the present analysis, data of patients with acute coronary syndromes, enrolled in 2007-2011, were used to analyze gender differences in revascularization, in-hospital complications, and 30-day mortality. Read More

    Soluble endothelial cell-selective adhesion molecule and incident cardiovascular events in a multiethnic population.
    Am Heart J 2017 Sep 23;191:55-61. Epub 2017 Jun 23.
    Division of Cardiology, Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX. Electronic address:
    Background: Cell adhesion molecules are key regulators of atherosclerotic plaque development, but circulating levels of soluble fragments, such as intercellular adhesion molecule (sICAM-1) and vascular cell adhesion molecule (sVCAM-1), have yielded conflicting associations with atherosclerotic cardiovascular disease (ASCVD). Endothelial cell-selective adhesion molecule (ESAM) is expressed exclusively in platelets and endothelial cells, and soluble ESAM (sESAM) levels have been associated with prevalent subclinical atherosclerosis. We therefore hypothesized that sESAM would be associated with incident ASCVD. Read More

    Depression is associated with recurrent chest pain with or without coronary artery disease: A prospective cohort study in the emergency department.
    Am Heart J 2017 Sep 10;191:47-54. Epub 2017 Jun 10.
    Yale School of Medicine, Department of Emergency Medicine, New Haven, CT. Electronic address:
    Background: Only a small fraction of acute chest pain in the emergency department (ED) is due to obstructive coronary artery disease (CAD). ED chest pain remains associated with high rates of recidivism, often in the presence of nonobstructive CAD. Psychological states such as depression, anxiety, and elevation of perceived stress may account for this finding. Read More

    A randomized, multicenter, open-label, blinded end point trial comparing the effects of spironolactone to chlorthalidone on left ventricular mass in patients with early-stage chronic kidney disease: Rationale and design of the SPIRO-CKD trial.
    Am Heart J 2017 Sep 24;191:37-46. Epub 2017 May 24.
    Birmingham Cardio-Renal Group (University of Birmingham Institute of Cardiovascular Sciences), Queen Elizabeth Hospital, Edgbaston, Birmingham. Electronic address:
    Background: Chronic kidney disease (CKD) is associated with increased left ventricular (LV) mass and arterial stiffness. In a previous trial, spironolactone improved these end points compared with placebo in subjects with early-stage CKD, but it is not known whether these effects were specific to the drug or secondary to blood pressure lowering.

    Aim: The aim was to investigate the hypothesis that spironolactone is superior to chlorthalidone in the reduction of LV mass while exerting similar effects on blood pressure. Read More

    Sex-based differences in quality of care and outcomes in a health system using a standardized STEMI protocol.
    Am Heart J 2017 Sep 17;191:30-36. Epub 2017 Jun 17.
    Cedars-Sinai Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA.
    Background: Recent data from the National Cardiovascular Data Registry indicate that women with ST-segment-elevation myocardial infarction (STEMI) continue to have higher mortality and reported delays in treatment compared with men. We aimed to determine whether the sex difference in mortality exists when treatment disparities are reduced.

    Methods: Using a prospective regional percutaneous coronary intervention (PCI)-based STEMI system database with a standardized STEMI protocol, we evaluated baseline characteristics, treatment, and clinical outcomes of STEMI patients stratified by sex. Read More

    New York Heart Association class and the survival benefit from primary prevention implantable cardioverter defibrillators: A pooled analysis of 4 randomized controlled trials.
    Am Heart J 2017 Sep 9;191:21-29. Epub 2017 Jun 9.
    Duke Clinical Research Institute, Durham, NC. Electronic address:
    Background: Primary prevention implantable cardioverter defibrillator (ICD) reduce all-cause mortality by reducing sudden cardiac death. There are conflicting data regarding whether patients with more advanced heart failure derive ICD benefit owing to the competing risk of nonsudden death.

