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    Mechanical circulatory support costs in children bridged to heart transplantation - analysis of a linked database.
    Am Heart J 2018 Apr 6;201:77-85. Epub 2018 Apr 6.
    Pediatrics and Clinical and Translational Science, University of Pittsburgh School of Medicine, Pittsburgh, PA.
    Background: Pediatric mechanical circulatory support (MCS) has evolved considerably over the past decade. Though marked improvements in waitlist survival have been realized, costs have not been reassessed. This project aimed to assess contemporary MCS costs in children bridged to heart transplant (HT). Read More

    International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial: Rationale and design.
    Am Heart J 2018 Apr 21;201:124-135. Epub 2018 Apr 21.
    National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD.
    Background: Prior trials comparing a strategy of optimal medical therapy with or without revascularization have not shown that revascularization reduces cardiovascular events in patients with stable ischemic heart disease (SIHD). However, those trials only included participants in whom coronary anatomy was known prior to randomization and did not include sufficient numbers of participants with significant ischemia. It remains unknown whether a routine invasive approach offers incremental value over a conservative approach with catheterization reserved for failure of medical therapy in patients with moderate or severe ischemia. Read More

    Validation of the Seattle angina questionnaire in women with ischemic heart disease.
    Am Heart J 2018 Apr 21;201:117-123. Epub 2018 Apr 21.
    University of Missouri- Kansas City, Kansas City, MO; Saint Luke's Mid America Heart Institute, Kansas City, MO.
    Background: Although the Seattle Angina Questionnaire (SAQ) has been widely used to assess disease-specific health status in patients with ischemic heart disease, it was originally developed in a predominantly male population and its validity in women has been questioned.

    Methods: Using data from 8892 men and 4013 women across 2 multicenter trials and 5 registries, we assessed the construct validity, test-retest reliability, responsiveness to clinical change, and predictive validity of the SAQ Summary Score (SS) and its 5 subdomains (Physical Limitation (PL), Anginal Stability (AS), Angina Frequency (AF), Treatment Satisfaction (TS), and Quality of Life (QoL)) separately in men and women.

    Results: Comparable correlations of the SAQ SS with Canadian Cardiovascular Society class was demonstrated in both men and women (-0. Read More

    Stroke type and severity in patients with subclinical atrial fibrillation: An analysis from the Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial (ASSERT).
    Am Heart J 2018 Apr 18. Epub 2018 Apr 18.
    Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.
    Background: The Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial (ASSERT) demonstrated that subclinical atrial fibrillation (SCAF) was associated with a 2.5-fold increased risk of stroke. However, the absolute stroke rate was only 1. Read More

    Design of a Phase 3 trial of intracoronary administration of human adenovirus 5 encoding human adenylyl cyclase type 6 (RT-100) gene transfer in patients with heart failure with reduced left ventricular ejection fraction: The FLOURISH Clinical Trial.
    Am Heart J 2018 Apr 6;201:111-116. Epub 2018 Apr 6.
    Veterans Affairs San Diego Healthcare System and Department of Medicine, University of California, San Diego, CA.
    The prognosis of patients with HFrEF remains poor despite the use of current medical and device therapies. Preclinical studies of HFrEF using IC delivery of RT-100, a replication deficient, E1/E3-deleted human adenovirus 5 encoding human AC6 was associated with favorable effects on LV function and remodeling. A recent multicenter, double-blind, placebo-controlled, phase 2 study demonstrated the safety of IC delivery of RT-100 in HFrEF patients and potential efficacy at the higher doses. Read More

    Prevalent digoxin use and subsequent risk of death or hospitalization in ambulatory heart failure patients with a reduced ejection fraction-Findings from the Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) randomized controlled trial.
    Am Heart J 2018 May 11;199:97-104. Epub 2018 Feb 11.
    Duke University Medical Center, Durham, NC; Duke Clinical Research Institute, Durham, NC.
    Background: Despite more than 200 years of clinical experience and a pivotal trial, recently published research has called into question the safety and efficacy of digoxin therapy in heart failure (HF).