    Methods: We performed a patient-level meta-analysis of New York Heart Association (NYHA) class II/III heart failure patients (left ventricular ejection fraction ≤35%) from 4 primary prevention ICD trials (MADIT-I, MADIT-II, DEFINITE, SCD-HeFT). Read More

    Temporal changes in myocardial infarction incidence rates are associated with periods of perceived psychosocial stress: A SWEDEHEART national registry study.
    Am Heart J 2017 Sep 3;191:12-20. Epub 2017 Jun 3.
    Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.
    Background: Psychosocial stress might trigger myocardial infarction (MI). Increased MI incidence coincides with recurrent time periods during the year perceived as particularly stressful in the population.

    Methods: A stress-triggering hypothesis on the risk of MI onset was investigated with Swedish population data on MI hospital admission date and symptom onset date (N=156,690; 148,176) as registered from 2006 through 2013 in the national quality registry database Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART). Read More

    Availability of patient decision aids for stroke prevention in atrial fibrillation: A systematic review.
    Am Heart J 2017 Sep 3;191:1-11. Epub 2017 Jun 3.
    Section of Cardiovascular Medicine, Heart and Vascular Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH; The Preference Laboratory, The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth, Lebanon, NH. Electronic address:
    Background: Atrial fibrillation is a common irregular heart rhythm that increases patients' risk of stroke. Aspirin, warfarin, direct oral anticoagulants, and an implantable device can reduce this risk. Given the availability of multiple comparable options, this decision depends on patient preferences and is appropriate for the use of decision aids and other efforts to promote shared decision making. Read More

    Growth-differentiation factor 15 and risk of major bleeding in atrial fibrillation: Insights from the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial.
    Am Heart J 2017 Aug 6;190:94-103. Epub 2017 Jun 6.
    Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden; Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
    Objective: To evaluate and validate the prognostic value of growth-differentiation factor 15 (GDF-15) beyond clinical characteristics and other biomarkers concerning bleeding and stroke outcomes in patients with atrial fibrillation in the RE-LY trial.

    Methods: GDF-15 was measured in samples collected at randomization in 8,474 patients with a median follow-up time of 1.9 years. Read More

    Time in therapeutic range and major adverse outcomes in atrial fibrillation patients undergoing percutaneous coronary intervention: The Atrial Fibrillation Undergoing Coronary Artery Stenting (AFCAS) registry.
    Am Heart J 2017 Aug 3;190:86-93. Epub 2017 Jun 3.
    Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom; Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. Electronic address:
    Background: Combination of oral anticoagulation (OAC) and antiplatelets is used in atrial fibrillation (AF) patients undergoing percutaneous coronary intervention and stent (PCI-S) procedure but is associated with increased bleeding when triple antithrombotic therapy (TAT) is used. Our aim was to analyze the impact of time in therapeutic range (TTR) on outcomes, in patients prescribed with TAT.

    Methods: Ancillary analysis from the AFCAS registry in patients assigned to TAT. Read More

    Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing evaluation: Rationale and best practices. A report from the cardiac safety research consortium.
    Am Heart J 2017 Aug 28;190:76-85. Epub 2017 May 28.
    Beth Israel Deaconess Medical Center, Harvard Medical School and Baim Institute for Clinical Research, Boston, MA.
    This white paper provides a summary of presentations, discussions and conclusions of a Thinktank entitled "The Role of Endpoint Adjudication in Medical Device Clinical Trials". The think tank was cosponsored by the Cardiac Safety Research Committee, MDEpiNet and the US Food and Drug Administration (FDA) and was convened at the FDA's White Oak headquarters on March 11, 2016. Attention was focused on tailoring best practices for evaluation of endpoints in medical device clinical trials, practical issues in endpoint adjudication of therapeutic, diagnostic, biomarker and drug-device combinations, and the role of adjudication in regulatory and reimbursement issues throughout the device lifecycle. Read More

    Interventions Supporting Long-term Adherence aNd Decreasing cardiovascular events (ISLAND): Pragmatic randomized trial protocol.
    Am Heart J 2017 Aug 21;190:64-75. Epub 2017 May 21.
    Clinical Epidemiology Program, Ottawa Hospital Research Institute, The Ottawa Hospital, Ottawa, Ontario, Canada; Department of Medicine, University of Ottawa, Ottawa, ON, Canada.
    Background: Guidelines recommend cardiac rehabilitation and long-term use of cardiac medications for most patients who have had a myocardial infarction (MI), but adherence to these secondary prevention treatments is suboptimal.

    Methods: This is a multicenter, pragmatic, 3-arm randomized trial. Eligible patients (n = 2,742) with obstructive coronary artery disease are randomized post-MI to usual care or 1 of 2 intervention arms. Read More

    Clinical outcomes with percutaneous coronary revascularization vs coronary artery bypass grafting surgery in patients with unprotected left main coronary artery disease: A meta-analysis of 6 randomized trials and 4,686 patients.
    Am Heart J 2017 Aug 18;190:54-63. Epub 2017 May 18.
    Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY. Electronic address:
    Some but not all randomized controlled trials (RCT) have suggested that percutaneous coronary intervention (PCI) with drug-eluting stents may be an acceptable alternative to coronary artery bypass grafting (CABG) surgery for the treatment of unprotected left main coronary artery disease (ULMCAD). We therefore aimed to compare the risk of all-cause mortality between PCI and CABG in patients with ULMCAD in a pairwise meta-analysis of RCT.

    Methods: Randomized controlled trials comparing PCI vs CABG for the treatment of ULMCAD were searched through MEDLINE, EMBASE, Cochrane databases, and proceedings of international meetings. Read More

    Retained cardiac implantable electronic device fragments are not associated with magnetic resonance imaging safety issues, morbidity, or mortality after orthotopic heart transplant.
    Am Heart J 2017 Aug 4;190:46-53. Epub 2017 May 4.
    Division of Cardiovascular Disease, Mayo Clinic Florida, Jacksonville, FL.
    Background: Cardiac implantable electronic device therapy (CIED) has revolutionized treatment for advanced heart failure. Most patients considered for orthotopic heart transplantation (OHT) are treated with implantable cardioverter defibrillators, cardiac resynchronization therapy, or both. These CIEDs are surgically extracted at the time of transplant. Read More

    Brain-derived neurotrophic factor rs6265 (Val66Met) polymorphism is associated with disease severity and incidence of cardiovascular events in a patient cohort.
    Am Heart J 2017 Aug 18;190:40-45. Epub 2017 May 18.
    Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC.
    Background: The rs6265 (Val66Met) single-nucleotide polymorphism in the BDNF gene has been related to a number of endophenotypes that have in turn been shown to confer risk for atherosclerotic cardiovascular disease (CVD). To date, however, very few studies have examined the association of the Val66Met single-nucleotide polymorphism with CVD clinical outcomes.

    Methods: In a cohort of 5,510 Caucasian patients enrolled in the CATHeterization GENetics (CATHGEN) study at Duke University Hospital between 2001 and 2011, we determined the severity of coronary artery disease (CAD) and CVD event incidence through up to 11. Read More

    Implantable cardiac monitors in high-risk post-infarction patients with cardiac autonomic dysfunction and moderately reduced left ventricular ejection fraction: Design and rationale of the SMART-MI trial.
    Am Heart J 2017 Aug 19;190:34-39. Epub 2017 May 19.
    Medizinische Klinik und Poliklinik I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany; German Center for Cardiovascular Research (DZHK), partner site: Munich Heart Alliance, Munich, Germany. Electronic address:
    Background: Most deaths after myocardial infarction (MI) occur in patients with left ventricular ejection fraction (LVEF) >35%, for whom no specific prophylactic strategies exist. Deceleration capacity (DC) of heart rate and periodic repolarization dynamics (PRD) are noninvasive electrophysiological markers depending on the vagal and sympathetic tone. The combination of abnormal DC and/or PRD identifies a new high-risk group among postinfarction patients with LVEF 36%-50%. Read More