    Methods: HF-ACTION ( Number: NCT00047437) enrolled 2331 outpatients with HF and an EF ≤35% between April 2003 and February 2007 and randomized them to aerobic exercise training versus usual care. Read More

    Trends and outcomes of cardiac transplantation from donors dying of drug intoxication.
    Am Heart J 2018 May 9;199:92-96. Epub 2018 Feb 9.
    Department of Medicine (Cardiology Division), Duke University Medical Center, Durham, NC, United States; Duke Clinical Research Institute, Durham, NC, United States.
    Background: Deaths from drug intoxication have increased in the United States but outcomes of recipients of orthotopic heart transplantation (OHT) from these donors are not well characterized.

    Methods: We performed a retrospective analysis of the United Network for Organ Sharing's STAR database between January 2000 and March 2014 and assessed mortality and retransplantation using adjusted Cox models by mechanism of donor death.

    Results: Of the 31,660 OHTs from 2000 to 2014, 1233 (3. Read More

    Rationale and design for the Vascular Outcomes study of ASA along with rivaroxaban in endovascular or surgical limb revascularization for peripheral artery disease (VOYAGER PAD).
    Am Heart J 2018 May 3;199:83-91. Epub 2018 Feb 3.
    CPC Clinical Research, Aurora, CO; University of Colorado School of Medicine, Division of Cardiology, University of Colorado Denver, Aurora, CO. Electronic address:
    Background: Patients with peripheral artery disease (PAD) undergoing a lower-extremity revascularization are at heightened risk for ischemic cardiac and limb events. Although intensification of antithrombotic therapy after revascularization has demonstrated benefit in coronary disease populations, this approach has not been well studied or shown consistent benefit in PAD. Recent trial evidence demonstrated that a treatment strategy of rivaroxaban added to background antiplatelet therapy reduced ischemic risk in patients following recent acute coronary syndromes, as well as in patients with stable atherosclerotic vascular disease. Read More

    Knowledge to action: Rationale and design of the Patient-Centered Care Transitions in Heart Failure (PACT-HF) stepped wedge cluster randomized trial.
    Am Heart J 2018 May 27;199:75-82. Epub 2017 Dec 27.
    Department of Medicine, McMaster University, Hamilton, Ontario; Population Health Research Institute, Hamilton, Ontario.
    Introduction: Heart Failure (HF) is a common cause of hospitalization in older adults. The transition from hospital to home is high-risk, and gaps in transitional care can increase the risk of re-hospitalization and death. Combining health care services supported by meta-analyses, we designed the PACT-HF transitional care model. Read More

    Comparison of Fractional FLow Reserve And Intravascular ultrasound-guided Intervention Strategy for Clinical OUtcomes in Patients with InteRmediate Stenosis (FLAVOUR): Rationale and design of a randomized clinical trial.
    Am Heart J 2018 May 6;199:7-12. Epub 2017 Nov 6.
    Ajou University Hospital, Suwon, Korea.
    Background: Coronary angiography has limitations in defining the ischemia-causing stenotic lesion, especially in cases with intermediate coronary stenosis. Fractional flow reserve (FFR) is a current standard method to define the presence of ischemia, and intravascular ultrasound (IVUS) is the most commonly used invasive imaging tool that can provide the lesion geometry and can provide the information on plaque vulnerability. The primary aim of this study is to compare the safety and efficacy of FFR-guided and IVUS-guided percutaneous coronary intervention (PCI) strategies in patients with intermediate coronary stenosis. Read More

    Resource utilization and outcome among patients with selective versus nonselective troponin testing.
    Am Heart J 2018 May 31;199:68-74. Epub 2018 Jan 31.
    Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, 800 E 28th St. Minneapolis, MN. Electronic address:
    Objective: In patients with suspected acute coronary syndrome (ACS), troponin testing is effective for diagnosis and prognosis. Troponin testing has now expanded to include patients without suspected ACS. This nonselective troponin testing has unknown consequences for resource utilization and outcome. Read More