    A randomized trial of a 1-hour troponin T protocol in suspected acute coronary syndromes: Design of the Rapid Assessment of Possible ACS In the emergency Department with high sensitivity Troponin T (RAPID-TnT) study.
    Am Heart J 2017 Aug 18;190:25-33. Epub 2017 May 18.
    School of Medicine, Flinders University of South Australia, Adelaide, Australia; South Australian Department of Health, Adelaide, Australia. Electronic address:
    Background: Protocols incorporating high-sensitivity troponin to guide decision making in the disposition of patients with suspected acute coronary syndromes (ACS) in the emergency department have received a lot of attention. Traditionally, patients with chest pain have required long periods of observation in emergency department before being deemed safe for discharge. In an era of limited health service resources, a protocol that could discharge patients safely within an hour of presentation is extremely attractive. Read More

    Stroke of Known Cause and Underlying Atrial Fibrillation (STROKE-AF) randomized trial: Design and rationale.
    Am Heart J 2017 Aug 19;190:19-24. Epub 2017 Apr 19.
    Stroke Service, Department of Neurology, Massachusetts General Hospital, Boston, MA.
    Background: Approximately 20% of ischemic strokes are associated with clinically apparent atrial fibrillation (AF). Regardless of stroke etiology, detection of AF in patients with ischemic strokes often changes antithrombotic treatment from anti-platelet to oral anticoagulation therapy. The role and the optimum duration of cardiac monitoring to detect AF in patients with strokes presumed due to large vessel atherosclerosis or small vessel disease is unknown. Read More

    Use of troponin assay 99th percentile as the decision level for myocardial infarction diagnosis.
    Am Heart J 2017 Aug 16;190:135-139. Epub 2017 Jun 16.
    St Louis University School of Medicine, St Louis, MO.
    Background: The Universal Definition of Myocardial Infarction recommends the 99th percentile concentration of cardiac troponin in a normal reference population as part of the decision threshold to diagnose type 1 spontaneous myocardial infarction. Adoption of this recommendation in contemporary worldwide practice is not well known.

    Methods: We performed a cohort study of 276 hospital laboratories in 31 countries participating in the National Heart, Lung, and Blood Institute-sponsored International Study of Comparative Health Effectiveness with Medical and Invasive Approaches trial. Read More

    Prevention of sudden cardiac death in the young: Developing a rational, reliable, and sustainable national health care resource. A report from the Cardiac Safety Research Consortium.
    Am Heart J 2017 Aug 18;190:123-131. Epub 2017 May 18.
    GPS Cardiology, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.
    This White Paper, prepared by members of the Cardiac Safety Research Consortium, discusses important issues regarding sudden cardiac death in the young (SCDY), a problem that does not discriminate by gender, race, ethnicity, education, socioeconomic level, or athletic status. The occurrence of SCDY has devastating impact on families and communities. Sudden cardiac death in the young is a matter of national and international public health, and its prevention has generated deep interest from multiple stakeholders, including families who have lost children, advocacy groups, academicians, regulators, and the medical industry. Read More

    Probing oral anticoagulation in patients with atrial high rate episodes: Rationale and design of the Non-vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes (NOAH-AFNET 6) trial.
    Am Heart J 2017 Aug 3;190:12-18. Epub 2017 May 3.
    Department of Cardiology, Heraklion University Hospital, Crete, Greece.
    Oral anticoagulation prevents ischemic strokes in patients with atrial fibrillation (AF). Early detection of AF and subsequent initiation of oral anticoagulation help to prevent strokes in AF patients. Implanted cardiac pacemakers and defibrillators allow seamless detection of atrial high rate episodes (AHRE), but the best antithrombotic therapy in patients with AHRE is not known. Read More

    Effects of serelaxin on the outcome of patients with or without substantial peripheral edema: A subgroup analysis from the RELAX-AHF trial.
    Am Heart J 2017 Aug 27;190:113-122. Epub 2017 May 27.
    San Francisco VA Medical Center, University of California, San Francisco, San Francisco, CA.
    Background: Acute heart failure (AHF) is a heterogeneous disorder, with most of the patients presenting with breathlessness along with varying degrees of peripheral edema. The presence of peripheral edema suggests that volume overload is the cause of decompensation leading to AHF, whereas breathlessness in the absence of edema may reflect a "vascular phenotype." This analysis investigated the characteristics, therapeutic response, and outcome of patients with AHF, with and without overt peripheral edema in the RELAX-AHF trial. Read More