    Is there a role for pharmacokinetic/pharmacodynamic-guided dosing for novel oral anticoagulants?
    Am Heart J 2018 May 10;199:59-67. Epub 2017 Oct 10.
    ACI Clinical, Bala Cynwyd, PA.
    The novel direct oral anticoagulants (NOACs) represent a major advance in oral anticoagulant therapy and are replacing vitamin K antagonists as the preferred options for many indications. Given in fixed doses without routine laboratory monitoring, they have been shown to be at least as effective in reducing thromboembolic stroke as dose-adjusted warfarin in phase 3 randomized trials and less likely to cause hemorrhagic stroke. Pharmacokinetic and/or pharmacodynamic subanalyses of the major NOAC trials in patients with atrial fibrillation have established relationships between clinical characteristics, and drug levels and/or pharmacodynamic responses with both efficacy and safety. Read More

    A genotype-directed comparative effectiveness trial of Bucindolol and metoprolol succinate for prevention of symptomatic atrial fibrillation/atrial flutter in patients with heart failure: Rationale and design of the GENETIC-AF trial.
    Am Heart J 2018 May 6;199:51-58. Epub 2017 Dec 6.
    ARCA biopharma, Westminster, CO; Section of Pharmacogenomics, University of Colorado Cardiovascular Institute, Boulder and Aurora, CO.
    Background: Few therapies are available for the safe and effective treatment of atrial fibrillation (AF) in patients with heart failure. Bucindolol is a non-selective beta-blocker with mild vasodilator activity previously found to have accentuated antiarrhythmic effects and increased efficacy for preventing heart failure events in patients homozygous for the major allele of the ADRB1 Arg389Gly polymorphism (ADRB1 Arg389Arg genotype). The safety and efficacy of bucindolol for the prevention of AF or atrial flutter (AFL) in these patients has not been proven in randomized trials. Read More

    Transcatheter closure of patent foramen ovale following cryptogenic stroke: An updated meta-analysis of randomized controlled trials.
    Am Heart J 2018 May 31;199:44-50. Epub 2018 Jan 31.
    Duke University Medical Center, Durham, NC. Electronic address:
    Background: Transcatheter closure of patent foramen ovale (PFO) after cryptogenic stroke has long been a contentious issue. Herein, we pool aggregate data examining safety and efficacy of transcatheter closure of PFO compared with medical therapy following initial cryptogenic stroke.

    Methods: We searched for randomized clinical trials (RCT) that compared device closure with medical management and reported on subsequent stroke and adverse events. Read More

    Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets (IMPACT) trial.
    Am Heart J 2018 May 9;199:37-43. Epub 2018 Jan 9.
    Department of Medicine, Division of Cardiology, Center for the Prevention of Cardiovascular Disease, New York University School of Medicine, New York, NY; Marc and Ruti Bell Program in Vascular Biology, New York University School of Medicine, New York, NY.
    Background: Patients undergoing cardiovascular (CV) procedures often have suboptimal CV risk factor control and may benefit from strategies targeting healthy lifestyle behaviors and education. Implementation of prevention strategies may be particularly effective at this point of heightened motivation.

    Methods: A prospective, randomized, pilot study was conducted in 400 patients undergoing a nonurgent CV procedure (cardiac catheterization ± revascularization) to evaluate the impact of different prevention strategies. Read More

    The prognostic value of the relationship between right atrial and pulmonary capillary wedge pressure in diverse cardiovascular conditions.
    Am Heart J 2018 May 31;199:31-36. Epub 2018 Jan 31.
    Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, United States.
    Background: Physical examination of jugular venous pressure is used to estimate right atrial (RA) pressure and infer left-sided filling pressure to assist volume management. Previous studies in advanced heart failure patients showed about 75% concordance between RA and pulmonary capillary wedge (PCW) pressures. We sought to determine the relationship between mean RA and mean PCW pressure and assess the clinical significance in a broad population of patients undergoing invasive right heart catheterization (RHC). Read More

    Rationale and design of a trial to personalize risk assessment in familial coronary artery disease.
    Am Heart J 2018 May 19;199:22-30. Epub 2017 Sep 19.
    Lipid Disorders Clinic, Department of Cardiology, Royal Perth Hospital, School of Medicine, University of Western Australia, Perth, Australia.
    Background: The lifetime risk of coronary artery disease (CAD) is doubled in people with a family history of premature disease, yet this risk is not captured in most 5- or 10-year risk assessment algorithms. Coronary artery calcium scoring (CCS) is a marker of subclinical CAD risk, which has been shown in observational studies to provide prognostic information that is incremental to clinical assessment; is relatively inexpensive; and is performed with a small radiation dose. However, the use of CCS in guiding prevention is not strongly supported by guidelines. Read More

    Catheter Ablation versus Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) Trial: Study Rationale and Design.
    Am Heart J 2018 May 7;199:192-199. Epub 2018 Mar 7.
    Duke Clinical Research Institute, Duke University, Durham, NC.
    The Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation (CABANA,NCT00911508)(1) trial is testing the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of eliminating atrial fibrillation (AF) is superior to current state-of-the-art pharmacologic therapy. This international 140-center clinical trial was designed to randomize 2200 patients to a strategy of catheter ablation versus state-of-the-art rate or rhythm control drug therapy. Inclusion criteria include: 1) age> 65, or ≤65 with≥ 1 risk factor for stroke, 2) documented AF warranting treatment, and 3) eligibility for both catheter ablation and≥ 2 anti-arrhythmic or≥ 2 rate control drugs. Read More

    Predictors of intra-aortic balloon pump hemodynamic failure in non-acute myocardial infarction cardiogenic shock.
    Am Heart J 2018 May 13;199:181-191. Epub 2017 Dec 13.
    Division of Cardiology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.
    Objectives: To characterize patient profile and hemodynamic profile of those undergoing intra-aortic balloon pump (IABP) for cardiogenic shock and define predictors of hemodynamic failure of IABP support.

    Background: Clinical characteristics of IABP support in cardiogenic shock not related to acute myocardial infarction (AMI) remain poorly characterized.

    Methods: We retrospectively studied a cohort of 74 patients from 2010 to 2015 who underwent IABP insertion for cardiogenic shock complicating acute decompensated heart failure not due to AMI. Read More

    The prognostic value of heart rate recovery in patients with coronary artery disease: A systematic review and meta-analysis.
    Am Heart J 2018 May 13;199:163-169. Epub 2018 Feb 13.
    Department of Cardiology, Academic Medical Center, Amsterdam, the Netherlands.
    Background: Routine outpatient care of patients with coronary artery disease (CAD) lacks a simple measure of physical fitness and risk of mortality. Heart rate recovery (HRR) is noninvasive and easily obtainable in outpatient settings. Prior studies have suggested that delayed postexercise HRR in the first minutes is associated with mortality in several types of populations. Read More

    Characteristics and long term outcomes of patients with acute coronary syndromes due to culprit left main coronary artery disease treated with percutaneous coronary intervention.
    Am Heart J 2018 May 22;199:156-162. Epub 2018 Feb 22.
    Division of Cardiovascular Disease, Mayo Clinic, Rochester, MN.
    Background: Patients with acute coronary syndrome (ACS) due to unprotected culprit left main coronary artery disease (LMCAD) treated with percutaneous coronary intervention (PCI) are rare, high-risk, and not represented in trials. Data regarding long term outcome after PCI are limited.

    Methods: Between January 2000 and December 2014, there were 8,794 patients hospitalized with unstable angina/non-ST elevation myocardial infarction (UA/NSTEMI) or ST-elevation myocardial infarction (STEMI) treated with PCI at our institution; of these, 83 (0. Read More

    Dual antiplatelet therapy for perioperative myocardial infarction following CABG surgery.
    Am Heart J 2018 May 11;199:150-155. Epub 2018 Feb 11.
    Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC.
    Objectives: Perioperative myocardial infarction (MI) after coronary artery bypass graft surgery (CABG) has been associated with adverse outcome. Whether perioperative MI should be treated with dual antiplatelet therapy (DAPT) is unknown. We compared the effect of DAPT versus aspirin alone on short-term outcomes among patients with perioperative MI following CABG. Read More

    Trends in the incidence and outcomes of patients with aortic stenosis hospitalization.
    Am Heart J 2018 May 13;199:144-149. Epub 2018 Feb 13.
    Schulich Heart Centre, Division of Cardiology, Sunnybrook Health Sciences Centre, University of Toronto, Ontario, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Ontario, Canada; Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada. Electronic address:
    Background: Although the burden of aortic stenosis (AS) on our health care system is expected to rise, little is known regarding its epidemiology at the population level. Our primary objective was to evaluate trends in AS hospitalization, treatment and outcomes.