    County socioeconomic characteristics and heart transplant outcomes in the United States.
    Am Heart J 2017 Aug 3;190:104-112. Epub 2017 Jun 3.
    Division of Epidemiology, The Ohio State University College of Public Health, Columbus, OH; Department of Internal Medicine, The Ohio State University College of Medicine, Columbus, OH.
    Background: Geographic disparities in survival after heart transplantation have received mixed support in prior studies, and specific geographic characteristics that might be responsible for these differences are unclear. We tested for differences in heart transplant outcomes across United States (US) counties after adjustment for individual-level covariates. Our secondary aim was to evaluate whether specific county-level socioeconomic characteristics explained geographic disparities in survival. Read More

    High-sensitivity C-reactive protein is an independent marker of abnormal coronary vasoreactivity in patients with non-obstructive coronary artery disease.
    Am Heart J 2017 Aug 2;190:1-11. Epub 2017 Apr 2.
    Division of Cardiovascular Diseases, Mayo College of Medicine, Rochester, MN. Electronic address:
    Background: Coronary endothelial dysfunction (CED) is an early stage of atherosclerosis and is associated with adverse cardiovascular events. Inflammation may play a role in the development of endothelial dysfunction. To date no study has evaluated the relationship between C-reactive protein and CED. Read More

    Design and rationale for the Influenza vaccination After Myocardial Infarction (IAMI) trial. A registry-based randomized clinical trial.
    Am Heart J 2017 Jul 18;189:94-102. Epub 2017 Apr 18.
    Karolinska Institutet, Cardiology Unit, Department of Medicine, Karolinska University Hospital, Stockholm, Sweden.
    Background: Registry studies and case-control studies have demonstrated that the risk of acute myocardial infarction (AMI) is increased following influenza infection. Small randomized trials, underpowered for clinical end points, indicate that future cardiovascular events can be reduced following influenza vaccination in patients with established cardiovascular disease. Influenza vaccination is recommended by international guidelines for patients with cardiovascular disease, but uptake is varying and vaccination is rarely prioritized during hospitalization for AMI. Read More

    Hemodynamic determinants of mortality after Fontan operation.
    Am Heart J 2017 Jul 2;189:9-18. Epub 2017 Apr 2.
    Department of Pediatric Cardiology, National Cerebral and Cardiovascular Center, Osaka, Japan.
    Background: Elevated central venous pressure (CVP), low cardiac output, and mild hypoxia are common early and late after Fontan operations. However, the association of these characteristics with late mortality is unclear. We aimed to elucidate the hemodynamic determinants of mortality after Fontan operation. Read More

    Seasonal and circadian variations of acute myocardial infarction: Findings from the Get With The Guidelines-Coronary Artery Disease (GWTG-CAD) program.
    Am Heart J 2017 Jul 12;189:85-93. Epub 2017 Apr 12.
    Brigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, Boston, MA. Electronic address:
    Background: Seasonal variation with winter preponderance of myocardial infarction incidence has been described decades ago, but only a few small studies have classified myocardial infarction based on ST-segment elevation. It is unclear whether seasonal and circadian variations are equally present in warmer and colder regions. We investigated whether seasonal and circadian variations in acute myocardial infarction (AMI) are more prominent in colder northern states compared with warmer southern states. Read More

    Effects of implantable cardioverter/defibrillator shock and antitachycardia pacing on anxiety and quality of life: A MADIT-RIT substudy.
    Am Heart J 2017 Jul 20;189:75-84. Epub 2017 Mar 20.
    University of Rochester Medical Center, Heart Research Follow-Up Program, Rochester, NY.
    Effects of implantable cardioverter/defibrillator (ICD) shocks and antitachycardia pacing (ATP) on anxiety and quality of life (QoL) in ICD patients are poorly understood.