    Methods: We performed a population-based observational study including 37,970 patients newly hospitalized with AS from 2004 and 2013 in Ontario, Canada. Read More

    Risk of cardiovascular events and incident atrial fibrillation in patients without prior atrial fibrillation: Implications for expanding the indications for anticoagulation.
    Am Heart J 2018 May 10;199:137-143. Epub 2018 Feb 10.
    Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN; OptumLabs, Cambridge, MA. Electronic address:
    Background: There is growing interest in the role for non-vitamin K antagonist oral anticoagulants (NOACs) in patients without atrial fibrillation (AF). We aimed to provide a comprehensive assessment of the risks of ischemic stroke, myocardial infarction (MI), AF, and major bleeding in patients without previously diagnosed AF.

    Methods: Using a large US administrative database, we identified 6,495,875 patients ≥50 years between January 1, 2011, and September 30, 2016, who were not diagnosed with AF and were not treated with oral anticoagulants or nonaspirin antiplatelet agents. Read More

    Rationale and methods of the Prospective Study of Biomarkers, Symptom Improvement, and Ventricular Remodeling During Sacubitril/Valsartan Therapy for Heart Failure (PROVE-HF).
    Am Heart J 2018 May 13;199:130-136. Epub 2018 Feb 13.
    Harvard Medical School, Brigham and Women's Hospital, Boston, MA.
    Background: Sacubitril/valsartan is an angiotensin receptor-neprilysin inhibitor indicated for the treatment of patients with chronic heart failure (HF) with reduced ejection fraction; however, its mechanism of benefit remains unclear. Biomarkers that are linked to ventricular remodeling, myocardial injury, and fibrosis may provide mechanistic insight and important clinical guidance regarding sacubitril/valsartan use.

    Methods: This 52-week, multicenter, open-label, single-arm study is designed to (1) correlate biomarker changes with cardiac remodeling parameters, cardiovascular outcomes, and patient-reported outcome data and (2) determine short- and long-term changes in concentrations of biomarkers related to potential mechanisms of action and effects of sacubitril/valsartan therapy. Read More

    Shared decision-making tool for thromboprophylaxis in atrial fibrillation - A feasibility study.
    Am Heart J 2018 May 12;199:13-21. Epub 2018 Jan 12.
    Department of Family and Community Medicine, University of Cincinnati, Cincinnati, OH.
    Background: Appropriate thromboprophylaxis for patients with atrial fibrillation or atrial flutter (AF) remains a national challenge.

    Methods: We hypothesized that a shared decision-making interaction facilitated by an Atrial Fibrillation Shared Decision Making Tool (AFSDM) would improve patient knowledge about atrial fibrillation, and the risks and benefits of various treatment options for stroke prevention; increase satisfaction with the decision-making process; improve the therapeutic alliance between patient and the clinical care team; and increase medication adherence. Using a pre- and post-visit study design, we enrolled 76 patients and completed 2 office visits and 1-month telephone follow-up for 65 patients being seen in our Arrhythmia Clinic over the 1-year period (July 2016 through June 2017). Read More

    Telemedicine cardiovascular risk reduction in veterans: The CITIES trial.
    Am Heart J 2018 May 10;199:122-129. Epub 2018 Feb 10.
    Health Services Research in Primary Care, Center of Innovation, Durham Veterans Affairs Medical Center, Durham, NC; Division of General Internal Medicine, Duke University, Durham, NC.
    Background: Comprehensive programs addressing tailored patient self-management and pharmacotherapy may reduce barriers to cardiovascular disease (CVD) risk reduction.

    Methods: This is a 2-arm (clinical pharmacist specialist-delivered, telehealth intervention and education control) randomized controlled trial including Veterans with poorly controlled hypertension and/or hypercholesterolemia. Primary outcome was Framingham CVD risk score at 6 and 12 months, with systolic blood pressure; diastolic blood pressure; total cholesterol; low-density lipoprotein; high-density lipoprotein; body mass index; and, for those with diabetes, HbA1c as secondary outcomes. Read More

    The cVAD registry for percutaneous temporary hemodynamic support: A prospective registry of Impella mechanical circulatory support use in high-risk PCI, cardiogenic shock, and decompensated heart failure.
    Am Heart J 2018 May 28;199:115-121. Epub 2017 Sep 28.
    Henry Ford Hospital/Wayne State University, Detroit, MI. Electronic address:
    Management of patients requiring temporary, mechanical hemodynamic support during high- risk percutaneous coronary intervention (PCI) or in cardiogenic shock is rapidly evolving. With the availability of the Impella 2.5, CP, 5. Read More

    Effects of a 12-week mHealth program on peak VO and physical activity patterns after completing cardiac rehabilitation: A randomized controlled trial.
    Am Heart J 2018 May 7;199:105-114. Epub 2018 Feb 7.
    Duke University School of Medicine, Division of Cardiology, Durham, NC and Duke Molecular Physiology Institute.
    Background: Site-based cardiac rehabilitation (CR) provides supervised exercise, education and motivation for patients. Graduates of CR have improved exercise tolerance. However, when participation in CR ceases, adherence to regular physical activity often declines, consequently leading to worsening risk factors and clinical events. Read More

    Effect of carvedilol vs metoprolol succinate on mortality in heart failure with reduced ejection fraction.
    Am Heart J 2018 May 31;199:1-6. Epub 2018 Jan 31.
    Krannert Institute of Cardiology Indiana University School of Medicine, Indianapolis, IN; Richard L. Roudebush VA Medical Center, Indianapolis, IN. Electronic address:
    Background: Beta blocker therapy is indicated in all patients with heart failure with reduced ejection fraction (HFrEF) as per current guidelines. The relative benefit of carvedilol to metoprolol succinate remains unknown. This study aimed to compare survival benefit of carvedilol to metoprolol succinate. Read More

    Hospital evaluation of health literacy and associated outcomes in patients after acute myocardial infarction.
    Am Heart J 2018 Apr 2;198:97-107. Epub 2017 Sep 2.
    Duke Clinical Research Institute, Durham, NC.
    Background: Low health literacy is common in the United States and may affect outcomes after myocardial infarction (MI). How often hospitals screen for low health literacy is unknown.

    Methods: We surveyed 122 hospitals in the TRANSLATE-ACS study and divided them into those that reported routinely (>75% of patients), selectively (1%-75%), or never (0%) screening MI patients for low health literacy prior to discharge. Read More

    Left ventricular ejection fraction reassessment post-myocardial infarction: Current clinical practice and determinants of adverse remodeling.
    Am Heart J 2018 Apr 5;198:91-96. Epub 2017 Dec 5.
    Libin Cardiovascular Institute of Alberta, University of Calgary, Calgary, Alberta, Canada.
    Background: Left ventricular (LV) dysfunction may be sustained or aggravated during the convalescent months following an acute myocardial infarction (MI) and is difficult to predict. We sought to determine current practice patterns of LV ejection fraction (LVEF) reassessment during the months following MI and evaluate the predictors and clinical significance of LVEF change in a prospective post-MI patient cohort.

    Methods: Patients with an acute MI between June 2010 and August 2014 were identified using the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease registry. Read More

    Symptomatic event reduction with extended-duration betrixaban in acute medically ill hospitalized patients.
    Am Heart J 2018 Apr 27;198:84-90. Epub 2017 Dec 27.
    Department of Medicine, Stanford University, Stanford, CA.
    Background: Approximately 15%-30% of patients in trials of medical thromboprophylaxis will have missing compression ultrasound (CUS) data. The goal of the present analysis was to perform analyses to minimize missing data.

    Methods: The APEX trial randomized 7,513 acutely medically ill hospitalized patients to thromboprophylaxis with either betrixaban for 35-42 days or enoxaparin for 6-14 days. Read More

    Ultrahigh-resolution ultrasound characterization of access site trauma and intimal hyperplasia following use of a 7F sheathless guide versus 6F sheath/guide combination for transradial artery PCI: Results of the PRAGMATIC trial.
    Am Heart J 2018 Apr 15;198:75-83. Epub 2017 Dec 15.
    Southern Medical Group, P.A., Tallahassee, FL.
    There exist limited data on the relative degree of acute injury and late healing of the radial artery after transradial artery (TRA) percutaneous coronary intervention (PCI) with a 7F sheathless guide catheter compared with a 6F sheath/guide combination. We used ultrahigh-resolution (55 MHz) vascular ultrasound to compare intimal-medial thickening (IMT) and early and late radial artery (RA) injury resulting from a sheathless 7F guide catheter versus a 6F sheath/guide combination for TRA-PCI.