    Methods: We evaluated changes in QoL from baseline to 9-month follow-up using the EQ-5D questionnaire in patients enrolled in the Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT) (n=1,268). We assessed anxiety levels using the Florida Shock Anxiety Scale (1-10 score) in patients with appropriate or inappropriate shocks or ATP compared to those with no ICD therapy during the first 9 months postimplant. Read More

    The Assessment of the Watchman Device in Patients Unsuitable for Oral Anticoagulation (ASAP-TOO) trial.
    Am Heart J 2017 Jul 15;189:68-74. Epub 2017 Mar 15.
    Vancouver General Hospital, Vancouver, British Columbia, Canada. Electronic address:
    Background: Oral anticoagulants (OACs) reduce stroke risks with nonvalvular atrial fibrillation (AF); however, they are underused because of absolute or relative contraindications due to real or perceived risk of bleeding. Although left atrial appendage closure is increasingly performed in OAC-ineligible patients, this has not been studied in a randomized controlled trial.

    Study Objectives: The ASAP-TOO study is designed to establish the safety and effectiveness of the Watchman left atrial appendage closure device in patients with nonvalvular AF who are deemed ineligible for OAC. Read More

    Impact of continuous positive airway pressure and oxygen on health status in patients with coronary heart disease, cardiovascular risk factors, and obstructive sleep apnea: A Heart Biomarker Evaluation in Apnea Treatment (HEARTBEAT) analysis.
    Am Heart J 2017 Jul 14;189:59-67. Epub 2017 Mar 14.
    Brigham and Women's Hospital, Boston, MA; Harvard Medical School, Boston, MA.
    Introduction: Obstructive sleep apnea (OSA) is associated with impaired health-related quality of life (HRQL). Treatment with continuous positive airway pressure (CPAP) has variable impacts on HRQL, and this may be influenced by patient's tolerance of therapy. The objective is to determine the impact of nocturnal supplemental oxygen (NSO) and CPAP on HRQL compared with healthy lifestyle education (HLSE) in individuals with OSA. Read More

    Utilization of cardiac resynchronization therapy in eligible patients hospitalized for heart failure and its association with patient outcomes.
    Am Heart J 2017 Jul 6;189:48-58. Epub 2017 Apr 6.
    Division of Cardiology, Duke University Hospital, Durham, NC, 27710; Duke Clinical Research Institute, Durham, NC. Electronic address:
    Objectives: We examined trends in CRT utilization overall and by sex and race and to assess whether CRT use is associated with a reduction in HF hospitalization and mortality.

    Background: It is unknown whether underutilization and race/sex-based differences in cardiac resynchronization therapy (CRT) use have persisted. The association between CRT and heart failure (HF) hospitalization and mortality in real-world practice remains unclear. Read More

    Factors associated with non-vitamin K antagonist oral anticoagulants for stroke prevention in patients with new-onset atrial fibrillation: Results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (ORBIT-AF II).
    Am Heart J 2017 Jul 4;189:40-47. Epub 2017 Apr 4.
    Duke University Medical Center, Durham, NC; Duke Clinical Research Institute, Durham, NC.
    Background: Several non-vitamin K antagonist oral anticoagulant (NOAC) alternatives to warfarin are available for stroke prevention in atrial fibrillation (AF). We aimed to describe the factors associated with selection of NOACs versus warfarin in patients with new onset AF.

    Methods: The ORBIT-AF II study is a national, US, prospective, observational, cohort study of anticoagulation treatment in patients with AF receiving NOACs or warfarin in the United States from 2013 to 2016. Read More

    Reliability of updated left ventricular diastolic function recommendations in predicting elevated left ventricular filling pressure and prognosis.
    Am Heart J 2017 Jul 4;189:28-39. Epub 2017 Apr 4.
    Heart and Vascular Institute, Cleveland Clinic, Cleveland, OH. Electronic address:
    An updated 2016 echocardiographic algorithm for diagnosing left ventricular (LV) diastolic dysfunction (DD) was recently proposed. We aimed to assess the reliability of the 2016 echocardiographic LVDD grading algorithm in predicting elevated LV filling pressure and clinical outcomes compared to the 2009 version.