    Methods: Forty-one consecutive consenting patients undergoing elective nonemergent TRA-PCI at a single institution from June 2016 to December 2016 were included. Read More

    Comparison of adverse event and device problem rates for transcatheter aortic valve replacement and Mitraclip procedures as reported by the Transcatheter Valve Therapy Registry and the Food and Drug Administration postmarket surveillance data.
    Am Heart J 2018 Apr 3;198:64-74. Epub 2018 Feb 3.
    Pharm3r LLC, New York, NY.
    Background: Although outcomes data on transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve repair (Mitraclip) are available via the Transcatheter Valve Therapy (TVT) registry, dissemination of TVT data is often delayed. The Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) system collects postmarket outcomes data in public medical device reports. We used natural language processing to compare the event rates for TAVR and Mitraclip in the TVT registry and from MAUDE data. Read More

    Two-year follow-up of patients treated with dabigatran for stroke prevention in atrial fibrillation: Global Registry on Long-Term Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF) registry.
    Am Heart J 2018 Apr 31;198:55-63. Epub 2017 Aug 31.
    Institute of Cardiovascular Sciences, University of Birmingham, UK and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. Electronic address:
    Background And Purpose: GLORIA-AF is a large, global, prospective registry program of newly diagnosed atrial fibrillation (AF) patients with ≥1 stroke risk factors. We describe the effectiveness and safety of dabigatran etexilate over 2 years from routine clinical practice in nearly 3000 patients from GLORIA-AF who are newly diagnosed with non-valvular AF and at risk of stroke.

    Methods: Consecutive enrollment into phase II of GLORIA-AF was initiated following approval of dabigatran for stroke prevention in non-valvular AF. Read More

    Temporal changes in radial access use, associates and outcomes in patients undergoing PCI using rotational atherectomy between 2007 and 2014: results from the British Cardiovascular Intervention Society national database.
    Am Heart J 2018 Apr 7;198:46-54. Epub 2018 Jan 7.
    Department of Cardiology, Sussex Cardiac Centre, Brighton and Sussex University Hospitals, Brighton, UK.
    Aims: Access site choice for cases requiring rotational atherectomy (PCI-ROTA) is poorly defined. Using the British Cardiovascular Intervention Society PCI database, temporal changes and contemporary associates/outcomes of access site choice for PCI-ROTA were studied.

    Methods And Results: Data were analysed from 11,444 PCI-ROTA procedures performed in England and Wales between 2007 and 2014. Read More

    Prognostic value of viral eradication for major adverse cardiovascular events in hepatitis C cirrhotic patients.
    Am Heart J 2018 Apr 7;198:4-17. Epub 2017 Nov 7.
    AP-HP, Hôpital Henri Mondor, Unité de Recherche Clinique (URC-Mondor), and Université Paris-Est, A-TVB DHU, CEpiA (Clinical Epidemiology and Aging) Unit EA4393, UPEC, Créteil.
    Background: The objective was to examine the role of a sustained virological response (SVR) on major adverse cardiovascular events (MACEs) in patients with compensated hepatitis C virus (HCV) cirrhosis.

    Methods: Patients with the following criteria were enrolled in 35 French centers: (1) biopsy-proven HCV cirrhosis; (2) Child-Pugh A; (3) positive viremia; and (4) no prior liver complication, and then prospectively followed. All patients received HCV treatment after inclusion. Read More

    Changes in glomerular filtration rate and outcomes in patients with atrial fibrillation.
    Am Heart J 2018 Apr 30;198:39-45. Epub 2017 Dec 30.
    University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Birmingham B187QH, UK. Electronic address:
    Background: Patients with kidney disease are more likely to develop atrial fibrillation (AF) than individuals with normal renal function, and more likely to suffer ischemic stroke (IS)/thromboembolism (TE). We investigated the relationship of kidney function evolution to IS/TE, mortality and bleeding in AF patients.