    Methods: We retrospectively identified 460 consecutive patients without atrial fibrillation or significant mitral valve disease who underwent transthoracic echocardiography within 24 hours of elective heart catheterization. Read More

    One-year mortality outcomes and hospital readmissions of patients admitted with acute heart failure: Data from the Trivandrum Heart Failure Registry in Kerala, India.
    Am Heart J 2017 Jul 2;189:193-199. Epub 2017 Apr 2.
    Public Health Foundation of India, New Delhi, India.
    Background: There are sparse data on outcomes of patients with heart failure (HF) from India. The objective was to evaluate hospital readmissions and 1-year mortality outcomes of patients with HF in Kerala, India.

    Methods: We followed 1,205 patients enrolled in the Trivandrum Heart Failure Registry for 1 year. Read More

    Electrocardiographic abnormalities and mortality in aging survivors of childhood cancer: A report from the St Jude Lifetime Cohort Study.
    Am Heart J 2017 Jul 4;189:19-27. Epub 2017 Apr 4.
    Department of Epidemiology and Cancer Control, St Jude Children's Research Hospital, Memphis, TN.
    Background: Electrocardiography (ECG), predictive of adverse outcomes in the general population, has not been studied in cancer survivors. We evaluated the prevalence of ECG abnormalities and associations with mortality among childhood cancer survivors.

    Methods: Major and minor abnormalities were coded per the Minnesota Classification system for participants in the St Jude Lifetime Cohort Study (n = 2,715) and community controls (n = 268). Read More

    Decline in peak oxygen consumption over time predicts death or transplantation in adults with a Fontan circulation.
    Am Heart J 2017 Jul 27;189:184-192. Epub 2017 Apr 27.
    Department of Medicine, Brigham and Women's Hospital, Boston, MA; Department of Cardiology, Boston Children's Hospital, Boston, MA. Electronic address:
    Peak oxygen consumption (pVO2) measured by cardiopulmonary exercise test (CPET) predicts mortality in adults with a Fontan circulation. The purpose of this study was to assess the additive prognostic value of change in pVO2 over time.

    Methods: We analyzed a cohort of adults (≥18 years old) with a Fontan circulation who underwent at least 2 maximal CPETs separated by 6-30 months at Boston Children's Hospital between 2000 and 2015. Read More

    Change the management of patients with heart failure: Rationale and design of the CHAMP-HF registry.
    Am Heart J 2017 Jul 29;189:177-183. Epub 2017 Apr 29.
    Ahmanson-UCLA Cardiomyopathy Center, Ronald Reagan UCLA Medical Center, Los Angeles, CA. Electronic address:
    Heart failure (HF) with reduced ejection fraction (HFrEF) is a common and costly condition that diminishes patients' health status and confers a poor prognosis. Despite the availability of multiple guideline-recommended pharmacologic and cardiac device therapies for patients with chronic HFrEF, outcomes remain suboptimal. Currently, there is limited insight into the rationale underlying clinical decisions by health care providers and patient factors that guide the use and intensity of outpatient HF treatments. Read More

    High-risk echocardiographic features predict mortality in pulmonary arterial hypertension.
    Am Heart J 2017 Jul 1;189:167-176. Epub 2017 May 1.
    Division of Cardiology, Mayo Clinic Florida, Jacksonville, FL. Electronic address:
    Aims: Echocardiography is the most common imaging modality for assessment of the right ventricle in patients with pulmonary arterial hypertension (PAH). Echocardiographic parameters were identified as independent risk factors for mortality in the Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) and other PAH cohorts. We sought to identify readily obtained echocardiographic features associated with PAH survival. Read More

    Multicenter Automatic Defibrillator Implantation Trial-Subcutaneous Implantable Cardioverter Defibrillator (MADIT S-ICD): Design and clinical protocol.
    Am Heart J 2017 Jul 4;189:158-166. Epub 2017 May 4.
    Heart Research Follow-up Program of the Cardiology Division of the Department of Medicine, University of Rochester Medical Center, Rochester, NY.
    Patients with diabetes mellitus, prior myocardial infarction, older age, and a relatively preserved left ventricular ejection fraction remain at risk for sudden cardiac death that is potentially amenable by the subcutaneous implantable cardioverter defibrillator with a good risk-benefit profile. The launched MADIT S-ICD study is designed to test the hypothesis that post-myocardial infarction diabetes patients with relatively preserved ejection fraction of 36%-50% will have a survival benefit from a subcutaneous implantable cardioverter defibrillator. Read More

    Cardiovascular events and hospital resource utilization pre- and post-transcatheter mitral valve repair in high-surgical risk patients.
    Am Heart J 2017 Jul 1;189:146-157. Epub 2017 May 1.
    Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC; Center for Population Health Sciences, Duke University School of Medicine, Durham, NC.
    MitraClip is an approved therapy for mitral regurgitation (MR); however, health care resource utilization pre- and post-MitraClip remains understudied.

    Methods: Patients with functional and degenerative MR at high surgical risk in the EVEREST II High-Risk Registry and REALISM Continued-Access Study were linked to Medicare data. Pre- and post-MitraClip all-cause death, stroke, myocardial infarction, heart failure (HF), and bleeding hospitalizations were identified. Read More

    Rationale and design of the Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation (ARTESiA) trial.
    Am Heart J 2017 Jul 24;189:137-145. Epub 2017 Apr 24.
    Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, Canada.
    Background: Device-detected subclinical atrial fibrillation (AF) refers to infrequent, short-lasting, asymptomatic AF that is detected only with long-term continuous monitoring. Subclinical AF is common and associated with an increased risk of stroke; however, the risk of stroke with subclinical AF is lower than for clinical AF, and very few patients with subclinical AF alone have been included in large AF anticoagulation trials. The net benefit of anticoagulation in patients with subclinical AF is unknown. Read More

    Rationale and design of the Hunting for the off-target propertIes of Ticagrelor on Endothelial function and other Circulating biomarkers in Humans (HI-TECH) trial.
    Am Heart J 2017 Jul 29;189:128-136. Epub 2017 Mar 29.
    Bern University Hospital, Bern, Switzerland. Electronic address:
    Background: Among the 3 approved oral P2Y12 inhibitors for the treatment for patients with acute coronary syndrome (ACS), ticagrelor, but not prasugrel or clopidogrel, has been associated with off-target properties, such as improved endothelial-dependent vasomotion and increased adenosine plasma levels.

    Methods: The HI-TECH study (NCT02587260) is a multinational, randomized, open-label, crossover study with a Latin squares design, conducted at 5 European sites, in which patients free from recurrent ischemic or bleeding events ≥30 days after a qualifying ACS were allocated to sequentially receive a 30 ± 5-day treatment with prasugrel, clopidogrel, and ticagrelor in random order. The primary objective was to evaluate whether ticagrelor, at treatment steady state (ie, after 30 ± 5 days of drug administration), as compared with both clopidogrel and prasugrel, is associated with an improved endothelial function, assessed with peripheral arterial tonometry. Read More

    Effect of aspirin on renal disease progression in patients with type 2 diabetes: A multicenter, double-blind, placebo-controlled, randomized trial. The renaL disEase progression by aspirin in diabetic pAtients (LEDA) trial. Rationale and study design.
    Am Heart J 2017 Jul 18;189:120-127. Epub 2017 Apr 18.
    Department of Internal Medicine and Medical Specialties, Sapienza University, Rome, Italy; Department of Anatomical, Histological, Forensic Medicine and Orthopedics Sciences, Sapienza University of Rome, Rome, Italy.
    Type 2 diabetes mellitus (T2DM) is one of the most common causes of chronic kidney disease and kidney failure. It has been estimated that the annual decline of estimated glomerular filtration rate (eGFR) among patients with T2DM is approximately 2.0-2. Read More

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