    Methods: In a cohort of 8962 AF patients, 2653 had serum creatinine data, with 10894 patient-years of follow-up. Read More

    Preoperative factors associated with worsening in health-related quality of life following coronary artery bypass grafting in the Randomized On/Off Bypass (ROOBY) trial.
    Am Heart J 2018 Apr 24;198:33-38. Epub 2017 Dec 24.
    Northport VA Medical Center, Northport, NY; Eastern Colorado Health Care System, Denver VA Medical Center, Denver, CO. Electronic address:
    For advanced coronary disease, coronary artery bypass graft (CABG) surgery generally improves patients' symptoms and long-term survival. Unfortunately, some patients experience worse health-related quality of life (HRQL) after CABG. The objective of this study is to report the frequency and risk factors associated with 1-year post-CABG HRQL deterioration. Read More

    Bioresorbable Polymer-Coated Orsiro Versus Durable Polymer-Coated Resolute Onyx Stents (BIONYX): Rationale and design of the randomized TWENTE IV multicenter trial.
    Am Heart J 2018 Apr 21;198:25-32. Epub 2017 Dec 21.
    Thoraxcentrum Twente, Department of Cardiology, MST, Enschede, the Netherlands; Department Health Technology and Services Research, MIRA-Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, the Netherlands. Electronic address:
    Aim: The aim was to compare in a noninferiority trial the efficacy and safety of 2 contemporary drug-eluting stents (DESs): a novel, durable polymer-coated stent versus an established bioabsorbable polymer-coated stent.

    Methods And Results: The BIONYX trial ( Read More

    Factors of health in the protection against death and cardiovascular disease among adults with subclinical atherosclerosis.
    Am Heart J 2018 Apr 11;198:180-188. Epub 2017 Nov 11.
    Ciccarone Center for the Prevention of Heart Disease, Johns Hopkins University School of Medicine, Baltimore, MD. Electronic address:
    Background: Although cardiovascular disease (CVD) prevention traditionally emphasizes risk factor control, recent evidence also supports the promotion of "health factors" associated with cardiovascular wellness. However, whether such health factors exist among adults with advanced subclinical atherosclerosis is unknown. We aimed to study the association between health factors and events among persons with elevated coronary artery calcium (CAC). Read More

    Improving patient risk communication: Translating cardiovascular risk into standardized risk percentiles.
    Am Heart J 2018 Apr 7;198:18-24. Epub 2017 Dec 7.
    Duke Clinical Research Institute, Durham, NC.
    Background: Current cholesterol guidelines recommend using 10-year risk of atherosclerotic cardiovascular disease (ASCVD) to guide informed decisions regarding statin therapy, yet patients may have difficulty conceptualizing absolute risk estimates. Peer comparisons may provide an improved tool for patient risk comprehension.

    Methods: Using data from the 2009-2014 National Health and Nutrition Examination Survey (NHANES), we estimated standardized risk percentiles for various age-, sex-, and race-specific subgroups based on their 10-year ASCVD risks using the Pooled Cohort Equations. Read More

    Health promotion: A step beyond prevention in cardiology.
    Am Heart J 2018 Apr 2;198:178-179. Epub 2017 Dec 2.
    Preventive Medicine Center Hospital Israelita Albert Einstein & School of Medicine, Faculdade Israelita de Ciência da Saúde Albert Einstein, Sao Paulo, Brazil; Center for Clinical and Epidemiological Research, University Hospital & Sao Paulo State Cancer Institute, University of Sao Paulo, Sao Paulo, Brazil; Diagnósticos da América (DASA), Sao Paulo, Brazil. Electronic address:

    Efficacy and safety of dabigatran compared with warfarin in patients with atrial fibrillation in relation to renal function over time-A RE-LY trial analysis.
    Am Heart J 2018 Apr 5;198:169-177. Epub 2018 Jan 5.
    Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden; Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.

    Changes in renal function in patients with atrial fibrillation: Efficacy and safety of the non-vitamin K antagonist oral anticoagulants.
    Am Heart J 2018 Apr 4;198:166-168. Epub 2018 Jan 4.
    Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom; Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. Electronic address:

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